Relationships With Industry Must be Open, Transparent

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. ▪