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                                 Primary Care Reports

                                     April 1, 2007

Smoking Cessation - A Practical Guide for the Primary Care Physi-
cian.
SECTION: ISSN: 1040-2497

LENGTH: 8904 words

 Smoking Cessation—A Practical Guide for the Primary Care Physician
   Author: Gregory R. Wise, MD, FACP, CPE, CPHQ, Associate Professor of Medicine,
Wright State University School of Medicine, Medical Director, Kettering Medical
Center Tobacco Treatment Center, Dayton, OH
   Peer Reviewer: Tammy Sims, MD, MS, Assistant Professor of Pediatrics and Center
for Tobacco Research an Intervention, University of Wisconsin School of Medicine
and Public Health, Madison.

  Issue Editor: Robert B. Taylor, MD, Professor Emeritus, Departmentof Family
Medicine, Oregon Health Sciences University School of Medicine, Portland.
   "Yes, we agree that smoking cigarettes, including our brands, causes lung cancer
and other serious diseases in smokers." —Thomas Dubois, Corporate Affairs,
Philip Morris Australia, 20021
   The escalating consumption of tobacco products is creating an unprecedented
worldwide pandemic that in the 21st century will result in 1        billion deaths
worldwide. No other disease or condition comes even close to the horrific personal,
economic, and health consequences of nicotine addiction. Tobacco companies produce
5.5 trillion cigarettesper year—nearly 900 cigarettes per year for every man,
woman and child in the world!2 In the United States, the primary care physician is
often the first line of clinical contact in identifying tobacco        dependence,
assessing willingness to quit, and providing effective smoking-cessation support
and treatment. The primary care physician can also serve as a catalyst for political
change."
   This issue will address the practical aspects of smoking cessationintervention
and will provide useful references to web-based resources to help both the patient
and the physician.
   —The Editor
   The Challenge
   Many primary care physicians over the years have become jaded and skeptical of
the success of tobacco cessation interventions. The perceived reasons are legion:
patients may not be motivated to quit, patients may be more concerned about their
other medical issues, treatment      modalities have not been viewed as affordable
or effective, and thehigh recidivism can be demoralizing for both the patient and
physician. A survey of more than 3000 U.S. family physicians, internists, OB/GYNs,
and psychiatrists was sponsored by the American Legacy Foundation and conducted by
the American Association of Medical Colleges.3 The September 2006 report concluded
that "many physicians lacked knowledge about smoking cessation services and often
failed to offer enough     encouragement or moral support to patients attempting to
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Smoking Cessation - A Practical Guide for the Primary Care Physician. Primary Care Reports April 1, 2007


quit."
   Despite this report, in recent years several factors have developed      that make
tobacco cessation efforts a more practical option than inthe past. More than a dozen
states in the United States now have clean indoor air ordinances. Washington, D.C.
went smokefree on January 1, 2007. This U.S. momentum is being paralleled by an
international movement as entire countries such as Ireland, Spain, Uruguay, England
and France are either now smokefree or have identified smokefree dates         in the
near future. In regions where the enacting of smokefree ordinances has been
accomplished, both adult and youth smoking rates haveconsistently declined. Another
propitious factor has been the introduction in 2006 of a new pharmacologic treatment
for smoking cessation.      Since the majority of smokers want to quit, the primary
care physician now has the background of scientific evidence showing the benefits
of cessation, the support of national and state "quit lines," increasingly effective
modalities of treatment, expanding insurance coverage of pharmacologic agents, and
a growing public intolerance to second-hand smoke—all leading to a cor-
responding increased interest in and motivation for cessation. Assisting a patient
in smoking cessation is arguably the most important intervention a physician can
makefor the patient's long-term health. The physician should be encouraged by the
fact that for the first time in U.S. history more Americanstoday are former smokers
than current smokers.
   Epidemiology
   Tobacco use remains the leading cause of premature death in the United States,
contributing to 444,000 deaths annually or 1 in 5 of alldeaths.4 Globally the leading
causes of death from smoking are cardiovascular disease (1.69 million deaths),
cancer (1.4 million deaths),and chronic obstructive pulmonary disease (0.9 million
deaths.5 Smoking is responsible for 25-30% of all cases of cancer and approximately
168,000 cancer deaths annually in the United States.6 Tobacco use has been associated
with the following malignancies: lung, mouth and pharynx, esophagus, stomach,
pancreas, bladder, kidney, breast, cervix,        and possibly acute myelogenous
leukemia. In regard to lung cancer, tobacco is linked to 90% of cases in males and
78% in females.7 Besides cancer, tobacco use and second-hand smoke have been
associated with     a host of diseases including heart disease, chronic obstructive
lung    disease, acute respiratory distress syndrome, stroke, venous throm-
boembolism, low bone density, gastroesophageal reflux, miscarriage, and        sudden
infant death syndrome. Approximately 21% of American adults (44.5 million in-
dividuals) and 22% of American high school students (3.75 million individuals)
smoke.4 Although tobacco consumption has declined from 14 pounds per year in the
1950s to about 5 pounds per year     in 2000, it is unlikely that the United States
will achieve its Healthy People 2010 objective of reducing smoking prevalence to
12% or less in adults and 16% or less in youth.4
   Secondhand Smoking
   In June 2006, the Department of Health and Human Services published          a
comprehensive report entitled "The Health Consequences of Involuntary Exposure to
Tobacco Smoke: A Report of the Surgeon General" (canbe downloaded at
http://www.cdc.gov/tobacco
).8 This report updates the health effects of secondhand smoke that result in
approximately 50,000 deaths annually in the United States in adults and children
who are nonsmokers. Additionally many thousands more suffer morbidity from
secondhand smoke, including exacerbations of asthma, respiratory conditions,
coronary heart disease, middle ear effusions, etc. The results of this comprehensive
report may be influential with smoking patients to induce them to either stop smoking
or be more considerate andcircumspect in regard to the effect of their secondhand
smoke on their families and friends. The report may also be influential with
policymakers to convince them to support comprehensive clean indoor air legislation.
   Benefits of Cessation
   Table 1 highlights the benefits of smoking cessation as identifiedby the U.S.
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Surgeon General.9 In addition to these health benefits, there are significant
financial implications. Smokers who quit can save as much as $2,500 per year.10 In
doing the math, a 40-year-old pack-a-day smoker who quits and puts the savings into
a 401(k) retirement     fund earning 9% a year will have $250,000 by age 70.11 For
society in general, smoking results in productivity losses of $92 billion annually
and an additional $75.5 billion in medical expenditures.12 On average, smoking
reduces a person's life expectancy by 14 years.        Table 1. Benefits of Smoking
Cessation
   *People who quit regardless of age live longer than people who continue to smoke.
   *Smokers who quit before the age of 50 reduce their risk of dying in half within
the next 15 years, compared to those who continue to smoke.
   *Quitting smoking substantially decreases the risk of lung, laryngeal, eso-
phageal, oral, pancreatic, bladder, and cervical cancers.
   *Quitting lowers the risk for other major diseases, including heart         disease
and stroke.
   Office Interactions
   Primary care physicians are in an ideal position to facilitate theidentification
of smokers and to initiate treatment. Those physicians     who see children and youth
are best positioned to provide true preventive medicine as most adult smokers who
smoke daily began smoking prior to the age of 18. Among daily adult smokers, 90%
tried their first cigarette and 70% were daily users at or before the age of 18.13
Genetics and parental influence play a significant role in smoking initiation in
children. As the role of peer pressure and the increased sensitivity of the brain
receptors play a stronger role in kids, the physician will need to send a strong
message to younger patients in terms that they will hopefully understand and act
upon. Kids often feelimmortal and theoretical risks of future cancer and heart
disease are     not as influential as the real short-term or visible consequences
of    smoking such as the out-of-pocket cost and clothes that smell of smoke, as
well as perhaps the awareness that they are being duped by seductive advertising
to fuel the profit lusts of "Big Tobacco." In theUnited States, about 60% of current
smokers in middle school and high     school report one or more quit attempts in the
year before being surveyed.14 Unfortunately the U.S. Preventive Services Task Force
2003 Recommendations find limited evidence supporting the effectiveness ofscreening
and counseling of children and adolescents in either preventing initiation or
promoting cessation of tobacco use. This limited evidence is due to a lack of clinical
studies and not due to researchshowing strategies to be ineffective. (For more
information, visit
www.ahrq.gov/clinic/uspstf/uspstbac.htm
.)
   Nicotine addiction should be viewed as a chronic, relapsing disease. Most adult
smokers have considered stopping and most have made at least one attempt to do so.
A recent survey has shown that 53% of smokers in the United States tried to quit
in the preceding year.13 Seventy percent of smokers visit a physician each year.15
The first step is for the primary care physician to consistently and diligently
identify tobacco users. The Joint Commission defines tobacco use as anyone         who
has smoked within the past 12 months. These patients are at higher risk due to the
recidivism known in this time frame. Some physicians may find it easier and perhaps
less threatening to patients if the       office nurse does the initial personal
history intake of smoking history. When multiple personnel (i.e., medical assistant,
nurse, doctor) inquire about tobacco use, it sends a strong message about the
importance of tobacco use and cessation to the health of patients. Of course, the
physician should personally follow up with more detailed questions regarding type,
duration, and amount of use as well as clearly       communicating to the patient
encouragement to quit.
   Seventy percent of current smokers want to quit, however, fewer than 7% of smokers
who attempt to quit remain smoke-free after one year.16 The average smoker will try
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to quit 6-9 times in a lifetime.17 Mark Twain said, "Giving up smoking is the easiest
thing in the world. I      know because I've done it thousands of times." Our job as
primary care physicians is to improve on those odds.
   Non-pharmacologic Treatment Options
   Counseling. In the office setting, the recommended approach is to utilize the
5 As or the perhaps more expedient 3 As and R. (See Tables        2 and 3.) Simply ask
all patients if they smoke. Even if a patient has quit within the past 12 months,
he or she is at increased risk for     relapse, and the physician should inquire about
potential triggers during the visit. If the patient currently smokes, the next key
component is simply advising the patient to stop smoking. Most patients have thought
about quitting or have made efforts in the past. Patients should not be surprised
that their doctor would advise them to quit. Although it is probably prudent not
to badger patients at every visit,        it is important that every visit be an
opportunity for the physician       or his staff to assess the patient's willingness
to quit. This approach can be done in a non-threatening manner, but the patient should
be reminded that the doctor is still willing to assist if the patientis ready. If
the patient is at a point of contemplation, then the physician should clearly outline
that he or she is available to assist the patient in smoking cessation and arrange
follow-up. The Legacy Foundation survey reported that surveyed physicians spend 2-10
minutes of an office visit dealing with smoking cessation.3 If that is the only amount
of time available to a physician, the best practice might be      to refer the patient
to appropriate community resources such as telephone quit lines or a tobacco
treatment center.
          Table 2. The U.S. Public Health service Clinical Practice Guideline: 5-Step
Brief Intervention for Smoking Cessation
   Table 3. The 3 As and R                               Ask        Systematically ask
smoking status of all patients at every visit.                 Advise
        Strongly advise all tobacco users to quit.                        Assess
        Assess the patient's willingness to make a quit attempt.
               Refer        Refer the patient to effective smoking cessation re-
sources.
   A systematic review of 17 clinical trials providing episodes of advice and
encouragement from a physician increased the rate of smokingcessation from 2-5% over
a 6-month period.18 Most primary care physicians are quite busy with their practices,
which often do not have staff trained or equipped to deal with intensive counseling
or non-pharmacologic intervention such as behavior modification. The physicians
should not feel guilty if their practices cannot provide that support.        However,
they are obligated to know what effective community resources are available to help
their patients. Unfortunately, non profit agencies such as the American Lung
Association and the American CancerSociety do not have sufficient staff or local
resources or programming to provide adequate support. Health maintenance or-
ganizations (despite their name) often do not provide group counseling programs or
even cover smoking cessation products in their formularies. Local hospitals usually
support community wellness programs, but their effectiveness is spotty as wellness
is not usually their core competence. Manystates are now offering telephone quit
lines and even regional tobacco treatment centers. Typically funded by the tobacco
settlement law suit money, these resources (if they haven't been squandered or
otherwise reappropriated by state legislatures) are designed to provide effective
and comprehensive smoking cessation counseling and pharmacologic treatment options.
   Nature of Nicotine Addiction
   Nicotinic receptors are found throughout the central nervous system. These
receptors facilitate the release of multiple neurotransmitters including ace-
tylcholine, norepinephrine, dopamine, serotonin, and beta-endorphins.19 Nicotine
is a powerful physiological and psychoactive substance that activates the brain
reward system by increasing dopamine release. The brain release mechanism is the
final common pathway responsible for many pleasurable experiences, such as sexual
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activity, eating, and the limbic effects of addictive drugs such as cocaine.
   Arterial levels of nicotine are present within 15 seconds of smoking a cigarette,
and this rapid absorption is responsible for the nearly immediate gratification
found by smokers. Nicotine competitively binds at nicotinic acetylcholine receptors
and causes a prolonged activation of these receptors.20 Chronic use of nicotine leads
to a desensitized state in which the receptors become unresponsive to agonists and
the user experiences diminished pleasure, requiring increasing levels of nicotine
to achieve the desired effect.
   Nicotine withdrawal symptoms have been well identified and consisttypically of
several of the following: irritability, craving, insomnia, headache, anxiety,
depression, and impaired concentration.21 Nicotine replacement agents mimic the
effect of nicotine on the nicotinicreceptors but do not duplicate the rapid response
associated with smoking a cigarette. Replacement agents, however, do provide a safer
alternative to combat the nicotine withdrawal symptoms without the other
unpleasant health consequences of smoking such as cancer and heart disease. Because
these agents have a slower release resulting in lower        blood levels, there is a
lower likelihood of addiction.
   The combination of cognitive-behavioral therapy and nicotine replacement therapy
has been found to be effective and safe in adolescent smokers 13-17 years of age.22
   Pharmacologic Treatment Options
   A recent review suggests that the best hope of improved treatment outcomes results
from combining existing and new pharmacotherapies with effective behavioral
therapy.23 Currently there are three categories of FDA-approved smoking cessation
pharmacological agents: nicotinereplacement products, the antidepressant drug
bupropion, and the alpha4beta2 receptor nicotinic acetylcholine partial agonist
varenicline(Chantix). Because there is already wide experience with the first two
categories, most of the current discussion will focus on the newest          agent
varenicline and its appropriate use in the primary care setting. Table 4 provides
a summary of the key comparisons between the available therapies.
   Nicotine Replacement Products. Nicotine replacement therapy (NRT) has been the
backbone of smoking cessation efforts. The delivery systems come in the forms of
chewing gum, skin patch, nasal spray, oral inhaler, and lozenge. None of these agents
delivers nicotine as rapidly      as smoking, but they do produce nicotine levels that
have been found      to be helpful in dulling the nicotine withdrawal symptoms.
Because of their wide availability, relatively low cost compared to prescription
agents, and low incidence of side-effects, they are often the first line of treatment
option. The disadvantages are their modest success rates and the fact that many
smokers who come to a physician's office may have already tried these agents and
failed and would be understandably reluctant to retry. In this scenario, altering
the deliverymethod from their previous attempt may be an effective strategy.
   Bupropion. The use of antidepressants as aids to smoking cessationhas been
studied, and their expected efficacy seems reasonable. Nicotine may act as an
antidepressant, and some smokers become depressed after quitting because quitting
unmasks underlying depressive symptoms        that already existed.
   Although other antidepressants may have efficacy, the sustained-release
formulation of bupropion is the only antidepressant approved bythe FDA for tobacco
use cessation. Bupropion is a relatively weak inhibitor of neuronal uptake of
norepinephrine and dopamine, but the mechanism of bupropion's action in enhancing
the ability of patients toabstain from smoking is unknown. Bupropion SR (Zyban)
appears to work     along dopaminergic and noradrenergic pathways to blunt the reward
associated with nicotine. Bupropion requires a prescription and has a small but real
risk of seizures.
   Hurt et al studied 612 subjects who were enrolled in four treatment          groups
(one placebo, and three with varying doses of bupropion) over          a course of 7
weeks.24 The abstinence rate at the end of 12 months was 12.4% for the placebo group
and 23.1% for the group who had takenbupropion 150 mg bid during the treatment phase.
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Although there was a     modest weight gain during the treatment phase (in both active
and placebo groups), by six months there was no significant difference among the
groups for the 59 subjects who remained continuously abstinent.          The authors
speculated that the efficacy of bupropion may be due toits effect on adrenergic and
dopaminergic mechanisms in the brain, rather than on its antidepressant properties.
Not all studies, however,       demonstrate efficacy. A recent study done in a
relatively resistantVeterans Hospital patient population showed no superiority of
a brief     7-week course of bupropion over placebo in quit rates at 1 year.25 On
the other hand, a rather large study done in a large health care system involving
over 1500 patients in which the use of bupropion SR along with mild or moderate
counseling resulted in 1-year quit rates of      23.6% to 33.2%.26 Effectiveness will
obviously vary depending upon the populations studied.
   Bupropion comes as a tablet and a sustained-release or extended-release
(long-acting) tablet. The regular tablet (Wellbutrin) is usually        taken three or
four times per day, with doses at least 6 hours apart. The sustained-release tablet
(Wellbutrin SR, Zyban) is usually taken twice per day, with doses at least 8 hours
apart. The extended-release tablet (Wellbutrin XL) is usually taken once daily in
the morning. The use of these formulations is FDA-approved only for major depression
and seasonal affective disorders. It is important to remember that only bupropion
SR (Zyban) is approved by the FDA for smoking cessation; this formulation is not
FDA-approved to treat depression.
   Bupropion SR typically is administered while the patient is still smoking as it
takes about one week to reach steady state blood levels.       The recommended dosage
is one 150 mg pill once a day for the first 3        days. After that, the dosage is
increased to one 150 mg pill twice a      day, taken 8 hours apart. As bupropion can
have a side effect of insomnia, the last dose of the day might be best taken several
hours before bedtime. The patient usually is advised to stop smoking after 5-7
days of treatment. Bupropion SR usually is recommended to be taken for 7-12 weeks.
If the patient is not successful in quitting by the seventh week, it is unlikely
that the patient will quit during this attempt at smoking cessation, and treatment
with bupropion should be suspended. Conversely, patients who are successful in
quitting should be     considered for ongoing therapy. Tapering the dose of bupropion
is not necessary when treatment is discontinued. Bupropion is contraindicated in
patients with seizure disorders, eating disorders, and those who use monoamine
oxidase (MAO) inhibitors. Hypertension requiring treatment has been reported in
clinical trials in patients taking bupropion SR, and blood pressure should be
monitored.27 As bupropion is a category B drug for pregnancy, it should be considered
only if behavioral interventions are unsuccessful.
   Varenicline. The newest agent, varenicline (Chantix), received FDAapproval in
May 2006 via the fast-track review process because of the       promise it offered in
association with a high level of clinical evidence and low risk of serious
side-effects. To date, varenicline arguably has demonstrated the highest level of
smoking cessation effectiveness of the currently available FDA-approved agents.
   The safety and efficacy of varenicline has been demonstrated in three large,
randomized, controlled trials.28-30 The findings from these       studies showed that
varenicline was four times as effective as placebo and twice as effective as
bupropion in smoking cessation.
   Mechanism of Action and Pharmacokinetics. Varenicline binds with high affinity
and selectivity to alpha4beta2 neuronal acetylcholine receptors. It is believed that
varenicline acts as a weak agonist and blocks nicotine's ability to activate
alpha4beta2 receptors and thus to       stimulate the central nervous mesolimbic
dopamine system. This system is thought to provide the underlying reinforcement and
reward experienced upon smoking. Varenicline has maximal plasma concentrations
within 3-4 hours after administration, and steady-state concentrationsare achieved
within 4 days.31 It bioavailability is unaffected by food or time of day. Va-
renicline's half-life is approximately 24 hours and is principally eliminated
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unchanged in the urine. There are no known pharmacokinetic factors related to age,
race, gender, smoking status, or the use of concomitant medications.
   Dosage. Varenicline is provided in tablets of 0.5 mg and 1 mg. Dosing should be
reduced in the presence of severe renal impairment. It is recommended that the
patient set a quit date and start vareniclineone week before this date in the
following dosage schedule:
   Days 1-3:                            0.5 mg once daily after eating
   Days 4-7:                            0.5 mg twice daily after eating
   Day 8 – End of treatment      1 mg twice daily after eating
   Varenicline should be taken after eating and with a full glass of water. The
recommended course of treatment is 12 weeks although an additional course of 12 weeks
of treatment can be given at the end of the first 12 weeks to further increase the
likelihood of long-term abstinence. Varenicline is supplied in a starting pack,
continuing pack and bottles of 56 tablets.
   How supplied        Description
   Packs                  First month of therapy:
   (Pack includes 1 card – 0.5 mg x 11 tablets and 3 cards – 1 mg x 14
tablets)
   Continuing months of therapy:
   Pack                     (includes      4 cards – 1 mg x 14 tablets)
   Bottles                  0.5 mg – bottle of 56
   1 mg – bottle of 56
   Clinical Outcomes. A randomized, double-blind, parallel-group, placebo- and
active-treatment-controlled clinical trial was conducted at19 U.S. centers.28 One
thousand twenty-five smokers were assigned ina 1:1:1 ratio to receive brief
counseling and varenicline 1 mg bid, bupropion SR 150 mg bid, or placebo. The primary
outcome was continuous 4-week abstinence measured for weeks 9 through 12 using
exhaled carbon monoxide monitoring. Varenicline (44.0%) demonstrated statistically
significant superior abstinence rates over both placebo (17.7%) and bupropion SR
(29.5%) for weeks 9 through 12. Abstinence rates did decline when measured for weeks
9 through 52: 21.9% for varenicline vs. 8.4% for placebo vs. 16.1% for bupropion
SR. Participants reportedthat varenicline reduced craving and withdrawal symptoms,
and for those who smoked while receiving the study drug, varenicline reduced smoking
satisfaction. The most common side effects were nausea (28.1% for those receiving
varenicline) and insomnia (21.9% for those receiving varenicline). Varenicline was
found to be safe and well tolerated,with study drug discontinuation similar to those
for placebo.
   Jorenby et al studied 1413 subjects in a double-blind, placebo-controlled trial
at 14 research centers.29 Subjects were randomized to varenicline titrated to 1 mg
twice daily or bupropion SR titrated to 150 mg twice daily or placebo for 12 weeks,
plus weekly brief smoking cessation counseling. During the last four weeks of
treatment, 43.9% of participants on varenicline were continuously abstinent
compared with 17.6% in the placebo group and 29.8% in the bupropion SR group. The
superiority of varenicline was statistically significant compared to the other two
groups. Treatment was discontinued in approximately 10.5% for varenicline, 12.6%
in the bupropion SR group, and 7.3% in the placebo group. The most common side effect
with varenicline was nausea, occurring in 29.4% of participants. Despite the nausea,
subjects     in the varenicline group gained an average of 2.29 kg compared to 1.52
kg in the placebo group and 1.32 kg in the bupropion group.
   Tonstad et al conducted a randomized controlled trial involving 1927 cigarette
smokers at multiple clinics in 7 countries to study the effect of maintenance therapy
with varenicline.30 One thousand two-hundred ten subjects (62.8%) were randomized
to additional treatment with varenicline or placebo. In an open-label 12-week study,
64.1% of varenicline-treated subjects were abstinent. In smokers who achieved
abstinence for at least 7 days at the end of the 12-week open-label course of
varenicline and who continued on varenicline for an additional         12 weeks,
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varenicline showed superiority over placebo in abstinencerates. This advantage was
maintained through the non-treatment follow-up to week 52. Carbon monox-
ide-confirmed continuous abstinence rateat 52 weeks was 43.6% with varenicline
compared to 36.9% with placebo. Varenicline was well tolerated, effective, and safe.
   During the open-label phase, adverse events led to treatment discontinuation in
11.9% of participants. About one-fourth of those participants who discontinued did
so due to nausea. The median onset to nausea was 8 days and the median duration was
20 days. The incidence of adverse events during the double-blind phase was similar
between the varenicline and placebo groups (46% and 45%, respectively).
   Adverse Reactions. In the pre-marketing experience with varenicline     with more
than 4500 subjects, the most common adverse reactions (occurring at rates greater
than 5% or twice the rate in placebo-treatedpatients) were nausea, sleep dis-
turbance, constipation, flatulence, and vomiting.31 For patients taking the maximum
recommended dose of 1mg bid, the incidence of nausea was 30% compared to 10% in
patients taking placebo. For patients taking 0.5 mg bid following initial titration,
the incidence of nausea was 16% compared to 11% for placebo. For most patients the
nausea was mild to moderate and often transient.
   Ongoing Support. The manufacturer of varenicline supplies a free "get ad-
vice-encouragement-support" program that offers daily activities        to manage
smoking triggers, gives personalized reports to help track        progress, and
provides a Cravings Hotline (1-877-CHANTIX or 1-877-242-6849 or
www.chantix.com
) for those patients having the urge to smoke. Pfizer has also set up a web site
that can be used by smokers to help in the cessation process:

www.mytimetoquit.com
.
   A recent study conducted by the Department of Clinical Epidemiology         and
Biostatistics at McMaster University reviewed the effectivenessof various
pharmacological interventions through a systematic reviewof the literature and
meta-analysis.32 Although varenicline seemed to       be the most promising agent,
Klesges et al address concerns that varenicline's purported greater effectiveness
in controlled clinical trials will carry over into the real world of medical
practice.33
   Special Populations
   Hospitalized Patients. A recent National Institutes of Health conference
conducted a systematic review of the literature regarding smoking cessation
strategies for adults and special populations.34 The review was limited to those
studies with six months or greater of follow-up period and minimal sample sizes of
30 patients for randomized, controlled trials and 100 patients for experimental or
observational studies. Extrapolation to current practices is tempered by the common
limitations to these types of review include varying sample techniques, high refusal
or attrition rates, high rates of nonadherence, and lack of consistent adverse event
reporting.
   Three hospital-based interventional studies were conducted to assess if smoking
cessation modalities were effective in the following populations: women admitted
to hospital with cardiovascular or peripheral vascular disease; smokers with
diabetes; and patients admitted foracute myocardial infarction, unstable angina,
or care following coronary artery bypass surgery. All the interventions included
nurse counseling, self-help materials, and follow-up contact and were compared to
brief advice to quit smoking or related self-help materials. Thesestudies failed
to show effective cessation rates in patients hospitalized with tobacco-related
clinical diagnoses.
   Pregnancy. A study randomly assigning pregnant women and their partners to one
of three non-pharmacological interventions showed no significant differences in
abstinence rates at any follow-up point between the groups.35 In late pregnancy,
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more partners were abstinent (15%)       compared to 5% in the usual care group (p =
0.02). Previous reviews,      however, showed that active counseling interventions
did result in significant reduction in continued smoking in late pregnancy.36,37
   Heart Disease Patients. Smoking cessation reduces the risk of cardiovascular
events, and it would be expected that an exceptionally motivated group of patients
would be those admitted to the hospital for myocardial infarction or unstable angina.
However, a recent study using a 12-week course of bupropion SR in patients
hospitalized for acute      cardiovascular disease did not show long-term smoking
cessation efficacy over intensive counseling.38
   Relapsing Patients. It is well known that nicotine addiction creates a high
likelihood for relapse after successful cessation attempts.What is not known is how
best to treat these relapsing patients. An interesting study was recently completed
in the U.S. Veterans Administration system involving patients who had been
prescribed smoking cessation pharmacological therapy in 2002 with either nicotine
replacement therapy or bupropion.39 One thousand nine hundred veterans were
randomized to one of two groups: one group received a phone call to assess smoking
status, quit challenges, and treatment preferences as well         as a computerized
progress note sent to providers communicating this        intervention information
while the other group received usual care.The outcomes were studied in 2003. The
intervention significantly increased repeat treatment rates and satisfaction with
services but didnot have a significant effect on abstinence rates. A subsequent
analysis of this study showed that almost two-thirds of relapsed smokers were
interested in recycling intervention within 30 days with the majority desiring both
behavioral and pharmacologic treatment.40 In multivariate analyses, independent
predictors of interest in recycling within 30 days included black race, lower smoking
level, and greater number of smoking-related health problems.
   Table 5 is a list of web sites that can be a practical adjunct andresource for
physicians and patients. Table 6 gives a summary of expected success rates among
the various treatment options.            Table     6. Comparison of the Various
Pharmacological Interventions
   Advocacy Efforts
   Assisting patients to stop smoking typically is a laborious one-on-one endeavor.
For a wider and more powerful impact, advocacy approaches promise greater scope and
effectiveness. There are several ways that concerned physicians can participate in
advocacy issues: fostering       local and state-wide smokefree initiatives, pro-
moting raising taxeson tobacco products, encouraging health plans and employers to
provide coverage for smoking cessation aids, and lobbying legislators to protect
kids and adults from tobacco industry advertising and promotion.
   Smokefree Initiatives. Secondhand smoke (along with radon and asbestos) has been
classified as a Class A carcinogen by the OccupationalSafety and Health Admin-
istration. The elderly and youth are particularly affected by secondhand smoke.
Children exposed to secondhand smoke have increased rates of respiratory disease,
middle ear disease, reduced levels of HDL-C, sudden infant death syndrome, and
cancer.41 Currently 15 states have smokefree ordinances or laws that restrict
smoking in workplaces. (For current list, see Americans for Nonsmokers'Rights web
site:
www.no
-smoke.org.) Ireland in 2004 became the firstcountry to pass a national workplace
smoking ban. Effective January 1, 2007, the District of Columbia initiated a smoking
ban in force throughout the city's bars and restaurants. Upon taking office as the
Speaker of the House in January 2007, Nancy Pelosi officially banned smoking in the
Speaker's Lobby. Nancy Pelosi said, "The days of smoke-filled rooms in the United
States Capitol are over. Medical science has unquestionably established the
dangerous effects of secondhand smoke, including an increased risk of cancer and
respiratory diseases. Iam a firm believer that Congress should lead by example."42
Creationof smokefree workplaces not only decreases the health risks of involuntary
                                                                                                 Page 10
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smoking but also leads to a higher rate of smoking cessation among active smokers.43
    Should not primary care physicians also lead by example by being vocal and
politically active to promote smokefree ordinances that savelives and reduce the
economic cost of smoking?
    Treaty Ratification. The Framework Convention on Tobacco Control (FCTC) is a
legally biding treaty negotiated by the 192 members of theWorld Health Organization
(WHO). The final agreement, reached in May2003, would encourage countries to:
    *Enact comprehensive bans       on tobacco advertising, promotion and
sponsorship;
    *Obligate the placing of       rotating health warnings on tobacco products;
    *Ban the use of misleading       and deceptive terms such as 'light'and 'mild';
    *Protect citizens from secondhand        smoke;
    *Combat smuggling; and
    *Increase tobacco taxes.
    To date, 168 countries have signed the treaty. The United States signed the treaty
in May 2004 but U.S. law requires that all treaties be ratified by the Senate. The
treaty has not been brought to the Senate for debate. Each U.S. physician supportive
of this treaty has twosenators—encourage them to act. (For more information,
see
www.who.int/tobacco/framework/countrylist/en/index.html
.)
    Compliance Checks. Under the Synar Amendment, which was enacted inJuly 1992 as
part of the Alcohol, Drug Abuse, and Mental Health Administration Reorganization
Act, states must conduct compliance checks and enforce their minimum age-of-sale
laws or risk losing block grantfunds. All 50 states and the District of Columbia
prohibit the sale of tobacco products to minors—most commonly defined as
persons under the age of 18. Although these periodic compliance checks to insure
that businesses are not illegally selling tobacco products to minors may be
performed, unfortunately there are few to no consequences for such activity.
Physicians, however, can be advocates for these compliance checks to be sure they
are occurring and to promote appropriate media coverage of the results.
    Tobacco Taxes. Because price is more influential in minors than inadults,
increasing taxes on tobacco products has consistently been associated with decreased
tobacco use by minors.44 Only relatively recently have states sought significant
increases in tobacco taxes. Until      a few years ago Kentucky, which has one of the
highest rates of smoking, also had the lowest tobacco tax (3 cents per pack). More
than adozen states are considering higher tobacco taxes this year with thefunds
targeted to help millions of uninsured people to obtain healthinsurance.45 Since
2002, 42 states have increased tobacco taxes withan apparent overall corresponding
decline in tobacco sales of 15% since 2000 with a steeper fall of 27% in the 19 states
and the Districtof Columbia where cigarette taxes are $1 per pack or more. The
increase tax has pushed the average price for a pack of brand-name cigarettes to
$4.26, up from $1.96 a decade ago.
    Two legitimate uses of taxes are to raise revenue and to positively          or
negatively influence product consumption. Currently the states with lowest excise
taxes are South Carolina ($0.07), Missouri, Mississippi, and Tennessee. States with
the highest excise taxes are New Jersey ($2.58), Rhode Island, New York, and
Washington. Although tobaccocompanies will always attempt to counter with re-
tail-level discounting and consumer incentives, physicians should still apply their
political influence to appropriately adjust tobacco taxes with the intent to
decrease smoking rates in their own communities.
    FDA Regulation of Tobacco. In February 2007 a bipartisan Family Smoking
Prevention and Tobacco Control Act was simultaneously introduced          in the U.S.
Senate and House of Representatives.46 This legislationwill give the FDA the
authority to regulate tobacco products to keeptobacco manufacturers from enticing
young people to smoke and to assist current smokers in quitting. Senator Kennedy
                                                                                                 Page 11
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said, "Congress cannot in good conscience allow the federal agency most responsible
for protecting the public health to remain powerless to deal with the enormous risks
of tobacco, the most deadly of all consumer products. Health experts believe this
legislation is the most important action Congress could take to protect children
from this deadly addiction." Congressman Waxman said, "The days of Congress doing
the bidding of the tobacco industry are over. This long overdue legislation would
give FDA     broad powers to regulate tobacco products and protect public health."
Congressmen from Kentucky (the country's largest producer of burley           tobacco)
are, perhaps understandably, not as enthusiastic.47 It is rather ironic that the
FDA has jurisdiction over nicotine replacementproducts but not over tobacco products
themselves. Physicians supportive of this legislation will have an opportunity to
be politically vocal with their elected officials.
   Hope for the Future?
   Despite the behavioral modification and pharmacological approachescurrently
available, treatment of tobacco addiction will remain frustrating and difficult for
physicians and patients alike. True breakthrough developments, however, may not be
far off. Recent research has identified the insula, a structure the size of a silver
dollar, enclosed within the cerebral cortex as a region of the brain linked to emotion
and addiction. Research was sparked by the case of a 38-year-oldman who abruptly
quit his two-pack-a-day habit after suffering a stroke. He lost his urge to smoke
virtually overnight and even asked fora room change to get away from another patient
who smoked. This man had suffered an insular stroke. A study involving 69
brain-damaged patients showed 19 had affected insulas. Of those 19, 13 had stopped
smoking (12 of whom quit instantly with no lingering urges).48 These findings suggest
that patients with insular lesions have a greater likelihood of long-term smoking
cessation with no relapse and no subsequent urges to smoke. The potential for
pharmacological therapy targetedat the insula may have similar results if nicotine
addiction can be eliminated while preserving the insula's beneficial functions.
   A non-pharmacological approach known as transcranial magnetic stimulation (TMS)
may be adapted one day to help smokers quit. TMS involves sending a magnetic current
into one side of the brain causing a temporary lesion. At this time these lesions
are achievable only in peripheral brain tissue and it is unclear if technology can
be adapted to     cause deeper lesions where the insula is located. Eichhammer et
al treated 14 smokers with rTMS (repetitive transcranial magnetic stimulation) to
the left dorsolateral prefrontal cortex.49 Cigarette smoking         was significantly
reduced (p <.01) in an active stimulation compared         with sham stimulation.
   At the end of 2003, three companies were working on the development            of an
anti-nicotine vaccine Xenova (TA-NIC), Nabi (NicVAX), and Cytos (Nicotine-Qbeta).50
The vaccine induces antibodies against the nicotine molecule, intercepting the
nicotine en route to its specific receptors. The binding of the antibody to nicotine
in turn significantly      decreases the nicotine concentration in the brain shortly
after smoking. This approach, therefore, interrupts the link between smoking and
nicotine-related gratification.
   Clonidine and nortriptyline have modest efficacy but side-effects limit their
use and they are not FDA-approved. Naltrexone, alprazolam,         silver acetate, and
lobeline have been used but none has FDA approval for smoking cessation. However,
the use of naltrexone (25 mg daily)        in conjunction with nicotine replacement
therapy produced less weight gain compared with those not taking naltrexone, but
there was no change in the quit rate over NRT alone.51 A 100 mg daily dose did increase
6-week quit rates but nausea was a frequent side-effect. Other therapeutic drugs
that are under development include rimonabant, mecamylamine, monoamine oxidase
inhibitors, dopamine receptor D3 antagonists, and inhibitors of nicotine meta-
bolism.52 Of particular interest is      rimonabant, the first in a new class of drugs
called selective CB1 blockers.19 By inhibiting the CB1 receptors associated with
regulating     the body's intake of food, reduced dependence on tobacco may be lead
to curbing the associated weight-gain often found after smoking cessation.
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   Summary
   At present, physicians have a constellation of aligned stars&mdash;increased
public awareness of the dangers of smoking and second-handsmoke; legislative
momentum for greater regulation and taxation; national support for smoking cessation
including free telephone quit lines and governmental agencies such as the CDC for
physician and patient      education; a newer, safer, and more effective pharma-
cological treatment modality; and wider coverage by third-party payers for smoking
cessation products. Perhaps the only element missing is the resolve ofphysicians
to consistently implement the 3As and R and make a difference in their patients'
lives.
   References
   1. Mackey J, Eriksen M, Shafey O, eds. The Tobacco Atlas, Second Edition. American
Cancer Society; 2006: 21.
   2. Worldwatch Institute web site. "Cigarette Production Drops." July 7, 2006.
Available at
www.worldwatch.org/node/4320
.
   3. Butterfield S. ACP Observer. November 2006:6.
   4. National Institutes of Health State-of-the-Science conference statement:
Tobacco use: Prevention, cessation, and control. Ann InternMed 2006;145:839-844.
   5. Mackey J, Jemal A, Lee NC, et al, eds. The Cancer Atlas. American Cancer
Society, 2006: 30.
   6. Cancer Facts & Figures 2007. Atlanta: American Cancer Society; 2007.
   7. Surgeon General. The Health Consequences of Smoking: Surgeon General's 2004
Report. Department of Health and Human Services (DHSS). Public Health Service (PHS),
Center for Disease Control (CDC), Centrefor Chronic Disease Prevention and Health
Promotion, Office of Smoking and Health, DHSS Publication No (CDC) 099-7830, 2004.)
   8. U.S. Department of Health and Human Services. The Health Consequences of
Involuntary Exposure to Tobacco Smoke: A Report of the Surgeon Gener-
al&mdash;Executive Summary. U.S. Department of Health and Human Services, Centers
for Disease Control and Prevention, Coordinating        Center for Health Promotion,
National Center for Chronic Disease Prevention and Health Promotion, Office on
Smoking and Health, 2006.
   9. US Department of Health and Human Services. The Health Benefitsof Smoking
Cessation: A Report of the Surgeon General. Rockville, MD:         US Department of
Health and Human Services, Public Health Service, Centers for Disease Control,
Center for Chronic Disease Prevention and        Health Promotion. Office on Smoking
and Health; 1990.
   10. Singletary M. Smoking poses wealth hazards. The Miami Herald, February 25,
2007, p 3E
   11. Smith H. "The High Cost of Smoking." MSN Money Central web site. Available
at
www.moneycentral.msn.com/content/Insurance/Insureyourhealth/P100291.asp
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   12. Centers for Disease Control and Prevention. Annual Smoking-Attributable
Mortality, Years of Potential Life Lost and Productivity Losses &ndash; United
States, 1997-2001. MMWR Morb Mortal Wkly Rep.2005;54(25):625-628.
   13. Smoking Cessation. Clinical Practice Guideline Number 18. U.S.Department of
Health and Human Services, Public Health Service, Agency for Health Care Policy and
Research, Centers for Disease Control, AHCPR Publication No. 96-0892; 1996:7
   14. Centers for Disease Control and Prevention. Youth tobacco surveil-
lance&mdash;United States, 2000. Morb Mortal Wkly Rep 2001;50(SS-4):30.
   15. Ockene JK. Smoking intervention: the expanding role of the physician. Am J
Public Health 1987 Jul;77(7):782-3.
   16. Fiore MC, Bailey WC, Cohen SJ, et al. Clinical Practice Guideline: Treating
Tobacco use and Dependence, Rockville, MD: US Dept of Health and Human Services,
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Smoking Cessation - A Practical Guide for the Primary Care Physician. Primary Care Reports April 1, 2007


Public Health Service, 2000.
   17. National Institute on Drug Abuse. Research Report Series. Nicotine addiction.
NIH Publication No. 01-4342, Preprinted 2001.
   18. Law M, Tang JL. An analysis of the effectiveness of interventions intended
to help people stop smoking. Arch Intern Med 1995;155:1933-41.
   19. Sims TLH. Using pharmacotherapy to treat tobacco dependence inprimary care
settings. Primary Care Reports 2004:75-86.
   20. Watkins SS, Koob GF, Markou A. Nicotine Tob Res 2000 Feb;2(1):19-37.
   21. DiFranza JR, Wellman RJ. A sensitization-homeostasis model of nicotine
craving, withdrawal, and tolerance: Integrating the clinicaland basic science
literature. Nicotine Tob Res 2005 ;7(1):9-26.
   22. Moolchan ET, Robinson ML, Ernst M, et al. Safety and efficacy of the nicotine
patch and gum for the treatment of adolescent tobaccoaddiction. Pediatrics
2005;115:e407-14.
   23. Talwar A, Jain M, Vijayan VK. Pharmacotherapy of tobacco dependence. Med Clin
North Am 2004;88:1517-34.
   24. Hurt RD, Sachs DP, Glover ED, et al. A comparison of sustained-release
bupropion and placebo for smoking cessation. N Engl J Med 1997;337:1195-1202.
   25. Simon JA, Duncan C, Carmody TP, et al. Bupropion for smoking cessation: A
randomized trial. Arch Intern Med 2004;164:1797-803.
   26. Swan GE, McAfee T, Curry SJ, et al. Effectiveness of bupropionsustained
release for smoking cessation in a health care setting: A randomized trial. Arch
Intern Med 2003;163:2337-44.
   27. Laine C, Goldmann D, eds. In the clinic: Smoking cessation. Ann         Intern
Med 6 Feb 2007:ITC2-1-16.
   28. Gonzales D, Rennard SI, Nides M, et al., Varenicline Phase 3 Study Group.
Varenicline, an alpha4beta2 nicotinic acetylcholine receptor partial agonist, vs
sustained-release bupropion and placebo for smoking cessation: a randomized
controlled trial. JAMA 2006;296:47-55.
   29. Jorenby DE, Hays JT, Rigotti NA, et al. Efficacy of varenicline, an al-
pha4beta2 nicotinic acetylcholine receptor partial agonist, vs         placebo or
sustained-release bupropion for smoking cessation: A randomized controlled trial.
JAMA 2006 ;296:56-63.
   30. Tonstad S, Tonnesen P, Hajek P, et al, Varenicline Phase 3 Study Group. Effect
of maintenance therapy with varenicline on smoking cessation: a randomized
controlled trial. JAMA 2006;296:64-71.
   31. Chantix (varenicline) Tablets. Full Prescribing Information. Pfizer Labs.
LAB 0327-2.0, May 2006.
   32. Wu P, Wilson K, Dimoulas P, et al. Effectiveness of smoking cessation
therapies: a systematic review and meta-analysis. BMC Public Health. 2006;6:300.
   33. Klesges RC, Johnson KC, Somes G. Varenicline for smoking cessation: definite
promise, but no panacea. JAMA 2006;296:94-5.
   34. Ranney L, Melvin C, Lux L, et al. Systematic Review: Smoking cessation
intervention strategies for adults and adults in special populations. Ann Intern
Med 2006;145:845-856.
   35. McBride CM, Baucom DH, Peterson BL, et al. Prenatal and postpartum smoking
abstinence a partner-assisted approach. Am J Prev Med 2004;27:232-238.
   36. Lumley J, Oliver SS, Chamberlain C, et al. Interventions for promoting smoking
cessation during pregnancy. Cochrane Database Syst Rev 2004;CD001055.
   37. Melvin CL, Gaffney C. Treating nicotine use and dependence of pregnant and
parenting smokers: An update. Nicotine and Tobacco Research 2004;6S2:S107-S124.
   38. Rigotti NA, Thorndike AN, Regan S, et al. Bupropion for smokers          hos-
pitalized with acute cardiovascular disease. Am J Med 2006;119:1080-1087.
   39. Partin MR, An LC, Nelson DB, et al. Randomized trial of an intervention to
facilitate recycling for relapsed smokers. Am J Prev Med2006;31:293-299. Epub 2006
Aug 22.
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   40. Fu SS, Partin MR, Snyder A, et al. Promoting repeat tobacco dependence
treatment: are relapsed smokers interested? Am J Manag Care 2006;12:235-243.
   41. Gold MS, Wang DQ, Bruijnzeel AW. Implications of secondhand smoke in pediatric
and adult health. Primary Care Reports 2005:49-60.
   42. dcist.com web site. "Smoking Ban Extended to Congress." Available at
www.dcist.com/archives/2007/01/10/smoking_ban_ext.php
.
   43. Bauer JE, Hyland A, Li Q, et al. A longitudinal assessment of the impact of
smoke-free worksite policies on tobacco use. Am J Public        Health
2005;95:1024-1029.
   44. Leverett M, Ashe M, Gerard S, et al. Tobacco use: The impact of        prices.
J Law Med Ethics 2002;30(3 Suppl):88-95.
   45. Wolff R. States consider tobacco tax hikes. USA Today, February      27, 2007,
page 1A.
   46. "Kennedy, Waxman, Cornyn, and Davis Introduce Tobacco Legislation." Press
Release, February 15, 2007. Senator Edward M. Kennedy website. Available at
http://kennedy.senate.gov/newsroom/press_release.cfm?id=30d49497-d37d-4c82-87e1
-3b6c9c51e4f1
.
   47. Patton J. Tobacco control bill filed. Lexington Herald Leader,February 16,
2007: page C7.
   48. Naqvi NH, Rudrauf D, Damasio H, Bechara A. Damage to the insula       disrupts
addiction to cigarette smoking. Science 2007 Jan 26;315(5811):531-534.
   49. Eichhammer P, Johann M, Kharraz A, et al. High-frequency repetitive
transcranial magnetic stimulation decreases cigarette smoking. J         Clin Psy-
chiatry 2003;64:951-953.
   50. Cerny T. Anti-nicotine vaccination: Where are we? Recent Results Cancer Res
2005;166:167-175.
   51. O'Malley SS, Cooney JL, Krishnan-Sarin S, et al. A controlled trial of
naltrexone augmentation of nicotine replacement therapy for smoking cessation. Arch
Intern Med 2006;166:667-674.
   52. Siu EC, Tyndale RF. Non-nicotinic therapies for smoking cessation. Annu Rev
Pharmacol Toxicol 2007;47:541-564.
   SOURCE-Primary Care Reports


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                                          2 of 9 DOCUMENTS
                                                                                           Page 15
The Truth About Drug Companies: How They Deceive Us and What to Do About It; Book Review Journal of
                the American Academy of Child and Adolescent Psychiatry June 1, 2005

                     Journal of the American Academy of Child and Adolescent Psychiatry

                                                   June 1, 2005

The Truth About Drug Companies: How They Deceive Us and What
to Do About It;
Book Review
BYLINE: Henderson, Schuyler W.

SECTION: Pg. 601(3) Vol. 44 No. 6 ISSN: 0890-8567

LENGTH: 2025 words

   The Truth About Drug Companies: How They Deceive Us and What to DoAbout It. By Marcia Angell.
New York: Random House, 2004, 291 pages,$24.95 (hardcover).
    As soon as I received the editorial go-ahead to review Marcia Angell's The Truth About Drug Companies,
I dashed off an e-mail to her publisher requesting a review copy of the book. Apart from the honor and glory
of book reviewing, our only recompense for hours of reading, research, contemplation, and writing is a free
book. But just becausewe get a free copy from the publisher does not mean our review of the book will be
compromised, or does it?
     I do not know whether donating a free book renders the reviewer more disposed to writing a positive re-
view or whether publishers believe that they are simply doing their duty. Many, however, have long been
convinced that the pharmaceutical industry swamps physicians with gifts, "educational" luncheons, and other
boons because it is an effective marketing strategy. Dr. Marcia Angell's timely and important book bolsters
this belief and provides further evidence that "the industry, corrupted by easy profits and greed, has deceived
and exploited the American people" (p. 237).
     Marcia Angell, former editor-in-chief of The New England Journal of Medicine, argues that although the
pharmaceutical industry promotesitself as dedicated to research and innovation, it is mostly a marketing
middleman. Thanks to generous laws, a vast lobby in Washington, and well-remunerated academic centers,
the industry takes products often developed at publicly funded institutions and sells them for a massive profit.
The public foots the bill twice, first as taxpayers whofund the research and subsidize the tax breaks and tax
incentives and then as patients purchasing the medications.
    The pharmaceutical industry's main defense--that it is an innovative industry providing life-sustaining
medications--is dismantled by Angell, who argues that, although the industry does have a valuable role to
play, it is not nearly as pioneering as it claims. One of the most surprising statistics that she offers is that of
the 78 drugs approved by the U.S. Food and Drug Administration (FDA) in 2002, only 17were new active
ingredients, and only seven of these "were classified by the FDA as improvements over older drugs.... Fur-
thermore, of those seven, not one came from a major U.S. drug company" (pp. 16-17). The industry is sus-
tained by its "me-too drugs," the "variations of older drugs already on the market" (p. xvi).
     Some may be concerned that her critiques are anti-industry per se,but the book does not read as an an-
ticapitalist screed. The pharmaceutical industry, as Dr. Angell points out, is hardly a poster child for the free
market, enhanced as it is by government subsidies, tax breaks, and effective monopolies; the free market is
certainly no friend of the industry, which uses law suits, patent law, and Congress to stifle competition from
within the country and, of course, from pharmacies across the border. Such an arrangement does little to
encouragefinancially risky, long-term development of new products, one of thepromises of capitalism and
entrepreneurship. In fact, the book adds only a little to the provocative debate about whether there is a role-
for free market dynamics in health care at all.
   The frank corruption that Angell describes should be deeply disturbing to physicians and patients alike.
She points out that the unscrupulous behavior of the industry has direct bearing on patient health:rushed
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The Truth About Drug Companies: How They Deceive Us and What to Do About It; Book Review Journal of
                the American Academy of Child and Adolescent Psychiatry June 1, 2005

marketing, acquiescent physicians, and, most of all, inadequate research (which includes measuring new
medications against placeboand not against older but efficacious medication) can have detrimental and even
fatal results for our patients. She alludes to the recentconcern about suicidality with selective serotonin reup-
take inhibitors, although this debate has reached its pinnacle after the book's publication; similarly, the Vioxx
"catastrophe" (Topol, 2004) has come to light since the book was released. But there is plenty of clinicalin-
formation that will be relevant to physicians in all fields, provided from her discussion of such drugs as Clari-
tin, Taxol, Epogen, andGleevec. Her chief concern is that the research on which medical judgments are
based is all too often shaped by the industry, but when the adverse effects hit the fan, it is the physicians
who must face thepatients to explain why and the patients who suffer through it all.
     Too often, such polemical books do the easy part (criticize) and fail to posit an alternative. Fortunately,
Angell offers a series of recommendations, including institutional changes such as the strengthening of the
FDA as an independent body, and the creation of an institute to oversee the clinical testing of drugs as well
as changes in continuing medical education and the financing of academic meetings. She even offers sound
guidelines for patients, with questions to ask physicians and government representatives about their rela-
tionship to drug companies and the simple direction to ignore all direct-to-consumer ads. She does, however,
leave out recommendations for medical journals, a worrying oversight from a former editor-in-chief, especial-
ly given the almost symbiotic relationship between journals and the industry.
      There is, unfortunately, a hurried quality to the book. This is reflected most obviously in a maddening re-
petitiveness, epitomized by the regular, almost pulsing, bracketed assurance that she will tell us"more about
this later" and the frequent reminder that she touched on something in a previous chapter. Many of the
chapters seem to follow a logic independent of the narrative structure of the book as a whole (or even the
title of the chapter), which suggests that it is the cobbling together of previous papers. Although some ma-
terial is explained very well in brief segments, in particular her description of the ALLHAT trial (pp. 95-99) and
the marketing of Neurontin (pp. 157-161), the book as a whole does not hold tightly together.
     This is substantive criticism for three reasons. First, the sloppiness of the editing limits the book's effect,
in much the same way asa poorly delivered speech can have the most sympathetic listener looking at his or
her watch. Second, it quietly undermines the credibility of the author, whose legitimacy as a former edi-
tor-in-chief of NEJM makes this such an important book: the leaky editing that she has permitted in this book
would never float in the journal that she helmed. Third, the book fails on this account to contend with the
pharmaceutical industry.
      Let us take a step back. Despite the numbers that Angell crunches,one might argue that the pharma-
ceutical industry is not very good atmaking a profit--they would probably be unable to do so if they did not
have vast government subsidies, stables full of belligerent lawyers, and government officials who need finan-
cial donors for re-election funds, and, of course, without the publicly funded researchers to provide them with
products and the compliant physicians to prescribe them. But they are geniuses at marketing. They are so
brilliant at this that, as Angell points out, they make us think that they are paradigms of free enterprise, that
they are the victims of government bureaucracy, and that they are the actual innovators. They can do this
because they understand the power of aesthetics and compelling promotion. They know the very letters that
doctors like (X and Z, for example,as in Xanax, Zyprexa, Clarinex); they know how to fill medical journals
with colorful, eye-catching bar charts and handsome couples enjoying heartburn-free strolls along the beach.
     I am not saying that form should therefore take precedence over substance and that the stylistic prob-
lems in Angell's book make her arguments obsolete (although she could learn something from the industry's
lean, effective presentations). Rather, she gets bogged down in the financial shenanigans and in disparate
anecdotes about industry mischief, without consolidating either her arguments or her moral outrage. She is
neither an investigative reporter able to penetrate the "black box" of the industry's finances (black box is an
interesting wordchoice that might have merited some reflection), nor a lawyer able to explain the minutiae of
patent law or the intricacies of the legislation that got us to where we are now (although she provides a fair
synopsis several times).
    The confusion and repetition in the book suggest that she is trying to get at the heart of something that
neither she nor, I might add,I fully understands and therefore ultimately loses sight of the social, cultural,
medical, and even political milieu in which the industry is operating. So, for example, Angell notes that Bob
Dole was a driving force behind the Bayh-Dole act and that he was later fired as a spokesman for Pfizer for
                                                                                           Page 17
The Truth About Drug Companies: How They Deceive Us and What to Do About It; Book Review Journal of
                the American Academy of Child and Adolescent Psychiatry June 1, 2005

being too old (p. 116), but she does not explore the astonishing connection between Dole's involvement in
industry-invigorating--one might say priapic--legislation followed some two decades later with a lucrative deal
as the unwilting face of Viagra. By comparison, the marketing of antipsychotics is told not only in enraging
detail in Whitaker's (2002) Mad in America, but with an understanding of the social context in which this
happens for Americans with schizophrenia.
      The most effective criticism of the pharmaceutical industry that Ihave seen is in Adbusters, a magazine
critically, sometimes obnoxiously, but always effectively, engaging with corporate and national advertising
and consumer culture. They have an ear for the important ironies that are at once manifested and elided in
marketing. The prominent irony in this case, and the moral crucible for us, is that physicians--advocates for
patients, people at their most vulnerable--and their organizing bodies (academies, associations, journals,
etc.) have adeeply conflicted relationship with the companies whose primary motive is not patient care but
profit from patient populations. Angell alludes to this without mounting a cogent attack on it.
    In a book that correctly rails against much modern medical research, the book's own research is unima-
ginative, convincing without beingthought-provoking. In fact, much of the research seems to come from
newspaper reports (including editorials and op-ed pieces, not necessarily reliable sources of facts or de-
pendable reflections of public opinion) and Web pages. She cites Families USA twice, first as a "non-profit
group" (p. 12) and then, in case we do not remember, as "a nonprofit foundation" (p. 49), neither of which
descriptions are in the slightest bit helpful. Is Families USA a Web-based, right-wing, pro-life think tank? A
Web-based homeopathic, natural medicine organization? As with most Web pages, it is still not entirely clear
even when you go to their homepage.
     Many health care professionals will read this with some shame in their hearts: shame as professionals,
as clinicians, as citizens, and as human beings. Interviews with Dr. Angell and several of her articles, includ-
ing an edited version of the first two chapters of the bookin the New York Review of Books in July 2004 (An-
gell, 2004), have made a very convincing case for an immediate reevaluation of the role that the pharma-
ceutical industry plays in the practice of medicine; this book is a step in the right direction, but only a step. It
should have been a slam dunk.
    Now just how critical of the book would I have been if I had actually paid for it?
     Angell M (2004), The truth about drug companies. The New York Review of Books 51(12) July 15, 2004;
http://www.nybooks.com/articles/17244 (accessed October 21, 2004)
    Topol EJ (2004), Failing the public health--Rofecoxib, Merck, and the FDA, N Engl J Med 351:1707-1709
   Whitaker R (2002), Mad in America: Bad Science, Bad Medicine and the Enduring Mistreatment of the
Mentally Ill. Cambridge, MA: Perseus
    Schuyler W. Henderson, M.D.
    Department of Psychiatry
    Columbia University
    New York
    DOI: 10.1097/01.chi.0000157547.41337.46
    Disclosure: The author has no financial relationships to disclose.
    Assistant Editor: Andres Martin, M.D., M.P.H.

LOAD-DATE: January 18, 2008

LANGUAGE: ENGLISH

ACC-NO: 133247202

DOCUMENT-TYPE: Book Review; The Truth About Drug Companies: How They Deceive Us and What to
Do About It (Book) Book reviews
                                                                                           Page 18
The Truth About Drug Companies: How They Deceive Us and What to Do About It; Book Review Journal of
                the American Academy of Child and Adolescent Psychiatry June 1, 2005


PUBLICATION-TYPE: Magazine

JOURNAL-CODE: 2250 ASAP

                                      Copyright 2005 Gale Group, Inc.
                                             All Rights Reserved
                                                    ASAP
                                 Copyright 2005 Lippincott/Williams & Wilkins



                                             3 of 9 DOCUMENTS


                                         Mental Health Weekly Digest

                                               August 23, 2004

LEGAL ISSUES;
Suit alleges Zoloft maker concealed evidence, misled doctors about
drug safety
SECTION: EXPANDED REPORTING; Pg. 31

LENGTH: 222 words

       A law suit has been filed alleging Zoloft-maker, Pfizer, misled physicians and the public regarding Zo-
loft's safety and efficacy, particularly with regard to suicidality and withdrawal symptoms caused by the drug's
use.
     The consumer protection lawsuit was filed in Superior Court in downtown Los Angeles.
    It details Pfizer's alleged actions and omissions that downplayed Zoloft's risks and exaggerate Zoloft's
benefits. Pfizer did so, the complaint alleges, by suppressing evidence concerning (1) Zoloft's lack of efficacy
compared to placebos in treating conditions for which Zoloft is prescribed; (2) Zoloft's propensity to induce
withdrawal and dependency; (3) the risk of increased suicidal and violent impulses in adult, child and ado-
lescent Zoloft users; and (4) Zoloft's causing other side effects such as convulsions and psychosis.
     The Plaintiff, Roberta Madison, is a nurse and doctor of public health. She has brought the action as a
private attorney general on behalf of all California residents who have been misled about Zoloft. California's
Unfair Competition Law provides that a private citizen may act as attorney general on behalf of consumers.
      This article was prepared by Mental Health Weekly Digest editors from staff and other reports. Copy-
right 2004, Mental Health Weekly Digest via NewsRx.com & NewsRx.net.

LOAD-DATE: August 20, 2004

LANGUAGE: ENGLISH

PUBLICATION-TYPE: Newsletter


                Copyright 2004 Mental Health Weekly Digest via NewsRx.com & NewsRx.net
                                                                                                        Page 19




                                             4 of 9 DOCUMENTS


                                    The Journal of Law, Medicine & Ethics

                                                  Winter 2004

Leopards in the Temple: Restoring Scientific Integrity to the Com-
mercialized Research Scene
BYLINE: Lemmens, Trudo.
    Trudo Lemmens, Lic. Jur., LL.M., D.C.L., is Associate Professor at the Faculty of Law of the University of
Toronto.

