Almost five years after the Food and Drug Administration announced a partial ban on silicone breast implants, billions of dollars' worth of litigation seems no closer to settlement. In the wake of the ban, tens of thousands of American women joined in a class-action suit against implant manufacturers, including the largest, Dow Corning, which as a result of the suit filed for bankruptcy in 1995. There are, in addition, perhaps tens of thousands of individual lawsuits pending in various American courts.
In 1994, manufacturers agreed to the largest class-action settlement ever -- $4.25 billion -- but it was not enough to cover all of the claimants who said their implants made them sick. Last month Dow Corning proposed setting aside up to $2 billion to settle claims as part of its bankruptcy reorganization plan. But most of the money would only be available if a "science trial" determined that implants cause diseases. Women in the United States had until last Wednesday to file claims; those living overseas have until February 14th. On Jan. 11, plaintiffs' attorneys requested permission to file a competing payment plan.
Some medical experts have criticized the proceedings as a colossal waste of money because, they say, the notion that silicone implants cause harm is unproven at best and a scam at worst. Salon talked with one of those critics, Dr Marcia Angell, M.D., Executive Editor of the prestigious New England Journal of Medicine and the author of "Science on Trial: The Clash of Medical Evidence and the Law in the Breast Implant Case" (W.W. Norton, 1996).
In "Science on Trial," you contend there is no proven link between breast implants and serious disease. You say the breast implant case got as far as it did because of our embrace of "junk science."
I used the breast implant controversy as an example of a growing phenomenon: the disconnect between scientific evidence and the way scientific questions are handled by the public, the media and in the courtrooms. Whether breast implants cause disease in the rest of the body is a scientific question. It's not a matter of opinion; it's not a matter of an adversarial process. Yet what we're finding is that people are pulling answers out of the air based on greed and bias and fear and anything but science.
How did people get to "pull answers out of the air"?
The media, at least initially, slavishly accepted the view that breast implants were dangerous devices foisted on the unsuspecting public by the greedy manufacturers, and the FDA had been complicit in covering it up. They accepted the story whole cloth and broadcast it to the public, and the public took that point of view. Add to that the fact that the plaintiffs' attorneys and some of their clients stood to make a great deal of money on the premise that breast implants cause serious disease, and the rest was almost inevitable.
As editor of the New England Journal of Medicine, how did you become interested in this controversy?
Initially because David Kessler, the head of the FDA, when he decided to ban silicone gel-filled breast implants in April 1992, submitted an article to us explaining why he had taken this decision. I was quite happy to publish it. I thought it was important. Yet as I read the article it struck me that he was making a mistake. He acknowledged there was no evidence that the breast implants were dangerous. But, he said, since the manufacturers had not fulfilled their obligation to show that they were safe, he was going to take them off the market. I thought that since a million or so women already had them and there was no evidence -- despite the fact that they'd been on the market for about 30 years -- that they caused dreadful diseases, that he would do well not to alarm these women. That he should have been more circumspect.
He should have insisted that the manufacturers generate the data they are supposed to generate. He could have penalized them in one way or another, but to yank them off the market in the face of the fact that a million women already had them and would be terrified by the implication of this, was, I felt, a misjudgment.
Did you have any preconceived notions about breast implants?
I had never thought about it before one way or the other. About the only position that I had was a great belief in patient autonomy. And a part of Dr Kessler's decision had to do with women who had breast implants for cosmetic reasons versus those who had them after mastectomies for breast cancer. What he said was, those who'd had implants for cosmetic augmentation would not be able to obtain silicone gel-filled breast implants at all. Whereas those who were getting them for reconstruction could do so only if they agreed to be in clinical trials. I felt that this was an invidious decision. It was in a sense passing judgment on women's reasons for doing it, that it was in some sense paternalistic.
You've described yourself as a liberal democrat and a feminist.
Yes. And I thought he was treating women like little girls.
Which, you think, helped generate the subsequent fear and hysteria.
In the editorial I wrote accompanying Dr. Kessler's paper, I said what I've just said to you: that I thought he made the wrong judgment and that it would lead to unwarranted alarm. And it did. Women rushed to court, rushed to their plastic surgeons to have the implants removed. A lot of women did both. There were even women who tried to carve out their own implants with razor blades because they thought they couldn't afford the plastic surgeons' fees. There was hysteria which the plaintiffs' attorneys jumped right on, and the trickle of lawsuit that had been going on throughout the '80s suddenly swelled to a torrent. Dow Corning alone had some 20,000 lawsuits filed against it in the two years after the ban.
