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New England Journal: Merck Concealed Data

Dec 8, 2005 | AP Vioxx maker Merck & Co. concealed heart attacks suffered by three patients during a clinical study of the now-withdrawn painkiller in a report on the study published in the New England Journal of Medicine in 2000, the journal wrote in an editorial released Thursday.

The editorial, written by the journal's editor in chief, Dr. Jeffrey M. Drazen, executive editor Dr. Gregory D. Curfman and a third doctor, also alleges 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 doctors wrote.

Adverse cardiovascular events include heart attacks, strokes and deaths.

Findings of the study in question have been a key part of testimony in the three product liability trials to date over the withdrawn drug, including one being deliberated Thursday by a federal jury in Texas.

Merck spokesman Chris Loder said the Whitehouse Station, N.J.-based company would issue a statement in response to the editorial Thursday.

Excluding the three heart attacks "made certain calculations and conclusions in the article incorrect," the doctors wrote, adding that they have asked the report's authors to submit a correction to the journal.

One of the study's authors was Dr. Alise Reicin, Merck's vice president for clinical research. Reicin on Wednesday testified in the Houston trial that the company never misled doctors and the public about studies linking heart attacks to Vioxx.

Merck withdrew Vioxx, once one of its top-selling drugs, from the market on Sept. 30, 2004 after other research showed the popular arthritis drug doubled risks of heart attacks and stroke with long-term use. The company now faces at least 7,000 lawsuits over Vioxx and legal liability some analysts have estimated at up to $50 billion. Those problems were part of the reason Merck last week announced plans to cut 7,000 jobs and close eight manufacturing and research facilities around the world as the first step in a sweeping reorganization.

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