The poison pill

The media, the government and the drug companies: They're all to blame for the fen-phen debacle, says "Dispensing With the Truth" author Alicia Mundy.

Published May 16, 2001 7:30PM (EDT)

"Dispensing With the Truth" is an exhausting book. In nearly 400 pages citing legal documents, studies, corporate e-mails, depositions and interviews, author Alicia Mundy methodically proves that the pharmaceutical company Wyeth-Ayerst knew that its fen-phen diet pills, which included the drugs Pondimin and Redux, were dangerous, but kept them on the market anyway. Thanks to corporate greed and FDA bumbling, nearly a third of the millions of fen-phen pill poppers will ultimately suffer some degree of heart and lung damage from these drugs.

The book began as an article assigned by Glamour magazine but ultimately published in U.S. News and World Report. Mundy started her search armed with just a handful of FDA documents -- most damningly, a transcript made by an FDA official of a phone conversation with Wyeth-Ayerst executive Bobby Sandage, in which Sandage reveals that the company knew about Redux's dangers and had considered withdrawing the drug's application, but didn't because it would have been financially ruinous.

Mundy, the Washington bureau chief for MediaWeek and a writer for Washingtonian magazine, is best known as the investigative reporter who originally broke the 1992 scandal revealing that top United Way executives were stealing money from the organization's coffers. Salon spoke with Mundy about the inner workings of the pharmaceutical industry, how the fen-phen tragedy unfolded and the stigma of "fat pills."

You write at one point in your book that Wyeth-Ayerst imagined their typical Redux user as "not necessarily ambitious, not very smart." Do you think that the dangers of the drug were shrugged off because fen-phen carried the stigma of being for "fat people?"

It's very distressing to tell other members of the media about this and watch them glaze over. Particularly men. They think: "Diet drugs, women's problems, who cares?" Then they get all excited about 200 deaths on the faulty Firestone tires. You look at this figure: Between the heart valve disease and lung disease, you're talking several hundred deaths so far. And 45,000 cases [of illness]. These are pretty big numbers.

At one point, I turned to a reporter and said, "If one of the side effects of this had caused your dick to turn black and fall off, it would be a major national story. There's a money trail, a paper trail, a federal whistleblower. You'd say: 'We've got to jump on this.'"

I find it fascinating and a little disappointing. It's almost as though the problems of the overweight [are] one of the last acceptable prejudices. "Put them in a corner and ignore them. They were overweight, they were probably going to die anyway."

But plenty of the women on fen-phen weren't even qualified to be taking it. You're hardly obese if you really need to lose just the last 15 pounds.

There's a stigma with that these are fat women; but in many cases they were just people just trying to lose 25 pounds for a wedding dress. There's a neighbor of mine who used to be a tennis teacher who was trying to lose those last 15 pounds you never get off. She's now a candidate for heart surgery.

Based on documents, I do believe that the company was quite literally banking on that. In the meetings with the FDA, Wyeth-Ayerst would talk about "Oh, obesity kills, this drug is needed for the morbidly obese." But they weren't planning on spending $53 million on public relations to launch a drug that was only going to be prescribed to the morbidly obese. That's not a very big number in this country.

I believe that they were counting on fen-phen getting handed out like candy at diet clinics -- which is, of course, exactly what happened. One cardiologist got called by one of the diet chains saying "You can earn some extra money every month; just fill out a pad of prescription pads for us." She declined, but I'm sure others took the bait.

What was the most shocking or dispiriting thing you came across in your research for this book?

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.

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.

This will turn your hair gray: There are many people out there who have no symptoms and in fact already have the beginnings of heart-valve disease. There's a lawyer out in the Midwest with 900 clients. Of those 900, originally 30 percent of them who had taken the drugs over a certain amount of time had no symptoms. But he made every one of them get an echocardiogram, and all but two or three did indeed have heart-valve disease. Some only had minor; some only had moderate. But the symptoms only begin to show when you get severe stages of the disease. Ultimately, you don't want to wait until so late in the game [to find out] that you need surgery when you're already in really bad shape. There's a victim in my book that died on the operating table.

