THE VIRGINIAN-PILOT
Copyright (c) 1996, Landmark Communications, Inc.
DATE: Wednesday, August 28, 1996 TAG: 9608280039
SECTION: DAILY BREAK PAGE: E3 EDITION: FINAL
TYPE: BOOK REVIEW
SOURCE: BY ANN G. SJOERDSMA
LENGTH: 89 lines
WHEN FDA commissioner David Kessler banned silicone-gel-filled breast implants in 1992 because of concern that the devices might cause certain diseases, no scientific evidence existed to prove such a risk. The implants were taken off the market not because they were unsafe, but because their safety had not been proved.
The result of this ``cautionary'' move?
Thousands of women, assisted by a national network of breast-implant lawyers, sued manufacturers, and negotiations for a massive class-action settlement soon began.
Four years later, the scientific evidence still doesn't exist. Two major epidemiologic (population) studies published since the ban have detected no increased risk of connective-tissue disease or related autoimmune disorders in women with silicone breast implants.
Yet, such implants, favored over saline-filled implants by women who enlarge or reconstruct their breasts, remain off the market, and sympathetic juries have awarded millions of dollars to women who say the silicone made them ill.
How can this be?
As Marcia Angell, M.D., convincingly explains in her superb new book, ``Science on Trial: The Clash of Medical Evidence and the Law in the Breast Implant Case,'' when money and emotion, not truth, rule the legal system, verdicts unsupported by reliable medical research result. The ``scientific method'' has little place in a court of law.
Executive editor of The New England Journal of Medicine, Angell became involved in the breast implant controversy when Kessler sent her an article about the ban. She was dismayed to learn how much he had been influenced by political pressure, public opinion and law, not science. She also feared that women would view the ban as proof of the implants' danger.
``At the time the FDA made its decision . . . we knew next to nothing. Incredibly, there had been no systematic studies of the effects of breast implants. We knew, of course, that there could be complications from the surgery itself . . . including infections and hemorrhage. We also knew that in many women the tissue around the implants scarred excessively, distorting and hardening the breasts. . . . And finally, we knew that in a significant percentage of women (the best estimates are around 5 percent) an implant ruptured, releasing silicone gel into the surrounding tissues and flattening the breast. But these local complications, unpleasant as they were, were not the basis for most of the alarm about breast implants, nor were they the focus of the multimillion-dollar lawsuits.
``Instead, a growing number of Americans had come to believe that breast implants could cause devastating effects on the rest of the body.''
Two years later, Angell, who describes herself as a feminist and liberal Democrat, received the Mayo Clinic's report of its epidemiologic study (the first) of whether silicone breast implants increase the risk of certain diseases.
The researchers found no link.
This alone, as Angell explains in an important chapter about the design and evaluation of scientific studies, does not mean that no link exists, only that objective evidence has yet to support one. Science, she notes, deals in probabilities, not absolute conclusions.
The Journal published the Mayo study shortly after implant manufacturers and plaintiffs' lawyers reached a $4.25 billion settlement (which later unraveled). Angell was immediately assailed for colluding with manufacturers, and study doctors were harassed with frivolous subpoenae to produce documents.
Struck by the discrepancy between the legal findings - a 1992 jury awarded one woman $25 million! - and the scientific evidence, Angell decided to launch an investigation into silicone implants, which were used for 30 years by millions of satisfied customers before their ban. Her book begins with an informative, largely anecdotal history of breast augmentation - the implant explosion occurred in the 1970s - and ends with justifiable concern for the future of science.
For what Angell discovered was not malfeasance by implant manufacturers, but corporate ennui compounded by government overreaction; mercenary lawyers taking advantage of contingency fees and plaintiff-friendly tort law; unethical physician-expert witnesses selling out to the highest bidder; media sensationalism fueling public hysteria; unsophisticated juries seeking to punish corporations, regardless of what the evidence shows, and much, much more - a scandal of greed, fear and ignorance.
``Science on Trial'' is a powerful tale of caution that extols critical analysis and freedom of informed choice. The final word: evidence. MEMO: Ann G. Sjoerdsma is a lawyer and book editor of The
Virginian-Pilot. ILLUSTRATION: BOOK REVIEW
``Science on Trial''
Author: Marcia Angell, M.D.
Publisher: W.W. Norton. 256 pp.
Price: $27.50 by CNB