Industry influence in medicine, including psychiatry, is wide, deep, and
ubiquitous, and simple solutions regarding conflict-of-interest issues are not
likely to be found. That much was agreed upon by a panel of five
psychiatrists—including experts in ethics, research, and medical
education—at a presidential symposium at APA's 2009 annual meeting in
San Francisco in May.
Outgoing APA President Nada Stotland, M.D., who served as a discussant,
said that at an organizational level, realignment of APA's relationships with
industry is likely to involve difficult financial trade-offs, such as when the
Association opted to phase out industry-supported symposia that are known to
be a popular attraction at APA's meetings; or it may involve eliminating
worthy programs such as fellowships for minorities that are supported by
industry.
Panel members were united in saying that pharmaceutical marketing, with
demonstrable effects on physician behavior, has reached into all areas of
medicine, including research, education, and clinical practice. But while APA,
and individual psychiatrists, may need to terminate or realign some forms of
collaboration with industry, the various academic, private, and industry
stakeholders should not be singled out for scorn; rather, new ways of
collaborating with industry must be devised, with appropriate safeguards in
place.
"The pharmaceutical industry makes products that help people,"
said Jonathan Weker, M.D., a private practitioner from Montpelier, Vt., and
APA Assembly member who has argued for years that the Association needs to
extricate itself from the grip of industry. "Pharma is not the evil
empire. We have to figure out a new relationship with industry." (See
Adopting a 'Professional Paradigm'
for comments by Weker about the evolution
of the relationship between physicians and the pharmaceutical industry.)
The five panel members were, in addition to Weker, past APA President Paul
Appelbaum, M.D.; Laura Roberts, M.D., chair of a committee to revise the
ethics principles for APA; Joel Yager, M.D., a professor of psychiatry at the
University of Colorado; and David Baron, D.O., chair of the Department of
Psychiatry at Temple University School of Medicine.
Weker's comments reflected an awareness both of the pervasive influence of
industry in all areas of medicine and of the difficulty of extricating
medicine from business interests that, after all, manufacture products that
benefit patients. As Yager said, quoting a colleague, "If it weren't for
pharma, we would still be giving people thorazine."
Nor is collaboration with industry the only, or the most pernicious,
conflict of interest in medicine. Baron, who wondered about the negative
consequences of cutting all ties with industry, noted that his institution
monitors all physicians on their patients' length of stay in the hospital."
Length of stay has a lot to do with hospital reimbursement.... I would
posit that that is a much greater conflict of interest.... This will affect my
reimbursement, so I have a conflict of interest to get [a patient] out
earlier.... Only focusing on pharma conflicts is a mistake."
Yet pharmaceutical-industry influence on medical education and clinical
decision making has rapidly become one of the most talked-about subjects in
American medicine.
While most physicians are not inclined to admit that their behavior is
influenced by industry marketing, published research suggests otherwise, said
Appelbaum, who presented an overview of that research.
"We know from multiple studies that meeting with pharmaceutical
representatives and accepting samples and meals from industry correlate with
increased requests for formulary additions of new, expensive medications;
prescribing of the new medications; and decreased use of generic drugs,"
Appelbaum said. "Frequently these decisions fail to take into account
that the newer medications are higher cost and frequently have not
demonstrated higher levels of efficacy than the older medications.
"Moreover, by definition newer medications with less of a track
record leave us inherently uncertain about their long-term
consequences," he said. "There are those who believe the high
incidence of metabolic side effects associated with second-generation
antipsychotics was driven by the rapid adoption by the field of those new
medications before we had a chance to learn what their longer-term
consequences might be."
Published studies supported by industry need careful scrutiny. Appelbaum
presented data indicating that studies showing positive results for a
sponsor's product are three to four times more likely to be published than are
negative ones. Negative studies are liable to go unpublished or their results
may be spun by post hoc analysis highlighting positive results for a subgroup
of patients, though there was no benefit shown for the sample as a whole.
Yager outlined a long list of design modifications that are sometimes
employed to skew results to a positive outcome for a sponsor's product. These
include using dosages of a comparator drug that are far outside the normal
range, using self-serving measurement scales that lead to misleading
conclusions, masking unfavorable side effects, cherry-picking subjects for
certain characteristics, and touting nonsignificant but favorable differences
and negating dropout differences statistically.
Roberts reminded psychiatrists that overlapping commitments are innate to
being physician-leaders who must play multiple roles and that the potential
conflicts of interest that arise out of those overlapping commitments can be
managed.
"Overlapping roles of professionals are necessary, but they always
introduce ethical vulnerabilities," she said. "So instead of
approaching these overlapping roles and potential conflicts of interest as
something horrible that 'other people do,' I would much rather we brought this
back home and acknowledge that we encounter these issues all the time. As
professionals we are expected to bring expertise and sophistication to the
management of these complex issues."
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She urged psychiatrists to acquaint themselves with the Institute of
Medicine report, "Conflicts of Interest in Medical Research, Education,
and Practice." The 300-page report contains 16 recommendations
addressing all areas of industry involvement in medicine (Psychiatric
News, June 5).
Appelbaum was chair of a work group that developed guidelines that are
undergoing consideration within APA addressing relationships with industry for
the individual psychiatrist.
Roberts also said that education around issues related to conflict of
interest is possible and proven to be effective. She presented data from her
research showing that medical students can be taught, using a structured,
criteria-based educational intervention, to identify ethical problems in
clinical trials.
The study, "Teaching Medical Students to Discern Ethical Problems in
Human Clinical Research," appeared in the October 2005 Academic
Medicine.
Yager described efforts at a number of academic medical centers to teach
students and trainees about conflict of interest. At UC Davis, for instance,
pharmacy students act as drug-company representatives in role-playing
exercises with medical students, and at the Mayo Clinic fourth-year students
take a pharmacology course that includes critical analysis of drug
advertisements.
The University of Colorado has developed an intensive four-year course in
evidence-based medicine that includes critical evaluation of studies and
instruction in the kind of design modifications that are used to distort
findings.
"The goal is to sow thoughtful skepticism," he said. ▪