The American Psychiatric Association (APA) has fired back a strong response to a recent article by the Washington Post questioning the possibility of pharmaceutical industry influence on decisions regarding the upcoming fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5).
The Post article specifically examined relationships with industry sources, including receiving partial income, for members of the DSM-5 Mood Disorders Work Group and the APA's Clinical Practice Guidelines Work Group on major depressive disorders. They also discussed the manual's dropping of the bereavement exclusion, calling that decision a potential "bonanza for the drug companies" and "opening the way for more...to be diagnosed with major depression — and thus, treated with antidepressants."
"While speculation is bound to occur, we think it is important to stay focused on the fact that APA has gone to great lengths to ensure that DSM-5 and APA's clinical practice guidelines are free from bias," said David Kupfer, MD, chair of the DSM-5 Task Force, in a release.
"Throughout the development of each product, APA established, upheld, and enforced its disclosure policies and relationship limits," said Dr. Kupfer.
He noted that no DSM-5 task force or work group member is allowed to have more than $10,000 of his or her annual income to be derived from industry sources, nor are members allowed to hold stock or shares valued at more than $50,000 in a pharmaceutical or device company.
With the Post article questioning whether these amounts are still too high, Medscape Medical News asked Dr. Kupfer if the limits should be lowered even more.
"When we established the limits on income from industry sources, we looked to make them more stringent than requirements for staff at the National Institutes of Health, members of advisory committees for the Food and Drug Administration, and most academic departments," he answered.
Dr. Kupfer added that each member agreed to follow these limits at the start of their work on DSM-5 — and to continue following them as long as they are involved in the development of the manual. "APA has looked to strengthen these policies even further for new clinical practice guidelines in development."
For the 6-member Clinical Practice Guidelines Work Group, Dr. Kupfer noted that the group's appointment in 2005 was at a time when the APA's conflict-of-interest policy emphasized disclosure instead of income limitations.
Still, the organization's board of trustees decided to appoint in 2010 an independent 5-member expert group to review guideline content for potential bias before publication. This expert group has no relationships with industry. And in 2011, the policies were tightened further to match standards published by the Institute of Medicine.
These included "establishing transparency, managing conflicts of interest, formulating work groups, using systematic reviews of evidence, articulating and rating recommendations in guidelines, obtaining external review, and updating guidelines," explained Dr. Kupfer.
The Washington Post article also brought up criticisms about the DSM-5's removal of the bereavement exclusion from the criteria for major depressive disorder, which would be replaced with cautionary notes for clinicians. But will these notes be enough to help differentiate between normal grieving and a potentially serious problem?
Providing "Greater Guidance"
"Yes," Dr. Kupfer told Medscape Medical News. "This change draws clinicians' attention to the distinctions between grief after a significant loss and depression. The exclusion criteria will be replaced by 2 notations — a footnote at the end of the criteria that cautions clinicians to differentiate between normal grieving associated with a significant loss and a diagnosis of a mental disorder, and a note embedded within the criteria that reminds clinicians that major depression and bereavement can coexist."
"This provides greater guidance to clinicians to help make this distinction and ensures that it is understood that sadness, grief, and bereavement are not things that have a time limitation to them, as dictated in DSM-IV's bereavement exclusion," he said.
He noted in the release that removing the exclusion "helps prevent major depression from being overlooked and facilitates the possibility of appropriate treatment, including therapy or other interventions."
The DSM-5 is on track to be published this May.
Medscape Medical News © 2013 WebMD, LLC
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Cite this: APA Answers Criticism of Pharma-Influenced Bias in DSM-5 - Medscape - Jan 04, 2013.