Vioxx off-label marketing activities are going to cost Merck & Co. a whopping $321 million in criminal fines. The U.S. Food & Drug Administration (FDA) approved Vioxx (rofecoxib), a painkiller, for three indications in May 1999.
Merck has pleaded guilty in recent months for illegally promoting Vioxx for the treatment of rheumatoid arthritis (RA) prior to its approval for that use in 2002, said Reuters. As we’ve previously explained, Merck promoted Vioxx from 1999 to 2002 for the treatment of RA; however, Vioxx had no indication for that disorder during that time. Merck was admonished for this conduct in a September 2001 FDA warning letter, said the U.S. Justice Department (DOJ) previously.
The DOJ stated that this settlement concerned allegations concerning Merck’s misleading statements about Vioxx’s heart safety in order to increase the drug’s sales and that Merck promoted the drug for RA before the drug was approved for that purpose, said Reuters.
Reuters noted that a related civil settlement was reached in November in which Merck agreed to pay more than $600 million to the federal government, 43 states, and the District of Columbia for a broader array of alleged improprieties. Merck did not acknowledge any wrongdoing in that matter, said Reuters.
Vioxx was approved for use in 1999, quickly becoming a bestseller for Merck, with annual sales of $2.5 billion; however, the painkiller was pulled off the market in 2004 after an analysis of patients using Vioxx linked the defective drug to more than 27,000 heart attacks or sudden cardiac deaths in the U.S. from 1999 through 2003. The withdrawal prompted thousands of product liability lawsuits that claimed Merck did not properly warn doctors and patients of the drug’s risks. During the five years it was available, researchers believe Vioxx caused some 40,000 deaths.
For instance, a study that appeared in the Archives of Internal Medicine, based on data Merck provided during legal action against it, revealed that patients taking Vioxx experienced a two-fold likelihood of developing blood clots or dying in the first six months after treatment was discontinued, confirming a prior study that pointed to Vioxx’s negative effects being seen up to one year following discontinuation. Another study found that evidence of cardiovascular risks linked to Vioxx might have been realized nearly four years before Merck pulled Vioxx.
Since its withdrawal, revelations about the way in which Merck marketed Vioxx have raised serious questions about Merck’s conduct including, for instance, a prior Australian Vioxx trial that revealed that Merck paid nurses to look through medical records for potential Vioxx patients without physician permission in the hopes of garnering 100 patients per doctor. Merck also apparently put on a year-end skit in which sales reps mocked the Journal of the American Medical Association, which published an article discussing Vioxx and issues with its cardiovascular side effects.
One of the most shocking tactics used by Merck was a push in Australia involving a fake medical journal, published by Elsevier, offering it like other peer-reviewed medical journals and with articles reprinted or summarized presenting Merck products, including Vioxx, favorably.