Stephen L. DeFelice, M.D., founder of FIM, the Foundation for Innovation in Medicine and SDF Consultants, conducted the first human study with Carnitine in the United States in 1965, evaluating its effect in patients with hyperthyroidism. The response was highly favorable and has since been confirmed by others. During one of his studies he stumbled on the possibility that Carnitine, with high concentrations in the heart, would protect the heart against a lack of oxygen. During the Vietnam War while he was stationed at WRAIR, the Walter Reed Army Institute of Research, he was in charge of designing and supervising clinical studies of potential new pharmaceutical therapies for the treatment of such conditions as malaria, radiation fallout from a nuclear weapon and toxins from biological warfare. These were drugs that had been previously discovered in other laboratory studies. Dr. DeFelice, along with the late Major James Vick, his good scientist friend, conducted a series of animal studies and confirmed that Carnitine has a dramatic effect on protecting the heart against a lack of oxygen.
Excited by these findings they also discovered in a number of laboratory studies that Carnitine protects against a variety of fatal toxins such as bacterial and snake venom. One of the toxic substances that they studied was Doxorubicin, a potent anticancer chemotherapeutic drug. Since then, there have been dozens of published studies to confirm their findings. Doxorubicin's dose to patients, unfortunately, is limited because it causes heart or cardiac toxicity. They felt that if the dose could be raised, maybe more cancer cells could be destroyed. This is where the Carnitine cancer connection began.
Dr. DeFelice and Major Vick wondered whether Carnitine, taken to reduce Doxorubicin's toxicity, would also block Doxorubicins cancer cell kill capacity. They had a colleague, Dr. Sam Barranco, a very well respected scientific expert in cancer research who agreed to help find out whether this was true. They tested these combined drugs in Chinese hamster ovarian culture cells and were pleasantly surprised. Carnitine did not block Doxorubicins cell kill capacity but, instead, it increased it tenfold!
DeFelice could not find anyone to sponsor a clinical study using these two pharmaceuticals in patients with ovarian cancer. But the promise of these substances was always on his mind reinforced by cancer deaths of friends, family, and others.
The next step was to study the effects of these drugs on human ovarian cancer culture cells in the laboratory. This led to yet another surprise. Carnitine not only increased Doxorubicins anticancer activity but Carnitine by itself killed more than 50% of the ovarian cancer cells!
It was clearly time for a clinical study in cancer patients.
Next page: The Clinical Study and Your Physician