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Vioxx, FDA Researcher E-Mails Suggest Merck May Have Known Of Vioxx's Risks
Did Merck officials know about the heart risks posed by its now-defunct painkilling drug Vioxx as far back as five years ago
The New York Times reported Sunday that in 2000, Merck overruled one of its own scientists after he suggested that a 73-year-old female patient in a Vioxx clinical trial had probably died of a heart attack.
In an e-mail exchange concerning Vioxx, a top Merck scientist repeatedly encouraged the researcher to change his views about the death "so that we don't raise concerns." In later reports to the U.S. Food and Drug Administration and in a paper published in 2003, the company labeled the cause of death as "unknown," the newspaper said.
The discussion of the woman's death appears in several previously undisclosed Merck records, including e-mails from Dr. Edward M. Scolnick, Merck's senior scientist from 1985 to 2002, and Dr. Alise S. Reicin, a vice president for clinical research. The messages point to Merck's concerns about data contradicting its view that Vioxx was safe, the Times said.
When Vioxx was pulled from the market last September, Merck officials said they had only recently learned that the drug posed a risk of heart attack and stroke. At least 4,600 people or their survivors are suing the drug company, saying Vioxx -- a member of a class of drugs called cox-2 inhibitors -- caused their heart attacks or strokes. The e-mails and other internal Merck documents, including the report of the woman's death, were given to the Times by an unnamed source working with plaintiffs, the newspaper said.
A lawyer for Merck told the Times that the company had disclosed all information from clinical trials about Vioxx to the FDA. And Scolnick's e-mails "merely reflected his concern that the FDA weigh Vioxx's benefits and risks fairly. The e-mail discussion between the Merck scientists reflected an honest scientific debate over the cause of the woman's death," the newspaper reported, paraphrasing the lawyer.
Earlier this month, another cox-2 drug, Bextra, was withdrawn from the market for the same cardiovascular concerns. A third cox-2, Celebrex, remains available to U.S. consumers, but the FDA has mandated that it carry a strong "black box" warning label indicating the potential for long-term heart risks.
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