Sarafem Marketing ‘Barrage’ Sparks Debate Over PMDD
The launch of Sarafem, a new medicine designed to treat premenstrual dysphoric disorder, has "rekindled a debate" among physicians and psychiatrists over whether the disorder is a "real" condition, the Washington Post reports. Marketed by Eli Lilly and Co., Sarafem is a "renamed and repackaged" version of the popular antidepressant Prozac that was developed to treat PMDD, a "severe version" of premenstrual syndrome believed to affect "millions" of women in the United States. Seeking to find "profitable new uses for Prozac" before its patent expires in August, Eli Lilly won FDA approval to market the drug as a PMDD treatment last summer. Because it is a "new application" for Prozac, Sarafem will remain patent protected until 2007, possibly resulting in higher prices for Sarafem as generic competition forces lower prices for Prozac. Currently, both drugs costs about $100 per month. Through the end of January, Sarafem sales totaled just over $19 million, and physicians had written 202,000 prescriptions for the drug.
However, the launch of Sarafem has "rekindled debate" over whether PMDD "stigmatizes women by characterizing them as having a mental illness once a month," the Post reports. In the 1980s, the American Psychological Association debated including PMDD as an "official condition" in its Diagnostic and Statistical Manual, the "official bible" of psychiatric disorders. However, a "major controversy" ensued, with women's groups saying that classifying "severe PMS" as a mental illness might "prompt employers to question women's competence or even cause courts to rule against 'mentally ill' mothers in custody battles." The association eventually placed PMDD in the appendix of its manual, listing it as a "disorder that is under evaluation." Critics of Eli Lilly's marketing campaign, however, say that ads for Sarafem "promot[e]" the idea that women with PMDD are subject to monthly mental illness. But some physicians feel that for some women, PMDD can pose a "serious problem" that interferes with women's professional and personal lives. Eli Lilly spokesperson Laura Miller agreed, stating that PMDD is a "unique disorder" and that Sarafem offers a treatment "with its own identity" that does not carry the connotations of Prozac (Vedantam, Washington Post, 4/29).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.