SECTION: Pg. 641 Vol. 32 No. 4 ISSN: 1073-1105

LENGTH: 11703 words

ABSTRACT
     Recent controversies show how commercial interests may impact on the integrity of medical research
and how this affects research subjects and health care consumers. While various regulatory mechanisms
rely on the integrity of medical research, none of them currently provide sufficient safeguards. New regulato-
ry measures are required to restore scientific integrity and to protect the public, including separating those
who have financial interests in the research outcome from those who conduct clinical trials. [PUBLICATION
ABSTRACT]

FULL TEXT
    Leopards break into the temple and drink to the dregs what is in the sacrificial pitchers; this is repeated
over and over again; finally it can be calculated in advance, and it becomes part of the ceremony. -Franz
Kafka
    Recent Controversies in Medical Research
    For more than two decades, significant controversies have been brewing over the efficacy and safety of
Selective Serotonin Reuptake Inhibitors (or SSRIs) and other treatments for depression, and also over the
expansion of their use for the treatment of a variety of other conditions. These controversies culminated, in
June 2004, with a lawsuit intended by Eliot Spitzer, Attorney General of the State of New York. The lawsuit
accused pharmaceutical giant GlaxoSmithKline of "repeated and persistent fraud by misrepresentation,
concealing and otherwise failing to disclose to physicians information in its control concerning the safety and
effectiveness of its antidepressant medication paroxetine" (better known as "Paxil") in treating children and
adolescents suffering from depression.1 The statement of claims discusses how GlaxoSmithKline (GSK)
manipulated the results of five different clinical trials of this SSRI drug, conducted throughout the 1990s.
These studies failed to demonstrate the drug's efficacy and indicated a possible increased risk of akathisia,
suicidal ideation and suicidality in children and adolescents. Even so, GSK had embarked on a well-planned
advertising campaign, using data from only one of these trials. They published carefully selected data in a
peer-reviewed scientific journal, the Journal of the American Academy of Child and Adolescent Psychiatry,
and distributed the article to sales representatives, with a memo emphasizing Paxil's "REMARKABLE Effi-
cacy and Safety in the treatment of adolescent depression."2 Their Medical Information Letters for physicians
confirmed this message, and referred to the journal article. The company continued to distribute such letters,
even after it had admitted to several regulatory agencies that there were concerns about safety and a lack of
evidence of efficacy for the use of this drug in children and adolescents.
                                                                                                 Page 20
Leopards in the Temple: Restoring Scientific Integrity to the Commercialized Research Scene The Journal of
                                   Law, Medicine & Ethics Winter 2004

      The selective release of data was part of the company's marketing strategy, as is clear from a confiden-
tial internal memo drafted in 2002, by a research team within GSK. It explicitly states that "the efficacy data
are insufficiently robust to support a regulatory submission" and that reporting such a statement to the regu-
latory authorities would be "commercially unacceptable" since it would undermine the overall status of the
drug.3 Admitting that clinical trials involving children and adolescents had produced negative results could
perhaps also have harmed the profile of the drug for the treatment of adults.
     The New York lawsuit came in the wake of U.S. Food and Drug Administration (FDA) hearings on the
safety and efficacy of SSRIs for children and adolescents suffering from depression. The hearings arose
from public warnings of a potential link between increased risk for suicide and the use of SSRIs among
children and adolescents. Unlike the British regulatory agency4 and Health Canada,5 the FDA had decided
to set up a task force and to hold public hearings on this issue. How high the stakes were became apparent
by the attempts to influence the process. Ten days before the hearings began, the American College of
Neuropsychopharmacology (ACNP) launched an "executive summary" of a "preliminary report" of its "Task
Force on SSRIs and Suicidal Behavior in Youth" which declared that SSRIs were effective and safe for use
in children and adolescents.6 Nine out often members of this Task Force had consultancy and other financial
relations with major pharmaceutical companies.7 Three had co-authored the journal article used to promote
paroxetene (Paxil) though, alarmingly, they admitted not having seen the full data.8
     The PDA's Psychopharmacologic Drugs Advisory Committee and Pediatric Drugs Advisory Committee,
which organized the hearings, ultimately recommended that SSRIs should contain a "black box" warning in-
forming physicians and the public of the increased risk of suicidal thoughts and behavior; and the FDA fol-
lowed this recommendation.9 However, the review process was beset with other controversies, for example
when it became known that an FDA drug safety analyst had concluded one year earlier that some patients
became suicidal as a result of taking SSRIs, and that in children and adolescents, the drugs' risks out-
weighed the benefits. Moreover, when some pharmaceutical companies wanted to add warning labels on
their drugs, the FDA had asked them to scale down these warnings because they might discourage physi-
cians from prescribing the drug, thus leaving many children and adolescents untreated.10
     Authorship concerns recur in another controversy surrounding SSRIs. In the British Journal of Psychia-
try, David Healy and Dinah Cattell show how Pfizer's SSRI drug sertraline (distributed under the name "Zo-
loft" in North America") was promoted through the publication of ghost-written articles that appeared in the
most influential medical journals, including the Journal of the American Medical Association, the American
Journal of Psychiatry and the Archives of General Psychiatry.11 The article by Healy and Cattell exposes the
growing involvement of specialized medical communication agencies in the preparation, publication and dis-
tribution of the results of medical research. Marcia Angell adds that these communication companies are in-
creasingly an integrated part of medical research conglomerates created by the world's largest advertising
agencies.12
      David Healy has been a central figure in controversies concerned with the impact of commercial interests
on academia. In addition to his academic critique on the continuing expansion of the SSRI use, Healy has
appeared since 1999 in American lawsuits as an expert witness for claimants who argued that SSRIs had
been responsible for their family member's suicide and/or violent behaviour.13 Such activities have brought
him on a collision course with the producers of SSRIs and with some members of the academic community.
When the Hastings Center Report included an article by Healy in a special issue on Prozacx14 Eli Lilly, pro-
ducer of the drug, withdrew its funding. Around the same time, Healy was offered the position of the director
of the Mood and Anxiety Program at the Centre for Addiction and Mental Health (CAMH), a leading psychia-
tric research institution affiliated with the University of Toronto. This offer was rescinded shortly after he gave
a public lecture at CAMH reiterating his view that pharmaceutical companies had failed to fully investigate
the link between SSRIs and an increased risk of suicide. The official explanation was that his lecture had
"created an extraordinary stir among his future colleagues" who felt that his views were "scientifically irres-
ponsible, incompatible with published scientific evidence and hence incompatible with the mantle of respon-
sibility of leadership of a clinical and academic program."15 The news media immediately linked Healy's dis-
missal with the high percentage (about 40%) of pharmaceutical funding for the Mood and Anxiety Program,
as well as close institutional research collaboration between the CAMH and Eli Lilly. Healy suggests that the
interference was indirect,16 and connects Dr. Charles Nemeroff to his dismissal. Nemeroff is a leading
                                                                                                 Page 21
Leopards in the Temple: Restoring Scientific Integrity to the Commercialized Research Scene The Journal of
                                   Law, Medicine & Ethics Winter 2004

American psychiatrist with close ties to the pharmaceutical industry, who had attended the same conference
and had previously had an altercation with Healy about his public positions on SSRIs.17
    Healy's lawsuit against CAMH and the University was settled out of court, and Healy became as part of
the settlement a visiting professor at the University of Toronto. But the case has become a seminal example
of how commercial interests can impact or appear to impact hiring decisions within academically-affiliated
research institutes. It creates the perception that commercial interests can harm the careers of academics
whose work threatens industry interests.18
     The nature of the conditions for which SSRIs are prescribed, the characteristics of the drug itself, and the
nature of the alleged side-effects may explain why so many controversies surround SSRIs. SSRIs were
originally developed for the treatment of depression, which is alleged to touch millions of people worldwide
and is the leading cause of disability in the world.19 But as David Healy pointed out in The Anti-Depressant
Era, pharmaceutical sponsors have been able to mould the definitions of diseases for which SSRIs are
claimed to work.20 This was possible largely because SSRIs seemed to affect a variety of mental conditions
and states connected to depression. While recognizing the potential human suffering behind depression and
related conditions, Carl Elliott states that that many of these disorders are surrounded by "a wide zone of
ambiguity that can be chiseled out and expanded."21 As a result, the conceptual boundaries of depression
"have been expanded relentlessly outward."22 SSRIs are now prescribed for anxiety, post-traumatic stress
disorder, premenstrual dysphoric disorder, obsessive compulsive behaviour and other disorders, the expres-
sion of which is sometimes severe, but sometimes akin to more modest human ailments.
     The scientific and political difficulties associated with investigating the side-effects also explain part of the
controversies. Clinical case-reports of individuals developing suicidal thoughts, becoming agitated, or at-
tempting or committing suicide while on anti-depressants have long been dismissed as inconclusive, be-
cause anti-depressants are prescribed to treat depression, which is already associated with a significant risk
of suicide. Clinical trials need to be designed quite carefully to be able to detect increased risk of suicide in
this population.
     In the absence of solid data, several researchers and the regulatory agencies may be genuinely worried
about the impact of "fear-mongering" on public health efforts to control depression. They fear that issuing
warnings based on preliminary findings of the side effects of these drugs could increase the incidence of sui-
cide due to patients' hesitation to seek treatment.23 The serious nature of the alleged risk, i.e., death by sui-
cide, makes it very cumbersome to weigh the risks and potential benefits of disclosure of this still speculative
information.
     The controversies over SSRIs are, however, not isolated cases. For instance, in the 1990s, the drug
combination Fen-Phen was prescribed to millions of people until research associated it with an increased risk
for pulmonary hypertension and heart valve disease.2* In 1997, the drug's producer Wyeth-Ayerst agreed to
pay $3.75 billion to settle one class action lawsuit, among other on-going lawsuits.25 The same company
had also promoted estrogen therapy for decades, first as a remedy to rejuvenate post-menopausal women,
and subsequently to reduce the risk of heart attacks, strokes and osteoporosis. It is only in 2002 that a large
independent study provided strong evidence that estrogen caused small increases in breast cancer, heart
attacks, strokes and blood clots.26
   In May 2004, the pharmaceutical giant Pfizer agreed to pay $430 million to settle a lawsuit by a former
employee turned whistle-blower, who was joined in the lawsuit by the U.S. federal government and 11 state
governments. The lawsuit exposes various marketing practices by the company Warner-Lambert - later
bought by Pfizer. Leading academic researchers were paid to deliver promotional lectures at educational
events and to publish favourable reports on the off-label use of its epilepsy drug, Neurontonin.27
    Most recently, Merck Frosst announced it was withdrawing its top selling arthritis drug Vioxx from the
market after research showed increased risk of heart attack and stroke. Already in 1991, experts urged for
appropriate clinical trial to assess cardiovascular risks and many epidemiological studies confirmed the exis-
tence of such risks.28 According to The Washington Post, the FDA even ignored safety reports by one of its
reviewers.29 For the Lancet, "[t]he Vioxx story is one of blindly aggressive marketing by Merck mixed with
repeated episodes of complacency by drug regulators."30
    The Controversies in Context: The Commercialization of Medical Research
                                                                                                 Page 22
Leopards in the Temple: Restoring Scientific Integrity to the Commercialized Research Scene The Journal of
                                   Law, Medicine & Ethics Winter 2004

     The SSRI and other controversies can be situated in the context of the commercialization of medical re-
search.31 The enactment of the Bayh-Dole Act of 1980(32) is generally heralded as the primary cause of the
increasingly commercial orientation of medical research in the United States. The Act allowed American uni-
versities and researchers to obtain privately-owned patents on the results of federally-funded research. The
goal of this legislation was to spur the development and commercialization of technology by providing uni-
versities and researchers with incentives to focus their research on marketable products. Before 1980, scien-
tists, particularly basic scientists, often frowned upon privatization of research findings as heresy.33 Science
was largely considered a public calling in which research findings should be shared and made publicly ac-
cessible. After 1980, however, researchers enthusiastically joined the patent race, and several funding agen-
cies started encouraging commercial partnerships, sometimes imposing private matching funding and pa-
tentable outcomes as preconditions for funding. The number of patents obtained and the creation of start-up
companies became measures of success for academicallyfunded programs. Although one of the ultimate
goals of patenting is to promote the introduction of innovative technologies on the market and thereby to
make innovations publicly accessible quickly, patenting affected the culture of sharing of data.
     Governments of other industrialized countries have also promoted the commercialization of research.
The Canadian Institutes of Health Research, for example, emphasize that they want to stimulate the fast ap-
plication of research, and the contribution of this research to the "knowledge-based economy."34 Other Ca-
nadian granting agencies more explicitly focus on promotion of high quality health research as a means to-
ward development of a vibrant biotechnology commercial sector.35
     As a result of these developments, researchers and academic institutions are increasingly involved in the
development of start-up companies with industry and often hold significant stock in companies that are
bringing their research to the market. Researchers have become part-time entrepreneurs. Since they them-
selves are increasingly being asked to be involved in patentable research endeavours within academia, re-
quiring delays in offering access to data, it may have become harder for them to see problems with pharma-
ceutical sponsors doing the same.
      The pharmaceutical industry also started to boom in the 1980s. Various blockbuster drugs have flooded
the markets since then. The U.S. dollar sales figures associated with certain drugs reveal what is at stake.
Pfizer's cholesterol-lowering drug Lipitor had sales of $9.2 billion in 2003;36 one tenth of the estimated total
market for that drug category.37 The new market for the penile erection dysfunction drugs is estimated at $6
billion by 2010.38 Global sales of Glaxo-SmithKline's successful SSRI paroxetine (Paxil) amounted to $4.97
billion last year.39
     With profits have come power, and the incentive to influence the market. The pharmaceutical industry
has extended its tentacles particularly to those involved in the process of creating and regulating scientific
knowledge and of transforming that knowledge into commercial products. It has attracted scientists to their
ranks and created strong financial ties at all levels. Academic researchers now top up their salaries with fees
or stock options that often surpass in value their academic income, for activities such as consultation, mem-
bership on advisory boards, and functioning as a member of pharmaceutical companies' speaker bureaus.
Even scientists of the National Institutes of Health (NIH) have developed paid relations with industry, receiv-
ing thousands of dollars and stock options for consulting services.40 Many members of very influential Food
and Drug Administration (FDA) advisory panels and other governmental panels also have financial relations
with industry.41
     Industry tactics increasingly seem to involve more long-term strategies to influence change. Pharma-
ceutical companies financially support those who can influence indirectly drug consumption and/or create
political pressure on the drug approval and government funding processes. Consumer and advocacy groups
receive generous funding from pharmaceutical companies. While benevolence and good corporate citizen-
ship is often the official explanation for such funding, teaming up with advocacy groups is clearly a business
strategy.42 A market report sold through various public relations agencies states bluntly that working with
patient advocacy groups should be a "prime target for sustained competitive advantage for drug compa-
nies."43 While such strategic alliances are primarily useful to increase sales and create new markets by
promoting disease 'awareness,' they are also used to exercise pressure to permit new forms of research
(e.g. involving-stem cells), to speed up drug approval, or to prioritize research.44
                                                                                                 Page 23
Leopards in the Temple: Restoring Scientific Integrity to the Commercialized Research Scene The Journal of
                                   Law, Medicine & Ethics Winter 2004

     Another aspect of the corporate strategy is the blurring of the line between the research stage and
post-approval marketing of drugs. Companies can strategically use special access programs and large
phase 3 and phase 4 trials to boost doctors' and patients' awareness of a drug and to jump-start prescription
patterns before or just after a drug hits the market.45 Including more subjects in such trials than are strictly
needed also "occupies the field" so that competitors who want to access the same patient population for drug
testing will have difficulty finding sufficient subjects.
     Sheldon Krimsky shows how commercialization has affected academic research, which is increasingly
funded by industry.46 Overall, corporate contributions to research and development in academic institutions
in the United States have risen by 875% between 1980 and 2000. The increase in industry funding has been
phenomenal in many leading academic institutions. Krimsky reports, for example, that Duke University's in-
dustry funding, which rose by 280% in the 1990s, now constitutes 31% of its overall budget. In the same pe-
riod, the University of Texas saw a 735% increase in its private funding, compared to a 491% increase at the
University of California at San Francisco. And 20% of the budget of the prestigious Massachusetts Institute
of Technology now comes from industry.47
     In addition, much more research is now taking place outside academia, particularly within Contract Re-
search Organizations (hereinafter CROs). CROs conduct large numbers of clinical trials within specialized
research centers, or coordinate such research undertaken in the community by primary care physicians. The
Office of Inspector General in the United States reports that the number of physicians in private practice par-
ticipating in research has risen by 300%.48 More than 60 percent of all clinical trials funded by industry are
now undertaken outside of academia, in contrast to only 20% in 1990.49 As a result of the growing competi-
tion, the costs, and the problems of access to research subjects, clinical trials are also increasingly con-
ducted in Africa, India, and Eastern Europe, raising concerns about exploitation and future availability of
these drugs in developing countries, representativeness of research results, and a host of other issues.
      Governmental policies, consequent shifts in institutional approaches to commercialization, and devel-
opments in industry has created a cozy space for interaction between industry and other "stakeholders," ful-
filling a governmental desire to promote economic development through industry-academia collaboration.
While it is hard to oppose the increased creation of health care products, it is clear that these developments
come at a price. The increased emphasis that governments place on the commercial outcomes and the crea-
tion of patentable products orients health research in a very specific direction. Health research inevitably fo-
cuses more on technological interventions and the use of new drugs and devices, and less on public health
measures which may be more cost-effective and offer more public benefit. There are, however, more direct
and immediate concerns.
    Traditional Research Ethics Concerns
     The commercialization of medical research raises a number of typical research ethics concerns related
to the recruitment of research subjects, exploitation of impoverished research subjects, and violations of in-
formed consent. The growing use of financial recruitment incentives, targeting both research subjects and
the health care workers who recruit them, has been discussed in the literature.50 Commentators have also
pointed out that financial interests may negatively impact researchers' dealings with research subjects during
a trial. When huge profits lure, and pressure mounts to bring novel drugs or therapies quickly to the market,
potential risks maybe perceived somewhat more lightly, and inclusion or exclusion criteria may become more
flexible. This seems to have happened in the well-known case of Jesse Gelsinger. Jesse Gelsinger died in a
gene transfer study for the treatment of OTC, a rare and potentially lethal liver disease.51 The researchers
and their institute at the University of Pennsylvania had significant financial interests that may have influ-
enced their appreciation of the risks involved, and their decision to include Gelsinger in the fatal study.
     The paradigmatic nature of the Gelsinger case has been recognized by the research and medical com-
munity. In the wake of the Gelsinger case, various influential reports have emphasized that the growing fi-
nancial interests in research may create risks to research participants. A special Committee of the Institute of
Medicine states in a 2003 report that the failure to protect Jesse Gelsinger was "paradigmatic of failures in
the system of protections itself." Included among these failures are the insufficient control over "conflicts of
interest of the investigators and the institutions" and the inadequacy of the review process.52 The report
emphasizes further how "[a] process for scrutinizing potential financial conflicts of interest...is vital to the
subsequent evaluation of participant risks and benefits."53 A Task Force of the Association of American
                                                                                                 Page 24
Leopards in the Temple: Restoring Scientific Integrity to the Commercialized Research Scene The Journal of
                                   Law, Medicine & Ethics Winter 2004

Medical Colleges states in its 2001 report on individual financial conflicts of interest that "opportunities to
profit from research may affect - or appear to affect - a researcher's judgments about which subjects to
enroll, the clinical care provided to the subjects, even the proper use of subjects' confidential health informa-
tion."54 Similarly, a 2004 Guidance document issued by the Department of Health and Human Services re-
commends that those involved in research should "consider whether specific financial relationships create
financial interests in research studies that may adversely affect the rights and welfare of subjects."55 Other
reports have analyzed how research subjects maybe affected by specific practices developed in the context
of the commercialization of research.56
    Systemic Concerns: Threats to the Integrity of Medical Research
     Commercialization of research raises also other fundamental concerns. "Financial interests threaten
scientific integrity," the Task Force of the Association of American Medical Colleges writes, "when they foster
real or apparent biases in study design, data collection and analysis, adverse event reporting, or the presen-
tation and publication of research findings."57
    Several empirical studies demonstrates a statistically significant association between source of funding
and research outcome. Industry-sponsored research is much more likely than non-commercially-sponsored
research to lead to a conclusion that a new therapy is better than the standard therapy.58 Although these
studies do not establish a causal relationship between industry funding and an outcome that benefits the
sponsors, they raise a red flag. For Sheldon Krimsky, "the appearance of a conflict of interest provides cir-
cumstantial evidence of an influencing motivation."59 But while the results of these studies can still be ex-
plained by the subtle, unconscious impact of investigators' financial interests on the outcome of their re-
search, several of the controversies mentioned earlier suggest the outright manipulation of science for mar-
keting purposes. Medical research in these cases becomes a fundamental link in a sophisticated marketing
scheme.
     In the new research environment, control of the research design, the selection of subjects, the interpreta-
tion of results and the release of data have become easier. Research is organized by sponsors directly or
within specialized Contract Research Organization, and involves a large number of community physicians
and academic researchers in different locations. Physicians and academic researchers get involved in many
of these industry-sponsored clinical trials as a side-activity, without strong intellectual investment. While
academic researchers may seem to offer greater legitimacy to a study, they are not necessarily involved in
the design of the study, often do not have access to the complete data and may do nothing more than collect
and forward information about a small number of research subjects in exchange for authorship credit. Even if
they want to challenge the research design, they may not be in a position to obtain fundamental changes to
the protocol.
     Commercial interests have also affected the integrity of the scientific literature, a crucial component of
independent science. For years, advertising revenues by pharmaceutical sponsors have been a core source
of funding for various medical organizations, such as the American Medical Association, impinging upon their
independence.60 Academic journals have also struggled with the question of how financial relations may
influence the independence of the authors and manuscript reviewers. While disclosure of financial interests
has now become standard in all but a few of the major academic journals, some journals have recently be-
come more lenient, for example towards conflicts of interests of authors of editorials and review articles. The
gold standard was always that those comparing various treatment options and making recommendations for
clinical practice should have no financial relations with either the producers or competitors of the products
discussed. Nevertheless, the New England Journal of Medicine recently announced that it would not always
require this because, according to the editors, it has become increasingly hard to find medical researchers
who have no financial links with producers or competitors.61
     The potential bias of financially interested authors of review articles is clear from a widely publicized con-
troversy around Nature Neuroscience. Until recently, that journal had stubbornly maintained that even dis-
closure of financial interests is not warranted, since science is transparent and independent. The journal pub-
lished a review article discussing new experimental treatments without disclosing that the first of two authors
held a patent for a recommended product and was a member of the scientific advisory board of two other
companies whose products were praised.62 Under the public pressure created after the New York Times
publicized this story, the journal finally revised its disclosure policy.63
                                                                                                 Page 25
Leopards in the Temple: Restoring Scientific Integrity to the Commercialized Research Scene The Journal of
                                   Law, Medicine & Ethics Winter 2004

    Relying entirely on the integrity of all the researchers involved seems naïve when so much money is at
stake. Warner-Lambert's promotional tactics for Neurontin, mentioned above, included payments of more
than $300,000 to a professor of the University of Minnesota for the publication of a book on the treatment of
epilepsy, and a similar amount to a colleague of the University of Florida for promoting the drug on the lec-
ture circuit.64 The Los Angeles Times mentions even higher amounts that prominent scientists within the
NIH have received for consulting with industry.65 Marcia Angell invokes these and other reports to illustrate
the significance of the financial conflicts of interest. Is it reasonable to trust the independence of researchers
with such significant financial interests and let them play an important role in determining evidence-based
medical practice?
    The growing phenomenon of ghost writing is clearly the most extreme challenge to the integrity of the
medical literature. Healy and Cattell's article, discussed above, is not the first to raise such concerns.66 A
1998 article in the Journal of the American Medical Association discusses an analysis of 809 articles in three
leading medical journals. It concludes that up to 11% of the articles used ghost authors, and 19% of them
used honorary authors, even though both practices violated existing authorship guidelines.67 Marcia Angell
also details the unscrupulous search of Warner-Lambert for academic authors willing to sign their name to
"scientific publications" promoting a drug's efficacy in exchange for money.68
    The concerns raised here traverse the traditional boundaries that have been drawn between research
ethics, drug regulation, and the regulation of medical practice. It is widely accepted that an Institutional Re-
view Board (IRB) must ensure that a trial has validity; that the sample is representative; and that results of a
study are publicly accessible. But already overburdened IRBs rely on the existing framework in which medi-
cal evidence is established and in which the safety and efficacy of therapeutic products has been vetted by
regulatory agencies. When they evaluate the validity of a comparative trial, for example, they will readily ac-
cept claims about the efficacy of an existing drug based on the peer-reviewed literature and on the fact that
the drug has been approved. The recent controversies tell us that that this reliance is inappropriate.
    Drug regulatory agencies also seem to rely on a well-functioning research ethics review system. Various
guidance documents on conflicts of interest69 and research ethics guidelines70 indicate that it is within the
mandate of research ethics boards to review conflicts of interest. Health Canada's Therapeutic Products Di-
rectorate even explicitly relies on research ethics boards (REBs) as a crucial link within the regulatory
process to prevent conflicts of interest from affecting research.71
     In an era of evidence-based medicine, evidence gathered in clinical trials and published in the scientific
literature forms the basis for the development of clinical practice guidelines. Furthermore, the FDA approval
system determines the therapeutic claims pharmaceutical companies can make about particular drugs. If this
approval system does not work adequately or if pharmaceutical companies are allowed to circumvent the
rules, for example through the promotion of offlabel use of drugs, clinical practice can no longer claim to be
evidence-based. An editorial in the Lancet, accompanying a meta-analysis of SSRI studies in children, rightly
describes the SSRI saga as a "disaster" for evidence-based medical practice.72
    The controversies discussed here suggest that while the integrity of research is a crucial requirement at
any of these levels, the existing regulatory mechanisms that exist at each level are not sufficient. But what
are the mechanisms that have failed us?
    Countervailing Forces
    The Market as a Corrective Force?
      It seems clear that market mechanisms do not curb the negative impact of conflicts of interest in the
context of medical research. There is a fundamental asymmetry when large pharmaceutical companies con-
trol the development of scientific knowledge about their products and then influence how these products are
used by doctors and patients. Competing interests of other producers do not compensate in this market
structure, because pharmaceutical companies often share core interests that remove incentives to challenge
a competitor's research. For example, as mentioned above, commercial interests have led to an expansion
of categories of disease for which drug treatments are available.73 Pharmaceutical companies share a
common interest in promoting such treatments even in cases where public health measures and preventive
medicine may be more effective and safer. This is certainly a concern in the context of SSRIs, which are
used to treat a wide range of conditions, where the line between disorder and variable mood is often porous.
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                                   Law, Medicine & Ethics Winter 2004

Market-driven research will not dispel any myths about the need for aggressive drug treatment for even the
mildest expressions of these disorders.
    Despite industry-sponsored commercials emphasizing a corporate commitment to improving health, a
pharmaceutical company's first commitment is to realize profits by promoting sales. The specific nature of
pharmaceutical products makes the clash between the public interest and industry interests particularly
problematic. Expanding markets for soaps and perfumes can occur without significant harm, but expanding
consumption of drugs beyond those who really need them creates serious risks to health.74 Philip J. Hilts, in
his history of the FDA, agrees that "oversupply and overpromotion in medicine is a serious matter. It does not
conform to the nature of the illness, or the practice of medicine, or the desire of the consumers, but purely to
the needs of the industrial marketing department."75
    Independent Scrutiny
    In light of the growing commercialization of academia, we cannot rely on the continuing commitment of
dedicated researchers who remain oblivious to the lure of lucrative relations with industry. Ultimately, it will
require a strong commitment, both by governmental agencies and by academic institutions, to reverse the
trend and to ensure a vibrant critical research scene. Reports that many researchers within the NIH, includ-
ing directors of specialized institutes, have supplemented their regular income with industry contracts are not
encouraging.76 We will need to strengthen the independence of research institutes and increase support for
organizations such as the Cochrane Group, an independent not-for-profit organization dedicated to providing
independent information on health care, to promote independent research.77
     One of the problems that those committed to independent scrutiny and meta-analysis will face is access
to research data, as is clearly highlighted by the SSRI controversies. It is this widely expressed concern78
that the editors of the major medical journals have tried to address recently. In the wake of Eliot Spitzer's
lawsuit against GlaxoSmithKline, the International Committee of Medical Journal Editors issued a joint
statement that its journals will require, "as a condition of consideration for publication," registration of clinical
trials prior to patient enrollment.79
     Such a clinical trials database will surely help. Access to data is a precondition for a critical review. If all
trials are registered, researchers can put pressure on sponsors and researchers to release data whenever a
registered clinical trial is finished and its results have not been publicized. The registry requirement would
have made it much harder for GlaxoSmithKline to publish selective results in the most influential
peer-reviewed journals. The journal editors acknowledge, however, that a registry is "only part of the means
to an end: that end is full transparency with respect to performing and reporting clinical trials."80
     The registry initiative does not bind all medical journals. Industry can still publish selective results using
less rigorous journals or other promotional tools. Moreover, this registry does not necessarily promote ap-
propriate comparative trials which could challenge studies controlled by pharmaceutical sponsors. Even if
clinical trials are registered and later published in leading medical journals, will there be independent scrutiny
of the methodology, data analysis and interpretations? The problems of potential bias in industry-sponsored
studies and the declining number of truly independent researchers remain a major challenge that requires
structural reform. A registry can only function appropriately if it is part of a well-functioning regulatory system.
    Unfortunately, the regulatory system currently in place seems insufficient. Two areas of regulatory over-
sight are worth mentioning here. The first is the research review system, built around local review of research
protocols, prior to commencing a study, by Research Ethics Committees (RECs). The second is the review
structure of governmental drug regulators such as the U.S. Food and Drug Administration.
    Review by Research Ethics Committees
     The requirement that research involving human subjects be reviewed by a committee independent from
the investigator and the sponsor is firmly entrenched in medical research all over the world. Research Ethics
Committees (RECs) - called Research Ethics Boards (REBs) in Canada and Institutional Review Boards
(IRBs) in the U.S.A. - are widely expected to deal with the inherent conflict of interest between the duties of
physicians towards their patients and the duties of clinician-researchers towards the advancement of
science. The imposition of review by RECs constitutes recognition of the danger that physician-investigators
can be tempted to relinquish their duty to the patient by giving priority to their scientific endeavours. It pro-
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                                   Law, Medicine & Ethics Winter 2004

vides an extra safeguard to ensure that in research involving humans, the interests and welfare of research
participants remains the paramount concern.
     But even in the U.S.A., where IRBs have been particularly integrated into the regulatory system, various
reports and commentators have questioned the efficacy and appropriateness of the existing system in the
changed research environment.81 It exceeds the scope of this paper to discuss all of the problems identified
in these reports. But one problem in particular should be highlighted here: the conflict of interest embedded
in the REC system itself.
     In most countries, RECs are part of established academic institutions and its members are connected to
the research interests within these institutions. Membership of RECs is dominated by medical professionals
and/or people with research interests within the institution. Although community representation has gradually
been added as a core requirement, it seems fair to argue that REC review in most countries currently re-
mains a largely peer-dominated, internal review system, tightly integrated in the local culture.82 A recent
survey of U.S. medical school faculty members serving on IRBs raises also concerns about financial conflicts
of interests of IRB members. Of the more than 2900 IRB members who responded to the survey, 47% had
done consultancy work for industry, which is a higher percentage than among medical faculty members who
do not serve on IRBs.83 It is fair to assume that these IRB members will less likely be concerned about the
potential impact of such consultancy relations on research. One could argue that they are themselves in a
situation of conflict of interest when evaluating the potential impact of financial relations in industry spon-
sored research.
     As RECs have assumed a more significant administrative role, with a mandate to evaluate the potential
impact of individual and institutional conflicts of interest, this model seems much less appropriate. Institution-
ally-based RECs are generally composed of people who, in their capacity as researchers or clinicians, report
directly to institutional officials with vested interests in the conduct of research. As such, they maybe reluc-
tant to make decisions detrimental to the financial interests of superiors and of the institution, since this may
bring them on a collision course with their superiors and ultimately even threaten their employment.84
     In addition, the commercialization of medical research has also led to a boom in the development of
commercial RECs, which are fully integrated in the industrialized research scene.85 Some Contract Re-
search Organizations have set up their own internal RECs, and several private RECs have also found a
niche in the commercialized research environment. The latter are for-profit organizations that have as their
sole commercial activity the review of research protocols for a fee. These RECs play an increasingly impor-
tant role, as more and more research has moved out of the academic setting and into the community. From a
regulatory perspective, it is problematic that they are in a clientprovider relationship and that they have a di-
rect financial interest in offering a service that satisfies their client. Refusal to approve a study may have sig-
nificant financial consequences for the contract research organization or sponsor who contracts with the pri-
vate REC; nothing in the system prohibits these sponsors from taking their study to another REC for approv-
al, undermining the RECs ability to make fully independent administrative decisions.
    Many of these RECs, institutional and commercial, may be doing a decent job. But the question is
whether these committees can be relied upon as independent administrative bodies entrusted with an im-
portant public policy task.
     The Department of Health and Human Services86 and the Association of American Medical Colleges87
recommend that specialized Conflict of Interest Committees be set up within institutions. These would have
an explicit mandate to review financial relations between individual researchers, the institution and the re-
search sponsors and would serve as an important resource for the review by RECs. Delegation of conflict of
interest review to such specialized committees would help to prevent RECs from becoming even more over-
burdened and could provide more effective control of financial interests. It is not clear, however, why they
would not face similar problems as RECs with respect to the lack of independence. Unless Conflict of Inter-
est Committees are established as independent administrative entities, it is not clear that they will offer much
additional protection. It is also interesting to point out that RECs and Conflict of Interest Committees have
been active in several institutions for some time, but their efforts did not prevent some of the most serious
research controversies of recent years. As the father of the late Jesse Gelsinger points out, the University of
Pennsylvania had a Conflict of Interest Committee and it had its research protocols reviewed by an appro-
priatelyconstituted IRB. Even so, major conflicts of interests were not dealt with.88 Moreover, the problem of
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                                   Law, Medicine & Ethics Winter 2004

the integrity of research clearly extends beyond academic institutions. It would be unrealistic, for example, to
establish Conflict of Interest Committees within Contract Research Organizations.
     Other initiatives must be mentioned in this context. Over the years, various institutions have developed
their own institutional policies and guidelines to deal with conflicts of interest.89 A variety of issues can be
covered by institutional policies. Several institutions have developed policies related to finder's fees, prohi-
biting payment for the mere referral of patients to research studies.90 Many institutions impose a careful re-
view of research contracts, in hope of ensuring that researchers have access to the full data of a study, and
that they are not bound by confidentiality clauses that could prevent them from disclosing the research re-
sults. These institutional policies are important and useful. They raise the ethical standards in those institu-
tions that implemented them.
     However, they cannot be seen as sufficient to safeguard the integrity of the entire system of medical re-
search. First of all, they only cover academic institutions. Secondly, the institutional policies vary, with many
institutions retaining a very flexible approach. A 2002 survey of provisions in clinical trials-agreements be-
tween American medical schools and sponsors suggests that much work remains to be done within aca-
demic institutions. The authors state that "academic institutions routinely participate in clinical research that
does not adhere to ICMJE standards of accountability, access to data, and control of publication" and that
institutions "rarely ensure that their investigators have full participation in the design of the trials, unimpeded
access to trial data, and the right to publish their findings."91
    Review by Drug Regulatory Agencies
    The most significant power to counterbalance the power of pharmaceutical companies lies with the drug
regulatory agencies. The FDA and drug regulatory agencies in other countries were established to enable an
independent assessment of the safety and efficacy of drugs before they are allowed onto the market. But the
controversies raise questions about how well they function and reveal some of their limitations.
     Before commencing clinical trials, sponsors have to file an Investigational New Drug Application, with
data from laboratory and animal studies to support the claim that research subjects will not be put at unrea-
sonable risk. They have to keep the agency informed of any serious and unexpected adverse events asso-
ciated with the experimental treatment and any other data that suggests risks to human subjects. After hav-
ing tested the drug through three stages of clinical trials, they have to submit data supporting the efficacy and
safety of the product to obtain approval for a specified use of the drug. The FDA also exercises control over
marketing and post-approval safety of drugs and medical devices.
      Concerns have been expressed that the PDA's mandate to protect public health has gradually expanded
to include protecting the interests of the pharmaceutical industry. Several developments suggest that the
FDA has also become the promoter of "industry wealth."92 First, drug regulatory agencies have yielded to
significant pressure by industry, and originally also patient advocacy groups, to decrease the administrative
burden and speed up drug approval. While legitimate concerns about regulatory delays in access to poten-
tially life-saving drugs were part of the motivation, industry interests seem to be the primary reason for con-
tinued pressure on regulatory agencies to keep shortening the review. In 2000, an investigative report ana-
lyzed the PDA's withdrawal from the market of "seven deadly drugs," associated with 1,002 deaths.93 FDA
reviewers interviewed for the article indicated that they were overwhelmed by the workload and felt pres-
sured to approve drugs. The article raised concerns that faster review may lead to hasty approvals and mis-
takes. Marcia Angell points out that the FDA has also been slow in pulling drugs off the market when there
were clear indications of harm.9'1 Writing about the Vioxx controversy, Topol argues that the FDAs inaction
is partially responsible for "an enormous public health issue," affecting millions of people.95
     While more drugs are developed than ever before, the budget of the regulatory agencies has not in-
creased in ways that promote best public protection. Since the adoption of the Prescription Drug User Fee
Act in 1992,96 the FDA receives a significant part of its budget from user fees paid by drug companies.97
The fees paid by industry are explicitly designated to speed up the review process of new drugs. Philip J.
Hilts points out that industry has obtained significant leverage because of its contributions to the drug ap-
proval system.98 This explains why monitoring of drug safety and control of marketing practices have not
received the same attention. In an article in the Washington Monthly, Stephen Pomper captures it nicely:
"[T]he FDA is in approval overdrive, while its safety side is stuck in low gear."99
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     Rebecca Eisenberg notes that arising out of its regulatory role, the FDA has gained an important function
when it comes to the promotion of innovation.100 The regulatory regime for drugs and medical devices has
de facto become an important regulatory means to obtain market exclusivity for new products and to guar-
antee financial returns for investors.101 This is a result of various legislative changes that aimed at influen-
cing specific areas of drug development. The Orphan Drug Act of 1983,102 for example, provides sev-
en-year market exclusivity for drugs that are designated by the FDA to treat "orphan diseases." The Drug
Price Competition and Patent Term Restoration Act of 1984,103 widely known as the "Hatch-Waxman Act,"
aims at giving generic drug companies faster access to the market by lifting the requirement that generic
drugs be submitted to the same clinical testing requirements as new innovative drugs. At the same time, it
tries to balance the interests of the generic drug industry with those of patent-holding companies. One of its
most controversial provisions obliges the FDA to automatically halt the regulatory review and approval of a
generic drug for a period of 30 months when a patent-holder claims that the generic drug company is infring-
ing a patent listed with the FDA. This provision, which works even when a claim is clearly unfounded, allows
patent-holders to delay generic competitors from entering the market, thus providing de facto a patent exten-
sion. Finally, in 1997, the FDA Modernization Act104 contained provisions to promote pediatric clinical trials
which also gave the FDA additional power to provide market exclusivity to pharmaceutical companies.
Companies which agree to test their drug in pediatric clinical trials receive an additional 6 months of exclusiv-
ity for their product, during which time the FDA would not approve generic competitors.
    These statutory provisions create direct connections between the FDA review process and the review by
the Patent and Trademark Office, blurring the distinction between drug regulation and patent protection.105
As a result, the FDA has grown into a crucial pillar of the regulatory promotion of innovation, a function that
may cause tension with its mandate to protect the public. For example, the role of the FDA in the patent re-
gime, with its inherent respect for the proprietary nature of information, may undermine its accountability to
the public with respect to its evaluation of drug safety and efficacy.
     There are also significant limits to how drug safety and efficacy are reviewed. Before a new drug can be
tested, the FDA reviews the toxicity profile and other relevant information provided in the Investigational New
Drug Application. Since 1998, applications have to include information on the financial interests of the re-
searchers involved in the supporting studies,106 although it is not clear how the agency uses this informa-
tion. It approves the proposed trial methodology and is involved in subsequent approval of the various trial
stages. Strict reporting obligations exist also during the trials. But as Michael Baram observes in the Ameri-
can context, the reporting obligations are extremely flexible, and "riddled with legalistic exceptions and defe-
rence to investigator judgment on critical matters."107 At the end of the process, the FDA determines wheth-
er the evidence provided shows the drug's efficacy and safety. On the basis of the clinical trials evidence, it
determines how the drug ought to be labeled.108 The agency relies, however, very much on the sponsors,
the researchers, and the IRBs to conduct and manage the trials.109 It has little control over how research
subjects are recruited, where they are recruited, where the research is taking place, who is involved in the
conduct of the trials, and so on. This gives contract research organizations and pharmaceutical sponsors
considerable leeway. For example, they may try to select a patient population that is more likely to respond
to drug treatment; or choose one that is more "drug naïve." Moreover, nothing prevents sponsors from re-
peating or modifying clinical trials after the first fail to show favourable results.
     There are limits on public scrutiny of the PDA's decisions. The FDA is obliged to keep the reports about
the safety and efficacy of these trials and any other communication about these trials confidential, since they
are defined as trade secrets.110 When approving a product, the FDA releases a "Summary Basis of Approv-
al," which includes the reviews of pharmacological, toxicological data and the comments of the FDA review-
ers but not all the detailed reports submitted to the agency.111
     Drug regulatory agencies primarily analyze whether the drugs tested seem safe and have a positive ef-
fect. They do not evaluate how effective the drugs are and whether they are better than products that are
already on the market. Marcia Angell points out that for drug approval purposes it generally suffices to submit
a few positive trials showing that this is the case.112 Considering the liberties that sponsors have in selecting
the patient population and conducting the trial, this requirement is not too much of a hurdle. In the context of
the SSRI trials, David Healy states that since the late 1980s, "it has not... been uncommon for new drugs to
be presented to the FDA which can only be shown to be superior to placebo in perhaps two out of six tri-
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                                   Law, Medicine & Ethics Winter 2004

als."113 Once a drug is approved, publication of selected clinical trial results and other marketing strategies
do the rest.
     The SSRI controversy is revealing in this respect. As discussed earlier, the FDA hearings and the recent
revelations in the scientific literature show us that publications in the scientific literature give a different story
about the efficacy and safety of those drugs for children and adolescents than the data collected and ana-
lyzed internally by pharmaceutical sponsors.114 The clinical trials evidence supporting claims of efficacy and
safety of these anti-depressants in adults also seems quite weak.115 Contrary to popular belief about the
efficacy of these drugs, the data suggested that these drugs may not be much better than a placebo. For all
these years, the regulatory agencies sat on information about negative trial results that a reasonable con-
sumer and the research community would have deemed relevant to public health. Yet, the agencies seemed
to lack the mandate and the legislative basis to reveal information that was not used to support the approval.
     The SSRI controversy also shows that the FDA does not currently focus its attention on post-marketing
monitoring for long-term effects. The biggest hurdle for drug companies remains the approval stage. It seems
remarkable, for example, as Healy reports, that after the 1991 hearings into the safety of SSRIs, FDA offi-
cials already discussed with Eli Lilly the need to undertake further research on the safety of Prozac and to
develop a more sensitive clinical scale to measure potential increased suicidal ideation. According to Healy,
the research was designed but never undertaken and the scale was developed but never used.116
     Another significant concern that arises from the SSRI controversies is the potential lack of independence
of the specialized standing advisory committees on which the FDA relies to review drug applications.117
These committees can also be called upon to review new data about safety of approved drugs, as was done
in the context of the debate about the safety of SSRIs for children and adolescents. The members on these
advisory boards are established medical researchers, many of whom have financial connections to the
pharmaceutical industry. News media investigations reveal that in more than 90% of the FDA committee
meetings, members with financial conflicts of interest participate in the discussions.118
     The SSRI controversy also brings to light how in the current research environment, the regulatory re-
quirement to conduct large clinical trials may be counterproductive if imposed blindly. The manufacturers of
SSRIs have always rejected clinical case-reports linking their products to increased suicidal ideation by refer-
ring to the absence of statistical evidence. Critics argue that clinically significant results can be obtained
through small studies and clinical case-reports, and that the company-sponsored trials used to support the
efficacy and safety of SSRIs were not designed to detect the occurrence of suicidal ideation. The regulatory
requirement of data gathering through clinical trials offers large pharmaceutical companies much power over
the gathering of information. Although these requirements are clearly intended to promote the establishment
of safety and efficacy before allowing a potentially harmful product on the market, they may in the current
context be manipulated for commercial purposes. Large pharmaceutical companies have the financial means
to conduct wide-ranging trials, but may be selective in the type of questions they want answered. Once a
drug is approved, there is considerable commercial pressure not to inquire further into potential side-effects,
and this absence of statistical evidence is then used as a shield against criticism. Few independent organiza-
tions have the financial means to conduct these trials in lieu of the companies. And until an organization such
as the NIH commits the time, personnel and finances to launch a large independent study, the drug can con-
tinue to be promoted on the market.
    Conclusion: Controlling the Leopards
     This discussion demonstrates how drug regulations, governmental patent policies, protection of human
subjects, and the integrity of medical research are fundamentally intertwined. The corporatization of medical
research stimulated through changes in the patent regime has clearly affected all levels of the production,
review and use of medical knowledge. Medical research has become integrated into a highly lucrative, com-
petitive market environment. The drug regulatory system has been adapted to accommodate innovation and
drugdevelopment. Academic research has been significantly commercialized, and the proportion and influ-
ence of commercial research outside of academiahave systematically increased. But the regulatory regimes
aimed at protecting research subjects and the public have not been significantly adapted to this changing
environment. Medical research continues to be regulated as if it were a charitable practice with a pure hu-
manitarian mission.
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     A solution must be based on an understanding of the interactions between the various regulatory re-
gimes and of their respective strengths and weaknesses. In all of these regulatory regimes, the integrity of
scientific research is crucial. Drug and device regulatory agencies rely on the data gained through clinical
trials to assess product safety and efficacy. Health care agencies, whether they are private or public, decide
whether to fund therapies on the basis of the results of scientific research. RECs have to evaluate risks and
benefits to human subjects, relying on data provided by sponsors and on the scientific literature and other-
wise publicly accessible data. As mentioned, their work is affected by conflict of interests.
     But while all these regulatory regimes pay lip service to the concern that conflicts of interest may affect
the conduct and outcome of research, none of them deal sufficiently with the underlying structural causes of
the demise of scientific integrity. In fact, as mentioned earlier, each seems to rely on the appropriate func-
tioning of the other regulatory regimes.119
     Fundamental change in the regulatory review of clinical trials is needed to separate those who design,
conduct and review the research from those who have financial interests in the outcome. Krimsky recom-
mends the establishment of a new National Institute for Drug Testing (NIDT).120 A company wishing to ap-
ply for approval of a new drug would negotiate an appropriate protocol with the NIDT. The NIDT would itself
organize the clinical trial, using qualified drug assessment centers. In Canada, a report of Royal Commis-
sioner Roy Romanow also supports the establishment of an independent National Drug Agency.121 Angell
recommends that a similar institute be established within the National Institutes of Health.122 Such an insti-
tute or agency would be able to root out many of the most troubling practices highlighted earlier. Industry
would no longer be able to hide negative trial data or selectively publish favourable results. Manipulation of
research design and patient selection would also be rooted out. Ghost-authorship would no longer be a con-
cern for physicians or for organizations involved in the development of clinical trials guidelines which rely on
the medical literature.
     The centralization of clinical trials would also make it possible to prioritize drug trials and to avoid the use
of research as a marketing tool. Currently, which drug trial goes ahead is determined more by commercial
ingenuity and the use of financial recruitment incentives than by promising science. Questionable practices
related to competitive research subject enrolment would become much harder in a centralized system. The
Romanow report further recommends in the Canadian context that the drug testing agency evaluate the effi-
ciency of drugs in comparison with other drugs and therapies, to determine their role in evidence-based
medical practice; and that it should also be involved in negotiating and monitoring drug prices. The imple-
mentation of these recommendations would constitute a major support for trustworthy evidence-based medi-
cine and accessible health care.
     An independent drug-testing agency or institute will unlikely be established overnight. But other less rad-
ical measures are quickly needed to tackle at least partially conflict of interest, which one commentator de-
scribed as "the foremost medical research issue of our age."123 As mentioned earlier, there is an urgent
need for a mandatory clinical trials registry, the strengthening of REC review and a further development of
institutional policies within academia.
     Existing professional regulations and traditional legal rules can also be used in the context of research.
In 1995, Bernard Dickens already noted that rules of professional conduct and the law of fiduciary duties can
be used to target inappropriate behaviour of individual health care professionals resulting from conflict of in-
terests.124 More recently, Paul E. Kalb and Kristin Graham Koehler have shown how regulatory and law en-
forcement agencies in the U.S. are increasingly using provisions in the False Claims Act and regulations
dealing with kickbacks and referral fees to combat inappropriate research practices.125 Professional organ-
izations and law enforcement agencies could also use other regulatory and legal means to curb detrimental
research practices.126 The initiative by the Attorney General of New York shows what legal remedies may
be available when pharmaceutical sponsors hide relevant risk information. An interesting more recent de-
velopment is that the securities and Exchange Commission is starting to scrutinize whether pharmaceutical
companies have misled investors by hiding negative data of clinical trials.127 When people are harmed by
inappropriate drug promotion practices, the tort system remains a possible remedy.
   However, focusing the blame on certain health care workers, researchers, companies, institutions and
government agencies, and only after something goes wrong in research or after an approved drug causes
harm is unlikely to heal the medical research enterprise as a whole. An overemphasis on remedies after
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                                   Law, Medicine & Ethics Winter 2004

harm has occurred ignores the rationale behind drug regulation and research ethics review. These regulatory
regimes are both based on the premise that when it comes to the health and well-being of people who par-
ticipate in research or who are in need of treatment, prevention of harm should be our goal.
    Krimsky and the Association of American Medical Colleges appropriately call for a new "culture of con-
science" and a revitalization of the values of academic science. A strong independent academic sector in
medical research is indeed crucial. While most medical researchers and academics will appreciate this as an
independent value, it may help to invoke a more utilitarian argument. In an interview with the Atlantic
Monthly, Nobel Prize Winner Paul Berg claims that the ability to conduct research without concern for imme-
diate commercial applications is what lies behind many of the most innovative discoveries, including Berg's
own theoretical academic research, which underlies much of the biotechnology revolution, so much heralded
by industry.128
     The necessary change within academia cannot be achieved without some incentives. The development
of tighter regulatory control and the threat of legal and regulatory sanctions as well as changes to the internal
professional reward structures of academia and increased public funding should provide the necessary in-
centives.
      Not unlike the leopards in Kafka's parable, the pharmaceutical industry has clearly become a fundamen-
tal part of the ceremony of science. But while Kafka's leopards are unaware of their role in the ceremony,
industry has deliberately taken control. The recent controversies constitute a wake-up call for regulatory and
funding agencies, academic institutions, the political community and the public. Industry can no longer be
removed from the temple of which it has become a constitutive part. New rules will not evict them, but may
still prevent them from interfering where it matters most: the inner sanctum of research, where research inte-
grity is held sacrosanct, research data are shared and scrutinized, and uncontrolled self-interested behavior
should be banned. While the leopards will still roam around in some parts of the temple, they should no
longer be allowed to dominate our most important rituals.
    Acknowledgements
    Much of the research for this paper was conducted while I was a member at the School of Social
Science at the Institute for Advanced Studies in Princeton. I thank the Institute as well as the Ontario Ge-
nomics Institute (Genome Canada) for its generous support. Members of the School of Social Science
(2003-2004) provided excellent comments on a related presentation. I am particularly grateful to Tod Cham-
bers, Louis Charland, Adriana Petryna and Carl Elliott for suggestions and discussions. Parts of this paper
are also developed in an article in the MonashBioethics Review (23:4,2004:1940) and in T. Lemmens, "Les
conflits d'intérêts dans le temple de la science médicale: diagnostic et options thérapeutiques," in Ysolde
Gendreau, ed., Dessiner la société par le droit/Mapping Society Through Law (Montréal, Les Éditions
Thémis, 2004) 77-115. I thank Linda Hutjens for providing excellent administrative and editing support and
Angela Long for work on the footnotes.

SIDEBAR
     Healy was offered the position of the director of the Mood and Anxiety Program at the Centre for Addic-
tion and Mental Health (CAMH), a leading psychiatric research institution affiliated with the University of To-
ronto. This offer was rescinded shortly after he gave a public lecture at CAMH reiterating his view that phar-
maceutical companies had failed to fully investigate the link between SSRIs and an increased risk of suicide.

SIDEBAR
    The SSRI and other controversies can be situated in the context of the commercialization of medical re-
search. The enactment of the Bayh-Dole Act of 1980 is generally heralded as the primary cause of the in-
creasingly commercial orientation of medical research in the United States. The Act allowed American uni-
versities and researchers to obtain privately-owned patents on the results of federally-funded research.

SIDEBAR
    While academic researchers may seem to offer greater legitimacy to a study, they are not necessarily
involved in the design of the study, often do not have access to the complete data and may do nothing more
                                                                                                 Page 33
Leopards in the Temple: Restoring Scientific Integrity to the Commercialized Research Scene The Journal of
                                   Law, Medicine & Ethics Winter 2004

than collect and forward information about a small number of research subjects in exchange for authorship
credit.

SIDEBAR
    The FDA and drug regulatory agencies in other countries were established to enable an independent
assessment of the safety and efficacy of drugs before they are allowed onto the market. But the controver-
sies raise questions about how well they function and reveal some of their limitations.

SIDEBAR
     The FDA is obliged to keep the reports about the safety and efficacy of these trials and any other com-
munication about these trials confidential, since they are defined as trade secrets. When approving a prod-
uct, the FDA releases a "Summary Basis of Approval," which includes the reviews of pharmacological, tox-
icological data and the comments of the FDA reviewers but not all the detailed reports submitted to the
agency.

SIDEBAR
     Recent controversies show how commercial interests may impact on the integrity of medical research
and how this affects research subjects and health care consumers. While various regulatory mechanisms
rely on the integrity of medical research, none of them currently provide sufficient safeguards. New regulato-
ry measures are required to restore scientific integrity and to protect the public, including separating those
who have financial interests in the research outcome from those who conduct clinical trials.

LOAD-DATE: October 25, 2007

LANGUAGE: ENGLISH

ACC-NO: 18317


BIBLIOGRAPHY: References
    1. AG New York v. GlaxoSmithKline, June 2, 2004 at paragraph. 38.
    2. Id. [emphasis in claim].
   3. Seroxat/Paxil - Adolescent Depression. Position Piece on the Phase III Clinical Studies, October 1998.
Document obtained from David Healy and in author's files.
     4. The British agency had explicitly advised against prescription of SSRIs other than fluoxetine (Prozac).
British Medicines and Healthcare Products Regulatory Agency, "Safety review of antidepressants used by
children completed," (Reference 2003/0505), available at http://www.mhra.gOv.uk/news/ssrLl01203.htm.
     5. Health Canada had issued a formal warning that SSRIs were not approved for use in children and
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summary of the preliminary report is available and that 9 months after this release, the full report has not
come out yet.
   7. The document contains extensive conflict of interest statements. Five were members of at least one
speaker bureau of a pharmaceutical company. see id., at 19-22.
                                                                                                 Page 34
Leopards in the Temple: Restoring Scientific Integrity to the Commercialized Research Scene The Journal of
                                   Law, Medicine & Ethics Winter 2004

    8. D. Healy, Letter to Peter J. Pitts, Associate Commissioner for External Relations, Food and Drug Ad-
ministration, February 19, 2004 (copy in files of author).
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2004, at A-I. U.S. Food and Drug Administration, "FDA Launches a Multi-Pronged Strategy to Strengthen
Safeguards for Children Treated With Antidepressant Medications," (October 15, 2004) (news release).
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2004, at A-02.
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   12. M. Angell, The Truth About the Pharmaceutical Industry: How They Deceive Us and What to Do
About It (New York: Random House, 2004): at 166. The fact that advertising agencies took the lead in these
acquisitions highlights some of the developments in medical research described further. see infm.
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24, 2004).
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    17. Dr. Charles Nemeroff was also the focus of a high profile controversy over his lack of disclosure of
significant financial interests in a review for Nature Neuroscience. see infra.
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   22. E. Shorter, A History of Psychiatry: From the Era of the Asylum to the Age of Prozac (New York:
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    24. For a detailed investigative journalism report on the Fen-Phen controversy, see A. Mundy, Dispens-
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    25. S.P. Duffy, "Judge Approves Fen-Phen Settlement," The Legal Intelligencer, August 29, 2000, at 1.
The court saga continues, though. In the coming months, more than 5,800 cases are expected to go to trial
in New Jersey alone. see C. Toutant, "NJ. Judge Readies First Batch of Fen-Phen Lawsuits for Trial," New
Jersey Law Journal, August 10, 2004.
    26. G. Kolata and M. Petersen, "Hormone Replacement Study a Shock to the Medical System," Neio
York Tunes July 10, 2002, at A-1.
   27. M. Petersen, "Court Papers Suggest Scale of Drug's Use," New York Times, May 30, 2003, at C-I; T.
Emery, "Whistleblower's Law Suit Being Closely Watched by Industry," Associated Press, August 10, 2003;
                                                                                                 Page 35
Leopards in the Temple: Restoring Scientific Integrity to the Commercialized Research Scene The Journal of
                                   Law, Medicine & Ethics Winter 2004

L. Kowalczyk "Pfizer Drug Strategy Probed: States Question Marketing Tactics for Neurontin," Boston Globe,
October 18, 2002, at D-2.
    28. EJ. Topol, "Failing the Public Health - Rofecoxib, Merck, and the FDA," New Engl. J. Med. 351
(2004): 1707-1709, at 1707.
    29. M. Kaufman, "FDA Official Alleges Pressure to Suppress Vioxx Findings," Washington Post, October
8, 2004, at A-23.
   30. Editorial, "Vioxx: An Unequal Partnership Between Safety and Efficacy," The Lancet 364 (2004):
1287-1288, at 1288.
    31. See T. Bodenheimer, "Uneasy Alliance: Clinical Investigators and the Pharmaceutical Industry," New
Engl. J. Med. 342 (2000): 1539-1544; and R.A. Rettig, "The Industrialization of Clinical Research," Health
Affairs 19, no. 2 (2000): 129-146. For two recent books on the subject, see S. Krimsky, Science in the Pri-
vate Interest: Has the Lure of Profit Corrupted Biomedical Research? (Lanham: Rowman & Littlefield, 2003);
and Angell, supra note 12 .
   32. Act of Dec. 12, 1980, Pub. L. No. 96-517, Section 6(a), 94 Stat 3015, 3019-28 (1980) (codified as
amended at 35 U.S.C. Sections 200-212 (2994).
    33. See A.K. Rai, "Regulating Scientific Research: Intellectual Property Rights and the Norms of
Science" Northwestern University Law Review 77 (1999): 77-152, at 93-94.
    34. See e.g. Canadian Institutes for Health Research, CIHR: Towards A National Health Research
Agenda (2001) at 10, available at http://www.cihr-irsc.gc.ca/e/publications/revolution.pdf; and CIHR, Trans-
forming Health Research In Canada, available at http://www.cihr-irsc.gc.ca/e/publications/cbj_supplement
_e.pdf (last visited October 24, 2004). This publicity appeared as a supplement in the magazines Canadian
Business and Actualité.
     35. Genome Canada and The Canadian Networks of Centres of Excellence Program (CNCEP) are the
best examples of such initiatives. See the discussion in "Les conflits d'intérêts dans le temple de la science
médicale: diagnostic et options thérapeutiques" in Ysolde Gendreau, ed., Dessiner la société par le
droit/Mapping Society Through Law (Montréal, Les Éditions Thémis, 2004): 77115. For Genome Canada,
see http://www.genomecanada.ca/ GCgenomeCanada/enBref/index.asp?l=e. The CNCEP "fosters powerful
partnerships between university, government and industry" and is "aimed at turning Canadian research and
entrepreneurial talent into economic and social benefits for all Canadians." See
http://www.nce.gc.ca/about_e.htm. One of its recently funded centers is the Stem Cell Network which, as
requested by the agency, has a dual mandate to promote high quality health research as well as the devel-
opment of a vibrant biotechnology sector around stem cell research and which is currently planning to set up
a commercial stem cell venture.
    36. M. McCoy, "Bristol-Myers Study Backfires," Chemical and EngineeringNews 82, no. 11 (2004): 8.
   37. R. Winslow, "For Bristol-Myers, Challenging Pfizer Was A Big Mistake," Wall Street Journal, March 9,
2004, at 1.
    38. S. Elliott, "Viagra and the Battle of the Awkward Ads," New York Times, April 25, 2004, at 3-1.
    39. Editorial, "Depressing Research," The Lancet 363 (2004): at 2088.
    40. D. Willman, "Stealth Merger: Drug Companies and Government Medical Research," Los Angeles
Times, December 7, 2003, at A1; D. Willman, "Ex-NIH Director Now Favors Limiting DrugCompany Ties,"
Los Angeles Times, March 13, 2004, at A-21.
    41. See infra notes 116-117 and text there.
     42. For a critical analysis of industry's use of patient advocacy groups, see B. Mintzes, Blurring the
Boundaries: New Trends in Drug Promotion (Amsterdam: Health Action International, 1998): Ch. 1, available
at http://www.haiweb.org-/pubs/blurring7blurring. intro.html (last visited October 24, 2004).
                                                                                                 Page 36
Leopards in the Temple: Restoring Scientific Integrity to the Commercialized Research Scene The Journal of
                                   Law, Medicine & Ethics Winter 2004

    43. F. Mills, Patient Groups a7id the Global Pharmaceutical Industry: The growing importance of working
directly with the consumer (Urch Publishing: London, 2000). Abstract available at http://
www.mindbranch.com/listing/product/R410-0024.html.
    44. In a recent lull-page advertisement in the New York Times, the American Alzheimer's Association in-
vited people to support "further research into prevention and a cure," to "help ensure that our memories of
Ronald Reagan live on." The advertisement, which contains the questionable statement that "treatments are
available," was sponsored by two producers of Alzheimer drugs, Pfizer and Eisai - not surprisingly also the
major contributors to the Association. New York Times, June 11, 2004 at A-17.
   45. For a discussion of the use of Phase IV trials to boost drug prescription, see Angell, supra note 12, at
161-169.
    46. See Krimsky, supra note 31, at 79-81.
    47. Id. at 80.
     48. Department of Health and Human Services, Office of Inspector General, Recruiting Human Subjects:
Pressures in Industrysponsored Research (June 2000), available at http://oig.hhs.gov
/oei/reports/oei-01-97-00195.pdf.
    49. See Angell, supra note 12, at 101.
    50. See T. Lemmens and C. Elliot, "Guinea Pigs on the Payroll: The Ethics of Paying Research Sub-
jects" Accountability in Research 7 (1999): 3-20, for a discussion of problems and for further references re-
lated to the use of payment to subjects. For a discussion of, and references to, the use of finder's fees to
promote recruitment, see T. Lemmens and P.E. Miller, "The Human Subjects Trade: Ethical and Legal Is-
sues Surrounding Recruitment Incenuves','Journal of Law, Medicine & Ethics 31 (2003): 398-418.
    51. J.A Goldner, "Dealing with Conflicts of Interest in Biomédical Research: IRB Oversight as the Next
Best Solution to the Abolition Approach," Journal of Law, Medicine & Ethics 28 (2000): 379-404. See also J.
Silberner, "A Gene Therapy Death," Hastings Center Report 30, no. 2 (2000): 6.
    52. Committee on Assessing the System for Protecting Human Research Participants, Institute of Medi-
cine, Responsible Research: A Systems Approach to Protecting Research Participants (Washington D.C.:
National Academies Press, 2001), at 38.
    53. Id. at 10-11.
     54. Association of American Medical Colleges, Task Force on Financial Conflicts of Interest in Clinical
Research, Protecting Subjects, Preserving Trust, Promoting Progress: Policy and Guidelines for the Over-
sight of Individual Financial Conflict of Interest in Human Subjects Research (2001): at 3, available at
http://www. aamc.org/members/coitf/start.htm.
    55. Department of Health and Human Services, Financial Relationships and Interests in Research In-
volving Human Siibjects: Guidance for Human Subject Protection, (2004) 69 Federal Register 26393 at
26394 [DHHS, Guidance Document]. See also EJ. Emanuel et al., "Oversight of Human Participants Re-
search: Identifying Problems to Evaluate Reform Proposals," Annals of Internal Medicine 141 (2004):
282-291.
    56. For the impact of commercial recruitment practices, see e.g. Department of Health and Human Ser-
vices, Office of Inspector General, Recruiting Human Subjects: Pressures in Industry-sponsored Research
(2000). For further references, see the articles supra note 50.
    57. Association of American Medical Colleges, supra note 54.
    58. See J. Lexchin et al. "Pharmaceutical Sponsorship and Research Outcome and Quality: Systemic
Review," British Medical Journal 326 (2003): 1167-1177; and J.E. Bekelman, Y. Li and C.P. Gross, "Scope
and Impact of Financial Conflicts of Interest in Biomedical Research," JAMA 289 (2003): 454-465 at 463.
    59. Krimsky, supra note 31, at 148-149.
                                                                                                 Page 37
Leopards in the Temple: Restoring Scientific Integrity to the Commercialized Research Scene The Journal of
                                   Law, Medicine & Ethics Winter 2004

    60. Hilts reports how concerns about advertising revenues led the American Medical Association to stop
publishing lists of fraudulent and useless drugs in the early 1950s. The association was losing the revenue of
drug advertisements in its publications. Protecting America's Health: The FDA, Business, and One Hundred
Years of Regulation (New York: Alfred Knopf, 2003): at 127.
    61. See J.M. Drazen and G.D. Curfman, "Financial Associations of Authors," New Engl. J. of Med. 346
(2002): 1901-1902.
    62. C.B. Nemeroff and MJ. Owens, "Treatment of Mood Disorders," Nature Neuroscience S, suppl.
(2002): 1068. See the discussion of the controversy in S. Brownlee, "Doctors Without Borders," Washington
Monthly 36, no. 4 (2004): 38-43.
    63. Editorial, Nature Neuroscience 6 (2003): 997.
    64. See Petersen, supra note 26.
    65. See Willman (2003), supra note 40.
    66. See D. Rennie and A. Flanagin, "Authorship! Authorship! Guests, Ghosts, Grafters, and the
Two-Sided Coin," JAMA 274 (1994): 469-471; Bodenheimer, supra note 31; W.T. Carpenter, "From Clinical
Trial to Prescription," Archives of General Psychiatry 59 (2002): 282-285.
   67. A. Flanagin et al. "Prevalence of Articles with Honorary Authors and Ghost Authors in Peer-Reviewed
Medical Journals," JAMA 280(1998): 222-224.
    68. Supra note 12 at 157-161.
    69. See e.g. supra note 55.
     70. See e.g. Medical Research Council of Canada (MRC), Natural Sciences and Engineering Research
Council of Canada (NSERC), Social Sciences and Humanities Research Council of Canada (SSHRC),
Tri-Council Policy Statement (Ottawa: Minister of Supply and Services, 1998), at Art. 4.1. In the section
dealing with clinical trials, the Policy Statement also explicitly requires REBs to examine the budgets of clini-
cal trials (see Art. 73).
   71. Regulations Amending the Food and Drug Regulations (1024 Clinical Trials), P.C. 2001-1042, C.
Gaz. 2001.II.1116, at 1131. See the discussion in Lemmens and Miller, supra note 50.
    72. Editorial, supra note 39.
    73. See Healy supra note 20.
    74. H. Dowling, cited in Hilts, supra note 60, at 125.
    75. Id. at 126.
    76. See text supra at note 41 and 65.
    77. The Cochrane Group keeps, for example, a detailed evidencebased database of various therapeutic
products. Available at http://www.cochrane.org/indexO.htm.
    78. See R. Drummond, "Fair Conduct and Fair Reporting of Clinical Trials," JAMA 282 (1999): 1766; and
A.D. Sniderman, "The Need for Greater Involvement of Regulatory Agencies in Assessing Adverse Drug
Reactions," Canadian Medical Association Journal 162 (2000): 209.
    79. C. De Angelis et al. "Clinical Trial Registration: A Statement from the International Committee of
Medical Journal Editors," New Engl. J. Med. 351 (2004): 1250-51. The committee includes the editors of the
Journal of the American Medical Association, the New England Journal of Medicine, theLancet and the Ca-
nadianMedicalAssociation Journal.
    80. Id., at 1251.
    81. Office of Inspector General, Department of Health and Human Services, Institutional Review Boards:
A Time for Reform (Boston, MA: Office of Inspector General, 1998); U.S. National Bioethics Advisory Com-
mission, Ethical and Policy Issues in Research Involving Human Participants (Bethesda, MD: National Bio-
                                                                                                 Page 38
Leopards in the Temple: Restoring Scientific Integrity to the Commercialized Research Scene The Journal of
                                   Law, Medicine & Ethics Winter 2004

ethics Advisory Commission, 2001); Committee on Assessing The System for Protecting Human Research
Participants, Institute of Medicine, Responsible Research: A Systems Approach to Protecting Research Par-
ticipants (Washington DC : National Academies Press, 2001). Similar criticism can be found in the Canadian
context. see: Law Commission of Canada, The Governance of Health Research Involving Human Subjects,
Michael M. McDonald, ed. (Ottawa: Law Reform Commission of Canada, 2000).
     82. See the discussion in D.R. Waring and T. Lemmens, "Integrating Values in Risk Analysis of Biomed-
ical Research: The case for Regulatory and Law Reform," University of Toronto Law Journal 54 (2004):
249-290 at pp. 277-282.
    83. E.G. Cambell et al., "Characteristics of Medical School Faculty Members Serving on Institutional Re-
view Boards: Results of a National Survey" Academic Medicine 78 (2003): 831-836, at 833834.
    84. See L. Francis, "IRBs and Conflicts of Interest," in R.G. Spece, D.S. Shimm and A.E. Buchanan, eds,
Conflicts of Interest in Clinical Practice and Research (New York: Oxford University Press, 1996): 418-436;
M.K. Cho and P. Billings, "Conflict of Interest and Institutional Review Boards," Journal of Investigative Medi-
cine, 45 (1997): 154-159; T. Lemmens and B. Freedman, "Ethics Review for Sale? Conflict of Interest and
Commercial Research Review Boards,"Milbank Quarterly 78 (2000): 547-584.
     85. See T. Lemmens and A. Thompson, "Non-Institutional Research Review Boards in North America: A
Critical Appraisal and Comparison with IRBs," IRB: Ethics and Human Research 23, no. 2 (2001): 1-12; and
Lemmens and Freedman, id.
    86. DHHS, Guidance Document, supra note 55, at 26396.
    87. Association of American Medical Colleges, supra note 54; and Association of American Medical Col-
leges, Task Force on Financial Conflicts of Interest in Clinical Research, Protecting Subjects, Preserving
Trust, Promoting Progress II - Principles and Recommendations for Oversight of an Institution's Financial
Interests in Human Subjects Research (2002), available at http://www.
aamc.org/members/coitf/2002coireport.pdf (last visited October 24, 2004).
    88. P. Gelsinger, "Uninformed Consent," in T. Lemmens and D.R. Waring, eds., New Directions in Bio-
medical Research: Regulation, Conflict of Interest, and Liability (Book manuscript under review, University of
Toronto Press).
   89. See S. Van McCrary et al., "A National Survey of Policies on Disclosure of Conflicts of Interest in
Biomedical Research," New Engl J. Med. 343 (2000): 1621-1626; and M.K. Cho et al, "Policies on Faculty
Conflicts of Interest at US Universities," JAMA 284 (2000): 2203-2208.
    90. See J. Thompson, P. Baird and J. Downie, The Olivieri Report: The Complete Text of the Report of
the Independent Inquiry Commissioned by the Canadian Association of University Teachers (Toronto: James
Lorimer, 2001); see Lemmens and Miller, supra note 50 at 412 and references there.
   91. K.A. Schulman et al., "A National Survey of Provisions in ClinicalTrial Agreements between Medical
Schools and Sponsors," New Engl. J. Med. 347 (2002): 1335-1341, at 1339.
    92. A.R. McCabe, "Note: A Precarious Balancing Act - The Role of the FDA as Protector of Public Health
and Industry Wealth," Suffolk University Law Review 36 (2003): 787-819.
   93. D. Willman, "How A New Policy Led to Seven Deadly Drugs,"Los Angeles Times, December 20,
2000, at A-1, available at http:// www.drugawareness.org/Archives/Miscellaneous/122002Howa new.html
    94. See Angell, supra note 12, at 209.
    95. See Topol, supra note 28, at 1708.
    96. Pub. L. No. 102-571, Title I, 102-105 Stat. 4491 (codified at 21 U.S.C. 379g, 379h). The permission
to use user fees was renewed in the Food and Drug Administration Modernization Act of 1997, 21 U.S.C.
301 (1997). For a discussion of this Act, see J. Kulynych, "Will FDA Relinquish the 'Gold Standard' for New
Drug Approval? Redefining 'Substantial Evidence' in the FDA Modernization Act of 1997," Food Drug Law
Journal 54 (1999): 127-149, at 127.
                                                                                                 Page 39
Leopards in the Temple: Restoring Scientific Integrity to the Commercialized Research Scene The Journal of
                                   Law, Medicine & Ethics Winter 2004

   97. See the discussion in Angell, supra note 12, at 210. See also Hilts, supra note 60, at 276-290; and
McCabe, supra note 91, at 792-794.
   98. Hilts, id., at 280. Marcia Angell states bluntly that the drug regulatory agencies have become "big
pharma's handmaiden." Supra note 12, at 243.
   99. S. Pomper, "Drug Rush: Why the Prescription Drug Market is Unsafe at High Speeds," Washington
Monthly 32, no. 5 (2000): SI37, available at http://www.washingtonmonthly.com/featnres/
2000/0005.pomper.html.
    100. R. Eisenberg, "The Robert L. Levine Distinguished Lecture Series: Patents, Product Exclusivity, and
Information Dissemination: How Law Directs Biopharmaceutical Research and Development," Fordham Law
Review 72 (2003): 477-491, at 489.
    101. Id., at 477. For a discussion of the effect of these statutory provisions, see also Angell, supra note
12, at 173-192.
    102. Orphan Drug Act of 1983, Pub. L. No. 97-414, 96 Stat. 2049 (1983) (codified as amended in sec-
tions of 15, 21, 26 U.S.C.). See the discussion in McCabe, supra note 91, at 795-796.
    103. Pub. L. No. 98-417,98 Stat. 1585 (1984) (codified as amended at 15, 21, 28, 35 U.S.C.).
    104. Pub. L. 105-115, 111 Stat. 2296 (1977).
    105. See Eisenberg, supra note 100.
    106. 21 C.F.R. 54(1998).
    107. See the discussion by M. Baram, "Making Clinical Trials Safer for Human Subjects," American
Journal of Law & Medicine 253 (2001): 271-283, at 262 and 274.
     108. The label determines the official purpose for which a drug can be prescribed. It does not prevent
physicians from prescribing the drug for other use - opening the door to various promotional tactics for
off-label use. Promotion of off-label prescription was one of the controversial practices in the case of Neuron-
tin (see supra).
    109. Baram, supra note 107, at 262.
    110. Id. at 253.
   111. Health Canada only gives access to the much less informative official product monograph. See J.
Lexchin, "Ssecrecy and the Health Protection Branch," Canadian Medical Association Journal 159 (1998):
481-483, at 482-483.
    112. See Angell, supra note 12, at 112.
    113. See Healy, supra note 13 at 85.
    114. E. J. Garland, "Facing the Evidence: Antidepressant Treatment in Children and Adolescents," Ca-
nadian Medical Association Journal 170 (2004): 489-492; CJ. Whittington et al., "Selectiveserotonin reuptake
inhibitors in childhood depression: systematic review of published versus unpublished data," The Lancet 363
(2004): 1341-1345.
    115. See Healy, supra note 13, at 83-90; and Angell, supra note 12, at 112-113.
    116. See Healy, id., at 116-119.
    117. See Angell, supra note 12, at 210.
      118. See id. and reference there. As mentioned, this is not unique to the drug regulatory agency. E. Mar-
ris, "Ethics Review Slams Government Panels Over Conflicts of Interest," Nature 431 (2004): at 3.
    119. Lars Noah, for example, seems to have confidence in the current REC review system because of
the existence of complementary regulatory regimes. see "Deputizing Institutional Review Boards to Police
(Audit?) Biomedical Research," Journal of Legal Medicine 25 (2004): 267-293, in particular at 273-275.
                                                                                                 Page 40
Leopards in the Temple: Restoring Scientific Integrity to the Commercialized Research Scene The Journal of
                                   Law, Medicine & Ethics Winter 2004

    120. See Krimsky, supra note 31, at 229.
    121. Commission on the Future of Health Care in Canada, Building on Values: The Future of Health
Care in Canada, Final Report (2002), in particular at 199-210, available at http://www.
hc-sc.gc.ca/english/pdf/romanow/pdfs/HCC_Final_Report.pdf
    122. See Angell, supra note 12, at 244-247.
     123. S. Neilson, "Healy and Goliath: The Creation of Psychopharmacology," Canadian Medicial Associa-
tion Journal 170 (2004): 501-502.
    124. B. Dickens, "Conflicts of Interest in Canadian Health Care Law," American Journal of Law & Medi-
cine 21, no. 2-3 (1995): 259280, in particular at 273-274.
    125. P.E. Kalb and K.G. Koehler, "Legal Issues in Scientific Research," JAMA 287 (2002): 85-91.
    126. See Lemmens & Miller, supra note 50.
   127. Jeffrey Krasner, "See focusing on drug makers: Full disclosure of tests called key," Boston Globe,
September 27, 2004, at C-4.
    128. E. Press and J. Washburn, "The Kept University," Atlantic Monthly (March 2000): 39-54, at 54.

