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Tuesday, February 06, 2007


In case you ever forget who the FDA is really working for, this will clear your head. If you have cancer it will make you furious, or maybe help you.

FROM Curing Cancer: A Patent Impossibility
by Bill Walker

The good news this month is that a Canadian team under Dr. Michelakis at the University of Ottawa has discovered that a simple, inexpensive chemical is a powerful anticancer agent, effective against a broad range of cancers. (Read their paper in the January Cancer Cell, subscription required). The bad news is that it is a simple, inexpensive chemical long used in medicine, and is not patentable. Thus there is no mechanism for getting the chemical (dichloroacetate, DCA) past the billion-dollar barrier of FDA approval. (The FDA actually only approved 17 drugs last year, and the drug industry spent 40 billion dollars on R&D).

So far Dr. Michelakis has demonstrated the effectiveness of DCA against various human cancer cell lines in a cell culture, and against human tumors growing on immune-suppressed rats. The drug has already been tested on human beings for many years as a treatment for a genetic enzyme deficiency. There are millions of terminal cancer victims on this planet. So, logically, the next step would be to find some volunteers and start trying to find the optimum human dose range, combinations of other apoptosis inducers that work synergistically with DCA, supplements to reduce side effects, etc.

Logically in our libertarian minds, perhaps. In the real world, nothing of the kind will happen. The FDA will not allow people in the orderly and profitable process of agonizing death by incurable cancers to try nonapproved drugs. No drug company, no matter how large, can afford to spend a billion dollars and 19 years getting a nonpatentable treatment through the bureaucratic minefield. There is no FDA-approved way to get there from here.