Merck chief quits as further material on Vioxx emerges

Merck chief quits as further material on Vioxx emerges

Sydney

Ray Moynihan

The chief executive officer and chairman of Merck, Raymond Gilmartin, resigned unexpectedly last week, the same day a damning US Congress report on the company was released.

Even though Mr Gilmartin stepped down hurriedly a year ahead of schedule, Merck’s official position is that the resignation was not connected to the growing global controversy over its anti-arthritis drug rofecoxib (Vioxx), which was withdrawn from the market late last year after studies produced evidence linking it to heart problems (BMJ 2004;329:816).

He will be replaced by the company’s current head of manufacturing, Richard Clark. “Dick is a great choice to become the next CEO [chief executive officer],” said Mr Gilmartin, in Merck’s prepared statement about his resignation. “He has successfully led many of the company’s most important strategic initiatives.”

At the same time as Mr Gilmartin was resigning, a leading Democrat member of the US Congress’s Government Reform Committee was releasing a scathing critique of the strategies Merck had used to market rofecoxib. In response to a request from the committee the company released more than 20 000 pages of internal documents and promotional memos, including course curriculums, training manuals, and talking points for its sales force (http://democrats.reform.house.gov/story.asp?ID=848)

“Based on a review of the Merck documents,” wrote the high profile Congressional representative Henry Waxman, “it appears that Merck sent over 3000 highly trained representatives into doctor’s offices and hospitals armed with misleading information about Vioxx’s health risks.”

According to Mr Waxman’s analysis, the Merck documents show that the company’s sales force was urged to persuade doctors that rofecoxib was much safer than other anti-inflammatory drugs, at a time when scientific studies were indicating the contrary. Drug representatives were apparently prohibited from discussing studies with contrary findings.

Mr Waxman details how the company carefully schooled its sales force on how to respond to the publication of negative scientific and media articles and on how to react to an important meeting of an arthritis advisory committee of the Food and Drug Administration. In one case a Merck bulletin had this advice for its sales force: “Do not initiate discussions on the FDA arthritis committee … or the results of the … VIGOR study.” This study, published in 2000, found that patients taking rofecoxib had a higher risk of myocardial infarction than patients taking another anti-arthritis drug, naproxen (New England Journal of Medicine 2000;343:1520-8).

“After each of these developments, Merck sent bulletins or special messages to its sales force, directing them to use highly questionable information to assuage any physicians’ concerns,” says Mr Waxman.

The Washington Post reports Dennis Erb, Merck’s vice president for global regulatory development, as saying the company’s actions were timely and appropriate and that staff were trained to be “accurate and balanced” in presenting information. “We believe Merck acted appropriately and responsibly,” he said (“Merck CEO resigns as drug probe continues,” 6 May 2005, www.washingtonpost.com).

Like other leading global drug companies, Merck is facing a challenging time politically, particularly in the United States. Recent figures from an investigation by the Center for Public Integrity, which is based in Washington, DC, indicate that the industry has spent almost $760m (£400m; €590m) on lobbying the US Congress over the past seven years.

Although the Bush administration is seen as extremely sympathetic to the industry, members of Congressional committees and other groups are increasingly strident in their criticisms of companies over rising drug prices, inappropriate influence over doctors, and an unhealthy closeness to the regulator, the FDA.

Mr Waxman’s analysis of the internal Merck documents notes that his committee did not receive documents from Pfizer, the manufacturer of another anti-inflammatory drug celecoxib (Celebrex), or from other competitor drug companies.