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David Gergen, editor-at-large of "U.S. News & World Report," engages Dr. Marcia Angell, executive editor of the "New England Journal of Medicine," and author of "Science on Trial: The Clash of Medical Evidence and the Law in the Breast Implant Case."

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DAVID GERGEN: Dr. Angell, your book is very much rooted in the controversy over breast implants. Let’s start there so people understand the background to the argument you make in your book.

DR. MARCIA ANGELL, Author, “Science on Trial”: Well the breast implant controversy was the most extreme example of the crazy way that we deal with health risks in this society. Here is a device that 1 million women had, they had been in use for almost 30 years, there were a few court cases, high stakes court cases, in the 1980's, and then the FDA banned them in 1992, just took them off the market.

DAVID GERGEN: Because there was no evidence from the manufacturers--

DR. MARCIA ANGELL: Exactly.

DAVID GERGEN: --that they caused--that they were safe.

DR. MARCIA ANGELL: Exactly. Exactly. The FDA requires that the manufacturers prove that they’re safe.

DAVID GERGEN: Right.

DR. MARCIA ANGELL: FDA doesn’t have to show that they’re dangerous. The manufacturers have to show that they’re safe. Well, they hadn’t done that. And so Dr. Kessler, the commissioner of the FDA, pulled them off the market. Then there was a flood of lawsuits. There had been a trickle through the 80's, but this became a flood--twenty thousand lawsuits, uh, that were filed against Dow Corning in just two years after the ban. Then the largest class action settlement in history--$4.25 billion awarded by the major implant manufacturers to all women who had breast implants--and only after all this had happened--two months, in fact, after the class action settlement was announced was the first scientific study published, and that study could find that breast implants did not cause the widespread systemic diseases that they were accused of causing.

DAVID GERGEN: The process was just backwards.

DR. MARCIA ANGELL: It was backwards. That’s right. You would think that you’d have the scientific evidence first and then have the lawsuits and the ban, but, instead, we have the ban, the lawsuits, and then the scientific evidence.

DAVID GERGEN: And so, in effect, the manufacturers felt forced to pay for damages which they had not caused.

DR. MARCIA ANGELL: That’s right, because it was becoming too expensive to defend each of those cases in court. All it took was a couple of high stakes wins for them to be brought to their knees essentially.

DAVID GERGEN: When you set out to do your book, you said you had a predisposition to the thing that perhaps the companies were largely at fault, but that’s not what you concluded after you looked at it.

DR. MARCIA ANGELL: I had a political predisposition to believe that. I’m a liberal Democrat, and I was only too ready to see the companies at fault, but I didn’t have a scientific predisposition to believe that. I’m a scientist, after all, and I don’t believe anything until I see the evidence.

DAVID GERGEN: And you found the major fault lay where?

DR. MARCIA ANGELL: I think that the plaintiffs’ attorneys, if I had to--

DAVID GERGEN: With the bar, with the legal profession.

DR. MARCIA ANGELL: Yes. If I had to name one set of villains, I think it would be the plaintiffs’ attorneys, but they weren’t alone. And part of it is a system in which they work, the tort system. Uh, in, in product liability suits, expert witnesses are called and they say whatever they want to. They can give little more than an educated guess in the courtroom. They don’t have to point to evidence. They don’t have to point to peer-reviewed evidence in the medical literature. They just say whatever they think. They’re hired by the adversaries. They’re paid by them. They rehearse in advance, and they’re arguing before juries. We’re the only country that uses juries for tort cases. So here highly technical matters, they’re being played out before juries by experts who may or may not have evidence, who in a sense are performers. And the jury sides with whoever gives the best performance in a sense.

DAVID GERGEN: Now money, in part, is driving the tort system. The lawyers in this case, and the settlement of the $4.25 billion that was involved in this settlement, the lawyers made a billion dollars out of it.

DR. MARCIA ANGELL: Well, they--that settlement collapsed because big though it was, it wasn’t enough to cover all the claims, so that settlement collapsed. But, yes, 1 billion [dollars] out of 4.25 [billion dollars] and that was considered just a little bit too little. That was 25 percent, whereas, in general, plaintiffs’ attorneys make 30 to 40 percent of whatever they can get. So one case, for example, a woman was awarded $25 million and her attorney was to get 40 percent of that.

DAVID GERGEN: So there’s an incentive for the trial lawyer to bring the suits because they can get--

DR. MARCIA ANGELL: Absolutely.

