Not So Fast, Merck

Merck last week announced one of the largest settlements in the history of civil litigation over its Vioxx painkiller drug that patients claimed caused heart damage and strokes. Merck presented the $4.8 billion settlement as almost "airtight."

But a little birdie, or rather, a little monkey tells me that one plaintiff is refusing to accept Merck's offer and is instead joining a petition being filed today with the Food and Drug Administration by

an international coalition of scientists and doctors (which) seeks to compel the agency to stem the flood of dangerous drugs reaching American consumers by mandating the use of scientifically superior non-animal testing methods when those alternatives exist.

Petition signatories include a plaintiff in a Vioxx lawsuit who refuses to accept the recently proposed settlement with Merck because she is concerned that misleading animal drug testing will continue to put consumers at risk. After taking Vioxx to cope with pain from a shoulder injury, Nancy Tufford was diagnosed with congestive heart failure. Vioxx, a painkiller that appeared beneficial to the heart in mouse studies, was withdrawn from the market after it was shown to be the likely cause of thousands of fatal cardiac events in people.

The information above arrived in my E-mail inbox, sent by the Physicians Committee for Responsible Medicine, or PCRM. PCRM lobbies for compassionate medical research when it is available and against unethical medical research on humans.

Nancy Tufford is not the only Vioxx plaintiff refusing to accept the settlement. Thousands of plaintiffs and scores of lawyers are now sorting through who will take the settlement offer and who will not, Forbes reported yesterday:

Ed Richards of the Louisiana State University School of Law, an expert on the law of mass torts, sees several ways plaintiff lawyers could break through the $4.8 billion ceiling, including pushing their least promising clients into the settlement and holding back the big cases, such as patients who suffered crippling cardiac damage and will require drugs and medical monitoring for the rest of their lives "Those are $10 million each, easy," Richards said. Even 500 such cases—a small percentage of the 45,000 plaintiffs and groups suing Merck—would run to $5 billion.

But Tufford may be unique in that her refusal to participate is based more on her concern for animal testing.

The New York Times reported in 2005 on the first Vioxx trial in which a "senior Merck scientist" testified:

In fact, as she later acknowledged, the studies that she mentioned had done little to resolve the question of Vioxx's risk in people using it for long periods of time. One was conducted on monkeys, a second on beagles and a third on the way that doses of Vioxx affected the clotting of blood in healthy young people with arm lacerations. Even after the 2000 clinical trial, Merck never conducted a large study specifically designed to measure whether the long-term use of Vioxx raised cardiovascular risk—even though Dr. Edward M. Scolnick, Merck's top scientist, said it was essential that Merck run such a clinical trial.

Indeed, PCRM points out that a significant percentage of drug tests on animals that show drugs are safe and effective don't pan out when tested on humans. And technological advances have multiplied the number of methods to use human-centered research such as microdosing, tissue studies, and virtual drug trials.

Tags: FDA | medicine | prescription drugs | Merck

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