Ad Refuels Debate Over Severe PMS Disorder
The woman in the television ad tries to pull a grocery shopping cart from a line. It refuses to budge. She yanks with increasing ferocity as her frustration mounts.
“It’s that week before your period,” a voice intones, “the irritability . . . mood swings . .. bloating. . . . Think it’s PMS? Think again. It could be PMDD.”
The ad is for Sarafem, a new psychiatric medicine designed to treat premenstrual dysphoric disorder or PMDD, a severe version of premenstrual syndrome said to afflict millions of American women.
Trouble is, psychiatrists haven’t decided whether the disorder is real, and the medicine isn’t new: Sarafem is the antidepressant Prozac, renamed and repackaged as a pink and lavender capsule.
Sales of Sarafem have soared, spurred by a multimillion-dollar marketing campaign by the drug’s maker, Eli Lilly & Co., which is searching for profitable new uses for Prozac. The drug’s patent expires in August, and its price is expected to fall.
The campaign has reignited debate over whether premenstrual dysphoric disorder stigmatizes women by characterizing them as having a mental illness once a month and raised concerns that Eli Lilly’s advertising barrage promotes that notion.
“Seeing it over and over legitimizes it. It makes the condition valid when it is not valid and gets in the mind of everybody that this condition is a valid condition,” said Sally Severino, a psychiatrist who helped advise the American Psychiatric Assn. on the disorder. “The more you repeat something, the more you believe it.”
Many doctors counter that medicines such as Sarafem help women who suffer severe discomfort, irritability and tension every month. A simple matter of medicine, they say, has been complicated by gender politics, drug marketing and the future of Prozac.
Eli Lilly told shareholders that the launch of Sarafem was tied to preparations for “Year X”--the company code name for the year patent protection runs out for Prozac, which last year grossed more than $2.6 billion.
“We intend to focus on Prozac in the United States right up to the last day of its exclusivity,” said Chairman and Chief Executive Sidney Taurel in the 2000 annual report. “And we’ll pursue related opportunities . . . [including] Sarafem, a newly introduced brand for women who suffer from premenstrual dysphoric disorder.”
Although Prozac’s patent expires in August, Sarafem remains protected until 2007 because it is a new application. So, if Indianapolis-based Eli Lilly drops the price of Prozac because of competition from generic versions, it could still charge a higher price for Sarafem, although it is the same chemical.
Eli Lilly spokeswoman Laura Miller defended the company’s decision to create a new brand name for Prozac, saying premenstrual dysphoric disorder is a unique disorder. The new packaging provides specific information to doctors about the condition.
“We asked women and physicians, and they told us that they wanted a treatment with its own identity,” Miller said. “Women do not look at their symptoms as a depression, and PMDD is not depression but a separate clinical entity. Prozac is one of the more famous pharmaceutical trademarks and is closely associated with depression.”
Sarafem costs the same as Prozac--about $100 a month. Miller would not say whether Eli Lilly planned to price the medicines differently once Prozac lost patent protection.
CMR, a Taylor Nelson Sofres company that tracks advertising and marketing data, said Eli Lilly spent $17 million in direct consumer advertising for Sarafem from October to the end of January. In addition, between the time Sarafem was launched in July through the end of January, the company spent more than $16 million promoting the drug to doctors and in scientific journals, according to IMS Health, a company that tracks the pharmaceutical industry.
Through the end of January, Sarafem had sales of more than $19 million, and physicians wrote about 202,000 prescriptions, according to IMS Health.
Eli Lilly pulled the shopping cart ad after the Food and Drug Administration castigated the company in November for marketing the drug too aggressively. The agency said the commercial pitched the medicine to women who had normal PMS and thereby trivialized the seriousness of premenstrual dysphoric disorder. Two new television advertisements were created, and ads continue to run in women’s magazines, Miller said.
The ad campaign has rekindled a debate over the disorder. In the 1980s, the American Psychiatric Assn. considered including it as an official condition in its Diagnostic and Statistical Manual--the official bible of psychiatric disorders.
The proposal triggered a major controversy. Some women’s groups said calling severe PMS a mental illness might prompt employers to question women’s competence or even cause courts to rule against “mentally ill” mothers in custody battles--a concern that has not materialized.
“When men get mood shifts, no one says let’s call it mental illness,” said psychologist Paula Caplan, a PMDD critic who wrote the book “They Say You’re Crazy.”
Medicating women’s emotional outbursts, Caplan said, appealed to women, “who are supposed to be the world’s cheerleaders,” and to their boyfriends and husbands: “Men who are not supportive are happy to say, ‘Yeah, baby, something is wrong with you.’ ”
Many doctors, however, argued that PMDD could be a serious problem that interfered with women’s lives.
Eventually, the disorder landed in the appendix of the psychiatrist’s manual, placing it in the category of a disorder that is under evaluation.
But Eli Lilly, armed with research that indicated Prozac could alleviate the symptoms of premenstrual dysphoric disorder, won approval last summer to market the drug for the condition. It was “the first indication for a drug that the Food and Drug Administration has approved for a nonofficial diagnosis,” said Darrel Regier, director of the American Psychiatric Assn.’s division of research and an expert on the process by which the association classifies new disorders.
The association supported the decision--and Eli Lilly--for stimulating research into PMDD, he said.
Some psychiatrists who helped write the classification, however, said they worried that Eli Lilly’s marketing would guide the research, instead of the other way around.
“The cart is before the horse,” said Severino, a professor emeritus of psychiatry at the University of New Mexico School of Medicine in Albuquerque. “By classifying it as a depression, it seems to me that treatment will be geared toward depression when we don’t know if it is a depression.”
It doesn’t help that distinguishing premenstrual dysphoric disorder from premenstrual syndrome is difficult. “Unlike any other kind of psychiatric condition, most women believe they have PMS, and most people believe women have PMS,” said Nada Stotland, a psychiatrist at Rush Medical College in Chicago who was designated by the American Psychiatric Assn. to speak about PMDD. “We now have a psychiatric disorder with [symptoms] that people believe all women have.”
