Dr. Marty Makary (00:00):
That was put out by their nutrition committee that basically said, "Peanut product avoidance in the first couple of years of life." I went back and had asked people, "Why did you say that? What science was it based on?" In transplant surgery, we've known for a long time that there's a principle called oral tolerance, or immune tolerance. That is, when you're exposed to an allergen early in life, that you're less likely to reject that allergen as your immune system is forming.
(00:35)
Well, they hadn't talked to anybody in that field. They did not know that literature, and the ignorance of groupthink issued this decree, which could make sense to somebody who doesn't understand oral immune tolerance. That ignited a modern-day peanut allergy epidemic, that started right around the time of the year 2000, when that recommendation was put out.
(01:05)
Of course, it became a perpetual vicious cycle. Because if more kids got an allergy, then you avoided peanut butter, or peanuts in that family, or that classroom, or that school district, and then less peanut allergen exposure would further increase the peanut allergy rates. So, it became this vicious cycle.
(01:28)
It wasn't really until a doctor named Gideon Lack had done a famous study called the LEAP Study. It was hard for him to get funding to do that study. "Well, we know this is true. Why would you want to study it?" Probably the same logic behind a lot of the groupthink mistakes of modern medicine. "Well, we know this is true. Why would you do this? This could sow doubt in the field. What if you get a result that goes against what we already know to be true?"
(01:58)
We see these arguments in many areas of medicine. We saw it with the opioids are non-addictive dogma that we got wrong as a medical field for 15 years. People were saying, waving the flag in the air, "Hey, the science is not consistent with this." So finally, Gideon Lack got that study done in 2013 to 2015.
(02:23)
You saw a massive realization, that the moniker that was put out in pediatrics residency programs, that was designed to be an easy-to-remember chant that would be recited by every pediatrician and family medicine doctor, counseling a parent who has an infant, "Remember, 1, 2, 3. Don't start milk products until they're one year of age. Don't start eggs until they're two, and don't start any peanut butter or peanut products until they're three." That became the dogma.
(02:55)
So, it really was not until 2015 that they realized they had gotten this tragically wrong. So, we're still reeling in from that mistake. Now, there's another piece to this besides early antigen exposure that we don't talk about, that we need to talk about. And it's not just with food allergies. It is with so many areas of medicine, because we're learning gut health is central to overall health,
(03:21)
It is the microbiome. This garden of over a billion different bacteria, not cumulative total, but different types of bacteria that are central to health. If you have inflammation of your gut, that's going to cause some minimal dilatation. If you have a clinical background, one thing you may know is that the most painful things in the human body is pain from something stretching.
(03:51)
So, when a kidney stone blocks the ureter, people think it's the sharp edges that cause the pain. No, it's the dilatation from the obstruction. When you have a gallbladder attack, it's the dilatation of the gallbladder. When you have a bowel obstruction, it's the dilatation of the bowel. Talk to anyone who's experienced any of those, those are the worst forms of pain in the entire human body.
(04:12)
Well, what's happening, when our microbiome is altered, it's increasing inflammation, and that's causing some dilatation. Now, it's not an acute inflammation. It's a very low-grade dilatation, and it's constant. It's always there. There's a lot of factors driving this. But when you're a four-year-old, or an eight-year-old, it manifests as just being sad. That's the clinical manifestation of that phenomena.
(04:43)
And so, what you have is, people where their gut health is not optimized, and then it leads to a whole host of other medical problems.
(04:52)
We also know that the microbiome is producing things central to health. It makes vitamins. It makes clotting factors. It makes serotonin, which is involved in mood. You've heard of serotonin. 90% of your body's serotonin is made in the microbiome. What's happening when we alter the microbiome in the modern world? Antibiotics can carpet-bomb parts of the microbiome, resulting in overgrowth of one type of bacteria.
(05:21)
A study out of the Mayo Clinic that was recently published, showed that kids who took antibiotics in the first two years of life had a higher rate of chronic diseases, from allergic rhinitis to obesity, compared to kids who did not have exposure in the first two years. Why is that? Well, it may be because their microbiome has been altered.
(05:45)
Now, the average two-year-old has already received over two courses of antibiotics in their brief two years, sometimes in their first day of life, just as a precaution. We're now trying to have better antibiotic stewardship. But we're not treating the microbiome with respect, and it may be because we don't really understand the microbiome. There's no research in the microbiome. Very little research.
(06:09)
I talked to the microbiome unit at the NIH. It was like a couple people. This is like the frontier in health. And so, it may very well be that there's an intersection between microbiome and peanut and food allergies. That's what a group of researchers at Harvard Medical School believe, when I spent some time listening to them. It's amazing how much you learn when you listen to folks.
(06:35)
They believe that there are some microbes that are deficient in people with food allergies, and they're trying to get more granular to find out which types of microbiomes are missing in people with certain types of food allergies. I think that's some of the most exciting work that's being done, and your group is funding it. And so, for that, I want to say thank you. This is very important work.
(06:59)
We need to focus on the important central issues to health that we have not been talking about that we need to talk about. And so, this administration's committed to looking at these issues. We talk about these things with NIH funding priorities. We talk about them at the FDA, where we have an intersection with some of these open biome type groups out there that are… We're doing work in the microbiome and they have products before the FDA.
(07:31)
FDA sometimes hasn't known what to do with these products. What do you do with a pill that has a million microbes in it? Are we going to regulate each microbe separately? Are we going to regulate it for one condition? Or recognize that if people feel better, maybe that's an outcome that we can recognize. Are we going to require randomized control trials for every microbe that could be… We don't do that with probiotics. So, what's the line between what we regulate and don't regulate?
(08:05)
These are the active discussions that we're having. But I do believe very firmly that gut health is central to overall health, and we have missed the mark when it comes to recognizing the principle of oral immune tolerance.
(08:20)
So, with that, I just want to say thank you. Thank you, Alana. I don't know if you have any other points you want to make. I know we're going to hear from some others in our administration, our head of the ARPA-H program. Anything else you'd like to add? Okay, great. Great. All right. Thank you for your work. Thank you. Thank you.
