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My name is David Stone. I live in Houston, Texas. I am a 30-something single white male. I am an Orthodox Christian and am a member of an English-language parish of the Russian Orthodox Church Outside of Russia (ROCOR).

Tuesday, December 06, 2005

Topol Testifies at Federal Vioxx Trial

Some of the more interesting testimony in the ongoing Federal Vioxx trial comes from the plaintiff's expert witness Eric Topol.

As this article from NPR relates:

"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.''

The article continues with the following details from Topol's testimony:

"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?''

One other interesting note related to Topol's testimony can be found in this article from Bloomberg. Defense lawyers for Merck were able to get Topol to admit that he himself had taken Vioxx off and on over the course of several years!

As this article states:

"During cross-examination, Topol acknowledged he took Vioxx for knee pain starting in 1999 and continued to use it intermittently for several years.

Challenged by the company's lawyers on why he would take a drug he considered unsafe, Topol countered that he didn't fit the profile of someone facing an increased risk heart attack or stroke from the drug.

``I didn't think I was one of the people who should be worried,'' he said. The doctor noted he was 45 years old at the time with no history of heart disease. "


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