ERIC J. SCHENKEL,M.D.

Director, Valley Allergy and Asthma Treatment Center

Easton, Pennsylvania

Thank you for affording me the opportunity to speak at this important hearing. I am a board-certified allergist, and Director of the Valley Allergy and Asthma Treatment Center and Valley Clinical Research Center in Easton, Pa. Although I have been active in clinical research in the allergy field for Merck, Glaxo, Aventis, Pfizer, and Schering, first and foremost, I take care of patients with allergic diseases.I am here on their behalf.And, believe me, those that take the medicines under discussion are very concerned about the issues being discussed.

I would imagine there are many allergy sufferers in this room. About 50 million Americans suffer from some form of allergy. And their numbers are increasing.

Allergic diseases, e.g., SAR and PAR, do not get the respect they deserve. There is a tendency to trivialize the illness, and doctors receive little training in allergy ."Big Deal! What’s so important about a runny nose??" I hear this all the time, as do my patients. The media doesn’t help, by portraying allergy sufferers as "wimps".

And yet it is clear that people with allergies suffer: millions of lost school days and lost time from work, sleep related issues, and billions of dollars of health care costs.

And think of the complications…asthma, sinusitis, otitis, urticaria, food allergy, anaphylaxis, etc. All are potentially serious.

I firmly believe that the tendency to trivialize allergies , and to self –medicate, has resulted in a near epidemic of "allergic complications".

The first stop for most allergy sufferers’ treatment is the drug store. As you are aware, there are well over 100 types of OTC allergy products out there. The choices are confusing, to say the least.Add to it the numerous herbal products, and it is a real mess, with potential drug interactions, etc. Most people are clueless.So, they pop a pill or use a spray. 40% of allergy sufferers take only OTC medicines! The allergies progress. Inflammation complicates things. Then, a health care provider is contacted. Complications require more therapy. And the epidemic expands…..

Another interesting statistic…although 20-30% of the population has allergies, up to 75% thinks they have allergies! And many take OTC antihistamines for the wrong reason!

The doctor-patient relationship is crucial for the proper treatment of allergies. . OTC treatment, self-medication, clearly disrupts this crucial "bond".These are diseases for which health care professionals need to expand their role in both diagnosis and treatment. I believe that the more OTC choices there are, and the less health care providers are utilized, we will continue with this spiraling epidemic of allergies and their many complications.

I also strongly object to the FDA comments in the Executive Summary that "allergic rhinitis and related conditions are generally amenable to self-diagnosis and self-treatment".This is just plain wrong. And it is bad health care philosophy.

Finally, I asked my patients about this issue of converting Allegra, Claritin, and Zyrtec to OTC staus. In a completely unscientific survey, 98 out of 100 consecutive patients felt a switch would adversely affect their health. Yes, it would hurt them in the pocketbook. But, just as important, in their quality of life. They couldn’t afford these important medicines if they weren’t covered by a prescription plan. And they simply can’t afford not to take them.

Thnk you for your attention.