Healthy Skepticism Library item: 873

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Publication type: news

Harris G.
Warnings Called Likely on Drug Risk for Suicide
The New York Times 2004 Sep 24

Full text:

A top Food and Drug Administration official told Congress on Thursday that the agency was likely to force drug makers to put the strongest possible warning on antidepressants regarding the drugs’ potential for increasing suicidal thinking and behavior in children.

“I’m not predicting that we won’t go with the black-box warning,” Dr. Robert Temple, director of the F.D.A.‘s office of medical affairs, told the House Energy and Commerce Committee. “My guess is that we probably will.”

Dr. Temple’s prediction came during a contentious all-day hearing on the drugs in which the panel accused the agency of attempting to suppress documents and failing to safeguard the health of children, charges that Dr. Temple and other F.D.A. officials strongly contested.

Members of Congress vented their frustrations about how the agency had handled the controversy, and said that it failed for years to recognize obvious signals that the drugs were unsafe.

Representative Joe L. Barton, Republican of Texas and the chairman of the committee, quizzed the officials about memorandums written in 1996 that raised questions about increased risk of suicidal behavior in children participating in a clinical trial of Zoloft.

But F.D.A. officials said that a close analysis of the study found no increased risk and that there was no reason for concern about the drugs and suicide until 2002. They proceeded cautiously, they said, because the medicines may keep many depressed teenagers from becoming suicidal.

Dr. Temple said the agency would decide within a few days whether to follow the recommendation delivered last week by its advisory committee to force drug manufacturers to place a very strong warning on the physicians’ prescribing sheet about the risk of suicide among teenagers and children who take the pills.

The star witness of the hearing was Dr. Andrew Mosholder, a drug-safety reviewer who in 2002 started asking questions of drug makers and eventually came to believe that the drugs increased the risk of suicidal behavior. Dr. Mosholder wrote a memorandum recommending that doctors be discouraged from using any antidepressants but Prozac to treat depressed children and teenagers.

Dr. Mosholder said his bosses thought his analysis was flawed and stopped him from testifying about his findings at a public hearing in February. But a study commissioned by the agency last year arrived at nearly identical conclusions to Dr. Mosholder’s.

Still, in his testimony before the committee on Thursday, Dr. Mosholder was diffident in manner and careful in his responses. He declined to endorse the most strident of the committee members’ charges.

Among those was a claim that top F.D.A. officials had demanded that, in a report Dr. Mosholder provided to Congressional investigators, he sign and present as his own a document that had been doctored by agency officials.

But Dr. Mosholder said he had not been asked to sign the statement, but rather to present the edited document to the Senate without signaling that it had been changed. He declined to do so. Agency officials said the requested changes would only have removed language that indicated that the agency had begun an internal investigation into the source of a leaked document.

Other agency officials told the committee that a 1996 memo raising the possibility that Zoloft might cause children and teenagers to become suicidal was dealt with appropriately. The study that was the focus of the memo involved 100 depressed children and teenagers who were given Zoloft and another 100 who were given a placebo. There was only one case in which a patient because suicidal, and that person had been given a placebo, not the antidepressant, said Dr. Tom Laughren, a top F.D.A. official.

Committee members and agency officials clashed repeatedly over how to characterize the effectiveness of antidepressants in children. Members of Congress pointed out that nearly all studies of antidepressants in children and teenagers had failed to show that they were effective for depression. With no benefit to recommend them and a risk for suicidal behavior, the members said they could not understand why the agency did not ban the drugs.

Dr. Temple responded that just because the trials had failed to show an effect did not mean that the medications were not working. “More than 50 percent of all trials in adults fail, too,” he said. “We don’t know why.”