Silicone studies, sensationalism, and stats
EIGHT YEARS AFTER the U.S. Food and Drug Administration subjected them to study, silicone breast implants are still drawing media attention--and raising questions about exactly what constitutes fair journalism.The controversy began in June 1988, when the FDA asked implant manufacturers to prove their safety and efficacy. (Actually, manufacturers had lost several lawsuits before then, but the cases received little publicity.) Still, media coverage didn't take off until "Face to Face with Connie Chung" aired the issue in December 1990. Chung interviewed five women, all of whom had implants, were ill, and believed the implants were causing their diseases. Media watchers credit that one program with setting off a chain reaction of similar shows, a national panic, and, ultimately, lawsuits settled for millions of dollars.
The early flood of coverage did not attempt to focus on scientific evidence, say some experts. Coverage "grew more sensational and uncritical with time," says New England Journal of Medicine executive editor Dr. Marcia Angell, in her forthcoming book, Science on Trial: The Clash of Medical Evidence and the Law in the Breast Implant Case (Norton, 1996). "The premise that breast implants were dangerous seemed to be tacitly accepted. The story played both to the American fascination with newly discovered mass health hazards and the penchant to assume a coverup in any disaster. Instead of presenting a complicated health story, the media simply generated outrage."
Recently, that coverage has begun to change, as a series of studies have failed to implicate implants in known connective tissue diseases. "A new study of silicone breast implants has found no evidence that they cause connective tissue diseases or other illnesses. This is the third large epidemiological study in the United States to find no harm from implants, leading some experts to say that if they cause any disease at all, it must be unusual or rare," The New York Times reported on June 16, 1994. Other media quickly followed suit, with the Los Angeles Times and Newsweek both casting doubt on a causal connection and Discover (December 1995) questioning both the accuracy of a test used to detect silicone and the credentials of its developer, a scientist who has served as an expert witness in many silicone lawsuits. By February 1996, even PBS's "Frontline" came down on the side of the implant manufacturers.
Does this change of the collective media heart signal a return to balanced journalism? Not necessarily. "Plaintiffs' attorneys are not quite as good at ongoing, relentless PR as industry people are," says Steven S. Ross, associate professor of professional practice in the Graduate School of Journalism at Columbia. "The industry believes it has been hosed. But it hasn't been hosed as much as it thinks it was."
Women with implants and their advocates maintain that the coverage is not impartial, failing to mention, for instance, that implant manufacturers and associations of plastic surgeons funded many of the large epidemiologic studies. Furthermore, say silicone victims, the press is twisting statistics that show silicone does cause harm, creating headlines that minimize the danger, such as "Study Cites Small Risks for Women From Breast Implants," in the Feb. 28, 1996, New York Times.
Part of the problem with media discussion of the studies is the difficulty of conveying a precise interpretation of statistical analysis in a brief news story, says Judith S. Jacobson of the division of epidemiology in Columbia's School of Public Health. The Times article notes that "women with implants were 24 percent more likely to report that they had connective-tissue diseases than those without implants," which is easily misinterpreted to mean that 24 percent of women with breast implants will get a disease. But, says Jacobson, the figure represents increased risk only relative to the comparison group: So if, for instance, 1 percent (or 0.01) of women without implants get a disease, 24 percent more than 1 percent (or 0.0124) of women with implants will get it. In this scenario, the risk of disease is higher in women with implants than in women without them, but still much lower than even a 2 percent absolute risk. "It's a lot duller to address these [statistical] issues--and nobody wants to read about a risk that is so small," says Jacobson. "But when a person gets a serious disease, it is 100 percent for that person. Women with breast implants who have diseases are entitled to sympathy, respect, and serious attention. But given that some women without implants also have similar conditions, and that many women with implants do not, it takes a lot of evidence to make a cause-and-effect connection."
As for claims that studies are tainted by funding, "there's always a legitimate question when you do a story to look at the funding to see how heavy-handed the funding source is on the study," says Ross. "But no one except the manufacturers are going to fund a really large study on breast implants." Generally, if a funding source is going to "have its finger on the scale," it will be in the study design. In the case of implant studies, this does not seem to have happened, says Ross, co-author of the landmark text Product Safety and Liability: A Desk Reference (McGraw-Hill, 1979).
Finally, says Ross, the media have failed to recognize that the issue actually comprises two separate stories--one about the women who have been hurt by implants, the other about women who may or may not have been hurt, what their risks are, and what they can do. Implants probably harmed almost all the women who sued before the class action suit, he says. "But, contrary to popular belief by journalists who don't know any better, people are not dropping dead in the streets from silicone implants. Journalists were too willing to make the leap from specific women with specific problems that could arguably be traced to implants, to the class as a whole. When you have a million people, you are going to have problems. Journalists feed the climate that allows a class action suit to happen."
Implants may have injured approximately 10,000 people so far (not all with connective tissue problems) and could hurt a total of about 50,000 as implants age and wear out. This doesn't mean that all 1.2 million implant recipients should get damages, Ross says, but that, since no one can predict who will be hurt, the recipients should be monitored. "Journalists are supposed to help shape that consensus," says Ross. "We have not done that."
--Devera Pine
DEVERA PINE is science writer/editor in the Office of External Relations at Columbia Health Sciences and managing editor of 21stC.PHOTO CREDIT: Food and Drug Administration
.