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SUBJECT: CAN TOBACCO CURE SMOKING? A REVIEW OF
TOBACCO HARM REDUCTION

CHAIRED BY: REPRESENTATIVE CLIFF STEARNS (R-FL)
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 HEARING OF THE COMMERCE, TRADE, AND CONSUMER PROTECTION SUBCOMMITTEE OF THE
  HOUSE ENERGY AND COMMERCE COMMITTEESUBJECT: CAN TOBACCO CURE SMOKING? A
   REVIEW OF TOBACCO HARM REDUCTIONCHAIRED BY: REPRESENTATIVE CLIFF STEARNS
  (R-FL)LOCATION: 2123 RAYBURN HOUSE OFFICE BUILDING, WASHINGTON, D.C. Federal News
                              Service June 3, 2003 Tuesday
LOCATION: 2123 RAYBURN HOUSE OFFICE BUILDING,
WASHINGTON, D.C.
LENGTH: 23953 words

    (PANEL ONE)
   REP. CLIFF STEARNS (R-FL): Good morning. The subcommittee will come to order. Without object, the
subcommittee will proceed pursuant to committee rule 4(e) so ordered. The chair recognizes himself for an
opening statement.
    I am pleased to welcome all of you to the Commerce, Trade and Consumer Protection Subcommittee
hearing on tobacco harm reduction. No one disputes the harm to human health from cigarette smoking.
Smokers are at sixteen fold increased risk of lung cancer, twelve fold increased risk of chronic obstructive
pulmonary disease, and a twofold increased risk of myocardial infarction.
    Oncologists estimate that smoking-related illnesses were responsible for 100 million deaths in the 20th
century. Those increases kill some 400,000 Americans every year. Over the last few decades, this country
has invested substantial public and private resources to encourage smokers to quit using tobacco. That in-
vestment has paid off. We have made great gains in reducing the use of cigarettes. While in 1965, 42 per-
cent of Americans smoked cigarettes, today only 26 percent of men and 22 percent of women are smokers.
    While this is the good news, as noted in the Institute of Medicine report, quote, "Clearing the Smoke,"
end quote, the decline in the rates of smoking among adults has leveled off during the 1990s. So where do
we go from here?
    Today were are here to discuss tobacco harm reduction. Harm reduction strategies have been used for a
number of years for a variety of different societal problems. For example, clean needle programs are used to
prevent the spread of HIV, methadone programs are employed to prevent the use of illicit drugs, and sex
education is provided to stem the rising tide of teen pregnancy and disease.
      The title of our hearing, quote, "Can Tobacco Cure Smoking?" end quote, at first blush seems counterin-
tuitive. However, there is an increasing amount of research suggesting that some tobacco products are less
harmful than others. For those smokers who can't seem to quit smoking, switching to a less hazardous
product could save lives.
    Today we will hear from a diverse group of experts espousing a range of opinions on issues of tobacco
harm reduction. We worked closely with the minority to ensure a fair and balanced staff of witnesses that can
speak to the science of this issue. One of our witnesses today, Dr. Brad Rodu, will assert that smokeless
tobacco products are 98 percent safer than cigarettes, and that by switching committed smokers to smoke-
less products, we can save lives. We will also hear of the potential societal harms that may result from pro-
motion of tobacco harm reduction claims. Some believe that switching from one tobacco product to another
does nothing to solve the tobacco problem.
     The Federal Trade Commission has general regulatory authority over misleading and deceptive adver-
tising, as well as the specific authority over the advertising and marketing of tobacco products. As tobacco
companies attempt to market their products as reduced risk, as one company has already tried to do, the
Federal Trade Commission will be in the position of evaluating these claims. So I look forward to Chairman
Muris, how his commission plans to deal with these, shall we say vexing issues.
    We will also hear from the surgeon general, who is the principal advisor to the secretary of Health and
Human Services on public health and scientific issues. Tobacco has long been a subject of surgeon general
reports. As we move into a new era of tobacco debates, we welcome Vice Admiral Carmona to the Com-
merce, Trade and Consumer Protection Subcommittee.
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  HEARING OF THE COMMERCE, TRADE, AND CONSUMER PROTECTION SUBCOMMITTEE OF THE
    HOUSE ENERGY AND COMMERCE COMMITTEESUBJECT: CAN TOBACCO CURE SMOKING? A
     REVIEW OF TOBACCO HARM REDUCTIONCHAIRED BY: REPRESENTATIVE CLIFF STEARNS
    (R-FL)LOCATION: 2123 RAYBURN HOUSE OFFICE BUILDING, WASHINGTON, D.C. Federal News
                                         Service June 3, 2003 Tuesday
     Our goal should always be to reduce the use of tobacco. In that light, today's hearing provides an oppor-
tunity to examine the efficacy of the tobacco harm reduction approach which calls for minimizing and de-
creasing amongst cigarette smokers without completely eliminating tobacco and nicotine use.
    In closing, I want to thank the witnesses for appearing before the committee. I look forward to their tes-
timony and in addition, I seek unanimous consent to enter into the record the written testimony of Mike Szy-
manczyk, chairman and chief executive officer, Philip Morris USA. Without objection, so ordered.
    At this point, I invite other members to do the same, if they wish to enter documents into the record and
with that, I welcome my ranking member for opening statement.
    REP. JAN SCHAKOWSKY: Thank you, Mr. Chairman. It's good to see you again.
    Well, you've got to hand it to the tobacco lobby. If there were such a things as a hutzpah award, which
roughly translates into brazen gall, the effort today, in my humble opinion, would be worthy of a prize. Under
the guise of concern for public health, the tobacco industry has us here to discuss its efforts to gain ad-
vanced government approval of a marketing campaign that would promote tobacco products and their bot-
tom line. "Smokeless tobacco", I put that in quotes, is a dressed-up name for dip, chew or spit tobacco. U.S.
Tobacco, UST, wants to market its spit tobacco as a safer alternative to smoking cigarettes.
    Smokeless tobacco is a threat to our nation's public health and specially to the health of our children.
Any type of claim that spit tobacco is a safer alternative to smoking requires a substantive body of evidence
and an independent regulatory body capable of examining the claims. Such evidence and regulation does
not exist. UST cannot back up their campaign slogans and that is why they have asked the FTC not the FDA,
the FTC being a non-scientific regulatory agency, to review the claims they want to make.
     Tobacco causes cancer and other diseases, whether you smoke it, chew it, suck it, put it up your nose. It
can, and after sustained use, probably will kill you. UST's argument that smokeless tobacco use as a heal-
thier alternative to smoking is analogous to suggesting that one is better off the fifth floor of a building rather
than the 20th because, of course, both are likely to cost you your life. They want to convince smokers who
may be trying to quit or have quit, non- smokers' children and others that their product is okay to use. If we
allow them to make these false claims, then the Congress will share the blame for more lives lost to tobacco
related diseases.
    The government has no business endorsing media campaigns for products like spit tobacco that lead to
disease and premature death. First, we should do no harm. If we send a message to the American public
that it's okay to chew tobacco, we will be doing harm. If we instead want to truly discuss ways to reduce harm
and promote health, we should spend time and money on legitimate ways to end the use of tobacco in any
form, period.
     Today, along with Congressman Waxman, I will be releasing a report entitled The lessons of "light," in
quotes, and low tar cigarettes. Without effective regulation, reduced risk tobacco products, so-called reduced
risk tobacco products, threaten the public health. Mr. Chairman, I ask unanimous consent to insert the report
into the hearing record.
    REP. STEARNS: Without objection, so ordered.
    REP. SCHAKOWSKY: Thank you.
     I think it's an important document to include in the official record because it underscores parallels docu-
mented by the Government Reform Committee's Democratic staff between the efforts of the tobacco industry
to mislead the public into believing that so-called light and low tar cigarette products are a healthier alterna-
tive to regular cigarettes and the efforts currently under way by UST to convince the Congress, the FTC and
the public of the virtues of its spit tobacco products.
    This report includes previously undisclosed internal industry documents and demonstrates that the
products that are marketed as light and low tar are in fact not. We know that the tobacco industry duped the
FTC's tests by designing cigarettes that only appeared healthier when tested by machines but they did not
provide lower amount of tar and nicotine to smokers.
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  HEARING OF THE COMMERCE, TRADE, AND CONSUMER PROTECTION SUBCOMMITTEE OF THE
    HOUSE ENERGY AND COMMERCE COMMITTEESUBJECT: CAN TOBACCO CURE SMOKING? A
     REVIEW OF TOBACCO HARM REDUCTIONCHAIRED BY: REPRESENTATIVE CLIFF STEARNS
    (R-FL)LOCATION: 2123 RAYBURN HOUSE OFFICE BUILDING, WASHINGTON, D.C. Federal News
                                        Service June 3, 2003 Tuesday
     We know that the industry has, for some time, been well aware of the dangers these products pose. In
an internal company e-mail included in this report, a senior research scientist at British American Tobacco
stated, quote, "Our main problem appears to be the notion that the technology exists to make cigarettes
which are appreciably less lethal. The technology does not exist. It will not exist." Unquote.
     The report also demonstrates that tobacco industry officials continue to deceive the public. With informa-
tion from industry, the National Cancer Institute and the Department of Justice, the report provides clear
examples of current, quote, "reduced risk," unquote product marketing, including the marketing of spit to-
bacco specifically designed to counter health fears, deceive consumers, deter quitting, and exploit the ab-
sence of effective regulation. If the FTC allowed for the marketing of light and low tar products in the past
and the public was harmed. Now major law suits have ensued. In my home state of Illinois a court recently
ruled against Phillips Morris and found that its creation of these brands was, quote, "immoral, unethical, op-
pressive and unscrupulous," unquote.
    And UST is here today trying to present a case that their spit tobacco products are not as harmful as
smoking, and therefore the company should be allowed to make such statements on their packaging. UST's
representatives want us to believe that they are offering a product that will improve overall health in the
United States. Quite the opposite is true. We know from industry documents that UST has purposely tar-
geted tobacco consumers in an effort to promote, quote, "dual consumption," unquote, not cessation of
smoking.
    We should not even be entertaining UST's claims absent a comprehensive review and serious regulation
by the FDA. The FDA should have authority over all tobacco products, including spit tobacco, and authority
to oversee the content, manufacture, sale and marketing of the product. Absent this regulation, allowing
marketing strategies that include comparative health claims will lure more kids into smokeless tobacco use
and addiction, discourage current users from quitting and may increase the overall amount of tobacco prod-
ucts being used in the United States.
    Mr. Chairman, I thank you for your indulgence in letting me go over. I think this is a very, very serious is-
sue and I appreciate the opportunity to discuss this important issue today with our witnesses.
    (Break in audio.)
    REP. CLIFF STERNS: I thank the gentlelady and now recognize the chairman of the full committee, who
probably won't agree with you when you mentioned tabasco sauce. The distinguished chairman of the com-
mittee, Mr. Tauzin.
     REP. W. J. (BILLY) TAUZIN (R-LA): Thank you, Mr. Chairman. I wouldn't recommend you smoke Ta-
basco sauce. It's not necessarily a good idea. Let me thank you, Mr. Chairman, for convening this hearing,
and I want to thank the chairman of the Federal Trade Commission and the Surgeon General for coming to
join us in what I hope will be a very instructive session, particularly as we move to the second panel as well
and get some insights as to this extraordinary issue.
     We've held hearings, as you know, in this committee on tobacco in the past. But this particular issue of
tobacco harm reduction is not one, I think, that has been the subject of a great deal of congressional debate
or, frankly, good understanding yet. It was back in 1964 that the surgeon general released a report finding
that cigarette smoking is a health hazard of sufficient importance in the United States to warrant appropriate
remedial action.
      We now know that smoking kills over 400,000 people annually in the United States alone. That's more
deaths each year from AIDS, alcohol, cocaine, heroin, suicide, homicide, motor vehicle crashes and fires
combined. We can't ignore those kinds of statistics. In the past four decades, we've made unprecedented
gains in preventing and controlling tobacco use. However, despite the massive education campaign, use of
litigation, substantial price hikes designed to curb smoking, people continue to light up.
   When asked, most smokers say they want to quit. I think that 80 percent will say that in most surveys.
Unfortunately, very few of them are able to break the habit. There's no debate that the best option for any
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  HEARING OF THE COMMERCE, TRADE, AND CONSUMER PROTECTION SUBCOMMITTEE OF THE
   HOUSE ENERGY AND COMMERCE COMMITTEESUBJECT: CAN TOBACCO CURE SMOKING? A
     REVIEW OF TOBACCO HARM REDUCTIONCHAIRED BY: REPRESENTATIVE CLIFF STEARNS
   (R-FL)LOCATION: 2123 RAYBURN HOUSE OFFICE BUILDING, WASHINGTON, D.C. Federal News
                                        Service June 3, 2003 Tuesday
person using tobacco products is to stop, stop using tobacco products. In particular, we need to continue to
do all we can to discourage the use of these products amongst children.
     But we also know that nicotine is a remarkably addictive drug. Some have likened the addictive qualities
of nicotine to the intense grip of cocaine or heroin. Unfortunately, there are people who, try as they may, are
unable or unwilling to kick the smoking addiction. Some in the medical community argue that we are giving
these hardened smokers only one uninviting option, quit or die. Increasingly there are calls for options other
than the quit or die approach, such as tobacco harm reduction. There are studies now that have found that
some tobacco products, such as smokeless tobacco, are less hazardous than cigarettes. Not un-hazardous
or not safe, but less hazardous.
     These studies have resulted in a call for campaigns that would encourage smokers to switch from ciga-
rettes to smokeless tobacco, which arguably could save many of the 400,000 who die every year, and that's
an intriguing concept. As science bears out these conclusions, we're faced with a myriad of questions that I
hope we begin to think about, perhaps begin to answer today, or at least set up a process whereby we might
have the type of forums and discussions with officials and citizens of our country to find the answers to these
questions. They include should we communicate this reduced risk information to the consumer?
     As a person who's faced with a quit or die option, one of my children, is that person entitled to know that
there's another option that can reduce the risk of death and perhaps even be a bridge to stopping smoking. If
so, how should we communicate this information. Obviously the concern is if you communicate it improperly
you might encourage people to continue using tobacco, and that's not the goal obviously. So how do you do
it properly?
    Will promotion of certain tobacco products as reduced risk dilute the anti-tobacco, anti-smoking message
that we're sending children in particular? And that's a deep concern. Finally, does the consumer have a right
to know about safer tobacco products, about reduced risk products? We know in other countries such as
Sweden they made that decision, consumers were entitled to know, and there have been some remarkable
results as a result of simply communicating that information to people who were faced with the quit or die
option.
    So these are questions I hope we'll answer today.
     The hearing is especially timely because the Federal Trade Commission is currently faced with a petition
from the United States Tobacco Company that requests advisory opinion on whether, based on current
science, it may advertise its smokeless product as a safer alternative to smoking. I hope the Federal Trade
Commission examines the issue carefully. I urge Chairman Muris to invest the commission's time and energy
in a tobacco harm reduction workshop to more thoroughly evaluate these claims. I think it's time for that, for
us to have a very open and informative workshop so we can understand whether we need to make some
new policy decisions in this country.
    Few medical questions have stirred more public interest or created more scientific debate than the to-
bacco health controversy. The relationship between tobacco and health does not lead to easy answers.
Nevertheless, the 400,000 yearly deaths by the United States -- the United States attributed to smoking, it's
increasingly apparent that we must continue to search for new and novel solutions. I want to thank you
again, Mr. Chairman, for holding the hearing and look forward to hearing from our two distinguished wit-
nesses today.
    REP. STEARNS: And I thank the chairman.
    The gentleman from Massachusetts is recognized.
     REP. EDWARD J. MARKEY (D-MA): Thank you, Mr. Chairman, very much, and thank you for holding
this hearing.
    To say that smokeless tobacco is a safer alternative to smoking cigarettes is very misleading. Smokeless
tobacco products have known carcinogens and that are linked to oral cancer, and they are addictive. This
method of harm reduction may simply be trading one vice for another. A few years ago I introduced the Ci-
                                                                                                     Page 45
  HEARING OF THE COMMERCE, TRADE, AND CONSUMER PROTECTION SUBCOMMITTEE OF THE
    HOUSE ENERGY AND COMMERCE COMMITTEESUBJECT: CAN TOBACCO CURE SMOKING? A
     REVIEW OF TOBACCO HARM REDUCTIONCHAIRED BY: REPRESENTATIVE CLIFF STEARNS
   (R-FL)LOCATION: 2123 RAYBURN HOUSE OFFICE BUILDING, WASHINGTON, D.C. Federal News
                                        Service June 3, 2003 Tuesday
gars Are No Safe Alternative Act that would impose restricts on the sale of cigars, because cigar use is not a
safe alternative to smoking cigarettes either.
      People need to be informed of all the health risks of all tobacco products. Just as with cigars and ciga-
rettes, children especially must not be influenced by misleading advertising that glorifies the use of these to-
bacco products. Three thousand young people begin smoking in the United States every day. One thousand
of these 3,000 will die from some lung-related disease. Twenty percent of all Americans who die each year
die from some lung-related, smoking- related disease. Obviously our goals should be to just stop it dead in
its tracks.
    I believe that people should make informed decisions for themselves as to which is the better alternative
and safer for them. However, people cannot make informed decisions about smokeless tobacco products
because we do not even know all the addictives that these products contain and what harm they may cause.
    In fact, when the state of Massachusetts that these ingredients be disclosed, the tobacco industry sued
them and won, so we do not even know all the ingredients in these products. There are state FDA approved
nicotine-based products that our state -- and when Massachusetts used them in an advertising campaign, it
helped to reduce use from 20 percent to 14 percent.
   But I do not believe that any governmental agency, the Food and Drug Agency, the Department of
Health and Human Services, or the Federal Trade Commission should promote the use of tobacco products,
especially when we know they are addictive, cancer causing and gateways to further tobacco use. The U.S.
Smokeless Tobacco Company continued to advertise in youth magazines, despite signing a master settle-
ment agreement in 1998 which prohibited indirect or direct advertising that targets youth.
     In Massachusetts, the attorney general was sued by the tobacco industry after trying to implement regu-
lations that would prevent advertising of smokeless tobacco products near schools or playgrounds. It is im-
moral to enhance a company's sales by targeting children to use an addictive substance that is detrimental to
their health and is also illegal. I think that we have a very important subject that we're debating here today,
but there is no greater cause of illness in the United States than tobacco. It is central to the responsibilities of
this committee that we do nothing that enhances the likelihood that young people will embrace this as a life-
style habit. I thank you, Mr. Chairman.
    REP. STEARNS: I thank the gentleman.
    And the gentleman, Mr. Whitfield.
    REP. EDWARD WHITFIELD (R-KY): Mr. Chairman, I guess we still have the policy of eight minutes if
you forego your --
    REP. STEARNS: That we do. If you forego your opening statement.
    REP. WHITFIELD: I'll forego my opening statement.
    REP. STEARNS: Okay. The gentleman foregoes his opening statement.
    Ms. McCarthy.
    REP. KAREN McCARTHY (D-MO): Thank you, Mr. Chairman. I'm going to be very brief and put my re-
marks in the record. I do want to thank you for this hearing and I'm glad to see the panel that we have before
us.
     I'm personally shocked by the tobacco and their gross misunderstanding of what an addiction is, and I
certainly hope today that we can shed some light on that gross misunderstanding. I really believe their com-
mitment should be to fund programs that dissuade our children from this addiction that their product causes,
and that they should be leading the effort to find and produce funds to help with programs that will actually
get individuals to quit. You cannot address an addiction successfully by saying, just have a little bit. It won't
work.
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  HEARING OF THE COMMERCE, TRADE, AND CONSUMER PROTECTION SUBCOMMITTEE OF THE
    HOUSE ENERGY AND COMMERCE COMMITTEESUBJECT: CAN TOBACCO CURE SMOKING? A
     REVIEW OF TOBACCO HARM REDUCTIONCHAIRED BY: REPRESENTATIVE CLIFF STEARNS
   (R-FL)LOCATION: 2123 RAYBURN HOUSE OFFICE BUILDING, WASHINGTON, D.C. Federal News
                                        Service June 3, 2003 Tuesday
    And so I look forward to the panel's testimony and hopefully that will help us -- help the industry under-
stand that their gross misunderstanding of what an addiction is is not acceptable to this Congress. Thank
you, Mr. Chairman.
    REP. STEARNS: I thank the gentlelady.
    The gentleman from New Hampshire, Mr. Bass.
    REP. CHARLES F. BASS (R-NH): Thank you very much, Mr. Chairman, and I appreciate this interesting
and somewhat quite controversial hearing.
     First of all, I don't smoke cigarettes and I don't chew tobacco. In fact, as a state senator I introduced a bill
to tax smokeless tobacco. However, I -- from my perspective there is a -- there are policymakers in govern-
ment and in Congress who, if they had their choice, would chisel off the tobacco leaves on the podium in the
Congress because somehow it would pollute and kill members of Congress who happened to walk nearby.
     And the issue that we're debating here or going to have a hearing on today is not whether tobacco is
safe for somebody to pick up and take up, but whether or not somebody who is smoking cigarettes who may
die of lung cancer that other remedial means such as stopping smoking completely or using some of these
other products which are advertised all over the place, whether those individuals ought to be able or ought to
at least know that if you have a cigarette, a pack or two cigarettes a day, or you have a can of smokeless
tobacco, which is going to be better for you?
     Now, they both may not be good for you, but I don't think you can escape the conclusion that if you have
a choice between these two products, that smokeless tobacco is probably going to be a better alternative
that will prolong your life. And as I understand it, the Federal Trade Commission has a procedure underway
to address this issue as to whether or not this industry can advertise in this manner, not bringing children in,
not talking about lung cancer. Nobody ever suggested that chewing tobacco caused lung cancer or anything
like that, but whether or not individuals who are addicted to cigarettes and have no other option might be
able to see advertising that indicates that chewing tobacco might be a better alternative.
    I think it's a fair issue and I'm looking forward to hearing testimony from both our Surgeon General and
the FTC as well as the succeeding panels, and I'll yield back, Mr. Chairman.
   REP. STEARNS: The gentleman yields back the balance of his time. The gentleman from Texas, Mr.
Green.
    REP. GENE GREEN (D-TX): Thank you, Mr. Chairman.
     I'd like to thank you and our ranking member for holding this hearing on tobacco harm reduction and the
Federal Trade Commissions role in determining appropriate advertising for smokeless tobacco. There's no
question that smoking and tobacco use is hazardous to our health. That is hopefully one issue that all of us
in the room can agree on.
     I represent an area where smokeless tobacco is used by a lot of our young men as a rite of passage.
Now this may not be the case in New York or San Francisco, but when we discuss how to help Americans
quit smoking and what warnings our tobacco products should display, the debate is bound to heat up. One
thing is certain in my mind, our efforts to discourage Americans from smoking cigarettes should not include
advocating the use of smokeless tobacco products.
     Tobacco kills, whether it's inhaled or whether it's chewed, and that is a message that as a parent I think
most folks would want our FTC and our government to do. Since the mid-1980s we have known that smoke-
less tobacco causes oral cancer. And to decrease ones risk of lung cancer by increasing his or her risk of
oral cancer is not in the interest of public health.
    In resolving this marketing issue the FTC is charged with insuring that we do not send mixed messages
to consumers. Currently, three rotating warning labels appear on smokeless tobacco packages. And they
read: One, the warning, "This product may cause mouth cancer." Another warning, "This product may cause
gum disease and tooth loss." And warning, "This product is not a safe alternative to cigarettes."
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  HEARING OF THE COMMERCE, TRADE, AND CONSUMER PROTECTION SUBCOMMITTEE OF THE
    HOUSE ENERGY AND COMMERCE COMMITTEESUBJECT: CAN TOBACCO CURE SMOKING? A
      REVIEW OF TOBACCO HARM REDUCTIONCHAIRED BY: REPRESENTATIVE CLIFF STEARNS
    (R-FL)LOCATION: 2123 RAYBURN HOUSE OFFICE BUILDING, WASHINGTON, D.C. Federal News
                                        Service June 3, 2003 Tuesday
     These warnings all send the same message. Smokeless tobacco is hazardous to your health. For the
FTC to consider a label effectively promoting smokeless tobacco as a lower risk alternative to cigarette
smoking, however, sends a very different message. And it says that if you're going to use tobacco products
but you also worry about your health, smokeless tobacco is the way to go.
   Not only is this message mixed, it also is based on questionable science. A policy shift of this magnitude
should not be based on the study of the Swedish smokeless tobacco, which contains fewer cancer causing
agents and is regulated by the government and cannot be advertised. There simply are no parallels to be
drawn on.
    While the FTC has limited jurisdiction over tobacco its mission is clear. It ensures that companies do not
market their products in misleading or deceptive ways. To advertise smokeless tobacco as healthier for you
than cigarettes is in my mind both misleading and deceptive because it holds the consumers hand as they
leap to the rationalization that smokeless tobacco use is somehow okay. I don't believe we should be in the
business of promoting that mindset.
    Mr. Chairman, and I don't know because we're checking it now, but I had the opportunity -- a former
Speaker of the House, Jim Wright a few years ago had reconstructive surgery at M.D. Andersen (ph) in
Texas because of jaw cancer. I happened to see Speaker Wright after that and talked to him while he was in
the hospital. I don't know the reason -- like a lot of times that things are developed -- but having been to M.D.
Andersen and some of our great cancer facilities I also know that that is not something we want to see,
whether it's in a former Speaker of the House or in our children. And I yield back the balance of my time.
    REP. STEARNS: The gentleman yields back the balance of his time. The gentleman from Arizona, the
vice chairman of the committee, Mr. Shaddock.
     REP. JOHN SHADEGG (R-AZ): Thank you, Mr. Chairman. And other than to express my appreciation
for your holding this important hearing, which can enlighten us all on this subject and to welcome Dr. Car-
mona who is a resident of my state of Arizona and who came to his current position from the faculty of the
University of Arizona, my alma mater, I'll waive my opening statement and take my eight minutes of ques-
tions.
    REP. STEARNS: The gentleman waives his opening statement. The gentleman from Florida, Mr. Davis.
    REP. JIM DAVIS (D-FL): Thank you, Mr. Chairman. I'll reserve my time for questions.
    REP. STEARNS: The gentleman reserves the balance of his time. Mr. Terry, we'd welcome an opening
statement.
    REP. LEE TERRY (R-NE): No opening statement.
    REP. STEARNS: No opening statement. Mr. Fletcher.
    REP. ERNIE FLETCHER (R-KY): I'll reserve.
    REP. STEARNS: Reserve the balance. The gentlelady, Ms. Cubin.
    REP. BARBARA CUBIN (D-WY): I will submit my statement for the record.
    REP. STEARNS: By unanimous consent so ordered. Mr. Ferguson, an opening statement?
    REP. MIKE FERGUSON (D-NJ): I will make an opening, Mr. Chairman.
    REP. STEARNS: Okay.
     REP. FERGUSON: Thank you very much. I'd like to begin by thanking you for holding this hearing on a
subject that really is terribly important to the public health of our nation. It's an undisputed fact that smoking is
a killer and according to the American Lung Association smoking related diseases claim an estimated
430,700 American lives each year. It is directly responsible for 87 percent of lung cancer cases and causes
most cases of emphysema and chronic bronchitis.
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  HEARING OF THE COMMERCE, TRADE, AND CONSUMER PROTECTION SUBCOMMITTEE OF THE
     HOUSE ENERGY AND COMMERCE COMMITTEESUBJECT: CAN TOBACCO CURE SMOKING? A
       REVIEW OF TOBACCO HARM REDUCTIONCHAIRED BY: REPRESENTATIVE CLIFF STEARNS
     (R-FL)LOCATION: 2123 RAYBURN HOUSE OFFICE BUILDING, WASHINGTON, D.C. Federal News
                                          Service June 3, 2003 Tuesday
      I've had several family members, including grandparents, who've died of lung disease, emphysema, lung
cancer and other ailments related to their smoking. This list of ailments that smoking causes or hastens is
well founded and it's alarming. And, it's proven that smoking contributes to cancer of the lungs, the oral cavi-
ty, the esophagus, the larynx, and is a contributing cause of cancer in the pancreas, bladder, kidney and cer-
vix. Finally, smoking costs the United States approximately $97 billion each year in health care costs and lost
productivity.
     We need to do all that we can to help current smokers to quit and to ensure that our children do not fall
victim to this deadly habit. Increased education and various other public health initiatives have brought a
gradual decline in smoking rates over the past 20 years. Studies have shown that 70 percent of smokers say
that they're interested in quitting. Thirty-four percent of smokers actually attempt to quite. However, only less
than 10 percent of those people and only 2.5 percent of total smokers actually end up quitting.
    I think it's safe to say that we have someone -- if you have someone close to you that has given up
smoking or has tried, we all know how tough it actually is to break the habit. There are many products on the
market that are specifically designed to help smokers break the habit. It's vital that the people of our country
are full informed of the risks involved, not only by smoking, but of the various treatments and alternatives that
help to wean someone off the habit.
    Many of the alternatives have undergone rigorous testing by the FDA, but that we must be mindful of
those alternatives that may actually lead to smoking or that actually may be harmful in their own right. Again,
I want to thank you, Mr. Chairman, thank the members of this committee, and I want to thank our panelists
who are here today. I yield back.
    REP. STEARNS: The gentleman yields back. I thank the gentleman.
      As customary, we allow our colleagues who are not a member of the subcommittee or a member of the
full committee for an opening statement and that's Mr. Waxman from California, and I welcome him.
     REP. HENRY WAXMAN (R-CA): I thank you very much, Mr. Chairman, for allowing me to participate in
this hearing. Let me state at the outset, I am not opposed in principle to harm reduction strategies that are
targeted towards addictive smokers, but as we explore these possibilities, we need to remember that un-
substantiated health claims for tobacco products can have disastrous consequences, keeping smokers from
quitting and encouraging teenagers to start.
   These are not abstract concerns. We've had a failed experiment with light and low tar cigarettes and the
advent of new reduced risk products poses similar risks.
   The report that we are releasing today with Representative Schakowsky finds disturbing parallels be-
tween the public health disaster of light and low tar cigarettes and what companies like U.S. Smokeless To-
bacco, UST, are trying to do now.
     Today, the subcommittee is considering their request to market its dangerous and addictive product as
safer than cigarettes. In November 1994, I chaired the last congressional hearing to focus on smokeless to-
bacco. We heard indisputable evidence that UST manipulated nicotine levels in its products to hook young
users and then graduate them to stronger products, and we heard UST deny that smokeless tobacco is ad-
dictive. Nearly nine years later, UST still argue that smokeless tobacco is not a proven cause of disease and
denies smokeless tobacco is addictive. UST claims its goal is to help smokers quit, but one of the company's
strategic objectives, is to promote dual consumption of cigarettes and smokeless tobacco, the very opposite
of cessation.
     In a recent response the UST wrote to a dear colleague I sent out, they denied some of the points that I
made. They said it was baseless to suggest the company added cherry flavoring to some of its products to
appeal to children, but accordingly to a 1980 memo, a UST senior vice president said that they were looking
to get younger and lighter users to prefer this flavor and the older users prefer a tobacco taste. They wrote
that they never employed a strategy to graduate young users to a more addictive product. The same docu-
ment, however, shows that the company's objective was to provide new users with an easy graduation
process. UST said it was misleading or inaccurate to suggest the company ever marketed to children, but a
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memo from a regional sales manager to the national sales manager indicates that UST had marketed
smokeless tobacco to children as young as 13 or 14 years of age.
     Mr. Chairman, because these documents speak to the clear need for effective and comprehensive regu-
lation prior to any health claims for smokeless tobacco, I'd like to ask unanimous consent to include in the
record a letter I've written to chairman Tauzin that describes and attaches these documents.
    REP. STEARNS: By unanimous consent, so ordered.
    REP. WAXMAN: And I look forward to the testimony of the witnesses.
    REP. STEARNS: And I thank this gentleman. If no one else takes recognition, then we'll welcome our
two distinguished panelists. The honorable Timothy Muris, chairman of the Federal Trade Commission. Vice
Admiral Richard H. Carmona, U.S. surgeon general and acting assistant secretary for health, the U.S. De-
partment of Health and Human Services. Welcome, and Chairman Muris, we'll start with you.
      MR. TIMOTHY MURIS: Thank you very much, Mr. Chairman, and I would just ask that the commission's
full statement be placed in the --
    REP. STEARNS: By unanimous consent, so ordered.
    MR. MURIS: I am Tim Muris, the chairman of the Federal Trade Commission. I'm certainly pleased to
appear here today to discuss the FTC's role in potential advertising of reduced risk tobacco products. The
FTC's mission is to prevent unfair competition and unfair or deceptive acts or practices in the marketplace.
The commission does this by ensuring that advertising and marketing claims are truthful and not misleading.
Our jurisdiction over marketing and marketing claims includes jurisdiction over claims for cigarettes, smoke-
less tobacco and other tobacco products.
    Indeed the FTC's law enforcement activities involving tobacco advertising and promotion date back to
the 1930s. Congress has given the commission administrative responsibilities for the health warnings re-
quired on cigarette packaging and advertising under the Cigarette Act. We also have both administrative and
enforcement responsibilities for the health warning required on smokeless tobacco and advertising under the
Smokeless Tobacco Act. The commission does not pre-screen advertising or marketing claims for tobacco or
any other product.
     Instead the agency addresses deception through post-market law enforcement. Health claims in adver-
tising are particularly important to us and I welcome your interest in the role we play in the marketing of po-
tential reduced risk tobacco products. This is a very important question. Despite the efforts of the govern-
ment and the public health community, millions of Americans smoke today and are addicted to nicotine.
Many of these smokers will ultimately die of smoking related illnesses if they do not change their behavior.
    In an ideal world we would wish that all of these people would choose to quit smoking and would be able
to do so once they tried. The real world is quite different, however. If truthful and substantiated, marketing
claims that a product will significantly reduce the health risk associated with smoking while satisfying the ad-
dicted smokers' craving for nicotine could provide a substantial health benefit to those consumers who can-
not or will not quit. Conversely, if those claims are untruthful, unsubstantiated or misrepresent the extent of
the benefit, they would harm consumers.
     For these reasons we would review advertising for potential reduced risk tobacco products on a
case-by-case basis to try to ensure that the information consumers receive about those products is accurate
and substantiated. This review would be conducted using the same legal framework that we use for all con-
sumer products under section 5 of the FTC Act. First we ask what messages consumers take away from the
advertising in question. The next issue is whether the claims are truthful, including the necessary substantia-
tion. The commission typically requires that health claims be supported by competent and reliable scientific
evidence.
    In determining whether harm reduction claims are substantiated, the commission would turn to experts,
both inside and outside the government's science based agencies for assistance in evaluating scientific evi-
dence. Let me close by mentioning that in my view the discussion of potential harm reduction tobacco prod-
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ucts should also encompass the question of whether so-called nicotine replacement products which currently
are marketed only for smoking cessation purposes have a larger role to play in the harm reduction arena.
     These products, which contain only nicotine and no tobacco should certainly be further evaluated for use
by consumers addicted to nicotine. In conclusion, thank you for the opportunity to discuss the commission's
role in this important and evolving public health issue. I'd be happy to answer any of your questions.
    REP. STEARNS: I thank the chairman, and we welcome the U.S. surgeon general.
    ADM. RICHARD H. CARMONA: Thank you, Mr. Chairman and distinguished members of the subcom-
mittee, thank you for the opportunity to participate in this important hearing. My name is Richard Carmona
and I'm the surgeon general of the United States. Let me start with a few statements that were once ac-
cepted throughout society that have now been relegated to the status of the myth. Men do not suffer from
depression. Domestic violence is a family or private matter. The HIV/AIDS epidemic is of no concern for most
Americans. All of us here know that these three statements are very dangerous public health myths.
    My remarks today will focus on a fourth public health myth which could have severe consequences in our
nation, especially among our youth. Smokeless tobacco is a good alternative to smoking. It is a myth, it is not
true. As the nation's surgeon general my top responsibility is to ensure that Americans are getting the best
science based information to make decisions about their health. So I very much appreciate the opportunity to
come before this subcommittee today and help refute this dangerous idea.
     First let me emphasize this. No matter what you may hear today or read in the press reports later, I can-
not conclude that the use of any tobacco product is a safer alternative to smoking. This message is espe-
cially important to communicate to young people who may perceive smokeless tobacco as a safe form of
tobacco use. Smokeless tobacco is not a safe alternative to cigarettes. Smokeless tobacco does cause can-
cer. Our nation's experience with low tar cigarettes yields valuable lessons for the debate over smokeless
tobacco.
    Tobacco use is the leading preventable cause of death in the United States. Each year 440,000 people
die of diseases caused by smoking or other forms of tobacco use. That is about 20 percent of all deaths in
the United States. The office I lead as surgeon general has long played a key role in exposing the risks of
tobacco use. In 1986 the surgeon general's report, The Health Consequences of Using Smokeless Tobacco,
reached four major conclusions about the oral use of smokeless tobacco.
    First, smokeless tobacco represents a significant health risk.
    Next, smokeless tobacco can cause cancer and a number of non- cancerous oral conditions. Third,
smokeless tobacco can lead to nicotine addiction and dependence. And fourth, smokeless tobacco is not a
safer substitute for cigarette smoking. Recognizing these serious health consequences, Congress passed
the Comprehensive Smokeless Tobacco Health Education Act in 1986. This law required the placing of a
surgeon general's warning on all smokeless tobacco products. Mr. Chairman and members of this subcom-
mittee, I respectfully submit that smokeless tobacco remains a known threat to public health just as it was
when Congress acted in 1986.
    Time has only brought more disease, death and destroyed lives. A national toxicology program of the
National Institutes of Health continues to classify smokeless tobacco as a known human carcinogen, proven
to cause cancer in people. As surgeon general I cannot recommend use of a product that causes disease
and death as a lesser evil to smoking. My commitment and that of my office to safeguard the health of the
American people demands that I provide information on safe alternatives to smoking where they exist.
     I cannot recommend the use of smokeless tobacco products because there is no scientific evidence that
smokeless tobacco products are both safe and effective aids to quitting smoking. Smokers who have taken
the courageous step of trying to quit should not trade one carcinogenic product for another, but instead could
use Food and Drug Administration approved methods such as nicotine gum, nicotine patches our counsel-
ing. While it may be technically feasible to someday create a reduced harm tobacco product, the Institute of
Medicine recently concluded that not such product exists today.
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     HOUSE ENERGY AND COMMERCE COMMITTEESUBJECT: CAN TOBACCO CURE SMOKING? A
      REVIEW OF TOBACCO HARM REDUCTIONCHAIRED BY: REPRESENTATIVE CLIFF STEARNS
     (R-FL)LOCATION: 2123 RAYBURN HOUSE OFFICE BUILDING, WASHINGTON, D.C. Federal News
                                            Service June 3, 2003 Tuesday
      When and if such a product ever is constructed we would then have to look at the hard scientific data of
that particular product. Our nation's experience with low tar, low nicotine cigarettes is instructive to the issue
at hand. Low tar, low nicotine cigarettes were introduced in the late 1960s and widely endorsed as a poten-
tially safer substitute for the typical cigarette on the market at that time. Within a decade the low tar brands
dominated the cigarette market. Many smokers switched to them for their perceived health benefits. Unfor-
tunately, the true health effects of these products did not become apparent for another 10 to 20 years.
   We now know that low tar cigarettes not only did not provide a public health benefit, but they also may
have contributed to an actual increase in death and disease among smokers. This has taught us that we
must move cautiously in recommending any supposedly safer alternative for people trying to quit smoking
because now, with more knowledge and the benefit of hindsight, the science does not support early recom-
mendations on low tar cigarettes.
      Mr. Chairman, in the interest of time, I will shortly ask that the remainder of my statement and the scien-
tific information contained in it be considered as read and made part of the record.
    REP. STEARNS: Without objection, so ordered.
    ADM. CARMONA: But before I do that, I would like to ask for this subcommittee and the Congress the
help in getting the message out about the dangers and myths of smokeless tobacco. All of us in this room
are very concerned about our nation's youth. Kids growing up today have a tough time of it. In addition to the
normal struggles of puberty, many kids are facing a hose of other challenges. Many, especially minority kids,
must struggle to find their way in unsafe neighborhoods. The temptation to engage in behavior that is not
healthy and the opportunity to do so is very hard for our young people to resist.
    According to a 2000 survey by the Substance Abuse and Mental Health Services Administration,
SAMHSA, and this is the national household survey on drug abuse, about 1 million kids from ages 12 to 17
smoke every day. Another 2 million kids smoke occasionally. And we know that smoking is often not a stand
alone risk behavior. It travels with others. The SAMHSA survey found that youth who are daily cigarette
smokers or heavy drinkers were more likely to use illicit drugs than either daily smokers or heavy drinkers
from older age groups. More than half of 12 to 17-year-olds who were daily smokers had also used illicit
drugs within the past month.
     Every day, more than 2,000 kids in the U.S. will start to smoke and more than 1,000 adults will die be-
cause of smoking. We have to get used to stop-starting but the answer is not smokeless tobacco. We have
evidence to suggest that, instead of smokeless tobacco being a less dangerous alternative to smoking, just
like smoking is a gateway to other drugs, smokeless tobacco is a gateway to smoking.
    So we must redouble our efforts to get our youth to avoid tobacco in all forms. We have some real work
to do on the culture of smokeless tobacco which is glamorized by some sports starts. Chicago Cubs Sammy
Sosa who has made a public commitment to avoiding smokeless tobacco is a great example for kids. Past
baseball great Joe Garagiola is now chairman of the Spit Tobacco Education Program and regularly lectures
to young players against the dangers of smokeless tobacco.
     As members of Congress, you can lead by example too not just in legislation but in your own lives. I en-
courage you to avoid tobacco in all its forms and not fall for the myth, a very dangerous public health myth
that smokeless tobacco is preferable to smoking. Do not let America's youth fall for this myth either.
   Mr. Chairman, I ask that my written testimony may be made part of the record and thank you and I'd be
happy to answer any questions.
    REP. STEARNS: Again, without objection, so ordered.
     I'll start the questions and, Admiral, I think I'll start with you. The European Union has a policy on
smokeless tobacco and it's been written by the leading tobacco control public health advocate in the Euro-
pean Union. And they stated that, on the average, quote, "Scandinavian and American smokeless tobaccos
are at least 90 percent safer than cigarettes." Now I respect your position. It's a lot different than all of ours.
But do you agree with the European Union policy that what they say is at least 90 percent safer than ciga-
rettes? I mean, just yes or no.
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    ADM. CARMONA: No, sir. I do not.
     REP. STEARNS: Okay. We note that the Institute of Medicine report states that smokeless tobacco --
quote, "the overall risk is lower than for cigarette smoking and some products such as Swedish snus (ph)
may have no increased risk." Now, that is the Institute of Medicine report. So I ask you, do you agree with the
Institute of Medicine report?
    ADM. CARMONA: That particular statement, no.
     REP. STEARNS: Okay. You know, the heart of our hearing today is smokeless as an alternative for
people who can't stop smoking and I'll give you an example. Let's say you had your son just turned 16 and
he had to drive a car and you had a small sports car in your garage and you also had a brand new Volvo and
I think all of us in this room will agree that the Volvo is safer than a very small sports car. And you knew your
son was just starting out. He had a look at the two products. Would you not say the Volvo is a lot safer for
your 16- year-old son to drive than a very small sports car?
    ADM. CARMONA: I think it's actually an unfair analogy, sir. In most cases, probably so. But --
    REP. STEARNS: They both are dangerous. But you know, what we're trying to do is just try to see if
there's degrees here and then work off the Institute of Medicine report as well as some of the European Un-
ion policy position.
    Chairman Muris, how does the FTC evaluate an advertising claim? For example, if there is dueling
science, like there might be here, with great respect for the surgeon general, how do you go -- how do you
actually reach a conclusion when there's this advertising claim and you have dueling science involved?
    MR. MURIS: Well, the first thing that we do is look to see what the message the advertising claim com-
municates to a reasonable person in the intended audience and that's a very important step because, de-
pending on how the various disclosures would be made, they would be viewed -- it would not surprise me, I
haven't seen copy testing of particular advertising because I don't know if they exist -- but they would be
viewed by the intended audience quite differently.
     Once we understand what the -- what we call the take away is, then we would look in terms of substan-
tiation at what we thought was competent and reliable scientific evidence. And again, it probably depends on
what the claim is. If the claim is one that's unqualified, it would not surprise me if people interpreted it as that
was something close to a scientific consensus or at least the majority of scientific views. So that would be
relevant.
     We also look at what we call the Pfizer factors. Pfizer was an FTC opinion about the substantiation doc-
trine about 30 years ago. One of the crucial factors there are trying to balance the impact of making mistakes
and you can make two sorts of mistakes here. You can make the mistake of allowing false advertising or of
preventing truthful advertising. We try to look at the consequences of those mistakes.
     REP. STEARNS: The FTC has brought a number of cases against companies making health claims re-
lated to cancer treatments, weight loss and cures for HIV AIDS, arthritis, hepatitis, Alzheimer's disease, di-
abetes and many other diseases. How has the FTC proceeded on those cases and how do these cases dif-
fer from advertising claims made by tobacco companies?
    MR. MURIS: Well, most of the cases that we brought involved fraud where there is no scientific contro-
versy. In weight loss advertising, for example, we have -- the surgeon general has helped us in this area --
we have a very aggressive campaign against deceptive and fraudulent weight loss advertising. We held a
workshop where we both participated last November where one of the things we were trying to do is to get
advertisers -- I'm sorry, the media to police some of the more obviously false claims. So it's an area in which
we spend a lot of resources. But it's an area in which we don't have to make difficult scientific choices.
    REP. STEARNS: I just conclude. Admiral, let's say we all know that smoking is the leading cause of
preventable death in the United States. But I've seen some people here in the House, members of Congress,
who can't seem to stop smoking. What do we do? I mean, a person can't stop smoking. I mean, how do we
approach those people?
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    HOUSE ENERGY AND COMMERCE COMMITTEESUBJECT: CAN TOBACCO CURE SMOKING? A
     REVIEW OF TOBACCO HARM REDUCTIONCHAIRED BY: REPRESENTATIVE CLIFF STEARNS
    (R-FL)LOCATION: 2123 RAYBURN HOUSE OFFICE BUILDING, WASHINGTON, D.C. Federal News
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     ADM. CARMONA: I think there's a wide range of possibilities that include substitution therapy, as I men-
tioned in my opening remarks, behavioral therapy and behavioral modification and of course, we need to
continue to do research in that area. But I think what we don't do is substitute one carcinogen for another.
    REP. STEARNS: I let you have the last word there. Okay, thank you.
    Ranking member.
    REP. SCHAKOWSKY: Thank you, Mr. Chairman.
     You referred to the Institute of Medicine and I have that report in front of me and I would just like to read
Conclusion 5 for Dr. Carmona. It says, "Regulation of all tobacco products including conventional ones is
recommended in the IOM 1994 as well all other PREP" -- and PREP stands for potential reduction exposure
products, so we're talking about spit tobacco -- "is a necessary precondition" -- we are talking about regula-
tion -- "is a necessary precondition for ensuring a scientific basis for judging the effects of using PREPs and
for assuring that the health of the public is protected." So they're making their conclusions by stating that all
tobacco should be regulated and so, I'm wondering then if in terms of the IOM report if you find any contra-
dictions in what they say and if you would find anything in what they say as in fact recommending the use as
a harm reduction alternative?
     ADM. CARMONA: No ma'am. The IOM report I think is a very good report and I think that one of its con-
clusions that's most important is that there -- they found that there really were no products that were availa-
ble today that had been scientifically tested, such as smokeless tobacco products that would be safe to
recommend or use. So I think their study was a very good one overall.
    REP. SCHAKOWSKY: Thank you.
    Mr. Muris, if the FTC were to regulate the advertising of spit tobacco and such an advertising campaign
had an incidental appeal to minors, would the FTC be able to regulate the advertisements on that basis
alone?
     MR. MURIS: Well, first of all, the FTC has two basis to proceed. One is on the basis of deception, and
we would obviously need to know a lot more so this answer is necessarily very, very qualified. I think in terms
of appeal to youth, the commission would be much more likely to proceed as it did in the Camel case based
on its unfairness jurisdiction. At least in that case the allegations were that the appeal to youth was far more
than incidental. I think -- again, I'd have to know a lot more, but that fact -- the fact if the appeal was just in-
cidental would make it very hard to use the unfairness jurisdiction.
     REP. SHCAKOWSKY: Right. And if such an advertising campaign were to result in more people using
smokeless tobacco, in addition to cigarettes, rather than instead of using cigarettes, would the FTC be able
to regulate the advertisements on that basis alone?
    MR. MURIS: It would be very hard for us to make public health judgments outside of the context of
whether the advertising was deceptive or not. That's primarily what we do. On the other hand, clearly when
you are balancing the -- my answer to the chairman's question, when you are balancing the two kinds of
risks, the consequence here of allowing advertising that it's in fact fraudulent, that's part of those conse-
quences, so we would consider it in that sense.
    REP. SCHAKOWSKY: If such an advertising campaign were to result in a dramatic reduction in the
number of people who quit tobacco completely, would the FTC be able to regulate the advertisements on
that basis alone?
     MR. MURIS: Again, I think my answer is identical. We wouldn't look at this on the first instance, under
our statutes, in terms of a simple public health calculation. We would however, that would be a very impor-
tant fact in terms of weighing the consequences of the substantiation as I just indicated to the last question.
    REP. SCHAKOWSKY: Would that be true then if such an advertising campaign were to result in a dra-
matic increase in the number of new tobacco users. Would the FTC be able to regulate advertisements on
that basis alone?
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    HOUSE ENERGY AND COMMERCE COMMITTEESUBJECT: CAN TOBACCO CURE SMOKING? A
     REVIEW OF TOBACCO HARM REDUCTIONCHAIRED BY: REPRESENTATIVE CLIFF STEARNS
    (R-FL)LOCATION: 2123 RAYBURN HOUSE OFFICE BUILDING, WASHINGTON, D.C. Federal News
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     MR. MURIS: I think my answer would be the same, and I would direct you in more detail to our testimo-
ny, particularly page nine, where we discuss some of those issues.
    REP. SCHAKOWSKY: So despite the fact that the advertisements were not directly aimed at children,
despite the fact that they said that you should use it as a substitute, if negative consequences occurred
you're saying that in fact, you could? I don't read your mandate that way, but --
      MR. MURIS: Well, first of all and most importantly, and this is -- asking any questions doesn't provide a
full context of what the advertising campaign would look like, and that full context would be essential and
possibly dispositive in what we could do. It is true, as our testimony states, that -- let me just quote it to you.
"Although a determination that an individual risk reduction claim is truthful and substantiated, would end the
commission's deception inquiry, broader public health issues may remain." And I'm -- and that's the sense in
which I was talking about how we don't under our statutes, make a simple public health determination, if that
determination could ever be simple.
    It is true, however, in looking at substantiation that the Pfizer factors require a balance of what statisti-
cians call type one and type two errors, which -- are as I explained, which are we try to look at the conse-
quences of us making a mistake, and the factors that you're talking about are consequences of a mistake,
and we would certainly consider those. And the presence of those factors would require us to want a higher
level of substantiation before we allowed the claims.
    REP. SCHAKOWSKY: (Off mike.) Thank you.
    REP. STEARNS: The gentlelady's time has expired. The chairman of the full committee, Mr. Tauzin.
   REP. TAUZIN: Thank you, Mr. Chairman. Let me see if I can do something that I've tried with my staff to
understand.
     Maybe I've got the experts in the country here in front of me now. Dr. Carmona, first of all let me thank
you for your strong and I think extraordinary advocacy to help Americans understand the dangers of smok-
ing. I don't think anyone quarrels with you on those issues today. What we are focusing on obviously, is a
question of whether or not there are other options than the quit or die option that Americans unfortunately,
are faced with, and -- when it comes to tobacco.
    In regard to that, I've tried to have an understanding with my staff on the nature of nicotine. I'm not a
smoker, I've never had this addiction problem for nicotine, my body doesn't crave, I don't desire, I don't
smoke and I don't want to smoke. And so I'm trying to understand it as a non-smoker. And I'm trying to place
nicotine in a category of substances that are addictive that I do understand. I understand cocaine and heroin
and what it does to lives in my district, and in this country. I understand that when people start on these kind
of addictive substances it can ruin their lives, and they crave it to the point where it can even kill them.
     I am a caffeine addict. I drink coffee all day long, I confess. I know what that addiction feels like, I know
when I have to have my cup of coffee in the morning, and I've got to have it all day long to keep me going.
But I also know that caffeine is not likely to kill me in the sense that cocaine and heroin might kill me. It might
not be good for me, it might make me overactive, it might make me hypertensive, I don't know what. But it's
not likely to do the damage that cocaine and heroin do. Where do you place nicotine, in that scale? Is it clos-
er to caffeine, or is it closer to cocaine and heroin?
    ADM. CARMONA: It's hard to put it in a scale in that comparison, but although they are both addictive,
they have different mechanisms of action, and the caffeine works by modifying certain enzymes that -- xan-
than oxidates (ph) I think specifically and it works through a phosphodiesterase mechanism they call it. And
what it does is it works on your cardiovascular system. It will speed up your heart and you'll have cardiovas-
cular effects that you become dependant on. And so --
    REP. TAUZIN: How about nicotine?
    ADM. CARMONA: Nicotine works by a different mechanism, but nicotine has direct adverse cardiovas-
cular effects that are tied to accelerating cardiovascular disease, it has bad effects on your heart, bad effects
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    HOUSE ENERGY AND COMMERCE COMMITTEESUBJECT: CAN TOBACCO CURE SMOKING? A
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on the blood vessels, and can accelerate athrosclerotic disease and so on. So that it's not just -- we're not
just talking about cancer here, we're talking about other effects on the body --
    REP. TAUZIN: It has other negative effects.
    ADM. CARMONA: Yes, sir.
    REP. TAUZIN: Does it have any positive effects? I was told by staff that there is at least some scientific
evidence that it has some positive effects on some categories of human conditions. Is that true or false?
    ADM. CARMONA: Well, only if you are talking about you know, biochemistry of the body, but --
    REP. TAUZIN: Like Tourette's syndrome?
    ADM. CARMONA: Oh you're talking about as a treatment? As a treatment, no.
   REP. TAUZIN: That's what I'm saying, it has positive -- isn't it used positively in some cases, like treat-
ments of Tourette's?
    ADM. CARMONA: I have never used it, and if it is then it's probably not very common, but I would im-
agine in the literature people have tried to use it.
    REP. TAUZIN: Yeah. Here's where I'm going, and I want your feedback on it. If Americans who have
accustomed to, addicted to the habit of getting nicotine into their body, were able to get it into their body in
some other fashion other than the use of tobacco, would that be a positive social development in America in
terms of the nations health? Or would it be a negative one?
    ADM. CARMONA: Well, again I -- I'm less inclined to comment on social developments, than I am on
science --
    REP. TAUZIN: Well, science then. Would it be good for Americans health, for people who need caffeine,
who believe they have to have it, I mean nicotine, are addicted to it, to get it in some other fashion other than
having to burn tobacco to get it?
    ADM. CARMONA: Well, we have mechanisms presently available through nicotine products that --
    REP. TAUZIN: I know we do, I'm asking you is that good?
     ADM. CARMONA: It is an option that's available. I mean the best of all options, obviously is not to smoke
at all, and not become addicted.
     REP. TAUZIN: Nobody disagrees with that. But if the option is quit or die, and what I'm saying is if you
have to get nicotine in your system because you're addicted to it, and you can't quit, I mean the quit rate is
like two or three percent a year in this country, and so we know people are having a pretty difficult time quit-
ting. Recognizing that, knowing that we're going to lose an awful lot of people to the effects of not quitting. If
these folks can get their nicotine in some other way other than burning tobacco and sucking all that nitrosa-
mines and all the other substances into their lungs, would that be a positive thing for the health of the coun-
try?
   ADM. CARMONA: Well yes, and it already is. We have patch, we have gum, we have mechanisms that
have been tested and found to be safe and effective means.
      REP. TAUZIN: Right. Let me turn to the FTC Chairman. If in fact people come up with products, whether
tobacco products, or non tobacco products, that can in fact deliver nicotine to folks who have been addicted
to it, and can't seem to quit using it, is your department the right agency to regulate the truth of those ads?
     MR. MURIS: Our mission is certainly to evaluate the truthfulness of, and including substantiation of ad-
vertising. That can require us, and in this case it would, to work with scientists both in and out of the gov-
ernment because the issues here in the substantiation arena are issues on which their experts --
    REP. TAUZIN: Yeah, you get thrown into the health arena here, you got --
    MR. MURIS: And we're not, right.
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     REP. TAUZIN: And you're not health officials. But nevertheless your agency's function is to examine the
truthfulness, or lack of truthfulness of advertising of American products. Is that part of your agency's --
    MR. MURIS: Yes, but what I'm' saying is the substantiation issues here turn on scientific issues to which
we --
    REP. TAUZIN: Therefore you'd have to turn to people like health department officials to help you.
    MR. MURIS: Absolutely.
     REP. TAUZIN: And if science was available to help you understand whether or not an advertisement was
in fact truthful or not truthful, that gave people in America better information about options that might be
available to them, when it comes to getting nicotine, would it be in the interest of this country for you and our
health officials to conduct some public forums, and to see whether or not all of this is a good avenue to ap-
proach or not?
    MR. MURIS: Well, in the abstract, Mr. Chairman, I certainly think that is a good idea, again because the
issues are ultimately scientific, we would need, they would need to take the lead, the scientific agency.
    REP. TAUZIN: Well, except that they tell us that it should be your lead because you end up being the
one to say yes or no on the truthfulness of the ads. If they can help you understand that and can help you
conduct forums that all of us in America, scientists, consumers, advocates, pro and con, all kind of people
can come and debate it and discuss it, why wouldn't you want to help create that type of forum for them?
    MR. MURIS: Well, that's a different issue than taking the lead. I certainly think that we would -- I know,
speaking for myself, obviously my colleagues would have to vote, that I would be willing to participate in such
a forum, not just to talk about particular products, although that would be important, but to talk about what
end points, what kind of scientific evidence is relevant. I mean I agree with the premise here, that we have
somewhere near 50 million people who smoke, and it's a very addictive product, I obviously defer to the
scientist on that, but it obviously is a very addictive product, many people have difficulty quitting, and I think
there are potential, and the key word is potential, public health benefits from addressing that issue. And it's
one --
    REP. TAUZIN: Well, we at least ought to hear about it and talk about it. Mr. Chairman, my time's up, but I
want just to make a point. If you don't take the lead, and the Health Department says you should take the
lead, and they don't want to take the lead, we never get these forums going. Somebody's got to take the lead
to organize it and I don't know whether you or Tommy Thompson -- we need to put you in a room together
and you all can flip a coin to see who calls the meeting, but my guess is it would help us immeasurably in this
country if one or both of you would take the lead. Thank you, Mr. Chairman.
    MR. MURIS: I understand, thank you.
    REP. STEARNS: Thank you, Mr. Chairman.
    The gentlelady, Ms. McCarthy, is recognized for questions.
    REP. McCARTHY: Thank you, Mr. Chairman, I pass.
    REP. STEARNS: The gentlelady passes, Mr. Whitfield.
     REP. WHITFIELD: Thank you, Mr. Chairman. Mr. Muris, it's my understanding that UST, U.S. Tobacco
had asked your agency I guess back in February 2002, for an advisory opinion to make certain statements in
its advertising about smoke -- their smokeless tobacco products. Is that advisory opinion still pending, or
what is the status of that?
    MR. MURIS: Well, it's not what they ask us to do. They didn't give us advertising on which they ask an
opinion, they gave us a general statement without the context of advertising, and is explained in our -- I can't
obviously talk about non-public proceedings in a public forum, but it's explained in our testimony generically
that presenting something to us in that manner causes problems. They withdrew the petition. They have re-
cently sent us additional information and asked that we hold a public forum, but the petition has been with-
drawn.
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    REP. WHITFIELD: And what would be the purpose of the public forum?
   MR. MURIS: I think -- although, they can speak for themselves. My understanding is the public forum
would involve some of the issues -- many of the issues I was just discussing with Chairman Tauzin.
    REP. WHITFIELD: One of the statements made evidently in their letter to your agency was that the
surgeon general in 1986 concluded that smokeless tobacco is not a safe substitute for smoking cigarettes.
While not asserting that smokeless tobacco is safe, many researchers in the public health community have
expressed the opinion that the use of smokeless tobacco involved significantly less risk of adverse health
effects than smoking cigarettes. Now, does your agency have the capability to render a decision on whether
or not advertising based on that type of a statement would be accurate or truthful?
     MR. MURIS: The question with such advertising would be whether it was substantiated. We would be --
we don't have expertise to evaluate the substantiation, the scientific evidence. We would turn to scientific
experts within and without the government. I cite a few very briefly we cite in our -- in the footnotes to our
testimony, just very brief introductions to some of the scientific evidence, but that's where we would have to
turn.
    REP. WHITFIELD: And you would be able to do that?
    MR. MURIS: Sure. We would certainly be able to ask for cooperation and assistance. Obviously it would
be in the -- that would be in the discretion of the people we ask as to how much they participated and what
they told us.
    REP. WHITFIELD: And going to these scientists to come up with a scientific analysis of the claims under
the current system that you would do that, you would feel comfortable with the conclusion made that made
the process --
     MR. MURIS: Well, the process -- let me again put the process in context. When you have advertising, we
look to see if the advertising in the first instance is deceptive. Advertising of this nature would almost certain-
ly be advertising that contained an explicit or implicit claim that there was substantiation for the risk reduc-
tion. We, again, are not experts on the science necessary to evaluate that claim, so that's why we would turn
to the scientific community. I have confidence in the process in general how it would work in this particular
case, you know, we would have to see.
    REP. WHITFIELD: Yeah. Admiral Carmona, would you support the abolition of all tobacco products?
    ADM. CARMONA: I would at this point. Yes, sir.
    REP. WHITFIELD: So you would support a law in Congress that all tobacco products would be illegal?
    ADM. CARMONA: No, sir, I didn't say that. If you ask me what I support, banning or abolishing tobacco
products, yes. Legislation is not my field. If Congress chose to go that way that would be up to them, but I
see no need for any tobacco products in society.
    REP. WHITFIELD: But if Congress were to pass legislation making tobacco an illegal product, you would
be comfortable with that?
    ADM. CARMONA: I would have no problem with that.
   REP. WHITFIELD: Okay. Now, the purpose of this hearing today -- if oral tobacco is to play a role in
harm reduction, would you agree it is not necessary to show that it does not cause cancer, but it simply
needs to be substantially less hazardous than smoking?
    ADM. CARMONA: If I understand your question correctly, sir, I would say that we already know it's a
carcinogen, one, and if we were looking to test any other theories, certainly the fact that it is a carcinogen
would be important. And in my mind you don't need to do any further testing. If you already know it's a carci-
nogen it would not be an acceptable substitute --
    REP. WHITFIELD: So whether or not it's less harmful would not make any difference to you then?
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      ADM. CARMONA: Well, I would -- if there are those who are doing research in this area and they have
thought of unique ways that this could be helpful, I'm always willing to listen to research. But right now subs-
tituting one carcinogen for another, I don't see a benefit.
   REP. WHITFIELD: Okay. And I understand that, but you're saying if there is scientific evidence there that
shows that it is less harmful, that that is something that you would be willing to look at?
    ADM. CARMONA: I'd always be willing to look at any scientific evidence, sir.
    REP. WHITFIELD: Okay. Now, the Royal College of Physicians in December, 2002, which is England's
oldest medical institution and among its functions is to advise the government, the public and the medical
community on healthcare issues, stated that as a way of using nicotine, the consumption of non-combustible
tobacco is of the order of 10 to 1,000 times less hazardous than smoking.
    Would you agree with that or not?
    ADM. CARMONA: I would not, sir.
    REP. WHITFIELD: Are you aware of any scientific data that would disagree with that statement?
   ADM. CARMONA: Sir, not so much disagree but I don't think they have enough scientific data to justify
making that statement.
    REP. WHITFIELD: You don't think they have enough data to justify --
    ADM. CARMONA: That statement, yes.
    REP. WHITFIELD: And you've read this report that they've rendered?
    ADM. CARMONA: Yes, I have, sir.
   REP. WHITFIELD: Now, on this issue of smokeless tobacco as a gateway to increased smoking, do you
have any evidence to show that it is a gateway to increased use of tobacco products?
   ADM. CARMONA: Yes, sir. There are studies to demonstrate that it does act as a gateway and can
eventually increase smoking in all individuals.
     REP. WHITFIELD: Now, what about -- there was reference earlier to this European Union study about
smokeless tobacco and in that study they make all sorts of statements. They said Sweden has the lowest
level of tobacco related mortality in the developed world by some distance, approximately half the tobacco
related mortality of the rest of the European Union. Sweden has the lowest male smoking prevalence in Eu-
rope. Half of the tobacco in Sweden is now consumed as a smokeless tobacco product, and this share has
steadily grown since 1970.
    And they go on and on and on and they make all sorts of arguments that one of the reasons that there's
less mortality in Sweden is because of these so called smokeless products. And I'm sure you've read those
reports as well, but do you have any scientific evidence that would refute that report?
    ADM. CARMONA: Well, on most reports, sir, I think there are many potential confounding factors that
have not been fully looked at. People smoke or chew for a variety of reasons, and to assume that a de-
creased morbidity and mortality in a population is solely due to the fact that somebody is chewing tobacco,
I'm sure they all drink milk also or have a cup of coffee every day and you equally attribute changes to other
variables that maybe haven't been looked at. So it's a much more complex problem.
    REP. WHITFIELD: I see my time has expired.
    REP. STEARNS: The gentleman's time has expired.
    The gentleman from Texas, Mr. Green.
    REP. GREEN: Thank you, Mr. Chairman.
     Admiral Carmona, during the previous Congresses members of the committee have introduced legisla-
tion which would give the FDA a broad authority to regulate tobacco products including strong restrictions on
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advertising and marketing tobacco products to young people, protection against exposure to environmental
tobacco smoke and tough company specific surcharges to encourage companies to reduce youth smoking.
Do you think it's important for our Congress this time to enact legislation to give the FDA that authority to re-
gulate these tobacco products?
   ADM. CARMONA: Well, sir, I appreciate the question but not being in the regulation business I think it's
important that Congress looks at this and makes a determination if it's something that they want to move
ahead with that would be in the best interests of the protection of the American public. Whether or not the
FDA does it, I think strong oversight and scrutiny is important by whatever mechanism you all choose to do.
    REP. GREEN: Okay, thank you. I understand the position you're in and I appreciate the best answer you
could give.
     Mr. Muris, one of the rotating warnings on packages of smokeless tobacco reads, "Warning: This product
is not a safe alternative to cigarettes." Let's say that you're a cigarette smoker who saw an ad promoting
smokeless tobacco as a product with reduced risk, if that was allowed, and you go to your local convenience
store and decide to try it out and yet while ripping open the top of it you read the warning, that this product is
not a safe alternative to cigarettes. Would you feel as if you've received a mix message as to the health ben-
efits of that package of smokeless tobacco?
     MR. MURIS: Well it obviously depends -- and this is just a prepossess, this is a very important part of
what we would do, is to look at the take away as to what a reasonable person in the intended audience un-
derstood. It obviously depends on what the advertisement said. It is quite possible that even though couched
in the language of safer, that people would receive -- you know, depending on how it was written and what all
was in the ad and the totality of the circumstances, it's possible that people would receive a message of safe,
in which case they would be conflicted.
     REP. GREEN: Okay, thank you. The Federal Trade Commission Act provides in that an act or practice is
illegal if it, quote, "Causes or is likely to cause substantial injury to consumers which is not outweighed by
countervailing benefits to consumers or to competition." Even if we were to assume that scientific evidence
were true that smokeless tobacco use can reduce the number of deaths associated with smoking, in your
opinion, does this outweigh the substantial injury caused to consumers?
     MR. MURIS: Well, you're now turning to a second part of our statute, which is unfairness. And I talked
about this briefly a little while ago. In the context that we would be looking at, and this is part of balancing in a
different way that I was mentioning before, but similarly of balancing the benefits and the costs. And that's
what that part of the statute requires. I think it's a factual question on which we'd have to seek evidence.
    REP. GREEN: Thank you, Mr. Chairman, and I yield back my time.
    REP. STEARNS: The gentleman yields back the balance of his time.
    The gentleman from New Hampshire, Mr. Bass.
     REP. BASS: Thank you, Mr. Chairman. As I mentioned in my opening statement, we've heard comments
about young men using smokeless tobacco as a rite of passage. We've heard a possible connection be-
tween health problems of the former speaker of the house and chewing tobacco, I don't know whether that's
true or not. The surgeon general's recommended that perhaps members of Congress need behavioral mod-
ifications, I would definitely agree with that.
    (Laughter.)
     But the real issue here today is a very narrow one. And my first question is for Chairman Muris. Under-
standing, sir, that the FTC has a difficult mission protecting consumers from deceptive and misleading adver-
tising, it involves judgment calls and reasonable persons' standards. And given that you already do this cur-
rently for weight loss products and other such items based on a comparative advantage, which is the subject
of this hearing, could the FTC establish guidelines that would offer needed protection and more accurate in-
formation, in your opinion?
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    HOUSE ENERGY AND COMMERCE COMMITTEESUBJECT: CAN TOBACCO CURE SMOKING? A
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    (R-FL)LOCATION: 2123 RAYBURN HOUSE OFFICE BUILDING, WASHINGTON, D.C. Federal News
                                            Service June 3, 2003 Tuesday
     MR. MURIS: Well, it would be -- in general I think you have to take advertising in its context and as you
find it. There's the issue I was just mentioning, the issue of how consumers understand claims, and then
there's the issue on which we spent most of the time in the questions you've asked me about the substantia-
tion. Because one of the claims that would be in these ads would be an explicit or an implicit claim that
there's scientific substantiation for a risk reduction claim.
     I think most -- I think we'd have to emphasize both things. I don't think we're ready to do guidelines, par-
ticularly involving the second issue, because we would need to have a much greater discussion with the
scientific community about what risk reduction claims mean, about the appropriate endpoints for measuring
them, about evidence from around the world about a whole host of issues.
     But it's perfectly legitimate or reasonable for the FTC to conduct studies involving comparative advan-
tages of one product over another. It doesn't have to be an absolute. There is nothing in principle that pre-
vents comparative claims. The commission -- my predecessor, one of the best things he did more than 30
years ago when he was at the FTC, he got the networks to eliminate their restrictions on comparative adver-
tising. Comparative claims are an important kind of claims.
    REP. BASS: Okay. Admiral, I appreciate your testimony and I would be -- my colleague from Kentucky,
Mr. Whitfield, brought up the issue of the English -- or the British report that, in essence, drew a conclusion
regarding the relative benefit or whatever of smokeless tobacco versus cigarettes. I'd be interested if you
would be willing to provide the subcommittee with a further explanation as to exactly what scientific evidence
you find in that report invalid.
     I will say now, I've never heard of it and I haven't read it, but you have basically disputed the claims that
are made in this report and said they were invalid and they're not based upon adequate funds. And if your
office or you would be willing to analyze those claims and explain exactly what mistakes they made that led
to that particular conclusion, I'd be interested to read about it.
    ADM. CARMONA: We'd be happy to provide you with the information, sir. And generally it's not that it's
invalid. We felt that there was not enough information to support their thesis that more research needed to be
done before you could come to that conclusion.
    REP. BASS: Okay. I don't think anybody here is suggesting, sir, that you recommend one product over
the other. But suppose -- or I don't like to use hypotheticals. Would you agree that advertising that explains
the mortality rates of one product over another that infers a conclusion that smokeless tobacco was less
harmful than cigarette smoking, would that fairly describe an aspect of the harm reduction that we are all
seeking?
     ADM. CARMONA: Well, we're all seeking harm reduction. I don't think that fairly describes quite a com-
plex problem, because where you might be able to argue that a product has one component that may reduce
risk, when you look at the product broadly and all of its risk factors, there may be more harm or less harm in
others. So I don't think, sir, it's as simple as just describing that, because there are many variables that we're
looking at in these comparisons.
       REP. BASS: Mr. Chairman, my time has expired, and the point that I'm trying to drive at in this line of
questioning is that there are no perfect products for any problem, and there is probably no substance in this
country or no issue or no product that is more controversial, with the possible exception of guns, than tobac-
co. However, it was in the context of this debate, if a public good is being achieved, albeit not a perfect one,
is it not a good idea for policymakers and agency heads to examine this realistically and objectively, because
ultimately we're all seeking the same goal, which is reduction in deaths due to this particular substance. And
I'll yield back.
    REP. STEARNS: And I thank the gentleman. And we've had a hearing dealing with guns too.
    REP. BASS: I know. Generally a good committee.
    REP. STEARNS: Gentleman from Massachusetts.
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     REP. MARKEY: Thank you, Mr. Chairman, very much. I do have a bias in this field. My father died from
lung cancer and he died three years ago. And although he smoked two packs of Camels a day from the age
of 12 until 67, it never caught him until he was 89, and then it just showed up even though he was otherwise
perfectly healthy, and then he died from lung cancer three years ago. Although the doctor had said until it
showed up that he was going to live to 100. So that's a big loss in our family to have a guy in perfectly
healthy condition mentally and physically to die because of it.
     But what I remember most is that when I was 13 he told me, because I was the oldest, that he started
smoking at 12 and that he knew I would be starting in the next couple of years because every boy smoked,
but that he shouldn't accept, him that is, to pay for the Camels, that I was going to have to earn the money.
Just don't take the money out of his pockets or anything. But he knew that we would all smoke. That was his
message to me when I was a 13-year-old boy.
     So because of the surgeon general's decision in the mid '60s and the continuation of public education,
we've been partially, at least, able to stem that tide of the inevitable deaths that occur from young boys and
girls starting to smoke because they feel like they have to.
     So one of my concerns here from a public health perspective is the secret additives that are included, not
only in cigarettes but also in these smokeless tobacco kind of products that are sold. And I know that HHS is
one of the only entities to have the secret list of ingredients. Do you think that it would be helpful for there to
be a release of the secret additives to the public so that even if smokeless tobacco is advertised as being
safer than smoking tobacco, that the public would then still be able to see what the additives were and to be
able to judge that it's still much too big of a risk to undertake at all, and help mothers and fathers to convince
their kids not to start? Doctor?
     ADM. CARMONA: Sir, I'm not aware of the legal complexities involving the release of such information,
but I know that our scientists have looked at it and in aggregate they've published information as to many
carcinogenic agents as well as other factors that are contained within smoke products that can cause not
only cancer but other disease. But as far as the release of that, I think it's out of the scope of my practice, sir,
and I'm not sure of the legalities of that but certainly --
    REP. MARKEY: Would you -- if it was within your power, would you make the list of the secret additives
public?
    ADM. CARMONA: I think that I would ask my colleagues who actually are at the bench doing the re-
search to ascertain of there was any additional benefit to that that would be released within the research, and
then I'd make my decision on that.
    REP. MARKEY: Any additional benefit --
    ADM. CARMONA: For public knowing the specifics, yes.
    REP. MARKEY: If the public knew what the additives were and it was determined that they would be
more likely not to start using it if they knew, would you then be supportive of releasing the additive informa-
tion?
     ADM. CARMONA: Again, sir, that is one of the factors I would consider, but also looking at the entire
context of how this information is being used by our scientists and if there was some improvement in health
status that could be achieved by releasing this information, then certainly that would move me in that direc-
tion.
   REP. MARKEY: So there are carcinogens in these additives. You also mentioned of other diseases
caused by these additives. What are they?
    ADM. CARMONA: Well, chronic obstructive pulmonary disease, acceleration of cardiovascular disease,
you know, stroke, heart attacks, things like that. So not all necessarily cancer-related, but very significant
diseases also.
   REP. MARKEY: So let me ask you, Chairman Muris, if the public doesn't have access to information
about secret ingredients and additives in smokeless tobacco, aren't claims regarding the potential health
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    HOUSE ENERGY AND COMMERCE COMMITTEESUBJECT: CAN TOBACCO CURE SMOKING? A
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benefits of smoking tobacco -- smokeless tobacco rather -- likely to be deceptive or misleading because the
information about the additives that are in the smokeless tobacco aren't available for the public to make that
determination themselves?
     MR. MURIS: Well, let me preface with two general statements. One, I have never looked explicitly at
what this information is but, from the standpoint of what we do, there would obviously be a heavy presump-
tion in favor of more information and not less and somebody would have to make a very good argument. Not
having looked at it, I don't know what that argument might be to withhold information.
    Thank you.
    REP. STEARNS: The gentleman's time has expired.
    Mr. Shimkus. No, Mr. Shadegg. Mr. Shadegg.
      REP. JOHN B. SHADEGG (R-AZ): Thank you, Mr. Chairman and thank you for holding this hearing. I will
tell you I am mystified by it all and I kind of wonder where it's taking us.
    Let me start with the issue of your jurisdiction at the FTC. As I understand it, you have jurisdiction arriv-
ing at the concept of deception and the concept of unfairness, is that correct?
    MR. MURIS: Yes.
    REP. SHADEGG: On the concept of deception, as I understand your testimony, before you could allow a
label to say this product is safer than, that is, smokeless tobacco is a safer alternative to cigarette smoking,
you would have to have evidence which substantiated that point. Is that correct?
    MR. MURIS: Among other things, yes, sir.
    REP. SHADEGG: Okay. Dr. Carmona, it is your belief that, while there have been studies done on that
point, they simply are not sufficient, that is, not enough studies or not enough subjects and not enough con-
trasting information to reach that conclusion. Is that right?
    ADM. CARMONA: In the particular instance of smokeless is safer --
    REP. SHADEGG: To reach the conclusion that smokeless is safer than.
    ADM. CARMONA: Yes, that's correct, sir.
    REP. SHADEGG: Okay. So you believe the FTC could not in fact substantiate that first threshold criteria
of whether or not it's safer than. Is that right?
    ADM. CARMONA: That's right, sir.
     REP. SHADEGG: The whole topic puzzles me. For example, this is a can of smokeless tobacco. This
particular can has the warning that says this product may cause gum disease and tooth loss. One of the is-
sues I hear in the testimony here today is a relative one, which is, if we say or we allow the claim to be made
that smokeless tobacco is safer than cigarettes, which you believe can't be substantiated but others believe
could be substantiated, are we then deceiving people into using smokeless tobacco as a safe alternative?
Now, we know that one of the labels that's already on smokeless tobacco says this product is not a safe al-
ternative to cigarettes. That raises the issue of, okay, what is the truth? If you give less than all the truth, are
you somehow deceiving people? And, Dr. Carmona, that's your concern, isn't it?
     ADM. CARMONA: Yes, sir. My concern is that, you know, that definition of the word 'safer', as it relates
to these products, that, in fact, if you take one piece out of context and make an assumption that, well, be-
cause there's less of a certain chemical, therefore it's safer where the science isn't there to support and we
ignore the fact that, as you just pointed out, sir, that gum disease, tooth problems and so on are also prob-
lematic, it's very difficult to say that and that's why I view that substitution argument as oversimplified for a
very complex problem and one that I could not support because it is still detrimental to the American public.
   REP. SHADEGG: Let me ask you both. As I read the information I'm provided right now, although the
warning on cigarettes is a surgeon general's warning and the warning on smokeless tobacco is not a surge-
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on general's warning, it just says a warning, both are a result of congressional actions and neither are as a
result of FTC action standing alone or surgeon general standing alone. Is that correct?
    ADM. CARMONA: I believe so, sir.
    MR. MURIS: Yes, the FTC got the ball rolling and then Congress stepped in 40 years ago, almost 40
years ago, sir.
   REP. SHADEGG: And so, it's going to be our job to try to spell out what should be at least currently or
should be specified on the label if anything.
     Dr. Carmona, if the Congress does not step in and specify what should be spelled out, do you have the
jurisdiction to issue your own warning?
    ADM. CARMONA: Well, I think that one of the things I have probably that's most important is the
so-called bully pulpit. I can certainly speak out regularly on the hazards of all tobacco products and I would
certainly intend to do that along with my colleagues, where the scientific basis allows me to do so.
   REP. SHADEGG: And I suppose it would be your position that, if someone were to propose that they
wanted to advertise smokeless tobacco as safer than cigarettes, you'd want to add what's not in fact safe
because of these other dangers. Right?
    ADM. CARMONA: I'd be opposed to such advertising.
     REP. SHADEGG: And you'd like to see the Congress, if the Congress were to step into this field and
specify what had to be put on claims about smokeless tobacco to make sure that if anyone had wanted to
make a claim that smokeless tobacco was safer than cigarettes that they'd go beyond that and say but,
however, it's still not safe because it cause all of these issues, the potential for mouth cancer, the potential
for gum decay, tooth disease, other things. Is that right?
    ADM. CARMONA: Well, sir, my intent would never be to attempt behavioral modification on the Con-
gress as --
    REP. SHADEGG: Well, except we look to you for extra feedback and we should.
      ADM. CARMONA: But what I would strongly support is that Congress take into account all of the scien-
tific evidence before, as some of which you've completely outlined right now, making the decision to protect
the American public.
     REP. SHADEGG: One of the things that concern me is that of all the three labels Congress has specified
for smokeless tobacco, and I understand they rotate, so my understanding is one third of all cans would have
to contain one of these, one third the second and one third the third. One of them quite frankly, I think, you
could make the claim that it is deceptive precisely because it doesn't go far enough.
    One of the three labels is, this product may cause gum disease and tooth loss. I would suggest that, if I
were a young kid picking up this can and read this particular can which says it may cause gum disease and
tooth loss, I would be a lot less concerned about its use than if it read, this product may cause mouth cancer,
which raises the next question of, well, why does it say mouth cancer? Why doesn't it say this product may
cause cancer? Because if you want to scare somebody and you warn them this product may cause cancer, I
suggest that's going to have a greater impact on them than perhaps any of the other three alternatives that
are there.
    So, one of my concerns is, why haven't we started down the slippery slope when it's the United States
that decides what the precise wording of any warning ought to be.
    ADM. CARMONA: We're certainly concerned, my colleagues and I, sir, that any references to 'safer' that
are not clearly spelled out and are not scientifically justified may in fact just do that, cause young people to
start earlier and feel that it's a safe thing to do, that there's relatively little risk and, as you've pointed out, the
whole story is not being told.
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     REP. SHADEGG: Let me go back to the FTC on the issue of -- one issue would be the issue of decep-
tion and that is, would it be deceptive to claim that smokeless tobacco is safer than cigarettes. Your second
element of jurisdiction is that of unfairness.
    Under the second rubric on fairness, would you consider it necessary to go on and provide the disclo-
sure, however not safe?
     MR. MURIS: Well, the commission has rarely, and I mean rarely, used unfairness to evaluate advertis-
ing. It almost always uses deception. There is a tremendous First Amendment problem from saying an ad-
vertisement is truthful, yet we can stop it. So we would much more likely use on the unfair -- I mean, the de-
ceptive authority. It's clear that any of these ads, we would be concerned with the take away and under-
standing -- by that I mean an understanding by the intended audience that no matter what the word said that
a lot of people thought that it meant safe. And that would be a concern.
   REP. SHADEGG: And you would be concerned that an implication that's safer might cause somebody to
conclude it was safe?
    MR. MURIS: Sure, depending on how the disclosure was made and what else was in the ad.
     REP. SHADEGG: Before my time expires, I simply want to conclude by pointing out that, according to
the information I have, in 1981, the FTC issued a report to Congress that concluded that health warning la-
bels had little effect on public knowledge and attitude about smoking. So it says public labels don't do any-
thing. Congress responded by enacting a law requiring health warning labels. I think it's quite interesting
what we do here.
    Thank you very much.
    REP. STEARNS: The gentleman's time has expired.
    Mr. Davis is recognized.
    REP. JIM DAVIS (D-FL): Thank you, Mr. Chairman.
    Chairman Muris, in reviewing your written statement on page 8, you suggest that in the context of safety
claims, the FTC has typically required a substantiation standard of competent, reliable scientific evidence. In
my opinion, this issue ultimately boils down to how much respect are we going to have for our consumers, for
our citizens in terms of how high a standard we set as far as judging the accuracy and truthfulness of any
disclosure you would approve and this Congress would approve so people can make safe decisions, not
necessarily the right decision. Can you elaborate a little bit as to exactly how high the standard is you would
employ if you were to find yourself in a proceeding judging the marketing of smokeless tobacco?
     MR. MURIS: Well, yes, sir. The first question obviously turns on what the ads would say in their full con-
text, and therefore what the takeaway from consumers would be. The more qualified the takeaway that the
consumers received, the lesser the substantiation. On the other hand, as I mentioned, the so-called Pfizer
factors before because I personally believe -- again, just speaking for myself. Obviously my colleagues could
have different views. Because the consequences of making a mistake here are so serious in terms of, you
know, the potential adverse effects on public health, people who might otherwise have quit, what the effects
might be on children, that would indicate that the bar should be very high.
    REP. DAVIS: The debate here today seems to center upon the word "safer." It seems to me as a lay-
person that by its very nature, in whatever context the word "safer" is used it invariably is a vague term. It is
not a qualitative connotation. Under what circumstances could "safer" ever constitute a sufficiently accepta-
ble standard under this very high standard you've just described?
      MR. MURIS: Well, again, there are two questions that I think you really have to keep distinct. One is how
consumers understand the words. And I believe that it's possible to communicate safer as opposed to safe.
But then the second question is about the scientific evidence, and the scientific evidence I believe would
have to be very high. But we don't even know -- I mean, again, we're not scientists. The scientific community
-- I think it would be very useful for them to do more work on issues involving what sort of evidence is it that
they would want, what sort of evidence that they would look at. Because I do agree with the general premise
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that some members have made that we do have upwards of 50 million people who smoke. Many of them find
it very difficult to quit. The simplest place to start, if I could just end, I believe, and I would like to explore with
the FDA the potential for broader based claims for the gums and the patches that the surgeon general men-
tioned. Right now those can only be used for very narrow purposes. They can't be -- they can only be mar-
keted as part of a quitting. They can't be marketed as sort of a long run replacement. It seems to me -- again,
it would be up to the FDA ultimately because they regulate this, but it would seem to me that there are very
large potential benefits from being able to tell people about the longer run possibilities.
    REP. DAVIS: Can I come in here on that? I don't think we should be afraid of the risk reduction the
surgeon general has said. I think we need to be painfully objective about this. But it just seems to me as a
layperson that the question isn't whether a safer type of marketing could ever be accepted under this very
high standard, but that it really would be a disclosure as to how much safer or how less safer, don't you
think?
     MR. MURIS: Oh, well absolutely you would need to understand the question of quantity in that sense,
not just the question of a qualitative difference, and I agree with that. It even may true of a complication of
the nicotine and why -- of the nicotine products, the gums and patches. And why I use the word "potential" is
there is some evidence -- and again I'm not a scientist but the scientists would have to explore it, there's
some evidence of potential dangers from nicotine itself beyond addiction.
     REP. DAVIS: In the footnote 17 on page eight you seem to acknowledge the possibility that if evidence
that's presented to you that you rely upon for approval later proves to be faulty, that's a problem. Do you
have the authority to go back and revisit any approval of the disclosure that's been made on a product, if
subsequent scientific evidence reveals it is not sufficiently accurate?
   MR. MURIS: Absolutely. And the basis of the substantiation doctrine by its very nature recognizes that
when the science changes, then the ability to make the claims changes.
    REP. DAVIS: I'd like to give the surgeon general the opportunity to comment on any of these points if
he'd care to.
     ADM. CARMONA: Well, sir, simply I agree with where you're going with this. I think there's a qualitative
and quantitative aspect to the word "safe" or "safer" and certainly quantitatively we have to be able to define
that but also in its entirety. As I alluded to earlier in my remarks, taking one variable out of context and simply
stating that there is an improvement or it is simply safer doesn't address the spectrum of risk, of which there
are many variables. So I think it's to the public's benefit that we're very clear on how that word is used.
    REP. DAVIS: Thank you, Mr. Chairman.
    REP. STEARNS: The gentleman's time has expired.
    Mr. Otter.
    REP. OTTER: Thank you, Mr. Chairman. I might preface this by saying that I'm a recovering smoker of
13 plus years, so I'm very aware and every day think about, you know, the error of my smoking in my youth
and my not so youth, judging from when I finally quit. But I do have some questions because I don't think
we're dealing with tobacco here, we're dealing with the question of a blank substance relative to other blank
substances, claims -- interpretation for whether or not they're allowed versus other claims. And hopefully we
can forget the word "tobacco" in the discussion today for purposes of thinking about whether or not safer,
which does seem to be the key word, is appropriate or inappropriate to be considered.
   And what I'd like to first of all do is ask the surgeon general one question, which is: what is the health
benefit of butter?
    ADM. CARMONA: Let's see, with -- there are nutrients within butter, there's --
    REP. OTTER: Butter is basically fat. Is that right?
    ADM. CARMONA: No, no, there's --
    REP. OTTER: What are the benefits of fat then, perhaps is a better question?
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   ADM. CARMONA: Fat is a necessary -- it's necessary, it's essential to our growing. Everything from
making steroids in your body to new cells require fats.
   REP. OTTER: And isn't the excess consumption of fat the number one health problem in America, in
combination with not enough exercise?
    ADM. CARMONA: It certainly contributes to obesity, sir. Yes, sir.
    REP. OTTER: Okay, and yet the low fat butters and the alternate butters appear to be able to claim that
they're better and safer. I've read enough packaging to get this idea that this plasticized butter that tastes
marginal at best -- not margarine, but marginal, gets to make that claim.
   And, Mr. Chairman Muris, I guess the question is: how do they get to make the claim that they're better if
essentially the difference is less fat, which the surgeon general has said is okay, it's essential?
    MR. MURIS: Well, health claims are regulated by a statute that Congress passed in 1991, the NLEA,
and there are a variety of hoops through which you have to jump. So it's -- even though we're involved in that
area and in fact Dr. McClellan, the head of the FDA, and I made an announcement last year where he is
hoping -- given the way science is changing, he's hoping that advertising and labeling can keep up with the
changes in science. But there's a special, you know, regulatory regime for those.
     REP. OTTER: Okay. So the fact that butter is essentially not bad and fat is not bad and that if you have
less of it, claiming that it's better would be probably inappropriate on the face of it all. Forgetting about the
taste of butter, forgetting about what we all put on, that in fact we have a different standard for tobacco than
we have for fat. Doctor, I guess my next question is you support banning tobacco. Does that allow you to be
an honest broker in the question of less bad and more bad? I would personally say that I would have a hard
time if I supported outright banning something, would be happy to see Congress passing a law that would do
that. And then I was asked, well, is -- are we going to allow the good instead of the perfect, even though the
good might in fact perpetuate consumption of this for a while? I would probably inherently say, well, geez, I
don't want to have anything that might lower a little bit the health risk but perpetuate the consumption. Is that
something that you're having to deal with in your testimony here today?
    ADM. CARMONA: Well, no, sir, and let me elaborate. First, I want to respectfully disagree with your
analogy with butter because it's much more complex than as presented and I think it's an unfair analogy.
Second, I'm not having any problem with it because the driving factor in what I have testified to is that the
substance we are talking about is a proven carcinogen. It causes cancer.
     REP. OTTER: And, reclaiming my time, I guess the -- from the witness, the problem we have is we're
talking about less and more and trying to understand whether or not less or more is an honest statement,
and that's why I'm trying to get to the bottom of this. It appears to me as though other than tobacco, we have
this theory that you're innocent until proven guilty. In tobacco you're guilty till proven innocent. And so for the
chairman, I guess, my question to you would be, because my time is evaporating here, we have made a big
point in this country, and accurately so, that we are concerned about secondhand smoke sufficiently that in
fact it has been found to be something that one has to get rid of, and that's why we banned smoking in public
areas in state after state. If in fact secondhand smoke is clearly bad, then aren't you better if you have no
secondhand smoke because you have no firsthand smoke? The risk to people around a smokeless tobacco
consumer is, by definition, zero versus whatever you have with cigars, pipes and cigarettes. Would that not
meet the first threshold of, well, a claim?
     MR. MURIS: Sure, but now you're addressing a different question. If smokeless tobacco made a claim
based on no secondhand smoke, that's -- you know, we would evaluate that on its merits. That's obviously
different than the earlier claim we were talking about.
   REP. OTTER: So just one last follow up. So what I'm hearing is that even though there's no smoke and
anybody could figure out that it must be safer, you're saying that if they made that claim then you would think
about evaluating it? Do we need science to determine --
    MR. MURIS: Well, no I'm saying --
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   REP. OTTER: -- (cross talk) -- has no second hand smoke claim?
    MR. MURIS: The evaluation could be very -- the evaluation could be very quick. But obviously if some-
one asked us to -- go back to the premise. The premise was we were asked about these claims. I can't give
an answer without an evaluation, even if the evaluation occurs in a twinkling of an eye.
    REP. STEARNS: The gentleman's time has expired.
    And the gentle lady from California, Ms. Solis.
    REP. HILDA L. SOLIS (D-CA): Thank you, Mr. Chairman.
     Thank you, Dr. Carmona, for being here. It's good to see you. I know on occasion we've talked about
some of these chronic illnesses that face our communities, especially minority communities and the Latino
community. And I want to ask you, and I don't know if this has come up, what the cost is in terms of preven-
tion for tobacco use now that you know of, in terms of the government trying to combat the use, trying to get
youth to stay out of, you know, going into that habit of smoking?
   ADM. CARMONA: I don't have a dollar amount for you. I certainly get that. But whatever it is, I know
when we look at prevention across the board we spend far, far too little on all prevention activities in this
country.
    REP. SOLIS: Would you say that the number of youth, particularly minority youth in terms of smoking,
has gone up in the last 10 years or has gone down?
     ADM. CARMONA: I think it has slightly increased. Where other areas or other subsets have decreased,
this is still a population that is at greater risk.
     REP. SOLIS: I saw some information regarding I guess the percentage decrease for young Latinas in
terms of smoking, and I was a little -- I kind of understand why that's happening because more women at
least are going in for prenatal care and are being advised of low birth weight that their child would experience
if they continue to smoke. Is that something that your office is advocating?
    MR. CARMONE: Well, the epidemiology and demographics of smoking are tracked very carefully by
CDC on a routine basis, and they have all of those numbers broken down, again, by ethnicity, by geographic
location, by age and so on. So it really depends which group you're speaking of. In some areas it has pla-
teaued out, but in some there are still subgroups, Latinos specifically, who are at slightly increased risk and
every once in a while we see a little increase.
    REP. SOLIS: One of the pieces of information that we were given is that in fact if you are advocating for
use of smokeless tobacco, that that probably or could lead to use of tobacco, cigarettes. What do you --
what's your opinion on that?
    ADM. CARMONA: Yes, we do look at smokeless products as being a gateway to smoking. It can be so a
sense of security that, again, as I've said earlier, that this is a lesser threat, it is a safer means to get your
nicotine and chew, and we are definitely concerned about that for the reasons I've already mentioned.
    REP. SOLIS: One of the other questions I have is women I think overall -- my understanding is that the
rate has actually gone up. Is that correct, I terms of cigarettes?
     ADM. CARMONA: It depends on the age group and I'd have to look at that data. But when you -- the ag-
gregate -- if it has, it's very slightly in aggregate. But, again, breaking down the populations -- minority popu-
lation, age and demographics -- you'll have peaks and leveling off periods that are different than the aggre-
gate data when you just lump all women together, for instance, nationally.
    REP. SOLIS: Information I have is that women account now for about 39 percent of all smoke related
deaths in the U.S.
    ADM. CARMONA: That's correct.
    REP. SOLIS: I would ask -- I guess one of the questions I would have is if we're trying to get women to
stop smoking and using an alternative measure here, in this case smokeless tobacco, I can't think of too
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many women who'd want to chew tobacco. You know, I don't -- you know, and I'd love to hear more about
that because I think that's the real issue that we're really skirting issue here, and how do you deal with that?
   ADM. CARMONA: Well, I think that's a, you know, social and cultural part of our society where young
men embrace that and most women reject it.
     REP. SOLIS: Well, do you think that we're going to -- wouldn't that have an impact on modifying maybe
their behavior?
    ADM. CARMONA: Oh, yes, ma'am. Absolutely.
     REP. SOLIS: So I'm still very skeptical about the direction of where we're going with all of this, because I
know that in our community -- and especially in California. The state of California is pretty progressive in
terms of prevention, tobacco smoking and all of that and restricting where you can use cigarettes. In fact, we
have an initiative that was passed, Prop. 10, that you're probably aware of that is dedicated -- a dedicated
source of funding strictly for prevention. So my question goes to while we're spending a lot of money to try to
treat the illness, cancer, respiratory emphysema, at the same time we're raising revenue to try to tell youth --
to give them the message and young people not to smoke. And then we're saying on the other hand, well, it's
okay to chew tobacco, when in fact studies I guess are not clear on how severe that might be. My question
is, you know, where are we going with this in terms of giving accurate information that smokeless tobacco
may be harmful, could be maybe in different degrees obviously. Maybe you don't get cancer in 10 years,
maybe you suffer from tooth decay a lot faster, which we see in our community by the way. And I would ask,
you know, what your opinion is on that?
    ADM. CARMONA: Congresswoman, my opinion is that -- as I've stated, that irrespective of the debate
here today, I see no scientific evidence to support the use of smokeless products for any reason and they
are hazardous to your health, from causing cancer to causing oral disease, including gingivitis, tooth decay,
as well as a host of other diseases. So without further evidence to refute that, I could not support its use in
any fashion.
    REP. STEARNS: The gentle lady's time has expired.
    REP. SOLIS: Thank you. Thank you very much.
    REP. STEARNS: Mr. Fletcher.
     REP. ERNIE FLETCHER (R-KY): Thank you, Mr. Chairman, and thank you for conducting this hearing.
Let me say first having spent most of my adult life, up until the political side of things, in encouraging people
to stop smoking and using tobacco products, I think it's interesting that we come to today where we are talk-
ing about relative risk of different products. There's no question as we look at the IOM report, 180,000 deaths
from cardiovascular disease, 150,000 from cancer, about 85,000 from respiratory diseases related to tobac-
co use. And so there's no question that if we had a perfect world that no one would smoke or use products
that are harmful to their health. But in fact that's not the case.
     We do have a free society and I think in a free society it's very important to remember that a couple of
things are important. One, I think it's extremely important to be intellectually honest with the population so
that they can make choices. Some people choose to smoke even though they know the risk is there. I think
75 percent of the people that are smoking would like to quit. That means there's 25 percent that don't even
want to quit. So outside of prohibition, which even though some may support that I think would probably have
-- nigh to impossible to control and regulate. We went through prohibition I think in the early part of the last
century with some abysmal results.
     But given that, let me look -- and I want to present a couple of things. I've looked over these reports and I
know the surgeon general has commented on that. One was the Royal College of Physicians in London, and
these are pretty reputable folks. In fact, they've been around a lot longer than most of our -- probably even
Harvard and some of our early medical institutions. I mean, these are folks that spend their life doing re-
search. And they come up and said a way of using nicotine in the consumption of non-combustible tobacco
is in the order of 10 to 1,000 times less hazardous than smoking, depending on the product. Some manufac-
turers want to market smokeless tobacco as a harm reduction option for nicotine users, and they may find
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support for that in the public health community. But the bottom line is they -- it's a pretty big spectrum so the
science is pretty unclear. It's 10 to 1,000 times -- even 10 is pretty significant if that's the low balling side.
     Now, I do not support and certainly have found it intolerable that companies in the past have made mar-
keting attempts toward younger individuals and maybe have not always been truthful in what they said they
market and things. And so I think it's clear that we have some sort of guidelines for advertising, for marketing
of products. But also look at -- given the fact that the Royal College says 10 to 1,000 less, there's also the
European -- these are some pretty reputable people too that have spent a lifetime just in research. They said
oral tobacco may play a role in harmful reduction. It is not necessary to show that it does not cause cancer, it
just needs to be substantially less hazardous than smoking, even allowing for the cautious assumption about
health impact. Snus, which is talking about the European, I guess, the smokeless tobacco and other oral to-
baccos are a very substantially less dangerous way to use tobacco than cigarettes. It goes on to talk about a
number of different other things, but it does at least acknowledge -- and this is a study of some physician
researchers -- that smokeless tobacco does reduce health.
    Now, the Scandinavian study -- and I know the surgeon general mentioned that some of the factors
weren't controlled. It was one of those studies where they were controlled fairly well. Let me read those to
you. This was the Langerhan (ph) study. It was a case controlled study. You know, patients with adenocar-
cinoma, with esophagus -- gastric, cardio and esophageal squamous cell carcinoma. It said, "Many potential
confounders were considered including age, sex, education, cigarette smoking, alcohol consumption, dietary
intakes" -- it did not mention coffee specifically -- "dietary intakes of fruit and vegetables and energy intake,
BMI, reflux symptoms, physical activities." It talked about the substantial reduction.
     I agree that science is not totally -- I mean, there's a lot of studies that can be done and the science is
not totally complete in this area. But one of the questions I've got for both of you is if we could have certainly
an initiative regulating tobacco products, whether it be FDA or whether it be FTC on the marketing of it, and it
marketed it in such a way that it was very clear that not namesake used the word "safe" or "safer," but say
you had a relative scale one to 10 and say you could say, well, given the current knowledge that we have,
you know, filterless cigarettes maybe a 10, smokeless somewhere less there. And, by the way, I come from
a district that produces burley, which is for cigarettes not for smokeless tobacco. Given the fact that we live in
a free society and that it's important to get information out, and given the fact that I know some people feel
that this gateway issue may promote more people, wouldn't it be incumbent upon us to provide that informa-
tion to them that there is a relative risk?
     And I say that because I've got a brother that I tried to get to stop smoking. He was smoking, we got him
to stop, but he started a different snuff. Finally, when we couldn't get him to stop altogether, we just kind of
quit and, yeah, he went back to smoking.
     But I never told him -- I never talked to him about reduced risk. And I just wonder, given the fact that
even secondhand smoke causes some injuries, what we might do if we give the public intellectually honest
information about the relative risk? And I'd just like both of you to comment on that.
     ADM. CARMONA: Well, if I might, I'll just comment on the science first and then I'll pass off to my col-
league on the advertising. I certainly respect your opinions as a colleague, as a fellow physician, sir. But the
Swedish study, I know that they looked at an end point of oral cancer risk and not cardiovascular disease or
other causes of mortality in a more broad sense. So it's only one end point. So I think when we -- the va-
riables also in outcome, as well as the inputs for the research, I think are equally important. The --
    REP. FLETCHER: But may I interrupt you and just ask you a question?
    ADM. CARMONA: Yes, sir.
    REP. FLETCHER: Do you believe there's -- that smoking has the same cardiovascular risk as smokeless
tobacco in the -- say, the Swedish smokeless?
    ADM. CARMONA: I'd have to review the data more specifically. But I know there's risk. If it's the same or
less, sir, then we get into that issue again of is it safer?
    REP. FLETCHER: Yeah, relative risk. I mean --
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    ADM. CARMONA: Relative risk, exactly.
    REP. FLETCHER: -- that's what the studies are about. There's no absolute.
    ADM. CARMONA: Yes, sir. And so the other issue is when we're talking about the amount of nicotine, for
instance, and you don't also talk about carcinogenicity, then you just negate the fact that we know that these
are cancer causing compounds. And so if you just address the issue of, well, is this a safe way of using this
to withdraw somebody from their nicotine addiction? Well, again, my premise is that if I know that this is a
carcinogen, then I really could not in good faith recommend it for any other use when I know, no matter what
else you're using it for --
     REP. FLETCHER: I agree. We don't recommend it for use, period. But I'm talking about a relative scale,
just getting information out to the public. It's kind of like on HPV and cervical cancer. You know that. We talk
about the use of condoms doesn't totally prevent HPV and cervical cancer, but it reduces the risk.
    ADM. CARMONA: Well --
     REP. FLETCHER: And we -- there's a lot of folks on different sides of the aisle have a different approach
to that.
     ADM. CARMONA: I understand and I can understand where you're coming from and where some of the
research is looking at this a little bit different as a matter of policy. But, again, it comes back to the cancer
causing effects or carcinogenicity of this for me that when you say on a relative risk and you say, okay, well,
smoking let's say is a 10 and maybe this product is a five, but it still causes cancer. So if you say the relative
risk is lower, all right, I can't argue with you if we show that statistically, but it's still a cancer causing agent
which is why I'm concerned.
    REP. FLETCHER: I agree.
    And, Chairman?
    REP. STEARNS: The gentleman's time has expired.
    The gentle lady, Ms. Cubin.
     REP. BARBARA CUBIN (R-WY): Thank you, Mr. Chairman, and thank you for calling this hearing today.
I was one of those members that did request it because I believe that knowledge is power. And I want to
point out that we are not here today talking about the ills of smoking. We all know that. We all believe it and
we accept it. We're also not talking about marketing tobacco products to children. If I had three wishes in my
-- found a bottle on the shore and the genie popped out, I would probably wish for enough money to take
care of myself and my family and meet our needs until we die. I would probably ask for good health for my-
self and my family. And the third thing would be that I would wish for all children to make decisions that were
beneficial to their bodies as far as health is concerned.
    So, you know, I'm a mother and I actually have a son that chews smokeless tobacco and I hate it. When
I was a little girl my grandfather chewed smokeless tobacco. I'm from Wyoming and probably we have as
many people that use smokeless tobacco as anyone. But what I'm thinking about are the 10 million adults
that are going to die in the next 10 years that are -- the next two decades I should say, that are going to die
from actions related to smoking, conditions related to smoking.
    I've a degree in chemistry and whenever we would be arguing an issue in science, the first thing we
would always do is challenge the studies that were cited by -- I was also in debate -- the studies that were
challenged by the other side. And so, Dr. Carmona, you don't accept as valid, because it is not comprehen-
sive enough, the study by Britain's Royal Academy of Medicine. Is that correct? Was that the reason you
gave during your questioning and --
   ADM. CARMONA: Yes, that was -- yes, not that it was invalid but that to make a decision like that, I
would need much more information. And my colleagues also who study this.
     REP. CUBIN: Yes, okay. Well, then does it follow that the same level of comprehensiveness must be
followed to support the statement you made that -- let me see, where do I have it here? That smoking is a
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gate -- or that smokeless tobacco is a gateway to smoking. Is there a study that you can cite that has more
comprehensive basis than the Royal Academy? And if so, would you please furnish that? I would like a
comparison actually of the studies themselves and why the study that you are quoting as far as a gateway to
smoking is concerned is superior to the basis of the study by the Royal Academy. Would you provide that to
us?
    ADM. CARMONA: Yes, ma'am. I --
    REP. CUBIN: Thank you.
    ADM. CARMONA: -- didn't mean to imply that it was superior, but would be happy to provide the infor-
mation to you.
    REP. CUBIN: Sure, you didn't say it was superior, but you base your opinion on something and I'm just
curious to know what that opinion -- you know, how you substantiate that in your own mind. And I'd appre-
ciate it if you would provide that to us. Another point that I wanted to bring up is that science is changing. Mr.
Muris brought that up earlier in response to a question that science is changing, and the 1986 Comprehen-
sive Smokeless Tobacco Health Education Act, Congress ordered that three messages be alternated on
snus cans.
    You notice I call it snus because that's what my grandpa always called it, that's politically correct to me.
Anyway, one of those statements is, "This product is not a safe alternative to cigarettes." Well, since your
agency did not come up with that language that it is not a safe alternative to cigarettes, Mr. Muris, I wonder if
you have a responsibility to -- I mean, obviously the Congress did that, but trying to decide who has the re-
sponsibility to get this information forward or to -- I mean, it's your agency's responsibility that correct infor-
mation be out there.
     This language was done in 1986, isn't there information that would cause you to at least look at that and
make a recommendation to the Congress, if they're the ones to do the language, which I don't frankly think
that the Congress should be doing that, I think it should be done in your agency?
    MR. MURIS: Well, the history of this issue is many, many years ago in the mid 1960s my agency tried to
do something and Congress immediately stepped in and --
    REP. CUBIN: Yeah.
    MR. MURIS: And my agency has had the wisdom since then to --
    REP. CUBIN: To stay out?
   MR. MURIS: Well, we've issued reports and we've done other things, but we haven't tried to by rule
making do something that Congress has made it pretty clear that it wants to do. Look, in the --
     REP. CUBIN: But that's really not my point. My point really is if this statement is factually wrong, I mean,
if we cannot make the statement that non tobacco products -- where'd I write this down? I wish I could keep
track. Go ahead and answer what you were going to say.
     MR. MURIS: Well, in the very large context, and I don't want to lose sight of that here in the specifics.
This hearing is very important because potentially, and that's obviously the key word, there are very large
public health benefits to be made from addressing the problem of people who can't or won't quit smoking.
And that's why I said a place to start, where I think we can do more and again, it's potential, and the FDA
already regulates this and that's why I said I would obviously need to talk to them, is with the non-tobacco
risk reduction products, the gums and the patches.
    They right now can only be marketed for a very limited purpose. So consumers can't be told about their
potential for that group of smokers who are unwilling to go off of nicotine entirely.
    REP. CUBIN: So what I've drawn from this hearing today so far is that if more people were using snus
instead of smoking cigarettes, that our national healthcare bill would be lower, that there wouldn't be people
suffering from second hand smoke from other smokers, that 10 to 1000 percent improvement would be seen
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in our national health picture. And I just think that rather -- it seems to me, General -- I mean Admiral, excuse
me.
    (Laughter.)
    That it's something that we should consider. I don't think anyone is saying that the use of snus is a
healthy thing to do, but I certainly don't think we can say that it is not a healthier thing to do than smoke cig-
arettes. My time is up, and if you'd like to respond to that that'd be great.
     ADM. CARMONA: I think my remarks, Ma'am, have been directed to the science that we have at hand
today, that there is no evidence at this point to use that as a substitute. What we do know about the product
is that it can cause cancer and other diseases. I also stated earlier though, if there is research to the con-
trary, if there is research that can define some role, my colleagues and I are always happy to look at that to
see if there is a possibility, but as of this date we have seen none.
    REP. STEARNS: The gentlelady's time has expired.
    The gentleman from Idaho, Mr. Otter.
     REP. C. L. "BUTCH" OTTER (R-ID): Thank you, Mr. Chairman, and I along with the rest of the panel
want to thank you very much for calling this most important hearing. I've always been adverse to putting the
fist of government into the glove of courtesy. I know many times when I was in my state legislature we
passed no smoking in public places, even though it was a private -- was not a government building or was
not a government called meeting. And I always voted against those kinds of bills because I felt that I had a
personal responsibility, if I didn't want to be in part of that environment that I should go to the restaurant
owner and say, I'm not going to eat here anymore as long as you don't have a no smoking section or as long
as I can't avoid second hand smoke."
    But I want to make an admission like my colleague from California, Mr. Issa, that I too am I recovering
smoker. I quit from my son's first birthday, 34 years ago. And it's probably one of the smarter things that I've
ever done. But I did it because I recognized that it's a personal responsibility, and it's unfortunate that so
many of the things that we do in Congress -- and I've only been here a little over two years and two months,
but so many of the things that we do here in Congress is we try to substitute the national consciousness and
the national treasury for personal choice.
     And of course I have to look right back on the immediate past of the tobacco lawsuits that we had. And
though even when I did smoke, 35 years ago, never bought a pack of cigarettes that probably didn't have
that warning on them. And I say probably because I doubt if I read it more than once or twice. Only as a no-
velty, I guess, when it first appeared. But I made that choice. I made that choice to smoke. And I watched as
the generation just before us, as many of the folks in my generation watched as that generation just before
us that had smoked 10 years more than we had started suffering the consequences of that behavioral
choice.
     Well, I think we've sent a far more dangerous message to our youth about smoking or not smoking or
choosing to use tobacco in any form or not to use it, when we've substituted the national treasury and the
national consciousness through Congress' action, through the Judiciary Department's action of putting a
lawsuit, bringing a lawsuit against the tobacco company. They were warned, don't smoke. Then we go back
and we sue them anyway and say, we're going to hold you responsible. That's past history, I disagree with
that. I suspect when I was in the military and I was -- you could have called me General Barbas (ph).
    I was in the armored cavalry and it wasn't unusual for us during training or during OJT or AIT to stop the
column and break and say smoke them if you've got them. And sometimes they were supplied in our food
packets.
    MR. : (Off mike.)
    REP. OTTER: Yeah, those too. Anyway, I suspect that that got a lot of people smoking. But anyway,
what I would like to ask I guess both of you, it hasn't been unusual for the government as Congressman Cu-
bin made the point earlier, that knowledge is power. And one of the responsibilities this republic, this gov-
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ernment does have to its citizens is to make them as knowledgeable as possible. And then stay out of there
way and allow them to use that knowledge for choices. And it seems to me that if there is evidence, and
whether or not you disagree with these early on reports, it hasn't been unusual, Mr. Muris, for the FTC to al-
low cigarette makers to say, this new filter that we've got on here allows for less tars and less nicotines.
      This new cigarette's a little less of this and a little less of that, and thereby enhancing the possibility that
it's probably not as dangerous as the one without a filter or as the one referred to earlier, and I don't want to
pick on any particular company, but the Camel cigarette. And I know that if you -- when I first standard
smoking, that if you could smoke a Camel, you were tough. You know, you probably got off a little easier with
something with a filter on it. But my point is that why isn't it your responsibility to make people more know-
ledgeable and therefore more free to make the right decision by saying -- by adding up and subtracting the
causes and the amount of danger there is in different products. We do it all the time. Less salt, less sugar,
less fat. We hear it all the time. Why isn't that our responsibility, irrespective of your feeling and the Admiral's
feeling of all of them being bad? And with that I'll let --
   REP. STEARNS: The gentleman's time has expired. Would you like to answer the question, Mr. Chair-
man?
    MR. MURIS: Sure, if you want.
    REP. STEARNS: Sure, go ahead.
     MR. MURIS: I do believe in the importance of knowledge, and as I mentioned just a few minutes ago, in
the potential for public health benefits from risk reduction products, there are obviously the important
attributes here. This is a product that, used as intended, causes you great damage and I think everybody
recognizes that, and our experience with the tar reduction has not been a particularly happy one because of
the phenomenon called compensation, by which people smoke the cigarettes harder, and therefore get more
damage than if they smoked them on some relative level. So, that just shows us that we need caution.
    REP. STEARNS: I would just briefly comment that I agree with your premise, sir, as far as the right to
people to choose, and in a perfect world we would hope that armed with the appropriate information that
people would make the right decisions, but often their individual decisions have impact on a population at
large and sometimes where I think markets fail or commonsense fails, regulations sometimes is essential.
    We do it with speed laws because we know people drive too fast and we've been able to demonstrate
that by slowing them down. There are less accidents. We know that seatbelts save lives and in many states,
people felt it was their right not to wear one, yet the impact of the population and the cost of health care as a
whole, was significant. So we had regulation for that, and helmets and a number of other things. And I think,
again in a perfect world, I would agree with you that it would be nice that people would make prudent deci-
sions based on the information before them which is part of my job, to bring that scientific information for-
ward.
   However, they don't always make the right decisions and their poor decisions can adversely impact the
population as a whole.
    REP. STEARNS: Gentleman's time has expired.
    The gentleman from Ohio, Mr. Brown, is recognized for five minutes.
    REP. BROWN: Thank you, Mr. Chairman. I would first like to recognize Dr. Carmona, whom I shared a
podium with at the American Public Health Association Meeting in Philadelphia and was very impressed with
his words then, and all that he shared with us.
    Mr. Chairman, I'd like to yield my time to Mr. Waxman, who has alerted Americans to the danger of all
forms of tobacco more than anyone in this body. So, Mr. Waxman, if I could.
    REP. WAXMAN: Thank you very much, Mr. Brown. Thirty years ago, the FTC was fooled by the tobacco
companies into allowing them to advertise low tar and light cigarettes and as a result, millions of Americans
switched to those products because they thought it would protect their health. As a result of that, millions of
Americans died, because these were not safer products, in fact, they weren't even what they claimed to be.
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      Now, I think what we have before the FTC, is another attempt by an industry to commit and fraud on the
American people. That's to try to present smokeless tobacco as a safer alternative. Now the first question is,
is it a safer alternative? And Dr. Carmona, you've been so clear in every question that's been raised on that
point. You don't believe it's a safer alternative. Is that a fair statement?
    ADM. CARMONA: Yes, sir.
     REP. WAXMAN: Now, let's say for argument purposes, it was safer, slightly. Harmful, but safer. Was on-
ly safer if people will use it instead of smoking. Not if they use it in addition to smoking. Is there any evidence
that anybody can show that people will give up cigarette smoking because they've got a safer alternative? I
submit there is no evidence at all. None.
     Now, another theory. If you advertise this product as a safer alternative to cigarettes, kids might start us-
ing this product. In fact, I think this is what this is all about. Kids are not using this smokeless tobacco as
much because they've caught on to the fact that it does them a great deal of harm. When this says cancer of
the jaw, kids start picturing what cancer of the jaw means. And more and more of them are giving up smoke-
less tobacco, but if they're told there is a safe alternative, they might say, well, I'll try this safer alternative but
we do have evidence, don't we Dr. Carmona, that people who use smokeless tobacco are starting to get the
nicotine habit and then they can move onto cigarettes. Isn't that an accurate statement?
    ADM. CARMONA: Yes, sir. There is scientific evidence to support that.
    REP. WAXMAN: So, the question that Mr. Muris said, is there a potential public health benefit? Well, it's
hard for me to see that there's a potential public health benefit. So the FTC allows this advertising that we'll
have to see 20 years down the road, what harm we've done because the FTC operates to allow advertising
unlike the FDA, which would screen any kind of claim in advance.
    Now, I really am struck by the fact that it's been a long time since the Congress has held any hearings
about tobacco. Today, two committees are holding hearings on tobacco. We're not looking at the Institute of
Medicine recommendations which said that they had a strategy -- This was a HHS advisory committee -- that
they thought could lead to a cessation of smoking and lead to three million lives being saved if five million
people could quit within one year. Instead, what the two committees of Congress are looking at, is what the
industries want. Today, we're looking at what U.S. Tobacco would like. This afternoon, we're going to look at
what U.S. Tobacco and Philip Morris would like. That's what the Congress has come to. We respond to the
industry pressure to bring this issue up.
     Mr. Muris, this is a hearing for you. This is a hearing to impress you. A lot of members of Congress would
like you to be receptive to U.S. Tobacco's attempt to rejuvenate their market. Well, I would hope that we rely
on science and the science isn't there. The science isn't there. The politics may be because tobacco is rich
and powerful, but the science is not there and I would hope you look at the science very, very carefully, and
I'm awfully nervous when a bunch of lawyers are making the decision on science, when it ought to be up to
something like the FDA or the Surgeon General or others who have scientific -- or the Institute of Medicine,
to make the decision. I know you'll consult with them.
    I don't know if you are aware, either of you, that Philip Morris once surveyed 85 former users of smoke-
less tobacco and found that 53 were now smoking and I'd like to introduce to the record Philip Morris's report
on how people who are using smokeless tobacco, didn't wean themselves off from cigarette smoking, that
they are either back to smoking or moved on to smoking. And I would hope that we can get in the --
    REP. STEARNS: By unanimous consent, so ordered.
     REP. WAXMAN: -- record. Mr. Chairman, I appreciate the opportunity you have afforded me to partici-
pate in this hearing, and I just hope that people don't get fooled a second time, the way the FTC was fooled
30 years ago, and then we look back 20 years from now and think about all the people that got cancer of the
jaw and moved on to cigarettes, and used cigarettes and smokeless tobacco and rather than a potential pub-
lic health benefit, we ended up with a potential public health disaster.
    REP. STEARNS: Gentleman from Ohio's time has expired.
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   Mr. Shimkus is recognized.
    REP. BOB SHIMKUS (R-IL): Thank you, Mr. Chairman, and I'm going to be brief. We've already been
here a long time and I think we're going in reciprocal debates on this issue.
     I will just say that we have a debate over different reports and basically is an agreement that there is a
risk to smokeless tobacco, but the real question is, is that they are a lower risk than smoking and whether
that's secondhand smoke or whether that's all these others things. Have we considered and I would think, to
Dr. Carmona first, have we as a country considered commissioning our own study that would address many
of the questions that we broached today, to ensure that we have factual scientific evidence. And if we have
not so far, would we consider doing so, and if not, why?
      ADM. CARMONA: Well, sir, there are many studies that have been done in the literature. I mean literally
hundreds of studies on a broad range of issues regarding smoking cessation and so on, and including
smokeless products and there are ongoing studies now both at CDC that are ongoing as we speak, and pro-
grams that are funded throughout the United States at universities and other areas that NIH funds that are
addressing many of these questions. Now, if there are specific questions that are not being answered or you
felt that needed to be addressed, certainly we'd be willing to entertain that and I'd pass it onto my colleagues
that are doing the research. But there is a broad range of research that has taken place and continues to
take place on these subjects.
     REP. SHIMKUS: So I guess the question for me will -- so based upon the current research that you have
available to review, and obviously you don't have the information from the ongoing research, nothing that has
been said with respect to the IOM report. That still doesn't provide enough information to make a determina-
tion whether there is any significant benefit for someone going from tobacco used in cigarettes versus
smokeless.
    ADM. CARMONA: I think the IOM report was fairly clear and said that there was no evidence and there
are no products on the market to date to advocate for that type of substitution. So the IOM report is fairly
clear, I think, in its conclusion.
    REP. SHIMKUS: That's all I have, Mr. Chairman.
    REP. STEARNS: I thank the gentleman.
    I want to thank both of your for your patience and we appreciate your testimony.
   REP. WHITFIELD: Mr. Chairman, may I just ask unanimous consent to -- I would like to submit one other
question to Admiral Carmona relating to the Center for Disease Control's --
    REP. STEARNS: Unanimous request is granted.
    REP. WHITFIELD: Thank you.
    REP. STEARNS: One minute. Oh, submit it for the record. By unanimous consent, so ordered.
    I would say just in conclusion that Mr. Waxman talked about a study that suggests that smokeless to-
bacco is a gateway to cigarettes, but I think it's also -- he should have been fair and pointed out that also a
study refutes that gateway theory, stating that the gateway study that was made was flawed. And Mr. Wax-
man, of course, will be in the second hearing this afternoon on the same subject.
    (REMAINDER OF HEARING TO FOLLOW)
    END

LOAD-DATE: June 6, 2003

LANGUAGE: ENGLISH

WITNESSES: PANEL ONE: TIMOTHY MURIS, CHAIRMAN, FEDERAL TRADE COMMISSION;
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  HEARING OF THE COMMERCE, TRADE, AND CONSUMER PROTECTION SUBCOMMITTEE OF THE
   HOUSE ENERGY AND COMMERCE COMMITTEESUBJECT: CAN TOBACCO CURE SMOKING? A
    REVIEW OF TOBACCO HARM REDUCTIONCHAIRED BY: REPRESENTATIVE CLIFF STEARNS
   (R-FL)LOCATION: 2123 RAYBURN HOUSE OFFICE BUILDING, WASHINGTON, D.C. Federal News
                               Service June 3, 2003 Tuesday
VICE ADMIRAL RICHARD H. CARMONA, U.S. SURGEON GENERAL AND ACTING ASSISTANT SEC-
RETARY FOR HEALTH, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES


TYPE: Washington-dateline general news.

