Few topics have elicited more heated discussion in medicine than its
relationship with the pharmaceutical industry, particularly as industry's role
in research and health care has expanded over the past decade. Currently,
industry is responsible for some 60 percent of research funding, as the
federal government does not support drug development and funds few clinical
trials.
Industry has funded professional education (CME) for more than two decades.
Over time, and in the face of increased regulation and requirements from the
Accreditation Council for Continuing Medical Education (ACCME), these
educational programs have evolved from near-total industry control to control
of topic, format, faculty, and content by sponsors such as medical
professional organizations (or specialty societies). Industry also funds
marketing, including exhibits at professional meetings, practitioner visits
("detailing"), and advertising aimed at both physicians and the
public to inform them about new products and indications, with the goal of
increased use.
Social-science research demonstrates that even highly educated physicians
respond to formal advertising, but also to relationships with industry
representatives and to gifts regardless of value. In our capitalistic society,
these promotional activities have been an acceptable part of a business plan,
with a goal of profitability. Increases in marketing budgets (as well as
consumer education) have been accompanied by an increase in the number of
prescriptions filled.
Media reports of these activities have influenced public perceptions:
policymakers have launched their own investigations of the role of industry in
shaping physician behavior, and patients have voiced concerns about how their
care is being affected. While the advent of effective psychiatric medications
has lowered costs of care, there also is concern that industry practices have
fostered unnecessary treatments or medical expense. And of course,
controversies fuel the rhetoric of antipsychiatry forces.
What are the issues for APA? Industry funds are valuable and have helped
APA hold national dues at the same level for a dozen years. Funding comes from
advertisements in publications, exhibits, industry-supported education, and
enrichment programs, such as the chief residents' conference. As a membership
organization, APA does not provide direct care, but our products influence
care. Thus, APA must ensure that all our programs for members and the public
are based on the best scientific information and are free from bias regardless
of funding source. Simply put, we must have full disclosure and control.
The research investigator who receives outside industry support must
disclose the source of funding and have full control of the research activity,
including subjects, methodology, data collection, and statistical analyses and
reporting results. All phase 2 and phase 3 clinical trials must be reported on
ClinicalTrials.gov.
While journals have been hesitant to accept reports that do not show positive
results, that hesitation seems to be changing. In any case, negative results
should be available to other scientists and the public. Education faculty must
provide complete personal disclosure and take total responsibility for program
content, which must be free from bias or favoritism, presenting a full account
of data, risks, and benefits.
APA follows the requirements of the ACCME (which in its last
re-accreditation survey awarded APA the highest category, as well as
commendations for management of industry support). We require disclosures of
conflicts from component members including those involved in program planning
and evaluation, candidates for election to the Board of Trustees, and authors
of books and studies published in our journals. There is expanded disclosure
for members who work on practice guidelines as well as DSM (which
also requires limits on industry support). APA maintains full control of all
educational programs including planning, content, faculty, and outcome
evaluation. Slides and hand-outs of industry-supported symposia are reviewed
in advance for quality and absence of bias—in short, these symposia are
thoroughly evaluated. We also maintain complete control of enrichment programs
for which we receive outside funding, appointing member-based oversight
committees free from conflicts of interest to set goals, review competitive
nominations/applications, design and implement content, and perform
evaluations.
What else should APA do? APA should educate trainees and practitioners
about physician-industry relationships and assist them to evaluate data
critically and recognize the impact of marketing. At the same time, we should
not demonize industry or encourage what begins to seem like the Salem Witch
Trials. The availability of effective medications has been a boon to those who
suffer from mental illness. Rather, we need to develop appropriate
partnerships that are open and transparent, with a goal to improving awareness
and understanding of mental disorders and to promoting the highest quality
patient care. ▪