Document Sample
                          MAY 9, 2007
           -- VERMONT: Datamining, PBM, detailing bill goes to conference committee
           -- IOWA: PBM transparency bill goes to Governor for signature
           -- TEXAS: PBM transparency bill passes Senate; House committee sends to floor
           -- MAINE: Joint health committee supports bills on datamining, academic detailing
           -- NEW HAMPSHIRE: Legislature sticks with datamining laws, AG appeals court ruling; meanwhile
           Vermont, Maine move ahead with prescriber privacy
           -- RHODE ISLAND: State acts on unused medicines redistribution
           -- 26 STATES AND DC: Oxycontin marketing settlement
** OUTRAGE OF THE WEEK: The NY Times documents oncologists, dialysis centers profiting from
“rebates” for prescribing high doses of risky drug
** DRUG PRICES: Criticism of biotech drug prices; reducing copays new strategy to cut costs; Brazil
moves to cut AIDS drug prices
** ADVERTISING & MARKETING: DTC moratorium scuttled over reimportation wrangling; EU considers
letting big pharma advise patients
** CONFLICTS OF INTEREST: Doctor payoffs, conflicts, honoraria examined in studies, editorials; FDA
and Australia experts off panels due to conflicts; anemia drug payout
** IMPORTATION: Once again, big pharma wins in Congress, why would we expect otherwise?
** TRADE: Implications for pharma in possible trade deals
** MEDICAID: Immigration rules cause loss of coverage
** MEDICARE: Seniors pressured to buy Part D, Medicare Advantage plans; hearing held by Congress;
formulary changes; problems with subsidies
** SAFETY & CLINICAL TRIALS: Paxil settlement, other litigation; Pfizer lacking researchers; Reps. Allen
& Emerson seek comparative studies; FDA warnings
** FRAUD & ABUSE: Serono, Lilly, Medici, J&J … and more!!! Also Oxycontin settlement with states
** PBM WATCH: How is it going with the CVS/Caremark nuptials?
** PATENTS & GENERICS: Lawsuits, intellectual property, Clinton AIDS deal, reverse payments
** INSIDE CMS: Bush names new director
** TIRED OF YOUR DAY JOB? Maybe its time to apply for a health fellowship in Australia….

Datamining, PBM and Detailing Bill Passes House; Will Go to Conference Committee with Senate
Times Argus, May 5, 2007, EXCERPT: “MONTPELIER — The Vermont House on Friday passed new
measures aimed at putting a lid on the marketing of prescription drugs to doctors and calling for broader
use of generic drugs. … The drug bill that passed the House also seeks to impose new restrictions on "data
mining," in which drug companies use information on which drugs doctors are prescribing to try to promote
their own medications. Rep. Steven Maier, D-Middlebury, described a scenario in which a drug company
representative drops some free samples off with a doctor, returns two weeks later and says, "I notice you
haven't prescribed any of my drugs." Rep. Harry Chen, D-Mendon and a physician, said doctors routinely
deny they are heavily influenced by the drug company visits, but there's ample data to show they are.
"They're good, the drug companies are good. Marketing works." Critics of the bill, though, noted that a
federal court in New Hampshire just this week struck down a similar law aimed at restricting the use of
aggregate data in drug marketing. The worry that if Vermont enacts a law it could face a similar fate. Rep.
Patricia O'Donnell, R-Vernon and a member of the House Health Care Committee, said her committee was
told this week by a lawyer from the attorney general's office that the drug industry would be likely to sue
over Vermont's law if it passes. "Every time we get into one of these lawsuits it costs of millions of dollars,"
O'Donnell said. She said the state should try first to save money on prescription drugs by getting more
Medicaid beneficiaries switched to generic medications. Drug reps' visits to doctors offices, hosting lunches
and other marketing activities are called detailing, and the bill would assess fees on the drug companies to
fund "counter detailing" — educational efforts aimed at getting doctors to prescribe less expensive

medications. The bill now is expected to go to a House-Senate conference committee to work out

PR Newswire, Release Date: 5/7/2007, SOURCE National Community Pharmacists Association
“ALEXANDRIA, Va., May 7 /PRNewswire-USNewswire/ -- The Iowa General Assembly has unanimously
passed legislation that would force pharmacy benefit managers (PBMs), the largely unregulated
corporations that administer the prescription drug benefit portion of health insurance plans for employers
and unions, to end their deceptive business practices and provide better safeguards for patients. A growing
number of states are enacting PBM bills, such as S.F.512 in Iowa, to require these drug middlemen to
disclose certain business practices that have been the subject of investigations and prosecutions. PBMs
influence 80 percent of drug coverage in the United States, which is why states such as Iowa are taking
steps to bring transparency to the business practices of these corporations. PBMs receive billions of dollars
in rebates from drug manufacturers in return for dispensing higher-cost brand-name drugs. The majority of
those rebate savings are not passed along to their clients -- such as private health plans and the Medicare
Part D program. PBMs also limit patient treatment options by offering shrinking and shifting formularies, or
lists of drugs that are covered for specific groups in a health insurance plan, and by requiring burdensome
pre-authorizations in order to obtain refills or formulary- restricted medications. These bureaucratic policies
discourage patients from obtaining their medications. "The National Community Pharmacists Association
wants to see statutes that protect both the employers who provide drug benefits for employees and
retirees, and the consumers who pay the premiums," said NCPA Executive Vice President and CEO Bruce
Roberts, RPh. "The PBM reform bill passed by the Iowa General Assembly contains much-needed
provisions that provide for the type of transparency and accountability that PBMs owe their customers and
the public as a whole." "Everyone in the drug delivery system is highly regulated and scrutinized, except for
pharmacy benefits managers. Given the history of investigations, litigation, and prosecution of the giant
PBMs; consumers and policy makers should be asking why PBMs alone should be exempt from
government oversight," said Roberts. "If PBM's expect to participate in public and private prescription drug
plans, they owe a fiduciary responsibility to patients and taxpayers -- not just to their shareholders.

The General Assembly's legislation requires PBMs to be certified as a third-party administrator and to
disclose any conflict of interest issues. It also prohibits PBMs from substituting a medication unless it is
made for medical reasons that benefit the beneficiary or result in financial savings to the employer.
The legislation gives the Insurance Commissioner the ability to adopt rules regarding timely payment of
pharmacy claims and establish an adjudication process for complaints and disputes between PBMs and
pharmacies. After those initial regulatory steps are undertaken, an interim study commission will be created
to assess additional disclosure, auditing, and enforcement issues. "Iowa's new PBM regulation law offers
essential protections for pharmacies, payers of health care benefits, and most importantly consumers," said
Thomas Temple, executive vice president and CEO of the Iowa Pharmacy Association. "In particular, the
new law provides for needed regulatory oversight of PBMs by the Insurance Commissioner's Office,
standards of fairness in PBM-pharmacy contracting practices, and safeguards for consumers relative to
drug substitution activity." Temple added, "The new law also will establish a process for resolving disputes
between PBMs and pharmacies and creates an Interim Legislative Study Committee to address issues
related to PBM transparency. The PBM regulation bill-a major legislative priority of the Iowa Pharmacy
Association-received support and endorsement from the Iowa Attorney General, organized labor, the Iowa
League of Cities, the Health Buyers Alliance of Iowa, and several corporate employer groups." The bill is
currently awaiting a signature from Gov. Chet Culver. The National Community Pharmacists Association,
founded in 1898, represents the nation's community pharmacists, including the owners of more than 24,000
pharmacies. The nation's independent pharmacies, independent pharmacy franchises, and independent
chains dispense nearly half of the nation's retail prescription medicines.”

Rep. Bill Callegari (R-Houston) picked up the PBM transparency bill, SB 1834 by Sen. Glen Hegar (R-Katy)
that passed the Senate last week. It was assigned to the House Committee on Government Reform where
Rep.Callegari shepherded it to a unanimous vote late last night. It is expected to be placed on the House
calendar at any moment.

On May 4 the Joint Legislative Committee on Health and Human Services voted unanimously to support an
academic detailing program with an initial finding of $100,000 (LD 839, sponsored by Rep. Treat). The
committee also voted 12-1 in favor of and amendment to LD 4 sponsored by NLARx member Senator Lisa
Marrache, which establishes a state-run opt out program for prescribers seeking to keep their prescribing
data confidential and not available for marketing purposes. The vote came after the lobbyist for IMS vowed
“to sue the minute the Governor signs the bill” even though it is narrowly crafted and avoids the outright
ban on marketing use of this data in LD 838, which a majority of the committee rejected last month. NLARx
member Senator Kevin Raye, a former top staffer to US Senator Olympia Snowe, objected to the
comments as “blackmail.” Both bills now go to the floor for a vote. The committee also held a hearing May
8 on LD 1440 which would ban pop up ads, instant messaging and other advertising embedded in
electronic prescribing software. The legislation is modeled on Florida law. Similar legislation has passed
the New Hampshire House (HB 134) and is in legislation that has passed the House and Senate in
Vermont (S.115).

“CONCORD -- Yesterday, the New Hampshire Attorney General’s Office announced it will appeal a District
Court decision that found unconstitutional a state law that protects physician prescription information from
use by pharmaceutical company marketing campaigns. “The court’s ruling puts the interests of large
companies ahead of the private citizens of New Hampshire,” said Rep. Cindy Rosenwald, sponsor of
2006’s Prescription Privacy Law, which was signed into law by the Governor. “Allowing the pharmaceutical
industry to manipulate physician prescribing behavior is like allowing a drug rep into the exam room to peer
over the doctor’s shoulder. It is clearly not in the best interests of patients.” The Prescription Privacy Law
effectively prohibited pharmaceutical marketers from obtaining each physician’s individual prescribing
history, targeting and tailoring the marketing message to that individual doctor. It was passed to protect
physician privacy, protect the health and safety of New Hampshire patients, and contain the overall cost of
health care in New Hampshire. On April 30, 2007, the Court issued an order that struck down the law,
stating that it unconstitutionally restricts protected speech. I’m disappointed in the decision. I’m very
pleased that the Attorney General has decided to appeal. The legislation is an important consumer
protection measure that sought to maintain privacy rights of physicians and keep the cost of prescription
drugs, and therefore healthcare, down,” said Senator Joseph Foster (D-Nashua).” Source: Rep. Cindy
Rosenwald. Statement of Attorney General: “Attorney General Kelly A. Ayotte announced today that she
will appeal a decision by the United States District Court, District of New Hampshire, that found a state law
that protects physician prescription information from use in pharmaceutical companies marketing
campaigns unconstitutional. In 2006, the legislature passed the Prescription Information Law, which
prohibited the use of prescriber information obtained from pharmacies for commercial purposes. This law
effectively prohibited pharmaceutical marketers from obtaining each physician’s individual prescribing
history, thereby targeting and tailoring the marketing message to that individual doctor. The Prescription
Information Law was passed as a measure to protect physician privacy, protect the health and safety of
New Hampshire patients, and contain the overall cost of health care in New Hampshire. On April 30, 2007,
the Court issued an order that struck down the Prescription Information Law, stating that the law
unconstitutionally restricts protected speech. Attorney General Ayotte said: “The State has a substantial
interest in protecting the privacy of New Hampshire physicians, defending the sanctity of the doctor-patient
relationship and reducing health care costs. Health care costs in the State of New Hampshire are
skyrocketing. The Prescription Information Law protects the State’s interests and the interests of New
Hampshire’s physicians and citizens, which strongly outweigh the pharmaceutical industry’s interest in
increased profits.” The Attorney General said that she will file an appeal of the Court’s decision with the
First Circuit Court of Appeals in Boston.”

