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Dr. James R. Baker: FARE Views

FARE’s Dr. Baker: Finding Peace of Mind While We Search for a Cure

Why FARE (Food Allergy Research & Education) thinks desensitization is a vital food allergy therapy on the path toward finding tolerance.

Parents of children with food allergies tell me their main focus for their child’s future is keeping their loved one safe and healthy. This brings up a thought-provoking question when it comes to where we are headed with research: do we seek to find a cure for food allergy or do we address the urgent need to have a treatment – something – that will protect the lives of individuals with food allergies?

In diseases such as cancer or cystic fibrosis, scientists have focused on finding treatments that will help those affected live longer, while science develops the understanding of the underlying problem – in order to find the cure. In contrast, the endpoint in food allergy research is more complex because there are multiple causes at play. Even among the strongest supporters of food allergy research, there are differences in what is viewed as a “cure.”

Therefore I think it’s worthwhile to define what we at FARE mean when we talk about a “cure.”

Desensitization, which may be achieved through oral immunotherapy (OIT), which is still in clinical trials, blunts an allergic response to protect an individual accidentally exposed to their allergen and thereby prevents a potentially life-threatening reaction. However, if the individual stops taking the therapy, the full allergic reaction returns.

Tolerance – or what researchers refer to as “sustained unresponsiveness” – means the individual is no longer allergic to the food and can freely incorporate it into their diet. With sustained unresponsiveness, for example, individuals could safely consume their allergen well after their treatment concluded, without ongoing treatment or maintenance doses.

With desensitization, you could gain peace of mind and a level of freedom from the threat of life-threatening reactions, but you likely will still carry epinephrine. With tolerance, you would be “cured.”

For many parents who have seen their child gasp for air in the midst of a terrifying anaphylactic reaction, a cure may be a long-term goal, but immediate protection is important, so desensitization is a significant option. Other parents, however, may feel this approach doesn’t go far enough because they want their child to be able to eat whatever they want, and to avoid any fear the food allergy could return.

Zeroing in on a single cure for food allergy has proven difficult since we still don’t understand the cause. Why can one child tolerate cooked egg with no problem while his friend can’t? Why do therapies currently being studied in clinical trials work for some but not others? Underlying some of the vexing issues about food allergies is the fact that reactions are highly variable, not just across the population, but even within a single person.

Families and individuals managing food allergies have clamored for a cure, and rightfully so. Too many lives have been lost to fatal food allergy reactions. But I feel it is vitally important to also give attention and investments to research that will provide protection from life-threatening reactions to the millions affected by food allergies.

Scientists are still gathering data to address fundamental questions about inducing tolerance to food. The pace of research has been frustratingly slow and we at FARE share this frustration. I would like to have a viable treatment tomorrow.

On the other hand, we cannot proffer things that are not proven, or more importantly, could be dangerous. That’s why we’re pulling out all the stops to accelerate research with initiatives such as the FARE Clinical Network and programs like the FARE Investigator in Food Allergy Awards. Fortunately, with generous community support, we have been able to provide resources for talented scientists who are newly dedicated to finding ways to protect food-allergic individuals.

I’m pleased to report that, for the first time, two companies working on therapies for food allergy are in Phase 3 (final) clinical trials. For some of you, that might beg the question of why we even need approval of the Food and Drug Administration. One of the main reasons is so that allergists across the country can offer consistent therapies – whether as OIT or the skin patch – to all patients with approved protocols and guidelines. These therapies would also be eligible for insurance coverage, which is a major problem with non-FDA approved approaches.

In January, I had the opportunity to offer comment at an FDA meeting of the Allergenic Products Advisory Committee, which was held to discuss safety and effectiveness data for food allergy immunotherapy products. I emphasized that although the reduced potential for an allergic reaction may not seem like a tremendous scientific advance, it could be the difference between life and death for many food-allergic individuals.

So for now, when we talk about therapeutic endpoints, we will focus on safe and effective treatments that desensitize rather than induce tolerance. We know these treatments will save lives now while we continue to build our understanding of food allergies to support further work for longer-term goals – such as a true cure. I feel this binary approach makes the most sense, and best serves the wishes of the allergic community.

Dr. Jim Baker is the CEO of Food Allergy Research & Education (FARE). For more information, visit Foodallergy.org.

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