DAVID GERGEN: There’s a big bonanza if you win.

DR. MARCIA ANGELL: Absolutely.

DAVID GERGEN: There’s an incentive for the expert witnesses to come in and say whatever they’re paid to say--

DR. MARCIA ANGELL: That’s right.

DAVID GERGEN: --because a lot of money is--

DR. MARCIA ANGELL: And some of them became very good at it. They testified in case after case. They got better and better at it, and they made a good living that way.

DAVID GERGEN: Right. And the juries can often be swayed by emotion.

DR. MARCIA ANGELL: Sure, sure. They see a woman in front of them. She may genuinely be ill. We don’t know whether it was caused by the breast implants or not, but she may be sick. She’s appealing, and on the other side is a big, impersonal, rich company, so the juries have a sort of Robinhood mentality. They want to even it up, and they do.

DAVID GERGEN: So how would you deal with the scientific witness that says science is at the basis of the court case, as opposed to the expert witnesses who are paid to say things?

DR. MARCIA ANGELL: I think that judges, judges should call expert witnesses for the court, neutral expert witnesses, who will testify on the state of the science to the judge, rather than the judges, the court relying on experts called by the adversaries. The judge should call the experts for himself.

DAVID GERGEN: Now they’re empowered to do that now.

DR. MARCIA ANGELL: They are. They have that option, but for some reason, they don’t exercise that option very much. I think they’re committed to the adversarial system. They believe in it. They believe that anything can be found out through argument, through controlled argument, but science can’t.

DAVID GERGEN: You also thought that the medical profession was complicit to a degree.

DR. MARCIA ANGELL: Not as a profession.

DAVID GERGEN: Not as a profession.

DR. MARCIA ANGELL: But there was--

DAVID GERGEN: Some practitioners.

DR. MARCIA ANGELL: --a collection of, of doctors who were, in essence, looking at patients who were sent to them by the plaintiffs’ attorneys, who were paid by the plaintiffs’ attorneys, who were giving the diagnosis that the plaintiff’s attorney wanted to hear, and who would come to court and testify as expert witnesses.

DAVID GERGEN: And you also put some of the blame on the journalistic profession.

DR. MARCIA ANGELL: Yes, yes.

DAVID GERGEN: And we shouldn’t leave that out. Because the sense--we create an alarm a day in the health care field in America.

DR. MARCIA ANGELL: Exactly.

DAVID GERGEN: We’ve become sort of overwhelmed with a sense they’re living in a sea of causal--

DR. MARCIA ANGELL: Absolutely.

DAVID GERGEN: --disorders.

DR. MARCIA ANGELL: Absolutely. There are waves of health arms that spread like locusts across the lands. I wrote the book because the breast implant story was the most extreme example, but by no means the only one. We can see it in electromagnetic fields, for example. People don’t look at the evidence. They say, oh, my gosh, here’s another health risk, here’s something else that’s going to kill me out there, and probably the big companies know about it, and probably the government is covering it up, I’d better go to court. There is that, that predilection. I think the media plays into it.

DAVID GERGEN: How do we deal with this anti-scientific feeling in the country and the lack of understanding of science?

DR. MARCIA ANGELL: Well, I think that we have to learn as kids in school about the way scientists think, about evidence, the role of evidence. In science, the conclusion follows the evidence, and until that evidence is there, you can’t say anything. You must wait. You can’t jump to conclusions. You must follow the evidence. In the courtroom, for example, it’s just the opposite. The expert’s opinion is the evidence. The conclusion comes first. Science, good science holds back until it sees the evidence. Something has to be counted, something has to be measured. In the case of the breast implant controversy, what was needed was an epidemiologic study to look at whether connective tissue diseases were more common--that is autoimmune diseases--were more common in women with breast implants than women without. If they weren’t more common in women with breast implants than women without, then there was no basis for saying that the breast implants caused the diseases.

DAVID GERGEN: And your final word, it would be a word of reassurance to American women who’ve had breast implants, that they should not be--

DR. MARCIA ANGELL: They have local effects. I don’t want to minimize the local effects, the effects of scarring around the implant--

DAVID GERGEN: Right.

DR. MARCIA ANGELL: --rupture--but as far as disease in the rest of the body, dread diseases, autoimmune disease in the rest of the body, if there is any connection, it’s very, very small at most, so, yes, women should be reassured.

DAVID GERGEN: Dr. Angell, thank you very much.

DR. MARCIA ANGELL: My pleasure.

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