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SCIENCE ON TRIAL: THE CLASH OF MEDICAL EVIDENCE AND THE LAW IN THE BREAST IMPLANT CASE, by Marcia Angell, M.D.

by Caitlin Burke

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Marcia Angell, the executive editor of the New England Journal of Medicine, is an intelligent, educated woman who has written an obviously well-researched book about the breast implant controversy. So why was I so resistant to her thesis? It has several parts, all of which are fairly straightforward and even intuitive: science and the legal system use different methods to obtain results; this gets sticky when the legal system evaluates scientific questions; most Americans don't understand science well enough to understand why this is so; the legal system could use a few changes; and, boy howdy, is the breast implant case sure a great example of all of the above. Unfortunately, she doesn't stop there. And while the way in which she provides context and explanations for her arguments is often compelling and easy to follow, Angell is mired in some methodology issues of her own.

Marcia Angell is like just about everyone who has had anything to say about the breast implant case: She wants to point fingers. Plaintiff lawyers and the media want to point fingers at breast implant manufacturers, and Angell wants to point fingers at the legal system and the media. She's also frustrated by doctors who have, in her view, taken advantage of the money involved in breast implant cases by testifying on the behalf of plaintiffs (this excludes patients' physicians, who often testify to avoid being sued). She couches her finger-pointing in a discussion of the different methodologies used by science and law -- the scientific method of inquiry versus the adversarial system that actually assigns responsibility -- but far from simple evaluation, her primary task is to demonstrate the inferiority of the legal method.

There's nothing wrong with attacking the U.S. legal system. A bloated and arbitrary creature in many ways, our legal system combines theatre and the Roman circus and, at least for civil cases, seems to exist primarily to redistribute money, especially to lawyers. It is particularly appropriate to recommend that the legal system have more respect for scientific method in the course of evaluating scientific questions, and the breast implant case is truly a fine example of a horrific failure to do this. Angell offers a number of interesting suggestions for legal reform, mostly along the lines of making personal injury law less lucrative and making the admission of scientific evidence as nonadversarial as possible. But Angell also wants to make points about the "growing" anti-science sentiment of Americans, as if this is a new phenomenon, and she is interested in devaluing just about any system of evaluation that is not the scientific method.

Angell is impressed with the work of Paul Gross and Norman Levitt, authors of Higher Superstition: The Academic Left and its Quarrel with Science, and she certainly emulates their methodology. Angell, of course, is a doctor; Gross is a biologist, and Levitt is a mathematician. Angell cites Gross and Levitt's assertion that literary criticism is "implicitly" ranked "lowest" in intellectual prestige in the academy, apparently in support of a notion that science "became" prestigious after World War II -- both of which are somewhat ahistorical (as well as debatable), as is the charge of a "new anti-intellectualism" in general. Like Gross and Levitt, Angell falls into the trap of applying the scientific method to every cause for evaluation she comes across, humorlessly overemphasizing radical rhetorical strategies and, with almost painful irony, amply illustrating why she really shouldn't be criticizing the folks who say there is no such thing as "value-free research."

The scientific method is an excellent tool, although its superiority to rhetoric across the board is questionable, but Angell seems to want both rhetoric and science in her argument of the breast implant case. For example, although she refers to "several" or "many" studies that fail to support a link between silicone leakage and autoimmune disease, she only actually describes two of them: the Women's Health Cohort study and the Mayo Clinic study (there seems to be a fleeting reference to a third study as well). She frequently explains that one study showed a small effect, which she describes as "hard to interpret," while the other showed no effect. She also points out that the Mayo Clinic study (no effect) involved a sample size so small that implants could in fact be associated with a tripling of risk of autoimmune disease without being detected by the Mayo Clinic's study. If, in fact, such a risk exists -- even if it is very small -- patients might well want to know about it, and product liability law might well encompass an interest, too. Yet somehow this information is adduced to support the contention that breast implant lawsuits are spurious.

Angell became interested in the breast implant issue when FDA Commissioner David Kessler, M.D., J.D., submitted an article to the New England Journal of Medicine about his decision to ban implants. Kessler cited several reasons for the ban, such as the manufacturers' inadequate safety data, but his decision certainly had a political component. Angell faults him for patronizing women, for belittling the choice to obtain cosmetic surgery and for seeming to suggest that breast implants confer no benefit and should therefore present no risk. A number of women considering implants might agree that for the kind of benefit implants confer, a tripling (for example) of even a small risk of autoimmune disease -- whether it's scleroderma, lupus or something new -- is simply not worth it. More to the point, caveat emptor is not the philosophy of product liability law any more than it is of the FDA, as Kessler underlined in his explanation. Angell seems to suggest that "hard to interpret" or very small risks are not the province of law, in part because we happily take small risks every day, but this seems to dismiss the very purpose of the FDA and it certainly doesn't admit a very large view of product liability.

Angell makes a detour from the breast implant case in a chapter describing methodologies and phenomena that, in her view, signal a new disrespect for the scientific method. These are typically popular phenomena, such as "alien abduction," or fashionable minority academic approaches, such as those criticized by Gross and Levitt. She suggests, for example, that "[anti-science feminism] plays into the anti-feminist conceit that women can't get their little minds around scientific concepts." While it may be true that some radical feminists want to "dismiss science altogether," it is interesting that Angell finds their view somehow less acceptable than her apparent approach -- that the scientific method is always the superior, if not in fact the only approach.

One of the great strengths of science is alleged to be its ability to pose testable hypotheses and to create conditions under which confounding variables can be controlled. These principles don't merely suggest that there are methodologies other than science, they dictate that. It may be that Angell is not interested in questions that cannot be evaluated scientifically. Very well. Then she might forebear to comment on the methodologies that may usefully be applied to more subjective questions. None of the issues raised in this chapter detract from Angell's comments about the legal system, but they certainly provide unnecessary amplification of her bias.

Marcia Angell believes in objective truth and science's ability to detect it. At the same time, she describes science as offering only tentative conclusions that must add up to, one presumes, truth in the aggregate. The only methodology that can answer a question, then, never actually provides a single, clear answer -- a rhetorical strategy worthy of lawyer. While Angell is hardly objective, Science on Trial remains interesting, informative, readable and thought-provoking, and Angell's bias is so obvious and consistent that it only grates seriously when she argues about the "new rejection of science." Dorothy Nelkin, in Selling Science: How the Press Covers Science and Technology, offers a much larger and more sophisticated view of medical reporting and the interaction between journalism and medicine, but Angell certainly makes some very interesting and eminently useful suggestions of ways in which the legal system can more accurately take account of scientific evidence while ably showing the complexities of the breast implant controversy.

The Breast Implant Controversy: A Snapshot in Documents and Pointers offers links to FDA breast implant advisories, other institutions, grassroots organizations and other WWW information about silicone-containing breast implants.

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