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Painful Withdrawal for Makers of Vioxx

The experts agreed unanimously that the trial had to stop. "Coming to that conclusion, it took our breath way," Neaton said. Vioxx was Merck's fourth top seller, and they knew their decision would be extremely harmful to the company.

Neaton immediately called Baron, who was conducting the trial with a grant from Merck, and explained the problem.

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)

When Neaton faxed him the "unblinded" data, the signal was clear: Within the small population of people suffering from cardiovascular disease, the number from the Vioxx group after 18 months of study was twice as high as the placebo group -- 15 heart attacks or strokes per 1,000 patients per year, versus 7.5 for the sugar pill. "I looked at it and concurred immediately that the trial should stop," Baron said. But first, Baron needed to get the approval of his steering committee of others involved in the trial. This took nearly a week, during which Baron took precautions to guard against leaks of negative information and insider trading of Merck shares.

On Sept. 23 the full committee agreed to halt the trial. That afternoon, Baron called his contact at Merck to say that the drug presented an unacceptable risk of cardiovascular damage.

Baron said in the next few days, as he presented the data to company officials and some outside Merck advisers, he experienced "no pushback at all." But then again, he said, "if an independent committee makes a recommendation like ours, only a fool would tell us to buzz off."

Ominous Voice Mail

Merck lab director Kim heard the news on when he dialed into his voice mail while driving to work, 7:30 a.m. on Sept. 24.

"I was stunned," said Kim who had expected positive results. He and other Merck scientists poured over the data, looking for flaws but finding none. At midday, Kim got the general counsel Frazier on the line and called Raymond V. Gilmartin, Merck's chairman, president and chief executive.

"The drug held up for three years. When you've been going this long you don't expect this kind of phone call," Gilmartin remembered in an interview soon after the drug was pulled.

Merck critics, and there are many, say the company had plenty of warning. Yet Merck continued advertising.

"There was so much denial over there," said David Moskowitz, senior pharmaceutical analyst for Friedman, Billings, Ramsey Co., noting that Merck officials were defending the drug to stock analysts just a few weeks before it was withdrawn.

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