Medical journal says Merck suppressed data on Vioxx |
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Sat, 10 Dec 2005 20:05
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NEW YORK: As the members of the jury in a U.S. district court deliberated whether drug maker Merck should be held responsible for the death of a Florida citizen who took the company's painkiller Vioxx for nearly a month, the drug maker got embroiled in another controversy when an article in the respected New England Journal of Medicine accused the company's scientists that they had downplayed the pain reliever's heart attack risk.
The online edition of the journal posted a rare "expression of concern" in which editors charged the scientists for failing to report three nonfatal heart attacks among Vioxx users who were at low risk of cardiac problems. The article said two Merck scientists knew about the three heart attacks more than four months before the journal published an article by the scientists about a 2000 Vioxx study, called VIGOR, which did not contain this information. The study was subsequently used as an argument favouring the drug's safety. The editors said they found that the information about the three heart attacks had been deleted two days before the article was submitted.
The editors said they had first come across the missing data in 2001, but did not think the authors knew about it. In late 2004, after the drug was withdrawn from markets, the editors accessed a computer diskette that had been submitted with the study and found a blank table with no data.
It was on 21 November when the publication's executive editor Dr. Gregory D. Curfman deposed at the third Vioxx trial in Houston that a memorandum dated 5 July 2000 came to light, indicating at least two of the VIGOR authors knew of the problems at least two weeks before submitting the first of two revisions, and four-and-a-half months before actual publication, of the study. The journal conducted further investigations, which revealed that the authors had originally known about the deaths.
The editors contended that the three heart attacks would have led to different conclusions about the drug's risk, especially for people not predisposed to heart conditions.
Merck issued a statement Thursday saying the heart attacks were reported after a cutoff date for data for the study. It also claimed the instances were promptly disclosed to the Food and Drug Administration and a news release was issued.
The pharma major had withdrawn Vioxx from the market in September 2004, when an estimated 20 million people were using it. The company now faces more than 6,500 lawsuits alleging the drug had caused heart attacks, strokes and deaths. The litigation, according to analysts may cost the company nearly $50 billion.
The journal brought out the information after testimony ended in the third Vioxx trial. The case has now gone before a federal court jury in Houston.
The disclosure by the journal is considered as a powerful evidence against the company, because its sources are impeccable and the journal always stands above suspicion.
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