Escaping the Food Allergy Prison

Every three minutes in the United States, an allergic reaction to foods sends someone to the emergency room. Today, we explore what life is like when you must avoid certain foods. But we also learn that there is hope for an escape from the food prison. Researchers like Clemson University's Sachin Rustgi are using cutting-edge genetic engineering tools to make foods safer for those living with allergies and food sensitivities. Guests: Sachin Rustgi, Clemson University Lisa Gable, FARE Emily Brown, Food Equality Initiative

The episode is available now at www.bio.org/podcast and via Apple, Google, and Spotify.

Audio Clip 1 (00:00):

... go to the story of a six year old boy who is allergic to nearly all foods. It's a rare medical condition. At first, he could eat only one food.

Audio Clip 2 (00:07):

It's hard. You see everyone and you feel like left out kind of, and you can't eat the same foods as everyone.

Audio Clip 3 (00:17):

Why do we need GMOs at all?

Audio Clip 4 (00:19):

Guys, this is a great story. This week, a 12 year old girl was able to do something she had never been able to do before. She was able to dig in to her Thanksgiving meal without any fear.

Michelle McMurry-Heath (00:35):

It is estimated that 32 million Americans and hundreds of millions more were worldwide suffer from food allergies or intolerances. Every three minutes in the United States, an allergic reaction to foods sends someone to the emergency room. Today, we explore what life is like when you must avoid certain foods. But we also learn that there is hope for an escape from the food prison. Researchers are using biotechnology to make foods safer for those living with allergies and food sensitivities. Cutting edge tools like genetic engineering are evolving the concept of food as medicine. I'm Dr. Michelle McMurry-Heath, and you're listening to, I am BIO.

Emily Brown (01:35):

My name is Emily Brown, and I'm the founder and CEO of Food Equality Initiative.

Emily Brown (01:47):

So I personally do not have food allergies, but I have two daughters that have multiple food allergies. They are both allergic to peanuts and tree nuts. What's unique about them, I think, is that not only do they affect the patient who is diagnosed, but definitely has a significant impact on the entire family. So definitely my children, we're all concerned about the things that they eat. We read food labels meticulously, making sure there are no traces of peanuts or tree nuts in any of their food. We're very cautious with bakery items. We don't by bakery goods that are potentially cross-contaminated with peanuts and tree nuts. And of course, for young children, this is a challenge or can be a challenge with birthday parties in schools and celebrations. They just want to feel normal like everyone else and not have to think about something before they eat a cupcake. And so they're reading all the labels, being very careful. I know initially when we were diagnosed, we did not go to church potlucks or anything. We were very insular for really the first few years, but we've been able to, with a lot of training and a lot of safety ground rules put in place, we've been able to become more social, but things like restaurants are still hard, and it can be a challenge. It's really the social psychological impact that I think has been the most difficult.

Michelle McMurry-Heath (03:20):

It's difficult to keep my own daughter on a steady, nutritious diet, even without food allergies. For Emily and other parents that have to consider allergies to peanuts, wheat or dairy, the job becomes even harder.

Sachin Rustgi (03:35):

You can go gluten free or peanut free. Yes, of course we can do that. But this is a very difficult and challenging life.

Michelle McMurry-Heath (03:49):

That's Sachin Rustgi. He's an Assistant Professor of Molecular Breeding at Clemson University's College of Agriculture. Sachin's team has been researching both wheat and peanuts, which are two of the crops that cause some of the most common allergies. He shared with us why these foods trigger such a strong reaction in some people.

Sachin Rustgi (04:12):

So wheat, actually sensitivity I will say like is much more complicated. So it is three different kind of reactions that a human experiences upon consumption, and that is only happening, like not in every individual, but the people who are sensitive, and they carry genetics for that, and not necessarily that genetics would play out from the very beginning. It could happen later during the life with the changes in the gut microbiota. So our gut is full of microbiome. And when that changes, it could actually trigger the reactions to the wheat proteins. So the reactions that we experience are actually wheat allergies. The second one is actually called celiac disease or wheat intolerance, so they cannot completely tolerate wheat, and it's a very chronic reaction to the thing that slowly increase with time, and it's a autoimmune disorder, so it's very complicated.