                              Copyright 2003 Federal News Service, Inc.



                                          6 of 9 DOCUMENTS

                                     FDCH Political Transcripts

                                          June 3, 2003 Tuesday

U.S. REPRESENTATIVE CLIFF STEARNS (R-FL) HOLDS HEAR-
ING ON TOBACCO HARM REDUCTION
LENGTH: 41648 words

COMMITTEE: TRADE, AND CONSUMER PROTECTION

SUBCOMMITTEE: HOUSE COMMITTEE ON ENERGY AND COMMERCE: SUBCOMMITTEE ON COM-
MERCE

 SPEAKER:
U.S. REPRESENTATIVE CLIFF STEARNS (R-FL), CHAIRMAN

WITNESSES:

TIMOTHY MURIS, FEDERAL TRADE COMMISSION
VICE ADMIRAL RICHARD H. CARMONA, U.S. SURGEON GENERAL
ROBERT WALLACE, MD, INSTITUTE OF MEDICINE
SCOTT L. TOMAR, DMD, JOURNAL OF PUBLIC HEALTH DENTISTRY, UNIVERSITY OF FLORIDA
COLLEGE OF DENTISTRY
BRAD RODU, DDS, UNIVERSITY OF ALABAMA AT BIRMINGHAM
STEVEN BURTON, GLAXOSMITHKLINE CONSUMER HEALTHCARE
RICHARD H. VERHEIJ, U.S. SMOKELESS TOBACCO COMPANY
MATTHEW L. MYERS, NATIONAL CENTER FOR TOBACCO-FREE KIDS
DAVID T. SWEANOR, NON-SMOKERS' RIGHTS ASSOCIATION



HOUSE COMMITTEE ON ENERGY AND COMMERCE: SUBCOMMITTEE ON COMMERCE,
TRADE, AND CONSUMER PROTECTION HOLDS A
HEARING ON A REVIEW OF
TOBACCO HARM REDUCTION

JUNE 3, 2003

SPEAKERS:
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U.S. REPRESENTATIVE CLIFF STEARNS (R-FL)
CHAIRMAN
U.S. REPRESENTATIVE FRED UPTON (R-MI)
U.S. REPRESENTATIVE ED WHITFIELD (R-KY)
U.S. REPRESENTATIVE BARBARA CUBIN (R-WY)
U.S. REPRESENTATIVE JOHN SHIMKUS (R-IL)
U.S. REPRESENTATIVE JOHN SHADEGG (R-AZ)
U.S. REPRESENTATIVE GEORGE RADANOVICH (R-CA)
U.S. REPRESENTATIVE CHARLES BASS (R-NH)
U.S. REPRESENTATIVE JOSEPH PITTS (R-PA)
U.S. REPRESENTATIVE MARY BONO (R-CA)
U.S. REPRESENTATIVE LEE TERRY (R-NE)
U.S. REPRESENTATIVE ERNIE FLETCHER (R-KY)
U.S. REPRESENTATIVE MIKE FERGUSON (R-NJ)
U.S. REPRESENTATIVE DARRELL ISSA (R-CA)
U.S. REPRESENTATIVE C.L. (BUTCH) OTTER (R-ID)
U.S. REPRESENTATIVE W.J. (BILLY) TAUZIN (R-LA)
EX OFFICIO

U.S. REPRESENTATIVE JANICE SCHAKOWSKY (D-IL)
RANKING MEMBER
U.S. REPRESENTATIVE EDWARD MARKEY (D-MA)
U.S. REPRESENTATIVE EDOLPHUS TOWNS (D-NY)
U.S. REPRESENTATIVE SHERROD BROWN (D-OH)
U.S. REPRESENTATIVE JIM DAVIS (D-FL)
U.S. REPRESENTATIVE PETER DEUTSCH (D-FL)
U.S. REPRESENTATIVE BART STUPAK (D-MI)
U.S. REPRESENTATIVE GENE GREEN (D-TX)
U.S. REPRESENTATIVE KAREN MCCARTHY (D-MO)
U.S. REPRESENTATIVE TED STRICKLAND (D-OH)
U.S. REPRESENTATIVE DIANA DEGETTE (D-CO)
U.S. REPRESENTATIVE HILDA SOLIS (D-CA)
U.S. REPRESENTATIVE JOHN DINGELL (D-MI)
EX OFFICIO

