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A Disorder Is Born

Behrendt and others point to the marketing of PMDD as being just the latest example of this trend. The package insert for Sarafem cites a definition of PMDD from the fourth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV), the psychiatrist's bible. According to the manual, the essential features of PMDD are "symptoms such as markedly depressed mood, marked anxiety, marked affective lability [mood swings], and decreased interest in activities."

What the prescription information fails to mention, however, is that PMDD is mentioned briefly in the main body of the manual as a "depressive disorder." But the full entry on PMDD is included in an appendix that lists conditions for which "there was insufficient information to warrant inclusion of these proposals as official categories ... in DSM-IV."

In other words, some critics charge, Sarafem is indicated for a disorder that may or may not exist.

"I have concerns about [formalizing] a social tradition of blaming women's behavior and bad moods on women's reproductive function," says Nada Stotland, MD, MPH, professor of psychiatry and obstetrics and gynecology at Rush Medical College in Chicago, and a member of a task force that determined DMS-IV diagnostic criteria.

Stotland, who acknowledges that she has given talks in venues supported by Lilly, tells WebMD that she argued against including PMDD in the main text of the manual.

"I would prefer to see us approach this interesting and worthwhile issue from the point of view, for example, of the effect of male and female hormones on behavior and mood, rather than picking out one sort of traditional condition," she says.

But Robert L. Spitzer, MD, professor of psychiatry at Columbia University in New York City and chairman of the work group to revise DSM-III criteria, has a different point of view.

"Many women's groups objected to the inclusion of the disorder, fearing it would stigmatize normal women, a view that I don't share," Spitzer says in an interview with WebMD. "My own view -- and the view of the people who originally proposed the category -- is that there is a small subset of women who suffer from this disorder, and the best thing you can do for these women is to recognize and develop effective treatments for it."

Behrendt, Stotland, and other critics acknowledge that some women have distinct physical changes related to their menstrual cycles, and that some women have debilitating problems that could be alleviated significantly by medication.

Where they draw the line, however, is in the classification of menstruation-related phenomena as disorders.

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