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.

	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

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?

The Free Software Project
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