Sachin Rustgi (05:10):

And then the third reaction is actually less well understood at the moment, and which is called also wheat sensitivity, although it used to be called gluten sensitivity. So gluten is a protein that cause the problems or trigger these reactions in human body. But now it was revised to wheat because not necessarily the proteins. There are other elements in the wheat grain which are non-protein and also cause this sort of problem. So it's largely the proteins that are responsible for the reactions.

Sachin Rustgi (05:40):

Peanut has pretty much the similar thing. Peanut does not have that many different reactions in the human being, so there is one set that we all know, it is peanut allergy, and the intensity of this allergy could vary in different individuals. Some individuals are highly sensitive to peanuts. Even like a peanut dust can cause severe reactions. The thing is there, and again, the culprit is the peanut proteins, and there are 16 different proteins in a peanut grain that cause these allergies. Out of those, there are actually four proteins that are known as the major allergens, so about 50% of the population that is so far tested actually respond to those proteins. So that's what we were targeting. So we were targeting to eliminate those proteins so the plant does not produce those major allergens, and that way we can minimize or reduce the allergenic potential of these grains. So if in case somebody is exposed accidentally with these grains, there won't be that severe reaction. So that is the idea.

Lisa Gable (06:56):

My name is Lisa Gable. I am the CEO of FARE. FARE is the world's largest NGO and private funder of food allergy research and advocacy, and our focus is working towards a future free of food allergies and intolerances.

Michelle McMurry-Heath (07:12):

Lisa joined BIO's Vice President for Agriculture and Environment, Sarah Gallo, to talk about the challenges of living with food allergies.

Sarah Gallo (07:22):

Can you share some data on how many people are living with allergies in the US, or if you have a sense of globally, just what the scale is of how many individuals are living through that?

Lisa Gable (07:33):

Sure. Food allergy and intolerance to one of the top nine food allergens affects the purchasing decision of 85 million Americans. It also affects individuals, part of that 85 million are 32 million people who live with potentially life threatening food allergies. That means through the accidental ingestion of food, that they could possibly die. The rest of the individuals in the 85 million are people with food intolerances or individuals who live with those who do. For people who are listening, let me give you the list at the top nine, because that's always a question that people ask. It's milk, wheat, soy, egg, peanut, tree nut, fish, shellfish, and sesame.

Sarah Gallo (08:14):

That is quite a few things. Thanks for sharing. That was going to be one of my questions. So I'm really glad to know sort of the scope of what we're talking about and where most people's allergens fall. And this is something I think even I myself get confused about sometimes, what is the difference between sensitivities and allergens?

Lisa Gable (08:34):

Sure. It's a point of confusion for a lot of people. And so today I'm actually going to give a plug for a new book that was launched yesterday by Dr. Ruchi Gupta and it's called Food Without Fear. And the reason that I mention it is that it really speaks to this question that so many people are asking. It talks about a spectrum of ailments with tricky masqueraders that create a lot of confusion and possibly misdiagnosis and sort of faulty and poor treatment. What she talks thought is that an individual may have food related conditions which result in stomach pain, diarrhea, hives, other types of ways that their immune system is acting up, but a life threatening food allergy is when someone has at least two of the body systems shut down with potentially plunging drops in blood pressure. And that's where it gets into being a life threatening allergy where you need to immediately administer epinephrine and take someone to the hospital.

Sarah Gallo (09:29):

So you talked a little bit there about the effects of people with allergies and what would happen if they were to ingest or consume food that would bother them. But I think there's probably some other kind of quality of life issues that surround individuals. And I really appreciate that you mentioned others that live with people that have allergies. So can you talk a little bit about just from FARE's research or your personal experience, what effects does it have on quality of life generally?

Lisa Gable (09:56):

Well, when we talk about quality of life, one of the things I like to highlight at the beginning is that it is an urgent, unmet medical need for innovative treatments in food allergy. And it's one reason I was so excited to be invited to this podcast because I believe that companies at bio are on the leading edge of helping to solve these problems. The standard of care has always been avoidance and that drastically impacts patient quality of life from results. And because there's a psychosocial burden for patients and families, is there in constant fear of accidental exposure to an allergen and the need to always be ready to have access to their emergency medical medications at all times. And patients need this medicine in order to accommodate their unique needs. And what works for one patient may not always work for another patient.

