There were so many. One of the things that really distressed me the most is that the first 13 reports labeled "valve disease" in America were sent from Fargo, N.D., to Wyeth-Ayerst in March of 1997. And the company effectively destroyed them -- or, as they like to say, "we overwrote them, we cancelled them out and later put them back in the database." FDA investigators found this out eight or nine months later, and some thought there should be action. But in the end, all the company got was a letter that basically said, "You should be better at organizing your files."

And the worst part is that in this interim period, as far as I can tell, no one from Wyeth ever picked up the phone to call the FDA and say "Hey, we've been notified by this doctor in Fargo and the Mayo Clinic that we've got a new [problem] on the horizon." The drug stayed on the market for another four or five months; they made millions of dollars more, during which time women took those drugs. One was Kim Schmidt Walker, whom I wrote about in the book. Now she's waiting for a heart transplant. She didn't take those drugs until April 28, 1997. I bet she would have liked to have known earlier that the company had already been notified that they had a problem.

Did the FDA have any power to stop Wyeth-Ayerst from selling a drug known to have serious health risks? How were they culpable in this mess?

Dr. Crary [from Fargo] sent reports in to the FDA during February and March. When he didn't get a response, he called the FDA in May of 1997, had his assistant fax 15 reports and promised 10 more. 25 reports from one city coming in, and what does the FDA official do with it? She doesn't mention it to [her superiors at the agency]. She waits a month, and then in her routine report on problems with Pondimin and Redux mentions that, by the way, there's this doctor in Fargo who's discovered something we should track.

	Also Today Better dead than fat The pharmaceutical industry hooked millions on the dangerous diet drug Fen-Phen, says a new book, by manufacturing demand and ignoring warnings. By Janelle Brown Print story E-mail story

It got buried. It was almost like it was Wyeth-Ayerst's defense being written out: "Look, even when they get bad news, the FDA doesn't know what to do with it. They process it and put it in the monthly update four weeks later!"

If I really had to choose one word to describe the FDA, I think "impotent" would do it. I've talked with staffers on the hill who deal with the FDA, and they are troubled that in the last few years so many cuts and rules have been applied. The drug company acts on the honor system: You hope they put the most important symptom first in their reports -- that they won't report a problem as "hair loss" when the person is keeling over in the cardiac ward.

Do you think the media was, in part, responsible for the fen-phen deaths? An Allure article jump-started the craze. And, as you point out in your book, much of what we read in the media about medical studies is biased, since it's been sponsored by the pharmaceutical companies themselves.

For me, that's one of the most important issues in this book: that the media as a general rule roll over, like my dachshund, for any medical study that comes along. They don't check out whether these things are legitimate or not. If you're a medical writer, these things come in to you and you don't know what's good and what isn't. It's got a big imprimatur next to it -- sometimes it will say the National Heart Lung and Blood Institute from the NIH -- and you don't know whether a pharmaceutical company has in fact sponsored that by sending money or other support.

After Pondimin and Redux were recalled, the first thing the drug company did was get a study launched on the first page of USA Today [showing the drugs were safe]. But when they tried to take the study to the New England Journal of Medicine so that they could get the Good Housekeeping seal of approval on it, the Journal said, "Wait a minute, let's recalculate these numbers." And then the study wasn't so happy. But you didn't see USA Today later running a huge article saying, "Hey, remember that front-page story saying that there was no heart problems related to these diet drugs? Whoops. It looks like it wasn't the case."

Why was Wyeth-Ayerst spending $100 million now for research, after the drugs are withdrawn? I think a lot of the research that was ginned up after the drugs were withdrawn was in part geared towards trying to convince women and their doctors that the problem was overblown. When you add up the numbers, between 6 and 7 million woman in America took these drugs. If every one of those people decided to join this giant mass settlement, at the very least just to get an expensive echocardiogram -- that's billions of dollars. That doesn't even count on paying for the damages.

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