    *
    STEARNS: Good morning, the subcommittee will come to order.
    Without objection, the subcommittee will proceed pursuant to committee rule 4(e). So ordered.
    The chair recognizes himself for an opening statement.
     I am pleased to welcome all of you to the Commerce, Trade and Consumer Protection Subcommittee
hearing on tobacco harm reduction. No one disputes the harm to human health from cigarette smoking.
Smokers are at a 16-fold increased risk of lung cancer, 12-fold increased of chronic obstructive pulmonary
disease and a two-fold increased risk of myocardial infarction. Oncologists estimate that smoking-related
illnesses were responsible for 100 million deaths in the 20th century. Those increases kill some 400,000
Americans every year.
    Over the last few decades, this country has invested substantial public and private resources to encour-
age smokers to quit using tobacco. That investment has paid off. We have made great gains in reducing
the use of cigarettes. While in 1965, 42 percent of Americans smoked cigarettes. Today, only 26 percent
of men and 22 percent of women are smokers.
    While this is the good news, as noted in the Institute of Medicine report, quote, "Clearing the Smoke",
end quote, the decline in the rates of smoking among adults has leveled off during the 1990s. So where do
we go from here?
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    Today we are here to discuss tobacco harm reduction. Harm reduction strategies have been used for a
number of years for a variety of different societal problems. For example, clean needle programs are used
to prevent the spread of HIV. Methadone programs are employed to prevent the use of illicit drugs. And
sex education is provided to stem the rising tide of teen pregnancy and disease.
      The title of our hearing, quote, "Can Tobacco Cure Smoking", end quote, at first blush, seems counterin-
tuitive. However, there is an increasing amount of research suggesting that some tobacco products are less
harmful than others. For those smokers who can't seem to quit smoking, switching to a less hazardous
product could save lives.
   Today we will hear from a diverse group of experts espousing a range of opinion on issues of tobacco
harm reduction. We worked closely with the minority to ensure a fair and balanced staff of witnesses that can
speak to the science of this issue.
    One of our witnesses today, Dr. Brad Rodu, will assert that smokeless tobacco products are 98 percent
safer than cigarettes. And thereby, switching committed smokers to smokeless products, we can save lives.
     We will also hear the potential societal harms that may result from the promotion of tobacco harm reduc-
tion claims. Some believe that switching from one tobacco product to another does nothing to solve the to-
bacco problem.
     The Federal Trade Commission has general regulatory authority over misleading and deceptive adver-
tising, as well as the specific authority over the advertising and marketing of tobacco products.
     As tobacco companies attempt to market their products as reduced risk, as one company has already
tried to do, the Federal Trade Commission will be in the position of evaluating these claims. So I look for-
ward to Chairman Muris, how his commission plans to deal with these, let me say, vexing issues.
    We will also hear from the surgeon general who is the principal adviser to the secretary of health and
human services on public health and scientific issues. Tobacco has long been a subject of surgeon general
reports. As we move into a new era of tobacco debate, we welcome Vice Admiral Carmona to the Com-
merce, Trade and Consumer Protection Subcommittee.
    Our goal should always be to reduce the use of tobacco. In that light, today's hearing provides an op-
portunity to examine the efficacy of the tobacco harm reduction approach, which calls for minimizing and de-
creasing death among cigarette workers without completely eliminating tobacco and nicotine use.
    In closing, I want to thank the witnesses for appearing before the committee. I look forward to their tes-
timony.
   And I wish, in addition, I seek unanimous consent to enter into the record the written testimony of Mike
Szymanczyk, chairman and chief executive officer, Philip Morris USA.
    Without objection, so ordered.
    At this point, I invite other members to do the same if they wish to enter documents into the record.
    And with that, I welcome my ranking member for an opening statement.
    SCHAKOWSKY: Thank you, Mr. Chairman. It's good to see you again.
    Well, you've got to hand it to the tobacco lobby. If there were such a thing as a chutzpah award, which
roughly translates into brazen gall, the effort today, in my humble opinion, would be worthy of a prize.
     Under the guise of concern for public health, the tobacco industry has us here to discuss its efforts to
gain advanced government approval of a marketing campaign that would promote tobacco products and
their bottom line.
   "Smokeless tobacco", I put that in quotes, is a dressed up name for dip, chew or spit tobacco. U.S. to-
bacco, UST, wants to market its spit tobacco as a safer alternative to smoking cigarettes. Smokeless to-
bacco is a threat to our nation's public health and especially to the health of our children.
   Any type of claim that spit tobacco is a safer alternative to smoking requires a substantive body of evi-
dence and an independent regulatory body capable of examining the claims. Such evidence and claims does
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not exist. UST cannot back up their campaign slogans. And that is why they have asked the FTC, not the
FDA -- the FTC being a nonscientific regulatory agency, to review the claims they want to make.
     Tobacco causes cancer and other diseases. Whether you smoke it, chew it, suck it, put it up your nose,
it can and, after sustained use, probably will, kill you.
    UST's argument that smokeless tobacco use is a healthier alternative to smoking is analogous to sug-
gesting that one is better off jumping off the fifth floor of a building rather than the 20th because, of course,
both are likely to cost you your life.
    They want to convince smokers who may be trying to quit or who have quit, non-smokers, children and
others that their product is OK to use if we allow them to make these false claims. Then the Congress will
share the blame for more lives lost to tobacco related diseases. The government has no business endorsing
media campaigns for products like spit tobacco that lead to disease and premature death.
   First we should do no harm. If we send a message to the American public that it's OK to chew tobacco,
we will be doing harm. If we instead want to truly reduce ways to reduce harm and promote health, we
should spend time and money on legitimate ways to end the use of tobacco in any form, period.
    Today, along with Congressman Waxman, I will be releasing a report entitled, "The Lessons of Light", in
quotes, "and Low Tar Cigarettes". Without effective regulation, reduced risk tobacco products -- so-called
reduced risk tobacco products threaten the public health.
    Mr. Chairman, I ask unanimous consent to insert the report into the hearing record.
    STEARNS: So ordered.
    SCHAKOWSKY: I think it's an important document to include in the official record because it unders-
cores parallels documented by the Government Reforms Committee -- the democratic staff -- between the
efforts of the tobacco industry to mislead the public into believing that so-called "light" and "low-tar" cigarette
products are healthier alternatives to regular cigarettes. And the efforts currently underway by USC to con-
vince the Congress, the FCC, and the public of the virtues of its spit tobacco products.
    This report includes previously undisclosed internal industry documents and demonstrates that the
products that are marketed as "light" and "low-tar" are, in fact, not. We know that the tobacco industry
duped the FTC's tests by designing cigarettes that only appeared healthier when tested by machines but that
did not provide lower amounts of tar and nicotine to smokers.
    We know that the industry has, for some time, been well aware of the dangers these products pose. In
an internal company e-mail included in this report, a senior research scientist at British American Tobacco
stated, quote, "Our main problem appears to be the notion that the technology exists to make cigarettes
which are appreciably less lethal. The technology does not exist. It will not exist."
     The report also demonstrates that tobacco industry officials continue to deceive the public. With informa-
tion from industry, the National Cancer Institute and the Department of Justice report provides clear exam-
ples of current, quote, "reduced risk", unquote, product marketing -- including the marketing of spit tobacco --
specifically designed to counter health fears, deceive consumers, deter quitting, and exploit the absence of
effective regulation.
     The FCC allowed for the marketing of "light" and "low tar" products in the past, and the public was
harmed. Now major law suits have ensued. In my home state of Illinois, a court recently ruled against Phi-
lip Morris and found that its creation of these brands was, quote, "immoral, unethical, oppressive, and un-
scrupulous," unquote.
   And USC is here today to try and present a case that their tobacco products are not as harmful as
smoking, and therefore, their company should be allowed to make such statements on their packaging.
USC's representatives want us to believe that they are offering a product that will improve overall health in
The United States.
   Quite the opposite is true. We know, from industry documents, that USC has purposely targeted to-
bacco consumers in an effort to promote, quote "dual consumption," unquote, not cessation of smoking.
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    We should not even be entertaining USC's claim absent a comprehensive review and serious regulation
by the FDA. The FDA should have authority over all tobacco products, including spit tobacco, and authority
to oversee the content, manufacture, sale, and marketing of the product. Absent this regulation, allowing
marketing strategies that include comparative health claims will lure more kids into smokeless tobacco use
and addiction, discourage current users from quitting and may increase the overall amount of tobacco prod-
ucts being used in the United States.
    SCHAKOWSKY: Mr. Chairman, I thank you for your indulgence in letting me go over. I think this is a
very, very serious issue, and I appreciate the opportunity to discuss this important issue today with our wit-
nesses.
    STEARNS: I thank the gentlelady, and now recognize the chairman of the full committee, who probably
won't agree with you when you mention tabasco sauce, the chairman, distinguished chairman of the com-
mittee. Mr. Tauzin.
   TAUZIN: Thank you, Mr. Chairman. I wouldn't recommend you smoke tabasco sauce. That's not nec-
essarily a good idea.
    (LAUGHTER)
     Let me thank you, Mr. Chairman, for convening this hearing, and I want to thank the chairman of the
Federal Trade Commission and the surgeon general for coming to join us, and I hope will be a very instruc-
tive session, particularly as we move to the second panel, as well, and get some insights as to this extraor-
dinary issue.
     We've held hearings, as you know, in this committee on tobacco in the past, but this particular issue of
tobacco harm reduction is not one, I think, that has been the subject of a great deal of congressional debate,
or frankly, a good understanding yet.
    It was back in 1964 that the surgeon general released the report finding that cigarette smoking is a
health hazard of sufficient importance in the United States to warrant appropriate remedial action.
    And we now know that smoking kills over 400,000 people annually in the United States alone. That's
more deaths each year from AIDS, from alcohol, cocaine, heroin, homicide, suicide, motor vehicle crashes
and fires combined.
    You can't ignore those kinds of statistics. And during the past four decades we've made unprecedented
gains in preventing and controlling tobacco use.
    However, despite the massive education campaigns and years of litigation, substantial price hikes de-
signed to curb smoking, people continue to light up.
    And when asked, most smokers say they want to quit, I think over 80 percent will say that in most sur-
veys, unfortunately very few of them are able to break the habit.
    There's no debate that the best option for any person using tobacco products is to stop, stop using to-
bacco products. In particular, we need to continue to do all we can to discourage the use of these products
from the children.
     But we also know that nicotine is a remarkably addictive drug. Some have likened the addictive qualities
of nicotine to the intense grip of cocaine and heroin.
     Unfortunately, there are people who, try as they may, are unable or unwilling to kick the smoking addic-
tion. And some in the medical community argue that we are giving these hardened smokers only one unin-
viting option, quit or die.
     Increasingly, there are calls for options other than the quit or die approach, such as tobacco harm reduc-
tion. And there are studies now that have found that some tobacco products, such as smokeless tobacco,
are less hazardous than cigarettes.
    Not unhazardous, or not safe, but less hazardous. These studies have resulted in a call for campaigns
that would encourage smokers to switch from cigarettes to smokeless tobacco, which arguably could save
many of the 400,000 people who will die every year.
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     And that's an intriguing concept, and if science bears out these conclusions, we're faced with a myriad of
questions that I hope we begin to think about, and perhaps begin to answer today, or at least set up a
process whereby we might have the type of forums and discussions with officials and citizens of our country
to find the answers to these questions.
     They include, should we communicate this reduced risk information to the consumer? Is a person who's
faced with a quit-or-die option -- one of my children -- is that person entitled to know that there is another op-
tion that can reduce the risk of death, and perhaps even be a bridge to stopping smoking?
    If so, how should we communicate this information. Obviously, the concern is if you communicate it im-
properly, you might encourage people to continue using tobacco, and that's not the goal, obviously.
     So how do you do it properly? Will promotion of certain tobacco products as reduced risk dilute the an-
ti-tobacco, anti-smoking message we're sending children in particular?
     And that's a deep concern. Finally, does the consumer have a right to know about safer tobacco prod-
ucts, about reduced-risk products? We know in other countries, such as Sweden, they made that decision,
that consumers were entitled to know.
   And there have been some remarkable results as a result of simply communicating that information to
people who are faced with the quit- or-die option.
    So these are questions I hope we'll answer today. The hearing is especially timely because the Federal
Trade Commission is currently faced with a petition from the United States Tobacco Company that requests
advisory opinion on whether based on current science it may advertise its smokeless product as a safer al-
ternative to smoking.
    I hope the Federal Trade Commission examines the issue carefully. I urge Chairman Muris to invest the
commission's time and energy in the tobacco harm reduction workshop to more thoroughly evaluate these
claims.
   I think it's time for that, for us to have a very open and informative workshop so we can understand
whether we need to make some new policy decisions in this country.
   Few medical questions have stirred more public interest or created more scientific debate than the to-
bacco health controversy. The relationship between tobacco and health does not lead to easy answers.
    Nevertheless, for 400,000 yearly deaths in the United States attributed to smoking, it's increasingly ap-
parent that we must continue to search for new and novel solutions.
     I want to thank you again, Mr. Chairman for holding the hearing and look forward to gearing from our two
distinguished witnesses today.
    STEARNS: And I thank the chairman. The gentleman from Massachusetts is recognized.
    MARKEY: Thank you, Mr. Chairman, very much, and thank you for holding this hearing.
     MARKEY: To say that smokeless tobacco is a safer alternative to smoking cigarettes is very misleading.
Smokeless tobacco products have known carcinogens, and they are linked to all cancer, and they are addic-
tive. This method of harm reduction may simply be trading one vice for another.
     A few years ago, I introduced the Cigars Are No Safe Alternative Act, that would impose restrictions on
the sale of cigars, because cigar use is not a safe alternative to smoking cigarettes either. People need to be
informed of all the health risks of all tobacco products.
    Just as with cigars and cigarettes, children especially must not be influenced by misleading that glorifies
the use of these tobacco products. Three thousand young people being smoking in The United States
every day. One thousand of these 3,000 will die from some lung-related disease.
   Twenty percent of all Americans who die each year, die from some lung-related, smoking-related dis-
ease. Obviously, our goal should be to just stop it dead in its tracks.
    I believe that people should make informed decisions for themselves as to which is a better alternative
and safer for them. However, people cannot make informed decisions about smokeless tobacco products
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because we do not even know all the addictives that these products contain and what harm they may cause.
In fact, when the state of Massachusetts asked that these ingredients be disclosed, the tobacco industry
sued them and won so we do not even know all the ingredients in these products.
     There are safe, FDA-approved nicotine-based products that are safe, and when Massachusetts used
them in an advertising campaign, it helped reduce use from 20 percent to 14 percent. But I do not believe
that any governmental agency -- the Food and Drug Agency, the Department of Health and Human Services,
or the Federal Trade Commission -- should promote the use of tobacco products, especially when we know
they are addictive, cancer causing, and gateways to further tobacco use.
   The U.S. Smokeless Tobacco Company continued to advertise in youth magazines despite signing a
master settlement agreement in 1998, which prohibited indirect or direct advertising that targets youth.
     In Massachusetts, the attorney general was sued by the tobacco industry after trying to implement regu-
lations that would prevent advertising of smokeless tobacco products near schools or playgrounds. It is im-
moral to enhance a company's sales by targeting children to use an addictive substance that is detrimental to
their health and is also illegal.
   I think that we have a very important subject that we're debating here today, but there is no greater
cause of illness in the United States than tobacco. It is central to the responsibilities of this committee that
we do nothing that enhances the likelihood that young people will embrace this as a life style habit.
    I thank you, Mr. Chairman.
    STEARNS: Thank you, gentleman. And gentleman, Mr. Whitfield.
     WHITFIELD: Mr. Chairman, I guess we still have the policy of eight minutes if you forego your (inaudi-
ble).
    STEARNS: Ms. McCarthy.
    MCCARTHY: Thank you, Mr. Chairman. I'm going to be very brief, and put my remarks in the record.
    I do want to thank you for this hearing, and I'm glad to see the panel that we have before us.
     I am personally shocked by the tobacco industry and their gross misunderstanding of what an addiction
is, and I certainly hope today that we can shed some light on that gross misunderstanding. I really believe
that commitment should be to fund programs that dissuade our children from this addiction that their product
causes, and that they should be leading the effort to find and produce funds to help with programs that will
actually get individuals to quit.
    You cannot address an addiction successfully by saying, "Just have a little bit. It won't hurt."
     And so I look forward to the panel's testimony, and hopefully that will help the industry understand that
their gross misunderstanding of what an addiction is, is not acceptable to this Congress.
    Thank you, Mr. Chairman.
    STEARNS: Thanks, young lady.
    The gentleman from New Hampshire, Mr. Bass.
    BASS: Thank you very much, Mr. Chairman, and I appreciate this interesting and somewhat quite con-
troversial hearing.
      First of all, I don't smoke cigarettes, and I don't chew tobacco. In fact, as a state senator, I introduced a
bill to tax smokeless tobacco. However, from my perspective, there are policymakers in government who --
in Congress -- who if they had their choice, would chisel off the tobacco leaves on the podium in the Con-
gress because somehow it would pollute and kill members of Congress who happen to walk nearby.
    And the issue that we're debating here -- or are going to have a hearing on today -- is not whether to-
bacco is safe for somebody to pick up and take up, but whether or not somebody who is smoking cigarettes
-- who may die of lung cancer, who, other remedial means such as stopping smoking completely or using
some of these other products which are advertised all over the place -- whether those individuals ought to be
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able -- or ought to, at least, know -- that if you have a cigarette, or a pack or two of cigarettes a day, or you
have a can of smokeless tobacco -- which is going to be better for you?
     Now they both may not be good for you. But I don't think you can escape the conclusion -- if you have a
choice between these two products, that smokeless tobacco is probably going to be a better alternative. It
will prolong your life.
     And as I understand it, the Federal Trade Commission has a procedure underway to address this issue,
so whether or not this industry can advertise in this manner -- not bringing in children in, not talking about
lung cancer or anything like that -- but whether or not individuals who are addicted to cigarettes and have no
other option, might be able to see advertising that indicates that chewing tobacco might be a better alterna-
tive. I think it's a fair issue, and I'm looking forward to hearing testimony from both our surgeon general and
the FTC as well as the succeeding panels, and I yield back, Mr. Chairman.
    STEARNS: The gentleman yields back his time. The gentleman from Texas, Mr. Green.
     GREEN: Thank you, Mr. Chairman. And I'd like to thank you and our ranking member for holding this
hearing on tobacco harm reduction and the Federal Trade Commission's role in determining appropriate ad-
vertising of smokeless tobacco.
    There's no question that smoking and tobacco use is hazardous to our health. That is, hopefully, one is-
sue that all of us in the room can agree on.
     I represent an area where smokeless tobacco is used by a lot of our young men as a rite of passage.
Now this may not be the case in New York or San Francisco, but when we discuss how to help Americans
quit smoking and what warnings our tobacco products should display, the debate's bound to heat up.
      One thing is certain in my mind. Our efforts to discourage Americans from smoking cigarettes should
not include advocating the use of smokeless tobacco products. Tobacco kills whether it's inhaled or wheth-
er it's chewed. And that is a message, as a parent, I think most folks would want the FTC and our govern-
ment to do.
    Since the mid 1980s, we have known that smokeless tobacco causes oral cancer. And to decrease
one's risk of lung cancer by increasing his or her risk of oral cancer is not in the interest of public health.
    In resolving this marketing issue, the FTC is charged with ensuring that we do not send mixed messages
to consumers. Currently, three rotating warning labels appear on smokeless tobacco packages, and they
read, one, the warning, "This product may cause mouth cancer." Another, warning, "This product may cause
gum disease and tooth loss."
    GREEN: And another warning, "This product is not a safe alternative to cigarettes."
    These warnings all send the same message; smokeless tobacco is hazardous to your health.
    For the FTC to consider a label effectively promoting smokeless tobacco as a lower-risk alternative to
cigarette smoking, however, sends a very different message. And it says that if you're going to use tobacco
products, but you also worry about your health, smokeless tobacco is the way to go. Not only is this mes-
sage mixed, it also is based on questionable science.
    A policy shift of this magnitude should not be based on the study of the Swedish smokeless tobacco,
which contains fewer cancer-causing agents and is regulated by the government and cannot be advertised.
There simply are no parallels to be drawn on.
    While the FTC has limited jurisdiction over tobacco, its mission is clear, it ensures that companies do not
market their products in misleading or deceptive ways. They advertise smokeless tobacco as healthier for
you than cigarettes, is, in my mind, both misleading and deceptive, because it holds the consumers hand as
they leap to the rationalization that smokeless tobacco use is somehow OK. I don't believe we should be in
the business of promoting that mind set.
   Mr. Chairman, and I don't know because we're checking it now, but I had the opportunity -- a former
speaker of the House, Jim Wright, a few years ago had reconstructive surgery at MD Anderson in Texas be-
cause of jaw cancer.
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    I happened to see Speaker Wright after that and talked to him while he was in the hospital. I don't know
the reason -- like a lot of times that things are developed -- but having been to MD Anderson, and some of
our great cancer facilities, I also know that that is not something we want to see, whether it's in a former
speaker of the House or in our children.
    And I yield back the balance of my time.
    STEARNS: The gentleman yields back the balance of the time.
    The gentleman from Arizona, the vice chairman of the committee, Mr. Shadegg.
   SHADEGG: Thank you, Mr. Chairman. And other than to express my appreciation for your holding this
important hearing, which can enlighten us all on this subject and welcome Dr. Carmona, who is a resident of
my state of Arizona, and who came to his current position from the faculty of the University of Arizona, my
alma mater, I will waive my opening statement and take my eight minutes of questioning.
    STEARNS: The gentleman waives his opening statement.
    The gentleman from Florida, Mr. Davis?
    DAVIS: Thank you, Mr. Chairman. I'll reserve my time for questions.
    STEARNS: The gentleman reserves the balance of his time.
    Mr. Terry, welcome an opening statement.
    TERRY: No opening statement.
    STEARNS: No opening statement.
    Mr. Fletcher?
    FLETCHER: Reserve the balance.
    STEARNS: Reserve the balance.
    The gentlelady, Ms. Cubin?
    CUBIN: I'll submit my statement for the record.
    STEARNS: By unanimous consent, so ordered.
    Mr. Ferguson, an opening statement?
    FERGUSON: I will make an opening statement, Mr. Chairman.
    STEARNS: OK.
     FERGUSON: Thank you very much. I'd like to begin by thanking you for holding this hearing on a sub-
ject that's really terribly important to the public health of our nation. It's an undisputed fact that smoking is a
killer. And according to the American Lung Association, smoking related diseases claim an estimated
430,700 American lives each year. And it's directly responsible for 87 percent of lung cancer cases and
causes most cases of emphysema and chronic bronchitis.
    I've had several family members, including grandparents, who have died of lung disease, emphysema,
lung cancer and other ailments that related to their smoking. This list of ailments that smoking causes or
hastens is well-founded and it's alarming. And it's proven that smoking contributes to cancer of the lungs,
the oral cavity, the esophagus, the larynx and is a contributing cause of cancer in the pancreas, bladder,
kidney and cervix.
     Finally, smoking costs the United States approximately $97 billion each year in health care costs and lost
productivity. We need to do all that we can to help current smokers to quit and to ensure that our children
do not fall victim to this deadly habit. Increased education in various other public health initiatives have been
-- have brought a gradual decline in smoking rates over the past 20 years.
   Studies have shown that 70 percent of smokers say that they are interested in quitting, 34 percent of
smokers actually attempt to quit. Moreover, only less than 10 percent of those people and only 2.5 percent
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of total smokers actually end up quitting. I think it's safe to say that we have someone close -- if you have
someone close to us that's given up smoking or has tried, we all know how tough it actually is to break the
habit.
      There are many products on the market that are specifically designed to help smokers break the habit.
It's vital that the people of our country are fully informed of the risks involved, not only by smoking but of the
various treatments and alternatives that help to wean someone off the habit.
    Many of the alternatives have undergone rigorous testing by the FDA, but that we must be mindful of
those alternatives that may actually lead to smoking or that actually may be harmful in their own right.
   Again, I want to thank you, Mr. Chairman, thank the members of this committee, and I want to thank our
panelists who are here today.
    I yield back.
    STEARNS: The gentleman yields back. I thank the gentleman.
     As customary, we allow our colleagues who are not a member of the subcommittee, who are a member
of the full committee for an opening statement, and that's Mr. Waxman of California. And I welcome him.
    WAXMAN: Thank you very much, Mr. Chairman, for allowing me to participate in this hearing. Let me
state at the outset, I'm not opposed in principal to harm reduction strategies that are targeted towards ad-
dicted smokers.
   But as we explore these possibilities, we need to remember that unsubstantiated health claims for to-
bacco products can have disastrous consequences, keeping smokers from quitting and encouraging tee-
nagers to start.
    These are not abstract concerns. We've had a failed experiment with light and low tar cigarettes. And
the advent of new reduced risk product poses similar risk.
    The report that we're releasing today with Representative Schakowsky finds disturbing parallels between
the public health disaster of light and low tar cigarettes and what companies like U.S. Smokeless Tobacco,
UST, are trying to do now.
    Today the subcommittee is reconsidering their request to market its dangerous and addictive product as
safer than cigarettes. In November, 1994, I chaired the last congressional hearing to focus on smokeless
tobacco. We heard indisputable evidence that UST manipulated nicotine levels in its products to hook
young users and then graduate them to stronger products. And we heard UST denied that smokeless to-
bacco is addictive.
    Nearly nine years later, UST still argues that smokeless tobacco is not a proven cause of disease and
denies smokeless tobacco is addictive. UST claims its goal is to help smokers quit, but one of the compa-
ny's strategic objectives is to promote dual consumption of cigarettes and smokeless tobacco, the very op-
posite of cessation.
     In a recent response, UST wrote to a dear colleague I sent out. They denied some of the points that I
made. They said it was baseless to suggest the company added cherry flavoring to some of its products to
appeal to children. But according to the 1980 memo, a UST senior vice president said that they were look-
ing to get younger and lighter users to prefer this flavor.
    WAXMAN: And older users preferred a tobacco taste.
    They wrote that they never employed a strategy to graduate young users to a more addictive product.
This same document, however, shows that the company's objective was to provide new users with an easy
graduation process.
   UST said it was misleading or inaccurate to suggest the company ever marketed to children. But a
memo from the regional sales manager to the national sales manager indicates that UST had marketed
smokeless tobacco to children as young as 13 or 14 years of age.
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     Mr. Chairman, because these documents speak to the clear need for effective and comprehensive regu-
lation prior to any health plans for smokeless tobacco, I'd like to ask unanimous consent to include in the
record a letter I have written to Chairman Tauzin that describes and attaches these documents.
    STEARNS: By unanimous consent, so ordered.
    WAXMAN: And I look forward to the testimony.
    STEARNS: And I thank the gentleman.
    No one else seeks recognition, then we'll welcome our two distinguished panelists: the Honorable Timo-
thy Muris, chairman of the Federal Trade Commission; Vice Admiral Richard H. Carmona, U.S. Surgeon
General and acting assistant secretary for health, U.S. Department of Health and Human Services.
    Welcome, and Chairman Muris, we'll start with you.
    MURIS: Thank you very much, Mr. Chairman. And I would just ask that the commission's full statement
be placed in the record.
    STEARNS: By unanimous consent, so ordered.
   MURIS: I am Tim Muris, the chairman of the Federal Trade Commission. I am certainly pleased to ap-
pear here today to discuss the FTC's role in potential advertising of reduced risk tobacco products.
     The FTC's mission is to prevent unfair competition and unfair or deceptive acts or practices in the mar-
ketplace. The commission does this by ensuring that advertising and marketing claims are truthful and not
misleading. Our jurisdiction over advertising and marketing claims includes jurisdiction over claims for ciga-
rettes, smokeless tobacco and other tobacco products. Indeed, the FTC's law enforcement activities in-
volving tobacco advertising and promotion date back to the 1930s.
    Congress has given the commission administrative responsibilities for the health warnings required on
cigarette packaging and advertising under the Cigarette Act. We also have both administrative and en-
forcement responsibilities for the health warning required on smokeless tobacco packaging and advertising
under the Smokeless Tobacco Act.
    The commission does not prescreen advertising or marketing claims for tobacco or any other product.
Instead, the agency addresses deception through post-market law enforcement.
    Health claims in advertising are particularly important to us and I welcome your interest in the role we
play in the marketing of potential reduced risk tobacco products.
     This is a very important question. Despite the efforts of the government and the public health community,
millions of Americans smoke today and are addicted to nicotine. Many of these smokers will ultimately die of
smoking-related illnesses if they do not change their behavior.
    In an ideal world, we would wish that all of these people would choose to quit smoking and would be able
to do so once they tried. The real world is quite different, however.
    If truthful and substantiated, marketing claims that a product will significantly reduce the health risks as-
sociated with smoking while satisfying the addicted smokers craving for nicotine, could provide a substantial
health benefit to those consumers who cannot or will not quit. Conversely, if those claims were untruthful,
unsubstantiated or misrepresent the extent of the benefit, they would harm consumers.
    For these reasons, we would review advertising for potential risk -- reduced risk tobacco products on a
case by case basis to try to ensure that the information consumers receive about those products is accurate
and substantiated. This review would be conducted using the same legal framework that we use for all
consumer products under Section 5 of the FTC Act.
    First, we ask what messages consumers take away from the advertising in question. The next issue is
whether the claims are truthful, including the necessary substantiation. The commission typically requires
that health claims be supported by competent and reliable scientific evidence. In determining whether harm
reduction claims are substantiated, the commission would turn to experts, both inside and outside the gov-
ernment's science-based agencies for assistance in evaluating scientific evidence.
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    Let me close that by mentioning that in my view, the discussion of potential harm reduction tobacco
products should also encompass the question of whether so-called nicotine replacement products, which
currently are marketed only for smoking cessation purposes, have a larger role to play in the harm reduction
arena. These products, which contain only nicotine and no tobacco should certainly be further evaluated for
use by consumers addicted to nicotine.
    In conclusion, thank you for the opportunity to discuss the commission's role in this important and evolv-
ing public health issue. I'd be happy to answer any of your questions.
    STEARNS: Thank the chairman.
    And we welcome the U.S. surgeon general.
    CARMONA: Thank you, Mr. Chairman and distinguished members of the subcommittee. Thank you for
the opportunity to participate in this important hearing. My name is Richard Carmona and I am the surgeon
general of the United States.
    Let me start with a few statements that were once accepted throughout society that have now been re-
legated to the status of myth: Men do not suffer from depression; Domestic violence is a family or private
matter; The HIV/AIDS epidemic is of no concern to most Americans.
    All of us here know that these three statements are very dangerous public health myths.
     My remarks today will focus on a fourth public health myth which could have severe consequences in our
nation, especially among our youth: Smokeless tobacco is a good alternative to smoking. It is a myth. It is
not true.
    As the nation's Surgeon General, my top responsibility is to ensure that Americans are getting the best
science-based information to make decisions about their health. So I very much appreciate the opportunity to
come before this subcommittee today and help refute this dangerous idea.
    First, let me emphasize this: No matter what you may hear today or read in press reports later, I cannot
conclude that the use of any tobacco product is a safer alternative to smoking. This message is especially
important to communicate to young people, who may perceive smokeless tobacco as a safe form of tobacco
use.
    Smokeless tobacco is not a safe alternative to cigarettes Smokeless tobacco does cause cancer.
    Our nation's experience with low-tar cigarettes yields valuable lessons for the debate over smokeless
tobacco.
    Tobacco use is the leading preventable cause of death in the United States. Each year, 440,000 people
die of diseases caused by smoking or other form of tobacco use. That is about 20 percent of all deaths in
our nation.
   The office I lead as surgeon general has long played a key role in exposing the risks of tobacco use. In
1986, the "Surgeon General's Report The Health Consequences of Using Smokeless Tobacco" reached four
major conclusions about the oral use of smokeless tobacco.
    MOREn
   CARMONA: First, smokeless tobacco represents a significant health risk. Next, smokeless tobacco can
cause cancer and a number of non-cancerous oral conditions.
    Third, smokeless tobacco can lead to nicotine addiction and dependence, and fourth, smokeless tobacco
is not a safer substitute for cigarette smoking.
   Recognizing these serious health consequences, Congress passed the comprehensive Smokeless To-
bacco Health Education Act in 1986. This law required the placement of surgeon general's warnings on all
smokeless tobacco products.
    Mr. Chairman and members of this subcommittee, I respectfully submit that smokeless tobacco remains
a known threat to public health, just as it was when Congress acted in 1986.
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    Time has only brought more disease, death and destroyed lives. The national toxicology program of the
National Institutes of Health continues to classify smokeless tobacco as a known human carcinogen, proven
to cause cancer in people.
     As surgeon general, I cannot recommend use of a product that causes disease and death as a lesser
evil to smoking. My commitment and that of my office to safeguard the health of the American people de-
mands that I provide information on safe alternatives to smoking where they exist.
   I cannot recommend the use of smokeless tobacco products, because there is no scientific evidence that
smokeless tobacco products are both safe and effective aids to quitting smoking.
     Smokers who have taken the courageous step of trying to quit should not trade one carcinogenic product
for another, but instead could use Food and Drug Administration-approved methods, such as nicotine gum,
nicotine patches or counseling.
   While it may be technically feasible to someday create a reduced- harm tobacco product, the Institute of
Medicine recently concluded that no such product exists today.
     When and if such a product ever is constructed, we would then have to take a look at the hard scientific
data of that particular product. Our nation's experience with low-tar, low-nicotine cigarettes is instructive to
the issue at hand.
    Low-tar, lo-nicotine cigarettes were introduced in the late 1960s, and widely endorsed as a potentially
safer substitute for the typical cigarette on the market at that time.
     Within a decade, the low-tar brands dominated the cigarette market. many smokers switched to them
for their perceived health benefits. Unfortunately, the true health effects of these products did not become
apparent for another 10 to 20 years.
   We now know that low-tar cigarettes not only did not provide a public health benefit, but they also may
have contributed to an actual increase in death and disease among smokers.
   This has taught us that we must move cautiously in recommending any supposedly safer alternative for
people trying to quit smoking, because now with more knowledge and the benefit of hindsight, the science
does not support early recommendations on low-tar cigarettes.
      Mr. Chairman, in the interest of time I will shortly ask that the remainder of my statement and the scien-
tific information contained in it be considered as read and made part of the record.
    STEARNS: Without objection so ordered.
     CARMONA: But before I do that, I would like to ask for this subcommittee and the Congress to help in
getting the message out about the dangers and myths of smokeless tobacco.
    All of us in this room are very concerned about our nation's youth. Kids growing up today have a tough
time of it. In addition to the normal struggles of puberty, many kids are facing a host of other challenges.
     Many, especially minority kids, must struggle to find their way in unsafe neighborhoods. With the tempta-
tion to engage in behavior that is not healthy and the opportunity to do so, it's very hard for our young people
to resist.
    According to a 2000 survey by the Substance Abuse and Mental Health Services Administration, SAM-
SA, and this is the national household survey on drug abuse, about 1 million kids from ages 12 to 17 smoke
every day.
    Another 2 million kids smoke occasionally. And we know that smoking is often not a stand-alone risk
behavior, it travels with others. The SAMSA survey found that youth who were daily cigarette smokers or
heavy drinkers were more likely to use illicit drugs than either daily smokers or heavy drinkers from older age
groups.
   More than half of 12- to 17-year-olds who were daily smokers had also used illicit drugs within the past
month. Every day more than 2,000 kids in the U.S. will start to smoke, and more than 1,000 adults will die
because of smoking.
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    We have to get youth to stop starting. But the answer is not smokeless tobacco. We have evidence to
suggest that instead of smokeless tobacco being a less dangerous alternative to smoking, just as smoking is
a gateway to other drugs, smokeless tobacco is a gateway to smoking.
    So we must redouble our efforts to get our youth to avoid tobacco in all forms. We have some real work
to do on the culture of smokeless tobacco, which is glamorized by some sports stars.
    Chicago Cubs' Sammy Sosa, who has made a public commitment to avoiding smokeless tobacco, is a
great example for kids. Past baseball great Joe Garagiola is now chairman of the National Spit Tobacco
Education Program, and regularly lectures young players against the dangers of smokeless tobacco.
   As members of Congress, you can lead by example, too, not just in legislation but in your own lives. I
encourage you to avoid tobacco in all its forms. Do not fall for the myth, a very dangerous public health
myth that smokeless tobacco is preferable to smoking.
   Do not let America's youth fall for this myth, either. Mr. Chairman, I ask that my written testimony may
be made part of the record, and thank you and I'd be happy to answer any questions.
    STEARNS: Again, without objection, so ordered. I'll start the questions, and Admiral, I think I'll start with
you. The European Union has a policy on smokeless tobacco, and it's been written by the leading tobacco
control public health advocates in the European Union.
    And they stated that on the average that, quote, "Scandinavian and American smokeless tobaccos are at
least 90 percent safer than cigarettes." Now, I respect your position is a lot different than all of ours, but do
you agree with the European Union policy, that what they say, at least 90 percent safer than cigarettes?
      I mean, just yes or no.
      CARMONA: No, sir, I do not.
   STEARNS: OK. We know that the Institute of Medicine in reports states that smokeless tobacco, quote,
"The overall risk is lower than for cigarette smoking, and some products such as Swedish News (ph) may
have no increased risk."
    Now, this is the Institute of Medicine report, so I ask you, do you agree with the Institute of Medicine re-
port?
      CARMONA: That particular statement, no.
   STEARNS: OK. You know, I think the heart of our hearing today is smokeless as an alternative for
people who can't stop smoking. And I'll give you an example.
    Let's say you had, your son just turned 16, and he had to drive a car, and you had a small sports car in
your garage, and you also had brand new Volvo.
      And I think all of us in this room would agree that the Volvo is safer than a very small sports car.
      DAVIS: I'd like to give the surgeon general the opportunity to comment on any of these points if he'd care
to.
    CARMONA: Well, sir, simply, I agree with where you are going with this. I think there is a qualitative
and quantitative aspect to the word safe or safer. And certainly quantitatively we have to able to define that,
but also in its entirety.
    As I alluded to earlier in my remarks, taking one variable out of context and simply stating that there is an
improvement, or it is simply safer, doesn't address the spectrum of risk, of which there are many variables.
So I think it's to the public's benefit that we are very clear on how that word is used.
      DAVIS: Thank you, Mr. Chairman.
      STEARNS: The gentleman's time has expired.
      Mr. Issa?
      ISSA: Thank you, Mr. Chairman.
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    I might preface this by saying that I am a recovering smoker of 13 plus years. So I am very aware and
every day I think about, you know, the error of my smoking in my youth and my not so youth judging from
when I finally quit.
     But I do have some questions because I don't think we are dealing with tobacco here, we are dealing
with a question of a blank substance relative to other blank substances claims -- interpretation for whether or
not they are allowed versus other claims. And hopefully, we can forget the word tobacco in the discussion
today for purposes of thinking about whether or not safer, it does seem to be the key word, is appropriate or
inappropriate to be considered.
   And what I'd like to, first of all, do is ask the surgeon general one question which is, what is the health
benefit of butter?
    CARMONA: There are nutrients within butter. There is...
    ISSA: Butter is basically fat, is that right?
    CARMONA: No.
    ISSA: What are the benefits of fat, then, perhaps is a better question?
    CARMONA: Fat is necessary. It is necessary, it is essential to our growing. Everything from making
steroids in your body to new cells require fats.
    ISSA: And isn't the excess consumption of fat the number one health problem in America, in combination
with not enough exercise?
    CARMONA: It certainly contributes to obesity, sir, yes, sir.
    ISSA: OK. And yet the low-fat butters and the alternate butters appear to be able to claim that they are
better and safer. I have read enough packaging to get this idea that this plasticized butter that tastes mar-
ginal at best -- not margarine, but marginal -- gets to make that claim.
   And Mr. Chairman Muris, I guess the question is how do they get to make the claim that they are better if
essentially the difference is less fat, which the surgeon general has said is OK, it's essential.
    MURIS: Well, health claims are regulated by a statute that Congress passed in 1991, the NLEA. And
there are a variety of hoops through which you have to jump. So it's -- even though we are involved in that
area, and in fact, Dr. McClellan, the head of the FDA and I made an announcement last year, where he is
hoping -- given the way science is changing -- he is hoping that advertising and labeling can keep up with the
changes in science. But there is special, you know, regulatory regime for those.
     ISSA: OK, so the fact that butter is essentially not bad and fat is not bad and then if you have less of it,
claiming that it's better would be totally inappropriate on the face of it all. Forgetting about the taste of but-
ter, forget about what we all put on, that in fact we have a different standard for tobacco than we have for fat.
    Doctor, I guess my next question is, you support banning tobacco. Does that allow you to be an honest
broker in the question of less bad and more bad? I would personally say that I would have a hard time if I
supported outright banning something, would be happy to see Congress passing a law that would do that
and then I was asked, "Well, are we going to allow the good instead of the prefect, even though the good
might in fact perpetuate consumption of this for a while?" I would probably inherently say, "Well, geez, I don't
want to have anything that might lower a little bit the health risk, but perpetuate the consumption."
    Is that something that you're having to deal with in your testimony here today?
    CARMONA: No, sir, and let me elaborate.
      First, I want to respectfully disagree with your analogy with butter because it's much more complex than
it's presented and I think it's an unfair analogy.
    Second, I am not having any problem with it because the driving factor in what I have testified to is that
the substance we are talking about is a proven carcinogen. It causes cancer.
    ISSA: And I am reclaiming my time -- I guess the -- from the witness.
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    The problem we have is we are talking about less and more and trying to understand whether or not less
or more is an honest statement. And that's why I am trying to get to the bottom of this.
     It appears to me as though, other than tobacco, we have this theory that you are innocent until proven
guilty. In tobacco, you are guilty until proven innocent.
   And so, for the chairman, I guess, my question to you would be -- because my time is evaporating here.
We have made a big point in this country, and accurately so, that we are concerned about second-hand
smoke. Sufficiently that, in fact, it has been found to be something that one has to get rid of and that's why
we have banned smoking in public areas in state after state.
    If, in fact, second-hand smoke is clearly bad, then aren't you better if you have no second-hand smoke,
because you have no first- hand smoke. The risk to people around a smokeless tobacco consumer is by
definition, zero, versus whatever you have with cigars, pipes and cigarettes. Would that not meet the first
threshold of a claim?
     MURIS: Well, sure. But now you're addressing a different question. If smokeless tobacco made a
claim based on no second-hand smoke, you know, we would evaluate that on its merits. That's obviously
different than the earlier claim we were talking about.
   ISSA: So just one last follow up. So what I am hearing is that even though there is no smoke, and any-
body could figure out that it must be safer, you're saying that if they made that claim, then you would think
about evaluating it. Do we need science to determine...
    (CROSSTALK)
    ISSA: ... second-hand smoke claim?
    MURIS: Well, no, I am saying the evaluation could be very -- the evaluation could be very quick. But
obviously, if someone asked us -- go back to the premise. The premise was, we were asked about these
claims. I can't give an answer without evaluation even if the evaluation occurs in a twinkling of an eye.
    STEARNS: The gentleman's time has expired.
    And the gentlelady from California, Ms. Solis?
    SOLIS: Thank you, Mr. Chairman.
     Thank you, Dr. Carmona, for being here. It's good to see you. I know on occasion you've talked about
some of these chronic illnesses that face our communities, especially minority communities and the Latino
community. And I want to ask you if -- and I don't if this has come up, what the cost is in terms of prevention
for tobacco use now that you know of?
    MURIS: It would be very hard for us to make public health judgments outside of the context of whether
the advertising was deceptive or not. That's primarily what we do.
     On the other hand, it, clearly, when you're balancing -- my answer to the chairman's question -- when
you're balancing the two kinds of risks, the consequence here of allowing advertising that is, in fact, fraudu-
lent, that's part of those consequences. So we would consider it in that sense.
    SCHAKOWSKY: If such an advertising campaign were to result in a dramatic reduction in the number of
people who quit tobacco completely, would the FTC be able to regulate the advertisements on that basis
alone?
     MURIS: Again, I think my answer is identical. We wouldn't look at this, in the first instance, under our
statutes in terms of a simple public health calculation. We would, however -- that would be a very important
fact in terms of weighing the consequences of the substantiation as I just indicated to the last question.
     SCHAKOWSKY: Would that be true, then, if such an advertising campaign were to result in a dramatic
increase in the number of new tobacco users, would the FTC be able to regulate advertisements on that ba-
sis alone?
    MURIS: I think my answer would be the same, and I would direct you in more detail to our testimony --
particularly page nine, where we discussed some of those issues.
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     SCHAKOWSKY: So, despite the fact that the advertisements were not directly aimed at children, despite
the fact that they said that you should use it as a substitute, if negative consequences occurred, you're say-
ing that, in fact, you could. I don't read your mandate that way, but...
    MURIS: Well, first of all and most importantly -- and asking any question doesn't provide a full context of
what the advertising campaign would look like, and that full context would be essential and possibly positive
in what we could do.
     It is true, as our testimony states, that -- let me just quote it to you -- "Although a determination that an
individual risk-reduction claim is truthful and substantiated would end the commission's deception inquiry,
broader public health issues may remain."
     And that's the sense in which I was talking about how we don't, under our statutes, make a simple public
health determination -- if that determination could ever be simple. It is true, however, in looking at substan-
tiation, that the Pfizer factors require a balance of what statisticians call Type One and Type Two errors,
which are, as I explained, which are -- we try to look at the consequences of us making a mistake.
    And the factors that you're talking about are consequences of a mistake, and we would certainly consider
those, and the presence of those factors would require us to want a higher level of substantiation before we
allowed the claims.
    SCHAKOWSKY: Am I over time? Thank you.
    STEARNS: The young lady's time has expired. The chairman of the full committee, Mr. Tauzin.
    TAUZIN: Thank you, Mr. Chairman. Let me see if I can do something that I've tried with my staff to un-
derstand. Maybe I've got the best experts in the country here in front of me now.
   First of all, let me thank you for your strong and, I think, extraordinary advocacy for helping Americans
understand the dangers of smoking. I don't think anybody quarrels with you on those issues today.
     What we are focusing on, obviously, is a question of whether or not there are other options other than
the quit-or-die option that Americans are, unfortunately, faced with when it comes to tobacco. In regard to
that, I tried to have an understanding with my staff on the nature of nicotine.
    I'm not a smoker. I've never had this addiction problem for nicotine. My body doesn't crave it. I don't
desire it. I don't smoke. I don't want to smoke.
     And so I'm trying to understand it as a nonsmoker. And I'm trying to place nicotine in the category of
substances that are addictive. I do understand. I understand cocaine and heroin and what it does for lives
in my district and in this country. I understand that when people start on these kind of addictive substances,
it can ruin their lives, and they crave it to the point that it can even kill them.
    I am a caffeine addict. I just drink coffee all day long. I confess. I know what that addiction feels like.
I know I have to have my cup of coffee in the morning, and I got to have it all day long to keep me going.
   But I also know that caffeine is not likely to kill me in the sense that cocaine and heroin might kill me. It
might not be good for me. It might make me overactive. It might make me hypertensive. I don't know
what. But it's not likely to do the damage that cocaine and heroin do.
    Where do you place nicotine in that scale? Is it closer to caffeine, or is it closer to cocaine and heroine?
     MURIS: It's hard to put it in a scale in that comparison, but although they are both addictive, they have
different mechanisms of action. And the caffeine works by modifying certain enzymes that oxidate specifical-
ly and that works through (inaudible) mechanism -- they call it. What it does, is it works on your cardiovas-
cular system. It'll speed up your heart, and you'll have cardiovascular effects that you become dependent
on.
    TAUZIN: How about nicotine?
    MURIS: Nicotine works by a different mechanism. Nicotine has direct adverse cardiovascular effects
that are tied to accelerating cardiovascular disease. It has bad effects on your heart, bad effects on the
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blood vessels, and can accelerate athrosclerotic disease, and so on. It's not just -- we're not just talking
about cancer here. We're talking about other effects on the body that...
    TAUZIN: It has other negative effects?
    MURIS: Yes, sir.
    TAUZIN: Does it have any positive effects? I was told by staff that there are at least some scientific
evidence that it has some positive effects on some categories of human conditions.
    Is that true or false?
    MURIS: Well, only if you're talking about the biochemistry of the body, but...
    TAUZIN: How about Tourette's Syndrome?
    MURIS: Oh, you're talking about as a treatment now?
   TAUZIN: Yes, that's what I'm saying, it has positive -- isn't it used positively in some cases, like treat-
ments of...
     MURIS: I have never used it. And if it is, then it's probably not very common. But I would imagine the
literature people have tried to use it.
    TAUZIN: Here is where I'm going, and I want your feedback on it. If Americans who have accustomed to,
addicted to the habit of getting nicotine into their body, who are able to get it into their body in some other
fashion other than the use of tobacco, would that be a positive social development in America in terms of the
nation's health? Or would it be a negative one?
    MURIS: Well again, I, you know, I am less inclined to comment on social developments than I am on
science.
    TAUZIN: Well, science then. Would it be good for Americans' health, for people who need caffeine and
believe they have to have it, I mean, or nicotine, are addicted to it, to get it in some other fashion other than
having to burn tobacco to get it?
    MURIS: Well, we have mechanisms presently available through -- to nicotine products that are ...
    TAUZIN: I know we do. I'm asking you, is that good?
    MURIS: It is an option that's available. I mean, the best of all option is obviously is not to smoke at all
and not to become addicted.
    TAUZIN: Well, nobody disagrees with that.
    MURIS: OK.
   TAUZIN: But if the option is quit or die, and what I'm saying is if you have to get nicotine in your system,
because you're addicted to it and you can't quit. I mean, the quit rate is like 2 or 3 percent a year in this
country. And so, we know people are having a pretty difficult time quitting.
     Recognizing that, knowing that we're going to lose an awful lot of people to the affects of not quitting, if
these folks can get their nicotine in some other way other than burning tobacco and sucking all the nitrosa-
mines and all the other substances into their lungs, would that be a positive thing for the health of the coun-
try?
   MURIS: Well, yes, and it already is. We have the patch, we have gum, we have mechanisms that have
been tested and found to be safe and effective means.
      TAUZIN: All right. Let me turn to the FTC (inaudible). If, in fact, people come up with products, wheth-
er it's tobacco products or non-tobacco products that can in fact deliver nicotine to folks who have been ad-
dicted to it and can't seem to quit using it, is your department the right agency to regulate the truth of those
ads?
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   MURIS: Our mission is certainly to evaluate the truthfulness of -- including substantiation of advertising.
That can require us -- and in this case it would -- to work with scientists both in and out of the government
because the issues here in the substantiation arena are issues on which their experts...
    TAUZIN: Yes, you get thrown into the health arena -- here, you've got...
    MURIS: ... and we're not. Right.
     TAUZIN: Yes, and you're not health officials. But nevertheless, your agency's function is to examine the
truthfulness and the lack of truthfulness of advertising of American products. Is that as far as your agency...
    MURIS: Yes, but what I am saying is the substantiation issues here turn on scientific issues to which
we...
    TAUZIN: Therefore you'd have (inaudible) like the health department officials to help you?
    MURIS: Absolutely.
     TAUZIN: And if science was available to help you understand whether or not an advertisement was in
fact truthful or not truthful, that gave people in America better information about options that might be availa-
ble to them when it comes to getting nicotine, wouldn't it be in the interest of this country for you and our
health officials to conduct some public forums and to see whether or not all of this is a good avenue for us to
approach or not?
   MURIS: Well, in the abstract, Mr. Chairman, I certainly think that is a good idea, again, because the is-
sues are ultimately scientific, we would need -- you know, they would need to take the lead, the scientific
agents.
    TAUZIN: Well, except that they tell us it should be your lead because you end up being the one saying
yes and no on the truthfulness of the ads. If they can help you understand that and can help you conduct
forums that all of us in America, scientists, consumers, advocates who helped (inaudible) pro and con, all
kind of people could come and debate it and discuss it, wouldn't -- why wouldn't you want to help create that
type of forum for us?
   MURIS: Well, that's a different issue than taking the lead. I certainly think that we would -- I know --
speaking for myself, obviously my colleagues would have to vote -- that I would be willing to participate in
such for a, not just for the talk about particular product, although that would be important, but to talk about
what end points, what kind of scientific evidence is relevant.
      I mean, I agree with the premise here that we have somewhere near 50 million people who smoke, and
it's a very addictive product. I'd obviously defer to the scientists on that, but it obviously is a very addictive
product. Many people have difficulty quitting. And I think there are potential -- and the key word is "poten-
tial" -- public health benefits from addressing that issue. And it's one of...
    TAUZIN: Well, we'd at least want to hear about it and talk about it.
    Mr. Chairman, my time is up. I just want to make a point. If you don't take the lead and the health de-
partment says you should take the lead and they don't want to take the lead, we never get these forums
going. Somebody has got to take the lead to organize it. And I don't know whether you or Tommy
Thompson -- we need to put you in a room together and you all can flip a coin to see who calls the meeting,
but my guess is it would help us immeasurably in this country. If one or both of you would take the lead --
thank you, Mr. Chairman.
    MURIS: I understand, thank you.
    STEARNS: I thank the chairman.
    The gentlelady, Ms. McCarthy is recognized for her questions.
    MCCARTHY: Thank you, Mr. Chairman. I pass.
    STEARNS: The gentlelady passes.
    Mr. Whitfield?
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    WHITFIELD: Thank you, Mr. Chairman.
    Mr. Muris, it's my understanding that UST, U.S. Tobacco, had asked your agency, I guess back in Feb-
ruary, 2002, for an advisory opinion to make certain statements in its advertising about their smokeless to-
bacco products. Is that advisory still pending? Or what is the status of that?
    MURIS: Well, it's not, you know, what they asked us to do. They didn't give us advertising on which they
asked an opinion. They gave us a general statement without the context of advertising. And as explained
in our -- I can't, obviously, talk about non-public proceedings in a public forum. But as explained in our testi-
mony, generically that presenting something to us in that manner causes problems.
    The withdrew the petition. They have recently sent us additional information and asked that we hold a
public forum. But the petition has been withdrawn.
    WHITFIELD: Now, and what would be the purpose of the public forum?
    MURIS: I think, although they can speak for themselves. My understanding is the public forum would
involve some of the issues -- many of the issues I was just discussing with Chairman Tauzin.
   WHITFIELD: One of the statements made, evidently, in their letter to your agency was that the surgeon
general in 1986 concluded that smokeless tobacco is not a substitute for smoking cigarettes.
   WHITFIELD: While not asserting that smokeless tobacco is safe, many researchers in the public health
community have expressed the opinion that the use of smokeless tobacco involves significantly less risk of
adverse health effects than smoking cigarettes.
     Now, does your agency have the capability to render a decision on whether or not advertising based on
that type of statement would be accurate or truthful?
    MURIS: The question with such advertising would be whether it was substantiated. We would be -- we
don't have expertise to evaluate the substantiation of the scientific evidence. We would turn to scientific
experts within and without the government.
    I cite a few very briefly -- we cite in the footnotes to our testimony, just very brief introductions to some of
the scientific evidence. But that's where we would have to turn.
    WHITFIELD: And you would be able to do that?
     MURIS: Sure, we would certainly be able to ask the cooperation and assistance. Obviously, it would be
in the discretion of the people we asked as to how much they participated and what they told us.
    WHITFIELD: And going to these scientists to come up with a scientific analysis of the claims, under the
current system that you would do that, you would feel comfortable with the conclusion made? I mean, the
process , you would...
     MURIS: Well, the process -- let me again put the process in context. When you have advertising, we
look to see if the advertising, in the first instance, is deceptive. Advertising of this nature would almost cer-
tainly be advertising that contained an explicit or implicit claim that there was substantiation for the risk re-
duction. We, again, are not experts on the science necessary to evaluate that claim. So that's why we
would turn to the scientific community.
   I have confidence in the process in general. How it would work in this particular case, you know, we'd
have to see.
    WHITFIELD: Admiral Carmona, would you support the abolition of all tobacco products?
    CARMONA: I would, at this point, yes, sir.
    WHITFIELD: So you would support a law in Congress that all tobacco products would be illegal?
    CARMONA: No, sir, I didn't say that. You asked me would I support banning or abolishing tobacco
products, yes. Legislation is not my field. If Congress chose to go that way, that would be up to them. But I
see no need for any tobacco products in society.
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   WHITFIELD: But if Congress were to pass legislation making tobacco an illegal product, you would be
comfortable with that?
    CARMONA: I would have no problem with that.
    WHITFIELD: OK.
    Now, the purpose of this hearing today -- if oral tobacco is to play a role in harm reduction, would you
agree it is not necessary to show that it does not cause cancer, but it simply needs to be substantially less
hazardous than smoking?
   CARMONA: If I understand your correctly, sir, I would say that we already know it's a carcinogen, one.
And, if we were looking to test any other theories, certainly the fact that it is a carcinogen would be important.
    And in my mind, you don't need to do any further testing. If you already know it's a carcinogen, it would
not be an acceptable substitute.
    WHITFIELD: So whether or not less harmful would not make any difference to you then?
    CARMONA: Well, I would -- if there are those who are doing research in this area and they have thought
of unique ways that this could be helpful, I am always willing to listen to research. But right now, substituting
one carcinogen for another, I don't see a benefit.
   WHITFIELD: OK. And I understand that, but you're saying if there is scientific evidence there that
shows that it is less harmful that that is something that you would be willing to look at?
    CARMONA: I'd always be willing to look at any scientific evidence, sir.
     WHITFIELD: Now, the Royal College of Physicians, in December, 2002, which is England's oldest med-
ical institution and among its functions is to advise the government, the public and the medical community on
health care issues, stated that as a way of using nicotine, the consumption of noncombustible tobacco is of
the order of 10 to 1,000 times less hazardous than smoking. Would you agree with that or not?
    CARMONA: I would not, sir.
    WHITFIELD: Are you aware of any scientific data that would disagree with that statement?
     CARMONA: Sir, not so much disagree, but I don't think they have enough scientific data to justify making
that statement.
    WHITFIELD: You don't think they have enough data to justify it?
    CARMONA: That statement, yes.
    WHITFIELD: And you've read this report that they rendered?
    CARMONA: Yes, I have, sir.
   WHITFIELD: Now, on this issue of the smokeless tobacco as a gateway to increased smoking, do you
have any evidence to show that it is a gateway to increased use of tobacco products?
     CARMONA: Yes, sir. There are studies to demonstrate that it does act as a gateway and can eventual-
ly increase smoking in all individuals.
     WHITFIELD: Now, what about -- there was reference earlier to this European Union study about smoke-
less tobacco. And in that study they -- then they call surface statements, they said Sweden has the lowest
level of tobacco related mortality in the developed world by some distance, approximately half the tobacco
related mortality of the rest of the European Union. Sweden has the lowest male smoking prevalence in
Europe. Half the tobacco in Sweden is now consumed as a smokeless tobacco product. And this share
has steadily grown since 1970.
    And they go on and on and on. And they make all sorts of arguments that one of the reasons there is
less mortality in Sweden is because of these so-called smokeless products. And I am sure you've read
those reports as well. But do you have any scientific evidence that would refute that report?
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     CARMONA: Well, on those reports, sir, I think there are many potential confounding factors that have not
been fully looked at. People smoke or chew for a variety of reasons. And to assume that a decreased mor-
bidity and mortality in a population is solely due to the fact that somebody is chewing tobacco -- I am sure
they all drink milk, also, or have a cup of coffee every day. And you could equally attribute changes to other
variables that maybe haven't been looked at. So it's a much more complex problem.
    WHITFIELD: Sir, my time has expired.
    STEARNS: The gentleman's time has expired.
    The gentleman from Texas, Mr. Green?
    GREEN: Thank you, Mr. Chairman.
     Admiral Carmona, during the previous Congress, as members of this committee have introduced legisla-
tion which would give the FDA a broad authority to regulate tobacco products, including strong restrictions on
advertising and marketing products to young people, protection against exposure to environmental tobacco
smoke and tough company- specific surcharges to encourage companies to reduce youth smoking. Do you
think it's important for our Congress this time to enact legislation to give the FDA that authority to regulate
these tobacco products?
    CARMONA: Well, sir, I appreciate the question. But not being in the regulation business, I think it's im-
portant that Congress looks at this and makes a determination if it's something that they want to move ahead
with that would be in the best interests of the protection of the American public. Whether or not the FDA
does it, I think strong oversight and scrutiny is important by whatever mechanism you all choose to do.
    GREEN: OK. Thank you. I understand the position you're in and I appreciate the best answer you
could give.
    Mr. Muris, one of the rotating warnings on packages of smokeless tobacco reads, "Warning, this product
is not a safe alternative to cigarettes."
     Let's say that you're a cigarette smoker that saw an ad promoting smokeless tobacco as a product with
reduced risk, if that was allowed, and you go to your local convenience store and decide to try it out. And yet,
ripping open the top of it you read the warning that this product is not a safe alternative to cigarettes.
    Would you feel as if you received a mixed message as to the health benefits of that package of smoke-
less tobacco?
    MURIS: Well, it obviously depends -- and this is just to preface this, this is a very important part of what
we would do is to look at the take-away as to what a reasonable person in the intended audience unders-
tood.
   MURIS: It obviously depends on what the advertisement said. It is quite possible that, even though
couched in the language of safer, that people would receive, you know, depending on how it was written and
what all was in the ad and the totality of the circumstances, it's possible that people would receive a mes-
sage of safe, in which case they would be conflicted.
     GREEN: OK, thank you. The Federal Trade Commission Act provides, in that an act or practices illegal if
it, quote, "Causes or is likely to cause substantial injury to consumers, which is not outweighed by counter-
vailing benefits to consumers or to competition."
    Even if we were to assume that scientific evidence were true that smokeless tobacco use can reduce the
number of deaths associated with smoking, in your opinion does this outweigh the substantial injury caused
to consumers?
     MURIS: Well, you're now turning to a second part of our statute, which is on fairness, and I talked about
this briefly a little while ago.
     In the context that we would be looking at, and this is part of balancing in a different way than I was men-
tioning before, but similarly a balancing the benefits and the costs, and that's what that part of the statute
requires.
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    I think it's a factual question on which, you now, which we'd have to seek evidence.
    GREEN: Thank you, Mr. Chairman, and I yield back my time.
   STEARNS: The gentleman yields back the balance of his time. Gentleman from New Hampshire, Mr.
Bass.
     BASS: Thank you, Mr. Chairman. As I mentioned in my opening statement, we've heard comments
about young men using smokeless tobacco as a rite of passage, we've heard a possible connection between
health problems of the former speaker of the House and chewing tobacco, I don't know whether that's true or
not.
     And the surgeon general's recommended that perhaps members of Congress need behavioral modifica-
tion, so I would definitely agree with that.
    (LAUGHTER)
     But the real issue here today is a very narrow one, and my first question is for Chairman Muris. Under-
standing, sir, that the FTC has a difficult mission protecting consumers from deceptive and misleading adver-
tising.
     It involves judgment calls and reasonable persons' standards, and given that you already do this cur-
rently, for weight loss products and other such items based on a comparative advantage, which is the subject
of this hearing, could the FTC establish guidelines that would offer needed protection and more accurate in-
formation, in your opinion?
     MURIS: Well, it would be, in general, I think you have to take advertising in its context and as you find it.
There's the issue I was just mentioning, the issue of how consumers understand claims, and then there's the
issue on which we spent most of the time in the questions you've answered, or asked me, about the substan-
tiation.
    Because one of the claims that would be in these ads would be an explicit or an implicit claim that there's
scientific substantiation for a risk reduction claim.
     I think most, I think we'd have to emphasize both things. I don't think we're ready to do guidelines, par-
ticularly involving the second issue, because we would need to have a much greater discussion with the
scientific community about what risk reduction claims mean, about the appropriate end-points for measuring
them, about evidence from around the world, about a whole host of issues.
   BASS: But it's perfectly legitimate, or reasonable, for the FTC to conduct studies involving comparative
advantages of one product over another, it doesn't have to be an absolute.
     MURIS: Oh, there is nothing in principle that prevents comparative claims. The commission, my prede-
cessor, one of the best things he did more than 30 years ago when he was at the FTC, he got the networks
to eliminate their restrictions on comparative advertising. Comparative claims are important kind of claims.
     BASS: OK. Admiral, I appreciate your testimony, and I would be, my colleague from Kentucky, Mr. Whit-
field, brought up the issue of the English, or the British report that, in essence, drew a conclusion regarding
the relative benefit, or whatever, of smokeless tobacco versus cigarettes.
   I'd be interested in if you'd be willing to provide the subcommittee with a further explanation as to exactly
what scientific evidence you find in that report invalid.
     I will say now I've never heard of it, and I haven't read it. But you have basically disputed the claims
made in this report that they're invalid, and that they're not based upon adequate science, and if you're offic-
er, you would be willing to analyze those claims and explain exactly what mistakes they made led to that par-
ticular conclusion I'd be interested to read about it.
    CARMONA: We'd be happy to provide you with the information, sir. And generally it's not that it's invalid.
We felt that there was not enough information to support their thesis, that more research needed to be done
before you could come to that conclusion.
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     BASS: OK. I don't think anybody here is suggesting, sir, that you recommend one product over the oth-
er, but suppose, I don't like to use hypotheticals, but would you agree that advertising that explains the mor-
tality rates of one product over another, that infers a conclusion that smokeless tobacco was less harmful
than cigarette smoking, would that fairly describe an aspect of the harm reduction that we are all seeking?
    CARMONA: Well, we're all seeking harm reduction. I don't think that fairly describes quite a complex
problem, because where you might be able to argue that a product has one component that may reduce risk,
when you look at the product broadly, in all of its risk factors, there may be more harm or less harm than
others.
    So I don't think, sir, it's as simple as just describing it, because there are many variables that we're look-
ing at in these comparisons.
     BASS: Mr. Chairman, my time's expired, and the point that I'm trying to drive at in this line of questioning
is that there are no perfect products for any problem, and there is probably no substance in this country, or
no issue or no product, that is more controversial, with the possible exception of guns, than tobacco.
     However, within the context of this debate, if a public good if being achieved, albeit not a perfect one, is it
not a good idea for the policymakers and agency heads to examine this realistically and objectively, because
ultimately we're all seeking the same goal, which is reduction in deaths due to this particular substance?
    And I'll yield back.
    STEARNS: And I thank the gentleman, and we've had a hearing dealing with guns, too. Gentleman
from Massachusetts.
    MARKEY: Thank you, Mr. Chairman, very much.
    I do have a bias in this field, my father died from lung cancer, and he dies three years ago, and although
he smoked two packs of Camels a day from the age of 12 until 67, it never caught him until he was 89, and
then it just showed up even though he was otherwise perfectly healthy, and then he died from lung cancer
three years ago, although the doctor had said until it showed up that he was going to live to 100.
    So that's a big loss in our family of a guy in perfectly healthy condition mentally and physically to die be-
cause of it. But what I remember most is that when I was 13, he told me, because I was the oldest, that he
started smoking at 12, and that he knew I would be starting in the next couple of years, because every boy
smokes, right, that he shouldn't expect him that is to pay for the Camels, that I was going to have to earn the
money. Just don't take the money out of his pockets or anything.
    But he knew that we would all smoke. That was his message to me when I was a 13-year-old boy. So
because of the surgeon general's decision in the mid-60s, and the continuation of public education, we were
partially at least to stem that tide of the inevitable deaths that occur from young boys and girls staring to
smoke because they feel like they have to.
    So one of my concerns here from a public health perspective is the secret additives that are included not
only in cigarettes but also in these smokeless tobacco kind of products that are sold.
    And I know that HHS is one of the only entities to have the secret list of ingredients.
     Do you think that it would be helpful for there to be a release of the secret additives to the public, so that
even if smokeless tobacco is advertised as being safer than smoking tobacco, that the public would then still
be able to see what the additives were and to be able to judge that it's still much too big of a risk to undertake
at all, and help mothers fathers to convince their kids not to start?
    Doctor?
   CARMONA: Sir, I'm not aware of the legal complexities involving the release of such information, but I
know that our scientists have looked at it, and in aggregate they've published information as to many carci-
nogenic agents, as well as other factors that are contained within smoked products that can cause not only
cancer but other disease.
     But as far as the release of that I think it's out of the scope of my practice, sir, and I'm not sure of the le-
galities of that, but certainly ...
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    MARKEY: If it was within your power, would you make this, the secret additives public?
   CARMONA: I think that I would ask my colleagues who actually are at the bench doing the research to
ascertain if there was any benefit, additional benefit, to that that would be released within the research.
    And then I'd make my decision on that.
     MARKEY: Any additional benefit, if the public knew what the additives were, and it was determined that
they would be more likely not to start using it if they knew, would you then be supportive of releasing the ad-
ditive information?
     CARMONA: Again, sir, that is one of the factors I would consider, but also looking at it in the entire con-
text of how this information is being used by our scientists and if there was some improvement in health sta-
tus that could be achieved by releasing this information, then certainly that would move me in that direction.
    MARKEY: So there are carcinogens in these additives. You also mentioned other diseases caused by
these additives. What are they?
   CARMONA: Oh, chronic obstructive pulmonary disease, acceleration of cardiovascular disease, you
know, stroke, heart attacks, things like that. So not all necessarily cancer related, but very significant dis-
eases also.
     MARKEY: So, let me ask you, Chairman Muris, if the public doesn't have access to the information about
secret ingredients and additives in smokeless tobacco, aren't claims regarding the potential health benefits of
smoking tobacco, smokeless tobacco, rather, likely to be deceptive or misleading because the information
about the additives that are in the smokeless tobacco aren't available to the public to make that determina-
tion themselves?
     MURIS: Well, let me preface with two general statements. One, I have never looked explicitly at what
this information is. But from the standpoint of what we do, there would obviously be a heavy presumption in
favor of more information and not less. And someone would have to make a very good argument -- and not
having looked at it, I don't know what that argument might be -- to withhold information.
    MARKEY: Thank you.
    STEARNS: The gentleman's time has expired.
    Mr. Shimkus?
    No, Mr. Shadegg? Mr. Shadegg?
     SHADEGG: Thank you, Mr. Chairman, and thank you for holding this hearing. I will tell you I am mysti-
fied by it all and I kind of wonder where it is taking us.
    Let me start with the issue of your jurisdiction at the FTC. As I understand it, you have jurisdiction arriv-
ing out of the concept of deception and the concept of unfairness. Is that correct?
    MURIS: Yes.
    SHADEGG: On the concept of deception, as I understand your testimony, before you could allow a label
to say this product is safer than, that is, smokeless tobacco is a safer alternative to cigarette smoking, you
would have to have evidence which substantiated that point. Is that correct?
    MURIS: Among other things, yes, sir.
    SHADEGG: OK.
     Dr. Carmona, it is your belief that while there have been studies done on that point, they simply are not
sufficient, that is, not enough studies or not enough subjects and not enough contrasting information to reach
that conclusion. Is that right?
    CARMONA: In the particular instance of smokeless...
    SHADEGG: Yes, to reach the conclusion that smokeless is safer than...
    CARMONA: Yes, that's correct, sir.
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   SHADEGG: OK. So you believe the FTC could not in fact substantiate that first threshold criteria of
whether or not it's safer than. Is that right?
    CARMONA: That's right, sir.
     SHADEGG: The whole topic puzzles me. For example, this is a can of smokeless tobacco. This par-
ticular can has the warning that says "This product may cause gum disease and tooth loss."
     One of the issues I hear in the testimony here today is a relative one, which is, if we say, or if we allow
the claim to be made that smokeless tobacco is safer than cigarettes, which you believe can't be substan-
tiated, but others believe could be substantiated, are we then deceiving people into using smokeless tobacco
as a safe alternative?
    Now, we know one of the labels that's already on smokeless tobacco says "This product is not a safe al-
ternative to cigarettes." That raises the issue of, OK, what is the truth? If you give less than all the truth, are
you somehow deceiving people?
    And Dr. Carmona, that's your concern, isn't it?
    CARMONA: Yes, sir. My concern is that, you know, that definition of the word safer as it relates to
these products. That, in fact, if you take one piece out of context and make an assumption that well, be-
cause there is less of a certain chemical, therefore it is safer where the science isn't there to support it.
     And we ignore that fact, as you just pointed out, sir, that gum disease, tooth problems and so on are also
problematic, it's very difficult to say that. And that's why I view that substitution argument as oversimplified
for a very complex problem and one that I could not support because it is still detrimental to the American
public.
     SHADEGG: Let me ask you both, as I read the information I am provided right now, although the warning
on cigarettes is a surgeon general's warning and the warning on smokeless tobacco is not a surgeon gener-
al's warning -- it just says a warning -- both are as result of congressional actions and neither are as a result
of FTC actions standing alone or surgeon general actions standing alone. Is that correct?
    CARMONA: I believe so, sir.
    MURIS: Yes, the FTC got the ball rolling but then Congress stepped in almost 40 years ago.
   SHADEGG: And so it's going to be our job to try to spell out what should be -- at least currently -- what
should be specified on the label, if anything.
     Dr. Carmona, if the Congress does not step in and specify what should be spelled out, do you have the
jurisdiction to issue your own warning?
     CARMONA: Well, I think that one of the things I have probably that's most important is the so-called
"bully pulpit". I can certainly speak out regularly on the hazards of all tobacco products. And I would cer-
tainly intend to do that, along with my colleagues, where the scientific basis allows me to do so.
    SHADEGG: And I suppose it would be your position that if someone were to propose that they wanted to
advertise smokeless tobacco as safer than cigarettes, you'd want to add, but not in fact, safe, because of
these other dangers. Is that right?
    CARMONA: I'd be opposed to such advertising.
    SHADEGG: And you'd like to see the Congress -- if the Congress were to step into this field and specify
what had to be put on claims about smokeless tobacco to make sure that if anyone had wanted to make a
claim that smokeless tobacco was safer than cigarettes that they go beyond that and say, but however, still
not safe because it causes all of these issues, the potential for mouth cancer, potential for gum decay, tooth
disease, other things. Is that right?
    CARMONA: Well, sir, my intent would never be to attempt behavioral modification on the Congress...
    SHADEGG: Well, because we look to you for expertise, and we should.
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    CARMONA: ... but what I would strongly support is that Congress take into account all of the scientific
evidence before us, some of which you have cleanly outlined right now, in making their decision to protect
the American public.
    SHADEGG: One of the things that concerns me is that of the three labels Congress has specified for
smokeless tobacco -- and I understand they rotate. So my understanding is that one-third of all cans would
actually contain one of these, one-third the second and one-third the third. One of them, quite frankly, I
think you could make the claim that it is deceptive precisely because it doesn't go far enough.
    One of the three labels is, "This product may cause gum disease and tooth loss." I would suggest that if I
were a young kid picking up this can and read this particular can, which says, it may cause gum disease and
tooth loss, I would be a lot less concerned about its use than if it read this product may cause mouth cancer.
    Which raises the next question of why does it say mouth cancer? Why doesn't it say this product may
cause cancer? Because if you want to scare somebody and you warn them this product may cause cancer,
I suggest that's going to have a greater impact on them than perhaps any of the other three alternatives that
are there.
   So one of my concerns is, boy, haven't we started down a slippery slope when it's the United States
Congress that decides what the precise wording of any warning ought to be.
    CARMONA: Well, we are certainly concerned, my colleagues and I, sir, that any references to safer that
are not clearly spelled out, are not scientifically justified, may, in fact, just do that, cause young people to
start earlier and feel that it's a safe thing to do, there there is relatively little risk and, as you've pointed out,
the whole story is not being told.
    SHADEGG: Let me go back to the FTC on the issue of -- one issue would be the issue of deception, and
that is, would it be deceptive to claim that smokeless tobacco is safer than cigarettes?
    Your second element of jurisdiction is that of unfairness. Under the second rubric, unfairness, would
you consider it necessary to go on and provide the disclosure, however not safe?
   MURIS: Well, the commission has rarely, and I mean rarely, used unfairness to evaluate advertising. It
almost always uses deception.
    There is a tremendous First Amendment problem from saying an advertisement is truthful, yet we can
stop it. So we would much more likely use on the unfair, I mean the -- our deceptive authority. It's clear
that any of these ads we would be concerned with a take-away, an understanding -- and by that I mean an
understanding by the intended audience that no matter what the word said, that a lot of people thought that it
meant safe.
      SHADEGG: And you...
      MURIS: And I think that would be a big concern.
    SHADEGG: And you would be concerned than an implication that's safer might cause somebody to con-
clude that it was safe.
      MURIS: Sure. Depending on the -- you know, how the disclosure was made and what else was in the
ad.
      SHADEGG: Before my time expires, I simply want to conclude by pointing out that according to the in-
formation I have, in 1981, the FTC issued a report to Congress that concluded that health warning labels had
little effect on public knowledge and attitudes about smoking.
      So it says public labels don't do anything.
   Congress responded by enacting a law requiring self-warning labels. I think it's quite interesting what
we do here.
      Thank you very much.
      STEARNS: The gentleman's time has expired.
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    Mr. Davis is recognized.
    DAVIS: Thank you, Mr. Chairman.
      Chairman Muris, in reviewing your written statement on page eight, you suggest that in the context of
safety claims, the FTC has typically required a substantiation standard of competent and reliable and scien-
tific evidence.
     In my opinion, this issue ultimately boils down to respect. How much respect are we going to have for
our consumers, for our citizens, in terms of how high the standard we set as far as judging the accuracy and
truthfulness of any disclosure you would approve, or this Congress would approve, so people can make safe
decisions, not necessarily the right decision.
    Can you elaborate a little bit as to exactly how high the standard is you would employ if you were to find
yourself in a proceeding judging the marketing of smokeless tobacco?
    MURIS: Well, yes, sir.
    The first question, obviously, turns on what the ads would say in their full context, and, therefore, what
the take-away from consumers would be. The more qualified that the take-away that the consumers re-
ceived, the lesser the substantiation.
    On the other hand, as I mentioned the so-called Pfizer factors before, because I personally believe --
again, just speaking for myself -- obviously my colleagues could have different views. Because the conse-
quences of making a mistake here are so serious in terms of, you know, the potential adverse effects on
public health, people who might otherwise have quit, what the effects might be on children, that would indi-
cate that the bar should be very high.
    DAVIS: The debate here today seems to center upon the word safer. It seems to me as a lay person,
that by its very nature and in whatever context the word safer is used, and it invariably is a vague term. It is
not a qualitative connotation.
    Under what circumstances could safer ever constitute a sufficiently acceptable standard under this very
high standard you've just described?
   MURIS: Well, again, there are two questions that I think you really have to keep distinct. One is how
consumers understand the words. And I believe it is possible to communicate safer as opposed to safe.
     But then the second question is about to the scientific evidence. And the scientific evidence I believe
would have to be very high, you don't even know -- I mean,again, we're not scientists --the scientific commu-
nity, I think it would be very useful for them to do more work on issues involving what sort of evidence is it
that they would want? What sort of evidence that they would look at? Because I do agree with the general
premise that some of members have made that we do have upwards of 50 million people who smoke.
Many of them find it very difficult to quit.
     The simplest place to start, if I could just end, I believe, and I would like to explore with the FDA, the po-
tential for broader based claims, for the gums and the patches that the patches that the surgeon general
mentioned.
    Right now those can only be used for very narrow purposes. They can't be -- they can only be marketed
as part of quitting. They can't be marketed as sort of a long-run replacement. It seems to be there again,
there would be up to the FDA ultimately because they regulate this. But it seems to me that there are very
large potential benefits from being able to tell people about the longer-run possibilities.
    DAVIS: And I commend you for that. I think that we should be afraid of the risk reduction. The surgeon
general has said that. I think we need to be painfully objective about this. But it just seems to me as a lay
person, that the question isn't whether a safer type of marketing could ever be acceptable under those very
high standards. But that it really would be a disclosure as to how much safer or how less safer, don't you
think?
     MURIS: Oh, well, absolutely you would need to understand the question of quantity in that sense, not
just a question of a qualitative difference. And I agree with that.
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    It even may be true a complication of the nicotine and why the nicotine products, the gums and the
patches and why I use the word potential, is there is some evidence, and again, I'm not a scientist. The
scientists would have to explore it. There is some evidence of potential dangers from nicotine itself beyond
addiction.
    In the footnote 17 on page 8, you seemed to acknowledge the possibility that if evidence that is pre-
sented to you, that you rely upon for approval, later proves to faulty, that's a problem. Do you have the au-
thority to go back and revisit any approval of the disclosure that's been made on a product if subsequent
scientific evidence reveals that it is not sufficiently accurate.
    MURIS: Absolutely, and the basis of the substantiation doctrine, by its very nature, recognizes that when
the science changes, then the ability to make the claims changes.
      DAVIS: I'd like to give the surgeon general the opportunity to comment on any of these points if he'd care
to.
    CARMONA: Well, sir, simply, I agree with where you are going with this. I think there is a qualitative
and quantitative aspect to the word safe or safer. And certainly quantitatively we have to able to define that,
but also in its entirety.
    As I alluded to earlier in my remarks, taking one variable out of context and simply stating that there is an
improvement, or it is simply safer, doesn't address the spectrum of risk, of which there are many variables.
So I think it's to the public's benefit that we are very clear on how that word is used.
      DAVIS: Thank you, Mr. Chairman.
      STEARNS: The gentleman's time has expired.
      Mr. Issa?
      ISSA: Thank you, Mr. Chairman.
    I might preface this by saying that I am a recovering smoker of 13 plus years. So I am very aware and
every day I think about, you know, the error of my smoking in my youth and my not so youth judging from
when I finally quit.
     But I do have some questions because I don't think we are dealing with tobacco here, we are dealing
with a question of a blank substance relative to other blank substances claims -- interpretation for whether or
not they are allowed versus other claims. And hopefully, we can forget the word tobacco in the discussion
today for purposes of thinking about whether or not safer, it does seem to be the key word, is appropriate or
inappropriate to be considered.
   And what I'd like to, first of all, do is ask the surgeon general one question which is, what is the health
benefit of butter?
      CARMONA: There are nutrients within butter. There is...
      ISSA: Butter is basically fat, is that right?
      CARMONA: No.
      ISSA: What are the benefits of fat, then, perhaps is a better question?
    CARMONA: Fat is necessary. It is necessary, it is essential to our growing. Everything from making
steroids in your body to new cells require fats.
    ISSA: And isn't the excess consumption of fat the number one health problem in America, in combination
with not enough exercise?
      CARMONA: It certainly contributes to obesity, sir, yes, sir.
    ISSA: OK. And yet the low-fat butters and the alternate butters appear to be able to claim that they are
better and safer. I have read enough packaging to get this idea that this plasticized butter that tastes mar-
ginal at best -- not margarine, but marginal -- gets to make that claim.
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   And Mr. Chairman Muris, I guess the question is how do they get to make the claim that they are better if
essentially the difference is less fat, which the surgeon general has said is OK, it's essential.
    MURIS: Well, health claims are regulated by a statute that Congress passed in 1991, the NLEA. And
there are a variety of hoops through which you have to jump. So it's -- even though we are involved in that
area, and in fact, Dr. McClellan, the head of the FDA and I made an announcement last year, where he is
hoping -- given the way science is changing -- he is hoping that advertising and labeling can keep up with the
changes in science. But there is special, you know, regulatory regime for those.
     ISSA: OK, so the fact that butter is essentially not bad and fat is not bad and then if you have less of it,
claiming that it's better would be totally inappropriate on the face of it all. Forgetting about the taste of but-
ter, forget about what we all put on, that in fact we have a different standard for tobacco than we have for fat.
    Doctor, I guess my next question is, you support banning tobacco. Does that allow you to be an honest
broker in the question of less bad and more bad? I would personally say that I would have a hard time if I
supported outright banning something, would be happy to see Congress passing a law that would do that
and then I was asked, "Well, are we going to allow the good instead of the prefect, even though the good
might in fact perpetuate consumption of this for a while?" I would probably inherently say, "Well, geez, I don't
want to have anything that might lower a little bit the health risk, but perpetuate the consumption."
    Is that something that you're having to deal with in your testimony here today?
    CARMONA: No, sir, and let me elaborate.
      First, I want to respectfully disagree with your analogy with butter because it's much more complex than
it's presented and I think it's an unfair analogy.
    Second, I am not having any problem with it because the driving factor in what I have testified to is that
the substance we are talking about is a proven carcinogen. It causes cancer.
    ISSA: And I am reclaiming my time -- I guess the -- from the witness.
    The problem we have is we are talking about less and more and trying to understand whether or not less
or more is an honest statement. And that's why I am trying to get to the bottom of this.
     It appears to me as though, other than tobacco, we have this theory that you are innocent until proven
guilty. In tobacco, you are guilty until proven innocent.
   And so, for the chairman, I guess, my question to you would be -- because my time is evaporating here.
We have made a big point in this country, and accurately so, that we are concerned about second-hand
smoke. Sufficiently that, in fact, it has been found to be something that one has to get rid of and that's why
we have banned smoking in public areas in state after state.
    If, in fact, second-hand smoke is clearly bad, then aren't you better if you have no second-hand smoke,
because you have no first- hand smoke. The risk to people around a smokeless tobacco consumer is by
definition, zero, versus whatever you have with cigars, pipes and cigarettes. Would that not meet the first
threshold of a claim?
     MURIS: Well, sure. But now you're addressing a different question. If smokeless tobacco made a
claim based on no second-hand smoke, you know, we would evaluate that on its merits. That's obviously
different than the earlier claim we were talking about.
   ISSA: So just one last follow up. So what I am hearing is that even though there is no smoke, and any-
body could figure out that it must be safer, you're saying that if they made that claim, then you would think
about evaluating it. Do we need science to determine...
    (CROSSTALK)
    ISSA: ... second-hand smoke claim?
    MURIS: Well, no, I am saying the evaluation could be very -- the evaluation could be very quick. But
obviously, if someone asked us -- go back to the premise. The premise was, we were asked about these
claims. I can't give an answer without evaluation even if the evaluation occurs in a twinkling of an eye.
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    STEARNS: The gentleman's time has expired.
    And the gentlelady from California, Ms. Solis?
    SOLIS: Thank you, Mr. Chairman.
     Thank you, Dr. Carmona, for being here. It's good to see you. I know on occasion you've talked about
some of these chronic illnesses that face our communities, especially minority communities and the Latino
community. And I want to ask you if -- and I don't if this has come up, what the cost is in terms of prevention
for tobacco use now that you know of?
     SOLIS: In terms of government trying to combat the youth, trying to get youth to stay out of -- you know
-- going into that bad habit of smoking.
     CARMONA: I don't have a dollar amount for you. I certainly can get that. But whatever it is, I know
when we look at prevention across the board, we spend far, too little on all prevention activities in this coun-
try.
   SOLIS: Would you say that the number of youth -- particularly, minority youth -- in terms of smoking, has
gone up in the last 10 years or has it gone down?
     CARMONA: I think it has slightly increased where other areas, or other subsets, have decreased. This
is still a population that is at greater risk.
    SOLIS: I saw some information, I guess, the percentage -- or decrease -- for young Latinas in terms of
smoking, and I was a little -- I kind of understand why that's happening because more women are going in for
prenatal care and are being advised of low birth weight that their child would experience if they continue to
smoke. Is that something that your office is...
    CARMONA: The epidemiology and demographics of smoking are tracked very carefully by CDC on a
routine basis, and they have all of those numbers broken down by ethnicity, by geographic location, by age,
and then so on.
    So, it really depends which group you're speaking of. In some areas, it has plateaued out, but in some
there are still subgroups -- Latinos, specifically -- who are at slightly increased risk, and every once in a
while, we see a little increase.
   SOLIS: One of the pieces of information that we were given -- in fact, if you are advocating for use of
smokeless tobacco, that that probably -- or could lead to use of tobacco -- cigarettes.
    What do you -- what is your opinion on that?
    CARMONA: Yes, we do look at smokeless products as being a gateway to smoking. It can bestow a
sense of security -- as I've said earlier -- that this is a lesser threat. It is a safer means to get your nicotine
and chew. And we are definitely concerned about that for the reasons I've already mentioned.
    SOLIS: One of the other questions I have is -- women, I think, overall, my understanding is that the rate
has actually gone up. Is that correct in terms of cigarettes?
    CARMONA: It depends on the age group. And I'd have to look at that data. But when the -- the ag-
gregate -- if it has, it is very slightly in aggregate. But in breaking down the populations -- minority popula-
tions, age, and demographics -- you'll have peaks and leveling off periods that are different than the aggre-
gate data when you just lump all women together nationally.
    SOLIS: Information I have is that women account now for about 39 percent of all smoke-related deaths in
the U.S.
    CARMONA: That's correct.
    SOLIS: I would ask -- I guess one of the questions I would have is -- we're still trying to get women to
stop smoking, and, as an alternative measure here, in this smokeless tobacco, I can't think of too many
women who'd want to chew tobacco. You know, I'd love to hear more about that because I think that's a
real issue that we're really skirting the issue here. And how do you deal with that?
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    CARMONA: Well, I think that's a social and cultural part of our society, where young man embrace that,
and most women reject it.
   SOLIS: Well, do you think that we're going to -- wouldn't that have an impact on modifying, maybe, their
behavior?
    CARMONA: Oh, yes. Absolutely.
     SOLIS: I'm still very skeptical about the direction of where we're going with all of this because I know in
our community -- especially in California. The state of California is pretty progressive in terms of prevention
-- tobacco smoking and all that and restricting where you can use cigarettes. In fact, we have an initiative
that was passed -- Prop 10 -- that you're probably aware of. That is a dedicated source of funding simply for
prevention.
     So my question goes to, while we're spending a lot of money to try to treat the illness -- cancer, respira-
tory, emphysema -- at the same time, we're raising revenue to try to tell you -- give them the message, and
young people -- not to smoke. And then we're saying, on the other hand, well, it's OK to chew tobacco
when, in fact, studies, I guess, are not clear on how severe that might be.
   My question is -- you know -- where are we going with this in terms of giving accurate information that
smokeless tobacco may be harmful -- could be, maybe in different degrees, obviously, maybe you don't get
cancer in 10 years. Maybe you suffer from tooth decay a lot faster, which we see in our community, by the
way.
    And I would ask what your opinion is on that?
    CARMONA: Well, Congresswoman, my opinion is that -- as I've stated -- that irrespective of the debate
here today, I've seen no scientific evidence to support the use of smokeless products for any reason. And
they are hazardous to your health -- from causing cancer to causing oral disease, including gingivitis, tooth
decay, as well as a host of other diseases. So, without further evidence to refute that, I could not support its
use in any fashion.
    STEARNS: The lady's time has expired.
    SOLIS: Thank you. Thank you very much.
    STEARNS: Mr. Fletcher.
    FLETCHER: Thank you, Mr. Chairman. Thank you for conducting this hearing.
    Let me say first. I spent most of my adult life, up until the political side of things, encouraging people to
stop smoking and using tobacco products. I think it's interesting that we come to the day that we talk about
the relative risk of different products.
    There's no questions. We look at the IOM report -- 180,000 deaths from cardiovascular disease,
150,000 from cancer, and 85,000 from respiratory disease related to tobacco use.
    And so there's no question that if we had a perfect world, that no one would smoke or use products that
are harmful to their health. But, in fact, that's not the case.
     We do have a free society. And I think in a free society, it's very important to remember that a couple of
things are important. One, I think it's extremely important to be intellectually honest with the population so
that they can make choices. Some people choose to smoke even though they know the risk is there. I
think 75 percent of the people that are smoking would like to quit. That means there's 25 percent that don't
even want to quit.
    So outside of prohibition, which some may support that -- I think probably neigh impossible to control and
regulate. We went through a prohibition in the early part of the last century with some abysmal results. But
given that, I want to present a couple of things.
   I've looked over these reports, and I know the surgeon general has commented on that. One was the
Royal College of Physicians in London. These are pretty reputable folks. In fact, they've been around a lot
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longer than most of our -- I believe, even Harvard and some of our early medical institutions. I mean these
are folks that spend their life doing research.
    And they came up and said a way of using nicotine -- the consumption of noncombustible tobaccos in
the order of 10 to a thousand times less hazardous than smoking, depending on the product -- some manu-
facturers went to market smokeless tobacco as harm reduction option for nicotine users, and they may find
support for that in the public health community.
      But the bottom line is there's a pretty big spectrum so the science is pretty unclear. It's 10 to a thousand
times -- even 10 is pretty significant if that's the low-balling side -- now I do not support -- and certainly found
it intolerable that companies in the past have made marketing attempts toward younger individuals and
maybe not always been truthful in what they said they'd marketed things. So I hope it's clear that we have
some sort of guidelines for advertising and marketing of products.
     But I also look at -- given the fact that royal colleges tend to -- a thousand times less -- there's also the
European -- these are some pretty reputable people too that spent a lifetime just on research. They said
oral tobacco may play a role in harmful reduction. It is not necessary to show that it does not cause cancer.
It just needs to be substantially less hazardous than smoking -- even allowing for the cautious assumption
about health impact. (inaudible) talking about the European -- I guess the smokeless tobacco -- and other
oral tobaccos are very substantially less dangerous way to use tobacco than cigarettes.
   It goes on to talk about a number of different other things. But it does indicate they've been truthful in
what they said they marketed and things.
    FLETCHER: And so I don't think it's clear that we have some sort of guidelines for advertising, for mar-
keting of products. But also look at, given the fact that Royal College's tend to a thousand times less.
There's also the European -- these are some pretty reputable people too,that spent a lifetime just in re-
search. They said, "Well, tobacco may play a role in harmful reduction. It does not necessarily show that it
does not cause cancer. It just needs to be substantially less hazardous than smoking, even allowing for the
cautious assumption about health impact.
    Snuff -- which is talking about the European, I guess, the smokeless tobacco. And other oral tobaccos
are very substantially less dangerous way to use tobacco than cigarettes.
     And he goes on to talk about a number of different other things, but it does at least acknowledge, and
this is a study of some physician researchers that smokeless tobacco has reduced health.
    Now the Scandinavian study, and I know the surgeon general mentioned that some of the factors weren't
controlled. It was one of those studies where they were controlled fairly well.
    Let me read those to you. This is the Largeron (ph) study. It was a case control study. The patients
had adno-carcinoma of the esophogus, gastric, cardio and the esophagus squamous cell carcinoma. It said,
"Many potential confounders were considered, including age, sex, education, cigarette smoking, alcohol
consumption, dietary intake" -- it did not mention coffee specifically -- "dietary intakes of fruit and vegetables
and energy intake, BMI (ph) reflux symptoms, physical activities."
     It talked about the substantial reduction. I agree that science is not totally -- I mean, there are a lot of
studies that can be done and the science is not totally complete in this area. But one of the questions I've
got for both of you, if we could have an initiative regulating tobacco products, whether it be FDA or whether it
be FTC on the marketing of it. And it is marketed in such a way that it was very clear that the (inaudible)
they say safer.
    But say you had a relative scale of one to 10, and say you could say, "Well, given the current knowledge
that we have, you know, filterless cigarettes, maybe a 10. Smokeless, somewhere less than three. And by
these, I come from a district that produces burley, which is for cigarettes, not for smokeless tobacco.
     Given the fact that we live in a free society and that it's important to get information out, and given the
fact that I know some people feel that this gateway issue may promote more people, but wouldn't it be in-
cumbent upon us to provide that information to them that there is a relative risk.
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     And I say that because I've got a brother that I tried to get to stop smoking. He was smoking. We got
him to stop. He started dipping snuff. Finally, when we couldn't get him to stop altogether, we just kind of
quit. And yes, he went back to smoking.
    But I never told him, I never talked to him about reduced risk. And I just wonder, given the fact that even
second-hand smoke causes some injuries of what we might do if we give the public intellectually honest in-
formation about the relative risk. And I'd just like both of you to comment on that.
    CARMONA: Well, if I might, I'll just comment on the science first. And then I'll pass off to my colleague
on the advertising.
   I certainly respect your opinions as a colleague, as a fellow physician, sir. But the Swedish study, I
know that they looked at an end-point of oral cancer risk and not cardiovascular disease or other causes or
mortality in a more broad sense. So it's only one end point.
   So I think when we -- variables also in outcome as well as the inputs for the research, I think are equally
important. The...
    FLETCHER: May I interrupt you just for...
    CARMONA: Yes, sir.
    FLETCHER: ... to ask you a question? Do you believe there's -- that smoking has the same cardiovas-
cular risks smokeless tobacco in the Swedish -- say in the Swedish smokeless?
     CARMONA: I'd have to review the data more specifically. But I know there's risk. If it's same or less,
sir,then we get into that issue again, is it safer?
    FLETCHER: Yes, relative risk. I mean (inaudible) studies are saying (ph), there is no absolute there.
     CARMONA: Yes. And so, the other issue is when we're talking about the amount of nicotine for in-
stance, and you don't also talk about carcinogenicity, then you just negate the fact that we know that these
are cancer causing compounds. And so if you just address the issue of, "Well, is this a safe way of using
this to withdraw somebody from their nicotine addiction?"
    Well, again, my premise is that if I know that this is a carcinogen, then I really could not in good faith
recommend for any other use when I know no matter what else you're using it for...
     FLETCHER: I agree. We don't recommend it for use, period. But I'm talking about a relative scale, just
getting information out to the public.
    It's kind of like on HPV and cervical cancer. You know that.
    CARMONA: Yes.
    FLETCHER: We talk about the use of condoms doesn't totally prevent HPV and cervical cancer, but it
reduces the risk.
    CARMONA: Well, and...
     FLETCHER: Well, and we -- there's a lot of folks on different sides of the aisle have a different approach
to that.
    CARMONA: I understand and I can understand where you're coming from and where some of the re-
search is looking at this a little different as matter of policy.
    But again, it comes back to the cancer causing effects, or carcinogencity of this from that when you say
on a relative risk. And you say, "OK, smoking,let's say is a 10. And maybe this product is a five, but it still
causes cancer."
      So if you say the relative risk is lower,all right, I can't argue with you if we show that statistically, but it's
still a cancer causing agent, which is why I'm concerned.
    FLETCHER: I agree. Thank you, Mr. Chairman.
    STEARNS: The gentleman's time has expired. The gentlelady, Ms. Cubin.
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      CUBIN: Thank you, Mr. Chairman. And thank you for calling this hearing today.
    I was one of those members that did request it because I believe that knowledge is power. And I want to
point out that we are not here today talking about the ills of smoking. We all know that. We all believe it
and we accept it.
      CUBIN: We're also not talking about marketing tobacco products to children.
     If I had three wishes in my bottle found along the shore and the Genie popped out, I would probably wish
for enough money to take care of myself and my family and meet our needs until we die. I would probably
ask for good health for myself and family. And the third thing would be that I would wish for all children to
make decisions that were beneficial to their bodies as far as health is concerned.
   So you know, I'm a mother, and I actually have a son that chews smokeless tobacco. And I hate it.
When I was a little girl, my grandfather chewed smokeless tobacco. I'm from Wyoming. And probably we
have as many people that use smokeless tobacco as any one.
    But what I'm thinking about, are the 10 million adults that are going to die in the next 10 years that are --
the next two decades I should say, that are going to die from actions related to smoking, conditions related to
smoking.
    I have a degree in chemistry. And whenever we would be arguing an issue in science, the first thing we
