Key Vioxx Research Was Written by Merck, Documents Allege
Tuesday, April 15, 2008; 12:00 AM
TUESDAY, April 15 (HealthDay News) -- Industry documents reveal that pharmaceutical giant Merck & Co. paid academics to put their names on Vioxx research published in top medical journals while company employees often ghost-wrote the studies on the controversial cox-2 painkiller.
The company apparently also exaggerated the safety of the medication in published clinical trials, and the academics frequently did not disclose industry financial support, the documents allege.
Two articles detailing these findings, the latest episode in the Byzantine tangle surrounding the former best-selling pain reliever, appear in the April 16 issue of theJournal of the American Medical Association.
The scope of the analysis was significant. The researchers combed through 250 documents that included 24 clinical trials, 72 review articles and numerous editorials to come to their conclusions. The Vioxx articles appeared in more than a dozen medical journals, including theNew England Journal of MedicineandJAMA.
"These are extraordinary manuscripts, and they reveal the inner workings of the promotion of a drug that ultimately turned out to be a hazard," said Dr. Steven Nissen, chairman of cardiovascular medicine at the Cleveland Clinic.
Nissen, who first warned that Vioxx caused heart problems in 2001, was not involved in either paper but said that he agreed with an editorial in the same issue of the journal that "the only people that need to change to stop this are physicians."
Vioxx was pulled from the market in 2004, after a study showed the drug increased users' risks of heart attack and stroke. And last November, Merck agreed to pay $4.85 billion to settle 27,000 lawsuits from plaintiffs who said they or family members were injured or died after taking Vioxx.
Since the findings of both new studies derive largely from documents associated with the litigation surrounding Vioxx, Merck representatives disputed the assertions.
"These allegations are not true. They're not new. A lot of these allegations showed up in litigation years ago, and our evidence successfully rebutted them," said Kent Jarrell, spokesman for Vioxx litigation on behalf of Merck. "This is an example of courtroom antics masquerading as scientific debate."
"We disagree with both articles," added Jim Fitzpatrick, an attorney with Hughes Hubbard & Reed, outside counsel for Merck. "We think the record of disclosure and transparency is really excellent."
Since Vioxx was removed from the market, there have been numerous allegations that Merck withheld and manipulated safety and efficacy data.
The authors of the firstJAMAstudy, who scoured litigation documents as well as the existing medical literature, say the issue is not really about Merck or about the physicians discussed in the paper, but a much larger and more troubling issue.