The majority of the scientific panel revising the U.S. manual for mental health diagnoses have financial ties to the pharmaceutical industry, according to a new analysis.
Based on a review of the panelists’ financial disclosures, 69 percent of the working group had current or past interests in drug companies.
“Three-fourths of the work groups continue to have a majority of their members with financial ties to the pharmaceutical industry,” according to the report, written by Lisa Cosgrove of the University of Massachusetts-Boston and Sheldon Krimsky of Tufts University School of Medicine.
The study, published in the Public Library of Science this week, also stated that it is “noteworthy that … the most conflicted panels are those for which pharmacological treatment is the first-line intervention.”
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Sixteen of the approximately 140 members on the panel are California physicians and researchers affiliated with institutions ranging from Stanford University to UC San Diego.
The revision of the American Psychiatric Association’s Diagnostic and Statistical Manual of Mental Disorders is a years-long process that typically receives scrutiny because it is universally used for mental health diagnoses and affects decisions ranging from insurance claims to litigation. The fifth edition will be published next year; the last major rewrite of the document was completed in 1994.
The new study follows a 2006 report by the same authors, who looked at the financial ties of the scientists revising the fourth edition of the manual, which found that 57 percent of the panelists had industry connections.
The psychiatric association subsequently crafted a policy requiring panelists to report their financial interests, which can be viewed on an association website. Those involved with the process also are required to limit the amount of income they receive from commercial interests to $10,000 per year during the time that they are working on the manual.
The association has not embraced the findings of the most recent analysis. Dr. John M. Oldham, president of the association, said in a statement [PDF] that he “strongly disagreed” with the article because it “does not take into account the level to which DSM-5 Task Force and Work Group members have minimized or divested themselves from relationships with the pharmaceutical industry.”
According to the association's own statistics, this year, 72 percent of the members have reported no relationships with the pharmaceutical industry, and the 28 percent who did had relationships that varied in scope, Oldham said.
But Krimsky said the psychiatric association’s disclosure policy doesn’t make fine enough distinctions between various activities. He said “we shouldn’t put all activities in one barrel,” and being on a “speakers bureau” contract with a pharmaceutical company is potentially more problematic than accepting research funds that are not tied to future equity in a drug.
The article also said that while none of the panelists working on the manual revisions reported participating in a speakers bureau, the authors found that 15 percent of them had “disclosed elsewhere that they were members of drug companies' speakers bureaus or advisory boards.”
Co-author Cosgrove said the study's findings ultimately illustrate that financial disclosure doesn’t go far enough in limiting actual, potential and appearances of conflict.
“Our data clearly shows that despite good intentions, transparency has not changed the composition of the panels in any significant way in terms of panel members being more independent,” she said. “I have become more skeptical of the benefits of transparency alone as a solution, because transparency can’t mitigate the potential for implicit or unconscious bias.”
However, task force member Helena Kraemer of the Stanford School of Medicine said she believes the disclosure process required by the psychiatric association is exceedingly thorough.
“I was required to report all income in far more detail than for the IRS!” Kraemer wrote in an e-mail. “I've long had no financial connections at all with drug companies. But, when I was required to report income for DSM screening, I had to report each source of income separately, in my case mostly small honoraria for speaking at other universities.”
The work groups with the greatest potential for conflict of interest with pharmaceutical companies, according to the report, are related to mood, psychotic and sleep-wake disorders. Sixty-seven percent of the 12-member mood disorders panel had ties to pharmaceutical companies, as did 83 percent of the 12-member psychotic disorders group. All seven of the researchers making up the sleep-wake disorders team had some kind of connection to pharmaceutical companies, the report said.
But Ruth O’Hara, an associate professor of psychiatry and behavioral health at Stanford's medical school who is a member of the sleep-wake disorders work group, disputes those numbers. “I have no funding or ties from any pharmaceutical company, including those that offer a treatment for sleep (disorders),” she said.
Sally J. Rogers, a psychiatry and behavioral sciences professor at UC Davis who sits on the panel revising the manual’s neurodevelopmental disorders, said conflicts of interest are “an important issue to have on the table, and it’s something we have to be extra thoughtful and vigilant about.”
Still, she believes the Cosgrove-Krimsky paper is based on a number of unproven assumptions, including the “underlying assumption that having financial relationships with pharma necessarily implies a bias towards pharma."
Given trends in the industry, associations with pharmaceutical companies also can reflect expertise. "People are sought out for their knowledge by various companies, and that's not necessarily a bad thing," Rogers said. "It's helpful to get high levels of expertise in treatment development."
She added that the scientists chosen to work on the manual revisions are at the top of their fields. “What was not reflected in the paper was the amount of screening and qualifications process of the people who came to the DSM committee,” she said. “There were multiple levels of screening and scrutiny.”
Thirteen of the 16 California panelists, including those who sit on the psychotic and mood disorders panels, did not respond to requests for comment.
Cosgrove, who is also affiliated with Harvard University, said the paper she and Krimsky wrote “is not a witch hunt.” “I don’t believe that anyone on the panel is purposefully making decisions that favor industry,” she said. “The issue is more subtle and just as impactful. We all have the potential for bias in a conflicted situation, and we’re all really defended against looking at those biases, and therein lies the danger.”
When asked about their connections to the pharmaceutical or medical device industries, Cosgrove reported having no ties, and Krimsky said he had once given a speech before pharmaceutical industry lawyers for which he was not paid, and he does take “medications every so often.”