Source: Press Release from The Prescription Project, May 8, 2007
“Boston, MA— New Hampshire Attorney General Kelly Ayotte announced last week that she will appeal the
decision of the US District Court, New Hampshire Circuit that found the New Hampshire law protecting
physician prescribing information from being sold to pharmaceutical companies for marketing purposes
“unconstitutional.” Despite this ruling, the states of Maine and Vermont are seeing strong bicameral
advances on similar prescription drug reform bills. State legislators in Maine and Vermont are moving
ahead on bills to protect prescriber privacy and reform prescription drug marketing activities, including the
sale of personally-identifiable prescribing data for marketing purposes to pharmaceutical companies. In
Vermont, bill S.115 would require physicians’ consent for their prescribing data to be sold and allocates
new resources for an “academic detailing” program that would send professionals to physicians’ offices
with independent, science-based information on the safest, most effective drugs. Different versions have
passed the Vermont House and Senate and will be reconciled in conference committee. The
comprehensive bill also includes a pilot program to offer free samples of generic drugs in physician offices.
In Maine, House and Senate committee members voted 12-1 to move to the floor the bill LD 4, which would
establish a system for physicians and other prescribers to opt-out of prescriber-identified data lists. Maine
legislators also voted unanimously to send an academic detailing bill, LD 839, to the full legislature for a
vote. “The sale of provider data to pharmaceutical companies allows sales reps to be very effective in
influencing physicians and drives them to prescribe the newest, most costly products,” said Jerry Avorn,
M.D. Professor of Medicine at Harvard Medical School. “This can also lead to the widespread use of riskier
drugs, as happened with Vioxx. It is time we control sales of this information and get physicians unbiased
information on drugs.” “It is very encouraging that the leadership in Vermont and Maine are taking on this
issue,” said Rob Restuccia, Executive Director of The Prescription Project. “Though the New Hampshire
ruling is a setback, states are making it clear that prescribing should be based on science, not marketing,
and physician data should not be sold without permission.” “The legislation being discussed in these
statehouses is thoughtful and timely,” said Marcia Hams, director of Prescription Policy Initiatives at The
Prescription Project. “These important bills contribute to the national conversation about health care
reform, and how critical prescription drug issues are to that conversation.”

Earlier this week, U.S. District Court Judge Barbadoro overturned New Hampshire’s data-mining ban,
which took effect last summer and prohibited pharmaceutical companies from using doctors’ prescribing
information in marketing specifically to each physician. The court ruled that it impinged on the first
amendment speech rights of data companies like IMS and Verispan, which sell physicians prescribing
records to pharmaceutical companies for millions of dollars each year. “Judge Barbadoro’s opinion is
sweeping and disturbing in many respects,” said Sean Flynn, a legal advisor to The Prescription Project. “It
prevents New Hampshire from implementing the same common sense data privacy laws that restrict the
trade in prescription records in Europe and several Canadian provinces.” According to Flynn, the case for
appeal is strengthened by the extent of Judge Barbadoro’s ruling and its implication that doctors do not
have the same rights to privacy that patients do. History also is favorable to New Hampshire’s appeal;
other recent pharmaceutical laws overturned in district courts have been subsequently upheld by the U.S
Court of Appeals and Supreme Court. Flynn said the scope and specificity of the bills pending in Vermont
and Maine make them less susceptible to rulings like the one in New Hampshire. "Several states around
the country are moving ahead to strengthen prescriber privacy protections and regulate marketing tactics,
despite the District Court’s action,” said Sharon Treat, Executive Director of the National Legislative
Association on Prescription Drug Prices. “We applaud New Hampshire Attorney General Ayotte's decision
to appeal this decision, which should not be the last word on such important questions of prescriber
privacy, First Amendment speech, and public health.”

“Each year in Rhode Island, thousands of dollars worth of prescription drugs are disposed of either
because the recipients of the medication have passed away or no longer require the drug's treatment.
In a time where prescription drug costs have sky rocketed due to inflation and demand, those suffering the
most from these increases are the elderly, the population of which uses more prescription drugs than any
other faction in the United States. While many discount drug programs offer seniors some amount of relief
on medication costs, new legislation currently awaiting Senate approval is taking a different approach by
aiming to redistribute unused medications instead of tossing them in the wastebasket. This legislation,
sponsored by Rep. Raymond J. Sullivan (D-Dist. 29), is an extension of a pilot program started in 2005 that
would allow for the redistribution of unused medications at nursing homes and assisted living facilities
across the state. "Essentially, we extended the pilot program for another two years and we also directed
the Department of Health (DOH) to notify, in writing, every eligible participating nursing home and assisted
living facility about the program," said Sullivan on Monday. "We also mandated that the DOH post a sign in
every facility making people aware that the program exists and how they can participate." Sullivan said that
a third aspect of the bill, which garnered House approval last week, also creates a five-member legislative
oversight commission to monitor the implementation of the program. "If there are concerns from
participating groups, now there's a forum for them to go to," he said. "I just want people to take advantage
of it because these are drugs that have already been paid for that are literally thrown away." The end-result
of the legislation would not only save patients money, but the healthcare providers as well, Sullivan said, as
they have to absorb the costs when they have patients who are uninsured and unable to pay for
medications. "Long term, I'd like to see us start an online tracking system so that at any given time, health
center doctors or folks participating in the program can log into a secured network and see what
prescriptions are available," said Sullivan. Prior to the 2005 pilot program, state law required that any
unused prescription medication be discarded. The pilot program was to end this year, but Sullivan's
legislation extended it to 2009. The program allows the medications, which have underwent a safety check,
to be donated to participating pharmacies where they would be distributed to uninsured senior citizens. "I
just want people to have access to the drugs that they need," he said. Sullivan said the hardest parts of
making the bill successful will be raising awareness of this service and getting individuals to see a different
perspective on the way leftover medication is utilized. "It's like anything, it takes time to change people's
minds because they are just so used to doing things this way," said Sullivan. "There are people out there
who can't afford these drugs and these drugs are available, we can make the available to them at no cost."
Ultimately, Sullivan said, the success of this program would effectively reduce the number of senior citizens
who are, many times, forced to choose between paying their utility bills or paying for their medications. "It's
not going to solve the problem of rising costs of prescription medication, it's not a silver bullet that's going to
change things overnight," offered Sullivan. "But you know what, if people participate, if organizations get
involved and make sure that the people that can benefit from this program know about it, it can make a big
dent, it can make a real difference."

May 8, 2007, Press Release: “Attorney General Steve Rowe announced today that Maine and 25 other
states, as well as the District of Columbia, have reached a settlement with Purdue Pharma regarding the
narcotic pain medication OxyContin. The settlement resolves concerns that Purdue had engaged in
extensive off-label marketing of OxyContin, a time-released, Schedule II opioid used for pain management
of moderate to severe pain over an extended period of time, and that Purdue failed to adequately disclose
abuse and diversion risks associated with the drug in violation of the states’ respective consumer protection
statutes. Rowe said, “OxyContin abuse has ravaged the lives of thousands of Mainers, including entire
families and communities. It has also contributed to increased crime rates and emergency medical
treatment.” Had Purdue Pharma limited its marketing to the drug’s approved uses and disclosed the
drug’s abuse and diversion risks up front, it is likely that much of the devastation could have been
prevented. This is a clear example of a pharmaceutical company putting corporate profits above the health
and welfare of people.” The settlement, in the form of a Consent Judgment, has been filed in Kennebec
County Superior Court. The settlement requires Purdue to market and promote OxyContin only in line with
FDA-approved uses, prohibiting Purdue from making any false, misleading or deceptive claim regarding
OxyContin. It also requires the company to continue its “OxyContin Abuse and Diversion Detection
Program,” established internally to detect problem prescribing, and requires all field personnel to undergo
training on the program before being allowed to promote OxyContin. Among the particular restrictions and
requirements contained in the settlements, are provisions that Purdue must:
      market and promote OxyContin in a manner consistent with its package insert and not in a manner
         that minimizes the approved uses for the drug;
      not market or promote OxyContin for off-label purposes – those beyond the approved indications
         and uses of the drug;
      have any recipient of funds or other remuneration for grants publicly disclose the existence of that
      not sponsor or fund any educational events where Purdue has knowledge that a speaker will
         recommend the off-label use of OxyContin;
      not base Purdue sales representatives’ bonuses solely on the volume of OxyContin prescribed;
      take into account in performance evaluations sales representatives’ educating prescribers about
         OxyContin and its potential for abuse and diversion.

Finally, the settlement provides for a monetary payment by Purdue to the states in the amount of
$19,500,000. Maine’s share of the settlement is $719,500. Taking part in the investigation of Purdue’s
business practices, as well as in today’s settlement, are the following states : Arizona, Arkansas, California,
Connecticut, Idaho, Illinois, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Montana, Nebraska,
Nevada, New Mexico, North Carolina, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas,
Vermont, Virginia, Washington, Wisconsin and the District of Columbia.


(5/8, Victoria Colliver, The San Francisco Chronicle) reports “...Health insurers routinely require patients to
pay a portion of their medication costs. But the stakes are becoming a lot higher as an increasing number
of high-priced biologic drugs come to market.”

[May 08, 2007,] “The Wall Street Journal on Tuesday examined how an increased number of
employers and health insurers have begun to reduce or eliminate copayments for certain medications for
chronic diseases as part of an effort to "curb soaring health care costs" by "preventing costly health crises
down the road." According to the Journal, "mounting evidence" indicates that higher copays for certain
treatments might not "make long-term economic sense" because they have "discouraged some people
from taking essential medications." A 2004 RAND study of more than 80 companies and commercial health
plans found that individuals who took medications for chronic diseases on a regular basis reduced their
treatments by between 8% and 23% when their copays doubled. In addition, early "experiments with
providing free drugs for chronic disease have produced results -- reducing costs and helping people stay
out of the hospital and emergency rooms," the Journal reports. Employers such as Marriott International,
Procter & Gamble, Eastman Chemical and Pitney Bowes have begun to reduce or eliminate copays for
certain medications. Andrew Scibelli -- manager of the health management programs at Florida Power &
Light, which has considered the reduction or elimination of copays for medications for diabetes and
coronary artery disease -- said, "Cost shifting (onto employees) is the easier way to attack cost. But it
comes right back at you because you're not attacking the root cause." Aetna Study. Health insurer Aetna
later this year plans to launch "one of the most ambitious studies of the tailored approach" to copays for
medications, the Journal reports. For the study, Aetna will eliminate copays for the four classes of
prescription medications recommended for individuals who have experienced heart attacks: statins, ace
inhibitors, beta blockers and ARBs. In addition, Aetna will examine the effect of the move on outcomes and
cost over a three-year period. Troyen Brennan, chief medical officer for Aetna, said that "we think we'll
reduce costs very rapidly" with the study. "If the three-year study bears out such cost savings," Aetna plans
to "implement the approach across its health plans and expand it to more than a dozen other types of
medications," the Journal reports (Fuhrmans, Wall Street Journal, 5/8).”

(5/8, Stephen Heuser, Boston Globe) reports “... In particular, congressional Democrats, insurance
companies, and some large employers have begun to push publicly against the high price of biotech drugs,
which often cost $20,000 a year or more per patient. The resistance is a new and unwelcome development
for an industry that has attracted money and good will by telling the story of its potential.”

