Up To 140,000 Serious Vioxx Cases Found by Controversial Graham Study

Merck's arthritis pain drug Vioxx might have caused as many as 140,000 cases of serious coronary heart disease in the U.S. since its launch in 1999, according to a study published by the British medical journal The Lancet.

The controversial study, which was led by FDA scientist David Graham, was the major impetus for the debate that has raged since last fall over the safety of Vioxx (rofecoxib) and other Cox-2 inhibitors. Vioxx was voluntarily recalled by Merck in late September 2004, in part because of the Graham's findings.

Graham, associate director of science for the FDA's Office of Drug Safety, first unveiled an abstract of the study at a scientific meeting in France last August, but the presentation included revised conclusions and recommendations. Graham said he was forced to revise his findings after the study came under heavy fire from the FDA's top officials, who, according to Graham, ordered him to change the conclusions before making the presentation. Graham later testified about his findings before the Senate Finance Committee and blasted the FDA for operating an ineffective drug safety program.

The Lancet was supposed to publish the study late last year, but Graham elected to withdraw the paper after he could not attain clear approval from the FDA allowing him to publish it. However, he ultimately decided to publish the study without the FDA's blessing, and his complete findings were scheduled to be published by The Lancet Jan. 25.