And how is Wyeth-Ayerst doing after all these lawsuits?

In the end, what's amazing to me is that the company is doing fine. Wall Street has not punished this company. Earlier this year Wyeth announced that it was having to increase the money it had put aside for liability in these diet drug cases. It had told its stockholders at the end of 1999 that it had the problem covered with about $4.75 to $5 billion. Now, a year later, they are saying they need $12.25 billion. I think you can buy a small Asian country for that amount of money. This is double what they had put aside before, and Wall Street didn't even burp.

What do Americans need to know about drugs and pharmaceutical companies that they don't?

Don't take anything that hasn't been on the market a year. That's one piece of good advice.

Most people think that the warning label that comes on the drug is what is supposed to be on the box -- that it is what the FDA wanted. What this book makes clear is that companies will do anything to avoid a very strong warning label against the drug. Companies will bring in anyone -- politicians and celebrities -- to convince the FDA not to put a "black box" [a warning of severe side effects] on the label. Because once doctors see a black box on the label, they think that, unless it's a cancer or diabetes or AIDS drug, it must have enough bad side effects that they shouldn't prescribe it to anyone. A weight loss drug with a black box probably would not have sold very well.

Americans and doctors look at the drug label, see a tiny warning but it's not in boldface, and think that it must mean that the FDA doesn't think it's serious. No, that means that the FDA was arm-wrestling with the drug company -- you have no idea whether the FDA thought the side effect was serious. All the label represents is a negotiation with well-paid lobbyists and FDA doctors. It's important to know.

The idea of affordable losses was brought up several times during the work, pharmaceutical companies arguing that a few people might get ill but that it was for the greater good. Did you agree with this? Was the drug useful for the obese?

There was a 3 percent difference between this drug and a placebo -- not to mention the fact that many people gain the weight back. That's from their own files.

No drug is perfectly safe; some people are going to have reactions. I know that will happen. I'm not saying that everything had to be 100 percent safe. And I'm not saying for a second that there weren't morbidly obese people who need something to jump-start a healthy weight loss program. This drug worked for many people, at least initially.

But then they'd get their appetite back again. In a couple months they regained the weight, even if they stayed on the drugs. In the end, you find out that this whole 'Obesity Kills!' campaign [a P.R. campaign in the late '90s that blamed obesity for 300,000 deaths each year] was in part being encouraged and financially supported by the drug company. This is the oldest thing in advertising: Create the demand and then sell the product.

In the end, how many people developed heart and lung disease after taking the drugs Pondimin and Redux? You write that 300,000 had joined the federal mass settlement; were that many people actually ill?

About 365,000 people have opted in to the giant federal settlement. Many of them may have no problems at all and may just want to get monitoring. Some of them will have problems, and they will be paid damages one way or another through that settlement. They can also opt out and sue on their own.

The company acknowledged a few months ago that it had cleared up about 45,000 individual cases [of sick fen-phen users] which would be an epidemic in my terms; the numbers could be as high as 100,000.

The Mayo Clinic has not backed down from their original studies, which said that basically between 25 to 30 percent of the people who took the drugs three months or longer were likely to develop heart-valve disease. Luckily, what they found out is that some women who took the drugs for a short time or developed only the most minor damage -- in about a third of those cases [the patients] have been lucky enough to have the disease regress. But the other two-thirds are staying the same or getting worse. And there is a latency problem: It can take up to six years to show up.

What impact do you want your book to make?

Seven drugs have been approved and withdrawn in the last three years. That's a lot of drugs that got approved during this new speeded-up approval process. You see the pattern: The FDA caves in; the company doesn't want a strong label; the drug gets put on the market, people die; the drug is recalled. You find out that the drug company fought having a strong label -- no black box, no warning words in big bold letters. You find the same names at the FDA rolling over and giving up to the pharmaceutical companies.

This is what we will keep seeing until someone, somewhere, gives the FDA power again to exercise over the companies. When are they going to learn?

By Janelle Brown

Janelle Brown is a contributing writer for Salon.

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