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Author Vioxx heart risk starts earlier than previously reported; New England Journal of Medic
Jan Drew

2006-06-28, 9:25 pm

http://www.newstarget.com/z019478.html

NewsTarget.com printable article
Originally published June 27 2006
Vioxx heart risk starts earlier than previously reported; New England
Journal of Medicine publishes corrections to previous Vioxx research
(NewsTarget) -- Editors at the New England Journal of Medicine (NEJM) have
published a correction to previous research on Merck's painkiller Vioxx. The
correction reveals that the heart risks associated with the drug begin much
earlier than Merck previously claimed.
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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