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 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.
Mosholder's report still has not been made public, but news of his 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 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 had found an unusually high correlation between their use by young patients and potentially suicidal behavior.
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 own 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 of the data, but some psychiatrists and congressional leaders who are following 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.
By ELIZABETH SHOGREN
Los Angeles Times
Published on: 04/06/04