Merck & Co., the manufacturers of the drug Vioxx, funded a study into the effects of the painkiller drug and the report arising out of the study was published in the New England Journal of Medicine in 2000. An editorial in The Journal released on December 8, 2005, stated that the report failed to disclose that three additional patients in the clinical study suffered heart attacks while using the painkiller.

The editorial, written by the journal’s editor in chief, Dr. Jeffrey M. Drazen, executive editor Dr. Gregory D. Curfman and managing editor Stephen Morrissey, 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. Excluding the three heart attacks “made certain calculations and conclusions in the article incorrect.”

Adverse cardiovascular events include heart attacks, strokes and deaths.
The findings of what has become known as the VIGOR study have been a key part of testimony in the product liability trials to date.

Merck said the information was not included because the heart attacks were reported after Merck’s cut-off date for collecting information on the patients in the study, and their company statement on the matter went on to read “Nevertheless, these additional events were disclosed to the FDA in 2000, presented publicly at the FDA’s Advisory Committee in February 2001, and included in numerous press releases subsequently issued by Merck.” Dr. Curfman said in an interview that Merck’s arguments about the cut-off date “don’t hold water” because journal articles are routinely updated with new data in the weeks before publication. “The health of the public, of many, many thousands of people, was at stake here,” he said.

Data in Thursday’s editorial show that 20 patients on Vioxx suffered heart attacks, instead of the 17 originally reported. Among patients in a comparison group taking the older, cheaper anti-inflammatory naproxen, there were four heart attacks. Dr. Curfman said that none of the three extra heart attacks was fatal, but all three of those patients were in a group at low risk of heart attack. The journal editor said he learned of the extra heart attacks and deleted data — including the number of patients in the study who died — when he gave a deposition on 21st of November, 2005 for attorneys representing Vioxx plaintiffs in the Houston trial and three other federal trials slated for early next year. At the deposition, the plaintiff lawyers showed him documents they subpoenaed from Merck, including a July 2000 internal memo containing the deleted data.

Curfman said he and Morrissey spoke with two researchers who led the study and the two, who do not work for Merck, said they would submit a correction to the journal as the editors requested.

The third author of the study was Dr. Alise Reicin, Merck’s vice president for clinical research. Reicin testified in the Houston trial that the company never misled doctors and the public about studies linking heart attacks to Vioxx.

Plaintiff’s attorneys declined comment in Houston when asked if the New England Journal revelations might prompt them to ask for a mistrial. The plaintiff’s attorneys for the trial in Houston honoured the judge’s request that they not to speak to the media about the New England Journal revelations until a verdict was reached.

A mistrial was declared for the first Federal trial challenging the safety of Vioxx but that was due to the jury being unable to come up with a unanimous decision and not because of the New England Journal of Medicine editorial. The retrial will commence on February 6, 2006 in New Orleans.