But in the lawsuits, some of which have resulted in huge awards to the plaintiffs, there was testimony from scientific experts about the harm.
Yes. What they do is they get someone who has minimal credentials. They can be scientists of no particular distinction and in a field that's irrelevant to the case in question, and they come and give their opinion and that's called scientific testimony. In fact their opinion can be little more than an educated guess. And in this case, it was a bought educated guess.
Dow Corning, in its bankruptcy reorganization plan filed with the court, is proposing what's been called a "science trial" with an advisory panel of scientists.
That's something I recommend strongly in the book. Instead of judges relying on experts produced by the two sides and paid by them, guaranteed to say what they're supposed to say with no particular evidence, the judges could find independent experts who would testify on the basis of the science --for example what has been published in the peer-review literature on this subject -- and would interpret that science for the judge.
A federal judge in Oregon, Judge Robert Jones, just did this in a breast implant case and I think it's a beautiful decision. He called four independent medical experts -- an epidemiologist, an immunologist, a rheumatologist and a toxicologist -- consolidated 70 cases in his district into one, and had them listen to all the testimony from both sides for four days, based on the scientific literature that supported each side's point of view. At the end, the independent panel wrote an evaluation of what it had heard. On the basis of those evaluations, which were scathing, the judge threw out the cases altogether. There was not one bit of evidence for the plaintiffs that met the standards set by the Supreme Court in 1993 -- that expert testimony must be both reliable and relevant.
Now a federal judge in Alabama who is overseeing a settlement involving three other implant manufacturers is doing the same thing.
Yes, but his panel won't issue its findings for probably another year. A district judge in New York is also doing the same thing. So I think the tide is turning against junk science in the courtroom. Judges are beginning to say, "Wait a minute, we've got to stop this stuff." Just having some man in a white coat saying, "Yeah, breast implants cause disease" is not the same thing as scientific testimony.
What about the argument that scientists can't find the "link" because they are looking for the wrong thing, that in fact what the plaintiffs have is not a traditional auto-immune disease, it's a new disease, "silicone toxicity"?
Well, prove it. From what I've read nobody has come up with a consistent description of this non-classical disease, much less objective criteria that can be measured. It's not enough to assert that there's this crazy disease that breast implants cause. OK, prove it, and I'd be the first the say, well, you've proved it. I know of no such studies. Speculation is no substitute for evidence.
Some critics have called "Gulf War Syndrome" junk science. But an article in the Journal of the American Medical Association earlier this month suggested there might be such a syndrome, caused by a combination of usually harmless chemicals. It strikes me that the jury is still out on this one.
Oh, you bet. But if you assert that chemicals in the Persian Gulf cause these diseases, the burden ought to be on people to show that they indeed have definable diagnosable disease caused by chemicals. It's not enough to say, "Oh, there was a place that was blown up and it's conceivable there were chemicals and it's conceivable that 20,000 people were exposed, and it's conceivable that instead of acting immediately, as sarin [a nerve gas] is known to act, it took a long time." Yes, it may be so, but it must be demonstrated. Otherwise you're just dealing with speculation and speculation is no way to reach a decision about something like this. This is not to say that the Persian Gulf War Syndrome couldn't be a real phenomenon caused by chemicals released in the air during the war, but we don't have the evidence.
Prospective plaintiffs might say, it's all very well for science to look at this, but science moves so slowly.
Yes, and that's the way it is. Having the judgment made in the absence of evidence that yes, chemicals caused your disease, I'm not sure would help the victims at all. They still have the disease. And they're still getting medical care, which in the army is free.
Why has "junk science" in general become so widespread? You've talked about health scares sweeping the country like locusts.
I think there is a lot of anti-science feeling, a kind of reaction against the sort of privileged position that science and scientists have had. There's also a kind of know-nothingism -- "Gee, this is hard, it makes my head hurt, why should I have to make my head hurt? It must be because these guys don't know as much as they think they do." Multiculturalists, feminists and others who are in many cases rightly resentful of the position of white men in our society, sometimes reject science in the process of rejecting the dominance of white men. That's a mistake.
And there's greed. In the breast implant case, there was a lot of money, and there still is -- billions at stake.
You describe it as a case of "follow the money."
Well, it's better than Perot
I have founded my own political party in Serbia. The Party of Ordinary Drunkards. We believe all people should be allowed to drink in peace and all taxes on alcohol and tobacco abolished.
-- 44-year-old Serbian rock star Bora Djordjevic, the "Bob Dylan of the Serbian protest movement." (From "Rocker's Raucous Role: Jeer Leader for Serbia" in the Friday, January 17 New York Times)