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SARAFEM: THE PROZAC MASK


Premenstrual Dysphoric Disorder, or PMDD, is a fresh-minted mental illness that purportedly affects 3 to 10 percent of all menstruating women. Mood symptoms like depression, anxiety, anger, irritability, or sensitivity to rejection are said to be so severe the week before a woman's period that it impairs her functioning. According to Dr. Jean Endicott, professor of clinical psychology at Columbia University's College of Physicians and Surgeons, What's ordinarily irritating becomes enraging."

To be diagnosed with PMDD, women must keep a daily diary of their symptoms for the duration of two menstrual cycles. The symptoms must kick in after ovulation and disappear once menstruation begins. "The timing is exquisite," remarks Endicott.

The timing is also exquisite for Eli Lilly and Company to make a financial killing off of PMDD. Next year, the drug company will lose its patents on the antidepressant Prozac, and with them its monopoly on the market. To ward off declining profits, Lilly has found another use for its wonder drug—treating PMDD.

In July, Lilly got Food and Drug Administration approval to market Prozac under the new name Sarafem. The company is packaging the drug in pretty pink and lavender capsules, exclusively for women, most in their late twenties or early thirties. Says Laura Miller, a spokesperson for Lilly, "Women told us they wanted treatment that would differentiate PMDD from depression."

Whether PMDD is a real condition is still subject to debate. Although both sides agree that a certain subset of women may be sensitive to normal hormonal changes, that's about all they agree on. The question remains, if women sometimes snap at their husbands if they don't pick up after themselves, or at their kids if they do poorly in school, should they be branded with a mental disorder? "Women are commonly in situations defined by stress—responsibility without authority," says Stotland. 'That's almost the definition of a typical woman's job."

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 drastically—from about $2.51 billion in 2000 to $625 million in 2003. Sarafem will provide a significant new market—women—to 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).

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 Prozac—and suffer fewer side effects like sexual dysfunction—the studies Lilly presented to the FDA looked solely at the effectiveness of daily doses, or roughly double the amount some researchers say is needed.

According to Caplan, almost all of the data the roundtable evaluated fell into two categories: the old problematic studies available to the DSM-IV group or the new research into using Prozac to treat PMDD. "There was nothing that looked at the validity of the PMDD construct," says Caplan.

Did Lilly railroad Sarafem through? Two members of the 16-person roundtable conducted PMDD research funded by Lilly, and another member has received honoraria as a speaker for Lilly. Endicott, who hasn't received research funds or speaking fees from Lilly, opened the company's November 1999 presentation to an FDA advisory committee, which voted unanimously in favor of the new PMDD indication for Prozac. In addition, the Society for Women's Health Research trumpets on its Web site an "unrestricted educational grant from Eli Lilly and Company," which they've used to promote PMDD awareness, including a national survey conducted in November to gauge women's awareness of PMDD and available treatment (i.e., Sarafem). "Lilly had done an extraordinary job of getting this to the public," says Stotland.

Researchers taking a ride on the drug-company gravy train is not unique to those who studied PMDD, but it can have effects on scientific research. "I don't think people falsify results. But what kinds of questions do you ask? Which results do you publish?" asks Stotland. "When I was a resident it was the departments who had money to bring in speakers. Now, it's the drug companies who are flying people around."

Incidently, at the time of the interview, Stotland was attending a PMDD conference held at a Palm Springs resort, courtesy of Eli Lilly.

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