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Study: DSM contributors linked to drug companies
(June 2006 Issue)

By Nan Shnitzler

Most of the psychiatric experts who contributed to the Diagnostic and Statistical Manual of Mental Disorders had financial ties to drug companies, says a study published in the April issue of the journal, Psychotherapy and Psychosomatics. Moreover, every expert who participated on the DSM panels for mood and psychotic disorders, typically treated with drugs, had such ties.

"I would think they could find one person, at least, who didn't," says lead author Lisa Cosgrove, Ph.D., a research and clinical psychologist at University of Massachusetts Boston. The study authors received no supplementary funding beyond their university employers.

Study researchers combed online and hard copy public documents, including the U.S. Patent Office database, corporate annual reports and journal public disclosure statements, to ferret out affiliations of mental health experts who worked on DSM-IV, the bible of mental health diagnosis and insurance coverage, which came out in 1994.

Out of 170 experts, 95 or 56 percent had financial ties to the pharmaceutical industry between 1989 and 2004. The most common links identified were research funding, consultancies, speakers' bureaus and corporate boards. The study did not track a timeline of affiliations, quantify the financial ties or determine that they affected the manual's outcome.

The authors were careful in the study not to equate financial interest with conflict of interest. They recommend that DSM and other psychiatry and psychology journals adopt disclosure policies to provide transparency to potential conflicts and to promote better-informed consumers.

"It's about raising awareness for the general public and mental health practitioners about these financial associations," Cosgrove says.

DSM-V, due to come out in 2011, will require full disclosure of both financial and organizational ties, says Jason Young, spokesperson for the American Psychiatric Association, which publishes DSM. In fact, the Association has led the charge for full disclosure of all results of clinical trials, positive and negative, and for chronicling them in a public register, says American Psychiatric Association Research Director Darrel A. Regier, M.D., M.P.H.

"We are aware there's a need for checks and balances in terms of what [information] drug companies release and where people are funded and how you monitor that in publications and the DSM," Regier says. But he found it odd that the study used public disclosure statements before they were common in the mid-1990s to call for the need for public disclosures today. Nineteen out of 45 psychiatry journals had disclosure policies at the time of the study, the authors report.

The study did raise potential ethical concerns. Co-author Sheldon Krimsky, Ph.D., a professor and ethics researcher at Tufts University, called the study "a warning signal." He thinks beneficiaries of drug companies' largesse could, even unwittingly, couch diagnostic criteria in pharmaceutically-friendly terms, help fast-track drug approval or cut corners in competition for research dollars.

Regier called such conclusions "speculation and assumption."

"I think that psychiatric diagnosis is particularly vulnerable to being influenced by pharmaceutical companies," Cosgrove says.

Cosgrove and Krimsky think the American Psychiatric Association should try harder to find DSM panelists who don't have relationships with the drug industry.

"We may think disclosure is the antidote, but we should be thinking about prevention. The APA shouldn't want the system of diagnostic categories to look like a system linked to drug industry interests," Krimsky says.

"We don't agree that anyone associated with a large clinical trial that receives some support from the industry should be disqualified. That's where much of the research critical for the development of treatments for these disorders is coming from," Regier says.

Regier cited an April 20 New England Journal of Medicine article that says in fiscal 2005, the pharmaceutical industry invested $51.3 billion in research and development, 78 percent more than the government devoted to the National Institutes of Health that year.

"We think that a combination of federal funding and industry funding will be necessary to advance these fields." Regier says. "I reject the idea that people doing industry-funded research somehow don't have credible scientific standing in the community."

The authors also think the Food and Drug Administration needs to be strengthened as an independent body. Krimsky proposes a "firewall" between drug companies and researchers who evaluate their products. Cosgrove does not think people with financial associations to drug companies should provide FDA testimony.