FDA Reform
by: Mark Sircus Ac., OMD
Medical News - November 5, 2003

A key advisory committee to the Food and Drug Administration recommended last week (October 2003) that silicone breast implants be allowed back on the market more than a decade after they were largely banished over safety concerns. The decision was a close call, with nine panelists favoring reinstatement and six opposed because of worries about possible long-term dangers. This admission, printed by the New York Times, exposes the heart of the problem with the FDA and its entire process of approvals of drugs, pesticides, food additives, medical procedures, vaccines and other related issues of public concern.

The Times mistakenly reports that the recent verdict to allow silicone breast implants “adds to a growing impression that the implants, once blamed for a range of serious illnesses in women, are relatively safe, or at least fit for resurrection under appropriate safeguards.” It would be interesting to know who wrote this for in reality such a statement makes no medical sense whatsoever. Many people have thought them unsafe enough to take them off the market and it is obvious that six very important medical people, members of the FDA advisory committee, do not think them safe either. Six doctors and scientists who are entrusted by the public to protect their saftery think these transplants are dangerous! Scientifically and medically it would be significant if even one of the fifteen voted against. It's no different in a murder trial, the jury gets hung with one vote. There can be no doubt. Should it be different when it comes to public safety with food and medical issues?

The Times reported, “The silicone breast implants had already been on the American market for 13 years when a 1976 law gave the F.D.A. authority to regulate them and other medical devices. At first the agency focused on devices it deemed riskier, but as complaints against the implants mounted, the F.D.A. called for evidence of their safety and effectiveness. The manufacturers proved woefully unable to supply it, so in 1992 the agency blocked general use of the silicone implants and restricted them to clinical studies, breast reconstruction in cancer patients and other limited purposes. Meanwhile, a barrage of lawsuits drove the main manufacturer into bankruptcy and led to payouts and settlements worth billions of dollars for the presumed victims. Saline implants, though deemed inferior in look and feel, took over the market.”

The Times goes on, “As the 1990's ended, however, an array of studies and expert panels largely exonerated the silicone implants as the cause of cancer, immunological diseases, neurological problems or anything more serious than localized pain, scarring and inflammation in the breast. The original alarms began to look overblown.” This statement grossly distorts the reality behind the FDA decision. Six medical scientists on the FDA do not agree with the New York Times. The FDA decision does not reflect on the safety of these implants because a significant percentage of the FDA, who are informed more than anyone on these issues, had great enough reservations to vote against FDA approval. FDA approval offers no guarrentte of saftey when men and woman of science and medicine within the FDA vote against approval of a particular product or medicine. There can be no democracy when it comes to medical safety, nothing less then medical truth and science is sufficient. When it comes to medicine a consensus would reflect solid science. Anything less strips medicine of its integrity as a science. Necessary changes in medicine and public health might best be inititated by dramatically changing the internal workings of the FDA.

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