APA 2009: Draft Guidelines to Address Psychiatrists' Relationship with Industry
May 19, 2009 (San Francisco, California) — In response to growing public concern about real and perceived conflicts of interest between the medical profession and the pharmaceutical industry, the American Psychiatric Association (APA) has developed a set of draft guidelines to help direct individual psychiatrists in their relationships with the pharmaceutical industry.
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| Dr. Paul Appelbaum |
In an interview with Medscape Psychiatry here at the APA 162nd Annual Meeting, Paul Appelbaum, MD, head of an 11-member working group on psychiatrists' relationship with industry that developed the draft document, said that the APA board of trustees took the decision on May 17 to distribute the draft document to its members for their feedback.
Although the exact timing or mode of distribution for the draft guidelines has not yet been determined, Dr. Appelbaum said it is likely it will be sometime within the next few weeks.
The proposed guidelines address such issues as gifts from the pharmaceutical industry, receipt of medical samples, attendance at industry-sponsored events, consulting for industry, contact with pharmaceutical representatives, and disclosure of relationships with pharmaceutical companies.
Changing Environment
This most recent move is part of a broader initiative by the APA to reduce ties with industry. In March, the APA leadership announced it would phase out industry-supported symposia along with industry-supplied meals at its annual meetings.
Last year, the issue of doctors' relationships with the pharmaceutical industry received wide media attention when allegations came to light that a number of notable psychiatrists, including Charles Nemeroff, MD, PhD, from Emory University, in Atlanta, Georgia, allegedly failed to accurately disclose payments from drug companies.
In January 2009, Sen. Charles Grassley (Republican, Iowa), ranking member of the Senate Finance Committee, and Sen. Herbert Kohl (Democrat, Wisconsin) reintroduced the Physician Payments Sunshine Act.
The bill requires drug and medical-device manufacturers to disclose all payments and gifts to physicians if the annual total to an individual is more than $100 per year, including funding given for continuing medical education and research grants, and all indications are that it is likely to pass this session of Congress.
The proposed legislation also requires that the Department of Health and Human Services (HHS) establish procedures for drug companies to submit information and for HHS to make this information publicly available on a Web site no later than November 1, 2009.
Dr. Appelbaum also pointed out that several states, including Minnesota and Vermont, have passed statutes requiring disclosure by industry of payments to physicians. In addition, Massachusetts has passed a law banning gifts from the pharmaceutical industry to doctors.
Not a Knee-Jerk Reaction
However, outgoing APA president Nada Stotland, MD, emphasized that the APA was addressing the conflict-of-interest issue long before it hit the media.
"Our members have been concerned about the appearance and the reality of conflict of interest and in terms of our industry-supported symposia for some years.
"Even though we had a very vigilant process with respect to industry-sponsored activities to ensure there was no bias, many of our members were very uncomfortable, so we took steps to address that and struck a working group to look at the issue in March 2008," she told Medscape Psychiatry.
The working group on psychiatrist's relationship with industry, she said, was a logical next step. "We have addressed managing relationships between the association and the pharmaceutical industry and made the decision to keep education and marketing activities separate. Now we want to help individual members manage their own personal relationships with industry," said Dr. Stotland.
Industry Funds Vast Majority of Research
In his presentation to conference attendees, Dr. Appelbaum pointed out that the pharmaceutical and device industry provides 60% of funding for biomedical research — which is more than all of the National Institutes of Health–funded research combined.
Furthermore, 25% of researchers receive funding from industry, and research suggests that 40% of researchers receive gifts of some sort from the pharmaceutical industry. Moreover one-third of researchers have personal financial ties with industry, and this is more than doubled among department chairs.
In addition, he said, industry provides more than 50% of funding for continuing medical education, which amounts to about $3 billion annually.
Individual physician contact with the pharmaceutical and device industry is also widespread and ranges from one-on-one regular contact with drug-company representatives for physicians in private practice to being a member of a pharmaceutical speakers' bureau or consulting for a drug or device company.
Research shows that meetings with pharmaceutical representatives and accepting medication samples and meals from industry correlate with increased requests for formulary additions and prescribing of new, often expensive medications and decreased use of generic drugs, said Dr. Appelbaum.
"When one hears this, you have to question is this a good or bad thing — newer medications are often better than older medications, and maybe there are good reasons to prescribe them. But studies also suggest that frequently these decisions fail to take into account that the newer meds are higher cost and frequently have not demonstrated higher levels of efficacy than the older medications."
New Framework Needed
"Moreover," he added, "newer medications by definition have less of a track record, which leaves us inherently uncertain about the possible long-term consequences.
"Some of our colleagues believe strongly that the high incidence of metabolic side effects associated with the second-generation antipsychotics was driven in substantial part by the field's rapid adoption of these new medications before we had a chance to learn exactly what the long-term consequences might be."
Not all interactions with industry are necessarily bad, said Dr. Appelbaum. In fact, he said, there are substantial benefits that can be derived from good collaboration between industry and clinicians. However, he added, it behooves all physicians to reexamine this relationship in light of the evolving environment.
"If we don't respond to the concerns that we see in the paper every day, it seems almost certain that we will face harsh, probably rigid, perhaps even punitive, external regulation, unless we can persuade the public at large that we can erect a framework they can trust and that the decisions made by physicians are made in our patients' best interest and not because of ulterior considerations driven by the relationships with industry," said Dr. Appelbaum.
Once the draft guidelines are circulated and feedback from the membership received, a revised document will be submitted to the board for a final decision in December.
American Psychiatric Association 162nd Annual Meeting. Presented May 18, 2009.
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