Merck & Co. forced one of its researchers to remove her name from a study linking Vioxx to heart attacks, then criticized the findings before ultimately pulling the arthritis drug from the market last fall, two of the scientist’s colleagues say.
“Even after funding and agreeing with the design of the study, Merck publicly discredited our findings,” Drs. Daniel Solomon and Jerry Avorn of Boston’s Brigham and Women’s Hospital wrote in this week’s Archives of Internal Medicine.
Merck spokeswoman Anita Larsen confirmed the company’s action, saying Merck believed the study’s conclusions “were not supported by the data.” The incident came a year before another study prompted the drug maker to withdraw Vioxx.
The journal contains several studies about Vioxx and Celebrex, the once popular and heavily promoted painkillers advertised as stomach-friendly alternatives to aspirin. They are under congressional and regulatory scrutiny.
Vioxx was withdrawn Sept. 30 because of a study suggesting it doubled the risk of heart attack and stroke. Celebrex maker Pfizer Inc. halted ads last month after a study linked high doses with increased heart and stroke risks.
Both drugs are in a class called Cox-2 inhibitors. The Archives reports, published Monday, precede a Feb. 16-18 Food and Drug Administration meeting on the safety of all Cox-2 drugs.
Also Monday, the watchdog group Public Citizen petitioned the FDA to immediately remove Celebrex and a related drug, Bextra, from the market because of the potential heart risks.
Meanwhile, the British medical journal Lancet is releasing a study on the heart dangers of Vioxx after withholding the report because the researcher said he had been threatened by his superiors at the FDA. The study links Vioxx to between 88,000 and 140,000 excess cases of heart disease in the United States a conclusion that has previously been disclosed.
Dr. David Graham, who works in the FDA’s office of drug safety, contended he was threatened with dismissal and said he asked the Lancet to withdraw the paper in November. Earlier this month, the FDA agreed the study could be published.