Speaker 1 (08:55):
Thank you, Dr. Makary.
(08:57)
Next, I'd like to introduce ARPA-H Director, Dr. Alicia Jackson. Dr. Jackson became the director of ARPA-H last month. At our annual summit in April, we welcomed ARPA-H leadership and are proud that the Food Allergy Fund is an ARPA-H Investor Catalyst Hub member. We are excited about the next phase of ARPA-H's involvement in food allergies, by bringing its unique, high-risk, high-reward model.
(09:19)
Dr. Jackson joins ARPA-H from Evernow, a company she founded and led as CEO, focused on transforming women's health and longevity during menopause. Previously, she served as a program manager and subsequently Deputy Director of DARPA's Biological Technologies Office, guiding an investment portfolio across bio-defense, novel medicine development, and bio-manufacturing, to protect the nation while advancing groundbreaking scientific capabilities.
(09:45)
She has served as a senate policy advisor as well as co-founder, board member, and advisor of several biotech and health startups. Dr. Jackson holds a PhD in material science from the Massachusetts Institute of Technology. Dr. Jackson.
Dr. Alicia Jackson (10:04):
Good morning. I'm very happy to be here. I want to give out a big thanks to Alana and the Food Allergy Fund, for bringing everyone together here around a topic. As Dr. Makary said, it is really growing into a crisis, and we don't seem to really understand at a root cause level what is driving it. We have a lot of hypotheses. But there does seem to be, what I would call a valley of death, between the very basic research that's going on and the commercial technologies available today.
(10:38)
That's really where ARPA-H plays. For those of you who aren't familiar with the ARPA model, I want to give a little bit of a background here, so you can really understand where we fit in the ecosystem of innovation, not just within the federal government, but really in the private sector as well. So, who here is familiar with even DARPA? Okay, quite a few people.
(11:02)
I did have the privilege of serving there for five years, both as a program manager, and then launching and becoming Deputy Director of the Biological Technologies Office. It really is what I would say the crown jewel of the US research and innovation enterprise. It's unparalleled across the world.
(11:21)
One of the really unique things about it, is that it can take on risk and fund very large problems in a way that neither the federal government traditionally, nor the private sector can take on. I know that even more deeply, having been in both now, the federal government and the private sector. Especially in a place where food allergy sits right now, there's a lot of hypotheses that are very risky to go after and to put big dollars after.
(11:50)
We tend to fund a lot of point solutions, or a lot of basic research, but clearly, there is something underlying all of this that we're seeing in immunology overall. And at an ARPA, whether it's a DARPA, or an ARPA-H, you can start to ask the big questions, which is, "What if? What if we could literally tomorrow flip a switch and reset everyone's immune system, so that they don't have a food allergy, they don't have an immunology issue?"
(12:17)
Those are the really big questions that we want to go after here. ARPAs work in a very different way, and part of the reason I'm saying this to all of you is because I need your help. We need your help at ARPA. Unlike a lot of different research agencies, it's very much not top-down. I'm here. I set the direction. We want to create breakthroughs in human health that actually change the course of human health.
(12:43)
We set big directions. Defeating disease, ensuring that our children live a decade longer than their parents, and ensuring that this nation is protected against whether natural or engineered bio-threats. But really, the program ideas come from our program managers. These are exceptional individuals. They can be from academia, industry, startups, even government labs, where they might've worked before.
(13:08)
The only requirements is that they are deeply technical. They have an incredible passion that they will break through a brick wall to achieve, things that everyone else might say, "Oh, this is going to take too long. There's no way we're going to be able to do it."
(13:22)
They're the people with the vision who say, "I'm going to do this. I'm going to bring every single resource to the table. I'm going to be able to work with startups, academia, large companies, non-profits, and make sure that we come together and put enough funding behind this, in a very strong technical direction, that not only can we make what seems impossible, probable, but we can create an entire field, an entire community, that can continue beyond us."
(13:52)
The other unique thing about the program managers, is that they're on a timeline when they come and work for us. Everyone gets about three years. So, the day that somebody shows up, the clock starts ticking. What that means, is that every day counts when you're an ARPA program manager. It's that kind of drive, when you wake up every morning and you think, "What happened today? What progress did we make? Are we actually moving forward?" that creates this incredible sense of urgency, and enables us to truly be a time machine.
(14:23)
We take something that we hope will happen in the next 20 or 30 years, and we ensure that it can happen within possibly the next five, or less than 10. That's why I'm very excited to be here, because I think food allergy falls right into this category. In order for us to go fund that? We need phenomenal program managers.
(14:46)
If you have people in your networks, academics who are willing to come and spend a few years here, or people from industry, or a startup founder who wants to come and literally make the biggest impact of their entire lives, not just for a startup scale, or a paper, but really to drive forward an entire field? This is the place to come.
(15:08)
Now, you have to be kind of fearless, a little bit crazy. My own experience was that when I showed up at DARPA, I started talking about this crazy thing called engineering biology, now known as synthetic biology, and everybody thought I was nuts when I showed up, and that was 15 years ago. But now when we hear it, we don't think about it as some new crazy thing off in left field. It's actually a field of science.
(15:32)
And that's what we can do here, which is, we can take these bold ideas, things that maybe don't follow medical dogma, things that seem just beyond our reach, or require close collaboration between the microbiome community, between immunologists, between potentially other fields that we haven't even been thinking about, and bring them all together.
(15:53)
Once we have that program manager, they're off to the races. They bring together the best people across the world to work on this problem. Whether that be here in the US, or some of the countries that we have deep collaborations with, they can choose anyone. We have incredible contracting flexibilities, unlike those in any other place in the government. It's known as other transactions.
(16:18)
It basically enables us to not just give money and say goodbye and hope it went to a great place, but actually to give very focused, significantly sized dollars, 10, 20, 30, 40, up to 100 or $200 million towards an area, and it allows us to manage it incredibly responsibly. We can turn that money off, we can turn it up. We can switch directions. Whatever we need to do, whatever that program manager needs to do, to help that community go towards a goal.
