Enzyme-potentiated desensitization (EPD) is back. (Editorial).

Patients in the United States can once again obtain enzyme-potentiated desensitization (EPD). This highly effective, revolutionary, safe, and cost-effective treatment of troublesome symptoms of allergy could not be obtained in the United States during the last 9 months of the year 2001 as a result of an order of the FDA. A new determination by the FDA now allows patients to "individually import" the potentiating enzyme and antigens required for EPD treatment.

During the time that EPD was not available in the United States, patients who required this treatment to maintain their well-being traveled to see doctors in Canada and other countries at great additional cost to obtain the necessary injections. Now, doctors trained in the use of EPD can once again treat their patients with this wonderful method. For each patient, they must send the following to McEwen Laboratories in England: (1) a prescription, (2) the patient's credit card authorizations, and (3) a written statement from the patient, describing his or her need to obtain and import the enzyme and antigens. The laboratory will then package the enzyme and antigens separately for each patient and send them to the treating physician, who will administer the treatment in the usual way.

McEwen Laboratories is actively working to satisfy all FDA requirements to eventually gain approval for routine use of EPD by physicians in the United States. An investigational study to evaluate the effectiveness of EPD in the treatment of hay fever is being developed. We anticipate that the study will start sometime in 2003. The utility of EPD in the treatment of otolaryngic allergy is described in an article by your editor in this month's issue of the EAR, NOSE & THROAT JOURNAL. This paper was originally presented to the Eastern Section of the Triological Society in 1999, but it was prevented from being submitted for publication by a ruling by the FDA and at the request of the American EPD Society, which was conducting an extensive study of EPD at that time.

Analogous to the availability of the totally implantable middle ear hearing aid, (1, 2) the routine availability of EPD (3) to U.S. patients seems to your editor to have had an unduly long delay. However, even the current, limited availability of EPD is a welcome improvement.

References

(1.) Pulec JL. The totally implantable hearing aid [editorial]. Ear Nose Throat J 1994;73:69

(2.) Pulec JL. Successful introduction of the totally implantable hearing aid [editorial]. Ear Nose Throat J 2000:79:760

(3.) Pulec JL. Enzyme-potentiated desensitization: A major breakthrough [editorial]. Ear Nose Throat J 1996;75:640.

JACK L. PULEC, MD

Editor-in-Chief

EAR, NOSE & THROAT JOURNAL