The Ready, Set, Food! co-founder discusses how research and federal advisory shapes parental understanding of immunotherapy and food allergy prevention.
Katie Marks-Cogan, MD
Last month, a team of allergists and clinicians penned and co-signed a letter to the US Department of Agriculture (USDA) calling for the change to their dietary guidelines in alignment with childhood food allergy prevention.
Included in the recommendation was lead author Jonathan M. Spergel, MD, PhD, professor of Pediatrics at Perelman School of Medicine and Chief of the Children’s Hospital of Philadelphia (CHOP) Allergy Section. Spergel also serves on the board of medical advisors for food allergy prevention company Ready, Set, Food! and spoke with the team prior to opining to the USDA.
In an interview with HCPLive®, Ready, Set, Food co-founder and chief allergist Katie Marks-Cogan, MD, discussed the details of the USDA letter, its role in bolstering food allergy care and prevention understanding, and what the future work of pediatric allergic research looks like.
HCPLive: What is actually being asked in this letter to the USDA?
Marks-Cogan: Just to give a little background: we know that millions of Americans already use the USDA guidelines to help them make decisions about nutrition and diet. This is really the first time that the guidelines are being given for the 0-2 year age group. So, there's actually congressional mandate for a guideline for this age range.
Given the importance of diet and nutrition in this age range, and all of the science that's come out about food allergy prevention and early sustained allergen introduction, we thought that it was really imperative to include this in the guideline.
We talked to Dr. Jonathan Spergel, who's the head of the CHOP allergy program, and he agreed with us, and basically spearheaded this. The interesting thing to note is that all of these top experts in food allergy who were able to sign the letter did so within a very short period of time. Basically, he was able to get all of the signers in 72 hours—which just helps strengthen the fact that the field wants to get the word out, and spread awareness about early allergen introduction and how important it is.
In talking to Jonathan, we wanted to focus on 3 major recommendations. They were that infants should receive a diverse diet in their first year of life, and that should also include allergenic foods. The other one point is that complimentary feeding or introducing solid starting at around 6 months of age should include all allergenic foods and especially peanut and eggs.
We already have national guidelines for peanuts, and we will hopefully very soon also be including a guideline, so that's really important to specify. The other really important point of the letter is to stress the introduction of allergenic food in infancy is safe, and that it could reduce the risk of food allergy development.
HCPLive: Paradigm-shifting research like the LEAP trial has painted food allergen exposure and immunotherapy in different light after years of stressed allergen-risk avoidance. But it now requires physicians address patient and family fears surrounding allergen exposure and immunotherapy. Is this letter something that helps to serve that requirement?
Marks-Cogan: I love that you brought that up, because that is really the mission. And I think for all of us who are so passionate about spreading awareness on allergy prevention, that's it. We need to actually spread awareness within the pediatrician community, but then we have to get that info to parents. And you're right: there was there was all of this fear.
We had those guidelines from the American Academy of Pediatrics back in the 2000s that recommended the delay of allergenic foods. Those were reversed in 2008. But the awareness about that reversal was not that broad. People weren't very aware of it.
So, there's still been a fear of food allergies in general, and of introducing foods that have just stayed for the last decade—as we've seen the epidemic worsen. So now, we are all about changing the paradigm and getting the word out. I mean, every day that goes by without parents knowing, hundreds of babies could develop food allergies. So it really does feel urgent. Yeah. I think that is one of the points of getting this letter out; there is an urgency here and everyone needs to know about it.
HCPLive: It seems like the need for improved public information on pediatric food allergy goes beyond just treatment, right?
Marks-Cogan: It's very important just getting education about food allergies in general out to the public—especially with all of the concentration on diet, and food intolerance versus allergy, having people understand the difference between them. There also needs to be an understanding that food allergy diagnosis is not just cut and dry.
You actually really need to see people who are experienced, because there's being sensitized to food, there's being actually allergic to food, and there's a need to understand the difference.
It does open up a much broader conversation. And I think that, as an allergist, we all realize that. So getting good content and education about food allergies in general is something that you're seeing a lot more people focus on.
HCPLive: There's been discussion around federal regulation of immunotherapy marketing, such as with the recently-approved AR101 (Palforzia) from Aimmune Therapeutics, serving as an additional vote of confidence for potential patients. What do you think the next step would be in improving food allergy patient confidence?
Marks-Cogan: I think it is collectively thought that it's very exciting that it was approved and that it's going to be an available option for parents and patients with peanut allergy. And I think in general, it adds to this whole focus on food allergy and spreading awareness. But I think that we need to understand that it's not a cure, and it's not going to be for every patient with peanut allergy course. It can be more expensive than just general oral immunotherapy.
So, we need to be very measured with all the response to Palforiza, and the media does as well, because we don't want to give parents a false hope. But, it also gives us another avenue for educating parents and the public on food allergy in general. From my standpoint with Ready, Set, Food, our mission is really to focus on food allergy prevention. It helps us as well, because we realize that there still is no true cure for food allergy, even though we have Palforzia. It's a wonderful addition and a wonderful option, but there is no cure.
So, we still need to focus a lot of our energy on prevention, and we have this beautiful science on prevention and early allergen introduction, so let's really focus on that.
HCPLive: Could you give some more details to where that research stands right now? What's next?
Marks-Cogan: Absolutely. We have our landmark trials—the LEAP trial, the EAT trial, and even the PETIT trial. There are a lot of trials in process that are looking at even earlier introduction. There are lots of combinations of things being looked: eczema care, early allergen introduction, even breastfeeding. So, I think there's just a lot more energy, time, and money being given to this. But for me, I've been advocating for early allergen introduction even before the LEAP trial. When it came out, it was very validating.
But I think one of the main issues with all this wonderful science and all of this great awareness is actually, how do we implement it into everyday life of busy families? And I think that's the biggest roadblock.
I did it with my son. He was born in May 2015, and LEAP came out in February 2015. I actually knew to give him bamba this many times a week, and I gave him pureed scrambled eggs, and I gave him Greek yogurt. And I tried to make sure that all the caregivers and everybody was on the schedule to feed him these foods, so that I can hopefully reduce his risk of developing allergies. And what I realized is that it's really hard.
It's really tough to feed babies, it's hard to feed them if they're not developmentally ready to be eating solids. And even when they are, giving them multiple allergenic foods multiple times a week is really tough. That was one of the motivating factors when Andy Leitner, who's one of the co-founders of Ready, Set, Food—when his son was diagnosed with severe food allergies, he thought, 'Is there something I could have done to help get allergens into my son earlier, to make it a reduced risk?' Those were the motivating factors.
So when you ask where is this is going, there are more studies that I hope will strengthen the studies that we already have. But the next step really is, how do we implement it? We have guidelines, the NIH guidelines, and they do give some tips on the DIY of implementing peanuts into babies' diets. And those are great. But I think when you actually sit down with a parent and say, 'Are you able to do that?', you're going to get a lot who say, 'No, this is really hard.'
I think that's what we're going to do next: try and figure out a way to actually implement these guidelines.