(16:47)
One of the things I know we've been working with the Food Allergy Fund on, and the Food Allergy Forum, is to be able to understand what are those key things that we need to move forward on. We're in the early days of those. We've identified broad areas.
(17:03)
But what we need at this point is some incredible people to come into ARPA-H, to sign up and say, "I want to make a huge difference here. I want to move this field forward. I want to make the future happen sooner, especially for every child today that may only be two or three, and starting to suffer from these, so that by the time they're 10 or 12, this no longer has to be an issue for them and their families, and wherever they go in life." I just want to close with, I'm very grateful to be leading this agency. I'm very grateful to have the opportunity to go tackle giant problems like this one, and work together with the community, and the best researchers in the world on it. I want to work with all of you. Please come to ARPA-H. Please come talk to us. Talk about the ideas, and go out into the community, and also tell people about this incredible agency, that if we get the right people in the door, we can make very big things happen.
(18:03)
I've had the opportunity of working at DARPA, where I myself have been able to see really things that were impossible not only become probable, but actually go into the field, out into the world, and make a very large difference. That is what we're offering here. I'm very grateful to everyone here. Thank you, and I'd love to talk to you further.
Speaker 1 (18:41):
Thank you, Dr. Jackson. We'll now take a coffee break in the Lincoln Foyer, and the program will resume promptly at 10:15. Thank you.
Speaker 1 (41:38):
Welcome back. Thank you for rejoining us. At the Food Allergy Fund we pride ourselves on fostering innovation by highlighting unique progress at early-stage companies around world. Today, we have with us three companies that represent food allergy prevention, treatment and the potential of wearable AI technology to track anaphylaxis and health data. We need to approach food allergy from a multifaceted approach, and that is what this panel will highlight. I'd like to turn it over to our moderator, Corrie Driebusch from the Wall Street Journal. Thank you.
Speaker 2 (42:09):
Great. Well, thank you so much and thanks to Alana and the Food Allergy Fund for hosting this wonderful event. I'm thrilled to share the stage with three executives who are working to prevent, diagnose, and treat food allergies. To kick off the conversation, going to turn to Michael Nelson, CEO of Intrommune Therapeutics. Michael, when investors are thinking about what companies to fund, they often talk about the total addressable market. How many people are going to use the product or are going to need it in the future? I'm curious, not everyone in this audience may be aware of the large percentage of the US population who is impacted by food allergies. Can you talk a bit about that population, as well as what you see as your company's total addressable market?
Michael (43:29):
Yeah, I appreciate the question and really appreciate Food Allergy Fund for having us here and putting together this group. It's fantastic and a real testament to what Food Allergy fund is doing, but also, the importance of food allergies.
(43:43)
The number of food allergies, I mean, you heard the numbers earlier, is 1 in 10 adults, 1 in 13 children, and that's 33 million people in the United States with food allergies. But it's not just the people with the food allergies, it's their entire families that are affected by food allergies. So, when you're talking about the market, there was a study that just came out from Chris Warren. The cost of food allergies, including indirect costs, is $370 billion a year. So, it's a huge number, the impact is tremendous. Of those 33 million, they're not all necessarily going to seek treatment. We always assumed it was something along the lines of about 10% as the addressable market for those people, so about 3.3 million or so, but that doesn't mean more shouldn't get treated. It comes down to cost and other issues.
(44:35)
But also prevention, we've heard a lot about gut microbiome and prevention. And we know that you can prevent food allergies, maybe over 80% of food allergies by providing early introduction of foods. And in terms of number of infants, I mean there's 3.6 million babies born every year, 40% of those children are at high risk of food allergies. They have atopic dermatitis, they have a family member with a history of atopy, so a family member with respiratory allergies, food allergies, asthma. So, those are the market that's there. So, we estimate the early introduction, early-exposure market to be about $13 billion total. But really, just spending a couple hundred million dollars a year on early introduction, you could get a huge cost savings. You could save billions of dollars for every year for the life of those infants by doing that early food exposure. So, the market is tremendous.
(45:47)
The issue is, I mean early introduction sounds easy, but actually, giving a kid a food every day… And you can't just do it once because if you do it once, you're actually sensitizing them. You have to do it multiple times. So, our company, Intrommune Therapeutics is developing products that are incorporated right into everyday routines. It's really people's habits. And so, we develop products that embed food, allow food exposure. So, we have a toothpaste for adults for our therapeutic, and you'll hear about therapeutics in the moment. And then, for younger kids rub it on their gums, they get exposure to first peanut and then multiple foods over time. And just built right into the things parents are already told, "Rub your into kid's gums and teeth to clean the teeth."
Speaker 2 (46:33):
That's great. Tal Golan, your CEO of Anjo. Tell us a little bit about your company and what do you see as your addressable market?
Tal (46:42):
Thank you. Joining Michael's remarks about the Food Allergy fund, thank you. I'm Tal, co-founder and CEO of Anjo. At Anjo, we're developing remote monitoring and early-detection, even prediction of anaphylaxis using advanced wearable devices using wearable devices and our proprietary software and algorithms. Our story started with my co-founder's daughter, who nearly died from an anaphylactic reaction at daycare. Even though everyone was very much aware of her allergy, what happened because of the delayed intervention is she spent four hours in the ICU where they literally fought for her life. She was lucky and recovered. We have friends and colleagues that were not so lucky. For those who are not familiar or aware, one of the most crucial factors to determine the outcome of an anaphylactic reaction is the timing of intervention. And the problem is most people have a difficult time differentiating between a mild reaction and a life-threatening one until major symptoms appear, but by then, the wolf is in the room. And so, we leveraged our sensor development and commercialization experience and set out to build a platform for detection,
Tal (48:00):
… continuous monitoring, detection of anaphylaxis. End of '24 reached clinical proof of concept in Israel after a feasibility study, and today we're proud to collaborate with leading research institutions led by renowned immunologists for the discovery of novel biomarkers for anaphylaxis and applying machine learning on multiple markers being collected in real time. Our mission is to take allergy care from being reactive to proactive and to provide precision, personalized data-driven personalized care and support and safety. Addressable market is similar to Michael what said, and we think the potential in what we define as we are able to map this autonomic dysfunction can apply to other conditions. We say, why is it only diabetes that have connectivity and alerts and technology? We bring the technology. We are on a mission to bring technology, excuse me, to the underserved allergic community and this will expand beyond that.
