Ready for another product liability bonanza? Personal injury lawyers and government bureaucrats are producing the sequel to the silicone breast-implant fiasco. This time the villain is fenfluramine. The "fen" in the popular and effective diet drug combination fen-phen was yanked from the market this summer.
The trouble began with a Cable News Network story in July linking 24 cases of valvular heart disease with use of fen-phen a mix of fenfluramine and phentermine. But the story was based on a preliminary study. It didn't confirm the cause of the valvular abnormalities or even that their incidence was greater than what would have occurred with or without the drugs.
In fact, the study didn't compare the rates of valvular heart disease between fen-phen users and nonusers. There were no data on the role obesity itself might play. Only five of the reported cases bad been confirmed by testing actual tissue.
The exact number of fen-phen users is unknown. Because the combination of drugs was never approved by the Food and Drug Administration - nor need it be for physicians to prescribe it - the number of fen-phen users is estimated in the millions.
Despite such wide use and the absence of previously reported side-effects, crude and inconclusive information was enough to put fen-phen in the FDA's cross hairs.
Right after the CNN broadcast, the FDA mailed a "Dear Doctor" letter requesting information about valvular heart disease in fen-phen users. By August, the FDA had collected 92 reports of disease among, 291 patients tested.
Within days and despite the availability of less drastic options. the FDA persuaded drug-maker American Home Products Corp. to pull fenfluramine and another diet drug, Redux, from the market "voluntarily."
Though phentermine is still available, it is not effective without fenfluramine. That has left millions of fen-phen users - including some suffering life-threatening "morbid obesity" out in the cold. But not the lawyers, Things are just heating up for them.
The wining formula - for the. lawyers, that is --- debuted in '92 when then-FDA Commissioner David Kessler virtually banned silicone breast implants. Then, as now, evidence of the products' harm was sketchy at best. It didn't matter. Within months, thousands of lawsuits were filed against implant makers.
Given the nod from the FDA, lawyers extorted a $4.25 billion settlement - one that stands despite later epidemiological studies that deny the harm of implants. So why mess with success?
By mid-September, about 100 fen-phen-related suits had been filed. Lawyers trolled for clients by advertising in major newspapers and TV Guide, declaring unequivocally that fen-phen caused injuries.
Web sites now abound. One syndicate of enterprising lawyers sells $250 subscriptions to a fen- phen newsletter. And mid-November saw an international conference of personal injury lawyers highlighting fen-phen litigation. In the words of one lawyer who personally has filed 60 fen-phen lawsuits, "Bingo!"
But the lawyers shouldn't turn in their Bingo cards yet. One survey found that of 746 patients treated with, only 57 cases of heart valve problems were reported -- a rate of less than 8% compared with 32% in the initial FDA survey.
This lower rate may approximate the "baseline" rate of heart valve disorders among obese people likely to take fen-phen. So obesity may be the cause of most or all of the cardiac abnormalities.
Not wishing to confuse the issue with facts, the FDA staunchly defends the drugs' recall, insisting that the 32% valvular anomaly rate-will be validated by forthcoming test results.
Incredibly. when American Home Products requested the original survey data on the 291 patients, the FDA stonewalled. Echoing the Environmental Protection Agency's defense earlier this year when asked for data supporting proposed air-quality standards, the FDA claimed the data weren't its to give.
The FDA's attitude is summed up best by its director of epidemiology, who said "We've done our job. We've done what is necessary to determine there is a problem.... Other information is up to (American Home Products) to find out."
What job is he talking about? Scaring people with inconclusive data? Launching massive personal injury litigation? Fattening up the personal injury lawyers -- who, not coincidentally, have contributed handsomely to Democratic Party campaign coffers?
It's time to put the personal injury lawyers on a diet. And since fen-phen is no longer available, here's the prescription: Curb the FDA's practice of "Shoot first; ask questions later."
Steven J. Milloy is executive director of the Advancement of Sound Science Coalition in Washington, D.C. Henry I. Miller is a senior research fellow at the Hoover Institution in California and was an FDA official from 1979 to 1994.
Material presented on this home page constitutes opinion of the author.Copyright © 1997 Steven J. Milloy. All rights reserved. Site developed and hosted by WestLake Solutions, Inc.