Synthetic Science

By Lila Rajiva, AlterNet. Posted February 24, 2004.

"It's only salt water," says the surgeon flapping the translucent rubbery disk. "If it bursts, it gets absorbed into your blood. The only problem is capsular contracture and I've seen that only once and she was someone else's patient."

The tired-looking woman in her thirties asks doubtfully if there are any other serious issues. "No," he says breezily, "all you have to think about is how you want to look. I'll take care of the rest."

A week before surgery and with the non-refundable down payment already made, a thirty-page consent form filled with technical jargon is handed to her to sign. There is no time to study it in great detail, no explanations given, no videotapes shown of the procedures. "That's just for the lawyers," says the surgeon as she hesitates. "Look, anything can be fatal," he adds. "There are more chances of your driving round the corner and being killed." She signs.

Missing from this conversation, a paraphrase of the experience of one of about 300,000 women who undergo breast augmentation every year in America, was any reference to the findings of the most recent and extensive studies of implants that show that not only silicone but saline implants, widely regarded as safe, are health hazards.

Early this February, after an advisory panel recommended that the ban be reinvestigated, the FDA upheld the ban on silicone implants saying that more research was necessary to prove their safety. The original ban went into effect in 1991 following a public storm over implants fuelled partly by a 1990 CNN Face To Face with Connie Chung that showed leaking silicone gel poisoning the immune system, causing crippling arthritis, skin lesions, and horrific disfigurements. The dangers of saline, which are less documented but equally worrisome, include bacterial contamination and hardening and deflation, leading to more surgery.

After the 1991 ban against silicone, 400,000 women pressed damages against manufacturer Dow Corning in a class action suit so extensive that Dow finally agreed to settle for over $4 billon. Aware that its long-term viability was in question, the company launched one of the most effective PR campaigns in history steered by DC-based Burson-Marsteller, the world's largest PR firm and the folks responsible for making over both the tobacco industry and Union Carbide.

How effective this campaign was can be deduced from the fact that within a few years the evidence against implants was being regarded as the epitome of "junk science." In an interview in February, 1996 with Frontline, Marcie Angell, editor of the prestigious New England Journal of Medicine and author of a 1996 book called "Science on Trial: The Clash of Medical Evidence and the Law in the Breast Implant Case," claimed that a number of studies proved that there was no scientific link between implants and cancer or autoimmune disease. The implication was that hysterical women instigated by lawyers salivating for multi-million dollar fees were storming the Olympian citadels of medicine with junk claims.

However, the research Angell cited to support her contention was actually a better candidate for the term "junk" than what she attacked. It was also more insidious because it carried the imprimatur of prestigious institutions like Harvard and Mayo. What casual readers could not know was that the 1994 Harvard study, like the others she cited, was damningly flawed in several ways:

• The sample size of 1,183 women was too small to study such rare diseases, included women with very recent implants (even one month), did not include women with ruptured implants, and followed the women for 9.9 years on average. Since most serious diseases that could be caused by silicone exposure would most likely develop several years after a rupture (and ruptures tend to happen after 7-12 years), the study was almost set up for diseases not to show up.
• Astoundingly, none of the women was actually examined in person. The findings were all based on questionnaires and records.
• Only classic autoimmune disease symptoms were evaluated whereas silicone poisoning, a new disease, manifests atypical ones.
• Finally, two of the authors admitted under threat of perjury that they were paid consultants of implant manufacturers and one admitted under oath that he knew that Dow Corning had donated $7 million to Brigham & Women's Hospital, a participant in the study.

Nor was this the only time the saintly NEJM had been surprised in bed with corporations. In 1996, the Journal ran an editorial claiming the benefits of diet drugs outweighed the risks without informing readers that the authors were paid consultants for companies that made or marketed one of those drugs, Redux, banned by the FDA in 1997. In November, 1997 it let the medical director of W.R. Grace and Co., a known chemical industry polluter, write a review panning a book linking environmental chemicals to higher rates of cancer. And the Journal itself concluded in a 1998 study that authors with ties to corporations invariably acted as shills.

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