Journal Runs Correction on Vioxx
The withdrawn painkiller Vioxx could cause heart problems for patients taking it for less than 18 months, according to a correction in the New England Journal of Medicine that disputes the company’s contention that the drug was safe when taken for a short time.
The journal said the original statistical analysis of a March 2005 study was incorrect and it was uncertain how long the drug could be safely taken before patients incurred an increased risk of stroke and heart attack.
In a letter concurrently published on the journal’s website, Dr. Steven E. Nissen of the Cleveland Clinic said his analysis of data showed an increased cardiac risk after just four months of taking the drug and continued for at least a year after patients stopped taking the drug.
Dr. Jeffrey Drazen, editor of the New England Journal of Medicine, said the correction was made with the cooperation of the two authors of the original study, Dr. Robert Bresalier of the M.D. Anderson Cancer Center in Houston and Dr. John A. Baron of Dartmouth Medical School.
Vioxx’s maker, Merck & Co., said in a statement Monday that it still believed that cardiac risks were elevated only in patients who had taken the drug for at least 18 months.
The company said it performed a variety of statistical tests to confirm its results, while the journal correction focused on only one.
Merck pulled Vioxx from the market in September 2004 after the study linked strokes and heart attacks to patients who had been taking the drug for more than 18 months. The results of the study have sparked about 13,000 lawsuits from people claiming the drug caused heart attacks and strokes.
The journal’s correction could undermine Merck’s litigation defense, which claims that Vioxx wasn’t responsible for injuries in people who took the drug for less than 18 months.
Merck has won three cases and lost three cases. Another trial is set to begin today in Los Angeles.
“The story that it takes 18 months to see harm is not true. That argument is gone,†said Dr. Curt Furberg of Wake Forest University School of Medicine in Winston-Salem, N.C., who challenged the earlier results.
Furberg, in another letter released on the journal’s website, called for a tougher reanalysis of the study data.
In an interview, Nissen said, “Merck is going to go down in flames†with its argument that Vioxx could be safely taken for 18 months.
The correction comes about a month after Merck submitted its complete study data to the Food and Drug Administration. At the time, Merck said that the published study contained an incorrect description of its statistical methods, but that the error did not affect the conclusions.
