Is banning direct-to-consumer advertising consistent with bioethical principles? by ProQuest


Whilst improved regulation and education will address it to some degree, major reforms to payment systems for drug companies and doctors are also required. [...] all these systemic reforms can be put in place, the best policy option is to ban the promotion of drugs to doctors and the public.10 Other negative aspects of DTCA include concerns about the emotion stimulated through advertisements, as well as their questionable educational value.5 DTCA critics cite the economic and time costs these ads bring into the clinic, touching on the issue of distributive justice.

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									                                            PA QUANDARIES
                                                  KEVIN MICHAEL O’HARA, MMSc, PA-C

    Is banning direct-to-consumer advertising
       consistent with bioethical principles?
›CASE                                               ous advertisements promoting medica-         result of unnecessary treatment than
Mr. G, a 24-year-old male, presented                tions for depression, insomnia, and          from not taking medication. This may
to his PA with concerns about mood.                 other common ailments. The perva-            challenge the “do no harm” principle
Recent physical examination findings                 siveness of these advertisements is not      of nonmaleficence, as well as the
indicated he is healthy. Mr. G reported             without possible consequence.                bioethical principle that obligates PAs
occasionally feeling “down,” but fur-                                                            and other medical providers to offer
ther questioning confirmed that the                  ›BIOETHICAL PRINCIPLES                       advice and treatment that will help the
patient did not have a mood disorder.               DTCA intersects all four ethical prin-       patient, known as beneficence.
Mr. G told the PA that he recently saw              ciples. If DTCA misleads or manipu-             Another bioethical concept is
several advertisements on television                lates a patient, concerns about patient      distributive justice, which looks at
and in magazines about a new medi-                  autonomy, beneficence, and nonma-             how communities and societies allo-
cation, described in the ads as being               leficence converge. If inaccurate infor-      cate resources. Stanford University’s
indicated for people with occasional                mation about medication convinces a          Encyclopedia of Philosophy describes the
mood swings. Mr. G said that he had                 patient to pursue treatment that may         most basic tenet of distributive justice:
done “quite a bit of Internet research”             not otherwise be needed or desired, the      “the first relatively simple principle of
and that he would like to try the medi-             patient’s decision-making autonomy           distributive justice examined is strict
cation. The PA performed a complete                 is threatened. The situation created by      egalitarianism, which advocates the
psychiatric evaluation and noted that               DTCA limits the autonomy of clinicians       allocation of equal material goods to all
prescribing this medication was not                 as well. The pressures and practice          members of society.”1 The concept is
indicated. The disappointed patient,                demands may sway a clinician to pre-         certainly complex and nuanced. Some
commenting that he “really thinks this              scribe medications without a clear indi-     argue that the concept in fact should
medication will help him feel better,”              cation. Furthermore, does the clinician      not require strict equality in distribution
left dissatisfied and said he would find              have an ethical obligation to respect and    of goods. In this case, the distributive
a “doctor who will listen to me.”                   act on a patient request that is based on    justice issue can be used to evaluate if
   Patients are surrounded by a vari-               DTCA exposure in order to preserve           public health would be better served if
ety of visual, auditory, and other forms            patient autonomy?                            the resources spent on DTCA were allo-
of product advertising. These products                 DTCA may result in a patient              cated for actual provision of care.
represent varied industries, including              receiving medication he or she does
service, diet, and more recently, phar-             not need. In this setting, the patient is    ›HISTORY OF DTCA
maceuticals. Legal and ethical concerns             more likely to experience harm as a          Understanding the issues surrounding
surround all forms of advertisement re-                                                          DTCA is enhanced by an appreciation
gardless of the product or the intended                                                          of their historical foundation. Before
audience. These concerns are notably                  CONTACT US                                 the 1980s, pharmaceutical advertising
relevant in the setting of pharmaceuti-               Do you have an ethical                     was not directed toward the consumer.
cal products and carry the additional                 quandary?                                  Many professional organizations and
weight of clinical relevance.                                                                    pharmaceutical corporations agreed
                                                      This department addresses the real-
   The issue is particularly concerning               world ethics concerns and problems
                                                                                                 that DTCA was inappropriate. The
with direct-to-consumer advertising                   of PAs. These might include problems       early 1990s set the stage for changes
(DTCA) of pharmaceuticals. Current                    in practice that may be inconspicuous,     in sentiment and practice. An eco-
popular media is crowded with numer-                  problems related to systems of care,       nomic recession and an increase in
                                                      problems related to the process of care,   managed care plans resulted in a rising
                                                      and preventive ethics.                     distrust of the medical establishment.
Kevin O’Hara practices in internal and HIV            Please e-mail your ethics question to      Many felt the lack of pharmaceutical
medicine in New York, New York, and is a gradu- We will          product advertising directed toward
ate student with the Department of Sociomedical       consider it for discussion in a future
Sciences at Columbia University, also in New
                                                                                                 consumers limited the consumer’s
                                                      installment of PA Quandaries               ability to acquire clinical decision-
York. He has indicated no relationships to dis-
close relating to the content of this article.                                                   making knowledge. Social movements

