DCA is non-
patentable as a compound, though a patent has been filed for its use in cancer treatment.
[35] Research by Dr. Evangelos Michelakis has received no support from the
pharmaceutical industry.
Concerns have been raised that without strong intellectual property protection, the financial incentive for drug development is reduced, and therefore clinical trials of DCA may not be funded.[15][16][17][36]
However, other sources of funding exist; previous studies of DCA have been funded by government organizations such as the
National Institutes of Health, the
Food and Drug Administration, the
Canadian Institutes of Health Research and by private charities (e.g. the
Muscular Dystrophy Association). Recognizing anticipated funding challenges, Dr Michelakis's lab took the unorthodox step of directly soliciting online donations to fund the research.
[37] After 6 months, his lab had raised over $800,000, enough to fund a small Clinical Phase 2 study. Dr. Michelakis and Dr. Archer have applied for a patent on the use of DCA in the treatment of cancer.
[38][39]
On 24 September 2007, the Department of Medicine of Alberta University reported that after the trial funding was secured, both the Alberta local ethics committee and
Health Canada approved the first DCA clinical trial for cancer.
[40] This initial trial is relatively small with enrollment of up to 50 patients.
When faced with the high costs of bringing a new pharmaceutical to market, estimated by
Tufts University to exceed one billion dollars,
[41] private investment interest in non-patentable pharmaceuticals is low.This problem is highlighted in the 2007
New York Times article by Ralph Moss titled "Patents over Patients".
[42]