The Boston Globe, GLOBE EDITORIAL, May 8, 2007
“BEHIND THE vibrancy of the life sciences industry so visible at the 2007 BIO convention this week in
Boston is a sobering statistic from the World Health Organization: Each year, 10 million people in poor
nations die because they lack access to existing medicines or vaccines. In his keynote address yesterday,
Michael J. Fox, the actor and founder of a Parkinson's disease research foundation, said that of the 30,000
known human diseases, there are treatments for just 10,000. Many of the diseases without treatments
afflict residents of resource-poor countries, which draw little interest from drug makers. This is a challenge
for biotech that goes beyond finding life-extending medications for cancer victims or a drug to encourage
the good cholesterol, as important as such advances would be. In much of the world, preventable or
treatable illnesses like tuberculosis and cervical cancer are still major killers. In his videotaped remarks to
BIO yesterday, Senator Edward Kennedy called for one approach to this imbalance in the world's access to
the fruits of biotechnology. His reform legislation for the Food and Drug Administration includes a plan for
accelerated FDA review of drug candidates for tropical diseases. Last year, Senator Patrick Leahy
sponsored a bill to ensure that medical technologies developed at federally funded labs would be available
not just to branded drug makers but also to low-cost generic drug makers serving developing countries.
This is also the goal of a student group called Universities Allied For Essential Medicines. It wants research
universities that hold rights to new medical discoveries to license them to branded drug makers with the
condition that they be usable by generic makers in developing countries. When generic makers are granted
these rights, neither the universities nor the pharmaceutical companies lose substantial revenues, since the
patented, branded versions of the drugs are usually unaffordable in low-income countries. At a UAEM
meeting at Harvard last month, Dr. Jim Kim, the former AIDS director for WHO and now chairman of the
Department of Social Medicine at Harvard Medical School, urged students to pressure universities to insist
on making their technology accessible to the poor. The benefits of medical advances from earlier
generations could also save lives with more support from the West and from the developing countries
themselves. In a report released this week, Save the Children says that 400,000 children die each year of
measles, which can be prevented by a 15-cent vaccine. "We must lead in compassion as we have led in
innovation," Kennedy told the BIO audience. Researchers, drug company executives, and elected officials
should seek all possible ways to make the miracles of medicine the birthright of all, not just the rich.”

(5/6, Stephen Heuser, Boston Globe) reports “...In Washington, a push is underway to reduce
biotechnology drug costs by allowing generic versions of biologically derived products, which — unlike
traditional drugs — have long been protected from such competition. At least one Wall Street analyst has
suggested companies need to rein in drug costs before they trigger bad publicity and, possibly, government
price controls. Industry leaders are starting to notice.”

By ALASTAIR STEWART, Wall St. Journal, May 5, 2007; Page B6
“SAO PAULO -- Brazilian President Luiz Inacio Lula da Silva Friday signed a compulsory license, breaking
the patent on an anti-retroviral AIDS drug made by the U.S. pharmaceutical giant Merck & Co. Brazil's
government issued the groundbreaking decree after rejecting a Merck offer to sell the drug at $1.10 per pill,
the equivalent of a 30% discount. Brazil claims the price is unjust considering it can acquire the drug for 45
cents from generic manufacturers, the president said in a statement. "Between our trade and our health
[interests], we chose to protect our health," said President Lula in Brasilia at a ceremony marking the
signing of the decree. Jose Gomes Temporao, Brazil's health minister, said: "We had eight meetings with
Merck and at none of them did they present a satisfactory proposal. At best, they proposed a 30%
discount. We told them we needed a 60% discount." Merck said in a statement that it is "profoundly
disappointed" by Brazil's decision to break the patent. A compulsory license allows a country to
manufacture or buy generic versions of patented drugs while paying the patent holder only a small royalty.
Brazilian law and rules established under the World Trade Organization allow for compulsory licenses in a
health emergency or if the pharmaceutical industry uses abusive pricing. This is the first time Brazil has
overridden a drug patent after threatening to do so on various occasions in the past. After Thailand moved
to override patents on three anti-AIDS drugs, including those made by Abbott Laboratories and Merck, the
U.S. placed Thailand on a list of copyright violators. During the signing ceremony, Mr. Lula warned that
Brazil could break other patents, if prices weren't affordable. "People shouldn't be able to get rich through
the misfortune of others," he said. The U.S.-Brazil Business Council expressed alarm at Brazil's decision.
"Just days after Brazil was recognized for improving its enforcement of intellectual property rights, this is a
major step backward for the country's development. Brazil is working to attract investment in innovative
industries that rely on IP, and this move will likely cause investments to go elsewhere," the council said in a
statement. Brazil provides free AIDS drugs to anyone who needs them and manufactures generic versions
of several drugs that were in production before Brazil enacted an intellectual property law in 1997 to join
the WTO.”


(5/7, John Wilkerson, reports “The Senate Monday (April 7) put off until Tuesday or
later in the week a final vote on a revised FDA reform bill that includes a compromise on citizen petition
restrictions and scraps an earlier proposal to let FDA impose a two-year moratorium on consumer drug
advertising.” (Paid Subscription Required)
Press release, International Society of Drug Bulletins, Verona /Bielefeld 4 May 2007
“The European Commission is supporting the demand of the pharmaceutical industry to get direct influence
on patients (1,2). It is expected that a legislative proposal having this effect will be introduced by the
Commission around September 2007. A foretaste of the bad quality be expected gives a ‘patient
information’ on diabetes recently drafted by the Pharmaceutical Forum with heavy company involvement.
The International Society of Drug Bulletins (ISDB) warns that industry is not a source of reliable and
trustworthy information and that it is a mistake to confuse advertising with information. In the contrary there
is a need to limit industry influence on patients and prescribers alike. What is needed is to improve drug
use with reliable, independent and comparative information so that patients and the public can make
informed choices (3). There are only two countries in the world that allow direct-to-consumer-advertising
(DTCA) of prescription drugs: the USA and New Zealand. In both countries it has been shown that DTCA
has detrimental effects on health. Pharmaceutical companies’ messages are focused on relatively few top
sellers, exaggerating effects and concealing risks, confusing patients and putting pressure on doctors to
prescribe drugs they would not use otherwise. Lack of comparative information in advertising means
people cannot choose among several options. It is only 5 years ago that the attempt to introduce direct to
consumer advertising of prescription drugs in the European Union was voted down by the parliamentarians
with an overwhelming majority (494 against, 42 in favour). Most of today’s members of European
Parliament (MEPs) are newly elected and know little about these discussions (4). The new move to
introduce DTCA comes disguised as a means “to improve the quality of information available to the public”.
The main actor behind this move is the Pharmaceutical Forum, a working group without any democratic
legitimacy that consists of two EU commissioners, three EU parliamentarians, Member State ministers, no
less than five pharmaceutical industry associations, representatives of health professionals and insurers.
Patients are ‘represented’ by the industry sponsored European Patients’ Forum. Why should one sit
together with industry to develop patient information? Health professionals, consumer and patient groups
that are independent of pharmaceutical companies, health authorities and funding bodies have not waited
for the pharmaceutical companies to take an interest in patient information. Many quality sources of
information are now available to the public in Europe and worldwide (3). Industry feels very confident that
DTCA or an equivalent will be allowed: marketing companies already offer seminars how to make best use
of this new opportunity to make more money. Pharmaceutical companies should rather do their homework
and supply properly labeled medicinal products accompanied by improved Patient Information Leaflets
(PILs). The route chosen by the Commission and the Pharmaceutical Forum goes into the wrong direction.
It will further the indiscriminate use of drugs, increase overall consumption of drugs, will be detrimental to
health (more adverse reactions, more medical errors), and result in higher health costs. The health
products market is not a market like any other. Patients are not consumers. So, how to increase pharma
companies competitiveness? By making medicines which offer real therapeutic advantage as defined in the
ISDB Declaration on therapeutic advance (5). In contrast to pseudo-innovations such products do not need
big marketing efforts. Sources: 1- Pharmaceutical Forum “Public consultation on Health-related information
to patients: the diabetes information package, and the quality principles” (available on; 2- European Commission "Draft report on current practice with
regard to provision of information to patients on medicinal products, in accordance with article 88a of
Directive 2001/83/EC, as amended by Directive 2004/27/EC on the community code relating to medicinal
products. 3- Joint declaration by HAI Europe, the ISDB, BEUC, the AIM and the Medicines in Europe
Forum “Relevant information for empowered citizens” 3 October 2006: 9 pages. Website: accessed 30 April 2007: 8 pages. 4- To learn more about this ‘historical
background’ read the text “BigPharma ’s health information: a growing danger in Europe” In Joint position
of the Medicines in Europe Forum, the International Society of Drug Bulletins, Health Action International
Europe “Health information: A clear division of roles is needed to protect public health” March 2007.
Website: : 2 pages. 5- ISDB Declaration on therapeutic advance in the use of
medicines ; Paris 15-16 November 2001. Website: : 12 pages.


May 6, 2007, Newsday:
“A new and disturbing study of doctors' close links with pharmaceutical companies adds urgency to calls for
greater scrutiny over questionable and potentially dangerous conflicts of interest in the practice of
medicine. The prestigious New England Journal of Medicine has published the results of a study showing

that 25 percent of doctors surveyed said they had received direct payments from pharmaceutical
producers. In addition, 94 percent of practicing doctors "have at least one type of relationship with the drug
industry." Most often, this means they've received meals, liquor, large quantities of prescription drug
samples, honoraria at symposiums or gone on junkets to conventions at resorts. These findings highlight
the need for reforms in the profession and more stringent controls in public health care policy, since the
study concludes that the existing, voluntary code adopted by the Pharmaceutical Research and
Manufacturers of America isn't working. It's particularly disturbing that these findings come in the wake of
several scandals in the health and research industries over conflicts of interest. The most notable was last
year's case of Dr. Trey Sunderland of the U.S. National Institutes of Health, who was shown to have
received $285,000 from Pfizer, the world's largest drug company, for cooperating with the firm without
having informed his superiors at the federal health research agency. The study's investigators point out that
more payments go to doctors who develop clinical guidelines and mentor other doctors in training than to
other types of doctors. At the very least, the study's findings should raise alarms within the medical
profession. Quite aside from the ethical aspects, they raise a key policy question: To what extent do the
relationships between doctors and drug or medical-device manufacturers benefit or work to the
disadvantage of patients? The onus of proving this should not fall solely on patients, who may have to ask
much tougher questions of doctors they should be able to trust implicitly.”

