WHO’S TO BLAME FOR REDUX AND FENFLURAMINE?

Question: who’s to blame for letting the public gobble up potentially deadly diet pills like so much popcorn? Choose from among the following: 1. The U.S. Food and Drug Administration, which brushed off scientists’ misgivings to approve the pills last year. 2. The drug companies that produced, tested and zealously promoted the pills. 3. The doctors and diet clinics that eagerly dispensed them, even to patients for whom they were never intended. 4. Uncritical media that ballyhooed the pills as “miracle” drugs and “magic bullets” in the war against fat. 5. A fanatically weight-conscious public so eager to shed pounds that it demanded the pills at any cost.

If the finger pointing that followed last week’s abrupt withdrawal of two of the country’s favorite diet pills looked like a multiple-choice law-school torts exam, the similarity was hardly coincidental. Even before the FDA urged the recall of Redux (dexfenfluramine)–and Pondimin (fenfluramine), the front half of the fat-pill combo known as fen/phen–scores of lawyers across the nation had already started filing lawsuits. After the recall, the legal assault turned into a stampede. “Everyone saw money,” says Jacoby & Meyers’ Gail Koff.

Some attorneys even took out newspaper ads desperately seeking any individuals who felt they had been hurt by the capsules. New York lawyer Paul Rheingold, author of four suits so far, describes the diet-pill debacle as such “easy” pickings that he expects “many thousands of lawsuits scattered all around the country.” Eventually, say some analysts, the Redux-fenfluramine recall could grow into one of the biggest medical-liability cases in history, perhaps exceeding the anticipated $2.4 billion from silicone breast implants.

Much of this legal furor is being vented against Wyeth-Ayerst Laboratories, a subsidiary of American Home Products, which makes fenfluramine and distributes dexfenfluramine, and Interneuron Pharmaceuticals, a small Lexington, Mass., firm founded by the M.I.T. neurologist who developed Redux. There’s also talk of bringing action against the FDA–though federal law usually protects government officials from suits challenging routine performance of duties like approving drugs. Whatever the outcome of the legal battles, they leave unsettled larger societal questions–about Americans’ infatuation with quick-fix remedies for whatever ails them, real or imagined, and their doctors’ willingness to cater to it.

When fenfluramine was approved in 1973, the FDA declared it safe for short-term use. The assumption: that it would be prescribed for only severely obese patients who seemed impervious to other treatment–“not,” as University of Pennsylvania cardiologist Frank Silvestry puts it, “to get into a bikini or wedding dress.” But in 1992 all that changed. Studies showed that if fenfluramine was taken with a kindred drug, phentermine, the euphonious fen/phen duo would help dieters shed pounds not only faster but with few side effects. Although the drugs were never approved for combined use, doctors exercised their right to prescribe them “off label”–and that usually meant together. The combo quickly became one of the drug industry’s hottest sellers.

There were skeptics even then. The little capsules, they warned, were only a stopgap, not the final answer to obesity, which is still handled best by eating less and exercising more. They also pointed to unknown dangers from long-term use as well as evidence suggesting a risk of neurological damage and a rare but fatal lung disease.

These cautionary words were all but lost in the hype surrounding the FDA’s approval of Redux in April 1996 (after a scientific advisory panel initially voted 5 to 3 against approval). By June, U.S. doctors had scribbled nearly 2.5 million prescriptions for Redux, and the number of people exposed to the drugs rose to an estimated 60 million worldwide.

Then the bubble burst. In July, Mayo Clinic doctors reported finding serious heart-valve damage in 24 fen/phen users. Several had to have valves replaced. Alarmed by the Mayo reports, other doctors began looking more closely at their fen/phen patients and found similar problems. The FDA sent a warning to physicians but stopped short of further action. Barely two months later, heart-valve problems were reported in 30% of 291 patients taking fen/phen or Redux, and the agency asked the companies to recall the drugs.

So who’s to blame? The correct answer is, all of the above.

–By Frederic Golden. Reported by William Dowell and Jane Van Tassel/New York and Dick Thompson/Washington