UPDATE : Several posts ago, I discussed anti-consumerist legal trends that would ultimately hurt patients in this country. The U.S. Supreme Court decision in Reigel v. Medtronic had allowed for the manufacturers of FDA-approved medical devices to escape state court lawsuits through federal preemption of such patients’ claims. And, as noted in the earlier post, FDA trials are not necessarily the meticulous process that patients have a right to expect.

In an article by Reed Abelson in today’s New York Times , we learn of yet another medical device that skipped through FDA trials, and is now being used to treat breast cancer, even though there is no proof yet that it is even medically effective. The treatment, MammoSite brachytherapy, consists of the insertion of radioactive “seeds” into the breasts of women diagnosed with breast cancer. The seeds irradiate the cancerous tissue, and hopefully eradicate the malignancy. It is an alternative to more traditional forms of radiation therapy, and in theory, has some advantages over it. But it is virtually an experimental treatment, because so few long-term studies of its effectiveness have been performed. In fact, the approval was based on a study consisting of 25 women that lasted only six years. But standards of success in preventing cancer recurrence are measured in intervals of five to ten years or more, as Ms. Abelson points out.

In the fast-track review conducted by the FDA, it is supposed to determine whether the product presents any undue safety risks. But how can the FDA have responsibly concluded that the seeds are safe, based on the minimal, and short lived trial that it conducted?

Unfortunately, what the patients who are trying this treatment may not realize is that, thanks to the Reigel decision, they will have no recourse in state courts if and when a deficiency in the MammaSite delivery of radiation causes them harm, or simply fails to do what standard radiation therapy does. And the cynic in me was jolted by Ms. Abelson’s report that critics of the new treatment contend that its popularity may be a result of the high reimbursements paid to physicians by insurers. So it seems that MammmoSite and the physicians who recommend utilizing it are making money, and the FDA is largely immune from liability if things go wrong, while most patients continue to believe that if the FDA approved it, it is certainly effective, and undoubtedly safe. There is something wrong with this picture.

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