Merck scientist says Vioxx heart risks weren't known

By Bloomberg News | August 11, 2005

WILMINGTON, Del. -- Merck & Co.'s painkiller Vioxx underwent rigorous testing that showed no evidence of heart risks before it went on the market, a company scientist said yesterday in the first trial over the drug.

Dr. Alise Reicin, vice president of clinical trials, testified Vioxx was tested on almost 10,000 people in 58 studies before it was submitted to the Food and Drug Administration for approval in 1998. Another 70 studies followed after the application, she said.

"It was one of the biggest programs that Merck, or any other pharmacy company, had conducted," Reicin testified in Angleton, Texas.

The jury must decide if Vioxx caused the 2001 death of Robert Ernst, 59, a marathoner. His family says Ernst died of a Vioxx-induced heart attack and accuses Merck of playing down the risks to boost sales. Merck counters that Ernst had an irregular heartbeat brought on by hardening of the arteries unrelated to the drug.

Reicin was involved with a Vioxx study that looked at gastrointestinal bleeding, a side effect of many painkillers. The study compared Vioxx to naproxen, the ingredient in Aleve, and showed higher cardiovascular incidents, including blood clots, than with naproxen, she said.

''There was a lower rate of thrombotic events with people taking naproxen than with people taking Vioxx," Reicin said. ''I still believe the difference was because of the heart-protectiveness" of naproxen. The FDA cast doubt on that theory in a 2001 warning letter to Merck about its Vioxx marketing tactics.

Government regulators said the argument that naproxen influenced the number of heart attack incidents was ''hypothetical" and that ''another reasonable explanation" was that the drug caused the incidents, according to the letter.

The company agreed to change its label, and reviewed the results of other tests, which compared Vioxx to other painkillers and with a sugar pill, Reicin said.

Another study showed an increased risk of heart attack and stroke, and ''Merck voluntarily withdrew Vioxx from the market."