Speaker 2 (49:19):
Great. Thank you. Dr. Brian Wong, you're CEO of RAPT Therapeutics. It's a publicly traded company. Investing in biotech companies tends to be a pretty niche market. RAPT recently did a stock offering, sold additional shares, raised millions of dollars. I'm curious what type of investors are buying your company and how has that changed over time since you went public? Has a more generalist investor started to take notice, and why do you think that is?
Dr. Brian Wong (49:54):
Yeah. First of all, I'd like to thank Alana and the Food Allergy Fund for this amazing forum. I'm deeply inspired by working with all of you to bring new therapies or cures to patients. Just a little bit RAPT and then I can talk about our investors. As many of you know, there was a recent breakthrough last year with the NIAID-sponsored study called OUtMATCH, which led to the approval of the first-generation anti-IgE called omalizumab or Xolair, which was approved for now all IgE-driven food allergies for patients one year and above. In a very short time, this is rapidly becoming the standard of care, with over 85,000 patients now, food allergy patients, on omalizumab, it's really transformed patients' lives because it addresses multiple allergens.
(50:42)
It's dosed subcutaneously, so you don't need to take it daily, but there's certain limitations of this drug. Because of its relatively poor half-life in potency, it can't address all patients, so roughly 25 to 30% of patients can't take omalizumab. The second, it does require very frequent subcutaneous dosing. 26 times per year, often multiple shots. Where RAPT comes in is that we're developing the next generation anti-IgE antibody. We think we can address all food allergy patients irrespective of their IgE levels. In addition to that, we can dose maybe four times a year with just one or two subcutaneous injections. I'm myself a food allergy patient, and just imagine being able to send your child to college knowing that they're going to be protected for a three or four month period or the child who needs to be protected from an anaphylactic reaction at school.
(51:44)
While we await these amazing cures, we think it's really critical to develop new therapies to address multiple allergens, reduce healthcare costs, and potentially even allow reintroduction of food back into the diet. This has really stirred the imagination of the investors as well. It started relatively small. Now that the omalizumab sales have increased, I think they're on the run rate of close to two or 3 billion in just the first 18 months, it really shows them that there's a market. We're seeing first the specialized healthcare investors start. Now we're seeing the vanguards and fidelities start to invest in this area. I think that's what'll lift all boats now. Whether it's wearables, the prevention, different modes of therapeutics, we're working on biologics, this will really, I think, increase the level of investment in the area. It's very exciting.
Speaker 2 (52:43):
That's great. Tal, back to you. Much of modern medicine is considered reactive and especially in the food allergy space. I'm wondering how your company is trying to change that.
Tal (52:57):
Yes.
Speaker 2 (52:58):
We spoke a little bit about it before, but…
Tal (53:01):
At the moment we wait for the allergic reaction to show itself and determine the symptoms. In fact, at the home and through diagnostics and therapies, we provoke the reaction and wait. What happens back at the home is that parents are left with life and death decisions based on subjective observations. We want to remove the ambiguity. We want to bring objective data and we want to bring early detection. I think many, if not all, critical medical conditions can be mitigated or solved with early detection. Anaphylaxis is a severe enough condition to deserve the same. We think with, and we have very strong data with preliminary studies that with the use of machine learning, multiple markers being observed continuously and in real time through anaphylactic reactions, we can bring not only early detection, but a holistic support to the… Whether it would be to the clinician or the consumer itself through therapies, through clinical trials, post-clinical trials, et cetera.
Speaker 2 (54:20):
Great. Michael, back to you. Desensitization is traditionally thought of in the doctor's office. If you can speak a little bit to how you're trying to change that and bring some more of that into the homes, and what are the benefits of that and also what are the risks?
Michael (54:41):
What we do, what we're developing is a toothpaste with multiple foods in it. We think we could also develop a toothpaste for alpha-gal, which is allergy to meat, red meat, that's usually set off by a tick bite. Right now, traditionally the way most food allergies are treated in the doctor's office and allergist's office is what's known as oral immunotherapy where they give increasing doses of the food you're allergic to the patient to eat it and eventually tolerize them to that food, desensitize them to the food, so that they could go out, and in most cases it's not a cure, but they could go to a restaurant if they accidentally eat something, they won't have a reaction. For our product, we've done our phase one study in adults. We actually saw indications of efficacy in adults, but we had safety. We had no severe or moderate systemic adverse events with our study. We were able to up dose in the doctor's office, but then the patient goes home and brushes their teeth and they're supervised by the physician.
(55:42)
Then when they went back, they up dose in the doctor's office and then they went home. All of that, it was done and mostly it was done at home. You're not getting the same limitations. With oral immunotherapy, you can't exercise for hours. You are not supposed to take hot showers. You're not seeing that with sublingual immunotherapy, and we're a form of sublingual immunotherapy. We contact more active parts of the mouth that have more of the Langerhans cells. The risk of course is you need that doctor supervision. You would want a device like Angio's. You'd certainly want emergency epinephrine because it's not… In most cases, it's not an outright cure, but you need that regular food exposure to actually modify the disease. Even biologics like Brian's, you have to keep taking it. A lot of the biologics on your development, they're knocking down the immune system. But once you stop taking it, you're right back where you started. Allergy immunotherapy actually modifies the disease and helps the body learn what to react to and not react to.
