Drug Firms Treat PMS As a Mental Disorder

IS SEVERE PMS, or premenstrual syndrome, a mental illness? Some pharmaceutical companies and psychiatrists are treating it as one. In new television ads, drug maker Eli Lilly is promoting the drug Sarafem to treat the problem, now dubbed Premenstrual Dysphoric Disorder (PMDD). But the pink and purple pills aren't a new drug -- they are simply repackaged Prozac, the popular antidepressant.

Makers of similar antidepressants, known as serotonin reuptake inhibitors, or SSRIs, also may follow suit. In January, Pfizer asked the FDA to approve Zoloft to treat PMDD. Forest Laboratories' Celexa and GlaxoSmithKline's Paxil also have been studied.

The medical community, however, remains divided about whether PMDD is a real disorder or simply a way for drug companies to cast a wider net in search of new customers. Critics are particularly concerned about labeling women as mentally ill because of problems associated with menstrual cycles.

"When you start calling what PMS is a psychiatric disorder, what are you saying about the women of this world?" says Nada Stotland, director of psychiatric education at the Advocate Illinois Masonic Medical Center in Chicago. "This lends itself to prejudices people already have about women being moody and unreliable."

ALTHOUGH THE FDA has approved Sarafem to treat PMDD, the psychiatric community is still debating the legitimacy of the disorder. The American Psychiatric Association includes PMDD in the appendix of its current Diagnostic and Statistical Manual of Mental Disorders, the part of the manual reserved for issues needing further research before being officially accepted as a mental illness.
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Fueling skepticism about PMDD and Sarafem is the fact that in August, Lilly, based in Indianapolis, loses patent protection on Prozac, a drug with $2.6 billion in sales last year, according to IMS Health. With Sarafem, the firm now has a separate patent to use the drug for PMDD through 2007, allowing it to partially offset losses in sales as rivals produce generic Prozac.

Repacking prescription drugs for other uses is becoming more common. Glaxo, for example, has repackaged its antidepressant Wellbutrin as the stop-smoking aid Zyban.

Many physicians argue that PMDD is a legitimate mental illness triggered by normal hormonal fluctuations in a woman's menstrual cycle. About 3% to 5% of menstruating women are affected. "This is a subset of women who have really, really severe mood changes and changes in their behavior," says Jean Endicott, professor of clinical psychology at Columbia University's College of Physicians and Surgeons. "It can be very debilitating."

Unlike other mental illnesses that affect a patient on a daily basis, PMDD is said to affect women during the week to two weeks before their period. The symptoms include depression, anxiety, tension, anger, irritability and the feeling of being overwhelmed or out of control. Other symptoms also are typical of traditional PMS, such as breast tenderness, headache, bloating and weight gain.

In order to be diagnosed with PMDD, a patient must have at least five symptoms, including one involving mood change, and be markedly impaired as a result. Patients should track symptoms for two months before a diagnosis is made.

About 60% of women who take Sarafem for PMDD will be helped, according to Dr. Endicott. Currently, the drug is taken every day, but researchers are studying dosing that would reduce the pills to several days a month, limiting side effects, which can include tiredness, upset stomach, nervousness, dizziness and difficulty concentrating.

A 38-YEAR-OLD Chicago flight attendant named Betsy, who didn't want her full name used, says the week before her period she felt like an "over-wound spring, getting wound tighter and tighter," and would often scream and lose control. "That's not my normal disposition," she says. "I knew something wasn't right."

She noticed the correlation with her menstrual cycle and discussed her problems with her gynecologist, who prescribed Sarafem. "It has completely taken away the symptoms," she says.

Dr. Stotland and other critics, however, worry that eager patients may push to be prescribed Sarafem as a quick fix, preventing doctors from diagnosing other serious health problems. Dr. Stotland says research has shown that more than half of the women who believe they have severe PMS actually suffer from other problems, such as depression, panic disorder or even domestic violence.

Lilly's marketing of Sarafem also has sparked controversy. The first ads showed a frustrated woman wrestling with a shopping cart. "Think it's PMS? It could be PMDD," the ads said. But the FDA said the ads trivialized the seriousness of PMDD, and the campaign was pulled. New ads show one woman arguing with her husband and another frustrated because she can't button her pants.

Lilly spokeswoman Laura Miller says the ads attempt to show the full gamut of PMDD symptoms. "It's up to the doctor and the woman to determine whether she has PMDD and whether treatment is appropriate," she says.

But Paula Caplan, a psychologist and affiliated scholar at Brown University's Pembroke Center for Research and Teaching on Women, says instead of labeling women as mentally ill, physicians should urge diet changes, exercise, less caffeine and even calcium supplements. "But nobody makes much money off calcium tablets," she adds.