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US: Vioxx 'a Hazard,' Doctor Testifies

The Associated Press
July 6th, 2006

Patients who took the painkiller Vioxx were at risk of heart attacks and strokes — something shown by studies conducted years before the product went on the market, a doctor testified Wednesday.

Dr. Lemuel Moye, a physician and professor of biostatistics at the University of Texas, took the witness stand as the first Vioxx liability trial in California entered its second week.

Moye concluded that the painkiller carried more risk than benefits to patients after he reviewed clinical trials conducted by Vioxx maker Merck & Co. dating to 1996.

"Vioxx is a hazard for a stroke and for heart attack," Moye testified.

The lawsuit was filed by 71-year-old Stewart Grossberg, a retired Northridge construction manager, who alleges that Vioxx caused him to have a heart attack in 2001, and that Merck marketed it without warning consumers of its potential problems.

Merck said there was no proof Vioxx caused the man's heart ailments.

Attorney Thomas Girardi, who represents Grossberg, is trying to show that Merck deliberately excluded arthritis sufferers — who tend to be at high risk of heart ailments — from Vioxx studies.

Patients in one study cited by Moye "were at lower risk of having heart attacks and strokes than perhaps the general population with arthritis," Moye said.

Merck was marketing Vioxx to arthritis sufferers when it went on the market in 1999.

Jurors also heard videotaped testimony from Merck biostatistics expert Dr. Deborah Shapiro, who said one section of a Vioxx study comparing incidences of heart attacks among users of Vioxx, placebos and other anti-inflammatory drugs was not submitted to the U.S. Food and Drug Administration.

Shapiro said, however, that the FDA was given all the information needed to evaluate Vioxx.

Grossberg's case targeting Vioxx is the eighth to go to trial nationwide. Another trial is continuing in Atlantic City, N.J.

Merck shares rose 7 cents to $36.69.





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