- The Washington Times - Wednesday, March 2, 2005

A Food and Drug Administration advisory panel is again preparing to review the science on the safety of silicone breast implants (SBIs). Though the scientific data will, once again, point to the safety of SBIs, it’s not clear science alone will drive the panel’s decision.

In October 2003, an FDA advisory panel voted in favor of SBIs, but trial lawyer-backed anti-SBI activists turned the process into a circus. Last year, the FDA delayed approval of SBIs pending collection of more safety data. The new data are in and, to no one’s surprise, SBIs once again seemed safe.

In an October 2004 study in the American Journal of Epidemiology, National Cancer Institute researchers detected no persuasive evidence SBIs caused connective tissue disorders — the allegation that ignited the SBI scare 20 years ago.

Researchers reported in a December 2004 study published in Breast Cancer Research that mastectomy patients with SBIs had similar, if not slightly less, sickness and death than mastectomy patients with other types of breast implants.

National Cancer Institute-funded researchers reported in the January 2004 Journal of the American Medical Association that, while breast implants may slightly reduce mammography sensitivity, “there is no evidence that this results in more advanced disease at diagnosis compared with women without augmentation.” All the new data reaffirm a 1999 report from the National Academy of Sciences’ Institute of Medicine concluding available medical and scientific evidence does not associate SBIs with cancer and other systemic diseases. But as so often where activists and personal injury lawyers are involved, having the science on your side isn’t always enough.

Consider, for example, the October 2004 National Cancer Institute study. Although the study reported no credible link between SBIs and disease, the anti-implant activists spin this study to demand larger and even longer-term research.

It seems anti-implant activists would like to spread the notion science cannot establish the safety of SBIs — a position entirely consistent with anti-SBI crusader Sybil Niden Goldrich, who once said of SBIs on PBS television’s “Frontline”: “The science? The devil with science. It doesn’t matter anymore.”

Ms. Goldrich’s group, Command Trust Network, circulated a memo to congressional staffers in October 2004, claiming that, in the January 2004 mammography study, “researchers have found that breast implants can result in undetected cancer.” This of course, contradicts the study result indicating women with SBIs are at no disadvantage in breast cancer diagnoses.

Now in the weeks leading up to the FDA advisory panel meeting, SBI opponents are stepping up efforts to mischaracterize the science on SBIs.

Last week, the National Organization of Women, National Women’s Health Network, National Research Center for Women and Families, and the National Council of Women’s Organizations began circulating a letter to secure senatorial opposition to the FDA advisory committee’s endorsement of SBIs and any forthcoming FDA approval.

In an effort to exploit the Vioxx controversy, the letter shrieks, “It is imperative to tell the [FDA] Commissioner that silicone breast implants should not be approved for general use until there is evidence that they are safe for long-term use.”

The letter, however, doesn’t mention the more than 7,000 women in the October 2004 study who were followed over 12 years, on average. Moreover, several other epidemiologic studies have maximum follow-ups ranging from 23 to 30 years.

“Barely one year after rejecting silicone breast implants, the FDA is again considering an application to approve these same devices,” claims the letter.

But the FDA never rejected SBIs. The agency simply requested more long-term safety data. The claim there aren’t long-term data supporting the safety of SBIs is flat-out wrong.

I’m not surprised by the distortions in the letter pushed by NOW and the other groups. NOW has had ties to personal injury lawyers involved in the multibillion-dollar SBI litigation.

A final concern for women who want the option of silicone breast implants is the chairman slated to head the FDA advisory committee, Dr. Michael Choti.

Not only did Dr. Choti vote against implants in the October 2003 meeting, he has since authored an article titled, “Against approving the use of silicone implants” in the fall 2003/winter 2004 issue of the journal for the American Society of Breast Disease that fully chronicles his personal slants and prejudices.

As the panel chairman will run the meeting and set the tone, it would seem someone less biased than Dr. Choti should be entrusted with this key position.

Anti-implant activists and their trial lawyer allies don’t want SBIs back on the market. FDA approval would essentially expose the 20-year anti-implant campaign as junk science.

The desperate activists and lawyers will, it seems, say and do anything to avoid that outcome.

Steven Milloy publishes JunkScience.com, is adjunct scholar at the Cato Institute, and is the author of “Junk Science Judo: Self-defense Against Health Scares and Scams” (Cato Institute, 2001).

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