ABSTRACT

The drugs were approved based on small, short-term trials that didn’t look for cardiovascular harms, in patients with a low risk for such events, although nearly half of real world patients with arthritis have coexisting cardiovascular disease. Like George Merck, the Food and Drug Administration’ (FDA) failed badly in its duty towards the patients. Merck also misled the readers by publishing a fake journal, the Australasian Journal of Bone and Joint Medicine, which looked like a peer-reviewed medical journal but was a marketing tool. Merck pleaded guilty in 2012 to a criminal violation of federal law related to its promotion and marketing of Vioxx and was to pay nearly a billion dollars in a criminal fine and civil damages. Merck spokespeople lied to the FDA and Congress about what and when the company knew that Vioxx is deadly. In May 2001, Merck produced the press release ‘Merck reconfirms favorable cardiovascular safety of Vioxx’.