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FDA held back results of child suicide study
Los Angeles Times
April 9, 2004

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.

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 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 recent CBS News report. 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 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 -- such as the ones obtained by the Times -- 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 antidepressants, especially for children and adolescents," Sen. Charles Grassley, R-Iowa, chairman of the Senate Finance Committee, said in a statement.

"The public deserves to know of every possible risk so that family members can closely monitor any changes in behavior," he said.

Suicide is the third leading cause of death in teenagers ages 15 to 19. From 1980 to 1997, the rate of suicide among this group increased by 11 percent. Suicide is rare but growing among younger children. The suicide rate for those 10 to 14 years old increased by 109 percent between 1980 and 1997, according to the federal Centers for Disease Control and Prevention.

Since peaking in the late 1990s, suicide rates appear to be declining among teenagers but remain a serious problem. Experts say depression is the leading factor in suicide.

Depression affects one in every 33 children and one in every eight adolescents, according to the National Mental Health Association. Although only one antidepressant, Prozac, is explicitly approved by the FDA for children, doctors routinely prescribe others to their young patients, and the use of these drugs by children has been steadily rising.

The antidepressant drugs -- Prozac, Zoloft, Paxil, Luvox, Celexa, Lexapro, Effexor, Wellbutrin, Serzone and Remeron -- are taken by 30 million Americans, according to some estimates. The first seven are serotonin reuptake inhibitors, and their sales in 2003 exceeded those of any other drug class except the group of painkillers that includes codeine.

An estimated 7 percent of the Americans taking the medications are children. Drug use is tracked by the number of prescriptions written. A total of 2.7 million antidepressant prescriptions were dispensed for children younger than 12, and 8.1 million were written for adolescents in 2002, according to FDA, although some individuals received more than one prescription a year.

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.

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