When consumers read about a South Texas jury finding Merck & Co. liable today for the death of a seventy-one-year-old man who had a fatal heart attack within a month of taking the painkiller Vioxx, they will likely conclude: "this is good -- a big bad company is being held responsible for their evil medicine causing harm." The company was ordered to pay $7 million in compensatory damages and $25 million in punitive damages.
Few will consider the following facts:
--A claim that Vioxx caused a heart attack after the patient used it for one month has no basis in medical science.
--Large-scale studies of thousands of people using pain killers -- both prescription drugs and over-the-counter ones like Advil and Aleve -- suggest that high-dose, long-term use may increase heart disease risk in susceptible users, but that is a far cry from establishing that a month of using Vioxx caused a heart attack.
--Vioxx is a member of a family of drugs called "Cox 2-inhibitors" that are showing great promise in preventing cancer -- including chemoprevention of cancers of the colon and breast.
--Legal judgments such as the one today can only serve to discourage the continued study of this class of drugs for cancer prevention purposes.
When drug companies are slapped with verdicts claiming their drugs are harmful -- even after years of research and the arduous process of FDA approval -- it can only serve to (a) cause the companies to raise drug prices to compensate for the financial judgments against them and (b) discourage future innovation in life-saving drugs because it simply becomes too costly. Who wants to invest in drug development when, after the enormously expensive and time-consuming FDA approval process, you can still be found liable of selling an allegedly dangerous drug?
Ironically, Merck, found by the jury to have sold a pharmaceutical that caused death in the course of one month of use, is the same company that is about to market a vaccine to protect women from cervical cancer. What if the economic impact of this and other verdicts (the score now is three wins and three losses in court cases against Merck on Vioxx) causes such negative economic fallout at Merck that this life-saving vaccine is not launched in a timely manner?
The time has come to seriously consider
1. establishing , as a routine component of all trials such as these, a "science court" -- a panel of qualified experts in medicine, epidemiology and pharmaceutical sciences -- that can advise juries on issues relating to medical causation. A science court in this Vioxx case would have advised the jury that the use of Vioxx for one month would be highly unlikely to be the cause of the plaintiff's heart attack; and
2. offering pharmaceutical companies limited liability for lawsuits against their newly introduced drugs once they have survived the rigorous FDA approval process. Such protection would enormously benefit American consumers who want new, innovative drugs at affordable prices. It would eliminate the extra "tax" added by the extraordinary cost of junk-science-based lawsuits against the manufactures of useful drugs -- lawsuits that only line the pockets of plaintiffs attorneys.
Elizabeth M. Whelan, Sc.D., MPH, is founder and president of the American Council on Science and Health (ACSH.org, HealthFactsAndFears.com). On a topic similar to Dr. Whelan's piece, this piece from MedicalProgressToday.com by ACSH's Dr. Gilbert Ross talks about the misguided safety concerns that have limited the use of Evista as a cancer-fighting drug.
