Medical Journal Questions Merck's Vioxx Data

"Lack of inclusion of the three events resulted in an understatement of the difference in risk" of heart attack between the Vioxx and naproxen groups, the editorial says.

That's important, the Journal adds, because the original article said the difference was caused by a reduction in risk thanks to naproxen. The new data, it adds, attributes the difference to "an increase in risk" with Vioxx.

The editorial says the July 5, 2000, memo contains other data "that we believe would have been relevant" to the original article. And after reviewing a computer disk, the editors say that "some of these data were deleted from the VIGOR manuscript" two days before it was first submitted to the Journal on May 18, 2000.

Merck says "the additional events referred to in the editorial were events that were reported after the prespecified cut-off date and therefore were not included in the primary analysis" of the original article. "We also note that these additional events did not materially change any of the conclusions in the article," the company says.

The lead author of VIGOR was Dr. Claire Bombardier of the Institute of Work and Health in Toronto. Bombardier has received clinical research support from Merck and has been a consultant to the company and to other firms. Another VIGOR author was Dr. Alise Reicin, Merck's vice president of clinical research.

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