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The British, on the other hand, actually banned the use of Paxil (under the drug's British trade name, Seroxat) for kids last June, and went on to ban the others in the following six months. Why the difference, when British authorities were looking at the same data as the FDA? One reason is that most studies on effectiveness aren't really definitive. They don't prove one way or the other whether the drugs work significantly better than placebos--and the Brits went with the more conservative interpretation. That, argues Dr. Graham Emslie, co-chair of the American panel and the author of several studies on SSRIs, is shortsighted. "A failure to show effectiveness is not the same as proving ineffectiveness."
Moreover, he argues, the evidence linking SSRIs to suicide is very weak. Autopsies on people who have taken their lives show that most victims hadn't taken an antidepressant, or had taken an overdose, in the hours before their death. The British cited "suicide-related events," not actual suicide, as the reason for the ban--and there's obviously a big difference. "About 2 million teens in the U.S. have clinical depression," says Dr. Harold Koplewicz, a psychiatrist and director of the NYU Child Study Center. "But 3 million kids have suicidal thoughts. They seem to be part and parcel of the adolescent experience." And, he points out, only a fraction of either group actually attempts suicide.
Finally, say critics, the British medical authorities looked at the evidence in an unsophisticated way. Many of the unpublished studies they reviewed came from the drug companies themselves, and at least some of those had been carried out for a very specific purpose. Under FDA rules, any company that tests its medications on young people at the FDA's request wins an extra six months' worth of patent protection, whether or not the results are positive. Since these studies were done for financial gain and weren't reviewed by independent scientists, they probably shouldn't be given full weight. Making them public, as activists demand, might muddy the waters rather than help families make informed decisions.
Nonsense, say scientists who favor sharing such data. The reason some studies remain unpublished is that the drug companies don't like to admit negative results. According to Dr. Martin Teicher, a researcher at McLean Hospital outside Boston who has published case reports linking suicide and Prozac use, an internal Eli Lilly study of adults taking the drug showed "a substantially greater incidence of suicide attempts in people in the study receiving Prozac than in people receiving placebo or other antidepressants."
But that study wasn't published, he says, while research showing no increase in suicide attempts was. Says Dr. Richard Harrington, an expert in child and adolescent psychiatry at England's University of Manchester: "It's very important that things get peer reviewed. There is no question about that. But if you have to make decisions about giving drugs to children, you might sometimes have to go on unpublished reports."