Beyond Depression

By MICHAEL D. LEMONICK

A brand-new drug can be like a license to print money. It certainly worked that way for Eli Lilly. When the company launched the antidepressant Prozac in 1987, nobody else had anything quite like it, and Lilly cleaned up. But then other pharmaceutical firms rushed in with their own versions, including Zoloft, Paxil, Celexa and the recently newsworthy Luvox, found in the blood of Columbine High School shooter Eric Harris. The competition has already eaten into Lilly's market share, and things can only go downhill from here.

That's true, if you're talking about Prozac simply as an antidepressant. But if a drug turns out to be good for something new, that presents a fresh marketing opportunity. And while the search for new ills to conquer is part of any drug's life cycle, the scramble is especially furious with mood drugs like Prozac and its kin. Prozac has been approved for bulimia and obsessive-compulsive disorder in addition to depression, while Zoloft can be used for OCD, and Paxil for both OCD and panic disorder.

Now Paxil and its manufacturer, SmithKline Beecham, are upping the ante. If the FDA agrees, and it probably will, SmithKline will soon be pushing Paxil as the first-ever formally sanctioned treatment for, of all things, shyness. This isn't as bizarre as it sounds. FDA approval would actually be for the treatment of "acute social phobia," a pathological form of shyness that's more akin to panic. For doctors, at least, it's no surprise that phobia and depression might be treated with the same drugs. "The big secret," says Dr. Brian Doyle, director of the anxiety disorders program at Georgetown Medical School, "is that we tend to use them all for the whole spectrum of depression and anxiety disorders."

The reason is that Paxil, Prozac, Luvox and the others all target the same brain chemical, called serotonin, which seems to govern mood. Too little serotonin, and patients tend to feel negative about themselves and the world around them in one way or another. How that dissatisfaction manifests itself--clinical depression, anxiety, phobias, obsessions, even eating disorders--depends on a complex web of factors that researchers have yet to unravel. But they do know that drugs that keep serotonin from being reabsorbed too quickly into the nerve cells--the so-called selective serotonin reuptake inhibitors, or SSRIs--tend to alleviate these symptoms.

It was only by educated trial and error, not from reading drug labels, that doctors learned how broadly useful SSRIs like Prozac, Paxil, Luvox and Celexa can be in treating not just depression, OCD, bulimia and panic disorder but also migraines, anxiety disorders, attention-deficit disorder, kleptomania, post-traumatic stress and even premenstrual mood swings. (Despite earlier claims about Prozac and attempts to link Luvox to the Colorado school shootings, there is no evidence that SSRIs themselves cause violent behavior.) Although the FDA hasn't approved all these uses for all the drugs, doctors are free to prescribe them for anything they like.

Still, once a firm finds a new use for a drug, it makes sense to get formal approval. That's the only way the company can legally start pushing the treatment in ads and in marketing pitches to physicians. Paxil may be the latest example of an SSRI expanding its franchise. But it's not the first, and it won't be the last.

--By Michael D. Lemonick. Reported by Alice Park/New York

With reporting by Alice Park/New York