WASHINGTON — Ten months ago, when concerns arose about a possible link between children taking antidepressant drugs and suicide attempts, senior officials at the Food and Drug Administration ordered their leading expert to head up an examination of the evidence.
When the government scientist filed his report last winter, however, his bosses decided to keep it secret -- even though it found that children who took the drugs were twice as likely to be involved in serious suicide-related behavior as those who did not.
Instead of revealing the findings, senior FDA officials ordered more studies, which were not expected to be completed until summer. They also squelched plans to have the author, Dr. Andrew Mosholder, present his conclusions to an FDA advisory committee when it took up the issue in February.
And in March, when the agency issued a warning about the possibility of problems for young patients taking the drugs, FDA officials said no conclusive scientific evidence existed on the link between antidepressants and potentially suicidal behavior by children. Officials said they based their action on anecdotal complaints from physicians and families that had been presented to the advisory committee.
They gave no hint that their own chief expert on the subject had examined the results of more than two dozen clinical trials conducted by antidepressant manufacturers, and that he had found an unusually high correlation between their use and potentially suicidal behavior in young patients.
The report still has not been made public, but news of Mosholder's conclusions first surfaced in a CBS News report last week. His findings were detailed in an internal FDA document obtained by the Los Angeles Times and authenticated by government officials.
In defending their decision to hold back Mosholder's report, his superiors questioned the reliability of the data on which he based his conclusions. They suggested drug companies, which manufacture antidepressant drugs and conducted the clinical trials in order to market them, might have been too quick to count some behavior as potentially related to suicide -- that is, too quick to raise questions about their products.
Among the kinds of actions the officials said should not necessarily have been counted as potentially suicide-related were instances of children who deliberately cut themselves.
