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Merck shares stung by editorial

Investors respond to a medical journal report that a Merck-funded study didn't note three heart attacks.

TRENTON, N.J. - Shares of Vioxx maker Merck & Co. fell for a second day Friday after the New England Journal of Medicine said authors of a study funded by Merck failed to disclose that three more patients in a 2000 clinical study suffered heart attacks while using the now-withdrawn painkiller.

Shares of Merck fell 55 cents, or 1.8 percent, to close at $29.13 Friday on the New York Stock Exchange.

Thursday's editorial, written by the journal's editor in chief, Dr. Jeffrey Drazen, executive editor Dr. Gregory 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 became known as the VIGOR study have been a key part of testimony in the three product liability trials to date over the withdrawn drug, including one in which a federal jury in Texas began deliberations Thursday afternoon. The research was published more than a year after the Food and Drug Administration approved Vioxx in May 1999.

The study was intended to compare whether Vioxx caused more stomach ulcers and bleeding among patients with rheumatoid arthritis than for those using the older, cheaper anti-inflammatory naproxen. Over an average nine-month period, Vioxx did score better on that count, but the study also showed there were a greater number of heart attacks among Vioxx users.

In the article, Merck explained differences found in that study by saying naproxen is cardioprotective.

Merck shares fell 61 cents, or 2 percent, to $29.68 in regular trading on the New York Stock Exchange, then fell 85 cents more, or 2.8 percent, to $28.85 in after-hours trading, after news of the editorial circulated.

In a statement issued late Thursday, Merck said the additional heart attacks "did not materially change any of the conclusions of the article." The company also 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.

"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," the company statement reads.

But Curfman said Merck's arguments about the cutoff 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.

[Last modified December 10, 2005, 00:51:18]