54 JAAPA • AUGUST 2010 • 23(8) •
stemming from the HIV/AIDS and              around people.” This type of anxiety         that can be treated.2 High volumes of
cancer communities erupted parallel         is often part of a normal life course        advertisements that show these types of
to these events, stimulating greater        and does not necessarily reflect pathol-      conditions in a distressing or negative
involvement in health care among            ogy. People viewing the advertisement        way can change how a person views his
persons outside the traditional medical     may identify with the actors’ por-           or her own experience with these condi-
establishment.2                             trayal, thereby expanding the scope          tions. This may threaten a patient’s abil-
   Pharmaceutical advertisers planned       of medicine to include stressful social      ity to make an informed decision and
their expansion into the enormous mar-      situations.                                  suggests other educational sources are
ket potential of television and radio.         Medicalization arises on at least three   needed to preserve patient autonomy.
In 1997, the FDA granted the phar-          levels: conceptual, interactional, and
maceutical industry a reprieve from         institutional.4 Each level has a presence    ›IS DTCA PROVIDING NEEDED
including the full brief of summary in      in the relationship between DTCA and         INFORMATION?
short television and radio advertising      medicalization. For example, the pres-       In 2005, the Journal of Bioethical Inquiry
segments.2 This allowance lead to a         sures that can push PAs to prescribe,        featured two papers that looked at the
significant increase in pharmaceutical       such as increasingly busy schedules and      issue of DTCA from opposing per-
advertising aimed at people outside the     the economics of clinical practice, are      spectives. Both sides of the argument
medical establishment. Total promo-         amplified when patient requests stem          regarding the allowance of DTCA pres-
tional spending for pharmaceuticals         from DTCA and, in turn, engender             ent interesting theories as to why their
in 1996 was US $11.4 billion, and 8         medicalization at the interactional level.   position best represents the health and
years after the emergence of television/    By conceding to patient prescription         welfare of our society.6
radio advertising, that sum neared US       demands, clinicians may be affirming             DTCA supporters cite an increased
                                                                                         understanding of disease and treat-
                                                                                         ment options as a positive attribute.7,8
“Common human experiences, such as                                                       They also attempt to demonstrate
                                                                                         several mechanisms through which
baldness, menstruation, and stress, have been                                            increased patient involvement can
turned into diseases that can be treated.”                                               bring about improved health out-
                                                                                         comes, including better medication
                                                                                         adherence.8,9 Support for DTCA is
$30 billion.3 During this time, money       the presence of an illness that requires     summarized as, “Those who sup-
spent specifically on DTCA burgeoned         treatment, thereby validating the pur-       port DTCA counter-argue that the
330% and came to represent 14% of           pose of DTCA. This can pose a viola-         ads are in principle no different to
the entire industry’s advertising bud-      tion of beneficence and nonmaleficence.        other forms of advertising, that they
get. Unfortunate parallel events were          A hallmark of ethical clinical practice   inform the population, and reassure
a reduction in FDA staff who review         is maintaining patient autonomy. This        individuals they are not alone with
pharmaceutical advertisements and an        affords the patient the possibility of       their problem and that help is avail-
alteration in the way a regulatory letter   making medical decisions that fit his         able. They are also said to encourage
could be presented to the industry.3        or her personal wishes, taking into          people to initiate discussions with
                                            account the many facets of a patient’s       their doctor.”6
›THE ROLE OF                                life (culture, economy, and logistics).         From the opposite perspective, a
MEDICALIZATION                              Autonomy incorporates knowledge of           rationale for a total ban of DTCA is
The impact of DTCA on American              the issues surrounding a medical deci-       described this way: Drug promotion
culture is complex. More specifically,       sion and the capacity to thoughtfully        should be evaluated according to its
DTCA has contributed to increasing          evaluate them. Advocates of DTCA             impact on health, access to information,
medicalization, a term that refers          suggest that DTCA can provide some           informed consent, and wealth. Drug
to labeling more and more human             of this knowledge. Opponents challenge       promotion currently does more harm
experience and behavior as a medi-          the value of this education and feel it      than good to each of these objectives
cal problem or illness for which the        produces more emotional sentiment            because it is usually misleading. This is
medical profession has treatment.4 As       than enlightenment.5                         a systemic problem. Whilst improved
DTCA creates excitement and inter-             The pervasiveness of advertising and      regulation and education will address
est, the media increase medicalization      the emotive storylines it carries make       it to some degree, major reforms to
through further reporting/coverage.         people identify with the products and        payment systems for drug companies
For example, many advertisements for        conditions. Common human experienc-          and doctors are also required. Until all
anxiolytics describe anxiety disorders      es, such as baldness, menstruation, and      these systemic reforms can be put in
as an “anxious feeling” or “nerves          stress, have been turned into diseases       place, the best policy option is to ban

