Only a few months of Vioxx could harm heart, journal says
WASHINGTON -- In an action that could hamper Merck & Co.'s ability to defend itself against thousands of lawsuits, a prominent journal yesterday published a correction saying that it does not take 18 months of Vioxx use to increase heart risk.
Dr. Gregory D. Curfman , executive editor of the New England Journal of Medicine , said the journal took the unusual step ``to make it completely clear to our readers" that suggesting someone needs to take Vioxx at least 18 months before suffering heart risk ``is, in fact, a misinterpretation of the data."
Heart risks from the painkiller could occur after as few as three months , according to a letter the journal published on its website yesterday .
The correction is to an article the journal published last year looking at Vioxx as a potential cancer prevention therapy. Heart problems detected in that study prodded Merck to take Vioxx off the market, but the paper's analysis has been central to Merck's defense against 13,000 lawsuits alleging cardiovascular harm from the drug.
In the lawsuits that Whitehouse Station, N.J.- based Merck has already faced in state and federal courtrooms, the company has said Vioxx was not to blame for heart attacks and strokes suffered by plaintiffs who used the drug for a few months.
The company voluntarily pulled Vioxx from the market on Sept. 30, 2004 , saying its cancer prevention study indicated the treatment could double the risk of heart attacks and strokes after 18 months of daily use.
Merck, in a written statement, said it ``stands behind the original results" published by the journal in March 2005 . Yesterday's correction came after the company itself pointed to a problem with its analysis, but does not change its conclusion or Merck's decision to defend each Vioxx case individually, according to the statement.
To date, three of six juries hearing Vioxx cases have issued verdicts favoring Merck. The company lost multimillion-dollar jury awards in three other cases. Jurors in Los Angeles and Atlantic City are hearing Vioxx cases this week.
The journal correction, however, hints at the possibility more lawsuits may be filed.
``This is a fundamental change in the interpretation of the study and it has major legal implications because a principal defense in the Vioxx cases has been that many of the people did not take the drug for more than 18 months," said Dr. Steven E. Nissen , interim chairman of the cardiovascular medicine department at the Cleveland Clinic Foundation .
Nissen and a public safety expert each wrote letters critical of Merck's data analysis that the journal published. Nissen and Dr. Curt Furberg , a public health sciences professor at Wake Forest University School of Medicine , served as advisers on a Food and Drug Administration panel that helped the agency decide whether Vioxx could again be sold to consumers.
A leading defense lawyer said judges -- if they decide the new information is important -- could permit such expert testimony even during ongoing cases. ``You can rest assured that the plaintiffs are going to be pressing to use the information, if they believe it can be helpful to their case," said Peter Bicks , partner in charge of Orrick Herrington and Sutcliff's New York office.
Merck already has submitted preliminary analysis to the FDA suggesting heightened heart risks from Vioxx can linger at least one year after patients stop taking Vioxx.
Yesterday's correction is the second acknowledged miscue by the venerable journal regarding pivotal Vioxx studies. In December , editors published an ``expression of concern" alleging that another research team minimized Vioxx risks by failing to report all cardiovascular problems.
Curfman said the Vioxx cancer prevention paper was subjected to ``extremely rigorous" review by five reviewers, when as few as two peer reviewers is typical. Journal reviewers could not have picked up the statistical error earlier, he said.
Diedtra Henderson can be reached at dhenderson@globe.com. 
