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FDA Urged Withholding Data on Antidepressants

Makers Were Dissuaded From Labeling Drugs as Ineffective in Children

By Shankar Vedantam
Washington Post Staff Writer
Friday, September 10, 2004; Page A02

The Food and Drug Administration has repeatedly urged antidepressant manufacturers not to disclose to physicians and the public that some clinical trials of the medications in children found the drugs were no better than sugar pills, according to documents and testimony released at a congressional hearing yesterday.

Regulators suppressed the negative information on the grounds that it might scare families and physicians away from the drugs, according to testimony by drug company executives. For at least three medications, they said, the FDA blocked the companies' plans to reveal the negative studies in drug labels, and in one case the agency reversed a manufacturer's decision to amend its drug label to say that the drug was associated in studies with increased hostility and suicidal thinking among children.

Rep. Greg Walden (R-Ore.) said the FDA should be encouraging drug manufacturers to disclose more information. (Ron Winn -- AP)

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"Why would FDA require a company to remove stronger labeling?" demanded an incredulous Rep. Greg Walden (R-Ore.) yesterday, at a hearing of the House Energy and Commerce subcommittee on oversight and investigations. "FDA should want to encourage a company to do that kind of thing."

Janet Woodcock, FDA's deputy commissioner for operations, responded that regulators believe the jury is still out on the drugs. The negative trials, she said, did not mean the medications were ineffective.

Several representatives noted that the study results were obtained at tremendous cost to the American public because Congress granted companies profitable patent extensions as an incentive to conduct the trials.

Rep. Henry A. Waxman (D-Calif.), a member of the subcommittee, said it was absurd to give companies profitable patent extensions on their drugs to encourage the trials and then limit dissemination of the results. He said his staff had estimated that a patent extension given to Pfizer Inc. was worth $1 billion dollars. Wyeth Pharmaceuticals, he said, made $500 million.

The hearing was prompted by widespread complaints that crucial information about the safety and effectiveness of antidepressant medications had not been communicated to physicians and the public. More than two-thirds of all studies of antidepressant use among depressed children have failed to show the drugs are effective.

Prozac is the only medicine to be specifically approved to treat children's depression, but a number of other drugs are widely prescribed.

Most physicians have not had access to the negative data and are prescribing the drugs to millions of American children largely because the drugs have proved effective among adults. Two internal FDA analyses recently concluded that the class of medications is associated with an increased risk of suicidal behavior among children.

At the hearing, Pfizer Vice President Cathryn M. Clary testified that FDA had told the company that existing language in the label for Zoloft, which suggested "that efficacy has not been established" for depressed children, was sufficient. Pfizer had planned to add that two studies of Zoloft found the medication was no better than sugar pills.

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