(5/9, Alex Berenson, Andrew Pollack, The New York Times, EXCERPT):
“Two of the world’s largest drug companies are paying hundreds of millions of dollars to doctors every year
in return for giving their patients anemia medicines, which regulators now say may be unsafe at commonly
used doses. The payments are legal, but very few people outside of the doctors who receive them are
aware of their size. Critics, including prominent cancer and kidney doctors, say the payments give
physicians an incentive to prescribe the medicines at levels that might increase patients’ risks of heart
attacks or strokes. Industry analysts estimate that such payments — to cancer doctors and the other big
users of the drugs, kidney dialysis centers — total hundreds of millions of dollars a year and are an
important source of profit for doctors and the centers. The payments have risen over the last several years,
as the makers of the drugs, Amgen and Johnson & Johnson, compete for market share and try to expand
the overall business. Neither Amgen nor Johnson & Johnson has disclosed the total amount of the
payments. But documents given to The New York Times show that at just one practice in the Pacific
Northwest, a group of six cancer doctors received $2.7 million from Amgen for prescribing $9 million worth
of its drugs last year. Yesterday, the Food and Drug Administration added to concerns about the drugs,
releasing a report that suggested that their use might need to be curtailed in cancer patients. The report,
prepared by F.D.A. staff scientists, said no evidence indicated that the medicines either improved quality of
life in patients or extended their survival, while several studies suggested that the drugs can shorten
patients’ lives when used at high doses. Yesterday’s report followed the F.D.A.’s decision in March to
strengthen warnings on the drugs’ labels. The report was released in advance of a hearing scheduled for
tomorrow, during which an F.D.A. advisory panel will consider whether the drugs are overused. The
medicines — Aranesp and Epogen, from Amgen; and Procrit, from Johnson & Johnson — are among the
world’s top-selling drugs, with combined sales of $10 billion last year. In this country, they represent the
single biggest drug expense for Medicare and are given to about a million patients each year to treat
anemia caused by kidney disease or cancer chemotherapy. Dr. Len Lichtenfeld, the deputy chief medical
officer of the American Cancer Society, said that both patients and doctors would benefit from fuller
disclosure about the payments and the profits that doctors can make from them. “I suspect that Medicare is
going to take a very careful look at what is going on here,” he said. Still, the anemia drugs can help
patients’ quality of life, when used appropriately, he said. “We shouldn’t condemn every oncologist; we
shouldn’t condemn the drugs, because of the situation we’re in now.”

Federal laws bar drug companies from paying doctors to prescribe medicines that are given in pill form and
purchased by patients from pharmacies. But companies can rebate part of the price that doctors pay for
drugs, like the anemia medicines, which they dispense in their offices as part of treatment. The anemia
drugs are injected or given intravenously in physicians’ offices or dialysis centers. Doctors receive the
rebates after they buy the drugs from the companies. But they also receive reimbursement from Medicare
or private insurers for the drugs, often at a markup over the doctors’ purchase price. Medicare has changed
its payment structure since 2003 to reduce the markup, but private insurers still often pay more. Combined
with those insurance reimbursements, the rebates enable many doctors to profit substantially on the
medicines they buy and then give to patients. The rebates are related to the amount of drugs that doctors
buy, and physicians that agree to use one company’s drugs exclusively typically receive higher rebates.

Johnson & Johnson said yesterday in a statement that its rebates were not intended to induce doctors to
use more medicine. Instead, the rebates “reflect intense competition” in the market for the drugs, the
company said. Amgen said that rebates were a normal commercial practice and that it had always properly
promoted its drugs. “Amgen is dedicated to patient safety,” said David Polk, a spokesman. “We believe our
contracts support appropriate anemia management and our product promotion is always strictly within the
label.” Both companies’ stocks fell yesterday after release of the F.D.A. report. Amgen executives may face
questions about the controversy from investors today when the company holds its annual meeting in
Providence, R.I. Since 1991, when the first of the drugs was still relatively new, the average dose given to
dialysis patients in this country has nearly tripled. About 50 percent of dialysis patients now receive enough
of the drugs to raise their red blood cell counts above the level considered risky by the F.D.A. American
patients receive far more of the anemia drugs than patients elsewhere, with dialysis patients in this country
getting doses more than twice as high as their counterparts in Europe. Cancer care shows a similar
pattern. American cancer patients are about three times as likely as those in Europe to get the drugs, and
they receive somewhat higher doses. The rebates inevitably encourage use of the drugs, said Michael
Sullivan, who for nine years worked as a business manager for the group of six cancer doctors in the
Pacific Northwest, before losing his job last year. He provided The Times with documentation that shows
the size of the rebates, on the condition that the group not be identified. “Personally, I think rebates should
go away,” said Mr. Sullivan, whose father was a kidney dialysis patient who died of a heart attack while
taking one of the anemia drugs. “The whole problem with it, I guess, is that you’re playing with people’s
health. It’s not the same as buying widgets.”

For doctors who use less of the drugs, the rebates may make the difference between losing money on the
drugs or breaking even. Mr. Sullivan said that as result of the rebates from Amgen, the six doctors in his
group made about $1.8 million in net profit on the drugs they prescribed. Unlike most drugs, the anemia
medicines do not come in fixed doses. Therefore, doctors have great flexibility to increase dosing — and
profits. Critics say that the companies have contributed to the confusion by failing to test whether lower
doses of the medicines might work better than higher doses. … Critics of the drugs say their increased use
has been driven by profit. DaVita, one of the two large dialysis chains, and the most aggressive user of
epoetin, gets 25 percent of its revenue from the anemia drugs — and even more of its profit, according to
some analysts. Dr. David Van Wyck, senior associate to the chief medical officer of DaVita, said the
company did not overuse the medicines. Doctors determine how much to use, Dr. Van Wyck said. “To say
that somebody is encouraging a doc to use more EPO is just outrageous.” … Dr. Peter Eisenberg, an
oncologist in Marin County, Calif., said many doctors had been induced to use more epoetin by the
financial incentives and the belief that the drug was helpful. “The deal was so good,” he said. “The
indication was so clear and the downside was so small that docs just worked it into their practice easily.
“Now it’s much scarier than that,” he said. “We could really be doing harm.” COMPLETE ARTICLE:

[Apr 30, 2007,] “Despite "efforts to curb drug companies' avid courting of doctors, the industry is
working harder than ever to influence what medicines they prescribe," the Washington Post reports. The
Post cited a study published last week in the New England Journal of Medicine that surveyed 1,662
physicians from November 2003 to June 2004 (Lee, Washington Post, 4/29). The study, led by researchers
at Harvard Medical School, found that 94% of respondents had relationships with pharmaceutical
companies in which the companies provided them with food and beverages, medication samples, and other
gifts and payments (Kaiser Daily Health Policy Report, 4/26). In addition, the Post cited two other studies
published last week in PLoS Medicine. One of the studies found that the estimated 100,000 pharmaceutical
company sales representatives who visit physician offices seek personal information they can use to form
relationships with physicians. The second study found that visits from pharmaceutical company sales
representatives prompted almost half of 97 physicians to increase prescriptions of gabapentin, an anti-
seizure medication. Eric Campbell, lead researcher of the NEJM study and an assistant professor of
medicine at Harvard Medical School, said, "We now know that virtually every doctor in the United States
has some form of relationship with the pharmaceutical industry. They are common" (Washington Post,

Posted: 07 May 2007 06:29 AM CDT
“That's what Dan Carlat, a Boston psychiatrist, does in his increasingly popular newsletter. A former
mouthpiece for industry, he eschewed the extra payments and perks after deciding that industry influence
was leading psychiatrists astray. "Instead of getting educated about psychotherapy, about how to better
manage our practices, about epidemiology and the public health concerns of underserved populations,
what we're getting is lecture after lecture about how to diagnose depression and use antidepressants to
treat it; how to diagnose insomnia and use sleeping pills to treat it; how to diagnose bipolar disorder and
use mood stabilizers to treat it," he tells The Boston Globe. This is an interesting choice of stories to run in
the city's big paper this morning, given that the BIO convention is town. Sends a rather uncomfortable
message to everyone heading toward the convention center right now. Further reading.... The full story in
The Globe; The Carlat Report.”

Pharmalot Blog, Posted: 09 May 2007 07:38 AM CDT
“The senior NIH researcher who became a symbol of the agency's improper entanglements with
drugmakers - and whose lasting presence on the federal payroll enraged members of Congress -has
retired from the government, The Los Angeles Times reports. Dr. P. "Trey" Sunderland III accepted about
$612,000 in consulting and speaking fees from Pfizer and about $200,000 from other companies from 1998
to 2004, all without getting required NIH approvals in advance. He pleaded guilty five months ago to a
federal conflict-of-interest charge and agreed to pay $300,000 to the government and to perform
community service. Sunderland's retirement surfaced in a probation report filed Thursday with a U.S.
District Court in Baltimore. The probation officer, Rasheed J. Tahir, wrote that Sunderland "is now privately
practicing psychiatry." Sunderland has paid the government about one-third of the $300,000 in restitution
and performed three-fourths of his required community service, the report said. Sunderland, 55, a
psychiatrist who specialized in researching Alzheimer's disease, had remained on the federal payroll
through March. His case was among scores that prompted a sweeping ban of drug-company consulting
fees and other industry compensation to NIH employees. The ban, which was ordered in 2005 by the NIH
director, was fought by many scientists at the agency who wanted the income from the drug companies.
The timing of the ban is of renewed relevance for Sunderland: He told colleagues at a national psychiatric
research conference in December 2006 that he was a consultant to Pfizer and another drug-maker,
AstraZeneca. Conference materials also show that Sunderland reported that he had received honoraria,
typically fees for speaking or making appearances, from Pfizer, Bristol-Myers Squibb and Janssen
Pharmaceuticals, a unit of J&J. Reached by telephone at the NIH headquarters in Bethesda, Md., Deputy
Director Raynard S. Kington declined to say whether the agency had granted Sunderland special
permission to accept compensation from any of the four drug companies. Sunderland's lawyer, Robert F.
Muse, declined comment on his client's disclosures at the December conference. He also declined to
discuss terms of Sunderland's discharge and retirement.”

Pharma Marketing Blog, May 09, 2007, excerpt:
“My fellow blogger Peter Rost over at Question Authority continues to milk an Astrazeneca internal
newsletter for stories. First it was the Zubillaga Affair, then the Missy Moran's MUMS Miasma, followed by
The Pink Cupcake Caper. Now it's the Doctor Freedland Fee Fest! (Sorry, doc, your name will forever be
linked to this issue in Google searches.) "Medical Bags of Money" The Astrazeneca newsletter reports that
Dr. Stephen Freedland -- faculty member of the Duke University School of Medicine -- was number one
among the "Top 3" Casodex (a prostate cancer drug) speakers in 2006, speaking 68 times on behalf of
Astrazeneca. Number 2 spoke only 21 time! Freedland is set to best that record in 2007, having
"moderated 21 programs" at the time of publication of the newsletter. Rost calculates that at "top dollar"
(about $3,000 per engagement, not counting travel expenses), Dr. Freedland earned as much as $270,000
during the '06-'07 time period in question, or at least $204,000 per year! Rost says he's "not implying
there's anything wrong with any of this, that's something others are more qualified to do . . . I'm just
showing you how the system works." But here's what I think is wrong with this. There is No Registry
Reporting Dollars Paid to Docs. The industry is reacting to pressure from Congressional committees
regarding CME funding by attempting to be "more transparent" and publishing registries of educational
grants (see, for example, "Lilly Discloses Funding" and "More firms say they will divulge CME grants").
However, if you look at Lilly's grant registry, you ONLY see grants made to organizations that
REQUESTED grants; you won't find any doctors' names on the list. Presumably, Lilly, like every other
pharmaceutical company, "utilizes" speakers like Dr. Freedland to "moderate" educational programs for
physicians. Why aren't these docs on the list? So, Astrazeneca may eventually report a modest grant of
$25,000 to Duke University School of Medicine (I'm just conjecturing here) for a specific educational
program it hosts, but it probably won't list the $204,000 paid to Dr. Freedland to "moderate" other
"educational" programs. NOTE: The Accreditation Council for Continuing Medical Education (ACCME),

which governs accredited CME providers like Duke University School of Medicine, in its Standards for
Commercial Support, prohibits pharma paid consultants like Dr. Freedland from speaking at or moderating
CME activities. It only allows honoraria to be paid out of the CME provider's grant budget, not from the
pharma company directly. Doctor Freedland may also receive "honoraria" from grant budgets OVER AND
ABOVE the $204,000 he received directly from Astrazeneca. The point is, some doctors are receiving a
LOT of dollars from pharmaceutical companies as "consultants" to speak on their behalf at "educational"
events hosted by these companies (apart from any honoraria they may receive from ACCME-accredited
educational programs). These dollars, which may dwarf most grants, are NEVER likely to show up in the
type of grant registries now being made public by some pharmaceutical companies. … Speaking of drug
industry influence on CME, you should read what my friend Jane Chin has to say on the subject: "Shedding
the light on potential industry influences on CME content and the role of medical education companies are
helpful to ensure that appropriate controls are in place for fair balanced, bona fide CME programs.
Therefore, asking questions about undue influences is an important activity on Senate Finance
Committee’s part. On the other hand, I do not believe in administrating ethics (it does not work that way).
Ethics is about personal accountability from each individual who makes or implements decisions around
CME" (see "Industry Funding of CME: The Next Chapter").”

