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The recent controversy over antidepressants, children and suicide is really about trust. Sick people have to trust their doctor's judgment about the drugs they take. Doctors have to trust the information they get from drug companies. The public has to trust government regulators to ensure that drugs on the market are safe and effective. Unfortunately, for depressed children, that critical trust has been squandered. Washington has to find a way to get it back.
The Food and Drug Administration acknowledged for the first time this week that widely prescribed antidepressants could cause some children and teenagers to become suicidal. An advisory panel recommended putting that caution in a "black box" on container labels, and adding a notice that most antidepressants don't lift depression in children. The FDA should adopt the recommendation. Mandating the black box, the FDA's most prominent warning, will fill the notification void for antidepressants. But that's not enough.
This problem arose because drug makers have been allowed to bury clinical trial results when outcomes were bad or inconclusive. That's what happened with trials of antidepressants that yielded evidence of suicidal thoughts in children. They weren't made public. Congress should require disclosure of all clinical trials. The industry is moving in that direction. It has developed a public database (www.clinicalstudyresults.org) that, beginning Oct. 1, will provide summaries of the final stages of clinical trials. But reporting the trials will be voluntary.
Eleven prestigious medical journals are assisting. The journal editors said they will publish results of clinical trials only if they were listed in a public registry before patients were enrolled. So readers could go there to find the results of other trials. Companies can choose not to register trials, but that would mean forgoing the marketing boost of journal publicity.
When it comes to powerful drugs of any kind, and the complex pluses and minuses inherent in their use, doctors and the public need all the information they can get.
Copyright C 2004, Newsday, Inc.
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