Press Articles

The Associated Press, "Merck in hot seat over latest Vioxx report; Scientists say company tried to distance itself from own study"

          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 said.
          "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 about six months 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 advertised as stomach-friendly alternatives to aspirin. 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          Vioxx was withdrawn Sept. 30, 2004 because of a study suggesting it doubled the risk of heart attack and stroke.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.

San Francisco Chronicle, "Studies confirm arthritis drugs raise heart attack risk"

          Two studies released Monday have turned up new evidence that all of the popular arthritis painkillers known as COX-2 inhibitors may put users at greater risk of heart attacks and strokes. COX-2 inhibitors, which are promoted as being less likely to cause gastrointestinal bleeding than other widely used painkillers, were aggressively advertised after they came on the market in the late 1990s.
          The first of the two papers published online by the journal Circulation found that patients who had had heart bypass surgery and were taking Pfizer Inc.'s Bextra, in combination with an experimental medication, were three times more likely to have strokes and heart attacks than patients taking a placebo. The statistically significant tripling of the risk showed up when researchers combined the results of two earlier studies involving more than 2, 000 people in a statistical technique called a meta-analysis. A second study found that when mice that are genetically prone to hardening of the arteries were treated with a COX-2 drug and an aspirin substitute, their condition worsened rather than improving, as researchers had anticipated.
          The latest bad news for makers and users of COX-2 drugs comes a month before the Food and Drug Administration is scheduled to hold an unusual three- day hearing Feb. 16-18 of two advisory panels to consider safety issues that have arisen around the class of drugs. Planning for the meeting began in the fall after Merck & Co. took its blockbuster COX-2 drug Vioxx off the market after a study it sponsored found heightened cardiovascular risk in volunteers taking the drug.

Red Nova News, "Studies Evaluate Effects of COX Enzymes"

          Two University of Pennsylvania studies published Monday show how cyclooxygenases or COX enzymes affect patients' risk of cardiovascular events.
          COX-2 drugs -- Celebrex, Bextra and Vioxx -- have been linked to increased risk of heart attack and stroke.
          An analysis of two clinical trials that alerted scientists to problems with Bextra last November found the Pfizer medication elevated the risk of heart attack and stroke three-fold in coronary artery bypass graft surgery patients.
          The research is published in the journal Circulation.

Reuters, "Researcher says 139,000 harmed by Vioxx"

          The U.S. drug safety officer who warned months ago about risks from Merck & Co. Inc.'s painkiller Vioxx won clearance to publish a study arguing the now-recalled drug may have caused up to 139,000 heart attacks and strokes, his attorney said Monday.
          Dr. David Graham is resubmitting the research to the Lancet medical journal after supervisors at the Food and Drug Administration granted permission, his attorney, Thomas Devine, said.
          Graham, associate director for science in the FDA's Office of Drug Safety, had withdrawn an earlier version of the study after agency officials complained he had not received proper clearance, said Devine, legal director for a whistle-blower protection group called the Government Accountability Project.
          Graham provided his estimates of harm from Vioxx at a Senate hearing in November. He said he used data from Merck studies of heart attack and stroke risk and applied them to the number of Vioxx users over five years. He calculated the drug may have caused between 88,000 and 139,000 excess cases of heart attack and stroke.
          Merck pulled Vioxx from the market on Sept. 30 after a study showed the drug increased heart attack and stroke risk in patients who took the drug for at least 18 months to try and prevent colon cancer. The company is facing liability lawsuits from patients and families alleging harm from the drug.