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Painful Withdrawal for Makers of Vioxx

Last week, Gilmartin and Kim still said that none of the earlier Vioxx studies, by either the company or others, convincingly showed increased heart and stroke risk from the drug. As a result, they said, there was no reason to stop the advertising campaign.

"We were acting totally consistent with the data we had," Gilmartin said. "We undertook right away to ask the right questions." The company was trying to get at cardiovascular risk, he said, by initiating three clinical trials that would together give important new information on the issue. Many doctors and patients liked Vioxx's track record on gastrointestinal problems, a major source of worry for arthritis patients.

_____Background_____
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)

But, on the phone call, when Kim delivered the new, more damaging results, Gilmartin's choices were bleak. Even if the painkiller stayed on the market, sales would almost certainly plummet because its advertising would be restricted and would have to carry a "black box" warning about the heart attack risks.

Gilmartin was clear that the trial should be halted and that the drug might have to be taken off the market . "Look Peter, we're going to make this decision based on what's in the best interest of science and patient safety," Gilmartin recalled saying. "It's not that we're unaware of the consequences, but it's a deep-seated belief that if you do the right thing, rewards will follow," he said of the decision to pull the drug.

The decision was also sound litigation strategy. The company was already facing two class action lawsuits alleging patient harm from Vioxx. Anything that smacked of a cover-up would have strengthened the plaintiffs' hands.

"Running away from your problems, denial, is the worst possible choice," said Anthony M. Sabino, professor of business law at St. John's University.

Over the next three days, Kim and his researchers convened three teleconferences with about 15 outside medical experts to get their advice. By then, Kim said, he was leaning toward pulling the drug. But the outside experts, most of whom had done previous work with Merck and were offered a fee for their consultation, had surprisingly mixed opinions.

A sizeable group were reluctant to give up a painkiller proven to have fewer gastrointestinal side effects than others and were not convinced the available alternatives were any safer, participants said. (On Friday, Pfizer Inc. issued a warning that its Cox2 drug Bextra may increase cardiovascular risk for some patients.) Duke University cardiologist Robert Califf argued strenuously on one teleconference for keeping the drug on the market with a much stronger warning label. He had been railing publicly for some time about the absence of long-term cardiovascular risk studies on painkillers, a situation that he said made selecting the right drug a "total crapshoot."

In his view, the new Vioxx data quantified the risk and made it manageable. "The curves show not even a hint of a detrimental effect for 18 months," and even after that the risks did not appear that large. "I thought the risk was going to be larger than it was," he said. "It should stay on the market as an alternative."

But Northwestern University rheumatologist Thomas G. Schnitzer argued for ditching Vioxx entirely because Merck's scientists could not explain why the drug started causing heart attacks after 18 months. Furthermore, Merck's carefully cultivated image would go out the window if Vioxx stayed on the market, he said, because Merck "prides itself on its ethical approach. I couldn't see Merck saying we're going to market a drug with a safety problem."


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