Probe Planned of FDA's Antidepressant, Suicide ReviewMay 2, 2004 | AP
A House committee says it will investigate whether the Food and Drug Administration fully disclosed the disagreement among its scientists about whether antidepressants might be linked to suicide in children.
The FDA insists it is not clear whether the drugs have any link to suicidal behavior by children or teenagers, noting that depression itself can lead to suicide. An extensive agency investigation is under way; results are due this summer.
But at a Feb. 2 public meeting, FDA officials announced that some agency scientists believe a link already is proved, and presented the cases of possibly suicidal behavior.
At that meeting, the FDA's scientific advisers concluded that such a link has not been proven. They said that until the issue is settled, parents need to be warned that the drugs may cause agitation, anxiety and hostility among patients unusually vulnerable to rare side effects.
Critics complain that the FDA scientist who told his bosses he was convinced of a link, Dr. Andrew Mosholder, has been muzzled. Mosholder attended that February meeting but did not discuss his conclusion.
In a letter to Congress that was released Thursday, the FDA offered an explanation: While his boss presented Mosholder's data, top officials did not think Mosholder should argue the case was closed when that was not the agency's position.
"Having Dr. Mosholder present his conclusion to the advisory committee, with the appearance that it was an agency determination might lead patients who were actually benefiting from the use of these drugs to inappropriately discontinue therapy," the FDA wrote the House Energy and Commerce Committee.
Time to get it right
The agency has urged caution in prescribing adult antidepressants for children. In addition, bowing to pressure from families, the agency warned last month that patients of any age should be monitored closely for signs of suicide when they first start antidepressants or change a dose.
But members of Congress question whether the FDA has gone far enough. Rep. Joe Barton, the House committee chairman, promised further investigation.
"There are troubling questions of whether FDA supervisors inappropriately suppressed significant information that would have been of consequence to their own advisory committee, not to mention the public," said Barton, R-Texas.
The FDA's drug chief, Dr. Robert Temple, said it is not unusual for agency scientists to disagree. He said the agency's advisers were given a clear picture of that disagreement and the data behind it.
"Nobody should think we're shrinking from this we raised it," he said.
"We don't want to scare people off drugs that may very well be useful. We don't want to exonerate drugs if they really are increasing the risk," Temple said. "We thought the investment of a few more months was worth it to get it right."
Last spring, the FDA spotted puzzling side-effect reports in studies of the use of the drug Paxil by children.
The FDA ordered details from the makers of Paxil and other antidepressants, reports that mentioned possibly suicidal behavior. That led the FDA to warn doctors to use caution when prescribing the drugs for minors while the agency assessed the risk.