Vioxx clinical trials are open to interpretation
By Trevor Schubert
Published on May 23, 2006
Last week medical experts took issue with that claim, stating that Vioxx’s risks emerged after as little as four months of use. The discrepancy is the latest example of how the same data can be interpreted in vastly different ways and how potential corporate pressure can alter the results of clinical trials, even when published in a leading medical journal.
Critics say it is clear that the original data analysis was done in a manner that minimized the risks of the drug. Some say the academic experts who collaborated on the study should have known about the four-month threshold and made the risks clear in The New England Journal of Medicine's March 2005 article.
“If you wanted to construct a legal defense that says nothing happens for 18 months, this is how you would cut the data," Steven Nissen interim chairman of cardiovascular medicine at the Cleveland Clinic said last week.
Merck said the new data that appeared to show an earlier risk from Vioxx, had not been complied in early 2005. But they defend the original article, saying it accurately represents the trial’s findings at the time.
The new data is certain to be used by lawyers representing former Vioxx users, who have filed more than 11,500 lawsuits against the drug giant.
Gregory Curfman, the executive editor of The New England Journal of Medicine, said he cannot comment on the new information available.
The journal has previously accused Merck of deliberately omitting information about three heart attacks from a paper in 2000 that reported on a previous Vioxx clinical trial.
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