Merck & Co used its salesforces to counter growing concern over health risks associated with its multi-billion dollar drug Vioxx (rofecoxib), according to documents released by the US Committee on Government Reform last week.
Despite earlier suggestions of cardiovascular risk, it was not until the end of last year that Merck was finally forced to pull Vioxx from the market, after a trial showed a doubling in heart attack and stroke amongst patients who took the drug for more than 18 months [[01/10/04a]]. Before its fall from grace, Vioxx reeled in an impressive $2.5 billion dollars for the full-year 2003, but the company has since faced a barrage of lawsuits and nose-diving financial results [[25/04/05a]].
And the situation could get a lot worse. The Committee reviewed more than 20,000 documents obtained from Merck, which showed it trained its fieldforces to provide “highly questionable information” to doctors regarding Vioxx and “pursued aggressive marketing strategies” to overcome the cardiovascular “obstacle.”
The first indication that all may not be well with Vioxx came from a study dubbed VIGOR in 2000, which found patients on the Merck drug had a five times greater risk of heart attack than those given the generic offering naproxen. The subsequent year, an FDA advisory committee met to discuss the drug’s CV effects, which was followed by an article published in the prestigious Journal of the American Medical Association.
After each occasion, the documents explain, Merck’s salesforce was directed to offer false information regarding Vioxx’ side effects. For example, after the FDA advisory panel hearing, sales staff were instructed “not to initiate discussions on the FDA arthritis committee…or the results of the…VIGOR study.” After the VIGOR study, they were told to show doctors a card indicating Vioxx could be eight to 11 times safer than other anti-inflammatory agents.
“When concerns about Vioxx’s safety arose, Merck appeared to use this highly trained salesforce to present a misleading picture to physicians about the drug’s cardiovascular risks. Merck’s promotional efforts appear to explain, in part, why Vioxx sales remained strong even as evidence of the drug’s dangers mounted,” the Committee concluded.
The news comes as Merck’s chief executive Raymond Gilmartin has stepped aside to make way for Richard Clark, currently head of the firm’s manufacturing division – despite having previously said he would remain in his post until his retirement next year [[06/05/05a]].
- Meanwhile, lawyers Kenneth Moll & Associates say they will file a class action lawsuit against Merck & Co on behalf of Italian consumers of the once-blockbuster painkiller Vioxx (rofecoxib). The suit accuses Merck of failing to properly research the known risks of Vioxx and warn consumers of potentially fatal side effects.