The journal issued an online change to the "Approve" study, which indicated that heart problems began only after 18 months of use. Those results led researchers to believe the drug was safe for short-term use. However, after the study authors admitted to statistical errors in their analysis, NEJM published the correction, which stated that heart risks were elevated the entire time patients were on the drug.
Dr. Steven Nissen of the Cleveland Clinic, a vocal critic of Vioxx, wrote a letter in the latest NEJM issue, reminding readers that Merck had used the now-false claim that Vioxx was safe for 18 months of use as part of its defense in the 11,500 lawsuits brought against the company by patients claiming Vioxx-related health troubles.
Kamran Abbasi, editor of the Journal of the Royal Society of Medicine, and former editor of the British Medical Journal, says the corrections to the Approve study demonstrate how little medical journals can do to police the system of drug safety research. "The reality is that journals are at the whim of powerful companies and their research departments." Abbasi says.
Merck has issued a statement saying it "stands behind the original results" of the Approve study.
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