Speaker 2 (56:47):
Yeah. That tees up for a great follow up that each of your companies do different things, but there seems to be a world in which you can all work together, particularly if you're wearing the wearable as you're doing some microdosing, you can maybe potentially tell if you're about to go into anaphylactic. But Mike, I'd love to talk with you about how you're seeing more different technologies working together in different… Yeah.
Dr. Brian Wong (57:12):
[inaudible 00:57:13]-
Speaker 2 (57:13):
Oh, sorry. Brian. Sorry.
Dr. Brian Wong (57:14):
Yeah. No. No worries. Actually, I'm talking to both of these gentlemen here. I think this is an area it's not a zero-sum game. There's really ways to work together and complement each other for the benefit of our patients. For example, one of the biggest challenges in clinical trials right now is the oral food challenge. This requires somewhat subjective monitoring of patients of whether they're having a reaction or not. If we could bring data, machine learning, wearables to a trial situation that could really protect patients during the actual study and make it a lot more efficient and faster. With respect to oral immunotherapy, combinations are probably what's going to allow patients sustainable benefit. Combining a biologic with an oral immunotherapy, particularly one that's very convenient, could be the next standard of care.
Speaker 2 (58:10):
Great. I guess for each of you, we can start with Tal, what do you see as the biggest barrier right now to progress in your space?
Tal (58:23):
Data. As mentioned before, we are, for good or bad, are generating new data that has not been collected yet. We're the first company to monitor multiple biomarkers in real time throughout the whole lifecycle of an anaphylactic reaction. It's in order to get quality data, we need meaningful collaborations, clinical studies and pilots. That requires funding. Funding, obviously it would be grants, philanthropy or investments. But yeah, our biggest push right now is for data because machine learning and AI is not of much use unless it has data.
Speaker 2 (59:09):
That's great. Brian, what would you say?
Dr. Brian Wong (59:14):
Obviously food allergy is a growing epidemic in the United States, and it's potentially lethal. There's a sense of urgency here to bring cures forward. But as we await cures to bring new therapies that can protect patients and children from anaphylactic reactions, reduce healthcare utilization, reduce ER visits, but also perhaps and looking forward to allow patients to actually introduce serving-size foods back into their diet. For us, we really need support. We'd like to partner with the agencies to accelerate the development of our drug called Ozureprubart. Very similar to how accelerated development was done in oncology, where there's different pathways that have been used in developing initiatives to speed along these really urgently needed new medicines. That's what I'm hoping to do with [inaudible 01:00:11] what we need.
Speaker 2 (01:00:12):
Yeah.
Michael (01:00:15):
For allergy immunotherapy traditionally, as you mentioned or mentioned is done in the doctor's office. Oral immunotherapy. Patients don't want to be eating what they're allergic to. One is they have taste aversion, but two, it causes lots of reactions. In one study, there was 14% of the patients needed emergency epinephrine. Patients don't want to do that. For me, with a mechanism that we believe is much safer, and our clinical study, our Omega study showed that, the issue is still the investors are hung up on allergy immunotherapy and is there really a market for it? I think that's starting to change, but investment has been very difficult. Funding is really key. Knowing what the goal posts are, or you talked about the oral food challenge. Knowing what the specific target is that we need to do and timelines. Everything just takes too long.
Dr. Brian Wong (01:01:17):
Yes.
Speaker 2 (01:01:18):
Yeah. We have time for probably one final question for the panel, but we're here in the room with some very big science and health decision makers in government. I guess this is your chance to speak directly to them. What can the government do to help your innovations and make them get to maybe get to market faster or help you?
Tal (01:01:38):
[inaudible 01:01:40]-
Dr. Brian Wong (01:01:41):
As I mentioned, I think we all recognize that this is a growing health epidemic in the United States. Bringing new therapies, new diagnostic measures, preventative measures to patients as quickly as possible is critical. From my standpoint, we are in a phase two trial with Ozureprubart, which is our long-acting IgE. We would love to partner with the FDA to find ways to accelerate the approval process of this drug and also perhaps identify novel trial designs and novel endpoints that could really shorten the timeline from this stage of development to drug launch. As I mentioned, there are several initiatives that the FDA has undertaken to provide these accelerated pathways. We'd love to be able to participate in some of those programs with the FDA and to really bring this therapy and multiple therapies to patients in need.
Michael (01:02:42):
For the therapeutic that we're developing. Well, a priority voucher would be really nice. But funding, we need funding. Working with the government and NIAID would be really helpful. On the prevention side, just certainty. Some of the stuff that we're doing, well, for the older kids, we're talking about a toothpaste with peanut protein in. We can't say anything. It's a toothpaste with peanut protein in it. That's all it is. Even though those kids don't have food allergies. Having some certainty around what we're doing and we're using all-natural products, but to get an alpha-gal product developed, our initial estimate is $1 billion to get that through to the market.
Speaker 2 (01:03:32):
Wow. In how long a time period?
Michael (01:03:35):
Five to seven years, and we've already been at it for 10 years.
Speaker 2 (01:03:43):
Yeah. [inaudible 01:03:44]-
Tal (01:03:44):
I would say recognizing the food allergy community I think this is a tremendous step towards that area and goal. The second thing we see that the pediatric population, anything related to product regulatory is extremely complex and difficult. We're seeing some programs backed by the FDA to help ease the effort, but I think there needs to be more there. I think we find a pediatric population at risk, especially those that can't voice their feelings or what they're going through and the path to do studies with pediatric is not easy and also the product development. I would say accessibility, accessible funding and recognizing food allergy for how critical of an issue it is. I would add anaphylaxis as a whole because we are discussing food allergies, but anaphylaxis touches other conditions and other anaphylaxis can be generated not only from food but other issues. That would be my [inaudible 01:05:00]-
Speaker 2 (01:04:59):
Your wish list. We do actually have a couple of minutes, so I'll steal a question from this morning's excellent panel. What gives you optimism? What is making you excited? Just to close off on a positive note, if you want to [inaudible 01:05:13] and go back.
Tal (01:05:13):
I-
Dr. Brian Wong (01:05:13):
Go ahead.
