The Fen-Phen Finale

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Science was with them, but not the courts. The producers of one of the drugs used in the "fen-phen" weight-loss drug combination, finalized a $3.75 billion settlement last month. Thousands of claimants say they were harmed by the drug. The manufacturers, American Home Products (AHP), have spent a total of $13.2 billion to cover the settlement and individual lawsuits, according to a company spokesman. In August 1999, AHP was held liable by a Texas jury for heart-valve damage alleged to have resulted from the use of its anti-obesity drugs, Pondimin (fenfluramine) and Redux (dexfenfluramine).

In October of that year, a report and an accompanying editorial in the widely-respected Journal of the American College of Cardiology (JACC) provided solid evidence that the alleged association of the diet drug combination, with heart damage was not as severe as initially reported. Alarming early case reports, based on small, poorly controlled studies, seemed to incriminate the drug combo in the production of an unusual form of cardiac valvular damage. Follow-up studies revealed that there was probably no significant relationship between use of fen-phen and adverse heart effects.

Over the past decade, jury decisions against the manufacturers of pharmaceuticals and other consumer products have been out of sync with the scientific literature on the subject. Manufacturers have been held liable and ordered to pay millions of dollars in damages despite the fact that scientific evidence did not support the claim of harm.

The October 1999 JACC issue reported a large, well-controlled study denying any association between fen-phen and heart damage. Dr. Nelson Schiller one of the world's experts on this kind of valve abnormality wrote an accompanying editorial, detailing the rise and fall of the phen-fen scare, and pointed out that " studies have become more scientifically rigorous, the role of fen-phen in valve disease appears to be approaching the vanishing point." Too late, it seems, for AHP.

There are insidious implications of unfairly holding manufacturers liable without cause, including presenting them with a major disincentive to invest in new products which might improve life for all of us. The solution to this dilemma is the formation of a "science court," which would impartially evaluate the data and advise judges and juries as to its findings on causation, or lack thereof.

Just such a science court was impaneled in the Dow-Corning silicone breast implant litigation, although too late in the process to insure justice for that manufacturer. Such tribunals need to be impaneled early in the litigation process to review scientific data in cases where attorneys uses dubious evidence to claim that a drug or consumer product is hazardous. In this way, manufacturers of useful, sometimes life-saving products can be protected from frivolous legal action. Such panels would be composed of acknowledged, nationally-renowned experts, with peer-reviewed publications pertaining to the subject under review. A science panel report on the current state of knowledge about the purported risks of fen-phen, for example, would inevitably render a clean bill of health.

What does all this mean for you and me? Why should we care about AHP? Here's why: the fen-phen litigation will prove chilling to the pharmaceutical industry as a whole. After all, who wants to expend years of scientific and technical expertise and millions of dollars to get a useful drug to market, only to have some completely unknown and unpredictable adverse reaction sabotage the product, and even perhaps the whole company? The day after a story appeared concerning AHP's attempts to settle the thousands of fen-phen lawsuits, another story described the huge potential public-health benefits to be derived from AHP's new vaccine against a common bacterial cause of childhood pneumonia and ear infections. Will the fear of baseless lawsuits stymie such lifesaving efforts in the future?

Panel findings of no hazard prior to or early in litigation would do a great deal to prevent verdicts that have no merit. This would make plaintiffs' lawyers think twice before initiating groundless lawsuits. If drug companies, fearing litigation for rare or hypothetical, non-existent drug reactions, stop developing and marketing beneficial, unique products, public health will suffer for it. We must find a way to avoid fiascoes like the fen-phen scenario, where science and the courts are totally discordant. Junk science, which cannot prevail in the clinic, laboratory, or peer-reviewed literature, cannot be allowed to triumph in the courtroom.

Gilbert L. Ross, M.D.
Medical/Executive Director, ACSH