In 2000, amid rising concerns that its painkiller Vioxx posed heart risks, Merck overruled one of its scientists after he suggested that a patient in a clinical trial had probably died of a heart attack.
In an e-mail exchange about Vioxx, the company's most important new drug at the time, a senior Merck scientist repeatedly encouraged the researcher to change his views about the death "so that we don't raise concerns." In subsequent reports to the Food and Drug Administration and in a paper published in 2003, Merck designated the cause of death as "unknown" for the patient, a 73-year-old woman.
The discussion of the woman's death is contained in several previously undisclosed Merck records, including e-mail messages from Dr. Edward M. Scolnick, Merck's top scientist from 1985 until 2002, and from Dr. Alise S. Reicin, a vice president for clinical research, that indicates Merck's concerns about data contradicting its view that Vioxx was safe.
In one e-mail message, Scolnick said the drug trial that included the woman's death had "put us in a terrible situation." In others, Scolnick fiercely criticized the Food and Drug Administration and said that he would personally pressure senior officials at the agency if it took action unfavorable to Vioxx. As lawsuits against Merck over Vioxx move toward trial, the documents could help plaintiffs paint a picture of the company that is at odds with Merck's public statements that it had no evidence of Vioxx's cardiac risks until last fall.
Theodore V.H. Mayer, a lawyer for Merck, said that the company had disclosed all information from clinical trials to the FDA, and that Scolnick's e-mail messages 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, Mayer said.
Merck withdrew Vioxx in September after a different clinical trial found the drug increased the risk of heart problems. More than 25 million Americans took Vioxx between 1999 and 2004, and at least 4,600 people or their survivors are suing the company, claiming Vioxx caused their heart attacks or strokes. The first individual cases are scheduled for trial next month in Alabama and Texas, filed by the survivors of two men who the suits say died of heart attacks after taking the drug.
