Even if Merck no longer calls its vice president of clinical research as a witness, the attorney, Mark Lanier, has said he will put Dr. Alise Reicin on the stand to contrast her previous testimony with information revealed by the NEJM. Lanier is scheduled to try the fourth Vioxx case in late February in Atlantic City.
''I plan on using it to show she's been less than honest with other juries," Lanier said.
The trial described in the Journal article was designed to show whether Vioxx could treat pain without causing stomach bleeding associated with older painkillers. The scientists running the trial also tracked serious cardiovascular side effects caused by Vioxx and naproxen, a painkiller sold as Aleve.
A Merck biostatistician, Deborah Shapiro, had alerted Reicin about additional heart attacks caused by Vioxx in a July 5, 2000 memo, Lanier said. Reicin and Shapiro were among the 13 authors of the Journal manuscript. Shapiro's memo reported 11 serious cardiovascular side effects that the company learned about after a study cutoff date, but before the article was published. Four of the five confirmed events were due to Vioxx. Three were heart attacks suffered by patients at low cardiovascular risk.
In addition, closer scrutiny of a computer diskette the authors submitted to the Journal revealed that a Merck computer was used to delete data from the manuscript, downplaying Vioxx's heart risks.
In earlier court cases -- and as late as Wednesday in Houston -- Reicin testified that Merck provided prompt and truthful details about Vioxx heart risks. A Merck spokeswoman said yesterday that the company declined to comment further.
Staffers working for Lanier are scouring Reicin's past testimony to determine whether it supports a perjury investigation.
Lanier said juries were unlikely to be asked to interpret scientific subtleties that interest physicians -- like the relative risk of suffering a heart attack while taking Vioxx increasing from 4.25 times to 5 times because of the more complete cardiovascular safety data.
''What a jury is going to get is A, Merck fudged on the details," Lanier said. ''B, the fudge was in their favor. C, it was on purpose. D, Merck lied about fudging, or at least covered it up. And E, the most prestigious medical journal in the United States of America has called their hand on it and said this is unethical and wrong."
Insiders view: This will be a true battle royal! Better than Matlock and Perry Mason all rolled into one!
Source: Boston Globe
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