Merck & Co. withdrew Vioxx from the market in September 2004 after study results showed the painkiller doubled patients' risk of heart attack and stroke. But could Merck have uncovered Vioxx's ill effects earlier? The answer, according to previously undisclosed Merck documents, is "yes."
Merck executives have long insisted that they never pursued a clinical trial to directly study the heart risks of Vioxx because other tests they were conducting would supply answers just as quickly. Company documents show that Merck was poised to begin a major cardiovascular study of Vioxx in 2002, but dropped the project just days before researchers planned to submit the study protocol to the Food and Drug Administration. The trial may have provided answers about Vioxx's heart risks to save the lives of thousands of people estimated to have suffered a heart attack or stroke resulting from Vioxx use.