The FDA Lets Thousands of Devices onto the Market Each Year with Only Cursory Review

November 4, 2008
Category: Uncategorized

When it comes to healthcare, is newer necessarily better? The idea that newer drugs are better than those that have been on the market for years has recently come under scrutiny. The higher costs of newer drugs, together along with their unknown side effects and contraindications, have led to the suggestion that one should never be the first to take a medication from a new classification of drugs!


A recent scrutiny of proton radiation therapy for cancer and radioactive seed implantation for breast cancer has revealed that the FDA lets thousands of devices onto the market each year after only cursory review and with no clear evidence that they help people. Meanwhile, the Centers for Medicare and Medicaid Services (CMS) may consider requiring evidence that proton therapy is better than other prostate treatments. CMS took public comment on the issue through Sept. 28. CMS could decide to fund proton therapy at the same level as other prostate cancer treatments, or only in clinical trials. The public has no idea that the clinical trials have not been done to vet radioactive seeds for breast cancer or proton therapy for prostate cancer.
For example, the FDA let radioactive seed implantation for breast cancer on the market after a study involving a tiny sample of twenty-five women. The fundamental question of how effective the device was against breast cancer remains unanswered, even today after six years on the market. The FDA defends their actions, stating they require a label that states that “this radioactive seed system has not been shown to be a substitute for conventional radiation.” There is, however, no guarantee that the patient has taken part in an informed discussion with their physician about the warning.

In 2000, Kenny Ausubel’s book When Healing becomes a Crime looked at Harry Hoxsey, who formulated an herbal cure for cancer, but also covered in great detail the role of the AMA, the FDA, and the US medical establishment in suppressing the cure. Ausubel highlighted the Kefauver Committee meetings in the Senate intended to expose and break the monopoly power of the drug companies. Committee testimony documented that the AMA was suppressing no less than a dozen cancer cures—yes, they actually said the word cures. In 1966, Sen. Estes Kefauver published his own book, In a Few Hands: Monopoly Power in America.
AAHF believes that FDA is a broken organization that obstructs medical science and innovation. Additionally, the FDA forbids and censures the communication of legitimate peer-reviewed scientific research. It is time to reform the FDA. Visit www.reformFDA.org to sign the petition joining AAHF and its partners in their efforts to totally reform the FDA in order to rebuild the American healthcare system.

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