reason: a conflict of interest. Until yesterday, Daryl Efron sat on the Royal College of Physicians committee
that is conducting the first government-sponsored review in a decade of ADHD treatment guidelines. But
earlier this week, it was disclosed that he also is a member of the advisory boards of both Novartis and Eli
Lilly. Novartis, of course, sells Ritalin and Lilly markets Strattera. And so he was asked to resign from the
committee by Australian health minister Tony Abbott. Efron has "done the honourable thing," says Abbott,
adding that it was "not a good look" for Efron to have sat on the boards and the committee simultaneously.
Last week, Efron denied his opinions meant the outcome of the long-awaited review into the diagnosis and
treatment of ADHD was prejudged. He said the committee worked under strict government guidelines. "The
important thing is we declare our potential conflicts of interest," Efron insisted. Abbott said while he had
faith in Efron's impartiality, it was important the public had confidence in the outcome of the review. The
RCP committee will recommend new clinical guidelines for general practitioners and specialists, who have
more than doubled prescription rates for Ritalin and the related drug, dexamphetamine – from 116,320 to
264,296 – in the past decade. Efron supports using Ritalin in some circumstances in children younger than
six years old, which is the current cut-off. Joe Tucci, who heads the Australian Childhood Foundation,
welcomed the resignation. "It makes us more hopeful that there will be an examination of the whole range
of issues around ADHD treatment rather than being focused on medication." Diagnosis: Efron apparently
suffered from another form Attention Deficit Disorder, which is a failure to appreciate the impression
occupying such dual roles can create in the public mind. This is a point the medical community may want to
focus on more often. Further reading... The Sunday Telegraph reports the resignation; The Royal College
of Physicians plans for new guidelines; The Daily Telegraph reports Efron's conflict.


SENATE PASSES WATERED-DOWN DRUG IMPORTATION AMENDMENT, 5/9: “After nearly a week of debate, the Senate passed by voice vote an amendment
allowing drug importation, but only after approving a modification to the measure that makes it essentially
meaningless. An amendment sponsored by Sens. Byron Dorgan (D-N.D.), Olympia Snowe (R-Maine) and
Chuck Grassley (R-Iowa) that would allow prescription drugs to be imported from certain countries passed
the Senate May 7. However, the Senate also passed a second-degree amendment from Sen. Thad
Cochran (R-Miss.) that would require the secretary of HHS to certify that allowing imported drugs would not
endanger American citizens and would result in lower prices. The amendment passed by a vote of 49-40.
That move seemingly gutted Dorgan’s amendment, as the FDA has previously said it is unable to ensure
the safety of imported drugs. Sen. Bernie Sanders (I-Vt.) called the Cochran amendment “a poison pill”
and said the vote was a “major victory” for the pharmaceutical industry, which “never, ever loses.” Sanders
added that voting for both the Cochran and the Dorgan amendments, as Sen. Edward Kennedy (D-Mass.)
did, did not make sense. Kennedy, a sponsor of S. 1082, which would reauthorize the Prescription Drug
User Fee Act (PDUFA), voted for both amendments. He said he would support the Cochran amendment in
order to allow the importation legislation to pass. All of the legislation in S. 1082 is threatened by “the

intransigence of a Republican leadership” refusing to consider legislation allowing importation, Kennedy
said. Dorgan has been flexible in allowing a debate on importation, but Republicans have only offered
“obstruction” and “rigid denial” in return, Kennedy said. The House strongly supports allowing importation
and will most likely pass its version of the bill without an amendment like Cochran’s, according to Sanders.
The House has not yet begun debate on the PDUFA reauthorization bill.”

[May 08, 2007,] “The Senate on Monday voted 49-40 to approve a second-degree amendment to a
bill (S 1082) to reauthorize the Prescription Drug User Fee Act that would not allow prescription drug
reimportation from other nations until the HHS secretary certifies that the practice would "pose no additional
risk to the public's health and safety" and would significantly reduce costs for consumers, the New York
Times reports (Pear, New York Times, 5/8). In addition, the Senate later by voice vote approved an
amendment proposed by Sens. Byron Dorgan (D-N.D.) and Olympia Snowe (R-Maine) that would allow
reimportation (Bridges, AP/Houston Chronicle, 5/8). The amendment attaches to the reauthorization
legislation a bill (S 242) introduced in January by Dorgan and Snowe that would allow consumers,
pharmacies and wholesalers to purchase FDA-approved prescription drugs that are manufactured at FDA-
inspected facilities in 19 industrialized nations. Under the legislation, which would establish a regulatory
framework for reimportation, FDA would regulate shipments of prescription drugs reimported into the U.S.
for commercial or personal use. The bill also would require FDA to inspect Canadian prescription drug
exporters 12 times annually (Kaiser Daily Health Policy Report, 5/4). However, the approval of the second-
degree amendment, proposed by Sen. Thad Cochran (R-Miss.), effectively "neutralized" the Dorgan
amendment, the AP/Chronicle reports (AP/Houston Chronicle, 5/8). According to The Hill, in "both the
current and Clinton administrations, HHS refused to guarantee that it could certify the safety of drugs
imported from other countries" (Young, The Hill, 5/7). Cochran said that "serious problems exist with
products from other countries" and that "hundreds, if not thousands," of consumers worldwide have
experienced problems with counterfeit prescription drugs (Cox/Richmond Times-Dispatch, 5/8).

Implications, Reaction. Thirty-three Republicans, 15 Democrats and one independent voted in favor of
the Cochran amendment, and 28 Democrats, 11 Republicans and one independent voted against the
amendment (Armstrong, CQ Today, 5/7). According to The Hill, the passage of the Cochran amendment
also might allow President Bush to approve the reauthorization bill, which he has threatened to veto in the
event that the legislation includes the Dorgan amendment (The Hill, 5/7). Senate Health, Education, Labor
and Pensions Committee Chair Edward Kennedy (D-Mass.) said that he voted in favor of the Cochran
amendment to prevent a veto of the reauthorization bill (Edney, CongressDaily, 5/8). Senate HELP
Committee ranking member Mike Enzi (R-Wyo.), who also voted in favor of the Cochran amendment, said
that the Senate should not consider reimportation "in the midst of our work on the biggest drug safety
reform in a decade "(New York Times, 5/8). However, Dorgan said, "Today is a day of lost opportunity"
(Alonso-Zaldivar, Los Angeles Times, 5/8). He called the passage of the Cochran amendment a "setback"
but "not the end of our effort," adding, "We're going to keep fighting" (Wilde Mathews, Wall Street Journal,
5/8). Sen. Bernie Sanders (I-Vt.), who voted against the Cochran amendment, called the amendment a
"poison pill" for legislation that would allow reimportation (AP/Houston Chronicle, 5/8). Sen. David Vitter (R-
La.), who also voted against the Cochran amendment, said, "Well, once again the big drug companies
have proved that they are the most powerful and best-financed lobby in Washington" (Cohen, Newark Star-
Ledger, 5/8). Cloture Invoked on Reauthorization Bill The Senate on Monday also voted 82-8 to invoke
cloture, or limit debate, on the reauthorization bill, "clearing the way for its passage," according to
CongressDaily (CongressDaily, 5/8). The legislation, which the Senate HELP Committee approved in April,
would reauthorize PDUFA, which will expire on Sept. 30, through 2012. The bill, sponsored by Kennedy, in
large part follows a proposal that FDA submitted to Congress earlier this year under which pharmaceutical
companies would pay the agency about $393 million in user fees in fiscal year 2008, compared with $305
million in FY 2007. The legislation increased the amount in the proposal by $50 million. According to the
Congressional Budget Office, the bill, which also includes a number of prescription drug safety provisions,
would cost $547 million over five years (Kaiser Daily Health Policy Report, 5/4). House Prospects The
House has not considered the reauthorization bill, but "drug importation language is expected to get a more
sympathetic hearing in that chamber," CQ Today reports. Rep. Rahm Emanuel (D-Ill.) in January
introduced a companion bill (HR 380) to legislation introduced by Dorgan and Snowe that might become an
amendment to the reauthorization legislation, according to a House Democratic aide (CQ Today, 5/7).
House Speaker Nancy Pelosi (D-Calif.) also has said that the reauthorization bill might include a
reimportation amendment, according to a congressional source (CongressDaily, 5/8).

   NPR's "Morning Edition" on Tuesday reported on the Senate debate of the reauthorization bill. The
segment includes comments from Dorgan; Snowe; Cochran; health care analyst Bob Lashefsky; and
Gerard Anderson, a professor at the Johns Hopkins Bloomberg School of Public Health (Rovner, "Morning
Edition," NPR, 5/8). Audio of the segment is available online.

(5/7, Kevin Drawbaugh, Reuters) reports “In a setback for supporters of legalizing the import of cheaper
drugs into the United States, the Senate voted 49-40 on Monday for an amendment to require safety
certification of drugs from other countries.”

(5/7, Roger Pilon, The Wall Street Journal) “...If companies are forced by the U.S. government to continue
supplying cheap drugs to countries from which they are then reimported to the U.S. -- crowding out the
higher-priced domestic supply of drugs -- it's only a matter of time until profits are insufficient to support the
enormous costs of R&D for future drugs...Mr. Pilon is vice president for legal affairs at the Cato Institute.”

Mike Adams Source: Source: , May 8, 2007, from Suddenly Senior (Excerpt):
“Consumers expecting a miracle in the Senate that would end Big Pharma's monopoly and the FDA-
enforced drug racket now operating in the United States will be sorely disappointed by yesterday's events.
Fifteen Democratic senators (led by Sen. Edward Kennedy) abandoned consumer interests and joined a
Republican-organized amendment that would protect Big Pharma's stranglehold over U.S. consumers by
blocking the importation of prescription drugs from other countries. The amendment in question is Senate
Amendment 1010: "To protect the health and safety of the public," sponsored by Sen. Thad Cochran (R-
MS) as an amendment to S.1082, the FDA reauthorization bill. The short text of the amendment requires
that the Secretary of Health and Human Services block all importations of medications unless HHS can
certify to Congress that such imports, "pose no additional risk to the public's health and safety." HHS
Secretary Mike Leavitt, of course, has no interest in allowing free market conditions to threaten Big Pharma
profits, thus the outcome of this amendment is obvious: It effectively overturns the Dorgan amendment that
would have allowed Americans to save billions of dollars on prescription drugs by purchasing them from
outside the United States under "free market" conditions. Fifteen Democratic senators voted in favor of this
amendment to defend Big Pharma's monopoly. Those senators are are: Max Baucus, Evan Bayh, Maria
Cantwell, Thomas Carper, Edward Kennedy, John Kerry, Mary Landrieu, Frank Lautenberg, Blanche
Lincoln, Robert Menéndez, Barbara Mikulski, Patty Murray, Ben Nelson, Jay Rockefeller, and Kenneth
Salazar. Thirty-three Republicans also supported the bill, which passed 49-40 (11 not voting). The
Republican senators who voted for this amendment are: Lamar Alexander, Robert Bennett, Kit Bond, Jim
Bunning, Richard Burr, Saxby Chambliss, Tom Coburn, Thad Cochran, Norm Coleman, Bob Corker, John
Cornyn, Michael Crapo, Elizabeth Dole, Pete Domenici, Michael Enzi, Lindsey Graham, Judd Gregg,
Chuck Hagel, Orrin Hatch, Kay Bailey Hutchison, Johnny Isakson, Jon Kyl, Richard Lugar, Mel Martinez,
Mitch McConnell, Lisa Murkowski, Pat Roberts, Arlen Specter, Ted Stevens, John Sununu, Craig Thomas,
George Voinovich, and John Warner.

