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Company-commissioned report exonerates senior managers, points fingers at sales team
Merck's upper management was innocent of any wrongdoing that led to the withdrawal of Vioxx, a $21 million report paid for by the company has found.
Merck researchers misattributed the reasons for Vioxx's (rofecoxib) cardiovascular side effects, but they never set out to conceal the risks of taking the drug, the 20-month investigation by Judge John S. Martin Jr., a former US District Judge for the Southern District of New York, and his colleagues at law firm Debevoise & Plimpton asserts.
Criticized in the press as a self-serving rebuttal to charges leveled by plaintiffs' lawyers and journalists, the so-called "Martin Report" holds that the aggressive--and perhaps unscrupulous--marketing tactics the company began to use even before the drug was approved came from inside the sales team, and not from senior management.
By blaming the sales team, the report absolves Merck's leadership of flagrant wrongdoing. The report also praises the company's new set of checks and balances on sales and marketing activities.
Merck had a responsibility to pay for the report, noted William Bowen, former president of the Andrew W. Mellon Foundation and a member of Merck's board of directors. Bowen chaired a special committee that organized the review. "The company had no effect at all on the findings and the conclusions," he said, noting that he has previously worked with Martin on another corporate investigation that produced unfavorable findings.
The report lists some of the sales and marketing tactics proposed to win over physicians who were considered anti-Vioxx. In the pre-approval period, the company sought to create physician advocates by holding advisory board meetings, giving grants to medical schools and medical education programs, starting a speakers' bureau, and hiring investigators for post-marketing studies. The focus of these activities was marketing-oriented, rather than educational, according to the report.
"While we do not condone such practices, we found no evidence that anyone in senior management encouraged or condoned them," the report said. "Nor did we review evidence that the sales representatives' recommendations for developing the physician into an advocate were followed."
The Martin investigation also scrutinized the now-infamous VIGOR trial, which studied the gastrointestinal effects of Vioxx by comparing the COX-2 inhibitor with non-steroidal anti-inflammatory drug (NSAID) naproxen. Merck scientists, the report found, attributed the greater number of cardiovascular events in the Vioxx arm to the cardio-protective effects of naproxen, which acts as an anticoagulant similar to aspirin. Vioxx, the scientists concluded, was cardio-neutral.
The VIGOR trial did not include a placebo arm, and Merck researchers decided that conducting such a Vioxx versus placebo trial would be unethical.
Merck disclosed the VIGOR findings to FDA, and after a back-and-forth, the agency agreed with the company that the cardiovascular data belonged in the "precautions" section, rather than under "warnings."
The report doesn't include anything that juries haven't already heard, noted Kent Jarrell, a spokesman for Merck's outside counsel. "We don't think it should impact the litigation because there?s nothing factually new," he said.
The next step is to have CEO Richard Clark read through the 183-page report and its 1,400 pages of appendices to see what lessons Merck can learn from it, Bowen said.
"We had an obligation to find out as much as we could about the development and marketing of Vioxx," Bowen said. "We want to be satisfied above all that no one had foolishly and recklessly put patients at risk. The findings gave us considerable reassurance."
The report could inspire changes in activities ranging from communications to sales, and might also aid Merck?s defense in the court of public opinion. "We do hope-because there?s been a lot of unfair criticism--that the report will help," Bowen said.