Correspondence

Developing Unbiased Diagnostic and Treatment Guidelines in Psychiatry

N Engl J Med 2009; 360:2035-2036May 7, 2009

Article

To the Editor:

In 1984, the Journal was one of the first medical journals to establish a policy requiring disclosure of financial interests for all authors of research articles. During the past 25 years, all medical specialties have been grappling with how best to manage conflicts of interest. Today, the field of psychiatry is perceived to have suffered a unique “crisis of credibility” with respect to the growing influence of pharmaceutical companies on organized psychiatry.1

The reaction of the organization that is increasingly in question, the American Psychiatric Association (APA), has ranged from calling for greater transparency — mandating that all members of task forces that produce its diagnostic guidelines (i.e., the Diagnostic and Statistical Manual of Mental Disorders [DSM]) complete financial-disclosure statements — to labeling critics' concerns about conflicts of interest as a “well documented antimedication bias.”2 However, it is clear that transparency alone is not enough of a safeguard: approximately 68% of the members of the DSM-V task force reported having industry ties, which represents a relative increase of 20% over the proportion of DSM-IV task-force members with such ties. Also, of the 137 DSM-V panel members who have posted disclosure statements, 77 (56%) have reported having industry ties, such as holding stock in pharmaceutical companies, serving as consultants to industry, or serving on company boards3 — no improvement over the 56% of DSM-IV members who were found to have such industry relationships.4 If financial conflicts of interest are not reduced, private-sponsor bias in research will be exacerbated.

Moreover, both disclosure requirements and specific policies about the management of existing conflicts of interest are missing in the APA's clinical practice guidelines. This is an especially important omission because these guidelines are seen by many as the standard for evidence-based medicine in clinical psychiatry. The APA is in the process of revising both its diagnostic guidelines and some of its most influential clinical practice guidelines (e.g., for bipolar disorder and major depressive disorder). Thus, it would be both timely and prudent for the APA to take this opportunity to address the gaps in existing policies regarding transparency and the management of conflicts of interest. For example, unrestricted research grants were excluded from disclosure requirements, and currently, there are no policies for managing indirect financial ties, such as industry funds that are pooled and given to academic departments, hospitals, and medical schools. To strengthen its current conflict-of-interest policy and monitor the process for the development of unbiased diagnostic and treatment guidelines, the APA will need to substantially free itself from its extensive financial ties to pharmaceutical companies.

Lisa Cosgrove, Ph.D.
University of Massachusetts, Boston, MA 02125
lisa.cosgrove@umb.edu

Harold J. Bursztajn, M.D.
Harvard Medical School, Boston, MA 02115

Sheldon Krimsky, Ph.D.
Tufts University, Medford, MA 02155

Dr. Bursztajn reports serving as a consultant to physicians and institutions seeking to craft conflict-of-interest policies and providing expert legal advice to both plaintiffs and defendants in cases involving product liability and the determination of competency to consent to neuropsychopharmaceutical treatment. No other potential conflict of interest relevant to this letter was reported.

4 References

1. 1

   Fava GA. Financial conflicts of interest in psychiatry. World Psychiatry 2007;6:19-24
   Web of Science | Medline

2. 2

   Kupfer DJ, Regier DA. Toward credible conflict of interest policies in psychiatry: counterpoint. Psychiatr Times 2009;26:40-41
   

3. 3

   Meet the work groups. Arlington, VA: American Psychiatric Association, 2008. (Accessed April 17, 2009, at http://www.psych.org/MainMenu/Research/DSMIV/DSMV/WorkGroups.aspx.)
   

4. 4

   Cosgrove L, Krimsky S, Vijayraghavan M, Schneider L. Financial ties between DSM-IV panel members and the pharmaceutical industry. Psychother Psychosom 2006;75:154-160
   CrossRef | Web of Science | Medline

Citing Articles (2)

Citing Articles

1. 1

   Lisa Cosgrove. (2011) The DSM , big pharma, and clinical practice guidelines: Protecting patient autonomy and informed consent. International Journal of Feminist Approaches to Bioethics 4:1, 11-25
   CrossRef

2. 2

   S Claiborne Johnston, Stephen L Hauser, Susan Desmond-Hellmann. (2011) Enhancing ties between academia and industry to improve health. Nature Medicine 17:4, 434-436
   CrossRef