Who is Dr. Randhawa?
Dr. Inderpal Randhawa is a leading specialist in internal medicine, pediatrics, immunology, allergy and pulmonology and has been successfully treating food allergy patients with food immunotherapy for over 10 years. Dr. Randhawa has successfully treated patients with allergy to milk, eggs, wheat, soy, peanuts, tree nuts, seeds, fish and shellfish. He has implemented a unique, comprehensive, and research-driven approach to food allergy diagnosis and treatment. He has successfully treated over 450 patients using his OIT protocol. 99% of his patients have graduated the OIT treatment. Safety is the hallmark of his program and he has completed over 6,000 successful food challenges.
Dr. Randhawa is currently the Director of the Gallegos Food Allergy Center at Miller Children’s Hospital. The Gallegos family specifically sought out Dr. Randhawa, who treated their own food-allergic son with food immunotherapy, to lead the Food Allergy Center which they created and funded. This bears testament to the fact that Dr. Randhawa is the one of the best doctors in this field.
Dr. Randhawa holds two academic appointments at the University of California Irvine and UCLA School of Medicine. Dr. Randhawa has published over 150 peer reviewed abstracts and articles spanning the fields of immunology, pulmonology and allergy. He is the program director and research coordinator of two nationally recognized training programs in allergy, immunology and pediatric pulmonology. Dr. Randhawa has served as primary investigator in over 25 clinical trials to date.
Dr. Randhawa has an amazing team of nurses who are dedicated to this mission of improving the quality of life of his patients by alleviating one allergy at a time.
Why is Dr. Randhawa’s OIT protocol unique?
Many OIT programs complete therapy when patients reach a goal dose of a food allergen. Those goal doses differ from program to program. For example, some OIT patients reach a “graduating” dose of 400 mg of peanut (the equivalent of 1 peanut). These patients maintain this dose daily but cannot eat more than one peanut daily. This provides “bite proof” protection but does not provide larger safety from anaphylaxis. Other programs aim for a goal dose of 4000 mg peanut (roughly 8-10 peanuts) given daily or three times a week. Although this dose provides some treatment benefit, it does not provide larger safety from anaphylaxis.
Dr. Randhawa’s program achieves a substantially higher maintenance dose, typically given weekly. In addition, the patient is free to eat a normal U.S. dietary intake of the allergic food involved. This larger maintenance dose provides a larger safety net from anaphylaxis while still achieving the treatment effect of food immunotherapy. Importantly, you may be free to enjoy foods and experiences that previously had been off-limits.
I have severe food allergies and have heard about OIT/food immunotherapy, but I am not really sure what is it? What is food immunotherapy?
As you may be aware, food immunotherapy is commonly called “OIT” or oral immunotherapy. The current programs in the United States use OIT with a specific, standardized dose escalation of whole food product (i.e. peanut) over a period of time to induce desensitization of that food in a food-allergic patient.
Food immunotherapy has been attempted for over 3 decades with the greatest success in the last 15 years. Other forms of food immunotherapy in use or in clinical trial include SLIT (sublingual immunotherapy, or drops sprayed under the tongue) and epicutaneous therapy (a patch applied to the skin).
Will food immunotherapy work for me?
Several studies have shown that common food allergens such as peanut, milk, egg and certain tree nuts can safely be introduced into the diet of allergic individuals even young children. Over time, these individuals can eat limited amounts of these foods with significant safety.
Patients who have taken a maintenance dose after achieving desensitization have remained tolerant and, in some cases, are able to eat their allergens freely. However, nearly all studies that later discontinued food treatment after a patient achieved desensitization failed. Therefore, it appears that patients who start food immunotherapy must remain in treatment for years, if not decades, by taking a regular prescribed maintenance dose in order to induce some form of tolerance.
Is this FDA approved? If not will the FDA ever approve a standardized food immunotherapy treatment for common food allergies such as peanut, milk, and egg?
The Food and Drug Administration (FDA) is a federal regulatory agency whose primary purpose is to approve and regulate human drugs and biologic agents. However, there are some areas which are beyond the purview of the FDA. For example, FDA policy expressly states that it “does not approve medical foods” as therapy. As a result, FDA policy likely precludes large dose OIT or food immunotherapy from resulting in FDA approval. The FDA plays a critical role in the advancement of drug treatments where one drug can be widely applied to many patients with a disease. However, the FDA does not approve nor regulate many treatments including OIT.
Importantly, lack of FDA approval does not disqualify OIT as a valid and appropriate treatment for food allergy. Many safe and effective medical treatments lack FDA approval, yet, are still widely used. For example, the FDA does not approve “allergy shots,” subcutaneous immunotherapy used to treat hayfever, or many other forms of allergy therapy. However, allergy shots are an effective and safe treatment for millions of patients annually as a result of decades-old protocols studied on thousands of patients.
