"The implant lawsuits have been labelled "an utter travesty" by Dr. Barry Arnason, chair of neurology at the University of Chicago School of Medicine, which played no role in the dispute, and "an outrage" by Dr. Bernadine Healy, former director of the National Institutes of Health, now director of health and science policy at the prestigious Cleveland Clinic.

Thursday, August 21, 1997

Fact, emotion clash in Dow case

Firms battle perception of public in implant trial

By James Tobin and Jim McClear / The Detroit News

The breast-implant lawsuits that threaten to devastate Dow Chemical Co., Dow Corning Corp. and their 49,000 employees rest on claims that have been largely discounted by major medical studies, experts say.

In the first implant lawsuit to come to trial -- part of the largest class action in American history -- a Louisiana jury will soon decide whether silicone leaking from the implants caused a range of health problems in the 1,800 women suing Dow. But the medical community has already given a near-unanimous verdict.

"The burden of scientific proof is very clear," Dr. Elizabeth Connell, an Emory University gynecologist who was chairwoman of a federal panel on the issue, told CNN Tuesday. "There is no significant association" between implants and the plaintiffs' illnesses.

That debate will now accelerate in the wake of the Louisiana panel's decision on Monday that Dow Chemical didn't do enough to study and publicize possible risks of the implants. The next phase in the lawsuit will begin next month.

Attorneys and other advocates for the plaintiffs argue that the medical problems of thousands of women who got the implants is all the evidence anyone needs that the companies did them wrong.

"It caused me a lot of misery," said Patricia Picano of Northville, who had implant surgery in 1985. The implants were removed in 1992 when doctors told her they were disintegrating.

"I feel better," she said, "but there's still a lot of soreness, and I'm not alone. It's caused a lot of women a lot of grief and Dow Chemical is still trying to get out of it instead of just admitting they made a faulty product. There's been a ton of misery and humiliation and they are still trying to make us look like losers," she said.

Nobody's saying such women are lying about their symptoms, Dr. Connell said.

But at the medical heart of the dispute, studies show that women with implants were no more likely to develop symptoms than women without them.

Between 1 million and 2 million women have gotten silicone gel breast implants since the devices were put on the market in the early 1960s. About 80 percent were sold to healthy women wanting breast modifications, the rest to women who had undergone mastectomies.

Most of the implants sold in the United States were made by Dow Corning, a joint venture of Midland-based Dow Chemical and Corning Inc. of New York.

Dow Chemical did not design or make the implants, a spokesman said. Its only role was to do worker-safety tests on silicone some years before implants were invented in 1962. But plaintiffs' attorneys targeted the chemical giant anyway, claiming it controls Dow Corning, which played a key role in developing the devices, and pushed it to market.

Starting in the early 1980s, women and their lawyers began to allege that silicone implants were causing connective tissue disorders (such as rheumatoid arthritis, lupus, and scleroderma), problems with the immune system, cancer, and vaguer complaints ranging from fatigue to headaches to aches and pains. Consumer groups and reporters took up the cry.

A federal panel headed by Connell found no evidence the women suffered problems in any greater percentages than the general population.

But David Kessler, commissioner of the U.S. Food and Drug Administration, who had appointed the Connell panel, asked manufacturers to quit making the implants anyway.

Kessler didn't say they were dangerous, just that the manufacturers hadn't proven them safe. But his action let loose a flood of lawsuits against Dow Corning and Dow.

Meanwhile, researchers were responding to individual case reports of medical problems in women with implants. Studies got under way to see whether those women were getting sick in larger percentages than women without implants -- the basic premise of epidemiological research.

Their studies cast severe doubts on the plaintiffs' claims. Among the findings:

n In 1994, a Mayo Clinic study published in the New England Journal of Medicine found no signs of a link between the implants and 12 connective-tissue diseases.

n In 1995, another New England Journal study, this one of 87,500 nurses, found no damning association. The group included 516 women who reported connective-tissue diseases. Of those, only three had breast implants – a proportion no higher than in women without the implants.

n In 1996, Dr. Charles Hennekens, a leading epidemiologist at Brigham and Women's Hospital in Boston, reported that medical records of more than 400,000 women showed a 24-percent greater chance of connective-tissue problems in women with implants. By contrast, cigarette smoking increases the risk of lung cancer by 2,000 percent.

The findings would mean at most one additional case of a connective tissue disorder per year for every 3,000 women with implants, Dr. Hennekens said.

Thomas Bleakley, a Detroit attorney whose firm represents 2,000 implant plaintiffs, said such studies are bad gauges of what causes illness.

"The use of epidemiology to make a cause-and-effect pronouncement is totally improper," he said. "Epidemiology is like a brief, bikini bathing suit. What it reveals is interesting, but what it covers up is critical."

The implant lawsuits have been labelled "an utter travesty" by Dr. Barry Arnason, chair of neurology at the University of Chicago School of Medicine, which played no role in the dispute, and "an outrage" by Dr. Bernadine Healy, former director of the National Institutes of Health, now director of health and science policy at the prestigious Cleveland Clinic.

The author of a book-length critique of the case, Dr. Marcia Angell, editor of the New England Journal, said it's a classic illustration of how scientific truth often gets twisted and misunderstood in highly publicized court cases.

"It clearly shows that in deciding about health risks, our courts and a substantial segment of the American public seem comfortable with methods that can only be described as anti-scientific and irrational," Angell wrote in the New England Journal.

"We are now experiencing a groundswell of anti-science feeling, which leads many people to discount scientific evidence, often in favor of anecdotes, irrational theories, or 'other ways of knowing.' When mass lawsuits are involved, the impediments to public acceptance of the scientific process become virtually insurmountable. Courts may find health hazards even when there is no good evidence. The public's alarm then takes on a life of its own..."

In such circumstances, the judicial system's ability to make a just decision becomes doubtful, some fear.

"Eventually, a jury will be asked to judge the scientific question, which is, 'Did the silicone in the women's bodies cause the health problems that the women claim it did,' " said Heidi Li Feldman, a University of Michigan law professor on leave at Georgetown University Law College, .

"In general, I believe that if presented with appropriate scientific testimony, which is explained to them by the witnesses, then jurors as educated people are capable of assessing that evidence," she said.

"What is potentially troubling is the fact that often scientific data or evidence is not presented in a clear fashion, and if you don't present it in a clear fashion, no decision maker, regardless of how expert he or she is, can make a good decision."

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Here's some miscellaneous stuff i collected on her:

cbs, health correspondent