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Scientist: Vioxx study showed no increased risk

Posted on: Tuesday, 11 October 2005, 10:54 CDT

By Jon Hurdle

ATLANTIC CITY, New Jersey (Reuters) - A Merck & Co. Inc. scientist testified on Tuesday that tests conducted on the Vioxx pain killer before the company sought approval of the drug showed no evidence of increased heart risk.

In marked contrast to the heated exchanges between the judge and a lawyer for the drug maker that roiled the courtroom on Friday, Merck attorney Stephen Raber calmly questioned Alise Reicin, vice president of clinical research at Merck Research Laboratories.

Merck, which has just begun presenting its defense in the second Vioxx civil case to go to trial, is accused of hiding heart risks of the once popular pain killer for years in an effort to preserve the drug's multibillion dollar sales.

Plaintiff Frederick Humeston, an Idaho postal worker who briefly took Vioxx to treat an old war wound, blames the drug for his 2001 heart attack. Merck says other factors, such as the man's age and weight, likely triggered the attack.

On Friday, New Jersey Superior Court Judge Carol Higbee threw out the testimony of Merck's first witness, prompting an unusual shouting match between the judge and Merck lawyer Diane Sullivan.

In her testimony on Tuesday, Reicin said that a total of 60 studies, covering about 10,000 patients, were conducted on the drug before it was submitted to the Food and Drug Administration for approval in November 1998. The jury was shown the results of tests in which patients with osteoarthritis were treated with Vioxx and other drugs.

"There was not any data in the osteoarthritis study to suggest that there would be increased risk," Reicin testified.

A comparison of those patients who suffered heart attacks showed a rate of 0.27 percent for those taking Vioxx and 0.26 percent for those taking non-steroidal anti-inflammatory drugs, according to the study data presented to jurors.

Other tests showed that heart attacks were suffered by 0.13 percent of Vioxx users, less than half of the 0.28 percent rate experienced by patients taking a placebo, or dummy pill, according to the research displayed to the jury.

The FDA approved the drug in May 1999, but Merck pulled it off the market last year after the company said studies showed increased heart risk after long-term use.

The Atlantic City trial began in mid-September and is one of about 5,000 Vioxx lawsuits Merck faces. In the first Vioxx trial, a Texas jury in August awarded the widow of a Vioxx user $253 million -- an award expected to be sharply reduced under Texas law. Merck is appealing the case.

Source: REUTERS

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