Normal Limits

"Chance is the very guide of life"

"In practical medicine the facts are far too few for them to enter into the calculus of probabilities... in applied medicine we are always concerned with the individual" -- S. D. Poisson

December 15, 2005

Merck lied

Editorial released online by the New England Journal of Medicine, on the paper published in year 2000 by Bombardier et al on Merck's Rofecoxib. The editorial is penned by editors Gregory D. Curfman, M.D., Stephen Morrissey, Ph.D., and Jeffrey M. Drazen, M.D.:
a memorandum... obtained by subpoena in the Vioxx litigation and made available to the Journal, [showed] that at least two of the authors knew about the three additional myocardial infarctions at least two weeks before the authors submitted the first of two revisions and 4 1/2 months before publication of the article.

We determined from a computer diskette that some of these data were deleted from the VIGOR manuscript two days before it was initially submitted to the Journal on May 18, 2000.

NEJM re-ran the main anlysis and found:



Dr. Curfman, as quoted in the NY Times article by Alex Brenson:
"They did not disclose all they knew," [Dr. Gregory D. Curfman, the journal's executive editor] said. "There were serious negative consequences for the public health as a result of that."

As we can see clearly from these numbers that the exclusion of these 3 cases of myocardial infarction does not change the main conclusion!

The culprits

The authors of the original study implicated are Claire Bombardier, M.D, and Alise Reicin, Merck's Vice President of Clinical Research.

The fall of Merck

The history of Merck is reviweed here. Merck famously commercialized morphine for medical use and with Pfizer was one of the first companies to mass produce penicillin.

According to NY Times:

Merck now faces more than 6,000 lawsuits from people who say they or their family members suffered heart attacks and strokes as a result of taking Vioxx, and tens of thousands more lawsuits are expected.

Despite Merck's recent victories in court, it looks more and more likely that Merck will be brought down by its COXII inhibitor.

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