Curing Cancer: A Patent Impossibility

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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).

Scientists have known since 1930 that cancer cells use glycolysis instead of aerobic respiration for energy. In other words, they don’t turn on their mitochondria and burn their glucose with oxygen, as do normal cells; they just convert it to lactic acid. While glycolysis provides about fifteen times less energy per blood sugar molecule, it works under the oxygen-deprived conditions inside early tumors. It also has the advantage of bypassing the mitochondria entirely, which allows the cancer cells to suppress the cell’s self-destruct mechanisms.

DCA forces the cell to turn on its mitochondria. This was the primary medical use of DCA in the past, to treat patients with rare metabolic deficiencies. For a normal cell, being "forced" to turn on mitochondria isn’t such a big deal… they’re already on.

But for a cancer cell, the mitochondria are time bombs. When the cancer’s mitochondria turn on, they run out of control, creating high hydrogen peroxide levels inside the mitochondria. This leads to a cascade of chemical reactions that eventually activates two different self-destruct ("apoptosis") pathways in the cell.

The ability to reactivate self-destruction is one of the "holy grails" of cancer research. There are other approaches to induce apoptosis in cancer cells, and perhaps some of them would actually work if they were combined with DCA. Also, even if it is eventually found that cancer can mutate and develop DCA resistance, the long period of regression could allow newer but slow anticancer concepts (such as telomerase inhibition) to finish off the remaining cancer cells.

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.

Someday a dedicated medical team working beyond the reach of the FDA (perhaps in Mainland China, which already contains numerous clinics that cater to foreign medical refugees) will defeat cancer1. In the intervening years or decades, terminal cancer patients in the US will be restricted to the same old patent medicines.

Note

  1. If you’re a dedicated medical team working beyond the reach of the FDA, the rats in the study were given the same dose of DCA as human patients with enzyme disorders, 50—100 milligrams of drug per kilogram of body weight, dissolved in their water.

Bill Walker [send him mail] works in HIV and gene therapy research in Rochester, Minnesota.

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