would always do is challenge the studies that were sited by our -- I was also in debate -- the studies that
were challenged by the other side. And so Dr. Carmona, you don't accept as valid, because it is not com-
prehensive enough, the study by Britain's Royal Academy of Medicine? Is that correct?
      Was that the reason you have during your questioning and statement...
    CARMONA: Yes. Not that it was invalid, but to make a decision like that, I would need much more in-
formation. And my colleagues also who study this.
      CUBIN: Yes. OK.
     Well, then does it follow that the same level of comprehensiveness must be followed to support the
statement you made that -- let me see, where do I have it here, that smoking is a -- that smokeless tobacco
is a gateway to smoking? Is there a study that you can cite that has more comprehensive bases that the
Royal Academy's?
     And if so, would you please furnish that? I would like a comparison actually of the studies themselves,
and why the study that you are quoting as far as a gateway to smoking is concerned is superior to the basis
of the study by the Royal Academy. Would you provide that to us?
      CARMONA: Yes, ma'am. I didn't...
      CUBIN: Thank you.
      CARMONA: ... mean to imply that it was superior, but would be happy to provide the information to you.
    CUBIN: Sure. You didn't say it was superior, but you base your opinion on something. And I'm just cu-
rious to know what that opinion, how you substantiate that in your own mind. And I'd appreciate it if you
would provide that to us.
    Another point that I wanted to bring up is that science is changing. Mr.Muris brought that up earlier in
the response to a question, that science is changing. And in 1986 Comprehensive Smokeless Tobacco
Health Education Act, Congress ordered that three messages be alternated on snuff cans.
      You notice I call it "snoof" cans because that's what my grandfather called it. That's politically correct to
me.
      Anyway, one of those statements is, "This product is not a safe alternative to cigarettes."
    Well, since your agency did not come up with that language that it is not a safe alternative to cigarettes,
Mr.Muris, I wonder if you have a responsibility to -- I mean, obviously the Congress did that, but trying to de-
cide who has a responsibility to get this information forward or to -- I mean, if your agency's responsibility is
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that correct information be out there, this language was based or was done in 1986. Isn't there information
that would cause you to at least look at that and make a recommendation to the Congress if they're the ones
to do the language, which I don't frankly think the Congress should be doing that. I think it should be done
in your agency.
    MURIS: Well, the history of this issue is that many, many years ago in the mid-1960s my agency tried to
do something and Congress immediately stepped in...
    CUBIN: Yes.
    MURIS: ... and my agency has had the wisdom since them to...
    CUBIN: To stay out...
    MURIS: ... well,we've issued reports and we've done other things, but we haven't tried to buy rule making
do something that Congress has made it pretty clear that it wants to do.
    Look...
    CUBIN: But that's really not my point. My point really is actually wrong, I mean, if we cannot make the
statement that cigarette or non-tobacco products -- well let me see. Where did I write this down? I wish I
could keep track.
    Go ahead and answer what you were going to say.
    MURIS: Well, in the very large context, and I don't want to lose sight of that here in the specifics. This
hearing is very important because potentially and that's obviously the key word, there are very large public
health benefits to be made from addressing the problem of people who can't or won't quit smoking.
     And that's why I said a place to start, where I think we can do more, and again it's potential and the FDA
already regulates this. And that's why I said I would obviously need to talk with them is with the non-tobacco
risk reduction products, the gums and the patches, they right now can only be marketed for very limited pur-
pose.
    So consumers can't be told about their potential for that group of smokers who are unwilling to go off of
nicotine entirely.
     CUBIN: So what I've drawn from this hearing today so far is that if more people were using snuff instead
of smoking cigarettes, that our national health care bill would be lower, that there wouldn't be people suffer-
ing from the use of -- or suffering from second-hand smoke from other smokers,that 10 to 1,000 percent im-
provement would be seen in our national health picture.
    And I just think that rather than our -- it seems to me, General -- I mean, Admiral, excuse me...
    (LAUGHTER)
    ... excuse me.
    CARMONA: No problem.
    (LAUGHTER)
    CUBIN: But it's something that we should consider. I don't think anyone is saying that the use of snuff is
a healthy thing to do. But I certainly don't think we can say that it is not a healthier thing to do than smoke
cigarettes.
    So my time is up, and if you'd like to respond to that, that would be great.
     CARMONA: I think my remarks, ma'am, have been directed to the science that we have at hand today,
that there is no evidence at this point to use that as a substitute.
    What we do know about the product is that it can cause cancer and other diseases.
     CARMONA: I also stated earlier, though, if there is research to the contrary, if there is research that can
define some role, my colleagues and I are always happy to look at that to see if there is a possibility. But as
of this date, we have seen none.
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    STEARNS: The gentlelady's time has expired.
    The gentleman from Idaho, Mr. Otter.
     OTTER: Thank you, Mr. Chairman, and I, along with the rest of the panel, want to thank you very much
for calling this most important hearing.
     I've always been adverse to putting the fist of government into the glove of courtesy. I know many times
when I was in my state legislature, we passed "no smoking" in public places even though it was a private --
was not a government building or it was not a government-called meeting. And I always voted against those
kind of bills because I felt that I had a personal responsibility, if I didn't want to be in part of that environment,
that I should go to the restaurant owner and say, "I'm not going to eat anymore as long as you don't have a
no-smoking section, or as long as I can't avoid second- hand smoke."
    But I want to make an admission like my colleague from California, Mr. Issa, that I too am a recovering
smoker. I quit for my son's first birthday 34 years ago. And it's probably one of the smarter things that I've
ever done.
    But I did it because I recognized that it is personal responsibility. And it's unfortunate that so many of
the things we do in Congress -- and I've only been here a little over two years and three months -- but so
many of the things that we do here in Congress is we try to substitute the national consciousness and the
national treasury for personal choice. And, of course, I have to look right back on the immediate past of the
tobacco lawsuits that we had.
     And even when I did smoke 35 years ago, I never bought a pack of cigarettes that probably didn't have
that warning on it. And I say probably because I doubt if I read it more than once or twice -- only as a no-
velty, I guess, when it first appeared.
    But I made that choice. I made that choice to smoke. And I watched as the generation just before us,
as many of the folks in my generation watched, as that generation just before us that had smoked 10 years
more than we had started suffering the consequences of that behavioral choice.
    But I think we've sent a far more dangerous message to our youth about smoking or not smoking, or
choosing to use tobacco in any form or not to use it, when we've substituted the national treasury and the
national consciousness through Congress action, through the Judiciary Department's action of bringing a
lawsuit against the tobacco company.
    They were warned, "Don't smoke." Then we go back, and we sue them anyway and say we're going to
hold you responsible. That's past history. I disagree with that.
    I suspect when I was in the military and I was -- you could have called me General (inaudible) -- I was in
the armored cavalry, and it wasn't unusual for us during training or during OJT to stop the column and break
and say, "Smoke them if you've got them." And sometimes they were supplied in our food packets. Yes,
those too. Anyway, I suspect that got a lot of people to smoke.
    But anyway, what I would like to ask, I guess, both of you, it hasn't been unusual for the government, as
Congressman Cubin made the point earlier, that knowledge is power. And one of the responsibilities this
republic, this government, does have to its citizens is to make them as knowledgeable as possible, and then
stay out of their way and allow them to use that knowledge for choices.
      And it seems to me that if there is evidence -- and whether or not you disagree with these early-on re-
ports -- it hasn't been unusual, Mr. Muris, for the FTC to allow cigarette makers to say, "This new filter that
we've got on here allows for less tars and less nicotine." This new cigarette -- a little less of this and a little
less of that. And thereby enhancing the possibility that it is probably not as dangerous as the one without a
filter. Or as the one referred to earlier -- and I don't want to pick on any particular company -- but the Camel
cigarette.
    And I know that when I first started smoking, if you could smoke a Camel, you were tough. You know,
you probably got off a little easier with something with a filter on it.
    But my point is, is that why isn't it your responsibility to make people more knowledgeable and then,
therefore, more free to make the right decision, by adding up and subtracting the causes and the amount of
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danger there is in different products? We do it all the time -- less salt, less sugar, less fat. We hear it all
the time.
    Why isn't that our responsibility irrespective of your feeling and the admiral's feeling about all of them
being bad?
    And with that, I'll let you...
    STEARNS: The gentleman's time has expired.
    Would you like to answer the question, the chairman?
    MURIS: Sure, if you want.
    STEARNS: Sure, go ahead.
    MURIS: I do believe in the importance of knowledge. And as I mentioned just a few minutes ago, in the
potential for public health benefits from risk-reduction products, there are obviously important attributes here.
This is a product that, used as intended, causes you great damage. And I think everybody recognizes that.
    And our experience with the tar reduction has not been a particularly happy one because of the pheno-
menon called compensation by which smoke the cigarettes harder and, therefore, get more damage than if
they smoke them on some relative level.
    So, that just shows us that we need caution.
    CARMONA: I would just briefly comment that I agree with you premise, sir, as far as the right of people
to choose. And in the perfect world, we would hope that, armed with the appropriate information, that
people would make the right decisions.
    But often their individual decisions have impact on a population at large. And sometimes, I think, where
markets fail or where common sense fails, regulation sometimes is essential. We do it with speed laws be-
cause we know people drive too fast. And we've been able to demonstrate that by slowing them down,
there are less accidents.
    CARMONA: We know that seat belts save lives. And in many states, people felt it was their right not to
wear one. Yet the impact to the population and the cost of health care on the whole was significant. So we
had regulation for that and helmets and a number of other things.
     And I think, again, in the perfect world, I would agree with you that it would be nice that people would
make prudent decisions based on the information before them, which is part of my job to bring that scientific
information forward.
   However, they don't always make the right decisions, and their poor decisions can adversely impact the
population as a whole.
    STEARNS: The gentleman's time has expired.
    The gentleman from Ohio, Mr. Brown, is recognized for five minutes.
    BROWN: Thank you, Mr. Chairman.
    I first would like to recognize Dr. Carmona, whom I shared a podium with at the American Public Health
Association meeting in Philadelphia and was very impressed with his words then and all that he shared with
us.
    Mr. Chairman, I'd like to yield my time to Mr. Waxman, who has alerted Americans to the dangers of all
forms of tobacco more than anyone in this body.
    So, Mr. Waxman, if I could?
    WAXMAN: Thank you very much, Mr. Brown.
    Thirty years ago, the FTC was fooled by the tobacco companies into allowing them to advertise low-tar
and light cigarettes. And as a result, millions of Americans switched to those products because they thought
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it would protect their health. As a result of that, millions of Americans died because these were not safer
products. In fact, they weren't even what they claimed to be.
   Now, I think what we have before the FTC is another attempt by an industry to commit a fraud on the
American people. And that's to try to present smokeless tobacco as a safer alternative.
   Now, the first question is, is it a safer alternative? And, Dr. Carmona, you have been so clear in every
question that's been raised on that point. You don't believe it's a safer alternative. Is that a fair statement?
    CARMONA: Yes, sir.
   WAXMAN: Now, let's say for argument purposes it was safer, slightly, harmful but safer. It's only safer if
people will use it instead of smoking, not if they use it in addition to smoking.
    Is there any evidence that anybody can show that people will give up cigarette smoking because they've
got a safer alternative? I submit there is no evidence at all, none.
     Now, another theory. If you advertise this product as a safer alternative to cigarettes, kids might start
using this product. In fact, I think this is what this is all about. Kids are not using the smokeless tobacco as
much because they've caught on to the fact that it does them a great deal of harm. When this says cancer
of the jaw, kids start picturing what cancer of the jaw means, and more and more of them are giving up
smokeless tobacco. But if they're told there is a safe alternative, they might say, "Well, I'll try this safer al-
ternative."
     But we do have evidence, don't we, Dr. Carmona, that people who use smokeless tobacco are starting to
get the nicotine habit, and then they can move on to cigarettes? Isn't that an accurate statement?
    CARMONA: Yes, sir, there is scientific evidence to support that.
    WAXMAN: So the question that Mr. Muris said is, is there a potential health benefit? Well, it's hard for me
to see that there is a potential public health benefit.
   So if the FTC allows this advertising, we'll have to see 20 years down the road what harm we've done
because the FTC operates to allow advertising, unlike the FDA, which would screen any kind of claim in ad-
vance.
     Now, I really am struck by the fact that it's been a long time since the Congress has held any hearings
about tobacco. Today two committees are holding hearings on tobacco. We are not looking at the Institute
of Medicine recommendations which said that they had a strategy -- this was an HHS advisory committee --
that they thought could lead to a cessation of smoking and lead to 3 million lives being saved, 5 million
people could quit within one year.
    Instead, what the two committees of Congress are looking at is what the industries want. Today we are
looking at what U.S. tobacco would like. This afternoon we will look at what U.S. tobacco and Philip Morris
would like. That's what the Congress has come to. We respond to the industry pressure to bring this issue
up.
   Mr. Muris, this is a hearing for you. This is a hearing to impress you that a lot of members of Congress
would like you to be receptive to U.S. tobacco's attempt to rejuvenate their market.
     Well, I would hope that we rely on science. And the science isn't there. The science isn't there. The
politics may be, because tobacco is rich and powerful. But the science is not there, and I would hope that
you look at the science very, very carefully.
    And I'm awfully nervous when a bunch of lawyers are making the decision on science when it ought to be
up to something like the FDA or the surgeon general or others who have -- or the Institute of Medicine to
make the decision. I know you'll consult with them.
    I don't know if you're aware, either of you, that Philip Morris once surveyed 85 former users of smokeless
tobacco and found that 53 were now smoking. And I'd like to introduce for the record Philip Morris' report on
how people who were using smokeless tobacco didn't wean themselves off from cigarette smoking, that they
are either back to smoking or have moved on to smoking.
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    And I would hope that we can get that in the...
    STEARNS: By unanimous consent, so ordered.
    WAXMAN: ... in the record.
     Mr. Chairman, I appreciate the opportunity you've afforded me to participate in this hearing. And I just
hope that people don't get fooled a second time, the way the FTC was fooled 30 years ago. And then we
look back 20 years from now and think about all the people that got cancer of the jaw and moved on to ciga-
rettes and used cigarettes and smokeless tobacco. And rather than the potential public health benefit, we
ended up with a potential public health disaster.
    STEARNS: The gentleman from Ohio's time is expired.
    Mr. Shimkus is recognized.
    SHIMKUS: Thank you, Mr. Chairman.
    And I am going to be brief. We've already been here a long time, and I think we're going in cyclical de-
bate on this issue.
     I will just stay that we have a debate over different reports. And basically is an agreement that there is a
risk to smokeless tobacco. But the real question is, is there -- isn't there a lower risk than smoking, and
whether that's second-hand smoke or whether that's all these other things.
     Have we considered -- and I would think I would go to Dr. Carmona first -- have we, as a country, consi-
dered commissioning our own study that would address many of the questions that were broached today, to
ensure that we have factual scientific evidence? And if we have not so far, would we consider doing so? And
if not, why?
    CARMONA: Well, sir, there are many studies that have been done in the literature, I mean, literally hun-
dreds of studies on a broad range of issues regarding smoking cessation and so on and including smokeless
products. And there are ongoing studies, both at CDC, that are ongoing as we speak, and programs that
are funded throughout the United States at universities and other areas that NIH funds that are addressing
many of these questions.
    Now, if there are specific questions that are not being answered or you felt that needed to be addressed,
certainly we'd be willing to entertain that, and I'd pass it on to my colleagues who are doing the research.
    But there is a broad range of research that has taken place and continues to take place on these sub-
jects.
     SHIMKUS: So I guess the question for me -- so based upon the current research that you have available
to review -- and obviously you don't have the information from the ongoing research -- nothing that has been
said with respect to the IOM report, that still hasn't provided enough information to make a determination
whether there is any significant benefit for someone going from tobacco used in cigarettes versus smoke-
less.
    CARMONA: I think the IOM report was fairly clear, and said that there was no evidence and there are no
products on the market today to advocate for that type of substitution. So the IOM report is fairly clear, I
think, in its conclusion.
    SHIMKUS: That's all I have, Mr. Chairman.
    STEARNS: Thank the gentleman.
    I want to thank both of you for your patience, and we appreciate your testimony.
   SHIMKUS (?): Mr. Chairman, may I just ask unanimous consent to -- I would like to submit one other
question to Admiral Carmona relating to the Center for Disease Control's...
    STEARNS: Unanimous request is granted.
    SHIMKUS (?): Thank you.
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    STEARNS: One minute? Submit it for the record by the unanimous consent order.
     I would say in just conclusion that Mr. Waxman talked about a study that suggests tobacco -- that
smokeless tobacco is a gateway to cigarettes. But I think it's also -- he should have been fair and pointed
out there's also a study that refutes that gateway theory, stating that the gateway study that was made was
flawed.
    So Mr. Waxman, of course, will be in the second hearing this afternoon on the same subject.
    So we welcome now the second panel. The second panel consists of Dr. Robert Wallace, MD, Institute
of Medicine, vice-chair, Committee to Assess the Science Base for Tobacco Harm Reduction; Dr. Scott L.
Tomar, editor, Journal of Public Health Dentistry, University of Florida, College of Dentistry, Division of Public
Health Services and Research; Dr. Brad Rodu, professor, Department of Pathology, University of Alabama at
Birmingham; Mr. Steven Burton, vice president of Smoking Controls Strategic Development and Switch,
GlaxoSmithKline Consumer Healthcare; Mr. Richard H. Verheij, executive vice president, U.S. Smokeless
Tobacco Company; Mr. Matthew L. Myers, president and CEO, National Center for Tobacco-Free Kids; and
Mr. David T. Sweanor, counsel, Non-Smokers' Rights Association.
    I urge the members to stay for the second panel, because if we're talking about the science, then we
have people who can actually speak to that science. And so it would be very helpful for members, if they
can, to come back to continue our discussion.
     We have an order in my witness list that I'll use, if you don't mind. And so I'm going to ask Dr. Wallace
to start off with his opening statement.
    Five minutes, and if you want to take less and make your opening statement part of the record, obviously
that would be appreciated.
    WALLACE: Sure.
    STEARNS: We have a large panel here.
    So we'll start off with you, Dr. Wallace. And welcome. Thank you.
    WALLACE: Thank you, Congressman.
    I was the vice-chair of the committee that put the "Clearing the Smoke" report together. And just for the
record, I'm a professor of epidemiology and internal medicine at the University of Iowa.
    I'm going to paraphrase my remarks, and I would like them to be entered into the record along with the
report itself.
    STEARNS: Your opening statement will be part of the record by unanimous consent. So ordered.
    WALLACE: Thank you.
    Let me first say in part because I responded to the earlier testimony this morning that we dealt with the
range of harm-reduction products in tobacco and not particularly related to smokeless tobacco. In fact, we
did consider smokeless, but we also considered other tobacco devices and delivery systems, and we also
considered nicotine replacement therapy as well.
    We basically had four conclusions from the -- in our report. And one is that we think that for many dis-
eases attributable to tobacco use, reducing the risk by reducing exposure to tobacco toxicants is in fact
feasible.
     However, while we think that manufacturers of these products should have an incentive to make claims,
this incentive could only be done in the context of a comprehensive national tobacco control program that
emphasized abstinence-oriented prevention and treatment, and only if the harm reduction assessment has
been thoroughly scientifically vetted.
    We also concluded that these potential reduced-exposure products have not yet been evaluated, as oth-
ers have said. And certainly not comprehensively enough to provide a scientific basis for concluding that
they are associated with reduced risk compared with conventional tobacco use.
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    We concluded that regulation of all tobacco products is necessary in order to assure a scientific basis for
judging the effects of particular products versus others.
    We concluded also that, from a public health perspective, and it's been said several times this morning,
that it's very important to understand the public health impact of introducing new products and making claims
about products. And therefore, the health and behavioral effects of all of these products must be monitored
on a continuing basis.
   We suggested a regulatory framework. It's long and detailed. And I would just highlight just four of the
many of the many principles.
     WALLACE: They included disclosure of product ingredients, toxicity testing, pre-market approval of
claims and issues related to labeling, advertising and promotion, and also post-marketing surveillance so
that, in fact, we can find out what happens to Americans when these products are released, both in terms of
their behaviors with respect to these products and in terms of their health.
      Finally, then, I just have three public health messages that are culled from the report. One is that the
committee strongly felt that the best strategy, of course, is to never use tobacco at all. And if you are using
it, to quit. And I think that needs emphasis.
     Secondly, with appropriate and comprehensive research, surveillance, education and regulation, that we
do feel that these products could possibly -- emphasize possibly -- reduce the risk, some of the risk of to-
bacco-related disease. But the net health impact, again, is unknown. And although the products may be
risk-reducing for an individual, they may, in fact, increase the risk to populations.
     And then finally, our third public health message is that we pled for a comprehensive and verifiable sur-
veillance system being the crucial link to understand the relationship between the availability of these prod-
ucts and reduced risks both to individuals and reduced harm to the public health in general.
    So I very much appreciate your willingness to hear me out, and I'd be happy to answer questions.
    STEARNS: And thank Dr. Wallace.
    Dr. Tomar?
    TOMAR: Good morning. My name is Scott Tomar. And for the record, I'm an associate professor with
the University of Florida College of Dentistry.
    I think you for the opportunity to testify on the issue of marketing smokeless tobacco as a potential
harm-reduction strategy for cigarette smoking. I think this is an important public health area, but it
represents a tobacco industry marketing strategy that is both highly flawed and potentially dangerous for
several reasons. And I'll outline these.
     First, smokeless tobacco causes cancer and is addictive. It is a mistake to promote it as a safer alterna-
tive to smoking while safe sources of nicotine are available, such as gum and patch.
    In the mid-1980s, the U.S. surgeon general and the International Agency for Research on Cancer con-
cluded that snuff use causes oral cancer, gum disease and nicotine addiction. Based on available evi-
dence, UST's products are still carcinogenic. More recent research suggests that snuff use may increase
the risk of cardiovascular disease, including heart attack.
    Smokers should be encouraged to use proven safe sources of nicotine to quit smoking and not snuff.
    Second, U.S. Smokeless Tobacco Company has a long history of marketing oral snuff to young males
with no history of tobacco use, including promotion of low-nicotine starter products. Allowing them to make
safety claims may increase nicotine addiction among youth.
    Heavy promotion of oral snuff led to huge increases in use among males from the early 1970s until the
mid-1990s. Between 1970 and 1991, the prevalence of snuff use among men 18- to 24-years-old increased
more than eightfold.
   This increase was no accident but was the result of a sophisticated marketing campaign that developed,
advertised and promoted use of oral snuff products with low levels of free nicotine as part of a graduation
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strategy that intended new users to move up to brands higher in nicotine, as tolerance developed. The
high-nicotine brands are highly addictive and high in cancer-causing nitrosamines.
    Public health groups work aggressively to educate young people on the dangers of oral snuff. In 2001,
14.8 percent of male high school students reported current use of smokeless tobacco, which is down from
20.4 percent in 1993. That decline was accompanied by an increase in the proportion of high school stu-
dents who perceived that regular use of smokeless tobacco carries great risk of harm. Allowing UST to make
claims that these products are relatively safe could reverse this trend and result in an increase in use by
youth.
   Third, UST has failed to protect consumers by failing to inform, by not lowering known cancer-causing
agents in its products or informing consumers about their toxic and addictive properties.
     Oral snuff contains dangerously high levels of cancer-causing agents called tobacco specific in nitrosa-
mines, or TSNAs. UST does not acknowledge or inform their consumers that conventional oral snuff causes
cancer or is addictive. In addition, UST refuses to report brand-specific product content, nicotine dosing or
the levels of TSNAs.
     A recent study conducted by the American Health Foundation found that snuff brands manufactured by
UST had TSNA levels that were 15 to 23 times higher than those found in a popular Swedish brand. And
that TSNA levels in UST's products, such as Copenhagen, increased as much as 137 percent after the
products were stored at room temperature for six months. In contrast, no significant changes were ob-
served in the TSNA levels of brands made by Swedish Match.
     That study demonstrates that it is technologically feasible to produce oral snuff products that are signifi-
cantly lower in TSNAs than those that are currently on the market. UST has the manufacturing technology
to reduce the level of nitrosamines in all of its brands. They have not done so.
     UST has refused to voluntarily reveal the amount of free nicotine in its product. When I was an epide-
miologist with the Office on Smoking Health, we asked the company to provide this information to the Amer-
ican people. They flatly refused and denied that they are able to manipulate the nicotine-dosing properties
of its snuff products. UST's contention is strongly contradicted by peer-reviewed science and by sworn de-
positions of its own chemists.
    When Massachusetts passed a law requiring gram-specific disclosure of additives that affect toxicity and
addiction, UST and the other tobacco companies sued the state.
   Fourth, promotion of oral snuff as a safer alternative to smoking may have unintended public health
consequences.
     I recently published two studies on this topic. The first looked at a smoking initiation among U.S. males
aged 12 to 17 and found that young males who were not smokers at baseline but used smokeless tobacco
were three times more likely than young males who never used smokeless tobacco to be smokers four years
later. In contrast only 2.4 percent of current smokers and 1.5 percent of never-smokers became smokeless
tobacco users by the four-year follow-up.
     The second study looked at adult male tobacco users and found that U.S. men were 2.5 times more
likely to be former snuff users who now smoked than to be former smokers who currently used snuff. One in
five males who were daily snuff users also smoked, as were 40 percent of occasional snuff users.
    These studies suggest that smokeless tobacco may be a gateway for adolescent smoking, males in the
United States are far more likely to switch from snuff to cigarette smoking than vice versa, and many men
who use snuff are still smoking.
     TOMAR: UST's current advertising for Revel, the brand who's marketed as a complement to smoking,
not as a complete substitute or as a way to quit smoking. The product is marketed for use in settings where
smoking is barred, and therefore undermines the impact of clean indoor air laws on smokers' decisions to
quit. UST uses similar marketing messages with Scope (ph) products. These products can actually delay
or prevent smoking cessation.
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    Hence (ph), there is no evidence that the oral snuff use is effective in helping smokers to quit either in
the United States or in Sweden. Not a single randomized control trial has been reported that shows that
there is...
     STEARNS: Dr. Tomar, your time has expired. You're over by a minute. You're welcome, if you can, to
finish up.
    TOMAR: All right.
    I'll save the rest for questions.
     Just concluding, that smokeless tobacco causes cancer. This promotion might actually increase ciga-
rette use. And many states in the United States have actually been able to reduce both smoking and
smokeless tobacco use without promoting one as a substitute for the other.
    STEARNS: OK. And I thank you very much, especially coming from the University of Florida, which I
represent. So I certainly welcome you. Appreciate your participating.
    Dr. Rodu?
    RODU: Mr. Chairman and members of the committee, I'm honored to appear here today.
     Despite limited success, the 40-year-old American anti-smoking campaign is an astounding failure in one
crucial respect: It has helped too few adult smokers to quit. National statistics reveal the magnitude of this
failure: 440,000 deaths a year.
    The campaigns fails inveterate smokers in two ways. First, they are counseled merely to change their
behavior. For example, a government smoking cessation manual tells doctors to recommend ineffective
coping tips such as, quote, "Keep your hands busy. Doodle, knit, type a letter," end quote. Quote, "Keep a
day dream ready to do," end quote.
    Second, smokers are told that they must achieve nicotine abstinence in order to quit. They are advised
to used nicotine medications temporarily. These medicines are expensive and unsatisfying. As a result,
they rarely work.
    A recent review reported a 7 percent success rate for over-the- counter nicotine medications. The au-
thors called this result, quote, "modest," end quote and even, quote, "efficacious," end quote. We call pro-
grams with 7 percent success rates abject failures.
    Over the past decade, we have developed an alternative quit- smoking strategy for inveterate smokers
based on permanent nicotine maintenance. Nicotine is addictive, but can be consumed as safely as caffe-
ine. It is tobacco smoke that kills. Eliminate the smoke, and you eliminate virtually all the risks.
    We recommend that smokers permanently switch to other products containing nicotine, including
smokeless tobacco. Ours is a harm- reduction strategy because we are focused on reducing disease and
deaths instead of tobacco and nicotine abstinence.
   We recommend smokeless tobacco because it has three attributes for long-term maintenance. First,
smokeless delivers nicotine nearly as rapidly and as efficiently as smoking. Yes, it is just as addictive as
smoking, which is why it is an effective substitute.
     Second, smokeless is 98 percent safer than smoking. Our research documents that the average smok-
er loses eight years of life. The average smokeless user loses only 15 days.
    The only consequential risk from long-term smokeless tobacco use is mouth cancer. Even this risk is
very low, proven by more than 20 epidemiologic studies over the past 50 years. In fact, the risk of death
from long-term smokeless use is about the same as that from automobile use.
     Third, smokeless actually works for smokers. In 1998, we published the first clinical trial testing smoke-
less as a cigarette substitute. Most of our subjects had failed repeatedly to quit using gum and patches.
Twenty-five percent of them quit with smokeless. We have seven years of follow-up now and the substitu-
tion is sustainable.
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    Population studies from Sweden prove that smokeless is an effective substitute. For 50 years, Swedish
have had the lowest smoking rate and the highest smokeless usage rates in Europe. The result, rates of
lung cancer, the sentinel disease of smoking, among Swedish men are the lowest of 20 European countries.
Not so for Swedish women, whose lung cancer rate ranks fifth highest in Europe.
    I understand tobacco use patterns in Sweden. I lived there for six months last year conducting research
on this subject. I published two studies with Swedish colleagues that clearly demonstrate that smokeless
was primarily responsible for a decline in smoking among men from 19 percent in 1986 to 11 percent in
1999.
    Throughout this entire period, men smoked less frequently than women, a pattern different from that of
every other society in the world where men invariably have higher smoking rates.
     Our strategy evoked criticisms that are inaccurate, irrelevant or both. The usual complaints involve pro-
tecting children. We emphasize that our strategy is tailored to adult smokers. This is not a children's issue.
Eliminating children's access to tobacco is important, but the 10 million Americans who will die from smoking
over the next two decades are now adults. Withholding life-saving information from these adults in the name
of protecting children is short-sighted, even immoral.
    For 10 years, we have been portrayed as lone advocates of our harm reduction strategy. But now good
company has joined us. Last year Britain's Royal College of Physicians reported that products like smoke-
less are safer than cigarettes. Their report stated, quote, "As a way of using nicotine, the consumption of
non-combustible tobacco is on the order of 10 to 1,000 times less hazardous than smoking depending on the
product."
    The report suggested that some smokeless manufacturers may want to market their products, quote, "as
a harm reduction option for nicotine users, and they may find support for that in the public health community,"
end quote.
     A growing number of public health experts now agree with our harm-reduction strategy because the an-
tiquated quit-or-die approach is increasingly recognized as insufficient. For 48 million American adults, cig-
arette smoke is the problem. To answer the question posed by this hearing, smokeless tobacco can be part
of the solution.
    STEARNS: Thank you, Dr. Rodu.
    At this time, Mr. Burton, would you give your statement, please?
    BURTON: Thank you, Mr. Chairman. My name is Steve Burton, and I'm responsible for the
over-the-counter stop smoking aids. They're marketed by GlaxoSmithKline Consumer Healthcare. I've
been involved in this field since 1996. And currently our products include the Nico-Derm nicotine patch, Ni-
corette gum and more recently, the Commit lozenge.
     GSK's chief concern is that unproven health claims for tobacco products threaten efforts to help smokers
quit. The distinction between so-called reduced-risk products and FDA-approved medicines could not be
clearer to us. The reduced-risk products are designed to perpetuate tobacco use, and our products are de-
signed to end tobacco use.
    The emergence of novel tobacco products must not obscure the fact that there is only one proven way
today to reduce the harm of tobacco use, and that is to quit completely.
    I've heard the term today about the committed smoker, and I have to tell you that in my experience with
consumers and the research that we have done, we don't find very many committed smokers. Over 70
percent of smokers want to quit at any one point in time, and nearly all smokers have tried to quit.
    BURTON: And over the past decade, we have made substantial progress in reducing the prevalence of
smoking. Prevention efforts have stopped millions of our young people from starting to use tobacco, and
courageous and motivated smokers who make multiple quit attempts on their way to becoming tobacco-free
are also heros in the fight against tobacco use.
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    Our plea today is to reject the policy that would discourage smokers from quitting. We do not accept the
proposition that smokers don't want to quit and that more cannot be done to increase the acceptance and
effectiveness of the quitting option.
    As we have already heard today -- and I'm not going to repeat comments from other members of the
panel -- there has been no reduction in the death and disease burden from tobacco from the use of light cig-
arettes. And the same may be true of the so-called reduced- risk products that are before this panel today.
    As we learn with life, the way in which consumers actually use a tobacco product in the real world largely
determines its risks, as much or more as the product's inherent toxicity.
     For example, it's very plausible that smokeless would be used in addition to existing cigarette consump-
tion rates. That would delay quitting, leading not to a decline but an increase in risk. In fact, dual use of
cigarettes and smokeless tobacco products has apparently been one of the marketing objectives of the
smokeless tobacco industry.
    Our own market research of Eclipse, one of these so-called reduced-risk products, brings this point
home. In a consumer survey, GSK found that almost a quarter, 24 percent, of smokers considered Eclipse
to be completely safe, with three-quarters expecting that Eclipse would reduce health risks by at least 50
percent.
    After hearing about Eclipse, there was a net decrease of 19 percent who were contemplating quitting
within six months, and 15 percent of young adults who had recently quit smoking were interested in buying
Eclipse.
    That's what the emergence of so-called reduced-risk tobacco products -- ex-smokers may start smoking
again. And, likewise, those who never smoked, particularly adolescents, may take up smoking for the first
time. And millions of smokers who otherwise might have quit completely could delay or miss opportunities
to become tobacco-free.
     In light of these threats, we need a regulatory body that evaluates the public health impact of so-called
reduced-risk products before they enter the market. That agency must have the in-house scientific exper-
tise to determine the appropriate design and evaluation of studies to be done before approval. That regula-
tory body is the Food and Drug Administration.
     It should decide whether there's an adequate scientific basis to support the so-called reduced-risk claims
that tobacco manufacturers seek to make.
     As to the treatment of tobacco dependence, we have certainly not exhausted our opportunities collec-
tively to innovate in this area. The experts agree that the appeal and effectiveness of currently marketed
treatments could be enhanced dramatically.
     FDA should encourage sponsors to develop new indications and uses for current products and work
flexibly with sponsors to accelerate developments of new and innovative treatments. Promising drugs should,
for example, be fast-tracked under FDA's existing authority, and there are new treatments on the way.
    On the tobacco side, GSK welcomes tobacco-based products proven to meaningfully reduce the risks of
smoking. Of course, health claims, either express or implied, must be approved by FDA before it being ex-
posed to the most vulnerable within our society -- those who have recently quit, are highly motivated to quit,
or are tempted to begin smoking.
   At GSK, we stand ready to assist the subcommittee today in any way that we can. We thank you for the
opportunity to appear before you today, and I'd certainly be happy to answer any questions that you may
have for me later.
    STEARNS: Thank you, Mr. Burton.
    And at this time, Mr. Verheij, if you would give your opening statement.
     VERHEIJ: Good afternoon, Mr. Chairman and members of the committee. I am Richard Verheij, Execu-
tive Vice President, External Affairs, for U.S. Smokeless Tobacco Company.
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    I would like to thank this committee for convening this hearing to examine the issue of tobacco harm re-
duction. We see this hearing as a significant step in the country's ongoing efforts to address the issues
raised by the continued use of tobacco products by millions of Americans.
     Indeed, 50 million Americans smoke. The Institute of Medicine has predicted that a significant propor-
tion of those individuals will continue to do so, despite a multitude of approaches with the ultimate objective
of total tobacco cessation.
    This prediction has prompted the public health community to consider new, complimentary strategies, in-
cluding tobacco harm reduction.
    As we proceed today, it is helpful to keep a couple of things in mind.
     First, this debate is not about whether smokeless tobacco is considered to be safe. Rather, it is about
the increasing consensus in the public health community that smokeless tobacco is significantly less harmful.
      Second, this debate is not about whether smoking cessation is the best public health strategy. Rather, it
is about whether there are complimentary strategies which public health advocates believe will save millions
of lives.
    We are here today because of the millions of adult smokers who do not quit and do not use medicinal
nicotine products. Many in the public health community believe that a harm-reduction strategy, based on
communicating to adult smokers truthful information about other options, can have a significant impact on
both those individual adult smokers and public health generally.
    Simply stated, many researchers have expressed the opinion that use of smokeless tobacco is signifi-
cantly less harmful than cigarette smoking. Based on that judgement, these same researchers advocate
that adult smokers who do not quit and do not use medicinal nicotine products switch completely to smoke-
less tobacco.
   There is increasing consensus on this crucial issue among members of the public health community,
some of whom are testifying before this committee today. However, despite this increasing consensus, it is
documented that the vast majority of adult smokers are unaware of this information.
   One researcher has stated that, quote, "Until smokers are given enough information to allow them to
choose products because of lower health risks, then the status quo will remain."
    Our company, along with those public health advocates, believe that it is crucial that this information be
made available to adult smokers. Such communication will help adult smokers make more informed choic-
es.
     We look forward to discussing the real question: how best to communicate this important information.
We know there are a variety of opinions on this topic. We welcome a serious and open dialogue that brings
to the table all relevant parties to express their viewpoints and concerns.
    That is why we urge the Federal Trade Commission to initiate a forum that would bring together all these
parties to examine the most appropriate means for communicating this important information to adult
smokers.
    Let me state clearly for the record that U.S. Smokeless Tobacco Company is committed to restricting
tobacco use to adults only.
    VERHEIJ: This commitment is not just rhetoric. It is backed by concrete action.
     In 1997, we were the only smokeless tobacco company to support the proposed tobacco resolution.
When that proposal failed, we became the only smokeless tobacco company to enter into the smokeless to-
bacco master settlement agreement with attorneys general of 45 states in various territories. We are pro-
viding more than $100 million to the American Legacy Foundation for programs to reduce youth usage of
tobacco.
    Our company is committed to proceeding in a responsible and deliberate manner that reflects the current
state of the science and addresses the concerns of the public health community. This debate presents a
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broad societal question: "How should we collectively communicate information to adult smokers that many in
the public health community believe will prolong and save lives?"
     This is truly an unprecedented opportunity. Public health advocates, researchers, tobacco control ac-
tivists and tobacco product manufacturers all agree on the fundamental principle that a harm- reduction
strategy could represent an important component of a comprehensive public health policy on tobacco.
    There may be disagreement on how best to implement the strategy. Nevertheless, given the stakes, this
issue deserves serious consideration. We believe this hearing represents a significant step in that process.
     Thank you for holding this very timely hearing. May I ask that U.S. Smokeless Tobacco Company's
written statement, which was submitted to the committee on May 30th, be incorporated in its entirety into the
hearing record after my statement.
    STEARNS: By unanimous consent, so ordered.
    VERHEIJ: Thank you.
    STEARNS: Mr. Myers?
    MYERS: Thank you. My name is Matthew Myers. I'm the president of the Campaign for Tobacco-Free
Kids, and I'm here representing my organization.
    Today this committee has been given a false choice. It's not about whether more should be done to re-
duce the harms of tobacco, but how. This committee and its members do not face the Hobbesian choice,
do nothing or choose to use smokeless tobacco. The choice isn't quit or die.
    Every one of the major public health organizations in this nation have an agenda to how we can reduce
the death toll of tobacco. And this committee, if it is serious about reducing the death tolls of tobacco, has a
prominent role to play.
    Let me start out by saying there are constructive things that we can and should to together. Despite the
rhetoric, this nation has never funded a sustained national preventive public education campaign aimed at
tobacco, either at children or to help people quit. If we want to reduce the number of people who smoke,
states like Massachusetts, California and Mississippi have shown we can do a great deal that we're not
doing.
    Two, the Department of Health and Human Services Interagency Council on Smoking and Health has
come up with a comprehensive report on smoking cessation. If we want to help those smokers quit, the
answer isn't to throw up our hands, as Mr. Rodu suggested. We have learned in states that have adopted
aggressive programs with quit lines and access to smoking cessation programs that we can dramatically re-
duce the number of people who smoke. We all say that there are people out there who can't quit, and there
are. But there are many people out there who can quit who we have not helped.
     Three, there are proven smoking-cessation products out there that have been shown to be safe and ef-
fective. We are doing far too little to encourage their broader use for harm reduction, to encourage their
development in a manner that will make a major difference.
     And fourth, our organization and every one of the major organizations in this nation, have come before
this committee before, and have urged this committee to grant the Food and Drug Administration compre-
hensive regulatory authority over all tobacco products.
    If we want to do harm reduction based on science, not rhetoric, if we want to make the truism that know-
ledge is power, then we will ensure that there's a government agency that has regulatory authority over the
product, so that we will know and consumers will know what is in that product. So that we will know and
consumers will know truthfully not just what the manufacturers want us to know, but the truth, the full truth
about the relative harmful effects of those products.
     We will be in a position where we will be able to control the advertising so we won't have to have a rhe-
torical debate in the abstract about whether marketing of relative health claims will make a difference in
terms of the number of people who start or stop. We will have the authority of the agency to accomplish the
goal we set out in this case.
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    So that if this committee is truly serious about reducing the harms caused by tobacco, let me suggest
there are three things we can do right off the bat.
   Let me also ask that we have this debate today about the use of smokeless tobacco in the real world.
And the real world is this.
   As Dr. Carmona has said, smokeless tobacco as used in the United States, has been conclusively
shown to be a cancer-causing agent. Smokeless tobacco as used in the United States is different than
smokeless tobacco as a product used in Sweden.
     It has far higher levels of nitrosamine. And in my testimony I have provided you specific studies that
have been done to demonstrate that smokeless tobacco in the United States has infinitely higher levels of
nitrosamine. The two most popular products both made by UST fall into that category.
      Second, smokeless tobacco products, or SNUS (ph) as Congresswoman Cubin referred to it, in Sweden
is controlled for other things. It's controlled for cadmium, lead, arsenic, nickel, chromium, benzoapyrine (ph).
It is controlled for none of those things in the United States.
     If Sweden has a different experience, it's because they have a different regulatory regime, they have as
different product.
   Three, Sweden is different for another reason that we need to think about seriously. Sweden bans to-
bacco advertising. Smokeless tobacco companies in Sweden did not make health claims on advertise-
ments. That's not what happened.
   The scientific community communicated accurate, healthful information to consumers in the absence of
consumers being bombarded by uncontrolled advertising. And that's what I really want to talk about here.
     In the United States today, in the absence of FDA regulation over this industry and this product, what are
we really talking about what we're talking about -- well, let me show you the reality of where we will see ad-
vertisements for smokeless tobacco products with claims that they're safer.
    MYERS: Off to my left are two ads. The first ad on the far right is Cocka-doodle-freakin'-doo.
     When we met with U.S. Smokeless Tobacco and said, "Is this the kind of advertisement that under cur-
rent law you would be permitted to make this claim in, the answer was yes. When we asked, would the FTC
have the authority to prohibit you from making such a claim in that ad if you got what you wanted, the answer
to that was no.
     They did say, however, that that ad embarrassed them because of its obvious appeal to kids, and on
February 28, 2002, wrote to us to say that ad would never appear again. Well, it didn't. The ad on the left
did.
     The reality is, in the absence of meaningful regulation over tobacco marketing, it's not a guess, it's a vir-
tual guarantee that we'll do the same thing we did in the 1980s: Use this kind of advertising to expand the
number of children who use tobacco products.
     And let me suggest, when it's a child who uses smokeless tobacco, we're not talking about reduction of
risk. We're talking about a cause of cancer.
    Now, a second thing that's very important and a very real concern...
    STEARNS: I just need you to sum up.
     MYERS: And I will. The risk of using smokeless tobacco to discourage quitting of those who can't is al-
so very real. The president of UST, in describing his marketing strategy, explicitly said the goal is dual use.
For people who might otherwise quit because of clean indoor air restrictions, we want them to be able to use
this product. For people who switch to dual use, they increase the risk of disease.
    And let me just finish with one critical last point. It's nice to have this debate in the abstract. We have to
have it in the reality. There may be a place to discuss the role of smokeless tobacco, but it should take
place only after this committee has granted -- has worked with the rest of Congress to grant the Food and
Drug Administration the kind of regulatory authority to accomplish you have all talked about.
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    We heard a great deal today about 400,000 people dying. There's much we can do to solve that prob-
lem.
    STEARNS: And I thank you, gentleman.
    Mr. Sweanor.
    SWEANOR: Thank you very much, Mr. Chairman. I'm David Sweanor. I'm a lawyer based in Canada.
I spent the last 20 years working full time in a broad range of tobacco-control activities, both in Canada,
where I'm very pleased with a lot of what we've accomplished, including the last 12 months. We appear to
have knocked per-capita consumption down by over 12 percent, which is a world precedent setting rate of
decline.
    I've also been very involved in activities globally, although the views I express today are going to be
those of mine and not for any of the organizations I work for.
    The public policy goal -- the public health goal of tobacco control is important to keep in mind. What
we're trying to do is we're trying to reduce death and disease. There's three broad ways we can do that.
We can reduce tobacco onset. We can facilitate cessation. And we can reduce toxicity for those who use
the product.
      This is important because the status quo is truly horrible. We've got a product that dominates the market.
It kills half of its long-term users. Among these long-term users, we have people who believe that nicotine
itself is what causes cancer. Many people don't want to use medicinal nicotine products because of the fear
of cancer. They're less likely to use them. They won't use them as long as they should or as much as they
should.
   They believe smokeless tobacco causes cancer at just as great a rate as smoking. And perhaps most
importantly, they believe light cigarettes are significantly less hazardous.
    Well, what do we do with a mess like this?
     And I think that a key part of understanding potential solutions is to recognize that though nicotine is the
primary reason people would be smoking, combustion is a primary reason that they're dying. So that, in
theory at least, reduced-risk products make a tremendous amount of sense. And, I think, properly regulated
by a body like FDA, these products have the potential to complement the other aspects of what we're doing
in tobacco control -- of supporting to prevent onset and to encourage cessation.
    But this isn't merely theoretical. We do have examples of elsewhere in the world where medicinal
products are given a broader range of indicated uses. We have examples of people who have used medi-
cinal products for years with no apparent ill effects.
    We do have the example from Sweden, where there's been a massive transformation in their market
from one dominated by cigarettes to one dominated by smokeless tobacco, with a concomitant decline in the
rates of disease that follows smoking, doesn't follow tobacco use.
     In theory, at least, there is a spectrum of risk here, and there would be the ability to offer products with
information so the consumers could decide where on that spectrum they want to be. I think to work, though,
you do need to have some form of comprehensive regulation. Without it, you can't guarantee public health.
You can't give consumers protection. And I'd argue you can't effectively allow the operation of a market-
place.
   Because there's a whole lot of questions that come up -- such as, "How do we know that a product really
does reduce risk on a one-to-one basis, compared to a standard cigarette?"
    I say that's fairly easy. There's no problem with that -- dealing with medicinal nicotine. I don't think
there's any problem with that dealing with low-notrisamine smokeless tobacco. The surgeon general clearly
does.
    How would we know that a product might only reduce some -- or what would be the impact if it only re-
duces some of the cigarettes somebody might otherwise smoke? Where does the product fit on that spec-
trum of risks? How does it impact on things like cessation and use uptake?
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    And how do you communicate a message to the public? Because one of the problems we have now is
that even totally truthful communications from the tobacco company will probably not be believed. There has
to be some way that people can get honest communications that are believable so that they are in a position
to do something about their own health.
    I think these are very difficult issues. But I think that there is also a need for prompt action. You've got
roughly 1,300 Americans dying every day as a direct result of cigarette smoking.
    What do we do? Well, we do need that broad regulatory framework for all tobacco products. And, in
the meantime, we need to look at things like what should we do with medicinal nicotine? One of the clear
consensus I've been hearing here today is everybody seems to think we should have broader access to
these products.
     Well, surely there can be some way that your committee can alert the FDA and the FTC that you want
them to do that. You want them to examine the role of these products in harm reduction. While they're at
it, what can they do to set something in place that allows the manufacturers of smokeless products to come
forward and say, "Here's what we've got on offer as well."
     There also clearly needs to be far more discussion about this. And there needs to be a way that people
can dialogue -- discuss what's happening. Cause I don't think it's any longer a question of "Will there be
alternative products?" or "Should we give information to consumers?"
     It's a question of "How are we going to evaluate those products?" and "How are we going to get truthful
information to consumers in a way that's actually going to allow them to make more informed decisions about
their own health?"
    Thank you.
    STEARNS: I thank you, gentlemen.
   We are in the process of having votes. We have a little over seven minutes left on the first vote, and we
have two five-minute votes. And I'll come back by voting early on the third vote.
   So I think we've got about a 15- to 18-minute break. So I appreciate that if you'll be patient with us, the
committee is going to be recessed for 15 to 20 minutes.
    (RECESS)
    STEARNS: I think at this point we've finished the opening statements, so I'll start with some questions.
Let me get right to this question.
    Dr. Rodu, oral cancer is a risk of using smokeless tobacco products. What is the risk of using such
products, and how does that oral cancer risk compare to the use of cigarettes? That's the bottom.
    RODU: Yes. Oral cancer is a risk of smokeless tobacco use. That risk has been well defined by 20 ep-
idemiologic studies. The risk can be quantified and was quantified by a 1981 study in the New England
Journal of Medicine of 100,000 long-term -- that is, above 40 years or so -- use of smokeless tobacco of
100,000 users. Twenty-six of them will develop oral cancer every year. Of that number, about 12 or 13
unfortunately -- it's tragic. But they will die.
    Now we also know the risks of smoking and the risks of mouth cancer from smoking are somewhere in
the range of double that risk. So the point I always make is that the smoker who switches to smokeless to-
bacco also reduces his or her risk for that disease as well.
    STEARNS: You heard the surgeon general when I tried to talk to him about the degree of risk between
cigarette smoking and the smokeless tobacco. And the surgeon general noted in his testimony that there is
no significant scientific evidence that suggests smokeless tobacco is a safer alternative to cigarettes. Can I
even try to push the idea of the Volvo versus the Miata, the very small sports car? Do you agree with his
statement?
    RODU: Quite frankly, I'm dumbfounded by his statement. The scientific evidence that's out there, both
from the 20 epidemiologic studies, from four cardiovascular disease studies in Sweden, from our work over
10 years published in numerous journals, including high quality journals like Nature, The American Journal of
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Medicine, I just don't know how a surgeon general can come to that conclusion. And in fact, I would be will-
ing to submit a portfolio of research to him for his review and response because I'm quite surprised.
    STEARNS: Dr. Wallace, what additional issues need to be researched before you would be comfortable
allowing companies to claim a reduced risk product, whether it be a cigarette, smokeless product or a medi-
cinal nicotine?
     WALLACE: Sure. There are many. We laid out in the report a long-term research agenda. But some
of the things that need to be done more quickly are to begin to understand how it affects the behavior if you
were to make a claim like that. How does it affect children's behavior? How does it affect physician beha-
vior in making recommendations? But most importantly, adult behavior, how does it change their habits?
How do they use tobacco products? And what happens to them in the long-term? All of these tobacco
products may have outcomes that include things other than cancer. And we have to pay attention to those.
So there's a whole menu of things to do. So there's a lot of research left to be done.
     A very important bit of the research agenda finally then would be to try to identify indicators in the body
that future risks of cancer, heart disease, small fetuses, whatever the outcomes happen to be, in fact might
be different and reliably predict in advance. Otherwise you have to wait a very long time to see the affects
of some of these products.
     STEARNS: Dr. Tomar, you heard Mr. Waxman (ph) talk. And in your opening statement we talked about
this report that you have. In a study conducted by Dr. Lynn Kozlowski recently published in nicotine and
tobacco research he indicated your gateway theory to be statistically unreliable because he argues you fail to
take into account well known psychosocial predictors of smoking initiation such as below average school
performance, depressive symptoms or fighting.
    Now this is an opportunity for you to give your side. So how do you respond to what he said about your
report?
     TOMAR: Well, there's two approaches. One, in the original paper that Dr. Kozlowski supposedly refuted
the argument I made in that paper is that if there are common psychosocial risk factors that account for
moving from one tobacco product to another, wouldn't we expect it to move in both directions. And in fact,
what we found was that 40 percent of young males who were using smokeless tobacco at the beginning of
that study four years later had either added cigarettes to their use of smokeless tobacco or had switched to
smokeless. We found almost no movement from cigarettes to smokeless tobacco. So that was the first one.
    And then actually you need to read the reply that's been accepted for publication in that same journal to
Dr. Kozlowski's analysis because (ph) I (ph) redid his analysis using the same variables that he claimed were
so critical that I had omitted. And in fact, when I did the analysis limited to the group that actually uses the
products, non-Hispanic white males and those who were under 16 at the beginning of the study, in fact,
smokeless tobacco was not only statistically significant predictor of subsequent smoking, it was a stronger
affect than the risk behavior predictors that he felt were such a critical omission.
    STEARNS: I'll let someone else. Dr. Rodu, you might want to comment on this based upon the study
from Sweden.
    RODU: Yes.
    STEARNS: Yes.
    RODU: Yes. We have a study of tobacco use among adults in Sweden. And we saw in essence no
affect of gateway from smokeless tobacco use to smoking. And that is among adults. Largely the predo-
minant public health message in Sweden, of course, is that snuse (ph) is safer than smoke. I don't think
there's anyone that doubts that in the Swedish environment.
    In the United States, the dominant public health message is that smokeless tobacco is just as dangerous
as smoking. And that's seen in Mr. Sweanor's testimony. And so, we have an open gate. It's an open
gate for transition back and forth between smoking and smokeless tobacco use based on convenience, not
based on health. You know, the other thing about gateway is that it's a convenient issue when you look at
smoking is a gateway to smokeless or vice versa and drinking and sex and all kinds of behaviors. When in
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reality these behaviors are all grouped, they're all associated, and they're all present in a small proportion of
our teenagers. And it's unfortunate. But it's association instead of causation.
     WALLACE (?): Mr. Chairman, could I just make two quick points with regard to that because I think
they're vitally important? One is Sweden does not permit the kind of advertising I showed before so that the
interaction between different products is really quite different because you don't have the same market
forces. As a matter of fact, in Sweden, the same company for a long time owned both the major cigarette
company and the same smokeless company.
     And the reason we have a real life example in the United States is, you know, in the mid 1970s, virtually
no kids used smokeless tobacco products. The kind of marketing that I showed you the UST was engaging
in through 2002 kicked in around late 1970s, early 1980s. And what we saw was a little explosion of smoke-
less tobacco use. And part of the ad themes in those cases was a safer message, implicit safer message
so that when we talk about a concern about kids in this country, we're not talking some sort of ephemeral
thing. We're talking about a real life example of what happened here.
     Now we don't have any different kind of regulation today. We had all hoped in 1977 that the master set-
tlement agreement would bring about a change in tobacco marketing by companies like UST. Instead what
we saw was a dramatic uptick in marketing, particularly in youth oriented magazines until several attorney
generals threatened them. When they got out of those magazines, they used carefully the word we're sus-
pending advertising in magazines like Rolling Stone, not we're getting out permanently. So that concern
that we all have is that in the absence of government regulation that controls the kind of marketing, that puts
in place the kind of regulations that they have in Sweden that the effort to promote health reduction will in
fact result in an explosion in youth smoking. Is it possible to deal with that? Perhaps if the FDA had full and
comprehensive regulatory authority that we could. But that's what we ought to really be talking about here.
    STEARNS: OK. My time has expired. The ranking member.
    SCHAKOWSKY: Thank you.
     Dr. Rodu, is it not true that in 1999 the University of Alabama at Birmingham received a five year, $1.25
million unrestricted research grant from the United States Tobacco Company of Greenwich, Connecticut?
    RODU: That's correct.
    SCHAKOWSKY: And is it also not true that the award supports the UAB tobacco research fund, and you
are the principal investigator?
    RODU: That's correct.
    SCHAKOWSKY: Thank you. I wanted to ask Mr. -- I want to say it right. Verheij?
    VERHEIJ: That's right.
      SCHAKOWSKY: Verheij a question. UST has indicated that it is a company that can be trusted not to
use health claims for smokeless tobacco to attract children or deter people from quitting. I want to talk a
little bit about the ads. But I would like to ask whether you have told the whole truth today to Congress
about levels of carcinogens called tobacco specific nitrosamines in your product. In your written testimony
you stated today, quote, "there is currently no difference in tobacco specific nitrosamine levels in U.S. moist
(ph) snuff compared to Swedish moist (ph) snuff."
    However, your testimony only includes data on U.S. brands up to 1994. And if you'll look at this chart
which is based on data provided by the Massachusetts Department of Public Health based on research by
the Institute for Cancer Prevention it shows that the levels of tobacco specific nitrosamines in your two lead-
ing products doubled between 1994 and today. The average level in the last four years has been 26.7 mi-
crograms compared to an average level of less than 10 in Swedish products for the last 20 years. Why did
you not share any more recent data than 1994 with the committee today?
     VERHEIJ: Well, we'd be happy to share recent data. The fact is that of products that we've introduced
into the market over the past year, they have some of the lowest nitrosamine levels of any product in the
world, including as a comparison to Swedish product. The data you have there is from the state of Massa-
chusetts. We met with the state of Massachusetts with respect to their methodology. In fact, I had a phone
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call with Dr. Connelly (ph) probably three weeks ago where he was giving me current data on some of our
leading brands. Our objective ...
    SCHAKOWSKY: Are you talking about your moist (ph) product?
    VERHEIJ: Yes indeed. And including two new pouch products that we've introduced. The fact is I think
as we indicated in our submission, we have reduced nitrosamine levels more than 80 percent in our products
over the last 20 years to the point that a Swedish government report in 1997 concluded that the differences
were so small at this point that the differences in relative risk were negligible. Our objective is to reduce ni-
trosamine levels to the lowest levels possible. In the context ...
    SCHAKOWSKY: Well, let me just say that my understanding is that the 2000 data which you were given
on October 16th, 2001 says that it's now 52.7 micrograms for that year.
    VERHEIJ: And I'd have to go back and look particularly at the timing of that. They were taking data six
months out from when the product was introduced on the shelf. Those products are not on the shelves after
six months at all. And in fact, looking at data that we have -- and again, I'd be happy to provide the commit-
tee -- in terms of our leading brands, we're talking about levels of 12 to 14 parts (ph) per million. We con-
tinue to work to reduce those to the lowest levels possible.
    SCHAKOWSKY: Do you put any shelf life or expiration date on your products?
     VERHEIJ: Actually we do. On the Copenhagen product, there's a made day. And within 30 days of
that made date, that product is either purchased or taken off the shelf by our salespeople. We have guar-
anteed until fresh dates on our other products which indicate the optimum period within which we think con-
sumers should purchase the product. So we do have made dates on that.
     SCHAKOWSKY: I understand that you've refused to accept a maximum shelf life for your product. That
is, any kind of requirement to have a shelf life. Is that true?
     VERHEIJ: Not at all. We had a good discussion with Dr. Connelly (ph) at the time, showed him the fact
that our products turn 52 times a year, the most shopped product other than milk in terms of date. And in
fact, these products were coming off the shelves. And any significant increase in nitrosamine levels were
towards the end of the six month period when these products are not available to consumers.
    SCHAKOWSKY: OK. Let me ask you this. In a letter you wrote -- or not you wrote, the company
wrote, February 5th, 2002, it says, quote, "it is UST's position that smokeless tobacco has not been shown to
be a cause of any human disease," unquote. That was in a letter from Brian Cays (ph), LLP to the Federal
Trade Commission. That's your submission to the FTC.
    VERHEIJ: And I think we've also made clear in our public filings that based on the scientific literature
taken as a whole, the company has not taken the position that the product is safe. And the question on the
table in the context of the debate we've all been talking about here is the fact that smokeless tobacco is con-
sidered to be considerably less harmful than cigarette smoking. And whether that information ...
    SCHAKOWSKY: No, no. That's not what I'm asking. Has not been shown to be a cause of any human
disease.
     VERHEIJ: I don't think that statement is inconsistent with the position that we've taken, which is we have
not taken a position that the product is safe.
    SCHAKOWSKY: Dr. Tomar, would you respond to that?
    TOMAR: Well, it seems to be contradicted by Dr. Rodu's earlier statement where he acknowledged that
these products cause cancer. It certainly has been established by the International Agency for Research on
Cancer and the U.S. Surgeon General.
    RODU (?): If I may follow-up on that? The fact is that based on studies that were available in 1986, the
surgeon general reached the judgment that smokeless tobacco can cause oral cancer.
    SCHAKOWSKY: You know, actually I have gone over my time already and want to make one other
point. So I just think that this is an astonishing statement given the unanimous actually, including Dr. Rodu's
statement about disease. Now why anyone would think that this magazine with Brittany Spears on the cov-
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er might be read by young boys I have no idea. But I just want to say this is December, 2001. And in it is
an ad showing a firefighter putting out a fire, clearly one of the heroes of 9/11, a bit braver, a pinch better.
And it's for Skoal.
    I just want to say that given that and the ad for Rooster, it is not credible to say that these products are
not pitched to children. Thank you.
    STEARNS: The gentlelady's time has expired.
    VERHEIJ (?): Mr. Chairman?
    STEARNS: Yes?
    VERHEIJ (?): Mr. Chairman, if I may for one second?
    STEARNS: Sure. Yes.
     VERHEIJ (?): I think there's been a lot of focus on old ad campaign, some of which, you know, once
certain concerns were brought to our attention like the Rooster ads that Mr. Myers showed we discontinued
those once we took a second look. The fact is what we're talking about in this debate is communications to
adults about information that there is increasing consensus in the scientific community that smokeless to-
bacco is considerably less harmful than cigarette smoking. And we are urging a workshop where all these
parties can participate so that we can come up with guidelines that will address everybody concerns before
those communications are made. And frankly, you could take our company out of it entirely. That means
the remaining issue is to what degree does the government and the public health community have an obliga-
tion to communicate this important information to adult smokers who are not (ph) quitting.
    STEARNS: The gentlelady's time has expired.
    The chairman of the full committee, Mr. Tauzin?
    TAUZIN: Thank you, Mr. Chairman.
     Mr. Myers, you've made the point several times that we tend to be debating this in the abstract. We
ought to look at real world information and real life conditions. And I think that's a good point. One of the
things you pointed out to us, however, was that in a story in the Washington Post over the weekend that said
smoking is projected to kill a billion people worldwide this century. And that one out of two long-term users
of cigarettes will die. And that's not abstract. That's real. And that's pretty awful.
    And I think what we're beginning to have here is a debate on whether or not we can do something about
those real life statistics. And I want to tell you a real life example, the reason why I've got such an interest in
here in this debate and why I want to see this indeed not just workshops and forums and discussions and
more hearings, I want to see the scientific evidence debated and the policy issues debated.
     One of the people I love dearest in my life is the former chief of my local staff who served me four times
as chief of staff. He has two sons. One's a Navy seal, and the other is a college student right now, he and
his son both addicted to smoking. They were able to use this product called Ravel (ph), which is one of the
newest, I think, products you were talking about, the pouch, spitless variety of smokeless tobacco. It's made
the difference for them. Both of these people used it where they've never been able to quit smoking before.
And they quit smoking, and now they quit using this product. And they're completely off the tobacco.
That's a real life example. I've got a couple of kids I'd love to see quit smoking. And they try, and they can't
quit. And if they're like this Ravel (ph), if there are products being developed that not only are considerably
less harmful than the cigarettes my children are smoking, ...
    MYERS: Mr. Chairman?
    TAUZIN: Let me just finish. If products like that, and there are products like that that can be a bridge for
people like my dear friend and his son went from smoking cigarettes to using these products to using no to-
bacco products, if there are products like that, doesn't it make sense for us to find some way to allow some-
one, if not the company, someone to communicate the existence of those products to the adults of this world,
the billion people worldwide who are going to die in this century if we don't give them another option?
    MYERS: Mr. Chairman, let me respond.
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    TAUZIN: Please.
    MYERS: Because the organizations with which I work spend day and night trying to figure out how we
can reduce the death toll from tobacco.
    TAUZIN: I know you do. I know you do.
    MYERS: We do it at all levels.
    TAUZIN: Yes.
    MYERS: We try to help prevent kids from starting, which is the best way.
    TAUZIN: Yes.
    MYERS: We try to make more funds available to help people to quit. And, you know, and sadly in most
states, we're not doing that so that your friends, your colleagues, your loved ones should have more re-
sources available to you. And I hope we'd work together.
    Third, based on your statement this morning, I know you share our concern that you don't want to see
the unintended consequences of this action. And for us to avoid the unintended consequences that will oc-
cur by the kinds of ads that I've shown, the only way we can do that and make sure that your loved ones are
provided the best tools available to quit, whatever they may be, is to make sure that we have a comprehen-
sive regulatory system.
    TAUZIN: Yes.
    MYERS: Because what I don't...
    TAUZIN: I have limited time, Mr. Myers.
    MYERS: But a lot of times...
    TAUZIN: No, no, no, no. You opened it up. Let me. I have limited time.
    MYERS: Go ahead.
     TAUZIN: That's a good debate. And we're having it. We've been having that one for years, whether
the Food and Drug Administration ought to regulate tobacco. And that debate's going to go on, I suspect,
for a long time. But in the meantime, my children are smoking cigarettes. In the meantime, there are
400,000 citizens that are going to die because they can't quit smoking even though they want to. I've got
some examples of what's going on in Europe. These are what's required in the E.U. on cigarettes.
    MYERS: Yes.
    TAUZIN: These are the warnings they put out in the E.U. Smokers die younger. Smoking kills.
Smoking seriously harms you and others around you. Smoking clogs your arteries and causes heart at-
tacks and strokes. Smoking kills. Smoking can damage the sperm and decreases fertility. I mean, the
E.U. puts out warnings like we don't even think about putting out on cigarettes. And the E.U. is now saying
leading tobacco experts in the E.U. are sending information to us telling us they think they made a mistake
when they partially banned smokeless tobacco products because they're looking at Sweden, and they're
seeing how Sweden is really seriously reducing the deaths from lung cancer to males who have been able to
use something other than a cigarette to get their nicotine habit satisfied. Answer, please.
     MYERS: Two quick points, and they're very important ones. One, we would welcome to work with you
to improve the health warnings on tobacco products ...
    TAUZIN: Good.
    MYERS: ... so that it's serious. Two, the recommendations ...
    TAUZIN: But wait a minute.
    MYERS: Wait. Let me respond to the E.U. ...
    TAUZIN: No, no, no. Wait a minute. Wait a minute. No, no, no, no.
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    MYERS: Go ahead.
    TAUZIN: I've got the time, and I'm not going to let you do that to me. I'm not telling you we don't have
these warnings. I'm telling you the E.U. is telling us these warnings are not working.
    MYERS: No, that's not what they're saying.
     TAUZIN: No. I'm reading their report, and they're telling us that they are seriously considering repealing
their ban because they're looking at the only country in the E.U. that met the World Health Organization's
target of reducing smoking prevalence to 20 percent. The only country was Sweden.
    MYERS: May I just have the opportunity because I...
    TAUZIN: Where in fact, they promoted the use of something other than smoking cigarettes.
     MYERS: I think it's very important to understand exactly -- the report you're referring to was written by
five people for the E.U., not the E.U. What it recommends, just as the Royal College of Physicians recom-
mends is that no health claims be permitted in the absence of a comprehensive regulatory system like we're
proposing for FDA. That's what the E.U. recommendation is.
   Now the E.U. has banned smokeless tobacco, and they said we should go back and relook at that. But
what they have said about health claims is that health claims should only be permitted within the context of a
comprehensive regulatory system so that we don't have the unintended consequences, so that we don't
market them to kids and so that we know what's in them.
    TAUZIN: My time is up. I'll accept the fact that we ought to be very, very careful how we regulate these
health claims, very careful.
    MYERS: But we're not doing that now.
    TAUZIN: But wait. Let me make the point. But we're never going to get there if the surgeon general
has never even read some of these later reports that indicate that there are alternatives that are less harmful
than smoking tobacco. We're never going to get there if the head of the FTC who has jurisdiction to verify
the validity of claims is not willing to lead a forum, a discussion.
     If the health department in this country is refusing to lead it because they think the FTC ought to lead it,
and if you're going to keep insisting that the Food and Drug Administration ought to do it, we're going to have
this debate forever while alternative options that should be discussed, that should be available to my children
and to my dearest friend who finally found one of these, used it and got off of cigarettes are never even dis-
cussed publicly because we're too scared to talk about the truth, about where the science is really going.
    If the science is really going there, if people in this country can know that there are alternatives for them
to use to get off of smoking cigarettes to get their nicotine highs, and they're not finding out about it because
we're too afraid, too unwilling to lead and have some open discussions and debates about them to figure out
how to regulate it properly to make it work well, then shame on us. And I agree with you. We ought to have
that great debate. Help us have that debate.
    MYERS: Mr. Chairman, my most important point...
    TAUZIN: Yes, sir.
    MYERS: ... is that in the absence of comprehensive regulation, your desire to do good will produce a
public health tragedy.
    TAUZIN: That's a fair concern...
    MYERS: It will turn into a marketing tool for the tobacco industry.
    TAUZIN: That's a fair concern. And that ought to be part of the debate.
    Thank you, Mr. Chairman.
    STEARNS: The gentleman's time has expired.
    The gentleman from Texas?
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     GREEN: (inaudible) and I appreciate the line of questioning from our chairman. I think our children or
smokers know the alternatives because, like our chairman, I've had a father in law who died of lung cancer
and a brother in law who died of lung cancer. And they tried everything. In fact, they even chewed, too.
And they still died of lung cancer. But that was because of smoking. But I think our children know alterna-
tives, just like they know alternatives already that we don't want to tell them about the use of condoms. But
that's a debate that this committee has had other times.
    Let me ask Mr. Sweanor. And having read your testimony where you talk about replacing dirtier delivery
systems to (ph) cleaner systems. And I know we talk about different ways, but obviously you've never sat
next to someone who chewed and had to spit in a cup next to you. But let me ask you some questions about
does Canada recognize smokeless tobacco as a safer alternative.
   SWEANOR: As far as I know that's a debate that simply hasn't happened in Canada. Smokeless to-
bacco is actually rarely used in Canada.
    GREEN: OK. You mean not even in the western provinces? Because ...
    SWEANOR: Elberta actually does have use of smokeless tobacco. And that's now a debate emerging
with the drugs education agency in Elberta.
     GREEN: Because we have rodeos in Texas, in the Midwest like in Canada and Elberta and other parts.
But what tobacco control measures are in place in Sweden that are not in place in the United States? For
example, the tax rates, the smoke free indoor air law includes restaurants (inaudible) advertising. Is there a
difference on how Sweden treats all tobacco products?
   SWEANOR: Yes, in different ways. There will actually be less protection from second hand smoke in
Sweden than what I find in many places in the United States now. But Sweden does have a ban on tobacco
advertising. It has fairly comprehensive...
    GREEN: Is that both a print ban and an electronic ban?
    SWEANOR: Yes. Yes. Like Canada or the rest of the European Union.
    GREEN: OK.
   SWEANOR: It has much larger warnings on packages, further disclosure to consumers, restrictions on
how the product is displayed at retail.
   GREEN: OK. Let me go on. Are Swedish customers or consumers told by companies or the govern-
ment that smokeless tobacco is a safer alternative to cigarettes?
    SWEANOR: I found that to be a very interesting thing because they are...
    GREEN: Is it a program by the companies or the government that allows them to say that it's a safer al-
ternative? Does Sweden do that?
    SWEANOR: No. My experience is that the government has not told them that. The companies have
not explicitly told them that. But that information has got to them through the scientific community and
through simply word of mouth.
    GREEN: OK.
    SWEANOR: I think very similar to...
     GREEN: OK. Let me because I only have a couple of minutes left. Are you aware that Sweden has an
active program to reduce snuff tobacco use, and that Swedish health ministry aims primarily to get people to
quit tobacco, smoking tobacco entirely?
    SWEANOR: Yes. That's certainly their goal is to try to reduce tobacco use entirely.
   GREEN: OK. OK. And so, all this study that's been talked about, the science that we're quoting a
Swedish study, even the Swedish health ministry has an enacted program to reduce snuff tobacco use?
    SWEANOR: Yes. It's aimed at overall reduction of death and disease by reducing tobacco use in all
forms as much as possible.
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    GREEN: Mr. Chairman, I'd like to introduce into the record and ask unanimous consent to introduce into
the record information from the Swedish health ministry about their handling of smokeless tobacco. And it's
addressed to Mr. Sarfenstein (ph). And it says your question number one whether advertising claims on
reduced risk are permitted for smokeless tobacco in Sweden in (ph) the regulations of tobacco products in
Sweden are contained in tobacco act.
    And I'll briefly say let's put the whole letter in the record, conclude it's not permitted to use advertising
claims on reduced risk as the legislation is not permitted for advertising for tobacco products as was defined
as commercial advertisement and according to the Swedish constitution. And know this ministry of health
and social affairs does not have a campaign to switch to smokeless tobacco in the meeting (ph). They have
a product that (ph) was (ph) snuff. I'd like to ask unanimous consent to have that placed in the record.
    STEARNS: Without objection, so ordered.
    GREEN: And with the brief time I have left, Mr. Verheij, UST uses a Swedish study as a foundation for its
argument that should be able to advertise that smokeless tobacco is less harmful. However, Mr. Myers
points out that sinnis (ph) products in Sweden are very different than the products marketed here. For ex-
ample, he states that the levels of cancer causing nitrosamines in Swedish products are much lower than the
United States. Could you comment on that in what brief time I have left?
    VERHEIJ: Be happy to. The fact is that we've successfully reduced nitrosamine levels in our products
to extraordinarily low levels. And some of the products we've introduced recently have levels much lower
than any other smokeless tobacco product in the world. Another reason why we believe the Swedish model
is applicable is, I think as Mr. Sweanor pointed out, the fact is that culturally and through the public health
community, the type of communication we're talking about is actually reaching adult smokers.
    GREEN: OK.
    VERHEIJ: That's not happening here in the United States.
   GREEN: OK. Let me talk about it, because I think there's a new study, I understood, from the state of
Massachusetts that indicates that nitrosamine levels are increasing in U.S. products. Is that your products?
And I'd like Mr. Myers -- if he had a brief comment on that.
    MYERS: Sure. The sad reality is that several independent studies done by the American Health Foun-
dation for the state of Massachusetts they found something quite inconsistent with what Mr. Verheij said.
What they found was for the two most popular products from UST, one study done in 2001 found that the
comparable Swedish product had 2.8 parts per million of nitrosamines. Whereas Copenhagen had 41.1 and
Skoal had 64.0. Those products aren't comparable by any remote imagination.
     And also attached to my testimony is an updated report. Again, while done for the state of Massachu-
setts, not done exclusively in Massachusetts. Samples were picked up around the country by one of the
most respected labs. And what it found there, too, is that in 2003, nitrosamine levels in the two most popu-
lar brands by UST remain about 10 times higher than those that we're comparing in Sweden. It's a very
disturbing thing, because the numbers for these two are 22.0 and 27.9 compared to under two for the com-
parable products in Sweden. So we are talking, not apples and oranges even, but apples and grapefruits is
the difference here.
     Unfortunately when the state of Massachusetts asked US Tobacco if they'd agree to a 10 part per mil-
lion, much higher than in Sweden, the answer was no. I think what it's time for us to do is compare apples to
apples. And if we're really interested in low nitrosamine, what we need to do is have a regulatory agency
that can set standards for it so that we can protect consumers, accomplish the goals of this committee.
    GREEN: Thank you, Mr. Chairman.
    VERHEIJ (?): Mr. Chairman, if I just may, because I think ...
    STEARNS: Sure.
    VERHEIJ (?): ... Mr. Myers is comparing apples and refrigerators. The fact is ...
    MYERS: I would think more like apples to gasoline maybe.
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    VERHEIJ (?): Well, ...
    MYERS: Because apples at least are healthful.
    VERHEIJ (?): Well, I think the fact is that the appropriate comparison between the data that Mr. Myers
cited from Sweden is a comparison to the types of products that Chairman Tauzin was pointed out, which is
the Revel product, which has the lowest levels of nitrosamines of any smokeless tobacco product in the
world. And that's the appropriate comparison between -- because pouch products are 50 percent of the
market in Sweden, unlike here, which is about 3 percent. So the notion is not to compare Copenhagen with
a pouch product in Sweden. They should be comparing a pouch product in Sweden with a pouch product in
the United States. And in fact, the levels are comparable or lower.
    MYERS: What's stunning is that UST has demonstrated in Revel that it can produce a low nitrosamine
product. But in the two products that it sells to most Americans, Copenhagen and Skoal, it has nitrosamine
levels multiples of that. If they can produce it for Revel, why don't they product it for every one of their
products? Why should some people be in more jeopardy than others?
    STEARNS: One last word here before we ...
     VERHEIJ (?): Absolutely. I appreciate that, Mr. Chairman. The fact is is that we're working to reduce
the levels of every product we have. In Revel, we're working with a product that was newly introduced last
year with new technology. We can now take that technology and start applying it to products like Copen-
hagen that have been on the market for 180 years. And that doesn't happen overnight without dramatically
changing Copenhagen. The overall goal is to reduce the levels to the lowest levels possible in the world in
such products as Revel.
    STEARNS: The gentleman's time has expired.
    The gentleman from Kentucky, Mr. Whitfield?
    WHITFIELD: Thank you, Mr. Chairman.
    Mr. Myers, you've made some comments, and Mr. Verheij made some comments about their product,
Revel and comparing that with Snooze (ph). And a number of people have indicated in their testimony to-
day that if the U.S. had a similar regulatory system as they have in Sweden, that that would make a differ-
ence. So is it your position that if the U.S. had a similar regulatory system that you would have no objection
to products like Snooze (ph) or Revel?
     MYERS: If the U.S. had a comprehensive regulatory system, then scientists with full knowledge about
the product would be able to make appropriate comparative science claims. We aren't in the position to do
that. You know, we just learned how little we really know. There was a recent study done on Marlboro that
we thought had reduced tar levels for many years that discovered, in fact, Marlboro's have among the high-
est nitrosamine levels of products anywhere in the world. What we need is an agency that can control each
of the potential toxic substances and then make a scientific decision. We'll abide by the science, whatever
that is.
    WHITFIELD: Now do you think that in Sweden and the European Union they have valid science on this
issue?
     MYERS: There are widespread disputes about both what the cause of the Swedish experience is and
what the impact of the Swedish experience is. But, you know, one of the very documents that you cited this
morning, the one written by the five scientists to the European Union had an explicit sentence in it that says,
we don't know if the experience in Sweden would apply anywhere outside of that experience because of the
full maze of regulatory mechanisms they have in place and the difference in the product.
     What I would be willing to say to you is let's give an agency like the FDA the kind of authority over it so
that it can make sure that if these products can, in fact, reduce the harm to disease, then there's an agency
that can control it so that they accomplish the goal. Step one is give an agency the authority to do the job.
   WHITFIELD: How many of you on the panel agree that there is sufficient scientific evidence already, in
Sweden or elsewhere, that smokeless tobacco is safer to use than cigarettes?
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    MYERS: I'd be happy to start that.
    WHITFIELD: I think I know how you...
    MYERS: Yes, but let me just say, because I think it's important.
    WHITFIELD: Let me get...
    MYERS: For the overwhelming majority of Americans ...
    WHITFIELD: Let me get Dr. Rodu...
    MYERS: ... smokeless tobacco is the cause of (inaudible) disease.
    WHITFIELD: Dr. Rodu, you raised your hand?
     RODU: Well yes, I raised my hand to agree with your statement that smokeless tobacco use is on the
order of 98 percent safer than smoking. I think that the epidemiologic research published by others over the
last 50 years substantiates that. Our own epidemiologic models substantiate that.
    STEARNS: Will the gentleman yield for just a second?
   Dr. Wallace, I understand you're on the first panel of another one. So we want to thank you for coming.
And you're welcome to leave now so that our colleagues can share your wisdom.
    WALLACE: Thank you, Congressman. I appreciate it.
    STEARNS: Sure.
    WHITFIELD: Mr. Sweanor, did you want to make a comment?
     SWEANOR: Certainly my view is on a one for one basis, there's no doubt that a smokeless tobacco
product such as is sold in Sweden or even in the United States is going to be much, much less risky than
getting your nicotine by smoking a cigarette.
     WHITFIELD: Now Mr. Myers, do you accept Mr. Verheij's statement that Revel has nitrosamines equal to
the level of Snooze (ph)? Or do you have any basis of knowing that?
    MYERS: It's exactly why we need a regulatory agency so that we can have a regulatory agency that
tests it, and we don't have to depend on what US Tobacco tells us.
   WHITFIELD: OK. I noticed that in the European Union, evidently they recently changed their warnings.
And they said this tobacco product can damage your health and is addictive as it applies to smokeless to-
bacco. But they removed the warning about cancer. Is anyone aware of that? Or ...
    MYERS (?): That's in Sweden, not in the European Union, sir.
    WHITFIELD: That was in Sweden?
    MYERS (?): Yes.
    WHITFIELD: OK.
   MYERS: Sweden doesn't permit the sale of smokeless tobacco. I mean, the European Union doesn't
permit the sale of smokeless tobacco.
    WHITFIELD: Mr. Sweanor?
   SWEANOR: It is an EU rule that applies to Sweden, which still has the ability to sell smokeless tobacco.
My understanding is it was removed because the evidence simply wasn't there to substantiate it. The evi-
dence coming out of Sweden could find no conclusive proof that the product was causing cancer at all.
      WHITFIELD: Recently CDC came out with a study about nitrosamines and the content in certain Ameri-
can products. And the bottom line to that is I know since that report has come out or since the beginning of
it, the way you dried (ph) tobacco has changed. The technology has been changed. But would you make
the argument that tobacco grown in foreign countries are safer than tobacco grown in the U.S.?
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    VERHEIJ (?): I'm glad you raised that issue. The study done by the CDC was of Marlboro's, manufac-
tured both abroad and here. It's an American brand, but it includes foreign made cigarettes under Philip
Morris Internationals as well. What it found was that Marlboro had higher levels of nitrosamines in the vast
majorities of countries in which it was sold, no matter where it was manufactured. The problem wasn't
American tobacco. It wasn't American manufacturers.
     The problem was how Philip Morris chose to manufacture that product, which was particularly disturbing
because a study by British American Tobacco showed that when Philip Morris actually enters countries with
Marlboro, they initially produce low nitrosamine products equal to the level in the country. And then gradu-
ally they raise them up so that there's a conscious decision going on or at least a non-caring decision going
on that has nothing to do with American tobacco. American tobacco is the best in the world.
    WHITFIELD: Mr. Rodu?
     RODU: Could I make one quick comment about nitrosamines to place it in perspective? The epidemi-
ologic studies performed between the 1950s and 1980s that show a relative risk of smokeless tobacco
mouth cancer association at about two to four were conducted in people who were using products where the
nitrosamine levels were in the hundreds. Now we're talking about nitrosamine levels in the single digits and
teens. And we're arguing differences that are very, very small compared to products used 40 years ago.
Thank you.
    WHITFIELD: I'd like to ask Mr. Myers just one other question, if I could. You've been pretty emphatic
about this, which I understand. But I didn't see this, but recently they said on C-Span that you replied to
someone who called in and that you made the comment cigarettes are the most dangerous form of tobacco
used. Literally one out of two long-term users of cigarettes will die from tobacco use. Smokeless tobacco,
cigars are harmful, but not to the same magnitude. Did you say that? Or ...
    MYERS: Sounds like an accurate quote of what I would have said. The important issue here is whether
or not the government is going to put a stamp of approval to make a health claim in an unregulated environ-
ment that could have tragic marketing consequences.
     The position I take that these claims should not be permitted in the absence of meaningful regulation re-
flects the absolute consensus of every, single major American public health organization, from the American
Medical Association to the American Cancer Society, the American Lung Association to the American Public
Health Association, to the American Dental Society. There is no emerging consensus on the other side.
This is the view of the public health community.
   STEARNS: Gentleman's time has expired. I would say to the gentleman from Kentucky I heard Mr.
Myers say that U.S. tobacco is the best in the world. So I think you can take that back to your constituents.
    The gentleman from ...
    WHITFIELD: Maybe you could go down and visit with my farmers.
    MYERS: I actually do all the time.
    STEARNS: Mr. Stupak?
   STUPAK: Thank you, Mr. Chairman. And I apologize for being late, but I did catch some of this in be-
tween meetings. So just a couple of questions, if I can.
    Is there any profile or high risk individuals who should not use tobacco? I mean, ...
    MYERS (?): Human.
     STUPAK: OK. Besides human. But I mean, is there certain characteristics you look for in some drugs
that are considered high risk patients for this use? Is there anything like that? No profile even (ph) like that
for none?
    MYERS (?): Not to the best of my knowledge. It is true that one out of two long-term users of tobacco
products will eventually die from the disease. That means one out of two don't. But it's worst than playing
Russian Roulette. The real concern is that virtually every one of them start as a child. And what we need
to do is break that step.
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      STUPAK: Dr. Rodu, in an answer to my friend's question over there, you were talking about when the
study was done between the '50s and '80s that certain parts were in the hundreds. And then you said now
it's down to single digits. And it really didn't make any difference from a health risk area. Can you explain
that a little bit more?
    RODU: OK. Yes, let me clarify that. When most of the epidemiologic studies were performed, it was
between the 1950s and 1980s.
    STUPAK: Right.
     RODU: They measured smokeless tobacco associated risks in users during that period. And during that
period, nitrosamine levels were in the range of the hundreds. They were quite a bit higher than they are
today. So we have a relative risk from that period in the range of two to four. And that's what we've based
all of our epidemiologic models on.
     Now we're talking about products that are substantially lower. And, in fact, the American Health Founda-
tion has said that they are at least 70 percent lower than they were in the 1970s. So we're talking about a
shift downward in risk from the 1950s through the 1980s. So we go from two to four down. We're going
toward one. And one being the risk of a non-user of tobacco.
    STUPAK: Is it fair to say, then, as maybe UST would argue, then, that it's safer now than it was in the
'50s to '80s.
    RODU: Well, I won't -- I mean, Mr. Verheij can respond for UST. I believe that products are safer now
than they were in the 1980s.
    STUPAK: Because of this nitrosamine?
     RODU: Yes, because of nitrosamine level reduction. Now when you have a relative risk to start with of
around two to four, it's very difficult to show without enormous populations and huge studies any more reduc-
tion in risk. So that reduction's going to be very difficult to quantify. But, in fact, the safer products can be,
the better off we all are.
    STUPAK: OK.
    Mr. Verheij, UST petitioned the FTC to advertise as (ph) safer, correct? And then that was withdrawn,
that petition?
    VERHEIJ: We actually petitioned the FTC for an advisory opinion.
    STUPAK: OK.
    VERHEIJ: We thought that instead of going out and communicating this information to adult smokers
who were not quitting that we would get some guidance from the federal government. It was unlike anything
any other tobacco company had ever done.
    STUPAK: But did you withdraw the petition?
    VERHEIJ: We've temporarily withdrawn the petition. We supplemented the record, probably, three weeks
ago.
    STUPAK: OK. And then there's been some talk about doing a workshop on this issue now, right, with
the FTC?
    VERHEIJ: That's certainly what we're urging, a workshop. We believe this is a process. The Institute
of Medicine report was a process. Our filing with the FTC was a process. This hearing today is part of the
process. And we think a workshop would be a very important part of the process.
    STUPAK: If you did a workshop, would FDA be invited to that workshop?
    VERHEIJ: Absolutely. We would encourage that.
    STUPAK: The Center for Disease Control?
    VERHEIJ: Absolutely.
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    STUPAK: OK. Should FDA regulate smokeless tobacco, then?
    VERHEIJ: Well, there have been a lot of proposals about FDA regulating cigarettes and smokeless to-
bacco. Historically we were opposed to that because that was -- it was going to regulate as a medical de-
vice.
    STUPAK: Right. But if you're talking about it being safer, smokeless tobacco to be safer, and if FDA
regulates Nicorette and all this other stuff to help you reduce your smoking, if this is a product that's safer
and encourages less smoking, shouldn't they also regulate smokeless tobacco, then?
     VERHEIJ: Well, as we've laid out in our public filings, we believe that if there was a regulatory regime
that recognized this concept of tobacco harm reduction and the distinct differences between smokeless to-
bacco and cigarettes, that's something the company would seriously consider supporting.
     STUPAK: If it's tobacco harm reduction, shouldn't we also know that, not only from an advertising point
of view, but also a health point of view and (ph) that (ph) where the FDA and CDC and others, NIH would
come in?
    VERHEIJ: I think that's implicit in the process. I think what you see here along (ph) in the panel, how-
ever, is a difference of viewpoint as when is that going to -- you know, when, in fact, we are going to begin
communicating to adults this information about the fact that smokeless tobacco is considerably less harmful.
Mr. Myers would say five years in the future when we get FDA regulation.
    STUPAK: Sure.
   VERHEIJ: Dr. Rodu said we should have started this 10 years ago. And so you see a range of views.
And that would be part of the discussion at the forum.
   STUPAK: But aren't you really saying that we should advertise first and then let the FDA look at it se-
condly?
    VERHEIJ: No.
    STUPAK: Is that what you were saying?
    VERHEIJ: I think the broader societal (ph) question is as we move through this process, what are we
going to communicate. And I believe Chairman Tauzin raised the concern about what are we doing today.
Yes, everyone's moving toward some increased regulation. But I think everyone, a number of people on the
panel here are saying what should be done today. What type of communication? Again, take the company
out of it. But what type of communication should come from the public health community to adult smokers
who are not quitting today?
   STUPAK: But shouldn't the public health concern be addressed before you advertise? I mean, there's
advertising for smokeless tobacco in Sports Illustrated, the USA Today sports page. And it seems like the
advertising is getting ahead of the health concerns.
   VERHEIJ: And I think, Congressman, that there's been -- I said the underlying assumption that there
would be some broadbased advertising in Sports Illustrated or some publication that has some concern.
Again, take the company out of it. Say there's no communication from the company.
    STUPAK: OK.
     VERHEIJ: The remaining question is what type of communication will come either from the government
or from the public health community about truthful, accurate information about the significant differences be-
tween smokeless tobacco and cigarettes.
    STEARNS: The gentleman's time has expired.
    The gentlelady is recognized.
    CUBIN: Thank you. Thank you, Mr. Chairman. It troubles me that I've heard today in this hearing that,
to paraphrase, we will not even consider a possible action that could benefit smokers unless we have federal
regulation of that. In fact, we won't even consider looking at whether or not a product is beneficial unless we
have federal regulation. I disagree with that very much. I don't think that the first thing that we ever should
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do is look to federal regulation to solve our problems. Although there certainly is a point in our society when
that is appropriate.
    As far as federal regulation of these tobacco products, tobacco, whether you smoke it or whether you
use Snooze (ph) is a legal product. Now if this should ever happen that it does become regulated under the
FDA, then what's the next thing? Are we going to be regulating creamed gravy? Or white sauce, as it
might be called here in the Northeast? It just bothers me that some people think the only way to solve a
situation is that government has to take control. Historically they don't do that with (ph) a job.
     So I don't think that you can rule out listening to scientists who have done studies. You can't rule out
listening to information and facts that are presented to you simply because the federal government doesn't
have regulation over that area.
   I would like to start by asking a question, this time a general question about truth in advertising. Com-
mercial advertising is protected by the First Amendment provided that it is truthful ...
    STEARNS: Will the gentlelady just move her mike a little closer to her?
    CUBIN: Yes.
    STEARNS: Yes. Good.
     CUBIN: Thank you. Providing that it is truthful and not misleading. The government may regulate
commercial speech if it has a compelling interest in doing so and its regulation is reasonably tailored to di-
rectly advance that interest.
    In relation to the promotion of tobacco reduction products, what compelling state interest is directly ad-
vanced by suppressing truthful, reasonably tailored messages to the public? Do you understand the ques-
tion?
    MYERS (?): I'll start with you because it's based on a misconception. And that is ...
    CUBIN: No, you won't start. You've talked more here today than everyone, and we know how you feel.
    MYERS (?): But the government doesn't prohibit them (ph).
    CUBIN: No, sir. I would like to address someone else.
    STEARNS: The gentlelady controls the time.
    CUBIN: Thank you.
     The question I want to ask is that the government can regulate commercial speech if it has a compelling
interest in doing that and the regulation is reasonably tailored to directly advance that interest that the federal
government has. So in relation to the promotion of tobacco harm reduction products, is there, then, a com-
pelling state interest directly advanced by suppressing this truthful, non-misleading advertising?
      VERHEIJ: Congresswoman, if I may start with that, and then maybe others will chime in? The fact is we
believe there is no compelling interest by the state, particularly when you look at the offsetting potential ben-
efit to the public health that people like Mr. Sweanor and Dr. Rodu and many others have articulated to the
fact that this information, through some mechanism -- and again, I think everyone focuses on our company
as proposing we'd be the only avenue. Frankly, we would like to get out in the middle of that fight because
of concerns and go back to if we are taken out of the equation, what obligation does the government or pub-
lic health community have to communicate this information to adult smokers.
    CUBIN: Exactly. Exactly. And there are scientists and researchers that are available that are
non-biased in whether or not -- like you said, take tobacco out of the equation -- that could produce good in-
formation that we could base decisions on without federal oversight and without federal regulation.
     If the information is accurate and fairly presented, doesn't the public have a right to receive that informa-
tion and evaluate for themselves the usefulness of that information?
    Yes, Dr. Rodu?
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    RODU: Ms. Cubin, we've tried for 10 years to publish strongly scientifically based research in order to
help -- and I believe your husband's a practicing physician.
    CUBIN: That's correct.
   RODU: In order to help people like him help their patients, because we believe knowledge is power.
And it can help him help patients to make decisions that allow them to lead longer and healthier lives.
     CUBIN: Thank you. I do appreciate that. And that is exactly the course that my husband has tried to
follow, because that's one thing he tells every, single patient that comes in there that smokes carte blanche,
you must stop smoking. And they tell him, I cannot stop smoking. And at that point, he needs help in deal-
ing with them when they have tried gum, and when they have tried patches. You know, anything else would
be a benefit to him and especially to his patients.
    RODU: Maam, we'd like to say he's in the trenches.
    CUBIN: Thank you.
     RODU: The closer you are to real patients and real problems, the more likely you are to consider an op-
tion like smokeless tobacco.
    CUBIN: And that is the truth. I agree with you.
    BURTON: Congresswoman, could I weigh in?
    CUBIN: I don't see who's weighing in?
    BURTON: I'm sorry. This is Mr. Burton.
    CUBIN: Yes, you bet, Mr. Burton.
     BURTON: I guess I'll come back to a comment that I think I heard the surgeon general make this morn-
ing, which was in the presence of truthful and accurate information, nonetheless consumers might be incap-
able of making the right decision in their own interest and as well as the interest of the public health.
    CUBIN: Excuse me. Would you repeat that?
     BURTON: Certainly. I guess the point I'm making or want to make is hearken (ph) back to something
that the surgeon general said. And I think I have this from my own experience in being before the agency,
the FDA on drug applications. One of the burdens we as a drug supplier have to meet is a demonstration
that information can be correctly interpreted, can it be understood by the average consumer and can the net
behavior be actually be within the bounds of what we expect and what we know to be a safe and efficacious
use of that product.
      So while I think in part my answer, and I think the part of the answer the surgeon general was that even
information -- and I'm not accepting that the information as you framed it is necessarily truthful and accurate.
But were it to be found to be so, I think the question is can consumers take that information, interpret it and
act accordingly. And I think from our research and from what we've heard from other public health experts,
it's not only an individual decision, but it's also a public health population impact that we need to be con-
cerned about. If that information is targeted to a different group of people like young adults who might oth-
erwise not start smoking, upon hearing what may be truthful and accurate information to a so-called commit-
ted smoker, if that young adult decides to begin using those tobacco products under the assumption that that
is a safe alternative, I think that is a public harm that I think counters the public interest of providing that ac-
curate information, if, in fact, (inaudible) is true.
     CUBIN: Thank you. I appreciate that. But that's a very weak response when you consider the 10 mil-
lion people that are going to die over the next two decades because we are worried about children starting to
use a tobacco product when, in fact, we don't even know, and I've heard no source that quotes that smoke-
less tobacco is a gateway drug.
    Just real quickly?
    STEARNS: The gentlelady's time has expired.
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    CUBIN: Real quickly. I've been waiting all day.
    STEARNS: OK. Do you want to take a unanimous consent?
   CUBIN: Well, what are you going to do, Markey? No. But I would like to ask one other question. I
would like to ask unanimous consent for one question.
    STEARNS: The lady asks unanimous consent for an additional question. Is there any objection?
    Mr. Myers, I understand you have been waiting patiently. You're going to have to be on this other panel.
So I think you're welcome to leave. You've yeomaned (ph) service here since 10 o'clock. So if you have to
go to be on the other panel,
    MYERS: It's not another panel, but I do have an emergency that I have to go to (OFF-MIKE).
    STEARNS: OK. Well, that's fine. That's fine. We appreciate your staying this long and your patience
and so forth.
    MYERS: Thank you.
    STEARNS: The gentlelady is recognized.
    CUBIN: I don't want to be redundant. And most of the questions that I wanted to ask have been asked
and answered. But I would like to ask Mr. Verheij a question. Back to the Swedish study that males are
reported to have the highest rate of smokeless tobacco use and the lowest rate of cigarette smoking in any
western country. And the daily use of smokeless tobacco by Swedish males now, as has been stated, sur-
passes that of the use of cigarettes. Tobacco related mortality in Sweden is reported to be lower than any
other European or American country.
     From the point of view of comparative health risk, comparing cigarette smoking to smokeless tobacco or
snuse (ph), as we call it, would you describe your company's Revel product and what your marketing plans
for that are?
     VERHEIJ: I'd be happy to. The fact is that a number of researchers believe the Swedish model is in-
deed applicable here in the United States. The difference is that, as I think one of the panel members
noted, there is a cultural acceptance there as to the fact that smokeless tobacco is considered to be signifi-
cantly less harmful than smoking. And yes, it's not a communication from a tobacco company to consumers
in a newspaper. But when I was there in September for a conference on smokeless tobacco, there was a full
page ad in the primary newspaper signed by four leading Swedish researchers talking about this conversion
from smoking to smokeless tobacco and the fact is how fortunate they thought Sweden was to have smoke-
less tobacco as an alternative for those smokers who do not quit. So I think that's a good example where
the communication does not have to come from a tobacco company.
     When we began marketing Revel or at least test marketing Revel, it was advertised at a product for the
times you can't smoke. The fact is we would prefer to market Revel to adult smokers who are not quitting
on the basis of completely switching from smoking to smokeless tobacco, because what we have found out
in the research is that to convince a smoker to switch to smokeless tobacco, they need a very compelling
reason. And they need a very compelling reason because an overwhelming percentage of them have been
taught over decades now that smokeless tobacco is as dangerous as cigarette smoking. And so they think
they're trading oral cancer for lung cancer.
    They are shocked when they are provided truthful, accurate information about research in this country
and other countries concluding that smokeless tobacco is significantly less harmful than cigarette smoking.
Once they hear about that research and actually accept it, then they have that compelling reason. And that is
exactly -- Revel is designed to attract adult cigarette smokers, adult cigarette smokers only. And I think any
communication we plan in conjunction to that will be directed to only that audience.
    CUBIN: Thank you.
    STEARNS: The gentlelady's time is expired.
    CUBIN: Thank you.
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                      FDCH Political Transcripts June 3, 2003 Tuesday