Lisa Gable (10:41):

And so there is an credible burden. For example, over the past week, we received a note that a 31-year-old man in the Midwest died due to accidental exposure of peanut butter. This is a 31-year-old man who is someone who is a very high-level individual in the field in which he served. Obviously from what we could see, practiced avoidance, was extremely careful and yet he died. And so it is life threatening. There's a lot of misunderstanding about how serious this condition is and how difficult it is even with ever vigilance to always know that you're going to be safe. So when a mom sends her child off to a sleepover or they go to summer camp, or you're sending your child off to college, the anxiety levels are extremely high.

Michelle McMurry-Heath (11:36):

As Sachin Rustgi explained earlier, allergic reactions are triggered by specific proteins in foods.

Sachin Rustgi (11:45):

The second one is detoxification. So we decided also to express the proteins because these proteins are actually kept in the plant for its own good. So when the plant germinate, it actually degrade these protein into small pieces and release the amino acids, which are the building blocks of proteins to actually carry out its own development. So the grain also contain the proteins that can actually degrade them into small or finer elements. We don't have those proteins. So we cannot process these proteins completely in our gut, so what happens in the individuals which are sensitive, they have a leak intestine. So these are small pieces which are not processed get into our bloody stream and cause the immune reaction.

Michelle McMurry-Heath (12:34):

Using conventional breeding, genetic modification and gene editing, Sachin's team at Clemson University is making progress on altering these proteins in wheat.

Sachin Rustgi (12:45):

However, like the other individuals, they also cannot process it. I mean, if I'm a healthy individual, I have no sensitivity for wheat, but I cannot also completely process. So the problem is not the processing. Is if it gets into the bloody stream or if it does not get into the bloody stream. So we excrete them out. So bio availability is the thing. So bio availability of these proteins is quite low because they cannot be completely processed. There are many different ways to get to the target that we want to get. So we can use mutagenesis, the old patient where we can treat the grains with the chemicals and then induce mutations in the DNA of the thing.

Sachin Rustgi (13:23):

That is a conventional method of breeding, or we can use genetic modification. So we use mutagenesis, we use genetic modification, we also use gene editing. That is a new technology you might be hearing a lot about like the CRISPR technology. So that's what we are also using. And in addition to this, we were also screening the natural gem plasm. And I can tell you, there is an interesting pattern we observed. The lines that were actually derived from the high LT2 regions of the [inaudible 00:13:51] were actually tend to lack some of these toxic proteins.

Michelle McMurry-Heath (14:00):

When we come back, we'll hear more from Sarah Gallo's conversation with Lisa Gable on the cost of food allergies and Sachin Rustgi will tell us how close we are to helping people with allergies experience food freedom. Are you signed up for Good Day BIO? It's the daily five minute newsletter at the intersection of biotech, politics and policy. Become a subscriber today at bio.org/goodday. In the United States, the Food and Drug Administration is responsible for ensuring the safety of our food supply. This includes foods enhanced through biotechnology. Here's more from Sarah and Lisa's conversation on the relationship with between FDA and food innovators.

Sarah Gallo (15:03):

So do you think there needs to be more done by the FDA? I know your group works very closely with the FDA and other agencies that are tackling this and trying to help get beneficial products into the marketplace to help people suffering from food allergies. But what more can be done by the FDA?

Lisa Gable (15:22):

Well, as we all know, the FDA fully understands this dynamic is there are two sides. There's the side that deals with food regulation and there's the side that deals with the regulatory aspects around therapies and diagnostics. And what causes a great deal of confusion today is that those two worlds are actually merging. And so we need to really look at the regulatory pathway for medical foods, biologics, multi allergen strategies, and innovative ways of delivering the food which serves to desensitize the patient, it's part of the treatment, to the patient. But one of the things that we actually are working with them right now on is conversations around establishing a baseline for what constitutes an allergy worthy of being listed. And we can look at the severity of the reaction, because some allergens like sesame have a more severe reaction, it's much more immediate, that causes that anaphylaxis and possible death, or the quantity of people who have a reaction.

Lisa Gable (16:25):

And so on that side of the fence, we're working with FDA and FARP. FARP is an industry funded consortium that develops for the food industry, industry credible information that allows them to explore what's going on with allergenic foods. And so we're building out a threshold data platform that retroactively looks at past oral food challenges and allows us to look at what point did patients react to the allergen? Because we actually want more specific data that allows us to both diagnose the disease, as well as understand what thresholds of consumption kick off the severity of the disease.

