Several other drug companies are racing to test anti-depressants for social phobia, also called "social anxiety disorder." American Home Products Corp. is launching tests of Effexor, while Pfizer Inc. and Solvay SA of Belgium have completed large studies of their psychiatric drugs Zoloft and Luvox. If Paxil does win approval for the new use, SmithKline Beecham says it would be intended only for people whose fear of embarrassment from social interaction is severely debilitating and traumatic. In extreme cases, psychiatrists say, the phobia can hamper one's ability to form relationships or hold down a job. It can also lead to alcoholism and even suicide.

"There are about 17 million people suffering from this in the United States," says SmithKline Beecham's chief executive, Jan Leschly. Tapping thatmarket could keep the sales of SmithKline Beecham's big blockbuster growing for years.

`Get an edge'

But some doctors warn that patients may clamor for Paxil to treat everyday bouts of shyness. "We don't want this to be something people use for simple stage fright," says Jack Gorman, a psychiatrist at Columbia University in New York. "One concern is that a lot of businessmen want to get an edge and think they'll make better speeches."

Paxil's new incarnation is thus likely to reignite the debate over using prescription drugs aimed at the seriously ill to treat people with milder complaints about their psyche and body. The debate burst out in the early 1990s when the anti-depressant Prozac found a huge following among patients with a grab bag of moderate mood complaints. Then came obesity drugs, widely used by people who just wanted to lose a few pounds, and Viagra, seized upon by men who sought a little extra zing in their sex lives.

Based on observations made in the early 1990s, doctors havebelieved drugs such as Zoloft, Prozac or Paxil can also help with a range of anxieties. While doctors can prescribe drugs as they see fit, drug companies can't market their approved drugs for additional uses without first conducting large studies required by the Food and Drug Administration.

With at least seven brand-name depression drugs battling for the medicine cabinets of this country, pharmaceuticals companies are testing the drugs for treating post-traumatic stress disorder, panic disorder-even mood swings from severe pre-menstrual syndrome.

SmithKline Beecham says Paxil won't help at all if it is used occasionally, say, before giving a big speech. "It is not a panacea pill," a company official says. Like many anti-depressants, Paxil takes weeks to start taking effect.

SmithKline Beecham says its marketing initially will focus on educating doctors about social phobia. Once physicians are clued in, the company says, it is considering a patient-education campaign about social phobias.

SmithKlineBeecham has given an unrestricted grant to the American Psychiatric Association and two other non-profit groups to develop public-service announcements about social phobia that will start appearing on billboards and at bus stops in several major cities next month. The advertisements liken social anxiety to "being allergic to people," but don't mention any specific treatment.

It is unclear how common social phobias are. One major survey published a few years ago in the Archives of General Psychiatry found 13 per cent of the population suffered from some form of social phobia at some point in their lives. But psychiatrists say perhaps 4 per cent to 5 per cent of the adult population suffers from the more severe form of the disorder.

One of the first researchers to identify social phobia was Isaac Marks, a British psychiatrist. Treating patients with various phobias in the mid-1960s, he found they seemed to fall into two main groups. Some had agoraphobia, an abnormal fear of being in open or public places;others were terrified of being embarrassed in social situations-that is, they had social phobia.

Pathological fear

In the mid-1980s, several psychiatrists in the US, including Michael Liebowitz of Columbia University and Murray Stein, now at the University of California at San Diego, started noticing that some patients who seemed to suffer from panic disorder didn't improve with standard treatments.

Upon closer examination, they found these patients actually didn't have classic panic disorder but instead were pathologically afraid of socialsituations.

One patient Liebowitz treated had panic attacks in subways but didn't respond to imipramine, a standard drug then used to treat such incidents. Quizzing the patient more carefully revealed that the panic attacks occurred only when other passengers were staring at him. Alone in his car, he was fine.

Researchers started looking for other patients who had acute fear of social situations and found lots of them. One government research team rannewspaper ads seeking patients who suffered extreme fear and anxiety in social situations and was inundated with calls.

These patients' fear, now called generalized social phobia, went beyond mere anxiety at performing specific tasks, such as playing an instrument in a concert, and extended to most or all social interactions.

In clinical trials of Paxil for depression, SmithKline Beecham researchers noted it was particularly helpful in treating depressed patients who had anxiety symptoms. After tests, they got the drug approved in 1996 for treating obsessive-compulsive disorder and panic disorder, which seemed the most serious and best-understood of the anxiety disorders at the time. Next, they turned to social phobia, after noticing research showing it was much more common than previously thought.

In a study of 187 social-phobic patients published last summer in the Journal of the American Medical Association, 55 per cent of those who took Paxil reported significant improvement in their social anxiety,compared with 24 per cent of patients who took a dummy pill. The study was funded by SmithKline Beecham. The drug's side effects can include difficulty with ejaculation, nausea and drowsiness.

At Pfizer, Cathryn Clary, medical director for central-nervous-system disorders, says the company is evaluating the data on Zoloft's effectiveness in treating social phobia. Solvay, while it hasn't made any final decisions on the matter, could apply to the FDA for approval of Luvox for social phobia in a year or so. As for Prozac, Eli Lilly says it currently isn't testing the drug for social phobia, though it is awaiting approval for mood swings from severe premenstrual syndrome.

(The Asian Wall Street Journal)