APA Criticized Over DSM-5 Panel Members' Industry Ties

Megan Brooks

March 20, 2012

March 20, 2012 — Two researchers have raised concerns that the upcoming Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) has been unduly influenced by the pharmaceutical industry, owing to financial conflicts of interest (FCOI) among DSM-5 panel members.

In an essay published in the March issue of PLoS Medicine, Lisa Cosgrove, PhD, from the Edmond J. Safra Center for Ethics, Harvard University, Cambridge, Massachusetts, and Sheldon Krimsky, PhD, from the Department of Public Health and Community Medicine, Tufts University, Boston, say the FCOI disclosure policy does not go far enough and has not been accompanied by a reduction in the conflicts of interest of DSM-5 panel members.

However, John M. Oldham, MD, President of the American Psychiatric Association (APA), "strongly" disagrees.

The APA's DSM-5 is scheduled for publication in May 2013. The DSM-IV, which was released in 1994, did not have an FCOI disclosure policy for experts involved in its development. For DSM-5, the APA instituted one.

Although the APA has made the disclosure of FCOIs of DSM panel members "more transparent," Drs. Cosgrove and Krimsky write, "transparency alone cannot mitigate the potential for bias and is an insufficient solution for protecting the integrity of the revision process."

"Although we appreciate that Cosgrove and Krimsky acknowledge the commitment the APA has already made to reducing potential financial conflicts of interest, we strongly disagree with their analysis and presentation of APA's publicly available disclosure documents. Specifically, the Cosgrove-Krimsky article 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," Dr. Oldham said in a statement.

Policy Gaps

However, the essay authors go on to say there are "important gaps in the current policy that need to be addressed," including the fact the current APA disclosure policy does not require panel members to specifically identify speakers' bureau membership. This information is listed under "honoraria."

Drs. Cosgrove and Krimsky note that none of the DSM panel members identified participation on a speaker's bureau, but they say an Internet search that they made of panel members showed that 15% had disclosed elsewhere that they were members of drug companies' speakers' bureaus or advisory boards.

They also assert that individuals who have participated on speakers' bureaus "should be prohibited from DSM panel membership. When no independent individuals with the requisite expertise are available, individuals with associations to industry could consult to the DSM panels, but they would not have decision-making authority on revisions or inclusion of new disorders."

Such changes "would accommodate the participation of needed experts as well as provide more stringent safeguards to protect the revision process from either the reality of or the perception of undue industry influence."

However, Dr. Oldham notes that in 2012, 72% of DSM-5 members reported no relationships with the pharmaceutical industry during the previous year and that the scope of the relationships reported by the other 28% of members varies: 12% reported grant support only, including funding or receipt of medications for clinical trial research; 10% reported consultations, including advice on the development of new compounds to improve treatments; and only 7% reported receiving honoraria.

Invalid Comparison?

In a written response, Drs. Cosgrove and Krimsky told Medscape Medical News: "Our paper accurately reported the commercial ties of DSM-5 members, as we obtained this data from the disclosure forms they submitted to the APA. We reported commercial ties as defined by the APA itself."

In his statement, Dr. Oldham asserts that the authors' comparison of DSM-IV and DSM-5 Task Force and Work Group members is "not valid" because there were no disclosure requirements for journals, symposia, or the DSM-IV Task Force at the time of the 1994 release of DSM-IV.

Drs. Cosgrove and Krimsky disagree:

"The first study we conducted on the DSM-IV and DSM IV-TR (Text Revision), published in 1994 and 2000, respectively, was based on objective information we obtained from published sources since the DSM did not disclose at that time the financial interests of panel members," they told Medscape Medical News.

"We used the same methodology in the current study, although the sources of information were different because DSM-5 did a lot of work for us by disclosing the financial ties. Thus, the statement that our comparison does not work is wrong," they added.

Dr. Oldham emphasizes in his statement that in assembling the DSM-5's Task Force and Work Groups, "the APA's Board of Trustees developed an extensive process of written disclosure of potential conflicts of interest."

Serious Issue

He added, "These disclosures are required of all professionals who participate in the development of DSM-5. An independent APA committee reviews these disclosure documents, which are updated annually or whenever a member's financial interests change. Individuals are only permitted to serve on a work group or the Task Force if they are judged to have no significant financial interests."

Dr. Oldham also noted that the "Board of Trustees' guiding principles and disclosure policies for DSM panel members require annual disclosure of any competing interests or potentially conflicting relationships with entities that have an interest in psychiatric diagnoses and treatments."

"In addition, all Task Force and Work Group members agreed that, starting in 2007 and continuing for the duration of their work on DSM-5, each member's total annual income derived from industry sources would not exceed $10,000 in any calendar year.

"This standard is more stringent than requirements for employees at the National Institutes of Health and for members of advisory committees for the Food and Drug Administration. And since their participation in DSM-5 began, many Task Force members have gone to greater lengths by terminating many of their industry relationships," Dr. Oldham said.

Dr. Oldham believes that potential financial conflicts of interests are "serious concerns that merit careful, ongoing monitoring. The APA remains committed to reducing potential bias and conflicts of interest through our stringent guidelines."

Dr. Cosgrove and Dr. Krimsky received no specific funding for writing the essay. Dr. Cosgrove, Dr. Krimsky, and Dr. Oldham have disclosed no relevant financial relationships.

PLoS Medicine. Published online March 13, 2012. Full article

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