    STEARNS: The gentleman from Massachusetts?
    MARKEY: Thank you, Mr. Chairman, very much.
      I don't think anyone's going to debate that it's less dangerous. I think we're going to accept the fact that
it's less dangerous. But that's a little bit like saying well, you know, we've been playing Russian Roulette with
three bullets in a six chamber gun. And now we're going to reduce it down to only one bullet in a six cham-
ber gun. So it's obviously a safer game playing Russian Roulette with only one bullet than three bullets in a
six bullet chamber. But eventually if you play the game long enough, then enough people are going to get
harmed that most people will say that's too dangerous a game to be playing. And I think that's, you know,
why you have the level of concern that members are indicating, Mr. Verheij, today.
    Let me ask this. If the Massachusetts attorney general and others wanted to examine and reveal to the
public the additives that are being put into smokeless tobacco products, why can't the public know what
those ingredients are so they can make up their own mind as to whether or not they or their family members
would use that product?
     VERHEIJ: As you know, Congressman, under the 1986 act, we as a company and an industry are re-
quired to report all of our ingredients to HHS, which I think the surgeon general confirmed this morning indi-
cated that they had an ability to look at that list. And every year we dutifully file that list. And to the extent
that HHS has a concern, it is explicitly authorized to report to Congress about the concerns they have.
     In connection with that, however, there are measures taken to protect the proprietary interest that the
companies have in the unique ingredients used in the product. As for another state as an example, Texas
has adopted a similar statute, and, in fact, the industry reports its ingredients to Texas. I think where the
difference was in Massachusetts that in our view, in the industry's view, that the statute at the time that was
proposed that was put into place was really not a disclosure statute. But it was really a forfeiture statute
where we would have forfeited the proprietary value of the ingredients we used. And the court of appeals
agreed with that argument.
    MARKEY: I understand that. But the problem is from a consumer perspective, as the surgeon general
said today, there are carcinogens in your product. And those carcinogens also contribute to other types of
diseases, cardiac disease in addition to respiratory.
    VERHEIJ: Well, I think now, if I understand your question correctly, we've shifted from ingredients which
are those items that are added to the product by the company, all of which are approved for use in food or
food grade, unlike other tobacco products. And I think by your question, I understand you want to shift to
constituents like nitrosamines. And as indicated earlier, the Massachusetts Department of Health has con-
ducted at least one survey. We have met with the department in terms of trying to evaluate that data. Dr.
Connelly (ph) of your state called me about three weeks ago.
    He was particularly concerned about levels in a competitor's product, gave me some idea of the levels of
the constituent levels in our product in the current survey. He's very concerned about the fact of being able
to continue that testing, although his budget has been cut dramatically. And we actually engaged in a dis-
cussion about industry funding of that survey for him on an annual basis so that the state of Massachusetts
can actually do that.
   MARKEY: Well, would U.S. Smokeless Tobacco Company support a regulation which mandates that all
smokeless tobacco products contain nitrosamine levels below 10 micrograms per gram if this were imple-
mented in Massachusetts?
     VERHEIJ: Well, I think we had an agreement with Dr. Connelly (ph) that everyone was moving in a direc-
tion of trying to reduce it to the lowest levels possible. I guess I'd have some questions about the level of 10
parts per million, because when Dr. Connelly (ph) proposed that, when he was advised by a newspaper re-
porter about the levels of nitrosamines in the Revel product, which are around two to three parts per million,
his response was well, there's no magic about 10.
     So I think it would be worthwhile for everyone, the industry and (ph) your state and Dr. Connelly (ph) to
get together and work out some standards that he, perhaps as an encouragement to the industry, goals and
targets -- which we'd be happy to sit down and work with him to do that.
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                      FDCH Political Transcripts June 3, 2003 Tuesday