Tal (01:05:20):
All right. I think the administration recognizes it that the potential of wearables, advanced wearables. It starts with a wearable, but there's already more advanced technological means to monitor us embedded in the clothes, cameras, et cetera, that can't… We're just scratching the surface. We can see large wearable manufacturers now leaning into health because they understand the potential. There's more work to be done on sensor development, but I think there's so much to understand about what goes in the human body throughout critical conditions and maybe before critical conditions. I don't know about microbiome, but I think we're just scratching the surface. I think the administration recognizes it, and we have to have more push towards development in the clinically grade medical or wearable devices to be accessible for the consumer.
Speaker 2 (01:06:11):
Yeah.
Dr. Brian Wong (01:06:11):
The fact that we're sitting here as a community with policymakers, regulator, companies, researchers, I think gives me a lot of hope that we'll find solutions. It's not going to be one-size-fits-all. There's going to be, I think, multiple prongs to treat patients at various stages of life. It's just really incredible that there's a community here working towards a common goal.
Speaker 2 (01:06:33):
That's great.
Michael (01:06:33):
Yeah. We've certainly seen a lot of progress. I think everyone in this room knows how important food allergies are. It's starting to filter out. Certainly people, families affected by it are aware of it, but I think a lot of the investors are starting to get a hang of it that this is something that they should be investing in, that there's a big issue here. But really the fact that we're actually starting to see some of these numbers and people being told or pediatricians telling patients like, "Feed your kids the foods," and you're starting to see the growth at least leveling off. That gives me a lot of optimism, that there really is something to that early exposure that makes a difference.
Speaker 2 (01:07:16):
Great. Well, thank you so much and thank you again, Alana.
Speaker 3 (01:08:21):
Secretary Kennedy, thank you so much for joining us today and for your leadership on chronic disease. We're both food allergy parents. My daughter's here today. Although our children are a generation apart, we've seen little progress as food allergies have risen to a public health crisis. I'm grateful to highlight this critical issue and to discuss how we can change the course of this disease. Food allergies have received the funding of a rare disease despite reaching epidemic levels over the last 20 years. To put it in context, in 2024, food allergy research received $2.69 per capita in NIH funding, while Crohn's and IBD received 38 and $59 respectively. Yet food allergy impacts nearly 10 times as many patients. We're working to close the research, investment and awareness gap. Why has food allergy remained a low public health priority even as it now impacts nearly 10% of the population?
Robert F. Kennedy Jr. (01:09:14):
It is an interesting question. I think the answer to that question is that the public health agencies have been focused on infectious disease rather than chronic disease. A lot of the chronic disease, particularly those that have gone to epidemic since 1990 when we saw this huge explosion in chronic disease happen, at least comparatively underfunded or disproportionately underfunded by the public health community. To me, the interesting question is why aren't we trying to figure out what's causing it? Because when I was a kid, I never met anybody with a peanut allergy. I had 11 siblings and around 70 first cousins, and I didn't know anybody in my school. I went to a bunch of different schools, to camps. I just didn't know. I never heard anybody with a peanut allergy. Heather Fraser in her book on the peanut allergy says that the epidemic began in 1990.
(01:10:32)
Prior to that, if you look through the scientific literature, it's really difficult to find anybody even mentioning or studying it. People just weren't studying it because it was not an issue. The year 1990 is interesting also to me because when Congress asked EPA to look at… Tell Congress what year did the autism epidemic begin? The EPA scientist came back and said, "It's a red line, 1989." Prior to 1989, it was in the 1970s, we did the biggest studies on autism, actually the biggest epidemiological study in history. It found an incident rate of 0.7 per 10,000, so less than one in 10,000. Then by the mid-90s, 1990s, it was going up to one in 600, et cetera. Then now it's one in every 31 kids. The question is why we asking and why aren't the public health agencies asking this question, what's causing it? This is an epidemic. Epidemic… Genes don't cause epidemics. They may provide a vulnerability,
Robert F. Kennedy Jr. (01:12:00):
… you need an environmental toxin, and so why aren't we trying to identify the toxins that are making our kids sick? And we saw these brilliant scientists up here, and I've been watching this since I became involved. I became involved, as you pointed out, because I had a son who was severely anaphylactic to not only peanuts, but all tree nuts and a lot of other stuff. He made, I think, 22 emergency visits by the time he was two years old. And so this really had focused my attention. He came close to dying so many times, and as you know, the whole world becomes hazardous. You send your child to a birthday party and maybe the cake had peanut oil or somebody cooked in the same pan, something with peanuts in it, two days before. And so everything is a trap, everything is a potential killer of your child.
(01:13:03)
I really focused my mind on it, but I was focused on, "Okay, what are we going to do to treat it and to prevent him from getting sick?" Also, my mind immediately went to the place of, "Why is this happening?" Five of my seven kids have allergies, what happened? Something happened, and it appears to have happened at a time around 1989, 1990. So you have to look at an environmental toxin that became ubiquitous during that year across all the different demographics from Cubans in Key Biscayne in Miami to Inuit in Alaska, everybody started getting these allergies at that time. And why have there been no studies on that? Why are not people looking at that? Why isn't the entire scientific community focused on studying it? It's a very easy study to do, you just make a list of all the potential culprits that fit those criteria, and then you begin eliminating them.
(01:14:14)
But those studies have never been done. We are going to do them now and we will identify what is causing these allergies. The allergies, as I said, they've exploded. They were so rare that CDC did not even start counting them until 1997. Oh, it's just an obvious question. And we have an institute, I wish I… I was supposed to watch Jay to speak. This program was running a little late and I have a really tight schedule today. But in his agency, there's a sub agency that was run by Anthony Fauci called National Institute for Allergic and Infectious Diseases. It's supposed to study allergic diseases. And my question is, why haven't they immediately look on this and say, "Why are there suddenly all these kids with these allergies?"