56 JAAPA • AUGUST 2010 • 23(8) •
                                                                    JAAPA needs
the promotion of drugs to doctors and
the public.10
   Other negative aspects of DTCA
include concerns about the emotion                                  Case of the Month                                                                 Heidi Menga, PA-C
                                                                                                                                                                                                                                                                            Interested in being
stimulated through advertisements, as                                                                                       as showing a thin left subdural hemor-
                                                                                                                            rhage with meningeal enhancement and
                                                                                                                            diffuse left hemispheric edema causing
                                                                                                                                                                              in men, lung cancer accounts for
                                                                                                                                                                              28% of all cancer deaths, with SCLC
                                                                                                                                                                              encompassing 18% of those deaths.2
                                                                                                                                                                                                                                                                            published in the premier
well as their questionable educational
                                                                                                                            mass effect on the ventricle and midline          Dissemination to regional lymph nodes
                                                                                                                            shift. Most significant was that the soft          (limited-stage) or distant metastasis be-

                                                                                                                                                                                                                                                                            journal for physician
                                                                                                                            tissue involvement extended from the              yond the hemithorax (extensive-stage)
                                                                                                                            occiput to the parietal and temporal              to the brain, liver, bone, or pleura is
                                                                                                                            regions on the left scalp. A brain MRI            often present at diagnosis. Brain metas-
                                                                                                                            with contrast demonstrated an apparent            tasis is found in approximately 10% of
                                                                                                                            diffuse left-sided subdural hematoma              patients at the time of initial diagnosis.3

value.5 DTCA critics cite the economic
                                                                                                                            with edema and a hypodense left tem-                 SCLC responds well to chemother-
                                                                                                                            poral region and confirmed the left-               apy, but tumors often recur as they

                                                                                                                                                                                                                                                                            assistants? We’re
                                                                     FIGURE 1                                               scalp soft tissue involvement (Figure 1).         become resistant to the drugs. In
                                                                     Soft tissue involvement seen on axial MRI                                                                extensive-stage tumors, the response
                                                                                                                            ›WHAT IS YOUR DIAGNOSIS?                          rate is 65% to 85%; 1% to 5% of patients
                                                                                                                            • Subdural hematoma with                          achieve a complete response. With treat-
                                                                    ›CASE                                                     cephalohematoma                                 ment, the median life expectancy of a

and time costs these ads bring into                                 A 61-year-old man presented to the
                                                                    emergency department (ED) in
                                                                    January 2008 complaining of a tender
                                                                                                                            • Undifferentiated small cell carcinoma
                                                                                                                            • Lymphoma

                                                                                                                                                                              patient with extensive-stage disease is 9
                                                                                                                                                                              months; the 2-year survival rate is less
                                                                                                                                                                              than 3%.1 Treatment administration

                                                                                                                                                                                                                                                                            looking for PA authors
                                                                    bump on the back of his head. He                                                                          for more than 6 months has not been
                                                                    denied any recent trauma but reported                   The patient underwent subtotal resection          found to improve survival.3 Radiation
                                                                    watering of the left eye and ringing in                 of the scalp tumor. Pathology confirmed            therapy is important for palliation of

the clinic, touching on the issue of dis-
                                                                    the left ear. CT of his head was sig-                   the tumor to be an undifferentiated small         symptoms. Patients with extensive-stage
                                                                    nificant for an old right basal ganglia                  cell cancer. Despite a normal-appearing           disease survive longer when two or
                                                                    lacunar infarct, but there were no acute                chest radiograph, the patient underwent           more drugs are used, compared with
                                                                    findings. He was discharged with a                       CT of his chest along with positron               single-agent therapy or low-dose regi-
                                                                    diagnosis of conjunctivitis.                            emission tomography (PET). Both scans             mens. Commonly used agents include

                                                                                                                                                                                                                                                                            to write for these
                                                                      In March 2008, the man returned                       confirmed a malignant left upper-lobe              cyclophosphami
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