In an admission that could undermine one of its core defenses in Vioxx-related lawsuits, Merck said yesterday that it had erred when it reported in early 2005 that a crucial statistical test showed that Vioxx caused heart problems only after 18 months of continuous use.
That statistical analysis test does not support Merck's 18-month theory about Vioxx, the company acknowledged yesterday.
But Dr. Peter S. Kim, Merck's chief scientist, said the company stood by the overall findings it reported in 2005 — including the conclusion that the drug's heart risks were not apparent if patients took it less than 18 months.
But outside scientists said yesterday that Merck's admission, when considered along with other clinical trials of the drug and studies tracking real-world Vioxx use, supports critics' longstanding claims that Vioxx caused heart problems quickly.
"There never was any evidence for the 18-month story," said Dr. Alastair J. J. Wood, a drug safety expert at Vanderbilt University.
More here at the New York Times.
Add this to other factors ( and here) and the result is a shaky defense at best.
In addition, the steering committee that oversaw the study, known by the acronym APPROVe, decided last week to review the additional data and prepare a report for publication in a peer-reviewed medical journal, Dr. Robert Bresalier of M.D. Anderson Cancer Center told The Associated Press on Tuesday.
The committee met in Philadelphia last Thursday and Friday.
"There's universal agreement that we need to look at this in as meticulous a manner as possible so that what's reported is correct," said Bresalier, who was lead author of the first report on the study, published in the New England Journal of Medicine in February 2005.
That report stated the increased risk of heart attacks and strokes for patients taking Vioxx didn't become apparent until after 18 months of use.
Dr. John A. Baron of Dartmouth Medical School, who chairs the APPROVe steering committee, said Tuesday the doctors at last week's meeting decided it would not be productive to publicly discuss their interpretation of the data until the detailed analysis is complete, "possibly in a matter of months."
Baron said once the analysis is done, the doctors will seek an appropriate publication, possibly the NEJM.
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