4/17/2008 - Merck is denouncing two articles in the current issue of the Journal of the American Medical Association (JAMA) that conclude the company withheld mortality data on its painkiller Vioxx before its approval and that Merck employees guest-authored and ghostwrote medical literature for the drug.
Both articles use documents that emerged during litigation over Vioxx (rofecoxib), which Merck voluntarily withdrew from the market in September 2004.
“Articles related to rofecoxib were frequently authored by Merck employees but attributed first authorship to external, academically affiliated investigators who did not always disclose financial support from Merck, although financial support of the study was nearly always provided,” the first JAMA article says. “Similarly, review articles related to rofecoxib were frequently prepared by unacknowledged authors employed by medical publishing companies and attributed authorship to investigators who often did not disclose financial support from Merck.”
The authors report finding documents describing Merck paying investigators honoraria of $750–$2,500 “for agreeing to serve as authors on review manuscripts ghostwritten on their behalf by medical publishing companies.”
Peter Kim, president of Merck Research Laboratories, responded, “We have explicit policies governing the authorship of papers related to Merck’s medicines and vaccines, and we take those policies very seriously. The outside authors of the papers about Merck’s clinical trials referenced in the JAMA article were intimately involved in the studies.”
Internal company analyses did not jibe with the reassuring safety conclusions in two journal articles about two separate clinical trials of the drug’s effects on the occurrence or progression of Alzheimer’s disease, according to the other JAMA article. In April 2001, the company’s internal intention-to-treat analyses of pooled data from the trials “identified a significant increase in total mortality … with overall mortality of 34 deaths among 1,069 rofecoxib patients and 12 deaths among 1,078 placebo patients. … These mortality analyses were neither provided to the FDA nor made public in a timely fashion,” the second article says.