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What are the potential implications for the diagnosis and treatment of mental illnesses when scientists and clinicians who receive funding from pharmaceutical companies work on the DSM? Can you cite examples where this has been relevant?

Dr. Cosgrove: The pharmaceutical industry can exert influence on panel members during their tenure on the DSM. Here’s one example:

In 1999, shortly before the patent on Prozac (fluoxetine hydrochloride) was about to expire, Eli Lilly organized a roundtable discussion attended by many of the PMDD subcommittee members. Shortly afterward, an article called "Is Premenstrual Dysphoric Disorder a Distinct Clinical Entity?" in the Journal of Women's Health and Gender-Based Medicine was presented as the state-of-the-science result of that roundtable. He/she was the lead author of that article.  The authors claimed that PMDD is a real and valid psychiatric disorder and fluoxetine hydrochloride is an effective treatment because fluoxetine hydrochloride improved symptoms of women with PMDD. However, it should be noted that numerous internationally known researchers (who do not have ties to the pharmaceutical industry) have documented the major methodological problems with research on PMDD (e.g., unclear definition, small sample sizes, lack of control group, lack of prospective rating of symptoms, failure to collect hormonal samples, etc). Also, the European Union regulatory committee decided that there was not enough evidence to support that PMDD was a real clinical disorder.

The FDA’s Psychopharmacological Drugs Advisory Committee (PDAC) met on November 3, 1999. There, representatives of Eli Lilly brought PMDD subcommittee member, Dr. X, first author of the roundtable paper, to speak. According to the minutes, "There was consensus among [PDAC] committee members that PMDD is a recognized clinical entity that is well-defined and has accepted diagnostic criteria." The PDAC voted "yes" unanimously on the question, "Has the sponsor provided evidence from more than one adequate and well controlled clinical investigation that supports the conclusion that Fluoxetine is effective for the treatment of Premenstrual Dysphoric Disorder?" It is hard to imagine what the outcome of that vote might have been without the assistance of this individual and the roundtable article, but the pharmaceutical company achieved its goal: Eli Lilly effectively extended the patent on Prozac insofar as they renamed fluoxetine hydrochloride  “Sarafem” and marketed it heavily as an effective treatment for PMDD.  

Lilly inundated women with advertisements encouraging them to take advantage of the “new” treatment that had been “developed.”   “PMDD affects millions of women. . . . but the good news is that your doctor can treat PMDD symptoms with a new treatment called Sarafem” (Eli Llily advertisement, 2001). It should also be noted that the FDA sent Lilly a letter of objection, stating that its television advertisement for Sarafem was “misleading and lacking in fair balance.”  Indeed, many women “treated” for PMDD have been prescribed Prozac without their knowledge.