Expert: Merck Previously Knew of Vioxx Heart Risks

The defense is expected to begin making its case today in the first federal Vioxx trial. The case involves the death in 2001 of a 53-year-old Florida man, Richard "Dicky" Irvin. He suffered a heart attack after taking the painkiller Vioxx for a month.

Last week, jurors heard from two prominent scientists, testifying for the plaintiff, who said unequivocally that Vioxx raises the risk of heart attacks.

Vanderbilt University professor and epidemiologist Wayne Ray said that patients could be at risk from Vioxx within a day of taking the drug.

Cardiologist Eric Topol of the Cleveland Clinic testified that drugmaker Merck had scientific evidence of Vioxx's cardiac hazards as far back as 1999 — well before it pulled the drug from market in September 2004.

Topol, who testified Saturday under subpoena, has been one of the most persistent critics of Merck's handling of Vioxx risks.

Topol told jurors that by 2000, Merck had evidence from two scientific studies to show that Vioxx was risky for the heart. That was four years before Merck pulled the drug from the market.

Topol said Vioxx's heart risks were demonstrated in studies that were actually designed to exclude those at risk of heart attacks. He said, with evidence from these two studies in hand, Merck should have immediately undertaken a study of Vioxx among patients who were at risk of heart attack. Indeed Vioxx was often prescribed to such patients, Topol said.

Topol told the jury that he started looking into Vioxx's risks in 2001. That's when he learned that in a large scientific study, called "VIGOR," patients on Vioxx had suffered five times as many heart attacks as those on an older painkiller, Naproxen. Merck said the study, completed in 2000, showed naproxen protected the heart. As a cardiologist, Topol said he was skeptical of that information because naproxen had been around for 20 years, and it had never been proven that naproxen had such large benefits for the heart.

Topol and two colleagues at the Cleveland Clinic published a paper in the Journal of the American Medical Association that argued the VIGOR study most likely showed that Vioxx raised the risk of heart attacks. They urged doctors to be cautious in prescribing Vioxx and another similar drug, Celebrex, to patients at risk of heart attack.

Topol told the jury that before he submitted the paper for publication, he sent a copy to a colleague at Merck. He wanted to understand why Merck's version of the VIGOR data had fewer heart attacks, strokes and deaths than the numbers subsequently made public by the Food and Drug Administration.

Topol's request for data triggered a visit from a senior Merck scientist, Alise Reicin. She told him that he'd gotten it wrong and would be "embarrassed'' if he published his paper. He said he found her comment "brazen.''

Internal Merck e-mails shown to the jury as part of Topol's testimony showed that Reicin subsequently reworked Topol's manuscript in an attempt, among other things, to "tone down'' its recommendation that Vioxx be avoided among patients with heart problems.

Another company e-mail acknowledged that the manuscript, as revised by Reicin, would not "completely neutralize the potential negative impact of the publication, but … (was) substantially improved from the original.''

None of the revisions made it into the paper Topol and his colleagues published.

Topol told jurors that late last year, soon after Merck withdrew Vioxx from the market, Merck CEO, Ray Gilmartin, approached the chairman of the board of trustees at the Cleveland Clinic, Malachi Mixon, to complain about Topol.

In the wake of the Vioxx withdrawal, Topol wrote opinion pieces in the New York Times and the New England Journal of Medicine criticizing the way Merck developed and marketed Vioxx. According to Topol's testimony, Merck CEO Gilmartin told Mixon, "What has Merck ever done to the Cleveland Clinic to warrant this?''

Merck didn't comment on Topol's testimony. The federal judge in the Vioxx case has forbidden both sides from speaking to reporters. But the company has long maintained that it did not know Vioxx was risky for the heart until last year, and that Merck acted promptly to voluntarily withdraw Vioxx immediately. The Whitehouse, N.J.-based company alleges that Irvin's heart attack was caused by a plaque rupture in Irvin's artery, not Vioxx.

Merck faces some 7,000 wrongful death and injury cases related to Vioxx. Close to half have been consolidated under one federal judge, making the judge and this trial particularly important to the course of the Vioxx litigation.

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