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Graham, associate director for science in the FDA’s Office of Drug Safety, had withdrawn an earlier version of the study after agency officials complained he had not received proper clearance, said Devine, legal director for a whistle-blower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 spokeswoman Anita Larsen said the company would not comment on Graham’s study because officials had not seen it.
But based on similar past statements by Graham, Merck believes “one cannot simply extrapolate data like that” to come up with an estimate of harm from the drug, Larsen said. Because heart attack and stroke are relatively common in the general population, it is difficult to determine how many cases may have been linked to Vioxx, she said.
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.
An FDA spokeswoman could not immediately be reached for comment on Monday.