Lisa Gable (17:05):

So for us, the FDA conversation is around fast-tracking diagnosis, diagnostics, and therapies, secondarily is removing barriers and looking at the entire FDA platform and structure, because we don't think the current regulatory environment accommodates what's going to solve this particular problem for the patient. And then on the other side is we are working with them on the food and food labeling side of things. So we have a fairly comprehensive engagement.

Michelle McMurry-Heath (17:40):

Increasing access to affordable, healthy, and nutritious foods is a matter of equity. And if we want to increase access to these foods, especially in historically neglected communities, we can't disregard the advances being made by scientists around the globe.

Sachin Rustgi (17:58):

To actually create a situation where we can remove or minimize the need for keeping a peanut-free or a gluten-free environment, because right now it's a very big financial burden and difficulty. I believe one of us is a parent of a child, so they know firsthand how difficult it is to actually keep track of everything. So we can actually reduce that risk of having an exporter, and even if we get exposed, to the severity of the reaction by creating the lines to reduce immunogenicity.

Michelle McMurry-Heath (18:46):

Emily Brown dreams of what a life without allergies would be like for her kids.

Emily Brown (18:50):

I mean, I think it would be life changing. They could eat peanuts and not be triggered. That would definitely be life changing, for them to be able to have these foods that are so integral in our community and within the cultural diets of our community. You think about how ubiquitous peanut butter is for young children. And so, I think it would be very meaningful for them.

Michelle McMurry-Heath (19:18):

In recent years medical professionals have been using exposure therapy, mostly in small children, to increase tolerance of foods to which patients are allergic. Trained professionals feed micro doses of allergens to the patient, and gradually increase the dosage to combat allergic reactions. In our conversation with Sachin Rustgi, he explained how biotechnology is helping to make this process more precise.

Sachin Rustgi (19:49):

A mild dose in supervised settings. That dose will be determined by an expert like a physician, so they can determine what dose does not cause difficulty. And then they gradually increase that dose. So right now they are doing it with a conventional peanut or a conventional wheat, but that could be done with a reduced allergenicity or reduced immunogenicity thing. And there you can soon get it to a larger dose because it already is reduced in the content of those allergens.

Audio Clip 5 (20:21):

So why are GMOs bad? They're not. They just aren't, not intrinsically, and certainly not for your health. We've been eating them for decades with no ill effects, which makes sense because a genetically modified organism is simply an organism like any other organism that produces tens of thousands of proteins, but one or two of them were proteins that were chosen specifically by us humans. Genetic engineering is necessary for the continued success of the human experiment here on planet Earth. Just like the advent of nitrogen fixing allowed for more fertile fields that saved millions from starvation, the fruits of genetic engineering, sometimes literally, will help us face the significant challenges of a world with more and more people in a climate that is less and less stable.

Michelle McMurry-Heath (21:04):

Genetically modified organisms, or GMOs, have been around since the 1990s. Despite the fear, GMOs are safe and no peer review scientific study has found otherwise. In fact, through genetic modification and gene editing, we can develop plants that are healthier, more resilient and environmentally friendly. Bio is committed to transparent dialogue around biotechnology in every aspect of our life, including in our food. Here's more from Sarah and Lisa's conversation.

Sarah Gallo (21:39):

Do you think that there are specific questions that biotech innovators can start thinking about now as they're developing and as they're doing outreach around products to deal with food allergies? Are there certain things that they should be prepared to answer from the patient community or from groups like yours, so that we can start that education process now?

Lisa Gable (22:01):

I am so excited you asked this question because I worked a lot on the GMO issues back in 2009 to 2016. And what we don't want is for some misinformation to get out and all of a sudden to begin to experience the fears that we have as it relates to GMOs. And so the most important thing is to begin that education process and create demand. What you want is to create an education process where you're working hand in hand with groups like FARE and getting the message out to patients, educating them on what the potential is, and literally have them demanding the solution when it comes to market. They understand it. They're not fearful of it. And in fact, they come to recognize the incredible transformation it could have for their lives.

Sarah Gallo (22:54):

So you talked a little bit about some of the research and challenges that you all oversee at FARE. What solutions do you see so far, or which ones most excite you, or is there anything that researchers are working on that you want to make sure that listeners are aware of?

