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by GINA KOLATA 05/16/95
(c) 1995 N.Y. Times News Service
In the case of silicone breast implants, the courts and much of the scientific world have proceeded on strikingly unparallel tracks. While the courts have handed down multimillion-dollar awards based on the presumption of a health hazard, leading Monday to Dow Corning's declaration of bankruptcy, the heavy-duty scientific studies now being completed have pointed to exactly the opposite conclusion, that there is no evidence that breast implants are harmful.
Part of the reason for this clash of cultures is that the legal world looks at individual cases of illness, whereas scientists hold that specially designed studies of whole populations are the only sure touchstone of truth. The cases that have persuaded the courts concern women who complain of debilitating and mysterious maladies that they attribute to silicone leaking from their breast implants. Several years ago, those individual cases, typically described as "anecdotes" by scientists, prompted several epidemiological studies to be undertaken in an effort to search for statistically valid links between the implants and any disease. The conclusions of seven large epidemiological studies have now been reported, with the surprising result that none have found any evidence of health effects from breast implants. These findings have carried particular weight among scientists. "I don't know a single, high quality immunologist who is convinced that there is a definable disease related to implants," said Dr. John Sergent, a professor of medicine at Vanderbilt University in Nashville and a former president of the American College of Rheumatology.
Health officials in other countries have also been persuaded by the epidemiological studies. France allowed the implants back on the market in February and Britain's Medical Devices Agency, which never stopped the sale of the implants, concluded again in December that they were safe.
The beginning of the end for breast implants in the United States came in 1992, when Dr. David A. Kessler, the head of the Food and Drugs Administration, announced that his agency was calling a voluntary moratorium on their use. He explained that there were insufficient data on record to show that the implants were safe and he was concerned by the numbers of women who had come forward with health complaints. Lawsuits by women claiming injury from the implants thenbegan to snowball. Many were based on the theory that although silicone was an inert substance, the chemical or its breakdown products nonetheless deranged the immune system, causing a variety of otherwise inexplicable maladies.
Medical experts summoned by the plaintiffs cited experiments showing that silicone could harm the immune systems of mice.Like many such experts, Dr. Nir Kossovsky, a materials scientist at the University of California at Los Angeles, who runs a testing laboratory for women with implants, said this "means that silicone can account for many of the symptoms reported by breast implant patients."
These medical experts have also criticized the epidemiological studies, saying that had they continued for longer or examined more women they would have found the same kind of illnesses that afflicted the plaintiffs.
But scientists who are persuaded by the new epidemiological studies view the treatment of the issue in the courts as a regrettable misuse of scientific evidence. They regard the medical experts who testified for the plaintiffs as hired guns who do not represent the consensus of opinion developing among authorities in the medical field.
Dr. Shaun Ruddyof the Medical College of Virginia, the president of the American College of Rheumatologyand a specialist in connective tissue diseases like those being claimed by women with implants, said that so much money was at stake that "it is very easy for people to lose their objectivity." He said he knew of academic doctors who started filling out forms for lawyers "at 1,000 bucks a pop."
"I'm tremendously bothered," said Dr. Elizabeth Connell, a professor of gynecology and obstetrics at Emory University School of Medicine in Atlanta. "I'm horrified." Dr. Connell headed an advisory panel to the Food and Drug Administration that concluded in 1991 that implants represented a public health need and should remain on the market while more studies went on.
In a second meeting on the devices, the group concluded in 1992 that there was still no evidence positively linking silicone implants to diseases and that there was still a public health need for the devices, but it recommended that women receiving them be followed in scientific studies to answer questions about their safety.
Kessler did not respond to a request for an interview.
Dr. Bernadine Healy, a former director of the National Institutes of Health who is now director of health and science policy at the Cleveland Clinic, described the breast implant litigation as"an abomination for women," and added, "It's an abomination economically." Dr. Healy said women were the pawns and the losers in what she regarded as a trial lawyers' game. "I find it hideous," she said.
Scientists who have produced evidence or spoken against the link between implants and illness say their treatment by the plaintiffs' lawyers amounted to harassment in some cases. One of the most influential papers that criticized the supposed link between implants and disease appeared on June 14, 1994, in The New England Journal of Medicine. It was a study by Dr. Sherine E. Gabriel and her colleagues at the Mayo Clinic in Rochester, Minn.
The study examinedthe medical records of all the residents of Olmsted County, from 1964 to 1991, just before the implants were removed from the market. They investigated a long list of medical problems, including connective tissue diseases, and concluded that of 749 women in the county with implants, none had excess medical problems.
Dr. Gabriel's study was accompanied by an editorial by Dr. Marcia Angell, the executive editor of the journal, noting that the courts had awarded multimillion-dollar awards on the basis of case histories that by no means showed cause and effect. Yet, she said, this misleading information "became accepted by the courts and the public as nearly incontrovertible truth."
Dr. Gabriel said that she was not naive when she published her paper, and that she knew it would infuriate lawyers for women with implants, particularly because it was financed in part by the Plastic Surgery Educational Foundation, the educational arm of the American Society of Plastic and Reconstructive Surgeons. But, she said, she had never taken sides on the implant issue, the study had been conceived and designed by the Mayo Clinic investigators and had been under way for several months before the group received the grant from the plastic surgeons and she did not think anyone would seriously accuse her of being biased.
As soon as the paper was published, plaintiffs' lawyers charged that the study was tainted because of the plastic surgeons' money. Dr. Gabriel was hit with demands by Charles E. Houssiere, a Houston lawyer who says he represents 2,000 to 3,000 women women who are suing implant manufacturers, that she produce documents.
"The magnitude of the demands is staggering, the burden is staggering," Dr. Gabriel said. "They want over 800 manuscripts from researchers that were here, they want hundreds of databases, dozens of file cabinets and the entire medical records of all Olmsted County women, whether or not they were in the study."
The ordeal has continued for a year so far, Dr. Gabriel said. "It has taken a huge amount of time and it has been extremely stressful," she said. "It has severely compromised my ability to do research."
And, she said, it has had a chilling effect on implant research in general. She said that colleagues had told her that after seeing what happened to her, they would not do an implant study. "Some determined that the price in terms of their own research careers is too high to pay," Dr. Gabriel said.
Mr. Houssiere said he asked for the documents to understand why Dr. Gabriel had concluded that there was no evidence that the implants caused illnesses. "The intent was to find out the basis of her opinion," he said. And, he added, he did find some things he will use against the implant makers in court. But he said that he could not reveal what he had found because "if I tell them, then they'll know and they'll be able to use it to defend themselves."
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