"73 physicians participated in the study at different centers (multi-center) in the USA and Canada. Patients were selected randomly for this study in many or most instances. However, a quite significant percentage of these of patients were selected because they had previously failed on treatment with both medications and conventional immunotherapy."
" Enzyme Potentiated Desensitization (EPD) is a unique method of immunotherapy, developed in the 1960s, which involves treating all types of allergy with combinations of a large variety of extremely low dose allergens. EPD is a cell-mediated type of immunotherapy. It has been employed to treat multiple conditions and appears to be a long lasting treatment option for allergy and autoimmune illnesses. It has also been employed for many conditions not generally thought to be due to any type of allergy or autoimmune disease. EPD is no longer available in the USA and has been replaced by Ultra Low Dose Enzyme Activated Immunotherapy (LDA)."
"Comparison of EPD to conventional immunotherapy
Conventional "escalating dose" (where the dose is started "low" - usually 1 to 10,000, and increased over time to as high as 1 to 10, 1 to 20 or 1 to 100) immunotherapy is employed in this country primarily to treat hay fever, cat and dust mite allergy, which are primarily IgE mediated. This type of therapy works by causing the patient to produce "blocking antibody" (specific IgG), which inhibits the histamine-releasing ability (which produces the allergy symptoms) of the mast cell. The higher the level of blocking antibody that can be produced, the more successful is the treatment. In order to produce adequate levels of blocking antibody, studies have shown that it requires administration of very high doses of allergen. Therefore, treatment using this method often causes intolerable swelling and other side effects before clinical efficacy can be attained, and can be dangerous due to the risk of severe reactions such as anaphylaxis, massive swelling, collapse and death.
In England, "conventional" (escalating dose) immunotherapy has now been banned by the Medicines Commission (26 deaths had been reported) except when given in a hospital setting where emergency resuscitation equipment is immediately available. On the other hand, EPD is allowed to be administered in physicians' offices in England. Hence there has been a virtual demise of conventional high dose immunotherapy in England. In the United States, at least 60 deaths have been recorded since treatment began in the 1930s as a result of conventional immunotherapy, but the actual number is likely closer to 100."
" It is very highly unlikely that EPD or LDA will ever receive FDA approval. The costs of FDA approval (the average cost of the average drug approved today is about 800 million dollars) are simply too great to allow either to be a financially viable treatment, even if they were approved. Further, the number of allergens contained in EPD and LDA is far too great for the FDA to consider approval, since the FDA's approval slogan is effectively, "one drug, one indication"."