Merck scientist says can't eliminate all drug safety risk

By KRISTEN HAYS - Associated Press

ANGLETON, Texas - Merck & Co.'s head of clinical trials testified in the nation's first Vioxx-related civil trial Thursday that consumers would have no new drugs if all safety risks had to be eliminated first.

But Dr. Alise Reicin told jurors that the company does "post-market surveillance" - continued monitoring and testing once the product is for sale. Such testing led to Merck's decision to pull Vioxx from the market last year when a study showed the drug could double risk of heart attack or stroke if taken for 18 months or longer.

Reicin, calm and composed, testified in a lawsuit over the death of Robert Ernst, a 59-year-old Texas man who died in his sleep after taking the once-popular painkiller for eight months to ease aches in his hands.

"Are safety concerns seen sometimes after things come to market? Yes, they are," Reicin said. "If society decided they didn't want to take that risk we would have no new drugs on the market."

Lanier also had noted that Reicin's 2001 performance review said her major efforts included "defending the Vioxx franchise."

"You are still the defender of Vioxx, aren't you?" he asked Thursday.

"Again, that's not how I would characterize my role," Reicin replied. "I would characterize my role as a scientist."

Ernst's widow, Carol, alleges that Merck knew years before the withdrawal that Vioxx posed heart dangers, but focused on aggressive marketing that helped turn the drug into a $2.5 billion seller. Her husband, a Wal-Mart produce manager, also ran marathons and was an occasional personal trainer.

Reicin reiterated what other current and retired Merck executives have said during the trial: Safety was paramount in 58 clinical trials involving 10,000 patients that were conducted before Vioxx won approval from the U.S. Food and Drug Administration to go on the market in 1999.

But Carol Ernst's lawyer, Mark Lanier, singled out several of those studies, challenging their results because so many were small and involved patients taking Vioxx for days or weeks rather than years.

Specifically, he noted a study in 1997 where an outside scientist noted Vioxx could possibly cause blood clots that may lead to heart attacks or strokes because it inhibited an enzyme that thins the blood. That feature helped Vioxx cut risk of stomach bleeds and ulcers that can come from taking painkillers like aspirin that don't inhibit the enzyme.

The coroner who performed an autopsy on Ernst testified that Ernst more than likely had a blood clot that led to a heart attack. She didn't note either in her report because, she said, vigorous CPR likely dislodged the clot and he died of an irregular heartbeat too fast for his heart to show damage. A pathologist testified for Merck that there was no evidence of either a clot or a heart attack.

Lanier asked Reicin why patients recruited to take Vioxx in a 1997 study were warned that the drug could cause blood clots or mild strokes, but weren't warned of possible heart attacks.

"It was a completely theoretical possibility at that point in time," she said. "The same question had been raised about Tylenol, but I don't think there's anyone in the (medical) community who thinks Tylenol causes heart attacks."

In 2000, a year after Vioxx had been on the market, a study showed Vioxx users suffered five times as many heart attacks as patients who took the older painkiller naproxen, sold under the brand name Aleve.

Reicin reiterated Merck's view that the study illustrated naproxen's heart-friendly qualities rather than a defect in Vioxx. She said previous studies comparing Vioxx to sugar pills showed little to no difference, and no patients in the Vioxx/naproxen study took sugar pills.

The same scientist who hypothesized in 1997 that Vioxx could cause blood clots was co-author of an article published after the Vioxx/naproxen study that said its results could be attributed to cardioprotective qualities or chance. But the scientist, as well as another author of the same article, didn't disclose with that article that they did consulting for Merck, Lanier noted.

"He didn't get money from us to write this article," Reicin said. "He has been a consultant to us. I can tell you it does not influence his judgment."

However, the FDA rebuked Merck for attributing the study's result to naproxen's cardioprotective effect without scientific proof. Lanier questioned why Merck didn't add cardiovascular warnings to its label until two years later.

"We wanted the label change to happen," Reicin said, but the company didn't immediately agree with all FDA suggestions on how Vioxx affected gastrointestinal and cardiovascular systems.