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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