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Caplan says that a diagnosis of PMDD will have far-reaching legal implications as well. Might women who've been labeled as mentally ill be deprived of the right to make their own decisions? Might they lose custody of their children in divorce cases? In other words, will PMDD sufferers be seen as the biological equivalent of Dr. Jekyll and Mr. Hyde?
That's already the most common complaint of PMDD sufferers, says Endicott, who reports women saying over and over, "This isn't me." Lilly promotional literature echoes this sentiment. "The good news is there is treatment available that can help you feel more like the woman you are every day of the month," the brochures say. But who is this woman? And why are we so concerned with her hormones?
One thing is for sure: Eli Lilly and Company has a financial stake in PMDD. Lilly's Prozac patents are expiring in 2001 and 2003. This means the market will open up to cheaper generic competitors. Analysts have estimated that Prozac sales will decline drasticallyfrom about $2.51 billion in 2000 to $625 million in 2003. Sarafem will provide a significant new marketwomento boost profits. That's a smart move, since women are the primary users of drugs that alter mood. And, according to documents posted on the FDA's Web site, Lilly has proposed a "pilot study of PMDD in adolescents to estimate its response to treatment with fluoxetine." Fluoxetine, by the way, is the generic name for Sarafem (and Prozac).
Another plus for Lilly is that creating a new and separate trademark for Prozac lessens the stigma associated with antidepressants, and lets the company dodge some recent bad press, from the publication of Harvard's Joseph Glenmullen's Prozac Backlashto a new study in Brain Researchthat suggests the antidepressant may cut off axons of the nerves they targetin effect causing brain damage.
By 2004, Sarafem sales are expected to climb to $250 million a year, according to Bear Stearn's Bottle Report. Lilly would not divulge projected sales nor the amount of money spent marketing, researching, and developing Sarafem, but their financial report shows a lot of zeroes. For the first three quarters of this year, the corporation spent close to $2.3 billion in marketing and administrative costs, much more than its research and development, which totalled about $1.5 billion.
But most extraordinary is that the federal government is convinced of the existence of PMDD, while the psychiatric community isn't so sure at all. PMDD is currently listed in the appendix of the DSM-IVthe psychiatrist's bible of mental illnessesas "needing further study."
The controversy began in 1987, when the compendium first included specific criteria for Late Luteal Phase Dysphoric Disorderthe former name for PMDDin its appendix as a "proposed diagnostic category" needing more research. In 1993, as the American Psychiatric Association's task force was compiling the fourth edition of the manual, the category was revisited. Should it remain in the appendix, get moved to the body as a recognized diagnostic category, or be removed altogether?
The committee decided to keep PMDD in the appendix. According to Psychiatric News, the APA's professional newsletter, "Members of the task force agreed there were a number of problems with methodology within the PMDD literature. The problems included unclear definitions, small sample sizes, lack of control groups, lack of prospective daily ratings of symptoms, no documentation of the timing and duration of symptoms, and failure to collect appropriate hormonal samples." However, the committee suggested specific criteria for diagnosing PMDD, including specs for symptoms and timing.
Five years later, the fate of PMDD was still unclear. In October 1998, the Society for Women's Health Research organized a discussion, headed by Endicott, to answer this question: "Is premenstrual dysphoric disorder a distinct clinical entity?" Once again, experts reviewed the PMDD literature, this time in the company of FDA and Lilly representatives.
Dr. Sally Severino, a now retired professor of psychiatry at the University of New Mexico, reiterated flaws in the research. First, just because women can be identified by PMDD criteria "is not proof that PMDD exists as a valid diagnosis." Second, although cross-cultural studies identified physical complaints related to menstruation, mood symptoms like anger and irritability were not found worldwide to the same degree as in America. Severino argued that if PMDD can't be identified in other populations, then "consideration must be given to the criticism that PMDD is a culturally bound syndrome or an unnecessary pathologizing of cyclical changes in women."
Ignoring these objections, the round table concluded that PMDD was a "distinct entity with clinical and biologic profiles dissimilar to those seen in other disorders." In other words, a mental illness.
What changed between 1993 and 1998? For one thing, Lilly funded a 1995 study that showed Prozac was effective in treating PMDD. Published in The New England Journal of Medicine, the study had a large sample size, and was placebo-controlled and double-blind (meaning neither the doctor nor the participant knows who's getting drugs or a sugar pill)all the makings of a pristine scientific inquiry. A slate of studies followed suit, all with the same results: About 60 percent of women diagnosed with PMDD respond to Prozac.
Yet one 1998 study discussed by Endicott's roundtable found that 55 percent of women diagnosed with premenstrual symptoms got significant relief from increased calcium intake. The group went on to comment that "the area of calcium is not well explored." That leads critics to wonder why other treatment options are getting the cold shoulder. "Why not spend pages and pages pushing calcium?" asks Caplan, who served on the 1993 DSM committee. And although there is evidence that people with PMDD can feel better with only intermittent doses of Prozacand suffer fewer side effects like sexual dysfunctionthe studies Lilly presented to the FDA looked solely at the effectiveness of daily doses, or roughly double the amount some researchers say is needed.
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