Big Pharma owns the U.S. Senate. What's clear from this vote is that the majority of U.S. Senators do not
represent the interests of the people. Backed by Big Pharma reelection campaign money, our lawmakers
are acting to directly enforce a Big Pharma monopoly at the expense of the public. While the exact same
medications are available from Canada, Europe and other countries for nearly half the price paid in the
United States, U.S. consumers will continue to be forced to pay monopoly prices on their medications
thanks to the great U.S. Senate sellout to Big Pharma. It's not just consumers who are financially harmed
by this drug price fixing scheme, either. Many corporations, city governments and states are headed to
near-certain financial bankruptcy in large part due to monopoly pricing on prescription drugs. The near-
collapse of the U.S. auto industry, for example, is largely due to health care costs. General Motors spends
more on health insurance than it does on steel. The cost of doing business in the United States is now
unbearable for many companies, and they're fleeing to other countries where health care costs are a
fraction of U.S. costs. Fifteen Democratic and thirty-three Republican senators believe U.S. citizens and
businesses should be forced to pay the highest prices in the world for medications. Monopoly market
conditions must be upheld. Keeping Americans diseased, uninformed and financially exploited is simply too
profitable to walk away from. And corporate control over the U.S. Congress has never been stronger. It is
no exaggeration to say that, with few exceptions, lawmakers no longer vote according to the interests of the
citizens they claim to represent. Rather than casting votes that actually protect the public interest,
lawmakers now spend their time determining which votes will get them reelected. That, of course, requires
money, and corporations have lots of that -- especially when they run FDA-enforced monopoly price fixing
schemes that clearly qualify as crimes under existing anti-trust legislation….”

”How many self-described "free" trade lawmakers in Congress can the drug industry make head to the floor
of the Senate and bare their corporate protectionist corruption for all to see? Based on a key vote
yesterday, the answer appears to be somewhere in the neighborhood of 49 (including 14 Democrats) - well
over what's necessary to control the federal government. That's right, as the Associated Press reports, "In
a triumph for the pharmaceutical industry, the Senate killed a drive to allow consumers to buy prescription
drugs from abroad at a significant savings from domestic prices." The legislation to allow imports of FDA-
approved medicines from other industrialized nations (a practice used by other industrialized nations
themselves) was sponsored by North Dakota Sen. Byron Dorgan (D) and has long been supported by the
vast majority of the American public in opinion polls. Yet right there on the floor of the U.S. Senate
yesterday afternoon, 49 senators voted through a poison pill amendment, invalidating Dorgan's legislation
and protecting drug industry profiteering. The sheer disregard for the truth and for consistency when it
came to both the policy and politics of this vote was, in a word, stunning.” For the full post, go to:


The Hill, The Executive, By Ian Swanson, May 03, 2007:
 “Research-based pharmaceutical companies could be among the biggest losers if House Democrats and
the Bush administration reach an agreement on trade, industry sources said this week. The administration
is prepared to accept changes demanded by Ways and Means Committee Chairman Charles Rangel (D-
N.Y.) that would lessen protections in trade deals for brand-name drugs, according to drug industry sources
and business lobbyists closely following talks. These protections consistently had been included in U.S.
trade deals that were approved by the Republican Congress. For example, the Central American Free
Trade Agreement (CAFTA) included “data exclusivity” provisions that can delay the arrival of generic drugs
on the market, sometimes even after a patent for a brand-name drug expires. Some public health activists
see the shift as a sign that the trend toward ever-stricter intellectual property rules for drug patents is
turning with a Democratic Congress. “We’d see that as an improvement,” a policy adviser at the advocacy
group Oxfam, Stephanie Burgos, said. Business lobbyists and some sources in the pharmaceutical industry
also said the trade talks reflect a tougher political climate for pharmaceutical companies. They noted that
while the administration is drawing a line in the sand over labor talks related to the trade deals, it is not
being as aggressive in defending the pharmaceutical industry. Industry sources said U.S. drug makers
realize they cannot stop the trade deals from being approved no matter how much they protest if there is a
deal between the administration and Rangel. As a result, they questioned how strenuously the drug lobby
would fight the deals if they move forward. Expending political capital on the trade agreements might not
make sense in a context in which U.S. drug producers are under siege on many other issues, one industry
source said, since while international patent rules are important, U.S. rules are even more valuable. Just
last week, the Senate approved legislation lifting a prohibition on government involvement in price
negotiations between drug makers and Medicare Part D plans. One industry source predicted that at a
minimum, U.S. drug makers would oppose pending free-trade deals with Panama, Peru, Colombia and
South Korea that have different provisions than deals approved by the Republican Congress. He also said
the changes “call into question the value of the intellectual property protections in the free-trade
agreements” for the industry. Rangel explained his position to drug industry representatives in a meeting
last week, sources said. A spokesman for the Pharmaceutical Research and Manufacturers of America
(PhRMA) said that discussions are continuing and that proposals on patent rules for pharmaceuticals in
trade deals are still evolving. He said U.S. drug makers share Rangel’s objective of providing access to
medicines for residents of trading partners.

Other lobbyists, however, predicted there would be at best only minor changes to the terms laid out by
Rangel and his staff if there were a separate deal on labor. Rangel is insisting on the changes in response
to long-standing complaints from members of his caucus, including House Oversight and Government
Reform Committee Chairman Henry Waxman (D-Calif.). Labor issues have been the major sticking point in
the talks, and labor and business sources said those talks hit a snag last week after a meeting between
Rangel and AFL-CIO President John Sweeney when Sweeney said labor could not support deals that
would prevent U.S. labor laws from being challenged for violating International Labor Organization
principles. One of the biggest changes Rangel is pushing deals with data exclusivity, which prevents
generic-drug makers from using the clinical test data used by brand-name drugs to secure marketing
approval for their generic drugs. In the Central American deal, this protection lasts five years. This has the
effect of preventing generic drugs from coming to the market. PhRMA has argued that such restrictions are
justified to reward the innovation of the research-based drug companies, and because of delays that can
prevent those drugs from coming to market during their patent life. The language Rangel is pushing would
start the data-exclusivity clock once a brand-name drug receives marketing approval in the U.S. Some
activists, however, argue this does not go far enough, and that poor countries such as Peru and Colombia
should not be subject to the same rules as U.S. law. Burgos said Oxfam’s position is that these countries
should only be subject to the standards of the World Trade Organization, and not the stricter terms of U.S.









Reprinted from the Apirl 20, 2007, issue of DRUG BENEFIT NEWS (excerpt):
“Medicare Part D sponsors burned the midnight oil to meet CMS's April 16 deadline for submitting 2008
Part D formularies -- a process that industry observers and executives say was made tougher by the
agency's delayed announcement of changes to formulary submission requirements. While CMS officials
say the new requirements for 2008, unveiled March 20, contained "no major changes," others described
them as "significant and unexpected." For example, CMS made thousands of changes to its formulary
reference file, a list of drugs with national drug codes (NDC) that Part D sponsors use to build formularies,
says David Smith, vice president of product development at formulary management technology firm
Zynchros, Inc. The formulary reference file provides proxy NDC codes (i.e., unique identifiers used by CMS
for reporting purposes) on drugs cleared for CMS reimbursement. The file previously contained more than
7,000 NDC codes, he tells DBN. "They dropped that down to about 4,500 in 2008," he says. "A whole
bunch of products were taken off the list. In a few situations, these were products they didn't want to cover
anymore, but mostly they were eliminating a whole bunch of redundancies in the original formulary
reference file." CMS also added roughly 1,000 NDCs, he says. Additional changes included new fields on
the formularies that classify drugs by type (i.e., brand, generic, non-preferred brand), specialty pharmacy
and those that require prior authorization, Smith explains. CMS announced the changes during a March 20
Webcast, but didn't publish the list of changes until March 23, three days before Part D sponsors could start
submitting their 2008 formularies, he notes. "All of these plans that have been busily preparing for 2008 --
they had been using the 2007 formulary reference file assuming there wouldn't be too many changes," he
says. "Everybody expected a few tweaks here and there, but enough that you could fix it and go on. But
this was such a huge change that people had to take thousands of products off their current formulary [and]
add a whole bunch of new products." "Based on what we hear from our customers, it has been a nightmare
for everyone," Smith adds. Zynchros markets an online tool that allows for the automatic translation of the
2007 formularies to the new 2008 drug list. Plans, PBMs Note Tighter Deadline. Part D sponsors and
experts queried by DBN agreed the changes were significant, but can be accommodated. They also note
that CMS's required changes came later than expected. … Significant changes for the 2008 formularies,
she notes, include raising from $500 to $600 the floor for specialty drugs. In 2008, only Part D drugs with
sponsor-negotiated prices that exceed $600 per month may be placed in the specialty tier, according to
CMS. Another significant change was CMS's decision to review formularies for a greater number of the
most commonly used drugs "long after pharmacy and therapeutic decisions have been made," Luddy
says…. Dan Mendelson, president of Washington, D.C.-based consulting firm Avalere Health, says the
changes signal that CMS is focusing on new quality measures and indicators. The new drug list is causing
some plans to re-evaluate part of their formulary structure, "because when you start making changes in a
formulary, there are also other collateral changes that need to happen," Mendelson added.”


