Scientist: Vioxx study showed no increased risk

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.