    MARKEY: I think in general that the American public has become acclimated to knowing what is inside of
the products which they purchase. My father late in life became a health food nut. I would have sworn that
a guy that used to just put the whole can of sardines and slice off 12 heads at once and then pop them all in
his mouth when I was a boy would become a health food fanatic at 70 and 75 and 80 and 85. But he did.
And so here's a product, though, that ...
    CUBIN: Would the gentleman yield?
    MARKEY: I'd be glad to.
    CUBIN: Are you supposed to cut the heads off of sardines before you eat them?
    MARKEY: Well, my father thought it was fun if they all squirted toward my brother's head and was just
kind of...
    CUBIN: Being from Wyoming, I don't have a lot of...
    MARKEY: My father's a milkman for the Hood Milk Company.
    CUBIN: Well, thank (ph) you (ph).
    MARKEY: And his form of humor was lost on my mother. Although my brothers and I thought it was
very funny.
    CUBIN: I can relate to that.
    MARKEY: But anyway, I'm just saying that his eating habits weren't the best. But he later just became a
fanatic and studying every, single ingredient and every, single thing that he put into his system. And but for
smoking, the doctor said he would have gone on indefinitely over the age of 100.
    And here's a product, though, that we know is inherently, you know, dangerous because of the carcino-
gens that are in it. And the more information which is out there, I think the more likely that there would be
an abstinence that was total. That was thought to be an unimaginably high goal a generation ago. But the
whole culture has changed. If my father could change, anyone could change.
     And all I'm saying to you is that that information is what you're denying the public under the guise of pro-
prietary information, competitive advantage. But, in fact, in my opinion, it's to deny the public the knowledge
of the danger which their bodies are being exposed to by having these kinds of products put near their bo-
dies.
    I thank you, Mr. Chairman.
   VERHEIJ: Mr. Chairman, if I may just respond to that last point? The fact is that I heard the surgeon
general this morning very strongly indicating that, in fact, as these ingredients are reported to (ph) our (ph)
government, they have mechanisms, including his bully pulpit is there was a concern to educate the public
about ingredients in tobacco products.
     We share your concern about educating the public, but in the context of educating the public about the
fact that there are dramatic differences between the relative risk between smokeless tobacco and cigarettes.
And they're not getting that information, either.
    STEARNS: The gentleman's time is expired. We'll allow you to answer. Do you want to reply also?
   TOMAR: Yes. I just wanted to speak to the issue of the additives to smokeless tobacco products. I
used to be an epidemiologist with the Office on Smoking and Health, and so I was able to see that list of
more than 500 chemicals that are added to smokeless tobacco products.
     When we were there, we asked them to provide brand specific information on that. And they refused.
They also don't provide any information on concentration or quantity on any of those 500 chemicals. And a
number of the chemicals that are added to those products are specifically to affect the nicotine dosing prop-
erties of those products. That feeds into their whole graduation strategy of being able to manipulate the ni-
cotine dosing properties.
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U.S. REPRESENTATIVE CLIFF STEARNS (R-FL) HOLDS HEARING ON TOBACCO HARM REDUCTION
                      FDCH Political Transcripts June 3, 2003 Tuesday

     We asked them to provide information on PH. The degree of alkalinity (ph) of the product affects the
rate of nicotine absorption. They refused to provide brand specific information. If the company really wants
to disclose truthful information to the public, they can start with what they already have.
    STEARNS: The gentleman's time is expired.
    The gentleman from New Hampshire?
     BASS: Thank you very much, Mr. Chairman. And I just want to emphasize that we are here today to
talk about relatively, not absolutes. And I don't think any member of this subcommittee believes that smok-
ing cigarettes or the use of tobacco products is good for your health or should be condoned, especially
amongst minors.
     And a lot of the debate today has revolved around accusations that somehow minors are going to get
into the business of chewing tobacco or smoking cigarettes, which has always been a problem. And in my
home state, it's a misdemeanor to possess tobacco products of any sort under the age of 18. There are
criminal penalties for that. And our (ph) local law enforcement community enforces that. And nobody here
today is advocating that.
     And so the issue is for those individuals that can't terminate the use of cigarettes, what other options ex-
ist. And we've talked about a lot of different opportunities and the other issue, whether or not the industry,
the smokeless tobacco industry can advertise or discuss in an advertisement any kind of relative benefit of
their product versus any other.
    I have two questions, one for Mr. Verheij and another one for Dr. Tomar.
    Mr. Verheij, if U.S. tobacco were to advertise smokeless tobacco products as being less harmful than
cigarettes, how would you advertise that fact under government guidelines, assuming you were to produce
under government guidelines without influencing minors to use the product?
    VERHEIJ: Well, we've given that some thought. And there are a number of ways that we communicate
directly to adults. We have adult only facilities where people are carded who are only 18 and over are ad-
mitted. In fact, we get information about the tobacco habits of those particular individuals. We find out if
they're smokers. And we could make a communication right there.
     There are also direct mail lists of adult smokers. We don't really -- and I mean, I think people envision
some broadbased advertising program. And frankly, it wouldn't be very effective, because it would be so
diffuse when you're really trying to address adult smokers who are not quitting.
     The optimal, from our standpoint, would be take us out of the equation. If, as Dr. Rodu indicated, all
those physicians in the trenches -- if it was physicians who (ph) were advised by the government that, in fact,
here they have a patient who's a smoker, who they've tried the gum, they've tried the patch. They're not
quitting.
   That they could advise that patient of smokeless tobacco as a significantly less harmful option, then the
company wouldn't have to make any type of communication if that's the type of communication the govern-
ment and the public health community were giving to the adult smokers who do not quit.
    BASS: OK.
    And Dr. Tomar, I understand that you are listed as an expert witness in an action brought by the Wash-
ington state attorney general to recover the healthcare costs of tobacco use. And that you prepared a report
estimating that the healthcare costs related to smokeless tobacco use were less than 1 percent of those of
cigarette smoking. Is that true?
    TOMAR: I would have to go back and look at the figures. It's been a number of years. I don't remem-
ber the exact figure.
    BASS: OK. Well, if you'd be kind enough to check up on that and advise the committee, I'd be very
grateful to you.
    Mr. Chairman, I yield back.
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U.S. REPRESENTATIVE CLIFF STEARNS (R-FL) HOLDS HEARING ON TOBACCO HARM REDUCTION
                      FDCH Political Transcripts June 3, 2003 Tuesday

    STEARNS: Do you mind yielding the balance to the gentlelady?
    BASS: Yes. I'd like to yield to the gentlelady from Wyoming.
    CUBIN: The question I wanted to ask -- and maybe, Mr. Burton, you'll know, or Mr. Verheij, maybe you'll
know. Are physicians right now prevented from telling their patients that they believe smokeless tobacco is
a healthier alternative, is healthier than smoking, although not a healthy alternative?
    And, Dr. Rodu, you may know that answer. Anyone. Anyone just speak.
     RODU: Well, let me start. Just based on our conversations with physicians, which we do on a frequent
basis in terms of trying to identify the issues related to smokeless tobacco -- and I believe there have been
some submissions for the record from treating physicians and head and neck surgeons. What is taught in
public health school is that smokeless tobacco is as dangerous as cigarette smoking. And they are stunned
to find out that many researchers believe that smokeless tobacco is significantly less harmful.
    CUBIN: But do you know, Dr. Rodu, is there a prohibition against physicians telling their patients that?
    RODU: No, none whatsoever. It's called informed consent.
    CUBIN: Correct.
      RODU: As long as we provide both the risks and the benefits of any treatment that we recommend, we're
fulfilling our obligations as health professionals in letting people make choices.
    CUBIN: And, Mr. Burton, is that the sort of thing that doctors also have to do when they are recommend-
ing a prescription that perhaps your company might manufacture when they're prescribing that medication?
    BURTON: Certainly. Physicians would advise their patients of the risks and benefits of a particular
course of action. Certainly I think a significant difference being the fact that when you're talking about
pharmaceuticals or medicines, they have been reviewed by the agency, the FDA.
    CUBIN: (inaudible)
    BURTON: They have been proven to be safe and effective. And the physician within that context can
go beyond based on his understand or her understanding of the science to maybe amplify what is in the ap-
proved labeling for that particular drug.
    CUBIN: Thank you.
    Thank you, Mr. Bass.
    STEARNS: And the gentleman's time has expired. And our hearing has expired. And we are complet-
ing by unanimous consent, all members will have five working days to enter any extraneous material they
wish to put in. I think it's been an excellent debate. And I want to thank the witnesses sincerely for this
long afternoon. We need to focus on the science of this debate. The science should lead the way. And if
the science tells us that lives can be saved, we need to investigate these options.
    I hope the Federal Trade Commission will seriously consider putting together a workshop on tobacco
harm reduction. If we can save even a handful of people out of the 400,000 people who die every year, it'll
be worthwhile to do.
     I also want to thank staff for getting all this balanced -- I think a very balanced hearing. And I think the
thesis of our hearing has been accomplished, namely that smokeless tobacco needs to be explored as an
alternative for persons who cannot stop smoking. And we need more research on that.
    And with that, the subcommittee is adjourned.
    END

LOAD-DATE: June 6, 2003

LANGUAGE: ENGLISH
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U.S. REPRESENTATIVE CLIFF STEARNS (R-FL) HOLDS HEARING ON TOBACCO HARM REDUCTION
                      FDCH Political Transcripts June 3, 2003 Tuesday

TYPE: COMMITTEE HEARING

 NOTES:
[????] - Indicates Speaker Unknown
   [--] - Indicates could not make out what was being said.[off mike] - Indicates could not make out what was
being said.

                           Copyright 2003 FDCHeMedia, Inc. All Rights Reserved.



                                              7 of 9 DOCUMENTS

                                                CFO Magazine

                                                  March 2002

Clinical Trials: CFOs in the Drug World
BYLINE: Kris Frieswick

LENGTH: 3519 words

HIGHLIGHT: A new kind of pricing pressure puts pharmaceutical finance chiefs in an unfamiliar role: evan-
gelist.

    Last December, Merck & Co., the world's third-largest pharmaceutical company, warned analysts that
earnings would be flat for 2002, due to disappointing sales for arthritis drug Vioxx and expiring patents for
other drugs. Stock of the drug maker fell about 15 percent on the news, which helped sink the shares of
many other pharmaceutical companies facing similar patent expirations.
      Yet, despite flat-lined earnings growth, Merck will increase research and development spending for 2002
to $2.9 billion, up 16 percent from 2001 levels. That money will support clinical trials of the 11 new drugs in
Merck's pipeline. "It was a tough decision," says Judy Lewent, CFO of Merck for the past 12 years. "But we
felt it was critical to continue investing in R&D, even if it contributed to flat earnings."
   Long known in finance circles for her mastery of sophisticated modeling techniques such as Monte Carlo
simulation, Lewent isn't about to take her money off the table now. "We had long discussions about it, and
came to the conclusion that our job is to balance the long and short term," she says. "To delay the spending
would have more serious repercussions than spending the money now."
     As tough as the decision to increase spending was for Lewent, most CFOs would love to be in a position
to make a similar one. Merck had a 2001 net income of $7.2 billion on companywide revenues of $47.7 bil-
lion, an increase of 7 percent over 2000's net income of $6.8 billion--healthy growth in a year when so many
other industries took a financial bath. Still, by the standards of the pharmaceutical industry, Merck is lagging.
On the whole, drug companies generate higher profits as a percent of revenues than any other industry, reg-
ularly topping 18 percent. Many of the major players, like Eli Lilly, Merck, and Pfizer, just paid the highest
dividends to shareholders in company history.
    But such success creates its own turbulence. The drug companies face intensifying price pressure, not
from commoditization or competition but from, in essence, bad PR. Trumpeting multi-billion-dollar profits has
made them a target for governments, corporations, and individuals eager to cut health-care costs. "Right
now, the pharmaceutical industry has a bull's-eye painted on its back," says Ira Loss, executive vice presi-
dent of Washington Analysis, an institutional investor research group.
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                     Clinical Trials: CFOs in the Drug World CFO Magazine March 2002


    And while justifying their profits to the critics, drug-company CFOs must also satisfy shareholders ac-
customed to those profits. Because of the high risks in pharmaceuticals, explains Eli Lilly and Co. CFO
Charles Golden, shareholders expect high returns. In 2000, for instance, Lilly paid out $1.12 billion in divi-
dends, out of net income of $3.05 billion. "I could lower my prices on products, but I probably wouldn't have
many stockholders," says Golden. "We can't remain as vibrant as we are if we don't have the cash flow or
income stream to absorb the risk."
     Lewent articulates the conflict quite clearly. "One of the biggest issues I face right now is rebuilding
shareholder confidence in future prospects for Merck," she says. "Another one is to continue to expand the
understanding, on a global basis, of the critical role of pharmaceuticals and innovation, and the balance be-
tween innovation, intellectual property rights, and investor returns. One [issue] hits on the fiber and mission
of the pharmaceutical industry, and the other one is critical to our shareholders and stakeholders."
      Medicines for Melancholy Ironically, much of the pressure Lewent and her peers face is a result of the
enormous demand for pharmaceuticals. Retail sales jumped by 18.8 percent in 2000 (primarily from the in-
creasing number of prescriptions, not price, according to the National Institute for Health Care Management,
a nonprofit research group). New drugs are hitting the market to treat common illnesses that were formerly
treated in other ways or not at all. For example, statins (like Pfizer's Lipitor), which reduce cholesterol, and
antidepressants (like Lilly's Prozac) have opened up huge markets. These and drugs such as Vioxx for arth-
ritis and Viagra for erectile dysfunction reflect the increasing demands of aging baby boomers.
    Pharmaceutical companies have become much more efficient at supplying drugs to meet this market.
Jonathan Symonds, CFO of AstraZeneca, which had sales of $16.4 billion in 2001, says R&D productivity
has increased 50 percent since 1999. (Pharmacos spend only 15 to 20 percent of their revenues on R&D--in
some cases, less than they spend on dividends. And once drugs are approved, gross margins soar to more
than 80 percent.)
    Drug companies are also sourcing new medicines from outside. Since 9 out of every 10 drugs in devel-
opment are dropped during the lengthy (up to 10 years) clinical trial and approval process, big pharmacos
are increasingly turning to in-licensing (buying rights to promising drugs already under development at other
companies) or are taking equity stakes in smaller drug companies.
    But extraordinary demand and efficient supply would mean nothing if the industry weren't operating in a
free market. What pharmaco CFOs fear most are constraints on this market. "The proper system is a
free-market system," says Lewent. "If there's value in it, there will be demand. Pharmaceuticals are not a
cost-plus business."
     Golden of Lilly points to Xigris, a treatment for severe sepsis that costs $6,800 per 96 hours of treatment,
as a perfect example of the free market at work. "We try our best to determine what people think is reasona-
ble," he says. "There is no other treatment today for sepsis [a massive, usually fatal infection]. You could de-
fine this drug as having infinite value, but if we priced it too high, it wouldn't be used too much. That's some-
thing we don't want." Golden says Lilly consulted with doctors, insurance companies, and its own sales staff
to determine the correct price point.
    Not many U.S. companies would put "maintenance of free market" at the top of their worry list, but the
pharmaceutical industry has genuine reasons for concern. As global businesses, they find themselves at
odds with the governments of many countries, especially in Europe. As Symonds of London-based AstraZe-
neca explains, "Medicaid and health-plan contracts in the U.S. are tough, but at least they're commercial.
What you see in other countries is that the government is controlling health systems. You have price reduc-
tions without the ability to have discussions about the product benefits."
     Pricing controls in European markets, such as France, which demands very low prices from drug mak-
ers, have pharmacos threatening to pull out of these markets. Developing nations and international
health-care organizations are demanding dramatically reduced or free medicines to treat the AIDS pandemic.
Largely due to price controls elsewhere, the United States funds development not only of the drugs it con-
sumes but also of the drugs other countries consume at discount prices. "There's no question that we sub-
sidize the rest of the world on this effort," says Loss at Washington Analysis. "This comes right out of our
pockets." At least for now, drug companies are free to charge what they feel they must to make up for the
foreign-profits constraints.
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                     Clinical Trials: CFOs in the Drug World CFO Magazine March 2002


    A Place for Profit But that may change. Activists, government leaders, and consumer groups in the
United States have begun to target the pharmaceutical sector for what they call excessive profits and for an-
ticompetitive behavior. Historically, drug costs were largely hidden, thanks to broad insurance coverage,
much of it paid for by employers. Today, individuals are increasingly called upon to pay some of their
health-care bill. Health insurance costs are on the rise again (11 percent for 2001), and prescription drugs
are the fastest-growing segment.
     To cut costs, employers are increasingly moving to a tiered system in which a larger copayment is re-
quired for brand-name prescriptions than for generic versions. Besides the approximately 50 percent of in-
sured employees facing these added costs, another 40 million Americans lacked insurance altogether for at
least a portion of 2000, and that number is expected to rise in 2001-2002. Add an additional 15 million to 25
million people without adequate prescription drug coverage, including 27 percent of Medicare recipients, and
a sizable constituency is born. Little wonder that prescription drug costs are under the most serious fire
they've faced since Sen. Estes Kefauver held drug-company antitrust hearings in Congress from 1959
through 1961.
     "There is a place for profit," says Larry D. Sasich, research director of the Public Citizen Health Research
Group, "but it has to be controlled by the government. The companies have hidden behind the facade that
their primary core is public health, [but] they make decisions based on the market."
    Pharmaco CFOs claim they are unfairly being targeted for cost cutting, considering drugs represent a
small portion of overall health-care costs and in many cases help consumers avoid more-expensive treat-
ments. "Would our customers like lower prices?" asks Eli Lilly's Golden. "Of course, but they realize our
therapies save lives. Mental health [drug therapy] is a great example. The price of the drugs is minuscule
compared with the economic cost of the disease."
      The critics argue that huge profits, like those at Pfizer, which saw net income more than double in 2001,
to $7.79 billion (it took large merger-related write-downs in 2000), make them sitting ducks for cost-cutting
initiatives--for fiscal and ethical reasons. "Some countries feel that it is wrong to make that much of a profit
from sick people," says Sasich.
     The drug companies have taken some steps to appease their critics, although to date most of their ef-
forts have been overshadowed by their efforts to protect shareholder value. Take, for instance, their stands
on federally and state-supported prescription drug benefits. With 25 states facing Medicaid shortfalls in 2002,
pharmacos say they fully support Medicaid and Medicare prescription drug benefits. "There are certain seg-
ments of the population that aren't represented by insurance coverage," says Lewent. "We are as active as
possible on efforts to find the solution to get coverage for those people. The answer is a federally supported
Medicare drug reimbursement program."
     Still, six drug makers, including Merck and Pfizer, refused to participate in another government-funded
prescription drug program, the Michigan Medicaid formulary program. The industry has filed lawsuits at-
tempting to block programs in both Michigan and Florida, claiming that the formulary program restricts pa-
tients from getting needed drugs. In fact, the programs don't block access, but they do force doctors who
wish to prescribe drugs not on the formulary to get prior approval from a team of Medicaid pharmacists and
doctors. The lawsuits contend that most doctors won't put in the extra effort.
    Medicaid directors say the drug companies are just trying to protect their profit margins. Pharmaco CFOs
say they fear a large, centralized prescription program would wield such immense buying power that it could
unilaterally demand lower drug prices for an enormous market base--as is the case in Europe. They favor
"market-based" systems instead--private insurance programs in which doctors are free to prescribe what
they want and drug makers can negotiate with the prescription programs on the prices they charge.
     While the suits have thus far yielded mixed results, at least one pharmaco has found a way to circumvent
the issue. Pfizer managed to get all of its drugs on the Florida formulary without cutting its prices. Instead, it
guaranteed that the state would get at least $30 million in savings by allowing Pfizer to underwrite a dis-
ease-management program, which closely monitors the care of the state's sickest Medicaid recipients. If the
state fails to realize the expected cost savings, Pfizer has promised to pay the difference.
   Almost all drug makers already offer some type of free or reduced drug program for low-income patients,
administered largely through physicians. This January, Pfizer unveiled a new program called Share Card,
                                                                                                         Page 150
                      Clinical Trials: CFOs in the Drug World CFO Magazine March 2002


which gives low-income Medicare recipients $15, 30-day prescriptions on any of its drugs (excluding one that
is comarketed with another company). Both CVS and Wal-Mart have signed on to the program, which has
received loud endorsements from some industry critics. Analysts also praise the move, saying that such pro-
grams may do more to defuse pricing pressures than any other measures.
     "The Pfizer program is a masterstroke," declares Loss of Washington Analysis. "It's easy to understand,
it provides a real benefit to people who need it, and I think a lot of the political pressure will be alleviated."
Loss says the program "gives politicians who aren't already opposed to the drug industry a reason to contin-
ue with their support."
     Overprotecting Patents? Unfortunately, the industry is giving politicians plenty of other reasons to be
against it, most notably with its efforts to block generic competition. Drug patents are in force for 17 years,
but since drug substances are usually patented about 10 years before a brand-name drug makes it to mar-
ket, new drugs have only a 7-year profit window.
     Drugs also often receive numerous patents, on everything from additional uses (called indications) to
methods of manufacturing. AstraZeneca is currently embroiled in a court battle over ulcer drug Prilosec. Until
last year, it was the largest-selling prescription drug in the world, with more than $6 billion in annual sales,
but its substance patent expired in October 2001. Generic makers jumped in, but AstraZeneca sought to
block them for infringing on a formulation patent that covers how the drug is protected from digestion by
stomach acid. That patent was issued six years after the substance patent was granted, and CFO Symonds
claims it is still in force. "Our belief is that we are dealing with nontrivial intellectual property," he says. "We
have a very important obligation to protect it."
     All the pharmaco CFOs agree that some companies have taken the issue of patent protection too far,
which harms the entire industry. Bristol-Myers Squibb Co., called by analysts the most aggressive at pur-
suing patent protection, was recently sued by 30 state attorneys general for violating antitrust laws. The suits
allege the company illegally kept generic versions of its BuSpar antianxiety medication off the market, cost-
ing consumers millions. It allegedly did so by making misleading statements to the Food and Drug Adminis-
tration (FDA) about the scope of a new "last-minute" patent for BuSpar in order to gain a few more months of
patent exclusivity. (BMS declined to comment for this story.) The Federal Trade Commission has filed a brief
in the case, and has launched an investigation into similar anticompetitive practices in the industry.
     "There is a point at which patent protection becomes frivolous protection of the product without sub-
stance," says Symonds. "There is a line that has to be drawn, beyond which all you do is undermine your
company's credibility and the industry's credibility." Golden of Eli Lilly agrees, and even though that company
is aggressively pursuing its Prozac patent, it has not attempted to patent additional indications for the prod-
uct, or variations to the original substance, which would have given it further exclusivity. "We didn't think it
was right to follow the path of getting a new patent on Prozac," says Golden. "We didn't think it was ethical."
    Lewent says that Merck has a general policy of looking forward, not backward, for sources of growth.
"For existing patents in place," she says, "we will defend them anywhere, anytime. With Vioxx, we had some
cases that we fought, and we prevailed. However, our basic view is that our role in the future of medicine and
therapy is to drive the R&D process and come up with the next generation. We believe that innovation is the
way to further the enterprise."
    As Seen On TV With patents expiring, pharmacos need to make the most of the market exclusivity that
they have, and they've done so to an increasing extent, using direct-to-consumer (DTC) advertising. But
these ads have come under fire from consumer groups and from some corporations that claim the ads drive
up drug costs by creating a desire for more-expensive drugs that consumers don't always need.
    "Direct-to-consumer advertising drives unnecessary utilization," says Rob Minton, manager of
health-care communications at General Motors Corp., which saw its cost for prescription drug coverage rise
to $1.3 billion in 2001. "When someone walks into a doctor's office and asks for a drug they saw advertised
on TV, most of the time the doctor will prescribe it, even if the patient doesn't need it."
    A recent internal GM study seems to validate Minton's theory. The study examined hundreds of GM em-
ployees who used Prilosec. Over three years, 92 percent of plan members receiving prescriptions for the
drug had no prior prescriptions or treatments for gastrointestinal (GI) disorders or heartburn. Most doctors
think Prilosec is the drug of choice for only a severe form of GI acid reflux; in other cases, generic Tagamet,
                                                                                                        Page 151
                      Clinical Trials: CFOs in the Drug World CFO Magazine March 2002


Zantac, or even over-the-counter Mylanta would work just as well--for a fraction of the cost. "In most cases,
the most expensive drug was the very first therapy, when only a small percentage really needed it," says
Minton.
     There's no hard data to support that statement, but one thing is certain: drug advertising works. A recent
study by the National Institute for Health Care Management showed that the increase in sales of the 50 most
heavily advertised prescription drugs accounted for almost half of the rise in retail spending on all prescrip-
tion drugs. The 50 drugs saw increased sales of 32 percent compared with 13.5 percent for all other drugs.
    DTC advertising spending by pharmaceutical companies has skyrocketed in recent years. Ad spending
alone (which includes advertising to doctors) rose to $2.5 billion in 2000 from $791 million in 1996. Pharma-
cos argue that the advertisements educate patients about their illnesses and may help more people get the
treatment they need, or encourage them to stay on a prescribed medication. "The evidence so far is that di-
rect-to-consumer advertising for critical disease has had a major beneficial effect," claims Lewent. "It's not
bringing in people who don't need it."
    The FDA is conducting a major study to determine whether this is the case. Some corporations aren't
waiting, though. In mid-2001, GM sent its in-house pharmacist, Cynthia Kirman, and the company's former
executive director of health-care initiatives, Jim Cubbin, to meet with representatives of the top five drug
manufacturers. "We wanted to let them know that we think their marketing practices are inappropriate and
that we are not happy about it," says Minton.
    Defusing the Pricing Bomb By their own admission, pharmaco CFOs haven't done a very good job of
defusing the drug-pricing bomb. "I think some of the criticism of the industry is justified," says Lilly's Golden,
"because we haven't done as good a job of making our case. Our ability to educate people about why we are
doing what we're doing with our pricing is probably our hardest challenge."
    The industry has spent considerable time and money making its case to lawmakers. Pharmacos hired
625 different lobbyists in 2000, and spent $262 million on lobbyists, political contributions, and issue ads
during the 1999-2000 election cycle alone, more than any other industry, according to Public Citizen's Con-
gress Watch and the Center for Responsive Politics. But programs like Pfizer's Share Card may be just as
effective at swaying public opinion. "Any money they lose on this program should be viewed as an invest-
ment," says Loss of Washington Analysis.
    Although programs help, it seems these CFOs are relying most heavily on the public goodwill generated
from the industry's role as discoverer of lifesaving drugs--and the potential threats to that role posed by profit
constraints--to eventually relieve the pressure to rein in prices. Says Lewent: "We hearken back to a quote
from George Merck [former chairman and son of the founder]: 'Medicine is for the people, not the profit. If
you take care of the people, the profits will follow.' That's the way we run our business."
     In the final analysis, says Golden, pricing pressures are not as big a threat as shareholder alienation.
"Ultimately, we exist with the support of our shareholders. If no one wants to buy our stock, we won't be in
business."
    On the other hand, "if they don't take control of the price problem, someone else will," says Loss. "And
they're not going to like who the 'someone else' is."
    Kris Frieswick (krisfrieswick@cfo.com) is a staff writer at CFO.

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                                              8 of 9 DOCUMENTS
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                              CFO The Magazine for Senior Financial Executives

                                                  March 2002

Clinical trials: A new kind of pricing pressure puts pharmaceutical
CFOs in an unfamiliar role: Evangelist.
BYLINE: Frieswick, Kris

SECTION: Pg. 55(5) Vol. 18 No. 3 ISSN: 8756-7113

LENGTH: 3603 words


HIGHLIGHT: drug companies balance investor returns and profits against price cut demands

    Frieswick, Kris
     LAST DECEMBER, MERCK & Co., the world's third-largest pharmaceutical company, warned analysts
that earnings would be flat for 2002, due to disappointing sales for arthritis drug Vioxx and expiring patents
for other drugs. Stock of the drug maker fell about 15 percent on the news, which helped sink the shares of
many other pharmaceutical companies facing similar patent expirations.
      Yet, despite flat-lined earnings growth, Merck will increase research and development spending for 2002
to $2.9 billion, up 16 percent from 2001 levels. That money will support clinical trials of the 11 new drugs in
Merck's pipeline. "It was a tough decision," says Judy Lewent, CFO of Merck for the past 12 years. "But we
felt it was critical to continue investing in R&D, even if it contributed to flat earnings."
   Long known in finance circles for her mastery of sophisticated modeling techniques such as Monte Carlo
simulation, Lewent isn't about to take her money off the table now. "We had long discussions about it, and
came to the conclusion that our job is to balance the long and short term:' she says. "To delay the spending
would have more serious repercussions than spending the money now.
     As tough as the decision to increase spending was for Lewent, most CFOs would love to be in a position
to make a similar one. Merck had a 2001 net income of $7.2 billion on companywide revenues of $47.7 bil-
lion, an increase of 7 percent over 2000's net income of $6.8 billion--healthy growth in a year when so many
other industries took a financial bath. Still, by the standards of the pharmaceutical industry Merck is lagging.
On the whole, drug companies generate higher profits as a percentage of revenues than any other industry,
regularly topping 18 percent. Many of the major players, such as Merck, Eli Lilly, and Pfizer, just paid their
highest dividends in history.
    But such success creates its own turbulence. The drug companies face intensifying price pressure, not
from commoditization or competition but from, in essence, bad PR. Trumpeting multi-billion-dollar profits has
made them a target for governments, corporations, and individuals eager to cut health-care costs. "Right
now, the pharmaceutical industry has a bull's-eye painted on its back," says Ira Loss, executive vice presi-
dent of Washington Analysis, an institutional investor research group.
    And while justifying their profits to the critics, drug-company CEOs must also satisfy shareholders ac-
customed to those profits. Because of the high risks in pharmaceuticals, explains Eli Lilly and Co. CFO
Charles Golden, shareholders expect high returns. In 2000, for instance, Lilly paid out $1.12 billion in divi-
dends, out of net income of $3.05 billion. "I could lower my prices on products, but I probably wouldn't have
many stockholders," says Golden. "We can't remain as vibrant as we are if we don't have the cash flow or
income stream to absorb the risk."
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                        CFO The Magazine for Senior Financial Executives March 2002

    Lewent articulates the conflict quite clearly. "One of the biggest issues I face right now is rebuilding
shareholder confidence in future prospects for Merck," she says. "Another one is to continue to expand the
understanding, on a global basis, of the critical role of pharmaceuticals and innovation, and the balance be-
tween innovation, intellectual property rights, and investor returns. One[issue]hits on the fiber and mission of
the pharmaceutical industry, and the other one is critical to our shareholders and stakeholders."
    MEDICINES FOR MELANCHOLY
      Ironically, much of the pressure Lewent and her peers face is a result of the enormous demand for
pharmaceuticals. Retail sales jumped by 18.8 percent in 2000 (primarily from the increasing number of pre-
scriptions, not price, according to the National Institute for Health Care Management, a nonprofit research
group). New drugs are hitting the market to treat common illnesses that were formerly treated in other ways
or not at all. For example, statins(like Pfizer's Lipitor), which reduce cholesterol, and antidepressants (like
Lilly's Prozac) have opened up huge markets. These and drugs such as Vioxx for arthritis and Viagra for
erectile dysfunction reflect the increasing demands of aging baby boomers.
    Pharmaceutical companies have become much more efficient at supplying drugs to meet this market.
Jonathan Symonds, CFO of AstraZeneca, which had sales of $16.4 billion in 2001, says R&D productivity
has increased 50 percent since 1999. (Pharmacos spend only 15 to 20 percent of their revenues on R&D--in
some cases, less than they spend on dividends. And once drugs are approved, gross margins soar to more
than 80 percent.)
    Drug companies are also sourcing new medicines from outside. Since 9 out of every 10 drugs in devel-
opment are dropped during the lengthy (up to 10 years) clinical trial and approval process, big pharmacos
are increasingly turning to in-licensing (buying rights to promising drugs already under development at other
companies) or are taking equity stakes in smaller drug companies.
    But extraordinary demand and efficient supply would mean nothing if the industry weren't operating in a
free market. What pharmaco CFOs fear most are constraints on this market. "The proper system is a
free-market system' says Lewent. "If there's value in it, there will be demand. Pharmaceuticals are not a
cost-plus business."
     Golden of Lilly points to Xigris, a treatment for severe sepsis that costs $6,800 per 96 hours of treatment,
as a perfect example of the free market at work. "We try our best to determine what people think is reasona-
ble," he says. "There is no other treatment today for sepsis[a massive, usually fatal infection]. You could de-
fine this drug as having infinite value, but if we priced it too high, it wouldn't be used too much. That's some-
thing we don't want." Golden says Lilly consulted with doctors, insurance companies, and its own sales staff
to determine the correct price point.
    Not many U.S. companies would put "maintenance of free market" at the top of their worry list, but the
pharmaceutical industry has genuine reasons for concern. As global businesses, they find themselves at
odds with the governments of many countries, especially in Europe. As Symonds of London-based AstraZe-
neca explains, "Medicaid and health-plan contracts in the U.S. are tough, but at least they're commercial.
What you see in other countries is that the government is controlling health systems. You have price reduc-
tions without the ability to have discussions about the product benefits."
     Pricing controls in European markets, such as France, which demands very low prices from drug mak-
ers, have pharmacos threatening to pull out of these markets. Developing nations and international
health-care organizations are demanding dramatically reduced or free medicines to treat the AIDS pandemic.
Largely due to price controls elsewhere, the United States funds development not only of the drugs it con-
sumes but also of the drugs other countries consume at discount prices. "There's no question that we sub-
sidize the rest of the world on this effort," says Loss at Washington Analysis. "This comes right out of our
pockets." At least for now, drug companies are free to charge what they feel they must to make up for the
foreign-profits constraints.
    A PLACE FOR PROFIT
     But that may change. Activists, government leaders, and consumer groups in the United States have
begun to target the pharmaceutical sector for what they call excessive profits and for anticompetitive beha-
vior. Historically, drug costs were largely hidden, thanks to broad insurance coverage, much of it paid for by
                                                                                                     Page 154
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                        CFO The Magazine for Senior Financial Executives March 2002

employers. Today, individuals are increasingly called upon to pay some of their health-care bill. Health in-
surance costs are on the rise again (11 percent for 2001), and prescription drugs are the fastest-growing
segment.
     To cut costs, employers are increasingly moving to a tiered system in which a larger copayment is re-
quired for brandname prescriptions than for generic versions. Besides the approximately 50 percent of in-
sured employees facing these added costs, another 40 million Americans lacked insurance altogether for at
least a portion of 2000, and that number is expected to rise in 2001--2002. Add an additional 15 million to 25
million people without adequate prescription drug coverage, including 27 percent of Medicare recipients, and
a sizable constituency is born. Little wonder that prescription drug costs are under the most serious fire
they've faced since Sen. Estes Kefauver held drug-company antitrust hearings in Congress from 1959
through 1961.
     "There is a place for profit' says Larry D. Sasich, research director of the Public Citizen Health Research
Group, "but it has to be controlled by the government. The companies have hidden behind the facade that
their primary core is public health,[but]they make decisions based on the market."
    Pharmaco CFOs claim they are unfairly being targeted for cost cutting, considering drugs represent a
small portion of overall health-care costs and in many cases help consumers avoid more-expensive treat-
ments. "Would our customers like lower prices?" asks Eli Lilly's Golden. "Of course, but they realize our
therapies save lives. Mental health[drug therapy]is a great example. The price of the drugs is minuscule
compared with the economic cost of the disease."
      The critics argue that huge profits, like those at Pfizer, which saw net income more than double in 2001,
to $7.79 billion (it took large merger-related write-downs in 2000), make them sitting ducks for cost-cutting
initiatives--for fiscal and ethical reasons. "Some countries feel that it is wrong to make that much of a profit
from sick people," says Sasich.
     The drug companies have taken some steps to appease their critics, although to date most of their ef-
forts have been overshadowed by their efforts to protect share-holder value. Take, for instance, their stands
on federally and state-supported prescription drug benefits. With 25 states facing Medicaid shortfalls in 2002,
pharmacos say they fully support Medicaid and Medicare prescription drug benefits. "There are certain seg-
ments of the population that aren't represented by insurance coverage, says Lewent. "We are as active as
possible on efforts to find the solution to get coverage for those people. The answer is a federally supported
Medicare drug reimbursement program."
     Still, six drug makers, including Merck and Pfizer, refused to participate in another government-funded
prescription drug program, the Michigan Medicaid formulary program: The industry has filed lawsuits at-
tempting to block programs in both Michigan and Florida, claiming that the formulary program restricts pa-
tients from getting needed drugs. In fact, the programs don't block access, but they do force doctors who
wish to prescribe drugs not on the formulary to get prior approval from a team of Medicaid pharmacists and
doctors. The lawsuits contend that most doctors won't put in the extra effort.
    Medicaid directors say the drug companies are just trying to protect their profit margins. Pharmaco CFOs
say they fear a large, centralized prescription program would wield such immense buying power that it could
unilaterally demand lower drug prices for an enormous market base--as is the case in Europe. They favor
"market-based" systems instead--private insurance programs in which doctors are free to prescribe what
they want and drug makers can negotiate with the prescription programs on the prices they charge.
     While the suits have thus far yielded mixed results, at least one pharmaco has found a way to circumvent
the issue. Pfizer managed to get all of its drugs on the Florida formulary without cutting its prices. Instead, it
guaranteed that the state would get at least $30 million in savings by allowing Pfizer to underwrite a dis-
ease-management program, which closely monitors the care of the state's sickest Medicaid recipients. If the
state fails to realize the expected cost savings, Pfizer has promised to pay the difference.
     Almost all drug makers already offer some type of free or reduced drug program for low-income patients,
administered largely through physicians. This January, Pfizer unveiled a new program called Share Card,
which gives low-income Medicare recipients $15, 30-day prescriptions on any of its drugs (excluding one that
is comarketed with another company). Both CVS and Wal-Mart have signed on to the program, which has
                                                                                                     Page 155
  Clinical trials: A new kind of pricing pressure puts pharmaceutical CFOs in an unfamiliar role: Evangelist.
                        CFO The Magazine for Senior Financial Executives March 2002

received loud endorsements from some industry critics. Analysts also praise the move, saying that such pro-
grams may do more to defuse pricing pressures than any other measures.
     "The Pfizer program is a masterstroke," declares Loss of Washington Analysis. "It's easy to understand,
it provides a real benefit to people who need it, and I think a lot of the political pressure will he alleviated!'
Loss says the program "gives politicians who aren't already opposed to the drug industry a reason to contin-
ue with their support."
    OVERPROTECTING PATENTS?
     Unfortunately, the industry is giving politicians plenty of other reasons to he against it, most notably with
its efforts to block generic competition. Drug patents are in force for 17 years, but since drug substances are
usually patented about 10 years before a brand-name drug makes it to market, new drugs have only a 7-year
profit window.
     Drugs also often receive numerous patents, on everything from additional uses (called indications) to
methods of manufacturing. AstraZeneca is currently embroiled in a court battle over ulcer drug Prilosec. Until
last year, it was the largest-selling prescription drug in the world, with more than $6 billion in annual sales,
but its substance patent expired in October 2001. Generic makers jumped in, but AstraZeneca sought to
block them for infringing on a formulation patent that covers how the drug is protected from digestion by
stomach acid. That patent was issued six years after the substance patent was granted, and CFO Symonds
claims it is still in force. "Our belief is that we are dealing with nontrivial intellectual property," he says. "We
have a very important obligation to protect it."
     All the pharmaco CFOs agree that some companies have taken the issue of patent protection too far,
which harms the entire industry. Bristol-Myers Squibb Co., called by analysts the most aggressive at pur-
suing patent protection, was recently sued by 30 state attorneys general for violating antitrust laws. The suits
allege the company illegally kept generic versions of its BuSpar antianxiety medication off the market, cost-
ing consumers millions. It allegedly did so by making misleading statements to the Food and Drug Adminis-
tration (FDA) about the scope of a new "last-minute" patent for BuSpar in order to gain a few more months of
patent exclusivity. (BMS declined to comment for this story.) The Federal Trade Commission has filed a brief
in the case, and has launched an investigation into similar anticompetitive practices in the industry.
     "There is a point at which patent protection becomes frivolous protection of the product without sub-
stance:' says Symonds. "There is a line that has to be drawn, beyond which all you do is undermine your
company's credibility and the industry's credibility." Golden of Eli Lilly agrees, and even though that company
is aggressively pursuing its Prozac patent, it has not attempted to patent additional indications for the prod-
uct, or variations to the original substance, which would have given it further exclusivity. "We didn't think it
was right to follow the path ofgetting a new patent on Prozac," says Golden. "We didn't think it was ethical."
    Lewent says that Merck has a general policy of looking forward, not backward, for sources of growth.
"For existing patents in place," she says, "we will defend them anywhere, anytime. With Vioxx, we had some
cases that we fought, and we prevailed. However, our basic view is that our role in the future of medicine and
therapy is to drive the R&D process and come up with the next generation. We believe that innovation is the
way to further the enterprise."
    AS SEEN ON TV
    With patents expiring, pharmacos need to make the most of the market exclusivity that they have, and
they've done so to an increasing extent, using direct-to-consumer (DTC) advertising. But these ads have
come under fire from consumer groups and from some corporations that claim the ads drive up drug costs by
creating a desire for more-expensive drugs that consumers don't always need.
    "Direct-to-consumer advertising drives unnecessary utilization," says Rob Minton, manager of
health-care communications at General Motors Corp., which saw its cost for prescription drug coverage rise
to $1.3 billion in 2001. "When someone walks into a doctor's office and asks for a drug they saw advertised
on TV most of the time the doctor will prescribe it, even if the patient doesn't need it."
    A recent internal GM study seems to validate Minton's theory. The study examined hundreds of GM em-
ployees who used Prilosec. Over three years, 92 percent of plan members receiving prescriptions for the
                                                                                                     Page 156
  Clinical trials: A new kind of pricing pressure puts pharmaceutical CFOs in an unfamiliar role: Evangelist.
                        CFO The Magazine for Senior Financial Executives March 2002

drug had no prior prescriptions or treatments for gastrointestinal (GI) disorders or heartburn. Most doctors
think Prilosec is the drug of choice for only a severe form of GI acid refiux in other cases, generic Tagamet,
Zantac, or even over-the-counter Mylanta would work just as well-for a fraction of the cost. "In most cases,
the most expensive drug was the very first therapy, when only a small percentage really needed it' says
Minton.
     There's no hard data to support that statement, but one thing is certain: drug advertising works. A recent
study by the National Institute for Health Care Management showed that the increase in sales of the 50 most
heavily advertised prescription drugs accounted for almost half of the rise in retail spending on all prescrip-
tion drugs. The 50 drugs saw increased sales of 32 percent compared with 13.5 percent for all other drugs.
    DTC advertising spending by pharmaceutical companies has skyrocketed in recent years. Ad spending
alone (which includes advertising to doctors) rose to $2.5 billion in 2000 from $791 million in 1996. Pharma-
cos argue that the advertisements educate patients about their illnesses and may help more people get the
treatment they need, or encourage them to stay on a prescribed medication. "The evidence so far is that di-
rect-to-consumer advertising for critical disease has had a major beneficial effect," claims Lewent. "It's not
bringing in people who don't need it."
    The FDA is conducting a major study to determine whether this is the case. Some corporations aren't
waiting, though. In mid-2001, GM sent its in-house pharmacist, Cynthia Kirman, and the company's former
executive director of health-care initiatives, Jim Cubbin, to meet with representatives of the top five drug
manufacturers. "We wanted to let them know that we think their marketing practices are inappropriate and
that we are not happy about it," says Minton.
      DEFUSING THE PRICING BOMB
    By their own admission, pharmaco CFOs haven't done a very good job of defusing the drug-pricing
bomb. "I think some of the criticism of the industry is justified," says Lilly's Golden, "because we haven't done
as good a job of making our case. Our ability to educate people about why we are doing what we're doing
with our pricing is probably our hardest challenge."
    The industry has spent considerable time and money making its case to lawmakers. Pharmacos hired
625 different lobbyists in 2000, and spent $262 million on lobbyists, political contributions, and issue ads
during the 1999-2000 election cycle alone, more than any other industry, according to Public Citizen's Con-
gress Watch and the Center for Responsive Politics. But programs like Pfizer's Share Card may be just as
effective at swaying public opinion. "Any money they lose on this program should be viewed as an invest-
ment," says Loss of Washington Analysis.
    Although programs help, it seems these CFOs are relying most heavily on the public goodwill generated
from the industry's role as discoverer of lifesaving drugs--and the potential threats to that role posed by profit
constraints--to eventually relieve the pressure to rein in prices. Says Lewent: "We hearken back to a quote
from George Merck[former chairman and son of the founder]: 'Medicine is for the people, not the profit. If you
take care of the people, the profits will follow That's the way we run our business."
     In the final analysis, says Golden, pricing pressures are not as big a threat as shareholder alienation.
"Ultimately, we exist with the support of our shareholders. If no one wants to buy our stock, we won't be in
business."
    On the other hand, "if they don't take control of the price problem, someone else will," says Loss. "And
they're not going to like who the 'someone else' is." *
      KRIS FRIESWICK (KRISFRIESWICK@CFO.COM) IS A STAFF WRITER AT CFO.

Healthy Profits: Merck
Earnings as % of revenue
Revenue
Earnings (*)
'97                                                       27.3
                                                            %
'98                                                       30.2
                                                                                                     Page 157
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                        CFO The Magazine for Senior Financial Executives March 2002

Healthy Profits: Merck
Earnings as % of revenue
Revenue
Earnings (*)
                                                         %
'99                                                    26.3
                                                         %
'00                                                    24.3
                                                         %
'01                                                    21.8
                                                         %
(*)BEFORE TAXES AND EXTRAORDINARY ITEMS
Source: Merck
Note: Table made from bar graph

Eli Lilly
Earnings as % of revenue
Revenue
Earnings (*)
'97                                                    36.3
                                                         %
'98                                                    28.9
                                                         %
'99                                                    32.4
                                                         %
'00                                                    35.5
                                                         %
'01                                                    30.8
                                                         %
(*)BEFORE TAXES AND EXTRAORDINARY ITEMS
Source: Eli Lilly
Note: Table made from bar graph

AstraZeneca
Earnings as % of revenue
Revenue
Earnings (*)
'97                                                                   20.8
                                                                        %
'98                                                                   19.0
                                                                        %
'99                                                                   10.6
                                                                        %
'00                                                                   22.7
                                                                        %
'01                                                                   25.9
                                                                        %
(*)BEFORE TAXES AND EXTRAORDINARY ITEMS, U.K. GAAP
Source: AstraZeneca
Note: Table made from bar graph

Pfizer
Earnings as % of revenue
Revenue
Earnings (*)
                                                                                                     Page 158
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                        CFO The Magazine for Senior Financial Executives March 2002

Pfizer
Earnings as % of revenue
Revenue
Earnings (*)
'97                                             20.7
                                                  %
'98                                             18.9
                                                  %
'99                                             25.4
                                                  %
'00                                             19.5
                                                  %
'01                                             32.0
                                                  %
(*)BEFORE TAXES AND EXTRAORDI-                 ITEM
NARY                                               S
Source: Pfizer
Note: Table made from bar graph

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                                             9 of 9 DOCUMENTS


                                        WA Business News (Australia)

                                               August 31, 2000

Mental illness greater issue
BYLINE: Kelly McCourt

LENGTH: 572 words

    MENTAL health and psychology were once considered the exclusive domain of the fatally ill or the fa-
natical hypochondriac.Today, not only are they very serious key issues in the private and family lives of mil-
lions, but large corporations are also examining the issue with greater interest and sincerity.Psychology and
mental health are no longer about just getting along, they're about getting ahead.Pursuing the idea that an
increase in the general mental well being of employees will lead to an increase in productivity, many busi-
                                                                                                      Page 159
                 Mental illness greater issue WA Business News (Australia) August 31, 2000


nesses have invested significant money into training employees in techniques ranging from time manage-
ment, to mediation to dealing with difficult people.It's not surprising that services to meet this increased de-
mand are making themselves known in almost every city in the country - and Perth is no exception.One look
at the amount of revenue raised by pharmaceutical like Pfizer from the simple sale of anti-depressants and it
becomes clear that mental health has become an extremely profitable business.Occupational Services of
Australia (OSA) is one of Australia's leading providers of Employee Assistance Programs and corporate
psychological services.Corporate mental health is something OSA takes very seriously - the range of work-
shops offered by this new age company is astounding.Its 1999 National Training Catalogue lists more than
40 psychologically based corporate techniques and workshops under the title of a dozen categories, all de-
signed to improve the well being and productivity of corporate employees.Everything from hostage and siege
management, mental illness in the workplace, to dealing with difficult people on the phone is covered.But it is
probably workshops such as "Strategies to Reduce Absenteeism, Sick leave and Turnover" that really prickle
the ears of bosses and managers.OSA divides that particular workshop into two categories, attacking the
problem from the perspectives of both health and psychology.They examine the reasons why employees
take time off, the impact of work on health, the psychological factors that reduce productivity, how to deal
with low moral, how to keep moral high and strategies for motivating employees.For obvious reasons, OSA
recommends this workshop for those in a supervisor role, managers, team leaders and supervi-
sors.Important politically correct issues are also addressed with workshops like "Dealing with gender issues
in the workplace".Common problems like team cohesion, insensitivity, discrimination, sexual harassment and
leadership problems, are all issues that can stem from gender issues in the workplace, and are all, at best,
avoided.Taking your employees through a basic workshop such as this could not only save you from a costly
law suit, but may well make things in general run that little bit more smoothly in the workplace.This particular
course tackles gender issues head on, covering both misogyny and man-hating.Other workshops like "Ba-
lancing Work and Family" may appear, on the surface to be less relevant for employees, but considering the
emotional and psychological impact families have on most individuals, it may well be of equal impor-
tance.The work and family workshop focuses on issues like assessing priorities, time management and
working effectively.There are also three other family oriented workshops including children and learning,
helping children through separation and divorce and being a parent.

LOAD-DATE: May 26, 2006

LANGUAGE: ENGLISH

PUBLICATION-TYPE: Newspaper


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