Speaker 3 (01:15:11):
Yeah, I mean, food allergy has been proliferating and it's very much a public health crisis that has flown under the radar, so I'm so excited that together, we can really shine a spotlight on what needs to be done to change the course of this disease. You've said that thanks to President Trump's commitment to make America healthy again, your leadership at HHS has delivered more public health wins than any previous administration. Can you walk through some of these successes, especially as they relate to food?
Robert F. Kennedy Jr. (01:15:40):
Specifically with food? I mean, I guess one of the most important things is the GRAS standards. GRAS standards, the acronym GRAS means generally recognized as safe. And when the FDA began regulating food in the 1940s, they were regulating contaminants in food since Upton Sinclair did his book, The Jungle, in the 1920s, and FDA was started as a result of that. They began regulating ingredients of food in the 1940s, but they said, "Well, we don't want to regulate ingredients that have been around forever like wheat and flour and yeast and sugars, so we don't want people to have to do new sets of studies on those kinds of foods because they're proven, they're generally recognized as safe." So they developed that category. "And if it is an ingredient that's been around for a long time, then we're not going to force you to do the studies."
(01:16:46)
The agency became captured by the food industry, that category was hijacked by the food industry. And every new ingredient that was developed by any food company was automatically generally recognized as safe. And the burden fell on the consumer and the government to prove harm if you didn't want the ingredient in the food, and the government doesn't have the money to do those tasks. And so it just opened this loophole that now we have 10,000 ingredients in our food that are illegal in Europe. And Europeans have 400 ingredients, we have over 10,000. And so we're closing that loophole, which we have to do with regulations, so that takes about six months, but we've already started that process. And then we're going to go back and do kind of triage where we have the power to force the companies that are making existing ingredients, go back and prove that they're safe.
(01:18:03)
And we have a high priority list of priority ingredients that are the most common ingredients, that we're going to make them test first. But we're going to go now, back through the entire list and make them just start testing it and telling us whether they're really safe or not. We're doing the SNAP waivers, 12 states have already gotten SNAP waivers, which we're encouraging. There are six states in line for them right now, these are food stamp waivers. About 10% of our food stamp expenditures go for soda drinks and about 8% go for candies and sweets. And so we're giving the poorest Americans diabetes from when they're little and we are paying for the diabetes through Medicaid, so it makes no sense. And so the SNAP waivers allow the states to step in and say, "In this state, we're not going to pay for soda drinks, we're not going to pay for food."
(01:19:10)
Some of them are doing ultra-processed food and other things that are SNAP. We're getting rid of the food dies, all of the petroleum nine petroleum-based food dies, we're doing that very quickly. We have this Operation Stork Speed to clean up baby formula. We're ending the war on saturated fats in this country, so we're going to publish dietary guidelines that are going to stress the importance of protein and saturated fats. And those will come out, I think next month. And I think that will really revolutionize the food system in the country and the food culture in this country, because it will be implemented almost immediately in the military and in federal institutions. And then next year as we go, we're going to be very aggressive about getting good food into the schools, the elementary schools, the public schools in this country. Those are some of the things that we're doing. We have a list of 100, but time is limited.
Speaker 3 (01:20:23):
Well, you're moving at breakneck speed, so we're all appreciative about it. But you mentioned the military, 78% of our children are ineligible to serve because of chronic disease and food allergy itself is an automatic disqualification from service, so food allergy touches on so many aspects of our society. When you spoke at the National Governors Association over the summer, you challenged Governor Polis on the root causes of peanut allergy specifically. Can you tell us a little bit about what you said in that exchange?
Robert F. Kennedy Jr. (01:20:54):
Well, governor Polis had advanced hypothesis about one of the cause of food allergies. A very popular hypothesis, in fact. It's one that Marty McCary talks about a lot, which is that, and maybe the peanut allergies are associated with the lack of peanut exposures to children, I guess in the '80s and '90s, that parents were told not to expose their children to peanuts. And that it was the lack of exposure, that early exposure that maybe is triggering peanut allergies. And people talk about Israel, where apparently there are very few peanut allergies, where there's early exposure to peanuts. To me, that is not a convincing hypothesis because number one, in my own personal experience, my house was so filled with peanut butter and I was eating peanut butter two meals a day, and my wife, when she was pregnant, was eating peanut butter. And the kids were given peanut butter from as soon as they could chew food.
(01:22:08)
And yet, we still had peanut allergies in our house. And that's kind of anecdotal, but more importantly, peanuts really were not eaten by anybody until George Washington Carver came along. And really, there was no mass consumption of peanuts until after peanut butter was invented. That was in the '20s. But really during World War I and World War II, it became a source of protein when there were restrictions on other sources of protein that people could get a hold of. And so suddenly, you had a whole population that was eating peanuts, and yet there were no peanut allergies. It doesn't make any sense to me that a peanut allergy is from a deprivation of peanuts. There's many countries in the world that only started eating peanuts recently, and you didn't see huge waves of peanut allergies. So that doesn't make a lot of sense.
(01:23:11)
I mean, one of the things that I said to Governor Polis, is that we need to look at aluminum adjuvants in vaccines, which fit the timeline perfectly. The increase of aluminum is in lockstep, which began in 1989, which is in lockstep with the expansion of peanut allergies. We don't have the science to say this is an effect or not. Or maybe other things, like for example, pesticides that fit the same timeline. Those are the kind of things that we have to look at. Aluminum adjuvants are designed to increase the immune response and to hyper-activate your immune system. And they do that along the, they cause Th 2 inflammation, which creates IG-2, which, the gentlemen up here were talking about mediated pathway. There are many, many studies that show, and you give animals aluminum adjuvants, they do develop allergies to proteins that are in the vaccine when they're given that, or that they're exposed to in the ambient environment.
