AN irate woman shrieks hysterically at her confused husband. Another sobs plaintively. A third glumly stares at her bloated figure in a dressing-room mirror.
“Think it’s PMS?” a female voice in the commercial coos. “Think again.”
Anyone who’s seen Eli Lilly’s controversial new TV ads might think doctors have discovered a new disease that makes some women “super-moody” before their periods, prone to debilitating tension, crying easily and blowing up at their loved ones. It’s not PMS, the ad insists, but PMDD: premenstrual dysphoric disorder.
“Doctors can now treat PMDD with Sarafem,” the commercial promises, “the first and only prescription medication for PMDD.”
Is this new “miracle drug” a medical breakthrough – or a clever marketing scheme?
What Eli Lilly’s new commercial doesn’t say is that Sarafem – marketed in pretty pink and purple pills – is simply a repackaged version of the popular antidepressant Prozac.
And some critics say PMDD is not a disease at all, but was invented by drug companies to make a financial killing.
“Most doctors are busy, and when a patient comes in and badgers them for a certain drug, they’re probably able to get it,” says Dr. Howard Berkowitz, director of the consultation emergency psychiatry clinic at Maimonides Medical Center in Brooklyn.
“It alarms me, because PMDD isn’t even a disease that the psychiatric community is sure exists.”
Proponents claim that premenstrual syndrome – often the butt of jokes and the bane of relationships – is finally gaining some recognition.
PMDD affects 3 percent to 5 percent of American women of childbearing age, according to the Society for Women’s Health Research, a nonprofit research foundation not connected to any pharmaceutical companies.
“Symptoms can become so severe the week before a woman’s period that she becomes literally unable to function,” says Jean Endicott, director of the premenstrual evaluation unit at Columbia University College of Physicians and Surgeons.
“For years, women have been told that their symptoms were in their head and they needed to live with it,” says Endicott, who has been studying premenstrual health for more than 20 years.
Doctors aren’t sure why these symptoms become more severe in some women, but suspect they are the result of shifts in hormones interacting with brain chemicals such as seratonin that control emotions.
“Unfortunately, women end up being undertreated because they end up talking to general practitioners who know nothing about the disorder and dismiss their symptoms,” adds Margaret Sewell, a psychologist at Mount Sinai Medical Center who is studying the effects of the antidepressant Paxil on PMDD.
Several studies – including one published in 1995 in the New England Journal of Medicine – have confirmed that Prozac reduces PMDD symptoms in about 60 percent of women who take it. Researchers are now studying whether women need to take Prozac continuously or just at the onset of symptoms.
In its promotional literature, Eli Lilly claims, “Sarafem contains fluoxetine hydrochloride, the same active ingredient found in Prozac.” And last July, the FDA gave Eli Lilly clearance to remarket the drug.
Not surprisingly, other leading drug makers are following suit. Pfizer filed last January for FDA permission to market its antidepressant Zoloft as a treatment for PMDD. Forest Laboratories’ Celexa and GlaxoSmithKline’s Paxil are also being evaluated.
Nada Stotland, chair of psychiatry at Illinois Masonic Medical Center in Chicago, says she worries about the implications of labeling women mentally ill.
“Everyone already thinks that everything reproductive about women is disabling,” she says. “For centuries, we’ve been subjected to stereotyping because of our hormones and told we can’t hold positions of power because we are moody and unreliable.
“Now that women have finally made some progress, why are we bringing up these old stereotypes again? To imply that women are disabled due to their hormones represents a potentially dangerous setback for women in the workplace.”
Fueling cynicism is the fact that in August, Eli Lilly loses patent protection on Prozac, and could lose billions of dollars in sales. But by remarketing the drug as Sarafem, the company gains a new patent.
“It’s a clever marketing ploy on Lilly’s part. As soon as Prozac loses its patent, they repackage it as new medication,” says Berkowitz.
The American Psychiatric Association’s Diagnostic and Statistical Manual of Mental Disorders lists PMDD in the appendix as a condition that needs further study before being labeled a mental illness.
And some gynecologists – the very doctors Eli Lilly is marketing the drug to – remain skeptical.
“I don’t think every woman who has gotten into an argument with her boyfriend 48 hours before her period has PMDD,” says Dr. Steven Goldstein, a professor of obstetrics and gynecology at New York University Medical Center, who says he has only a “handful” of patients on medications like Sarafem.
“Does Sarafem work? Usually. But I prefer to put women on the birth control pill, or recommend exercise or adding in more calcium and Vitamin B-6 to their diet before even thinking about putting them on an antidepressant,” he adds.
Dr. Peggy Polaneczy, an ob/gyn at Weill-Cornell Medical Center, says that most women who walk into her office claiming they have PMDD actually suffer from a chronic mood disorder.
“When you question them or have them keep a two-month chart, it becomes apparent that they’re suffering from a low-level depression or anxiety that simply worsens around their period,” she says. “That’s not to say there aren’t women who are as happy as a clam most of the month, but who become anxious or depressed before their period. But they’re in the minority.”
Dawn, a 28-year-old nurse from Virginia, says she suffered severe PMDD for 10 years before being put on Sarafem last January.
“I was fine most of the month, but that week before my period, I’d be a basket case,” says Dawn, who says her symptoms vanished a month after she started on Sarafem.
“I’d get really edgy and if anyone looked at me the wrong way, I’d start to cry. It was really scary and frustrating. You feel like you can’t lead a normal life – like your hormones control you.”
But Stotland still questions whether women like Dawn are truly ruled by their hormones.
“No one wants to admit they suffer from a psychiatric disease like depression,” she says. “That seems frightening and unmanageable. It’s so much easier to have a hormonal disease that can be treated with a special PMS medication that comes in a flowered box.
“It’s a very attractive magnet to hide whatever is really bothering you.”