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September 24, 2004
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Lawmakers Take FDA to Task on Antidepressants
* A House subcommittee says the agency held back data on the drugs' risks to children.

  Times Headlines

By Elizabeth Shogren, Times Staff Writer

WASHINGTON Members of Congress on Thursday accused the Food and Drug Administration of suppressing information, for as long as eight years, about the increased risks of suicidal thought and behavior in children and teenagers taking antidepressants.

"There is something terribly rotten at the FDA," said Rep. Peter Deutsch (D-Fla.). "No agency charged with protecting public health should have behaved with such indifference."


During a House subcommittee hearing on the FDA review of clinical trials involving the widely prescribed drugs, the legislators also criticized FDA officials for withholding information from clinical trials about the lack of benefit for children from most antidepressants.

"The FDA knew about the lack of efficacy in these clinical trials several years ago, and nothing has been done to change labels to inform doctors, patients and parents," said Rep. Greg Walden (R-Ore.), chairman of the hearing of the House Energy and Commerce oversight and investigations subcommittee.

FDA officials defended their decisions to keep data gathered in clinical trials from the public.

"The higher-ups felt the data weren't ripe for presentation," said Dr. Robert Temple, a director at the FDA's center for drug evaluation and research.

Temple said agency officials were worried about scaring young patients away from the drugs.

"Having untreated depression is risky too," he said.

About 1,600 teens many of them suffering from depression commit suicide each year, according to the FDA.

The FDA is under intense congressional scrutiny for its failure to move more quickly to warn doctors and parents about the increased risk of suicidal behavior in children on antidepressants. Two FDA advisory committees recommended last week that the agency order drug companies to place prominent warnings on drug packaging and on the prescribing information that goes to physicians.

"We don't want children taking an antidepressant drug if there appears to be quite a bit of evidence that not only does it not help them, but in some cases it actually hurts them by increasing the risks" of suicidal thought, said Rep. Joe Barton (R-Texas), chairman of the Energy and Commerce Committee.

Doctors last year wrote about 15 million prescriptions of nine antidepressants for children and teens, according to an analysis from the FDA and from IMS Health, a pharmaceutical information and consulting company.

Fluoxetine hydrochloride, marketed by Eli Lilly & Co. as Prozac, is the only antidepressant approved by the FDA for use in children because it has met the agency's standard of effectiveness in clinical trials. But because they are not prohibited from doing so, physicians regularly prescribe other similar drugs to young patients.

In Thursday's daylong hearing, legislators questioned a decision by senior FDA officials to prevent an agency researcher, Dr. Andrew Mosholder, from presenting his analysis of data from clinical trials of antidepressant use by children to two FDA advisory committees in February. His report showed that children taking the drugs were almost twice as likely to exhibit serious suicide-related behavior as those taking placebos.

Mosholder presented his findings at last week's advisory committee meeting, but only after news of his report had leaked to the media and a reexamination of the data by a Columbia University team and another FDA researcher had confirmed his conclusions.

Mosholder analyzed data on Prozac, Zoloft, Celexa, Effexor, Luvox, Paxil, Remeron, Serzone, Wellbutrin and Lexapro. All but Lexapro were included in the reexamination of the clinical trials.

The legislators also grilled FDA officials about documents from as early as 1996 that suggested a possible connection between antidepressants and suicidal tendencies in children.

In March 1996, Dr. James F. Knudsen, an FDA researcher, wrote to an executive at Pfizer Inc. that "there appears to be an increased frequency of reports of suicidality in the pediatric/adolescent patients exposed to" the company's antidepressant, Zoloft, in clinical trials.

But Dr. Thomas Laughren, the FDA team leader who supervised Knudsen, told the hearing that he analyzed the data referred to in the letter and concluded that they did not "represent a signal of risk."

He said there was no reason the question of whether the drugs caused suicidal tendencies in children should have been on the agency's "radar screen" between 1996 and last year, when Mosholder's analysis revealed the possible link.

But legislators on the panel were not convinced.