(01:24:39)
And so that's something that we need to look at. And there's a couple of scientists, a guy called Anthony Mawson from the University of Mississippi, and another scientist called Gallings from Europe, that have looked at allergies in vaccinated children versus unvaccinated children. And I think Mawson's study found that vaccinated children had 30 times the rate of allergic night of rhinitis as unvaccinated children. And the hypothesis is that when you get that aluminum vaccine, if there's a Timothy Wheat outbreak at that time, that maybe that might give you a lifetime allergy to Timothy Wheat if you're sensitized by the aluminum at that time. But again, we don't know. I mean, the problem is there haven't been any human cohort studies. There's lots and lots and lots and lots of animal studies. Why didn't CDC or NIH, NIAID do those human studies? Because it's pretty easy to figure this out, and we will figure it out.
Speaker 3 (01:25:45):
In general, it seems that food allergy is the perfect storm, right? It's multiple factors that have come to a peak and a crescendo in this generation. To your point, in terms of early introduction and exposure, the only thing I craved my entire pregnancy was peanuts. I ate cans and cans of peanuts, probably too many peanuts. More than any human being should eat. But nevertheless, we talk to hundreds and thousands of families every year in the work that we do, and all of them have done early introduction. And it works for some, it doesn't work for others. And for the kids who are already living with food allergies and for the adults who are developing allergies later in life as well, half are now starting in adulthood. We need to look at all these factors that are contributing to the rise in the disease.
Robert F. Kennedy Jr. (01:26:29):
There may be many factors, there may be only one, we don't know. Why don't we know? Because there's been basically malpractice in the government-funded scientific community. Why wasn't this a question that was being asked, that was being demanded as soon as this allergy started to appear? Why weren't we putting out requests for proposals, saying, " Tell us why this is starting?" Instead, it became a verboten subject, you weren't allowed to study it and science warned each other against studying it. And so we're going to study it now, we're going to break that omerta. We're going to end the taboo and we're going to find out what's causing it.
Speaker 3 (01:27:21):
That's a very exciting moment. Food allergy is in much need of research, certainly. What do you see as the single most decisive step that this administration can take to end the childhood chronic disease epidemic?
Robert F. Kennedy Jr. (01:27:38):
I mean, I would say if I had to guess about the most important exposures, I would point my finger at ultra-processed food. And again, it's criminal that we do not have a clear answer to that right now. But there is a lot of accumulating scientific data and scientific studies, and also just common sense that point to ultra-processed foods. There's all kinds. I mean, our kids are swimming around in a toxic stew with micro plastics, EMF radiation, and then pesticides and all of these toxic exposures that are affecting them from birth. And so addressing in a specific sense, President Trump has asked us to address those, to identify what the culprits are and then to eliminate them. And then I think in a broader sense, we need to realign.
(01:28:54)
We need to make sure that we're getting gold standard science, and that the science is not responsive to prejudice or to bias, or to official orthodoxies, that people are allowed to ask questions and they're allowed to question everything, and that there's nothing that is off-bounds. I think Jay Bhattacharya is working really successfully to redirect, to recalibrate the compass at NIH where people feel safe, researching formally taboo subjects. And that's what he said to me from day one, is, "We need to break the taboos so people can ask questions. And then I think sort of the last category is what we're doing at CMS, which is to realign the perverse incentives that incentivize everybody, the hospitals, the doctors, the scientists, the government, to keep people sick.
(01:30:04)
We literally are incentivized to keep people sick. You can make more money by keeping… The hospitals make more money, the doctors make more money, the insurance companies make more money. Everybody's making more money for keeping us sick. No matter how good-hearted you are as an individual, those incentives will affect societal behavior. And what we're trying to do is to realign those incentives so that you can do well by doing good, and people are going to be rewarded for making their patients better, rather than for giving them a bunch of tests and then making their money on the friction, or giving them interventions that they don't need, that we're all incentivized to make Americans healthier.
Speaker 3 (01:30:52):
Absolutely. The economic impact of food allergy alone, every three minutes, someone goes to the emergency room. 30% of food allergy moms are dropping out of the workforce, $ 30 billion on direct medical costs and the list goes on and on. So I think if we start with food allergy, and really, we talked earlier today in the program about gut microbiome health and thinking of food allergy as the canary in the coal mine for chronic disease that often presents in the first two years of life earlier than many other childhood conditions such as autism, juvenile diabetes, asthma, et cetera, so we can figure out what's going on with food allergy, crack that nut, no pun intended, I think it'll have lifelong gut health implications.
Robert F. Kennedy Jr. (01:31:30):
Yeah. And I think when we figure out the answer for food allergies, that there's a whole list of atopic diseases that exploded simultaneously in lockstep with food allergies, eczema or allergic dermatitis is what it used to be called. Which again, I didn't know anybody with eczema when I was a kid, and now you have a whole generation that has eczema. Anaphylaxis, atopic diseases. And I'll say one thing about the residual food proteins and vaccine, because the science suggests that aluminum alone will not cause allergies, but there are… Well, when it's combined with a protein, if it's a latex protein or a dairy protein or a peanut protein, that's when you get this heightened immune response.
(01:32:29)
But in the 1990s, there were a lot of anaphylaxis cases suddenly exploding in Japan, and they traced it to gelatin in the live virus vaccines and the MMR vaccines and some of the other vaccines they had over there. And by 2000, they had removed it all and the anaphylaxis dropped dramatically. And so I think we do have human models where you can look at sort of broad allergic reactions that take place across an entire society that are linked to the vaccine schedule. And there's no question about this science, there was all kinds of studies done on the Japanese example. And so it's something, it's just another piece of evidence in the puzzle that we are now going to put together at NIH and at the other agencies and figure out exactly what is causing this.
Speaker 3 (01:33:33):
Well, we're so grateful for your leadership and for the beginning of putting the puzzle pieces together, so thank you so much, Secretary.
Robert F. Kennedy Jr. (01:33:39):
Thank you.
Speaker 3 (01:34:05):
It is now my privilege to introduce NIH Director, Dr. Jay Bhattacharya, and NIAID Acting Director, Dr. Jeffrey Taubenberger. Dr. Bhattacharya [inaudible 01:34:11] the 18th director of the NIH earlier this year. He previously held a tenured professorship in the medical school at Stanford University. His research focus-