What is a clinical trial? How successful are clinical trials in peanut and food allergy treatment?
A clinical trial is a research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes. Clinical trials are very important in the study of disease diagnosis and treatment. However, clinical trials typically must complete 4 phases of study before being considered for FDA approval, a process that can take 10 years or longer. To date, up to 75% of most clinical trials fail to reach phase 4 study success and therefore are not eligible for FDA approval. Typically, a singular drug or treatment protocol is applied generally across a population of patients with the same disease regardless of their unique profiles. Therefore, unless the success rate of that generalized treatment is significant, the financial incentive to continue the studies is limited.
To date, no food allergy treatment has completed a phase 3 or phase 4 trial. In fact, most food immunotherapy in clinical trials are in phase 1 or phase 2 development in the US. As a result, no food allergy treatment using food immunotherapy has reached FDA consideration. Furthermore, even if FDA policy did not preclude the approval of medical food-based therapy, any potential FDA approval of food allergy treatment currently being tested is many years away.
What is Dr. Randhawa’s protocol for OIT treatment?
Dr. Randhawa’s treatment protocol is unique and customized depending on the needs of each of his patients. Some of the features of his protocol are:
- The goal of Dr. Randhawa’s treatment protocol is “dietary tolerance,” allowing patients to safely eat a normal dietary intake of the specific food allergen without being at risk for a reaction. Once this clinical milestone is achieved, the long-term strategy is to induce immunological tolerance to the allergic foods by continued dietary intake over years of time.
- Dr. Randhawa utilizes uniquely comprehensive and cutting-edge diagnostic tools including comprehensive skin testing, patch testing, component resolved diagnostics, gastrointestinal testing, immune system diagnostics, and lung function analysis. Each patient receives a detailed and customized diagnosis and a specific, unique protocol of treatment.
- The Food Allergy Center is a clinic physically located in Miller Children’s Hospital. This hospital-based setting allows for maximum safety. All patients are monitored utilizing cardiac, respiratory and telemetry monitoring during food dosing and challenges. A staff including an RN, respiratory therapist, and physician are on hand at all times during treatment. Safety is the hallmark of this program with over 6,000 successful food challenges completed.
- Joint support of the program by Miller Children’s Hospital and the Gallegos family’s generous donation affords access to all patients, with minimal to no out-of-pocket cost. The alliance creates a medical home for food allergy patients between 6 months to 21 years of age.
Will I graduate from Dr. Randhawa’s program?
Since its inception, Dr. Randhawa has treated more than 450 patients with food immunotherapy at the Food Allergy Center. TPIRC doctors have nearly a decade of experience in OIT and have achieved an unmatched 99% success rate. Its nearly 1,000 OIT patients have achieved larger maintenance doses than those following other protocols, including more than 300 peanut graduates safely eating at least 60 peanuts daily. Patients whose peanut tolerance was less than 1/100 of a peanut prior to treatment now safely ingest peanuts without restriction. Dr. Randhawa also has successfully treated patients with allergy to milk, eggs, wheat, soy, tree nuts, seeds, fish and shellfish.
The following table summarizes some key differences among food allergy programs nationally, and why Dr. Randhawa’s approach is so successful:
| Typical ClinicalTrial Setting | Typical Private Practice Setting | Dr. Randhawa and the Food Allergy Center | |
| Safety of Setting | Research facility; treatment conducted by non-M.D.s | Typically in an office setting; treatment conducted by non-M.D.s | Clinic within a hospital with doctors, RNs, and other specialists on staff; all challenges overseen by Dr. Randhawa; emergency facilities on site |
| Risk of Adverse Reactions | 2-5% require EpiPen during home dosing | 2-5% require EpiPen during home dosing | <1% require EpiPen during home dosing |
| Patient Access | Limited, based on the conditions of the study | Limited, based on practice approval policies and financial considerations | Open |
| Cost | Associated costs of travel and lodging | Some are purely out-of-pocket; others bill insurance but associated therapy costs may not be fully covered, resulting in out-of-pocket expenses of $1,500-$2,000 per month | Insurance billed with no additional therapy costs |
| Patient Restrictions | Restricted by conditions of the study (i.e. age, severity of prior reactions, etc.) | Restricted by practice policies (i.e. age, severity of prior reactions, diagnosis of asthma, etc.) | None |
| Foods Treated | Typically limited to one food (e.g. peanut only) | Typically limited to peanut only, with some offering treatment for milk, egg, and a few tree nuts | Treatment available for peanut, milk, eggs, wheat, soy, all tree nuts, seeds, fish and shellfish |
| Medication Use During Treatment | Dependent on conditions of the trial, regardless of patient’s individual needs | None | Customized, strategic use of medications to reach dose goals while minimizing frequency and severity of reactions and side-effects during treatment |
| Success Rate | 70-85% | 50-80% | 99% |
What makes Dr. Randhawa’s protocol and experience unique in treating patients with food allergies?
