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FDA OKs Release of Vioxx Data

Agency scientist suspects link to heart attacks

Jan 4, 2005 | AP

The Food and Drug Administration has given a whistle-blower permission to publish data indicating that as many as 139,000 people had heart attacks that may be linked to Vioxx, the scientist's lawyer said yesterday.

Dr. David Graham, a scientist who works in the FDA's office of drug safety, has said he was not allowed to publish his data questioning the safety of Vioxx, a pain medication principally used to treat osteoarthritis. In addition, an FDA official sent e-mail messages to the medical journal Lancet trying to persuade the journal not to publish the data.

Noting its own safety concerns, manufacturer Merck & Co. Inc. voluntarily pulled Vioxx from the market in late September.

Graham testified in November before a Senate committee that the FDA fumbled in its handling of safety concerns around Vioxx and had mishandled concerns about five other widely used drugs. He contended that the FDA has an inherent conflict of interest that triggers "denial, rejection and heat" when safety questions emerge about products it has approved.

The FDA denies the allegations, and controversy over the agency's role continues.

But the question of publication of the Vioxx data appears to be settled. The FDA told Graham yesterday that he could go ahead and publish his research, which shows that 88,000 to 139,000 people have had heart attacks that could be linked to Vioxx, with 30 percent to 40 percent of them fatal, said Graham's attorney, Tom Devine.

The report will be resubmitted to Lancet, a British medical journal, which is expected to publish it, Devine said. Lancet editor Richard Horton has been sharply critical of the FDA as well.

Devine, legal director of the Government Accountability Project, said the FDA go-ahead is a positive sign.

"For the short-term at least, the FDA has decided to stop suppressing controversial research on Vioxx," he said.

Graham could not be reached for comment but Devine said of his client: "He's pleased and relieved." The FDA did not respond to a request for comment.

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