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New England Journal of Medicine Questions Merck Vioxx Study

Posted on: Thursday, 8 December 2005, 21:00 CST

By Bruce Japsen, Chicago Tribune

Dec. 9--In an unusual move, the New England Journal of Medicine Thursday questioned the integrity of a key study Merck & Co. has used to defend its troubled painkiller Vioxx, asking the authors to correct it.

In an editorial posted Thursday on its Web site the Journal said a study funded by Merck concealed heart attacks suffered by three patients which "made certain calculations and conclusions in the article incorrect."

The development could be a potential blow to Merck's defense of future product liability claims in more than 6,000 lawsuits over Vioxx, including 2,900 suits in federal court and 2,750 in New Jersey state court.

Plaintiff attorneys have suggested thousands more lawsuits could be filed, including in various state courts, which could complicate Merck's legal strategy.

The editorial, written by Journal Editor in Chief Dr. Jeffrey M. Drazen, Executive Editor Dr. Gregory D. Curfman and a third doctor, also alleged that the study's authors deleted other relevant data before submitting their article for publication.

"Taken together, these inaccuracies and deletions call into question the integrity of the data on adverse cardiovascular events in this article," the physicians wrote in the editorial, which will appear in the Dec. 29 issue of the journal. "We have asked the authors to submit a correction to the Journal."

For its part, however, the New Jersey-based drug giant defended its research, saying it promptly and appropriately disclosed the results of the study.

Merck said the "additional events referred to in the editorial" were reported after a "pre-specified" cut-off date and therefore were not included in the primarily analysis reported in the journal article.

"Nevertheless, these additional events were disclosed to the FDA in 2000," the company said.

"Merck is confident in its research," a company statement released late Thursday afternoon said. "Merck only recently learned of this editorial. We have not had an opportunity to formally respond in the New England Journal of Medicine, given the timing of its publication."

Merck said it planned a "more complete response" to the editorial in the future but did not specify when.

A key defense Merck has put forth in trials over the drug is that the company adequately and properly disclosed Vioxx's risks during clinical trials and after the drug came on the market in 1999. The New England Journal editorial, and Merck's request, could help plaintiffs paint the drug-maker as doing whatever it could to cover up information that would harm consumers.

So far, Merck has lost one trial in Texas state court and won another in Atlantic City, N.J. Currently, the first federal trial involving Vioxx use is in jury deliberations.

Attorney W. Mark Lanier who won a case this summer against Merck on behalf of a widow whose husband died after taking Vioxx said he is "salivating" at the opportunity to use the New England Journal information in future trials.

"Merck has built a house of cards," Lanier said in a telephone interview Thursday evening. "Merck is in deep trouble."

Because an estimated 20 million people worldwide took Vioxx, the controversy has drawn wide attention and prompted stricter warning labels for some of the nation's best known pain pills. The Food and Drug Administration is also under fire.

Merck voluntarily withdrew Vioxx from the market in September 2004 after finding that patients who took the drug for 18 months had an increased risk of cardiovascular events such as heart attack and stroke. Some people who took Vioxx for shorter durations have also alleged that Vioxx caused their cardiac events.

About 20 million Americans took Vioxx, largely a treatment for osteoarthritis and chronic or periodic pain before the company pulled it from the market. Merck's worldwide sales of Vioxx in 2003 -- the last full year of sales -- were $2.5 billion, or 11 percent of the company's total sales that year.

The withdrawal sparked a flurry of lawsuits against Merck, alleging people died or were injured due to cardiac events caused by taking Vioxx.

Some analysts have estimated Merck could be on the hook for up to $50 billion in potential liability stemming from Vioxx.

Dow Jones newswires contributed to this story.

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MRK,

Source: Chicago Tribune

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