Merck Officials Reportedly Ignored Conclusion About Death in Vioxx Trial
Merck officials in 2000 ignored the conclusion of a senior scientist that the COX-2 inhibitor Vioxx -- which the company withdrew from the market last September over safety concerns -- had probably caused the death of a patient in a clinical trial, the New York Times reports. According to several e-mail messages related to Vioxx, Alise Reicin, a vice president for clinical research at Merck, repeatedly asked Edward Scolnick, senior scientist at the company from 1985 until 2002, to revise his position about the death "so that we don't raise concerns."
Merck cited the cause of death of the patient, a 73-year-old woman, as "unknown" in later reports to FDA and in a paper published in 2003. In one e-mail message, Scolnick wrote that the trial -- called Advantage -- had "put us in a terrible situation." In e-mail messages sent on April 7, 2001, to Douglas Greene, an executive vice president at Merck Research Laboratories, Scolnick raised concerns that the Advantage trial had no scientific purpose. The Merck marketing department had developed the Advantage trial as a promotional tool to introduce about 600 physicians to Vioxx, according to the Times.
"This course is just stupid," Scolnick wrote, adding, "Small marketing studies which are intellectually redundant are extremely dangerous." Jeffrey Lisse, a rheumatologist at the University of Arizona who led the Advantage trial, reported in the 2003 paper that five patients who took Vioxx had experienced heart attacks during the trial, compared with one who took naproxen, a difference with no statistical significance. However, the paper did not mention the cardiac deaths of the 73-year-old woman and two other trial participants, the Times reports.
Theodore Mayer, an attorney for Merck, said that the company had disclosed all data from trials of Vioxx to FDA and that the e-mail messages from Scolnick only indicated his concern over agency evaluation of the risks and benefits of the medication. The e-mail messages between Scolnick and Merck officials also represented legitimate scientific debate over the cause of the death of the 73-year-old woman, Mayer said.
However, Robert Myerburg, director of cardiology at the University of Miami Medical School who reviewed the e-mail messages at the request of the Times, said, "A fatal event not being treated as objectively as possible surprises me," adding, "It looks like they're playing around with this death."
According to the Times, as a number of lawsuits related to Vioxx proceed to trial, the e-mail messages "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" (Berenson, New York Times, 4/23).
Merck CEO Raymond Gilmartin on Friday said that the company has entered discussions with FDA about the possible return of Vioxx to the market, Bloomberg/Richmond Times-Dispatch reports. The return of Vioxx could help Merck "more in fighting personal injury lawsuits than by lifting profit," according to Bloomberg/Times-Dispatch.
FDA officials announced this month that the agency "will carefully review any proposal from Merck" to return Vioxx to the market. "It's too early to tell, frankly," whether Vioxx will return to the market, Gilmartin said, adding, "We'll be supplying additional information to (the FDA) and, as they announced, they will have an advisory panel" to address the issue (Bloomberg/Richmond Times-Dispatch, 4/23).