Immuno-augmentative therapy consists of daily injections of processed human blood products that are designed to stimulate the patient's immune system to attack cancer cells. IAT was developed by Dr. Lawrence Burton, Ph.D. In the mid-1970s, Dr. Burton established the Immunological Researching Foundation in Great Neck, New York, and filed an investigational new drug application for IAT with the Food and Drug Administration. However, because Dr. Burton did not provide the experimental evidence for IAT that the FDA requested, the application was not approved. In 1977, Dr. Burton relocated to the Commonwealth of the Bahamas, established The Immunology Researching Centre, and began using IAT to treat persons with cancer.
In the mid-1980s, the safety of all products derived from human blood, including IAT, came under questioning as the scientific community learned about the human immunodeficiency virus, which causes acquired immunodeficiency syndrome. In 1985, at the request of the families of two patients who had returned to the United States from Dr. Burton's clinic, a Washington state blood bank examined 18 sealed IAT specimens. All of the samples tested positive for hepatitis B; some of the samples were positive for HIV. These findings were confirmed by subsequent analyses by the Centers for Disease Control and Prevention, the National Cancer Institute, and independent laboratories.
In July 1985, at the request of the Bahamian Ministry of Health, representatives from the CDC and the Pan American Health Organization visited the Immunology Researching Centre to investigate the manufacturing process used for IAT. The CDC and PAHO concluded that the manufacture of IAT represented a serious health hazard, and the Bahamian Government closed the clinic. The clinic reopened in March 1986 after Dr. Burton agreed to follow certain quality control procedures, including screening blood sources for HIV and hepatitis B and conducting standard blood donor screening and collection practices. In July 1986, the FDA issued an import ban prohibiting anyone from bringing IAT into the United States. This ban is still in effect.
A sample of IAT frozen in a block of ice was offered to and analyzed by the FDA during the summer of 1987. Although the sample was not sterile, there was no evidence of HIV or hepatitis B.
Although Dr. Burton described his success in treating cancer patients in newspaper, magazine, and television interviews, several attempts to plan a clinical trial in collaboration with Dr. Burton were unsuccessful. Dr. Burton died in 1993. The Immunology Researching Centre remains open under the direction of Dr. R. J. Clement.