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The U.S. drug safety officer who warned months ago about the risks from Merck'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 stated.
Dr. David Graham is resubmitting the research to The Lancet medical journal after supervisors at the Food and Drug Administration (FDA) granted permission to do so.
Graham, associate director for science in the FDA's Office of Drug Safety, had withdrawn an earlier version of the study after agency officials complained he had not received proper clearance, said Thomas Devine, legal director for a whistle-blower protection group called the Government Accountability Project.
Graham provided his estimates of 28,000 Americans harmed by Vioxx® at a Senate hearing in November of last year.
He states he used data from Merck studies of heart attack and stroke risk and applied them to the number of Vioxx® users over five years. Now he calculates the drug may have caused between 88,000 and 139,000 excess cases of heart attack and stroke.
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