FDA withholds drug study results

Youths' suicide attempts linked to antidepressants, government report shows

April 06, 2004|By Elizabeth Shogren | Elizabeth Shogren,LOS ANGELES TIMES

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 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 are 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 expert on the subject had examined the results of more than two dozen clinical trials conducted by antidepressant manufacturers and had found an unusually high correlation between their use by young patients and potentially suicidal behavior.

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 justifying their decision to hold back Mosholder's report, his superiors questioned the reliability of the data on which he based his conclusions. They suggested the drug companies, which manufacture the 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 these officials said should not necessarily have been counted as potentially suicide-related were instances of children who deliberately cut themselves.

Some FDA officials defended the decision to sit on the report and seek more analysis, but some psychiatrists and congressional leaders who are following the FDA's handling of the issue were angered that the agency had kept Mosholder silent.

"Evidence that they're suppressing a report like this is an outrage, given the public health and safety issues at stake," said Dr. Joseph Glenmullen, a Harvard psychiatrist who wrote a book on the problems with the drugs known as serotonin reuptake inhibitors, which alter brain chemistry to manage depression. "They've been claiming that there's no evidence. Here's the evidence."

Senate and House committees have ordered the FDA to hand over documents that might illuminate what the agency knew about the possible link between the drugs and suicidal behavior. They specifically asked for any of Mosholder's reports, e-mails, correspondence or notes on pediatric or adolescent antidepressant trials.

These members of Congress are concerned that the FDA may be keeping information from Americans that would help them better assess the possible risks of taking antidepressants or giving them to children.

"It would have been very wrong for the FDA to withhold any information it had about unintended consequences that might result from the use of anti-depressants, especially for children and adolescents," Sen. Charles E. Grassley, an Iowa Republican.

In studying reports from 28 clinical trials, most of them unpublished and thus not open to public inspection, Mosholder concluded that the data showed a "statistically significant" risk of serious suicidal events among children taking the drugs. And he stressed that what he acknowledged were limitations in the data he was analyzing would not change his conclusion.

"Finding a statistical association despite these limitations makes the finding difficult to dismiss," he wrote in one of the documents, which was authenticated by government officials familiar with the document. FDA officials would not comment directly on the documents.

Dr. Robert Temple, associate director for medical policy at the FDA's center for drug evaluation, said that Mosholder "thought those data were persuasive just as they were." But his superiors believed that it was "premature" to come to the conclusion that the drugs were linked to suicide, Temple said.

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