PUBLIC CITIZEN RENEGOTIATES PAXIL SETTLEMENT, 5/8: “Public Citizen secured an improved settlement for some parents who claim
GlaxoSmithKline (GSK) misled them about the effects of antidepressant Paxil in children under 18, the
group announced. Thousands of parents sought damages from the company, saying GSK failed to warn
the drug was ineffective and had an increased risk of side effects when taken by children, Public Citizen
said. Under the original settlement, the company agreed to create a $63.8 million settlement fund to pass
class members’ attorney fees and out-of-pocket expenses. However, Public Citizen filed an objection to the
settlement Feb. 23 because it required class members to submit proof of out-of-pocket purchases to
recover the money. Some of the purchases were made more than a decade ago, the group said. With the
original settlement, class members who could not provide proof of the expenses would have received $15
maximum. In addition, there was a cap on the share they could receive — up to $300,000 if more than
20,000 undocumented claims were made, regardless of how much money remained in the settlement fund.
Under the new settlement, class members who cannot provide documentation of purchases can receive up
to $100, according to Public Citizen. The new settlement also eliminates the $300,000 cap for those

By CQ Staff, The Commonwealth Fund, May 7, 2007:
“May 4, 2007 -- Reps. Tom Allen, D-Maine, and Jo Ann Emerson, R-Mo., plan to introduce legislation
Monday that would increase federal investment in research to determine the most effective medicines and
medical treatments. The measure would authorize $3 billion over five years for research conducted by the
Agency for Healthcare Research and Quality (AHRQ), the federal agency that has done comparative
effectiveness reviews on renal artery stenosis, anemia drugs used by cancer patients, and other items.
Comparative effectiveness research compares outcomes associated with different therapies for the same
condition, allowing providers and patients to avoid ineffective or costly treatments. Among its provisions,
the legislation would establish a comparative effectiveness advisory board appointed by the Comptroller
General at the Government Accountability Office that includes employers, consumers, health care
providers, researchers, and others, to provide input on research priorities and methodologies. Separately
on Monday, the Blue Cross and Blue Shield Association is expected to announce its proposal for a public–
private entity to explore the effectiveness of new and existing medical procedures, drugs, devices, and

May 5, “Eighty percent of participants in Pfizer clinical trials come from just 26 percent of
the research sites, according to an internal survey the company conducted of studies it sponsored between
2000 and 2006. While 8 percent of the sites in all Pfizer clinical trials from 2000 to 2006 failed to enroll any
patients, in oncology the figure was 37 percent, Peter DiBiaso, director of clinical trial recruitment services

for Pfizer, who presented the data at the Association of Clinical Research Professionals’ annual conference
April 23 in Seattle, said. “With $20,000 to $25,000 in site initiation costs, you do the math.” Additionally, 11
percent of the sites enrolled just one subject. From Pfizer’s perspective, this is “almost worse” than the site
failing to enroll any subjects at all, since with even one participant the sponsor still incurs risk and costs,
according to DiBiaso. Pfizer’s survey also showed that 74 percent of investigators were used for only one
protocol each, and 86 percent of investigators were used for a single development phase of a clinical trial,
DiBiaso said. Twelve percent of investigators were used for two phases, 2 percent for three phases and 0.1
percent for all four phases. “More troubling, only 15 percent of Phase III investigators are used for Phase IV
studies,” he added.”

Pharmalot blog, Posted: 09 May 2007 07:16 AM CDT
“ In just the last month, plaintiffs have filed more than 350 products-liability cases in Delaware state court
against AstraZeneca over its Seroquel schizophrenia drug, a surge exceeding the total number of cases
filed there in the last two years. The National Law Journal reports that plaintiffs lawyers contend that there
is nothing behind the uptake - they point out that Delaware is AstraZeneca's home state and the cases
would have been filed eventually anyway. But a defense observer believes plaintiffs lawyers may be trying
to force an early settlement of the Delaware cases that would influence the settlement of the rest of the
litigation - and avoid the federal multidistrict litigation in Tampa - because Delaware is on a fast track for
trial and discovery. The lawyers are posturing nicely. Mike Kelly, managing partner of McCarter & English's
Wilmington office, who leads AstraZeneca's Seroquel defense team in Delaware state court, says the
drugmaker won't settle. "In boxing terms, we will go toe to toe - no 'rope a dope' here. We stand behind
Seroquel, which is a great product that has helped a lot of people." But Paul Pennock of Weitz & Luxenberg
in New York, who is co-lead plaintiffs counsel in the federal Seroquel MDL, lead counsel in New Jersey and
also involved in the Delaware litigation, calls AstraZeneca's approach "foolish." "We're going to take
scorched earth back at them." If the surge in Delaware is part of a strategy, its aim is to spread out large
numbers of cases to give plaintiffs "as many different pressure points on AstraZeneca as we can obtain,"
he says. The litigation arose from a label change ordered by the FDA four years ago, indicating patients are
at a heightened risk of contracting diabetes. No link has been proven, but plaintiffs who took the drug
before that date claim injury and a lack of adequate warnings. Pennock notes that Lilly settled litigation over
Zyprexa and agreed to pay more than $1 billion to settle 28,500 state and federal claims while denying
liability. That litigation has been notable thanks to a controversy over public disclosure of thousands of
pages of documents indicating Lilly failed to disclose side effects and improperly marketed its drug to docs.
You can read the full story here. Hat tip to Furious Seasons.”

By Catherine Larkin and Shannon Pettypiece, Bloomberg, summary: “Wyeth's manufacturing plant in
Guayama, Puerto Rico, passed a U.S. regulatory inspection a year after being cited for safety lapses,
allowing some of the company's most important new drugs to come to market. Link:

Bloomberg, By Jason Gale, summary: Astellas Pharma Inc., Japan's third- largest drugmaker, and
FibroGen Inc. said a U.S. patient died of liver failure after taking their experimental anemia medicine. Link:

Date Published: Monday, May 7th, 2007, News Inferno
“Late last week, the U.S. Food and Drug Administration issued a warning to healthcare professionals and
drug manufacturers about the potential presence of diethylene glycol (DEG) in prescription and over-the-
counter drugs. DEG is a known poison used in the production of antifreeze and it can be fatal if consumed
by humans. DEG is often added to glycerin as a cost-saving measure for counterfeiters; glycerin is a thick
sweetener that is commonly used in liquid medications. “At the present time,” says the agency, “FDA has
no reason to believe that the U.S. supply of glycerin is contaminated with DEG, though the agency is
cognizant of reports from other countries over the past several years in which DEG-contaminated glycerin
has caused human deaths. FDA is emphasizing the importance of testing glycerin for DEG due to the
serious nature of this potentially fatal problem in combination with the global nature of the pharmaceutical
supply chain and problems that continue to occur with this kind of contamination in some parts of the global

supply of glycerin.” Most recently, an outbreak of DEG poisoning in Panama was traced to a batch of
contaminated cough syrup, which led to more than 40 confirmed deaths and hundreds of illnesses–many
estimates put those numbers even higher. Similar outbreaks were reported during the 1990s in Haiti,
Argentina, Bangladesh, India, and Nigeria. In fact, a rash of DEG poisoning killed more than 100 people in
the United States in 1937, a problem that led directly to the Federal Food, Drug, and Cosmetic Act and the
creation of the U.S. Food and Drug Administration in the first place. In all of the aforementioned cases, the
FDA notes that “pharmaceutical manufacturers of the syrups that contained contaminated glycerin did not
perform full identity testing on the glycerin raw material” and that the manufacturers only “relied on the
certificate of analysis (COA) provided by the supplier.” In most cases, the COA documents were not
accurate. According to the FDA’s most recent guidance on the matter, they are asking all manufacturers to
conduct an “identity test” for DEG on all lots of glycerin and to be vigilant about ensuring the integrity of its
supply chain. This weekend, the New York Times ran a major story about diethylene glycol and its common
use by drug counterfeiters. The Times’ investigation traced the source of the majority of DEG
contamination to China. Although the FDA did not specifically mention China as a potential source of the
problem, it appears that much of the contaminated glycerin originated there. As proved by the recent
outbreak of melamine contamination in Chinese vegetable proteins, the Chinese government’s food- and
drug-safety measures continue to fall short of the norm for the developed world.”

ISTA CHALLENGING T-PRED NOT APPROVABLE LETTER, 5/8: “The FDA issued a not approvable letter for Ista Pharmaceutical’s eye treatment T-
Pred because a clinical trial did not meet the expected endpoints, the agency said. However, the company
said it disagreed with the agency’s decision and would request a meeting with the FDA. T-Pred is a topical
steroid to treat inflammatory eye conditions with a risk of bacterial infections, the company said in a
statement. A clinical study of the drug met the endpoints that Ista and the FDA had agreed to in a protocol
assessment, company president and CEO Vincente Anido said. However, the FDA said data from the
clinical trial was not sufficient to approve the drug. The company plans to request a meeting with the FDA
“as soon as possible” to work with the agency and bring the drug to patients, Anido added. Ista completed
a Phase III clinical study in 2005 meant to compare the bioequivalence of prednisolone concentrations
between T-Pred and competing product, Allergan’s Pred Forte. The company says its product achieved or
exceeded the goal of the study in both protocol and intent-to-treat patient populations. In addition, T-Pred
showed equal antimicrobial activity to other combination products approved to treat the indication,
according to Ista. But the FDA said the study did not show sufficient equivalence in the prednisolone
concentrations between T-Pred and Pred Forte. The data also did not show equivalence in the kill time
between the tobramycin components in T-Pred and Tobrex, although T-Pred did show equivalent kill time
compared with two other eye products, the FDA said.”

By Luke Timmerman, Bloomberg: summary: Amgen Inc., the world's largest biotechnology company, is
struggling to retain sales of its anemia drugs after studies found they can cause lethal side effects in high
doses. Link:

By Lisa Rapaport, Bloomberg, summary: Wyeth's Pristiq and Johnson & Johnson's Ditropan XL, two non-
hormonal drugs designed for other purposes, reduced the frequency and severity of menopause symptoms
in studies. Link:


By DAVID ARMSTRONG, May 3, 2007, Wall St. Journal:
“Four former executives of Serono Inc. were found not guilty by a federal court jury of charges they offered
bribes to doctors in exchange for writing prescriptions for an AIDS drug sold by the company. The
executives, who all faced charges of criminal conspiracy, are John Bruens of San Diego; Mary Stewart of
North Andover, Mass.; Melissa Vaughn of Louisville, Colo., and Marc Sirockman of Flemington, N.J.
Attorney Adam Hoffinger, who represented Ms. Vaughn, said the jury returned the not guilty verdicts after
deliberating for three hours. "The speed of the verdict confirms what we believed: that this case shouldn't
have been charged in first case," he said. A spokeswoman for the U.S. Attorney's office in Boston, which
prosecuted the case, did not have an immediate comment. The indictment alleged that the executives were
part of a scheme to offer bribes to doctors to get them to prescribe Serono's AIDS-wasting drug, Serostim.
The alleged conspiracy was hatched, according to the indictment, to bolster disappointing sales of the
product. Among the alleged inducements offered to doctors was an all-expenses paid trip to Cannes,
France, in 1999. Separately, a unit of Serono pleaded guilty in 2005 to two counts of conspiracy and
agreed to pay a $704 million fine to resolve criminal and civil charges related to the marketing of Serostim.”

