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FDA in denial

Wednesday April 07, 2004

When the Food and Drug Administration issued a warning about a possible link between antidepressants and suicidal behavior in children and teenagers, officials said that they were doing so without scientific evidence.

They said that the warning was based on complaints from doctors and families of young patients.

It turns out that FDA officials were being less than truthful. The agency did have scientific evidence of a link. One of its own experts studied clinical trials that had been conducted by drug manufacturers. He filed a report last winter that said children taking such medication were twice as likely to exhibit suicidal behavior as those who did not.

The agency chose to keep that information quiet while it ordered additional studies, withholding it even from an FDA advisory committee.

Officials are defending their decision, saying that the drug company trials may have been too hasty in labeling behavior suicidal. Children who intentionally cut themselves, for example, might not be trying to kill themselves.

But it hardly seems like overreaction to take self-destructive behavior very seriously, particularly in young patients who are depressed and taking drugs that have been called into question.

Given what is at stake, the decision to keep information under wraps is inexcusable. Releasing the research would have given additional support to the FDA's warning, making it even clearer to doctors and patients that these drugs must be used with caution and careful monitoring.

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