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Aloe Irritates the FDA

Joe DiStefano, a licensed nutritionist, and Daniel Mayer, an osteopath, had two Florida clinics in which they administered a product called Albarin, an extract of aloe vera, to cancer patients. Albarin had been developed by Ivan Danhof, M.D., Ph.D., a retired professor of medicine known as the “father of aloe vera” because he had spent much of his career researching the plant’s properties. After two decades of research, he developed the intravenous extract, which proved highly effective against cancer. The clinical program was part of an investigational new drug (IND) application Danhof had submitted to the FDA.

According to an article by John Hammell in the April 2002 Life Extension, DiStefano and Mayer did no advertising and charged only $1,200 for a series of forty treatments, or as many as the patient needed for remission — less than the cost of one chemotherapy treatment. They turned no one away for financial reasons. They had a remission rate of 94% in the first hundred patients, who came from hospices, and 80% overall.

Danhof, in Texas, was about to file data from these cases to support his IND application when the FDA raided the clinics and closed them down, in direct opposition to the wishes of the patients there. One said to the FDA agent in charge, “We’re all adults here, making free-will choices. Why don’t you get out of here and leave us alone?” To which the FDA agent replied, “This will be your last treatment!” A number of the patients demonstrated repeatedly at the Tampa federal courthouse, and eight were dead by 2002.

The FDA conducted the raid because it had received complaints about the treatments — but not from patients. The complaints were from local oncologists, who regarded the clinics as competition. Apparently satisfied with putting the clinics out of business, the FDA did not prosecute DiStefano, Mayer, and Danhof.