By Jerry Avorn
A FEW BLOCKS from the high-rise casinos of Atlantic City, Merck & Co. Inc. is in the middle of a multi billion-dollar bet. A jury is about to decide whether the pharmaceutical giant knew that its blockbuster Vioxx could cause heart attacks, but then minimized that risk in the information it gave to doctors and patients. The decision could have implications for the prevention of future drug disasters more profound than all the tepid plans being discussed by Congress and the FDA.
Faced with thousands of patients assigned to her jurisdiction suing the drugmaker for Vioxx-related heart damage, Superior Court Judge Carol Higbee decided to first resolve a few over-arching issues, before getting to the details of each individual case. She'll instruct the jury first to determine whether the pain reliever could ever increase the risk of heart attack. Most experts agree that it does, and Merck took the drug off the market in 2004 when its own clinical trial proved it, but the company still does not fully acknowledge this fact. Next, she'll ask the jury a kind of pharmacological Watergate question: What did the company know, and when did it know it? And finally, did Merck misrepresent this risk in its promotional materials?
A Merck study published in 2000 had documented a five-fold increase in heart attacks in patients given Vioxx. But the FDA did not effectively follow up on this clear alarm signal, and the company itself avoided doing the key studies its own executives said would be needed to clarify the problem. Enter the jury. In the face of a weakened safety surveillance function at FDA and often-spotty corporate responsibility by manufacturers, liability suits by patients now constitute the nation's last defense against preventable drug risks. Judge Higbee's decision to resolve these basic questions in one stroke for all her Vioxx cases means that if the jury rules against Merck, all future cases in her jurisdiction will begin by assuming that the drug can indeed cause heart attacks, and that Merck inadequately warned doctors and patients about its danger. Subsequent juries would then be asked just to determine whether the drug helped precipitate a heart attack in that particular plaintiff. That's one reason this verdict is so important.
The Atlantic City case (in which I testified pro bono on behalf of the patients) could be devastating for Merck in another way. It may lead to the loss of mega bucks in a host of other cases brought by healthcare payers -- unions, retiree funds, insurers -- that spent a great deal paying for Vioxx during its five years on the market. If a product is known by its maker to be unsafe and the danger is hidden, that's consumer fraud, which can carry treble damages in New Jersey. Settlements in those cases could run into additional billions of dollars. The company is also said to have racked up more than a billion dollars in lawyers' expenses .
The breathtaking profits that Vioxx generated may have encouraged Merck executives to take the chance of stonewalling on its cardiac risks. But what is at issue is more than high-yield corporate roulette. Human lives hung in the balance. Also at stake is the future of the capacity to detect and prevent new drug safety catastrophes. Of the $2.5 billion that Americans spent annually between 2000 and late 2004 on Vioxx, about $1 billion was taxpayer money, paid out each year through Medicaid, the Veterans Affairs Department, and other public sources. If the Atlantic City decision goes against Merck, the company is likely to disgorge billions of those profits into the pockets of insurers, patients, or their bereaved families, and their lawyers. Yet a fraction of these sums to pay for a national program of drug risk-benefit assessment that could have identified these issues before putting 20 million people at risk, still cannot be found.
Amid these shifting tides of bonanza or bankruptcy, the federal drug safety research effort piddles along in perpetual drought. FDA has to rely on contributions from pharmaceutical companies to support its drug evaluation activities, and has a trivially small budget to track the safety of thousands of prescription drugs that Americans take daily. Surely if taxpayers, insurers, patients, and the pharmaceutical industry can ante up lottery-sized amounts to pay drug bills or tort settlements, they ought to be able to redirect a tiny fraction of those massive expenditures to fund the kind of federal drug evaluation research that could prevent the next Vioxx, or at least catch it before millions suffer preventable harm. If the relatively small stake needed is laid down to play that hand, the wager would pay off. Yet an effort of that scale isn't on the table. The proposals being debated in Washington fall short of the necessary substantial reform . But as long as Congress and the FDA keep hanging out at the nickel slot machines, don't bet on any worthwhile policy jackpots.
Dr. Jerry Avorn, a professor of medicine at Harvard Medical School and Brigham and Women's Hospital, is author of "Powerful Medicines: the Benefits, Risks, and Costs of Prescription Drugs."
source - the Boston globe