Plenty of Villains, Too Many Victims

As Capitol Hill thrashes out the limits of a patient's right to sue health care providers, all involved should make Alicia Mundy's Dispensing With the Truth: The Victims, the Drug Companies, and the Dramatic Story Behind the Battle Over Fen-Phen a frequently consulted reference. Her book, which was in part inspired by Jonathan Harr's A Civil Action, chronicles, with passion and precision, the sequence of events that led to the Fen-Phen weight-loss drug disaster that left thousands of women dead or crippled by heart disease. She follows several teams of lawyers and doctors as they search for the truth, and she shows how the Wyeth-Ayerst pharmaceutical company, a division of American Home Products, helped precipitate a public health crisis, then peddled deadly snake oil to resolve it. Meanwhile, the government agency that should have been guarding the public interest stood idly by.

Mundy, now the Washington bureau chief of Mediaweek, has written extensively about pharmaceutical issues. Her book balances disdain for the drug company's lies and manipulation, and intense sympathy for the drug's victims. At she same time, she shows a keen, cool eye for the failings and foibles of health care professionals and plaintiffs' lawyers.

Mundy's heroes are not cardboard cutouts. In a medical journal article, the Fargo, N.D., doctor who first brought the heart problems caused by Fen-Phen to Wyeth's attention denied credit to a medical technician who noticed the problem. The lead ambulance chaser, a Boston lawyer, is an egotist and a blowhard. And the battles between plaintiffs' attorneys all over the country over strategy, turf, and their own profits are unseemly, at best.

But the lawyers weighed in after a massive failure by the Food and Drug Administration. According to Mundy's account, the agency was more a drug industry partner than a watchdog. Wyeth's behavior was despicable, but what was truly shocking was the FDA's refusal to acknowledge the company's malfeasance.

"Politics had trumped science at the FDA," the author writes. "Officials now spoke of the pharmaceutical industry, not the American people as 'our clients.' Pharmaceuticals were playing hardball like doctors at the FDA had never seen before, backed by Congress. The FDA had to accede to the new culture, or its budget would be decimated." This is how Mundy describes the circumstances under which the agency granted an unprecedented second Advisory Committee meeting to decide the fate of the Fen-Phen's sister diet drug, Redux. Mundy was lucky enough to have the assistance of a disgruntled FDA employee, Dr. Leo Lutwak, who guided her through his fight against the diet drugs within the agency.

According to Lutwak, then-FDA Commissioner David Kessler was "constantly battling the influence of the drug industry and its allies in Congress. But some of Kessler's subordinates were not of the same vertebrate class and folded easily. Life after the FDA could lead to lucrative second careers at the pharmaceuticals. The revolving door at the FDA had been getting quite a workout."

Congress was not blameless in the creation of the FDA's culture, and the pro-industry pressure did not come only from deregulation-minded Republicans. Mundy singles out Rep. Tom Lantos, D-Calif., for meeting with FDA officials to oppose an open meeting on Redux, a drug Wall Street expected to make $220 million in 1997 for the pharmaceutical firm Interneuron, another American Home Products unit. The meeting was closed, and Interneuron founder Dick Wurtman says he received a phone call from "someone affiliated" with Lantos several months later to ask for a campaign contribution to Dick Swett, Lantos's son-in-law, who was then running for the Senate in New Hampshire.

Mundy's narrative sometimes loses its way in the tangle of attorneys, company executives, doctors, regulatory details, and legal cases. But such lapses are rare, considering the ambitiousness of her investigation. And the overwhelming greed and insensitivity of the companies shine through. It seems, judging from the text and the acknowledgments, that Wyeth and American Home Products didn't cooperate with her or respond to her queries. That's a shame. Given the their conduct, it's hard to see how cooperating with the author could have generated any sympathy for them, but it would have added an interesting dimension to the story.

Mundy, however, is able to quote liberally from internal e-mails and memos that came to light in the pretrial discovery process. "Can I look forward to my waning years signing checks for fat people who are a little afraid of a silly lung problem?" one Wyeth administrator asked in a 1996 e-mail. In a 1997 memo, Wurtman wrote: "Now everything is clear. The coordinated attack on REDUX during the past few weeks is part of a conspiracy-led by FAT WOMEN ... to keep EVERYONE fat."

Throughout, Mundy is focused on the victims. She begins her book with the story of one of the "fat women," a 20-something Boston woman named Mary Linnen, who took Fen-Phen for only 23 days to lose weight so that she could fit into her wedding dress. Linnen found herself with heart disease so severe she was forced to wear an external pump with a tube that ran into her chest. For the last months of her life, she could barely risk being in crowds, or sleeping on her side, or making love. Any time of the day or night, an alarm might sound, and she would have two minutes to reset or repair the pump, or call an ambulance, before the device failed. Mary Linnen died in 1997, at age 30. According to Mundy, by the end of 2000 nearly 300,000 people, mostly women such as Mary, were joining a class-action settlement for possible heart-valve damage, and in January 2001, American Home Products increased its liability reserve fund to more than $12 billion.