A Disease for Every Pill
An anonymous woman tries to disentangle a shopping cart from an interlocked row of them, outside a suburban store. She is frustrated and angry. She becomes even more exasperated when another shopper enters the frame, calmly unhooks a cart and glides smoothly on her way. Watching this TV advertisement unfold, it might look like the woman is experiencing little more than a normal bout of tension or stress. But the folks at the drug company Lilly know better. This woman may need a powerful antidepressant because she is suffering from a severe form of mental illness known as PMDD. "Think it's PMS? It could be PMDD," intones the voiceover.
Columbia University Professor Jean Endicott tells us premenstrual dysphoric disorder (PMDD) is a psychiatric condition suffered by up to 7 percent of women. Paula Caplan of Brown University claims that the condition has essentially been invented and that there is no strong scientific evidence to distinguish it from normal premenstrual difficulties. Even worse, argues Caplan, using a medical label to explain away the severe distress some women experience in the lead-up to their period runs the risk of masking the underlying causes of their suffering.
In the United States, the Food and Drug Administration has accepted that the condition PMDD exists and has approved Lilly's Prozac and several similar antidepressants for its treatment, yet in other parts of the world it is not even a recognized disease. It is not listed as a separate disorder in the World Health Organization's International Classification of Diseases. And even in the United States, despite the hard work of Endicott, Lilly and other pharmaceutical companies, PMDD still has only a partial listing in the psychiatrists' manual of diseases, the DSM, and is therefore not seen as a fully official category of illness.
Yet this scientific controversy is invisible in the avalanche of television and magazine advertisements about PMDD in the United States--much of it targeting young women. The $500 billion pharmaceutical industry has identified another new mega-market--women of childbearing age--and the world of marketing demands simple, clear messages. The emotional ups and downs preceding your period are no longer a part of normal life--they are now a telltale sign you could have a psychiatric condition. As Caplan puts it, by watching these ads "women are learning to consider themselves mentally ill."
A friendly and hardworking academic, Endicott operates from a small office buried in the basement of a psychiatric hospital in New York City. In stark contrast to Caplan, she insists PMDD is a genuine disorder that can be "very disabling" and is often not properly diagnosed or treated. She welcomes drug company efforts to have the condition taken more seriously. It was Endicott who led the key scientific meeting--funded by Lilly and attended by company representatives--that paved the way for two of the most important developments in the life of this young disorder: FDA acceptance of the condition and approval of Lilly's antidepressant as the first drug to treat it. As to the appropriateness of drug companies advertising disorders like this on television, Endicott is a strong believer. "I think it educates people," she says.
The pharmaceutical industry in the United States now spends more than $3 billion a year on direct-to-consumer advertising, promoting its most lucrative brands. Increasingly, however, these commercials are not just selling drugs but also the diseases that go with them. The shopping-cart ad for PMDD is part of a new form of TV advertising designed to introduce millions of people to previously unheard-of conditions. While the advertising claims made about the benefits and risks of medicines are regulated by law--albeit very loosely--claims about diseases remain a virtual free-for-all.
The story behind the "discovery" of PMDD illustrates how an unknown, unofficial and, for some, unreal condition can be pushed from the back pages of the psychiatrist's manual into glossy magazines and onto TV screens. In the late 1990s Lilly's antidepressant Prozac--whose chemical name is fluoxetine--was about to lose its patent, and the manufacturer stood to lose hundreds of millions of dollars because of the emergence of cheaper generic competitors. Winning approval of the drug for a new disease might re-energize sales of this blockbuster chemical.
In late 1998 Lilly helped fund a small meeting, impressively titled a "Roundtable" of researchers, which discussed PMDD. The meeting of just sixteen key experts took place in Washington, and it was attended by a group of FDA staff and at least four Lilly representatives. The chair was Columbia University's Endicott, who had by then been pushing for the acceptance of this disorder for more than a decade. This time, though, Endicott had a giant pharmaceutical company on her side.
The meeting reached two important conclusions, both highly favorable to Lilly: There was now an alleged consensus that the disorder existed, and most people present thought there was sufficient evidence to support the use of antidepressants like Prozac to treat it.
By Christmas of 1999 a meeting of advisers to the FDA had voted unanimously to approve Lilly's fluoxetine for the treatment of PMDD. Soon after, the FDA formally gave Lilly the green light to market its drug for PMDD, and Lilly organized a launch to do just that. But in an extraordinary turn of events, the pill did not debut under the name Prozac. After doing some market research with doctors and potential patients, Lilly decided to repaint Prozac in attractive lavender and pink and rename it Sarafem.