Pharmalot Blog, Posted: 08 May 2007 12:30 PM CDT
“Those whistle-blowing sales reps caught another one. Medicis agreed to settle allegations the company
violated the False Claims Act concerning claims submitted to Medicaid, the Justice Department announced
today. The settlement resolves charges Medicis promoted a topical skin preparation, Loprox, for use on
children under the age of 10, without FDA approval. The US and four former Medicis employees alleged
that from approximately November 2001 through April 2004, Medicis sales personnel targeted
pediatricians, urging the docs to use Loprox as a treatment for diaper rash. Loprox, which is approved as a
fungicide for kids over 10, isn't a “medically accepted indication” for the treatment of diaper dermatitis and
other skin disorders in children under 10. “This settlement demonstrates our ongoing commitment to
protecting funds for federal health care programs,” said Assistant Attorney General Pete Keisler.
“Pharmaceutical companies need to know that they will be held accountable for off-label marketing
schemes and other illegal activities that affect those programs.” In the case against Medicis, the United
States alleged that the Medicaid program paid millions of dollars for Loprox prescriptions that would not
have been reimbursed if government authorities had known that the prescriptions resulted from the
company’s off-label marketing campaign. Medicis sold its pediatric sales unit in 2004. As a result of the
settlement, the whistleblowers will collectively receive in excess of $1,078,000 as their statutory award.
Under the qui tam provisions of the False Claims Act, private parties can file an action on behalf of the US
and receive a portion of the settlement if the government reaches a monetary agreement with the

Medicis Pharmaceutical Corp. has agreed to pay $9.8 million to settle an off-label marketing case involving
Loprox, a topical fungicide marketed as a diaper rash cure. Loprox is not FDA-approved for patients under
10 years of age. >> To read more

U.S. Oncology reports two seeming unrelated bits in their latest SEC Form 10-K. One note say cancer
patients are suddenly using a lot less anemia drugs, and as a result U.S. Oncology will bank $8-10 million a
year less than expected. The second note says that in 2005 the company was subpoenaed by the U.S.
Department of Justice about contracts and relationships with pharmaceutical companies. Coincidence?
>> To read more

Eli Lilly faces a rising mountain of liability over off-label marketing of anti-psychotic medication Zyprexa
which has reportedly been promoted for use by patients suffering from dementia, depression and autism.
Zyprexa, had $4.2 billion in sales in 2005, and is only FDA-approved for schizophrenia and bipolar
disorders. Along with the U.S. Department of Justice, numerous states have also filed suit or launched
investigations, including FL, TX, CA, IL, MT, LA, WV, AK, NM, OR, VT, and MS. >> To read more

Pharmalot, Posted: 08 May 2007 07:55 AM :
“For two years, federal prosecutors in New Jersey have been building a case that the nation's largest
makers of artificial hips and knees defrauded the government and taxpayers by paying surgeons to use
and promote their products. The evidence includes statements from prominent doctors around the country
who allegedly accepted lavish vacations, gifts and "consulting fees" as high as $200,000 a year from the
implant makers for little or no work, said four attorneys who have been briefed on aspects of the case. The
info comes from sources close to the probe, according to John Martin of The Star-Ledger of New Jersey,
which owns Pharmalot. There is no allegation that the practice jeopardized patients or subjected them to
substandard products or treatment. But the sources say prosecutors contend that the money had a sole
purpose -- to buy surgeons' loyalty to specific products -- and that doctors often failed to reveal such a
conflict to their patients. If true, such payments would violate the federal anti-kickback statutes that govern
hospitals and health professionals who participate in Medicare. "What the government is alleging is that the
companies hired the doctors in order to get their business," said one attorney, who, like others, asked not

to be named because his client had not authorized him to publicly discuss the investigation. "In the hip and
knee industry, it's a doctor-driven business." Now in its final stages, the investigation could end as soon as
this summer with a settlement of hundreds of millions of dollars, a pledge by the industry to reform and the
installation of a federal monitor, according to the sources. The holdout has been DePuy Orthopaedics, a
subsidiary of New Brunswick-based Johnson & Johnson, which is resisting a settlement, the sources said.
The stalemate recently has sparked a new round of subpoenas and threats of indictments against doctors,
executives or the manufacturers they work for, the attorneys said. Besides DePuy, which is based in
Warsaw, Ind., the other subjects include Zimmer Holdings Inc. and Biomet Inc., also of Warsaw, Ind.;
Stryker Corp. of Kalamazoo, Mich.; and Smith & Nephew PLC, a British company with U.S. headquarters in
Tennessee. Together the companies control more than 90 percent of the US market in reconstructive
implants, an industry surging as America ages. They employ tens of thousands worldwide and have
combined annual revenue of more than $15 billion. Each has acknowledged aspects of the probe, as well
as a second unrelated price-fixing investigation by the Justice Department's Antitrust Division, in regular
Securities and Exchange Commission reports. In one such filing in February, Stryker warned investors: "As
a result of these investigations, the Company's future operating results could be negatively impacted by
settlements of these matters." For decades, companies have treated doctors to lavish dinners or
sponsored Caribbean getaways with the hopes of landing their business. And the biggest manufacturers
jockeyed to align themselves with the industry's best known names, the same way a sneaker or apparel
company signs an athlete as a pitchman. But just as Tiger Woods has to wear and promote Nike products,
the doctors' contracts require them to earn the fees, by hosting training seminars, offering public speeches
or helping to develop new products. And their own codes of conduct require them to tell their patients if
they are being paid by manufacturers. In some cases, investigators uncovered what two sources called
"egregious" violations in which doctors received payoffs for the equivalent of a no-show consulting job.
Others, they said, were more subtle, such as an all-expenses-paid trip or stipend for delivering a speech at
a ski resort -- sometimes to just one or two other consultants. "Universally, we're all opposed to those sorts
of arrangements," he said. "It was clear in many respects that these guys were the bought-and-sold guys"
says William Dowling, a Morristown orthopedic surgeon who sits on the board of directors of the NJ
Orthopaedic Society.”


The Motley Fool, Ryan Fuhrmann, CFA, May 8, 2007:
“CVS/Caremark (NYSE: CVS) was a combined entity a full 10 days during the first quarter. While it's too
early to see if CVS blazed a new health-care trail by combining a drugstore chain with giant pharmacy
benefit manager (PBM) Caremark, there are still interesting tidbits to pass along from recently reported
results. During the company's first-quarter conference call, it admitted to "a lot of noise" in the financials as
a result of the Caremark acquisition. In addition to customary merger and integration charges, shares
outstanding increased from those issued to buy Caremark, and interest expense jumped markedly from
other drugstore acquisitions. CVS/Caremark saw continued strong same-store sales trends at its
drugstores as total comps advanced 7.5% for the quarter. Drugstores report sales from two perspectives:
pharmacy and front-end. Pharmacy comps grew an impressive 7.8%, while front-end merchandise comps
improved 6.6%. CVS is seeing lower pharmacy comps as generic drugs lower sales growth. While they
bring in higher profit margins to drug retailers selling generics, patent expirations hurt pharma giants such
as Pfizer (NYSE: PFE). The coming year will likely see more murky financials as CVS works to fully
integrate Caremark. However, the long-term potential remains worth investigating, as the erstwhile
Caremark was a leading PBM with prodigious cash flow-generating capabilities. The company is also
ramping up the opening of MinuteClinics inside its CVS stores; it hopes these quick-care clinics will make
going to the doctor as simple as picking up a prescription. During the earnings conference call,
management estimated that 25% of patients who head to the company's 180 existing MinuteClinics have
never been in a CVS. Quick-care clinics have significant potential and are also being pursued by big-box
behemoth Wal-Mart (NYSE: WMT). Yet currently, CVS believes its MinuteClinic count outnumbers the next
three competitors combined. It also believes these clinics will bring core Caremark clients outdoors, as they
currently rely on the PBM's mail-order business to receive prescriptions. Overall, the Caremark integration
appears to be progressing as planned. For the time being, archrivals Walgreen (NYSE: WAG), Long Drug
Stores (NYSE: LDG), and Rite-Aid (NYSE: RAD) are primarily sticking to their retail store knitting, but they
may have some catching up to do if CVS/Caremark realizes the huge potential in combining drugstore,
PBM, and quick-care clinic businesses under one retail umbrella.”


(5/8 PharmaTimes) reports “Any legislation to create a regulatory pathway at the US Food and Drug
Administration for follow-on biologics should provide no less than 14 years' data exclusivity for pioneer
products, the Biotechnology Industry Organization has stated...The industry group made its demand just as
Congress was being told that the protection of monopolies and the financial bottom line have harmed the
industry's goal of ‘solving the mysteries of disease.’”

(5/8, Allan Coukell, WBUR, Boston's NPR) reports “As they prepare to leave Boston at the close of the big
‘BIO International’ conference on Wednesday, thousands of biotechnology executives will be looking to the
future. One of the issues they'll be thinking about is competition from the less expensive copy-cat drugs.”

(5/7 The Pink Sheet) reports “A bill introduced by Rep- Bobby Rush, D-III banning ‘reverse’ settlements
between brand and generic companies would give the Federal Trade Commission the power to allow any
such agreement it deems furthers market competition.” (Paid Subscription

(5/6, Robert Cohen, The Star-Ledger) reports “...The drug and computer industries aren't ordinarily
adversaries in the marketplace or the courtroom, but their needs and business models are in conflict about
the patent issues.”

(5/9, Celia W. Dugger, The New York Times) reports “...Standing next to Thailand's health minister, Mr.
Clinton also forcefully endorsed recent decisions by Thailand and Brazil to break patents held by American
pharmaceutical companies that are charging prices Mr. Clinton described as exorbitant, but that drug
company officials said were reasonable.”

(5/7 Bloomberg) reports “...The acquisition would give Teva, based in Petah Tikva, Israel, wider distribution
of its products and extend its global lead over Novartis AG, the world's second-largest generic-drug maker.”

(5/7, Ronald A. Cass, The Wall Street Journal) “...The real story is that the USTR and U.S. government are
doing too little -- not too much -- to safeguard IP rights, especially when it comes to pharmaceuticals. And
despite all the shouting, that is more true today than a decade ago...Mr. Cass is chairman of the Center for
the Rule of Law...”


(5/7, Steve Brown, Drug Industry Daily) reports “President Bush announced former HHS Deputy Chief of
Staff Kerry Weems as his nominee for Centers for Medicare & Medicaid Services (CMS) administrator. If
confirmed by the Senate, Weems would succeed former CMS Administrator Mark McClellan, who resigned
in October.” (Paid Subscription Required)


“On behalf of the Australian Government Department of Health and Ageing, The Commonwealth Fund is
pleased to announce the 2008-09 Packer Policy Fellowship, an Australian-American health policy
fellowship program. The Packer Policy Fellowships offer a unique opportunity for outstanding, mid-career
U.S. professionals--academics, physicians, decision makers in managed care and other private health care
organizations, federal and state health officials, and journalists--to spend up to 10 months in Australia
conducting research and working with leading Australian health policy experts on issues relevant to both
countries. In addition to undertaking original policy research, fellows will participate in seminars and policy
briefings, which include meetings with senior officials at the commonwealth and state levels, ministerial
officers, service providers, academics, and other stakeholders in the public and private sectors. At the end
of their tenure, fellows produce a report and present project findings to senior government officials and
policy experts at a final reporting seminar. Australia, like the U.S. and other similar developed countries,
faces health policy challenges in relation to demographic change, affordability, safety and quality in health
care, adoption of new treatment technologies, workforce issues and meeting the needs of special
populations. The Australian Government Department of Health and Ageing hopes to enrich health policy
thinking as Packer Policy Fellows study how Australia approaches health policy issues, share lessons
learned from the United States, and develop an international perspective and network of contacts to
facilitate policy exchange and collaboration that extends beyond the fellowship experience. To apply,
applicants must submit a formal application, including a project proposal that falls within an area of mutual
policy interest to Australia and the United States, such as: health care quality and safety, the private/public
mix of insurance and providers, the fiscal sustainability of health systems, management of health care
delivery, the health care workforce, and investment in preventive care strategies. U.S. citizenship is a
requirement for eligibility. The Fellowships provide up to $55,000 (AUD) for six to 10 months in Australia. In
addition, a supplemental allowance is provided to fellows accompanied by a spouse and/or children. The
deadline for receipt of applications for the 2008-09 fellowships is August 15, 2007. For further
information on the 2008-09 Packer Policy Fellowships and to obtain an application, please see For questions, contact Robin Osborn, The Commonwealth Fund,
212-606-3809 or “


EDITOR’S NOTE: In accordance with Title 17 U.S.C. Section 107, this material is distributed without profit
to those who have expressed a prior interest in receiving the included information for research and
educational purposes.



Shared By:
shensengvf shensengvf http://