BMJ, doi: 10.1136/bmjusa.03090002, (Published 30 September 2003)

Editorial

Psychiatric diagnosis, drug development, and ethics

Accurate assessment and proper prescription

From BMJ USA 2003;September:468

Shorter and Tyrer in their Education and Debate article "Separation of anxiety and depressive disorders: blind alley in psychopharmacology and classification of disease" (BMJ USA p 511) correctly point out that psychiatric diagnosis is stuck in a rut. Unfortunately, their analysis is flawed and their prescription is too narrow. They conflate three separate (though somewhat related) issues, each with its own pathophysiology, diagnosis and treatment: 1) drug development incentives and disincentives, 2) the influence of the pharmaceutical industry on clinical practice and research, and 3) fundamental tensions in psychiatric classification.

The data regarding the relationship between new drug development and the number of Diagnostic and Statistical Manual of Mental Disorders (DSM) categories and assumptions regarding the "slowdown in drug discovery" are questionable at best. Over the past two decades, pharmaceutical company investment in central nervous system research has skyrocketed and the Pharmaceutical Research and Manufacturers of America's web site (www.phrma .org) reports no fewer than 31 new medications in development for anxiety or depression indications (seven for both anxiety and depression). Thus, there is little evidence of "the end" of the development of new medications, much less a linkage with the development of new diagnoses (or the failure to officially adopt their favored new diagnosis).

Shorter and Tyrer do have a point in that regulators have too strongly directed incentives for industry towards demonstrating superiority of new medications over placebo for specific "official" disorders. Not only has this driven them away from a symptomatic focus; it also provides no incentive for industry to produce data on the comparative effectiveness of their products — another focus of great relevance for clinicians. The prescription for this is not to change the psychiatric nosology but to direct regulators to change their regulations.

The authors are also correct in highlighting the pervasive influence of big pharma on practice and research. The impact is both obvious and direct, through advertising and detailing, as well as through purchasing the influence of leaders in the field. Industry also operates in a more subtle and insidious manner: for example, by flooding the literature with articles not on their drug but on the disorder for which their drug just happens to be an indication. Again, this problem needs to be addressed — by government, academic institutions, psychiatry, and industry coming up with enforceable ethical rules and mechanisms to more clearly illuminate conflicts of interest and eliminate those that are clearly inappropriate. Also, journals and professional associations should limit the lucrative charade of industry-supported supplements and symposia that are not truly independent and peer-reviewed. Research organizations such as the NIH need to consider the growing expanse of industry-driven research and to more assertively incorporate counter-programming strategies (eg, comparative trials, independent confirmation of industry studies) into their own research-funding priorities.

All of these approaches have little to do with changing the classification of anxiety and depression and formally adding a new diagnosis of "mixed anxiety-depression." It is true that the current psychiatric classification is very far from ideal. While there is hope that the new neuroscience and molecular genetics will one day enable the development of a nosology that is truly based on etiology, such a hope is unrealistic in the short run. Instead, a more pragmatic, yet still evidence-based approach will need to be applied in the near term (eg, the development of DSM-V and ICD-11). One idea is to place clinical utility as a preeminent value in making changes to the diagnostic system, and to explicitly gather data to formally assess the clinical utility of specific proposals for change. Such an approach might well result in the diagnostic changes proposed by Shorter and Tyrer. Then again, it might not — it depends on how the evidence turns out.

Department of Psychiatry, University of Pittsburgh School of Medicine, Western Psychiatric Institute and Clinic, senior scientist and director, RAND — University of Pittsburgh Health Institute, Pittsburgh, PA. pincusha{at}msx.upmc.edu

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Education and debate BMJ USA p 511

Competing interests: The author was vice chair and staff director of the task force on DSM-IV and co-chair of the task force on DSM-IV-TR.

References

1. Kupfer DJ, First MB, Regier DA, eds. A research agenda for DSM-V. Washington, DC: American Psychiatric Press, 2002.
2. Phillips KA, First MB, Pincus, HA, eds. Advancing DSM: dilemmas in psychiatric diagnosis. Washington, DC: American Psychiatric Press, 2003.
3. First MB, Pincus HA, Levine JB, Williams JBW, Ustun B, Peele R. Using clinical utility as a criterion for revising psychiatric diagnoses. Am J Psychiatry (in press).

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