When Shedding Pounds Meant Courting Danger

The Wall Street Journal, May 10, 2001

By Sally Satel

A Review of Dispensing With the Truth, By Alicia Mundy, (St. Martin’s, 402 pages, $24.95)

IT’S A BAD TIME to be a pharmaceutical company in America. Hardly a day goes by that drug makers are not blamed for pricing the elderly out of their pills or withholding AIDS cures from Africa. Meanwhile, companies have paid billions of dollars in damages for harm allegedly caused by devices and medications (e.g., breast implants, Norplant) that were later exculpated by epidemiological study.

In “Dispensing With the Truth,” Big Pharma is again in the crosshairs. Alicia Mundy tells the story of a costly tort battle, 300,000 plaintiffs strong, against American Home Products. Decades ago, the Food and Drug Administration separately approved fenfluramine (fen) and phentermine (phen) for weight loss, but starting in 1992 these drugs were prescribed together. Fen-phen became wildly popular; between 1994 and 1997 an estimated six million people took it.

Then, trouble. The first wrongful death suit (pulmonary complications) was filed in May 1997, and that summer the Mayo Clinic reported that 24 of its patients who took fen-phen displayed heart-valve problems. The Mayo study prompted the FDA to request that American Home Products, the maker of fenfluramine and the distributor of a newer sister drug (Redux), pull the medications, and it did. The phentermine half of the dyad, approved as an appetite suppressant as long ago as 1959, was not suspected and is still available.

So many lawsuits these days run counter to the evidence. But in the case of fenfluramine, there was good reason to be concerned, especially about heart-valve problems. In fact, a number of studies published after 1997 found that patients who took fenfluramine had a several-fold higher incidence of valve abnormalities compared with those who took a placebo. (Notably, though, despite the use of fenfluramine for almost a quarter-century, there had been no reports of valve defects before the fen-phen combination took off.)

What is more, many of the doctors who prescribed fenfluramine were lax about observing FDA-approved instructions. Not only was it to be used short-term (about two months), it was intended for patients with morbid obesity — that is, individuals who weighed at least 100 pounds more than normal and were at high risk for related complications such as arthritis, diabetes and infertility: people, in short, for whom a small drug-related risk was a fair trade-off. Women and men who wanted to lose 20 or even 40 pounds to look better in a bathing suit were not supposed to be good candidates for the drug, yet it was precisely those people who thronged the offices of diet doctors (and who are named in the lawsuits).

So who was to blame? The lax doctors? American Home Products for promoting fenfluramine and for trying to downplay potential lung complications? The FDA for allowing Redux to go to market when some of its own officials had reservations? The absence of rigorous side-effect monitoring? The media for hyping fen-phen as a magic bullet? The millions of flabby, sedentary adults clamoring for a quick weight-loss fix? A cosmetic culture that prizes thinness?

There are plenty of culprits, although to spread the blame around properly would require a subtle analysis of risk, regulation and responsibility. Alas, Ms. Mundy’s account is one-dimensional, with characters straight from central casting: rapacious corporate executives, creaky FDA bureaucrats and avenging plaintiff’s lawyers (who must constantly adjust their haloes as they battle the other two).

Most disappointing is Ms. Mundy’s medical reporting. She wrongly scoffs at follow-up reports suggesting that the heart-valve abnormalities were unlikely to progress (and actually often improved) after patients discontinued fenfluramine. She also plays up the drama over the first study of fen-phen, claiming that the subjects were “human guinea pigs.” But this is alarmist and naive: The study followed routine procedures for testing approved medications used in new ways (e.g., in combination).

Ms. Mundy devotes hundreds of pages to legal wrangling, trying to make it the stuff of Perry Mason drama: “Seething, Fishbein shot off a letter to the FDA requesting the depositions of Friedman, Lumpkin and others. And he asked the agency to explain what they meant in the JAMA article, noting that the MDL was in possession of 105 valvulopathy ADEs they believed the FDA had not been shown by the company.” Erle Stanley Gardner would have used fewer acronyms.

On nearly every page we encounter a lawyer who is “shocked,” “ballistic” or “apoplectic” over the nefarious tactics of his adversaries. So intent is Ms. Mundy on demonizing American Home that she overlooks perhaps the most culpable players in the story: the strip-mall “pill mills” that handed out fen-phen scripts with abandon.

Readers deserve a more sophisticated treatment of this rich story. In 400 pages, Ms. Mundy eludes any discussion of the trade-offs that are inherent in innovation — after all, even the most conscientious clinical trials cannot guarantee the absence of problems among potentially millions of users — and she fails to ask whether there are rules or mechanisms that might minimize harm while sustaining progress. Lamentably, “Dispensing With the Truth” is big on blame but thin on analysis.

Dr. Satel is the author of “PC, M.D.: How Political Correctness Is Corrupting Medicine” and a fellow at the American Enterprise Institute.