Dr. Mary Morris on “The Smartest Doctor in the Room” Podcast

Indeed we can. We have been treating for severe food allergies, actually, since the late 1960’s in our clinic. Interestingly, when I joined the clinic, my dad had already been treating children and adults for serious food allergies including things like eggs, milk and peanuts. Back in the 70’s, early 80’s, peanut allergy wasn’t as common as it is now, but there certainly were people who had anaphylaxis to those foods, even back then.

I learned from my dad, the Protocol of starting with a very small concentration of whatever the patient's allergic to and gradually increasing those doses over the course of several months, even up to a couple of years. By doing it slowly and gradually, we have an extremely good safety profile with using sublingual immunotherapy.

When I joined the practice, I kept looking around going “Dad, people don’t really know how to do this! We really need to get researchers involved and prove, using randomized placebo controlled double blind trials, that it actually is not only safe, but effective.”

I learned this Protocol, was practicing for many, many years with my dad and decided that I would try to approach some of the top researchers in the United States and see if they could actually do these types of studies. With one of the researches that I had approached, we were able to do a Protocol that used the experience from our clinic along with his top academic research facility, and actually do the trials that were needed to show that SLIT worked for peanut.

When I would talk to other allergists, everyone would say “If you can show that it works for peanut, then we’ll believe it.” That was why we had chosen peanut.

When we first started doing research studies, the researcher that I was working with thought if we do high doses and are more aggressive, even if there are more reactions along the way, maybe we have a chance of curing this indefinitely. So, that is something that was thought 15 years ago — that OIT was going to allow you to tolerate big amounts. The ability to have peanut butter sandwiches every day, that kind of thing.

SLIT uses much smaller quantities. For example, with peanut OIT trials, typically 2,000-4,000 mg was needed to see an effect. With SLIT, we take a much smaller amount, 2-4 mg, put it under the tongue and it interacts with the immune system that way. We avoid the stomach acid, digestion, all of those sorts of things. Because of that, we can get a level of tolerance, even with that minuscule amount of antigen that we’re giving the person.

Because the dose is so much smaller, obviously safety is a factor. One of the things that I think really is important for patients to speak to their allergist about is their goals. If their goal is to safely treat their child to the point where they don’t have to worry about an accidental exposure, then SLIT is by far the best decision, in my opinion. We don’t have anaphylaxis with treatment. We don’t have Eosinophilic Esophagitis from the treatment. We don’t have people having reactions at home in an unsupervised setting. SLIT safety wise, by far, it shows a better safety profile.

With the efficacy, we know that we now have multi-center randomized double blind placebo controlled trials showing that we can achieve at least 500 mg-1,000 mg of peanut protein. If we can tolerate that amount, the risk with an accidental exposure — eating out, cross contamination, one bite of something containing peanut — we know that it is less than that amount. We decrease the risk of a bad reaction 100 fold, right out of the block. Within a couple of years on immunotherapy, the studies that are doing longer follow up — like four year follow up — some of those children can handle a total of 4,000 mg of peanut protein, which is equivalent to around 10 peanuts, without a reaction.

Within a year, studies are showing that patients can tolerate three peanuts. If you go through treatment even longer, the amount is even higher, like 9 -11 peanuts. Those are levels that are clinically meaningful, meaning if you can tolerate 2, 3, 4 peanuts, your risk of accidentally getting an exposure and having a serious reaction drops drastically. If keeping the child safe is the most important think, SLIT has absolutely been shown to do that.

I think one of the concerns I have about OIT that only now do we really recognize, is that we thought initially that with the capsules that once you got to a certain level and were able to tolerate it, that no reactions could occur later on. Unfortunately, with capsule immunotherapy, if the child has a fever, onset of period, exercise — all of those things, unfortunately, have caused anaphylaxis in children who are already on the maintenance dose. With allergy drops, we don’t have to worry about concurrent illnesses, exercise, there are no restrictions.

If someone wants to make the OIT capsule that’s one size fits all and doctors write a prescription for it and fill it at the pharmacy — that’s something that requires FDA approval. Our medical licenses allow us to use our best judgement and use whatever treatment we feel is best for the patient with their understanding and consent.

