EMSA now reporting to Barry Gertz in MRL who is famous for making these false statements.....
Merck exec says studies proved Vioxx safe
ATLANTIC CITY, N.J. (AP) — Pharmaceutical giant Merck & Co. performed several studies in the late 1990s that proved the safety of its now-withdrawn painkiller Vioxx, a top executive told jurors Thursday morning.
Dr. Barry Gertz, executive vice president of clinical pharmacology at Merck Research Laboratories, said the Whitehouse Station-based firm did three studies on dogs and one on rabbits to determine whether Vioxx reduced prostacyclin, a naturally occurring chemical in the body that helps prevents blood clots and opens blood vessels.
Frederick "Mike" Humeston, 60, an Idaho postal worker, blames his intermittent use of Vioxx over two months for his September 2001 heart attack. Merck says Humeston's job stress and health risks, not Vioxx, caused his heart attack.
Humeston, 60, of Boise, is one of about 6,500 former Vioxx users suing Merck over the drug, which the company pulled off the market in September 2004 after long-term use was linked to increased risk of heart attacks and strokes.
An internal Merck study that ended in 1997 suggested Vioxx could cause a reduction in prostacyclin in the urine. Humeston's lawyers have pointed to that study as proof Merck knew its blockbuster pain reliever could lead to heart attacks.
But testimony from Gertz, who appeared for the company, bolstered Merck's argument that the company performed subsequent studies to see if Vioxx reduced prostacyclin and could cause heart attacks, and found that it did not.
Humeston lawyer Chris Seeger suggested in his cross-examination that "all that testimony about bunny hearts and dogs" had little bearing on how the medicine could affect humans.
"Veterinarians didn't prescribe Vioxx, did they?" Seeger asked.
"No," Gertz answered.
With the jury out of the courtroom, the attorneys squabbled before Judge Carol E. Higbee about Gertz's mention of the fact that the drug had been withdrawn from the market. The subject came up in opening arguments, and Higbee ordered it off-limits because she says it would distract from the key question of whether Merck thought Vioxx was safe in 2001.
Merck lawyers say they want to talk about the voluntary withdrawal because they say that shows — contrary to Humeston's claims — company officials cared about patient safety.
In a blow to the company, Higbee said Thursday she wouldn't allow discussion of the withdrawal. But she would permit testimony that Merck stopped certain studies in 2004 because Vioxx had then been shown to double the risk of heart attacks after 18 months of use.
Merck lawyer Stephen Raber protested that Seeger's questioning had been designed to elicit mention of the withdrawal. Higbee disagreed and told Raber to instruct his witness not to bring it up again.
In the first Vioxx trial in August, a Texas jury found Merck liable in a Vioxx user's death. Damages there will be cut to about one-tenth of the jury's $253 million award due to that state's caps on punitive damages.
