Merck's Vioxx Under Fire Again

Researchers examined "cardiovascular thrombotic events" during the study period and for two years after VICTOR was halted. The median treatment before such events, including heart attack, stroke and blood clots, was 157 days for Vioxx patients and 195 days for placebo patients.

The relative risk of a dangerous side effect occurring during treatment, or within 14 days of treatment, was more than double for the Vioxx group. Relative risk compares the percentage of side effects among Vioxx patients with the side-effect percentage for placebo-takers.

The VICTOR trial was designed to test 7,000 patients. Half were to have received Vioxx or a placebo for 24 months, and half were to have received the Merck drug or a placebo for 60 months. When the test was halted, only 2,434 patients were enrolled, and only 4% had received Vioxx for more than two years.

Although the NEJM article was subject to a publication embargo, a Merck executive told analysts on July 23 that the findings were old news. "I think we indicated many times that this is but one study," said Graeme Bell, executive director of investor relations, responding to an analyst's question during Merck's second-quarter earnings presentation.

"You know the history in terms of [VICTOR] being stopped prematurely, and that such data, in and of itself, has been available" to people and their lawyers, Bell said. This data has been used by plaintiffs in many trials, he added.

"We feel that one data point in and of itself can draw no conclusion whatsoever," Bell said. "We remain steadfast based on the scientific evidence relating to" the results of the APPROVE trial.