Scientists Should Decide Silicone Safety

Silicone breast implants are coming back. That's good news for breast cancer survivors and other women who want implants.

Blocking the way, though, are junk science-fueled, anti-implant activists and their personal injury lawyer-sponsors who may be poised to steer the outcome of an upcoming federal report on SBI safety.

A new federal law enacted in October requires the National Institutes of Health to report to Congress on the status of breast implant research. Activists had perennially lobbied for the provision until it was finally inserted into a broader bill updating medical device regulation.

SBIs are the poster child of 1990s' junk science. That decade saw personal lawyers generate about 170,000 plaintiffs, now in the final stages of extorting a $4.5 billion settlement from former SBI manufacturers.

Yet no scientific evidence supported claims that SBIs caused disease -- so concluded a comprehensive 1999 review of the relevant scientific data by multidisciplinary experts at the National Academy of Sciences' Institute of Medicine.

But the report came too late to prevent the damage done by Food and Drug Administration Commissioner David Kessler's 1992 ban on SBIs. Kessler's shoot-first-ask-questions-later action was a bureaucratic blunder that opened the litigation floodgates. The ban forced implant manufacturers to buy peace from tort lawyers rather than risk unpredictable litigation that might last for decades.

With extensive study failing to provide evidence that SBIs cause disease, several manufacturers now are preparing to seek "pre-marketing approval" for SBIs from the FDA.

Unfortunately, the new law leaves the activists and lawyers well-positioned to pervert the process and recreate the junk science circus of the 1990s.

The NIH point person on SBIs is Louise Brinton, chief of the National Cancer Institute's environmental epidemiology branch. That description, though, doesn't do her justice.

Brinton has an extensive history of collaborating with anti-implant activists and tort lawyers, according to John Meroney of the American Enterprise Institute.

A Freedom of Information Act request revealed that, while working as a government employee on a $4 million study of implants, Brinton was in contact with attorney LeRoy Hersh, a member of the Plaintiff's Steering Committee of top lawyers handling implant litigation. Hersh's firm won $1.7 million from Dow Corning in 1985 in one of the first major SBI cases.

Brinton eventually agreed in 1995 to serve as a consultant for Hersh.

Tort lawyer Stephen Sheller arranged a speaking engagement for Brinton before prominent SBI plaintiff attorneys in July 1995. She was a guest of trial lawyers at yet another meeting in Miami in November 1995.

Brinton allowed tort lawyers to help her develop a 28-page research questionnaire sent to study subjects. The lawyers shared the draft with anti-implant activists who apparently weren't happy with the draft. Brinton was advised to be more definite about her goal.

Appealing to the victimology, Brinton responded on government letterhead: "The study provides an opportunity for women who may be suffering as a result of implants to be heard. Now is your chance."

Ties to anti-implant activists also were uncovered. Brinton asked the head of American Silicone Implant Survivors for "any support [she] could provide" and advice on how to best recruit "implant survivors."

Brinton participated in an August 1995 conference call with activists where she described earlier SBI studies as "bad science" and said, "We need your help in telling women that this one is valid."

Though Brinton's own research so far has failed to link SBIs with health problems, she seems to have a problem communicating these results to the media.

"Study Links Breast Implants To Lung and Brain Cancers" headlined an April 2001 New York Times report about a Brinton study, despite the fact that the study made no such linkage and Brinton acknowledged as much.

Part of this communications breakdown may be due to Diana Zuckerman, a scientific advisor on Brinton's studies and, incidentally, a key spokesperson for activists.

Despite Brinton's acknowledgement of no demonstrable cause-and-effect relationship between implants and disease, Zuckerman tells congressional and FDA staff, and the media that Brinton's studies report women with SBIs "are at significant risk for debilitating and fatal disease."

I don't know for sure that Brinton is biased against SBIs. But her background raises serious questions about her qualifications to lead the NIH study. In addition to her apparent conflict-of-interest, as a mere epidemiologist, Brinton lacks the necessary medical and scientific expertise to properly conduct the study.

Rather than risking a hijacking of the NIH study by anti-implant activists and lawyers, the NIH should immediately engage a panel of independent experts from a variety of relevant disciplines to produce an unbiased and unimpeachable report -- as the Institute of Medicine did in 1999.

Qualified and reputable clinicians and scientists -- rather than irrational activists and unscrupulous lawyers -- should determine whether women once again will be able to choose silicone breast implants.

Steven Milloy is the publisher , an adjunct scholar at the Cato Institute and the author of Junk Science Judo: Self-defense Against Health Scares and Scams (Cato Institute, 2001)

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