Lisa Gable (23:12):

Well, I'm so glad you asked because, having been in tech and in the food space and working with agriculture pretty much for the last 25 years, I find this to be one of the most exciting times in innovation. FARE has launched a program called SEED, which is a research effort that's going to determine whether early dietary introduction of eight potentially allergenic foods reduces the prevalence of allergies to children, by introducing it to babies between four and six months old, early and often for two years. And that is incredibly exciting. We have seen great results from the LEAP study, which was co-funded by FARE, that introduced peanut to babies. Now that LEAP study has been in market, I would say, for five years, this is its fifth anniversary, we are seeing a precipitous drop in peanut allergies as a result. And then finally, what I would say is the area that I know your members are working on, which is that we have allergen immunotherapies in multiple forms that people are working on today. Shots, drops, powders patches, which involves exposing the immune system to what the patient is allergic to, which is very different from other traditional medicine approaches. And it's again for this reason and many other reasons why the traditional regulatory approaches to evaluating it are not appropriate to apply.

Lisa Gable (24:35):

So there are a lot of exciting things that your members are doing in this field. We've got people who are looking at shots, drops under the tongue, powders, lots of exciting ways of both delivering the allergen to the patient's immune system. Secondarily is we're talking about the introduction of food. I mean, people talk about food as medicine all the time. And I've been in the food and beverage world now for 15 years, and I truly believe in the food allergy space, we've proven food as medicine.

Lisa Gable (25:09):

Through the early introduction of proteins to a baby, you're talking about off the shelf proteins that you're delivering to a baby to potentially reduce their getting a food allergy. Even when we're talking about these products, you're talking to many cases, some form of a food. That's what it is and medically tailored meals. So, food allergies is really on the leading edge of food as medicine, but we have to clearly define it because all of the work that I'm talking about is also backed up by clinically-based research.

Lisa Gable (25:42):

We're working closely with the FDA. We talk to NIH all of the time. It's really important for innovators and I lived in Silicon valley for 15 years and sometimes they dismiss Washington. As we talked about with gene editing, it's really important to start working with the regulatory environment and the government very early on, as well as the patient groups to basically get the marketplace ready to receive the products that you're creating.

Michelle McMurry-Heath (26:09):

We asked Sachin if he felt there might be resistance to products developed through biotechnology.

Sachin Rustgi (26:16):

I won't say like it's a complete resistance because so far, like most of the people that I met, they understand, and it is not the problem. I mean, changes are taking place. Like even I can tell you, like in Argentina recently that genetically modified wheat has been approved. And that was the first of its kind like because nowhere in the entire world like a genetically modified wheat is actually approved, but that's a good move. I think like it's just like the need and then the people are realizing like since the environment is changing and these crops like, especially wheat, is very well adapted.

Sachin Rustgi (26:54):

Like it can grow in very diverse environments from Scandinavia to in African nations. You can imagine like, I mean, this has a strain which can tolerate heat, drought and many other problems that we might experience in future. But like the people are slowly understanding it is important and we have to be adaptive of all technology that exists today, including genetic modification so we can actually meet the needs of future.

Emily Brown (27:23):

So I think biotechnology could play a key role in either reducing food allergies or helping people overcome their allergies through different various therapies and treatments that are emerging. Like all things, I believe that it's going to take innovation and really the community coming together to really discover what works best for most people. And I think allergies are so individual. I think, there may not be one therapy that works best for everyone, but there may be a host of different treatment options where people may be able to choose what works best for them.

Emily Brown (28:04):

But, I am optimistic that the individuality and the diversity of biotech industry will be helpful in determining a future free from fear of your food.

Michelle McMurry-Heath (28:21):

Do you or someone you know have food allergies? You can learn more about safe and healthy food at foodequalityinitiative.org. Thank you to all of today's guests, make sure to subscribe, rate and/or review this podcast and follow us on Twitter, Facebook and LinkedIn @iambiotech and subscribe to GoodDay BIO at bio.org/goodday. This episode was developed by executive producer, Theresa Brady and producers, Connor McCoy, Cornelia Poku, and Maryland Sawyer. Sound design and mixing by Jess Fenton, theme music created by Luke Smith and Sam Brady.

Michelle McMurry-Heath (29:08):

On our next episode, we share two inspiring patient stories that illustrate the great lengths people will go to, to fight for themselves and the ones they love. See you in a couple of weeks.