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CEO defends Merck on Vioxx

Confirmation of woes came 'out of blue'

Merck & Co.'s chairman and chief executive Raymond Gilmartin yesterday defended his firm's handling of earlier health warnings about Vioxx and said he was "stunned" when he learned two weeks ago that a Merck clinical trial had confirmed the drug could cause strokes and heart attacks.

Gilmartin said in an interview in Boston that he first learned of definitive evidence of Vioxx's dangerous side effects in a telephone call from Merck's president of research, Peter S. Kim. In that call, Kim reported to Gilmartin that a clinical trial oversight committee had recommended halting a study of Vioxx as a treatment for colon cancer because the risk to patients was too high.

"It was totally out of the blue," Gilmartin said. "I was stunned. This was totally unexpected." A month earlier, Merck had defended the safety of Vioxx after a separate study suggested it could harm patients.

By Sept. 27, four days after Kim's phone call, Gilmartin had agreed to pull the $2.5 billion-a-year arthritis pain drug off the market. Merck disclosed the decision Sept. 30, triggering a 25 percent drop in the market value of the company and a flood of lawsuits.

The news also has caused some researchers to question the safety of the entire class of anti-inflammatory drugs known as Cox-2 inhibitors, which includes Pfizer Inc.'s Celebrex and Bextra. Pfizer has said there are no indications of heart risk with its drugs.

Gilmartin discussed Vioxx with the Globe at the opening of Merck's research facility in Boston yesterday. After a dedication ceremony for the lab complex, Gilmartin hosted a private lunch for members of Boston's biotech community. His message: The world's third-largest drug company will continue to boost research budgets and is ready to strike licensing deals with biotech companies and academic researchers.

Despite the company's efforts to move forward, however, it was a "bittersweet day," in the words of the new building's namesake, former Merck research president Dr. Edward M. Scolnick, who oversaw Vioxx development and approval in the 1990s.

"It's a sad time, mostly for patients, many of whom had their lives transformed by Vioxx," Scolnick said.

The potential for elevated cardiovascular risk for Vioxx was first reported in a medical journal in 1999, the same year the medication was approved by the US Food and Drug Administration to treat arthritis pain. A clinical study sponsored by the company in 2000 also indicated a higher degree of risk for cardiovascular complications, which prompted the company to insert a relatively mild caution into its label in 2002.

But the company and the FDA insisted that the indications of risk were small and inconclusive. Merck continued to aggressively market its drug directly to consumers through television and magazine advertising campaigns.

In August, in research sponsored by the large health insurance company Kaiser Permanente, an FDA researcher, and other scientists reported that a review of medical records showed Vioxx could be responsible for as many as 27,000 heart attacks. The Times of London, quoting one of that study's authors, reported this week that the drug may have been responsible for 7,000 deaths.

In the interview yesterday, Gilmartin dismissed that study's findings because it was based on a review of medical records, not a clinical trial. "You can't take a study like this and take a patient population and extrapolate those kinds of numbers," he said. "It's just not valid to do that."

Christopher Rowland can be reached at crowland@globe.com.

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