Reports Raise Questions Over Merck Actions in Studies About Vioxx
Merck employees or paid consultants, rather than the physicians listed as lead authors, wrote several published studies of the COX-2 inhibitor Vioxx, and the company downplayed evidence that the medication tripled risk for death in patients with Alzheimer's disease, according to two reports published on Wednesday in the Journal of the American Medical Association, USA Today reports.
Merck in 2004 voluntarily withdrew Vioxx from the market because of a link between the medication and increased risk for cardiovascular events (Sternberg, USA Today, 4/16).
According to the Wall Street Journal, the reports "provide an unusual inside look at how pharmaceutical companies can use academic collaborators and medical journals as important tools to market their drugs" and "fuel a growing debate over drug companies' conduct in controlling and reporting results of clinical trials" (Winslow/Johnson, Wall Street Journal, 4/16).
For the first report, lead author Joseph Ross of Mount Sinai School of Medicine and colleagues examined 250 court records and found that 16 of 20 early studies of Vioxx listed the lead author as an academic researcher, although internal documents listed a Merck employee as the author of the first draft.
The report also found that Merck hired companies to write 72 scientific review articles and paid physicians between $750 and $2,500 to publish the articles in their own names. Fifty of the 72 article studies listed only an academic researcher as author, and only half disclosed the financial relationship between Merck and the author, according to the report (Dembner, Boston Globe, 4/16).
In addition, the report found "scant evidence that the recruited authors made substantive contributions" to the studies and articles, the New York Times reports (Saul, New York Times, 4/16).
The second report -- compiled by Bruce Psaty and Richard Kronmal, both of the University of Washington -- found that Merck attempted to minimize the deaths of participants in two studies designed to determine whether Vioxx could reduce the symptoms or treat Alzheimer's (Cohen, Newark Star-Ledger, 4/16).
A report Merck filed with FDA in July 2001 said that 29 of 1,000 Alzheimer's patients who took Vioxx died, compared with 17 who took a placebo, but an internal document dated three months earlier said that 34 of 1,000 Alzheimer's patients who took Vioxx died, compared with 12 who took a placebo, the report found.
According to the report, the difference in the report filed with FDA resulted because Merck reported only the deaths that occurred when patients took Vioxx and as long as two weeks later, compared with three months later for those who took a placebo (Brown, Washington Post, 4/16).
In an accompanying editorial, JAMA editors wrote that the results indicate a need for "drastic actions." According to the editorial, although all the involved researchers, regulators and journal editors are responsible, physicians who lend their names to studies and scientific articles are "unprofessional and demeaning to the medical profession" (Song, Seattle Times, 4/16).
JAMA Editor-in-Chief Catherine DeAngelis said that independent investigators should collect and analyze studies funded by the pharmaceutical industry. In addition, DeAngelis "lambasted medical ghostwriters," the Philadelphia Inquirer reports. She said, "We've given up the profession, and we've got to get it back" (Stark, Philadelphia Inquirer, 4/16).
Jim Fitzpatrick, an outside attorney that represents Merck, said that, although the company in some cases pays consultants to "facilitate the publication" of studies and scientific articles, the academic researchers "were involved with the drafting and review of the papers that bear their name." He added that Merck in 2003 adopted guidelines to make the financial relationships between the company and study authors more transparent (Wall Street Journal, 4/16).
In addition, Merck disputed the report related to the risk of death for Alzheimer's patients who took Vioxx. "These are allegations that have been made and rebutted in the litigation," Fitzpatrick said. Fitzpatrick and Merck spokesperson Kent Jarrell added that Merck later submitted to FDA the revised data on mortality rates for Alzheimer's patients who took Vioxx.
However, Psaty said that Merck submitted the revised data in multiple, qualified reports that concealed the overall mortality rates (Paulson, Seattle Post-Intelligencer, 4/15).
PBS' "NewsHour with Jim Lehrer" on Tuesday included a discussion with NewsHour health correspondent Susan Dentzer about the reports (Lehrer, "NewsHour with Jim Lehrer," PBS, 4/15).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.