Jeffrey M Factor MD
Although we agree with Dr Sampson’s comments that the long term implication of oral immunotherapy to foods is yet to be determined, we disagree with the conclusions and recommendations about the current use of oral immunotherapy. At a dedicated food allergy treatment center, we have been treating patients having peanut allergy using oral desensitization for 18 months and we have enrolled over 160 patients to date. We believe this is the largest single series of patients receiving oral immunotherapy to peanut.
Additionally, we have participated in an IRB approved study on the safety and efficacy of our treatment and have presented data on method, results, and improvement in food-specific quality of life in patients receiving oral immunotherapy to peanut. The quality of life data is now in press. The protocol we have used is very similar to those studied by researchers at Duke University (Burks et al.) and the University of Arkansas (Jones et al.) that are part of the NIH food consortium. We defined as our goal to reduce anxiety of patients as a result of consuming foods containing a small amount of peanut, such as accidental ingestions and contamination. We felt that allowing the patients to eat the equivalent of three peanut M&M’s would accomplish our goal.
Based on the published data, our goal has been to ‘desensitize’ and not inducing ‘tolerance’ (attempt to cure) these patients since the results have not been very convincing in this regard. Our experience with peanut desensitization by board certified allergists at a clinical center devoted to this treatment alone has been very convincing regarding the safety and effectiveness of our treatment.
The protocols we have followed are not without adverse effects. In fact, gastrointestinal symptoms during the build-up phase of our treatment are relatively common. These symptoms are managed by dosing reduction and/or modification. The great majority of these patients have had a resolution of symptoms and are able to achieve the maintenance dose. None of our patients have experienced anaphylactic reactions requiring epinephrine during the build up to maintenance. We have observed more significant reactions requiring epinephrine in 12 cases/76,000 total maintenance doses administered (an incidence of 0.03%). These reactions were associated with specific circumstances such exercising too soon after receiving oral maintenance dose, menses, viral or febrile illnesses. This experience has helped us better manage our patients on maintenance therapy, and hopefully add to the literature in safely treating peanut allergic patients receiving oral desensitization.
The positive effects on perceived and real quality of life have been clinically and statistically significant, for children, adolescents as well as parent perceptions of their children’s experience. There are countless examples of patients’ testimonials who have commented how oral desensitization to peanut has ‘changed their life.’ These experiences are real and poignant, and patients have not had any regret in participating in this treatment. We also know that many patients with peanut allergy suffer from significant psychosocial impairment as a result of this diagnosis. This is of great concern. The positive effects of peanut oral immunotherapy may mitigate these effects.
Any new therapy raises a lot of issues especially in the context of limited controlled clinical studies. This does not mean, however, that a modality of such benefit be set aside until all the requisite assessments are completed. There a many examples of treatment that have not been examined extensively by researchers yet are accepted forms of treatment. Even in our field, treatment such as inhalant immunotherapy and drug desensitization, are examples of this. Furthermore, full understanding of the ‘immunologic changes brought about’ by these treatments has not precluded their effective and accepted use.
I am somewhat taken aback by Dr Sampson’s reference to ‘retail oral immunotherapy’ as if the treating patients with oral immunotherapy as being motivated by some degree of recklessness and greed. This discounts the fact that we truly believe what we are doing is the right thing for our food allergic patients. In the absence of grants or other institutional sources of funding it is necessary to seek payment or reimbursement. It should be noted that the five board certified Allergist who are conducting this study are receiving no monetary remuneration. We assume that Dr. Sampson and his colleagues do receive compensation. Concerning his comments about management problems and ‘after hours support and encouragement ‘, we are all private practitioners and we are very used to providing this for our patients. We don’t have study coordinators or fellows handling these problems. We are available 24 hours a day. In addition all the nurses in our center have children with food allergies and therefore can relate very well to our patients. Concerning the management of severe allergic reactions, I feel that we are just as competent in recognizing and treating mishaps as Dr.Sampson and his colleagues. We too, are working to get a better understanding of these reactions, and how they can be prevented.
We have been doing food challenges, antibiotic challenges and drug desensitization for years. One of our physicians made a significant contribution to the field of penicillin allergy by demonstrating that patients could be tested for penicillin allergy electively, in spite of the recommendations of those in academia that it should not have been done. When he embarked on this venture he was seriously criticized by the experts in the field. Today his approach is the standard of care in the evaluation of this condition.
Although as Dr Sampson points out that ‘the history of medicine is replete with how premature adoption of new techniques can go wrong’ where is the evidence for that thus far? Treatment of food allergies by OIT is still ongoing in much the same way at research centers. It is also true that those who push forward with newer therapies open the door for those who otherwise have limited options.
As Emerson stated, “Do not go where the path may lead, go instead where there is no path and leave a trail”. We believe oral immunotherapy has shown more than just promise in our patients and advocate its ongoing use in clinical practice.
Jeffrey M Factor MD
Louis M Mendelson MD
Mitchell R Lester MD
Joseph Sproviero MD PhD
Jason O Lee MD