Dr. Randhawa has board certifications in internal medicine, pediatrics, immunology, allergy and pulmonology. He holds two academic appointments at the University of California Irvine and UCLA School of Medicine. Dr. Randhawa has published over 150 peer reviewed abstracts and articles spanning the fields of immunology, pulmonology and allergy. He is the program director and research coordinator of two nationally recognized training programs in allergy, immunology and pediatric pulmonology. Dr. Randhawa has served as primary investigator in over 25 clinical trials to date.
Dr. Randhawa gained interest in food allergy as a sub-investigator in one of the first studies conducted on food allergy utilizing omalizumab (trade name Xolair). While promising, the study was halted due to adverse effects from anaphylaxis. Then, in 2005, Dr. Randhawa witnessed a dramatic and unprecedented increase in the pediatric intensive care unit admission rate as a result of anaphylaxis. The negative outcomes from these clinical cases drove Dr. Randhawa to query where food allergy treatment was directed. After discussions with national leaders in immunology and allergy, Dr. Randhawa focused on studying food allergy treatment in the unique model of drug desensitization.
As part of the breadth of his specialties, Dr. Randhawa cares for lung transplant patients, many of whom have life-threatening allergies to essential drugs. In order to safely administer an indispensable drug to such a patient, Dr. Randhawa implements a patient-specific desensitization protocol that includes comprehensive analysis of the patient’s allergy risk factors, immune system status, a blockade of certain immune system targets, and deployment of the allergic drug to the patient. This invaluable experience has further informed Dr. Randhawa’s implementation of his food immunotherapy protocol.
If I graduate from Dr. Randhawa’s OIT program, what will it mean for me?
Dr. Randhawa’s program achieves a substantially higher maintenance dose, typically given weekly. In addition, you may be free to eat a normal U.S. dietary intake of the allergic food involved. This larger maintenance dose provides a larger safety net from anaphylaxis while still achieving the treatment effect of food immunotherapy. Importantly you may be free to enjoy foods and experiences that previously had been off-limits.
What does Dr. Randhawa’s food immunotherapy program aim to achieve in the future?
Food immunotherapy is in its infancy. The likelihood of clinical trials resulting in FDA approval for food immunotherapy is not promising. However, other research modalities have collected and published enough data to promote a clear and accelerated protocol to provide food allergy treatment to the millions of children at risk for anaphylaxis.
Dr. Randhawa believes that food immunotherapy treatment should be expeditiously studied to develop nationally published, recognized and accepted protocols to give more patients access to food immunotherapy. As a result, he is studying food allergy at the cellular, molecular and clinical level in order to categorize and individualize food allergy treatment. In addition, he is expanding the number of food immunotherapy patients that he is treating to over 1,000. This unprecedented number of treated patients combined with molecular data results will provide the rubric of developing such protocols. The development of these protocols will ensure greater success for more patients and a decreased risk of adverse events. Without the development of such protocols, access to food immunotherapy will continue to be highly restricted.
The Food Allergy Center’s primary goal is to maintain and grow the program to achieve its mission of providing food allergy treatment safely with a clear long term therapeutic benefit. As such, Dr. Randhawa has expanded his clinical team to include a triple board-certified immunologist-allergist in the Fall of 2015. The new physician will participate in the clinical care of food allergy patients and direct protocol development. He also will assist in development of clinical and translational food allergy research expansion. With years of outcome data now complete, a number of manuscripts will be published specific to food allergy treatment under Dr. Randhawa’s program in early 2016.
The second goal of the program is to focus on collaboration to advance the development of research protocols. Spearheaded by Dr. Randhawa, the Translational Pulmonary & Immunology Research Center (www.tpirc.org) will serve as a nonprofit hub of basic science research, clinical science research, and food allergy advocacy and support. Located in proximity to the Food Allergy Center at Miller Children’s Hospital, this center will house doctorate researchers, fellows in training and other local scientists interested in studying food allergy diagnostics and treatment. Further collaboration with local universities, institutes and pharmaceutical companies will assure a bright future for expeditious food allergy treatment for millions nationwide!
[1] Disclaimer: The human body reacts differently under the same set of circumstances. Hence, the responses are typical for a majority of the patients. However, each patient’s treatment will depend on the merits of the individual case. These FAQs do not constitute medical advice under any circumstances whatsoever nor are a guarantee of the results of the treatment in any manner.
