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Painful Withdrawal for Makers of Vioxx

At lunchtime on Monday, Sept. 27, it was time to make a final decision. Kim, Frazier and Gilmartin gathered in the chief executive's conference room overlooking Merck's wooded campus in Whitehouse Station, N.J. The lab director's message came in two parts: the experts were divided over whetherMerck had to pull Vioxx off the market, but Kim thought they should do it anyway.

Gilmartin said he agreed the drug should be pulled but wanted to take a decision of that magnitude to his board of directors who concurred when they met the next day. By then, Merck had notified the FDA that it needed an emergency meeting that afternoon, and asked that top officials be present.

FDA Official Alleges Pressure to Suppress Vioxx Findings (The Washington Post, Oct 8, 2004)
Researchers Expand on Dangers of Vioxx, Drugs in Same Class (The Washington Post, Oct 7, 2004)
Promise and Peril of Vioxx Cast Harsher Light on New Drugs (The Washington Post, Oct 3, 2004)
Merck Withdraws Arthritis Medication (The Washington Post, Oct 1, 2004)

In the meeting, top FDA officials were shown preliminary slides from the colon polyp study and were told by Merck that the drug would be withdrawn. The FDA Center for Drug Evaluation and Research director Steven Galson said there was discussion of keeping the drug for short-term use, but the company did not think it was practical.

Fearful of a leak, Merck officials waited until the next day, Wednesday, to tell international affiliates of the planned withdrawal and asked them to hold off on telling their regulators until the news was made public. Three Merck officials sat up all night Wednesday answering e-mails and phone calls from the foreign medical directors.

Withdrawal day started early, with an 4 a.m. e-mail to Merck's 60,000 employees alerting them to a major announcement. At 9 a.m. on Sept. 30, Gilmartin and Kim took the stage at the Hilton Times Square and faced a room packed with reporters and television cameras.

"This morning Merck is announcing a voluntary worldwide withdrawal of Vioxx," Gilmartin began.

Warning From the FDA

Since the Merck decision, public health advocates and some congressional leaders have asked pointedly why the FDA, the nation's arbiter of drug safety, did not act sooner itself. The FDA's Galson said that his agency met often with Merck to discuss earlier troubling Vioxx studies, and said that "we insisted that we needed more information about the cardiovascular risks." In 2001, the agency formally warned the company against misleading doctors about those risks, and in 2002, the FDA required stiffer wording on the drug label.

Nonetheless, the agency had agreed with Merck that the 2000 study had too many confounding aspects to be definitive. The national adverse event reporting system that helps the FDA flag dangerous side effects was of little use in this case because the ailments possibly caused by Vioxx -- heart attacks and strokes -- are so common.

Galson also said that Vioxx safety follow-up was complicated by the fact that it is unethical to give placebos to arthritic patients, because their pain needs treatment. Instead the FDA strongly supported the Merck decision to use three placebo-controlled trials in healthy people to test whether the drug was protective against prostate and colon cancer and colon polyps and also to study cardiovascular risk.

The FDA's own study of the Vioxx safety issue has become mired in controversy. The FDA safety officer in charge of the report, David Graham, concluded that Vioxx posed much greater cardiovascular risk than the other major drug in its class, Celebrex. He presented that information at a French conference this summer. Galson has said, however, that he only saw a short abstract of the study and so could not act on its conclusions, a contention that Graham disputes.

The controversy grew on Friday when Grassley asked Merck, among other things, about an e-mail provided by Graham in which a Merck official complained that the FDA had not lived up to a prior agreement to alert the company before releasing any negative information about its products.

The FDA's opportunity to act independently on Vioxx ended on Sept. 27, when the fax came from Merck asking for an urgent meeting with senior officials. The next day surprised FDA officials learned the drug would be pulled.

Despite the criticism directed at his agency, Galson remains unapologetic. "We did the right things based on what we knew at the time," he said. But taking the drug off the market, he said, was the right thing, too.

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