May 15, 2006
Evidence continues to show that top authorities at the New England Journal of Medicine made serious mistakes over their publication of Vioxx data. If the Journal had not made these errors, critics argue, thousands of consumers may have been saved from exposure to the dangers of Vioxx.
Concern over the NEJM’s publication of Vioxx VIGOR clinical findings began in 2001. In August 2001, the editor of the Journal, Dr. Drazen, appeared on a radio show in Seattle, Washington. A pharmacist, Dr. Hrachovec, called in to express concern that important facts had been omitted from the Journal’s article about the Vioxx clinical study. Dr. Drazen was quick to dismiss concerns and the important facts about Vioxx heart risks remained hidden from consumers and health professional everywhere.
The VIGOR study showed that Vioxx users were at a significantly greater risk of heart attack and stroke compared to subjects using a traditional NSAID, naproxen. The authors of the 2001 Journal article about the VIGOR study, including Merck employees and consultants, failed to fully disclose the instance of heart attacks in Vioxx subjects .
They also offered unsubstantiated claims that naproxen actually offered heart protection , the supposed reason why naproxen users suffered fewer heart attacks than Vioxx users during the study.
Three years later, Vioxx was pulled from the market after another study confirmed the increased cardiovascular risks associated with Vioxx. However, in that span of three years, Vioxx became the most popular pain reliever available, was used by millions, and caused death or serious injury to thousands. As of today, at least 11,500 Vioxx lawsuits have been filed against the makers of this drug, Merck, for serious Vioxx injuries and deaths.
While Merck has suffered its fair share of the blame over Vioxx, the Journal’s role in this debacle has not received enough attention, many critics contend.
The New England Journal of Medicine is one of the most respected medical journals in existence. The findings published in this journal have astronomical effects on the way medicine is practiced in the United States and abroad.
Conclusive evidence shows that the Journal failed to adequately report the clinical findings associated with Vioxx. Had they reported on Vioxx responsibly, the drug’s risks would have been better understood and thousands of patients may not have received this dangerous and defective drug.
Doctors, like pharmacist Jennifer Hrachovec. M.D. and others, submitted letters of concern to the Journal in 2001, yet their legitimate contentions went ignored . The FDA added warnings about the cardiovascular risks of Vioxx in 2002, yet the Journal turned a deaf ear to concerns about Vioxx and failed to adequately convey these risks as a responsible medical publication should.
Medical experts are now saying that the Journal should have been more vigilant about correcting problems with their published medical findings. “They absolutely should have corrected in 2001,” says Stanford researcher Gurkirpal Singh M.D. about the Journal’s failure to correct their mistakes once the damage was done.
He firmly believes that if the Journal reported responsibly on Vioxx cardiovascular risks in 2001, sales of this blockbuster drug “would have been killed.” Millions of people would never have been exposed to the serious and life-threatening risks posed by this Vioxx. Many lives would have been saved.
