Medical journal criticizes Vioxx maker's reporting
The New England Journal of Medicine on Thursday accused researchers funded by Merck & Co. of understating the health risks of the painkiller Vioxx by withholding adverse data from a 2000 report on the drug.
In a rare "Expression of Concern" published online, editors of the journal said the Merck scientists failed to report three nonfatal heart attacks among the Vioxx users. The total number of heart attacks among the drug users was actually 20, they said, not the 17 reported.
Experts disagreed on how medically significant the three heart attacks were, but agreed that the omission of the cases could bolster claims that the company was deliberately withholding data about the drug's health risks. Merck voluntarily withdrew the drug from the market in September 2004.
In a statement released late Thursday, Merck said the three heart attacks were disclosed in information sent to the Food and Drug Administration in 2000 and in press releases issued at the time of the study.
The three heart attacks were not included in the report, the statement said, because they occurred "after the pre-specified cut-off date" for analysis of the study results.
But the journal's executive editor, Dr. Gregory D. Curfman, rejected Merck's explanation.
"It would have been their responsibility to provide us with an update after the cut-off time," especially in light of the fact that three heart attacks occurred shortly after the study's end, he said.
The editors also said the study's authors withheld more relevant data about strokes and other heart problems caused by the drug, producing inaccuracies and deletions that "call into question the integrity of the data."
The accusations by the prestigious journal could hurt Merck's ability to defend itself in the 6,500 lawsuits blaming Vioxx for heart attacks, strokes and deaths. Analysts have estimated the cases could eventually cost the company up to $50 billion.
Before Merck withdrew Vioxx from the market, it was one of the most widely prescribed -- and expensive -- drugs on the market.
It is part of a class of drugs known as COX-2 inhibitors, which are designed to reduce pain without triggering the gastrointestinal bleeding produced by aspirin and other non-steroidal anti-inflammatory drugs, such as naproxen.
The 2000 study, involving more than 8,000 patients, did show less bleeding with Vioxx, but it also showed a 220 percent increase in the risk of heart attacks and other cardiovascular events for Vioxx compared to naproxen. The absolute number of events in both groups was low, however -- less than 1 percent.
If the extra three heart attacks are included in the data, Vioxx produced a 300 percent increase in risk.
In a rare "Expression of Concern" published online, editors of the journal said the Merck scientists failed to report three nonfatal heart attacks among the Vioxx users. The total number of heart attacks among the drug users was actually 20, they said, not the 17 reported.
Experts disagreed on how medically significant the three heart attacks were, but agreed that the omission of the cases could bolster claims that the company was deliberately withholding data about the drug's health risks. Merck voluntarily withdrew the drug from the market in September 2004.
In a statement released late Thursday, Merck said the three heart attacks were disclosed in information sent to the Food and Drug Administration in 2000 and in press releases issued at the time of the study.
The three heart attacks were not included in the report, the statement said, because they occurred "after the pre-specified cut-off date" for analysis of the study results.
But the journal's executive editor, Dr. Gregory D. Curfman, rejected Merck's explanation.
"It would have been their responsibility to provide us with an update after the cut-off time," especially in light of the fact that three heart attacks occurred shortly after the study's end, he said.
The editors also said the study's authors withheld more relevant data about strokes and other heart problems caused by the drug, producing inaccuracies and deletions that "call into question the integrity of the data."
The accusations by the prestigious journal could hurt Merck's ability to defend itself in the 6,500 lawsuits blaming Vioxx for heart attacks, strokes and deaths. Analysts have estimated the cases could eventually cost the company up to $50 billion.
Before Merck withdrew Vioxx from the market, it was one of the most widely prescribed -- and expensive -- drugs on the market.
It is part of a class of drugs known as COX-2 inhibitors, which are designed to reduce pain without triggering the gastrointestinal bleeding produced by aspirin and other non-steroidal anti-inflammatory drugs, such as naproxen.
The 2000 study, involving more than 8,000 patients, did show less bleeding with Vioxx, but it also showed a 220 percent increase in the risk of heart attacks and other cardiovascular events for Vioxx compared to naproxen. The absolute number of events in both groups was low, however -- less than 1 percent.
If the extra three heart attacks are included in the data, Vioxx produced a 300 percent increase in risk.
posted by Chris Placitella at 6:05 AM
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