Just like with allergy injection immunotherapy, we use standardized extracts that are under the FDA review. We customize them for each patient. Depending on what you’re allergic to, how allergic you are, we mix them for that individual patient. For airborne allergy, the extracts that we use are identical to what an allergist would put into their allergy shot. Instead of giving it by an injection, we use those same extracts and put them under the tongue.

Same is true with food items. We get the extracts from antigen manufacturers, just like every allergist does. They’re typically used for skin prick testing and diagnostic purposes. We take those exact same extracts that every allergist has sitting on their shelf and we custom mix them for the individual. It’s an off label use, meaning it’s not a standard product, but it is certainly something that allergists have done for a hundred years. It’s not a drug, it’s small amounts of what the person is actually allergic to and use it to build up their own immune system tolerance to it.

The issue is, is it really important to build up that safety margin? There are families and children that are very comfortable with just avoiding and carrying their EpiPen. For them, the daily administration of something to prevent a problem, and maybe SLIT isn’t right from them.

But especially if it’s a family that has a lot of anxiety about travel, school, going to a friend’s house, those are the families that I think, we have already a safe and effective treatment for gaining a safety margin.

The Protocol is shared, and published. If their allergist wants to look into sublingual immunotherapy for peanut allergy, they’re in the published studies, exactly step by step how to do it. The extracts that are used, they already have sitting in their fridge. I think for that set of families, who really want to be sure that their child is safe — the way that we get them safe is also extremely safe — then I think the allergy drop way of doing it is in my opinion the best way to go.

I actually think the immune system, while it’s still developing in 2-6 year olds, is actually easier to change the path with allergy drops than in an adult. I know that we have treated successfully teenagers and adults, and certainly those people are still responsive to treatment, but I think it takes longer.

Similarly to some of the early introduction of food studies, for example to peanut, I do think there’s an opportunity, with the younger children, to change the entire course of their allergic disease and even future development of allergies.

We know with, for example, airborne allergy immunotherapy, if we see a child that’s only dust mite allergic and we start treating them for their dust mite allergy at age 3 or 4, their risk for development of other airborne allergies, and even the development of asthma, is markedly lower. So from my standpoint in America, we don’t give allergy shots under the age of six. I think we as allergists are really missing a golden opportunity for intervening and stopping the allergic march. Not only foods, but even airborne treatment in a young child, allergy drops are the way to go, just because we don’t have any severe reactions.

Often, the children who have peanut, egg, milk allergies also have airborne allergies, or if they don’t already, often they will develop them in early childhood. I believe it is a definite advantage to be able to treat their airborne allergies, as well as their food allergies with SLIT. I think that was one of the things my dad was just brilliant in figuring out. Similarly to how we give allergy shots in America, where we don’t only do dust mite, or only do grass shots, he figured out a way to treat all of them simultaneously. Same thing with foods. He figured out that there were no problems with the Protocol that we have to treat foods simultaneously. He figured that out just by treating lots and lots and lots of patients.

People definitely weren’t putting out the welcome mat, that’s for sure. I think that I really learned from my dad that it isn’t about us, it’s about the patient. I think one of the ways that I was finally able to get some researchers to finally agree to do the studies, was I would say, perhaps you were unaware of this study, perhaps you’re unaware that we have 230,000 that we’ve treated this way, perhaps you’re unaware that we’ve had no anaphylaxis from our treatment. I look retrospectively at the patients that we treat with peanut allergy, and over 88% of them, once they were on treatment and had an accidental exposure, they didn’t feel the need to give an EpiPen. Nothing happened. I think finally, they wondered if what I was saying is true.

It has taken decades and decades of repeating myself and as you say, being very brave, because people have been extremely dismissive of this way of doing immunotherapy. I’m not sure why. In Europe, it’s commonplace. So I don’t understand why there’s still some dismissiveness about the route of administration, but there still is. There’s still work to do and I’m still out there working.

I think of the patients I see every day and the variety of things that are treatable, that we are actually getting at the root of the problem by giving them allergy treatment that modifies their immune response not only when they’re taking it, but changes it to the point where even when stopping treatment, the benefit remains. If I could get every patient, family member and allergist to understand that immunotherapy is disease modifying. It is something that we can give that changes the root of the problem. What an amazing tool.