Last week, a Texas jury awarded $23 million to a former user of the diet drug combination "fen-phen." American Home Products, which made fenfluramine, or the "fen" portion of fen-phen, has an excellent shot at a successful appeal. But the company's shareholders are much less fortunate. The verdict cost stockholders $8 billion in share value in one afternoon and cast a pall over the stock for the foreseeable future.
Unscrupulous personal injury lawyers operating in an unbridled tort system deserve much of the blame. But a great deal of fault lies, as it did with silicone breast implants, with the Food and Drug Administration.
The fen-phen saga began in July 1997 when the New England Journal of Medicine rushed to publish a Mayo Clinic report that 24 fen-phen users had heart-valve damage. The report was hardly an exhaustive scientific study and only a few of the claimed cases of heart-valve damage had actually been verified. The FDA then sent a "Dear Doctor" letters to physicians requesting information about heart-valve disease among fen-phen users. A month later, the FDA had collected 92 reports of disease among 291 patients tested. Within days--and despite the availability of less drastic options--the FDA called for a halt in fen-phen use and persuaded American Home Products to pull fenfluramine and another diet drug, Redux, from the market "voluntarily."
There still was no scientific evidence against fen-phen, such as a controlled comparison of heart-valve damage incidence among users and non-users of fen-phen. If there was a real and significant problem with fen-phen, one would think it would have shown up much earlier and in many more individuals, since the combination had been used for years by millions of people. The FDA's hasty action in this case opened the litigation floodgates, just as the agency's 1992 moratorium on silicone breast implants did. More than 3,100 lawsuits have been filed across the nation. The Texas case was the first to reach a jury, and will likely inspire many more lawsuits.
Two years after the FDA's action, though, we still don't know whether fen-phen caused any harm. One recent scientific study reported no significant increase in heart-valve problems in those who used fen-phen for less than six months. Another reported no increase in problems for those who took the drugs for less than three months. The American Heart Association says it's too soon to tell whether fen-phen caused significant damage to anyone and whether the effects wore off when use stopped. And in the Texas case, the plaintiff's own cardiologist testified that her heart problems predated her use of fen-phen.
Ironically, American Home Products' last encounter with a federal agency's junk science actually benefited its shareholders. A 1981 study by the National Institutes of Health reported that intrauterine birth control devices including A.H. Robins Company's Dalkon Shield increased the risk of pelvic infection by 60%. In addition to virtually ending the use of IUDs in the U.S., the study spurred lawsuits that forced A.H. Robins into bankruptcy proceedings.
In 1991 the original data used in the NIH study was reanalyzed. A study published in the Journal of Clinical Epidemiology reported the NIH study "showed almost compete disregard for epidemiologic principles in its design, conduct, analysis and interpretation of results." Unfortunately for A.H. Robins, the reanalysis was two years too late. In December 1989, American Home Products purchased A.H. Robins at a steep discount in what was then termed a "steal deal."
There is a solution to this madness--and it isn't only tort reform. A new federal law was enacted in October 1998 requiring that federally funded scientific data used to support federal regulatory action be made available to the public through the Freedom of Information Act. The law is intended to facilitate independent review of science used by regulatory agencies.
A.H. Robins might have survived the Dalkon Shield debacle if it had had timely access to the NIH's study data. When the FDA browbeat American Home Products into withdrawing fenfluramine from the market, the agency refused to provide to the company the original data gathered from its "Dear Doctor" letters, rendering American Home Products virtually defenseless.
Though the new "data access" law appears to be a godsend, the pharmaceutical industry, including American Home Products, has worked to block its implementation, claiming the new law will compromise medical privacy and intellectual-property rights. The data access law will do nothing of the sort. Its purpose is limited and well-defined: ensuring that federal agencies don't run amok with junk science. A recent study in the Journal of Human and Veterinary Toxicology, made possible through FOIA, refuted a widely publicized National Cancer Institute study used in the agency's jihad against the widely-used lawn herbicide 2,4-D.
American Home Products' shareholders may well be asking why the company didn't support the data access solution $8 billion ago.
Mr. Milloy is an adjunct scholar at the Cato Institute and publisher of the Junk Science Home Page.
Comments on this posting?
Click here to post a public comment on the Trash Talk Bulletin Board.
Click here to send a private comment to the Junkman.