VIOXX REPORT CLEARS MERCK OF IGNORING RISKS, BUT SLAMS "POOR JUDGMENT"
Authors of a new report say it exonerates Merck from allegations that the company knowingly kept its painkiller Vioxx on the market despite underlying cardiovascular risks, but investigators also condemn Merck's "poor judgment and errors," including public statements that downplayed the health hazards.
Merck pulled the drug from the market roughly two years ago after preliminary clinical trial results found an increased risk of heart attack and stroke in patients taking the treatment.
"Critics contend that senior officials at Merck knowingly put patients at risk of cardiovascular risks rather than jeopardize the profits that Merck generated from the sale of Vioxx. After an exhaustive investigation, we have concluded that there is no basis for such a claim," John Martin and colleagues from law firm Debevoise & Plimpton wrote in their report, which Merck released along with related documents Sept. 6. Merck paid the firm $21 million to conduct the 20-month investigation.
Martin is a former judge for the U.S. District Court for the Southern District of New York and a former U.S. attorney for the Southern District of New York.
However, the report also chides Merck for putting out press releases and promotional materials -- which sales representatives used to sell the drug to doctors -- that did not provide enough context or were not clear enough about the cardiovascular safety of Vioxx (rofecoxib). The report also says that a member of Merck's marketing department compiled a list of "36 Physicians to Neutralize," and a chart that included "comments regarding the means by which the physician might be converted to an advocate," including "show me the money," and "offer medical school grant."
Report authors said while they do not excuse these practices, they "found no evidence that anyone in senior management encouraged or condoned them."
Investigators, in a statement, said they examined Merck's conduct regarding Vioxx in four areas: Merck's alleged knowledge of cardiovascular risks before FDA approval; Merck's scientific response to cardiovascular data from a trial known as the VIGOR trial; Merck's analysis and reporting of cardiovascular data from a later trial, known as the APPROVe trial; and Merck's marketing of Vioxx.