Studies add to data that tarnished arthritis drugs
CHICAGO (AP) – 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 drugmaker to withdraw Vioxx.
The journal contains several studies about Vioxx and Celebrex, the once popular and heavily promoted painkillers. They are under congressional and regulatory scrutiny.
One new report echoes previous data suggesting that in some older patients the drugs might not offer as much protection as thought against gastrointestinal problems. A separate study suggests they have been over-prescribed, frequently to patients at low risk for GI problems. And other research supports evidence that Vioxx increases some patients’ blood pressure.
Vioxx was withdrawn Sept. 30 because of a study suggesting it doubled the risk of heart attack and stroke. Celebrex maker Pfizer Inc. halted its 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 come just weeks before a Feb. 16-18 Food and Drug Administration meeting on the safety of all Cox-2 drugs. Also Monday, Public Citizen petitioned the FDA to immediately remove from the market Celebrex and a related drug, Bextra, because of the potential heart risks.
Critics say Merck attempted to suppress Vioxx risks found in studies. The company maintains it has acted responsibly.
The author-removal incident, mentioned in previous news reports, involved a Merck study patients taking Vioxx, Celebrex, other painkillers or none of the drugs. The results, published last year in the journal Circulation, showed Vioxx patients faced a higher heart attack risk than the others.