LIVE: RFK JR. holds roundtable on Lyme disease

Life of Lyme patient, someone who suffers from chronic illness from Lyme. I myself have a similar story to what your children faced. I went into the hospital 15 years ago, thought I had a stroke. They dismissed me without any diagnostics. I went to a personal physician who said that there could be Bell's palsy and let's test you for Lyme. And he came back all excited to me, like it was like lighting 8 candles of Hanukkah the first day. You have all 10 bands. You're positive. I never saw that before. And he treated me. And after I was treated, slowly within the year, my whole body started deteriorating and falling apart. And we started doing some more research. And I learned about all the different co-infections. That ticks carry that we're unaware of, that the hospitals was unaware of, that the doctor was unaware of and didn't test me for. And I took tests for these co-infections, Bartonella, all these things, and I had every different type of co-infection, and we couldn't treat one before the other and learn about one before the other. I established, since I had the Orthotics Jewish Chamber of Commerce, a big network of a big network of doctors and we established a call center and we started referring people who are suffering from different symptoms to be able to diagnose and explain to them, create a panel of different blood work they should take to be able to know that there's different co-infections. We shared it with hospitals. I created R&D papers. I met with governors. With the Secretary of Health from different states, and we showed them that this has to be implemented to the hospitals. So first of all, I want to thank you. We're working since last November, Secretary Kennedy discussing about creating this initiative, and you're true for your word. Dr. Raz, we met by the inauguration, the president's, and we spoke about initiative that me and the Secretary was working about, that you embraced it right away. And a special shout out to Chris Smith, who's the oldest senior congressman who tirelessly effort working together with us on this and many other things. And it's frustration. I remember Chris telling me, CDC walked into my office and said we failed in Lyme. And I just want to finish with a takeaway of prevention because I'm not a doctor, but we do have the biggest referral department and we save tons of— over 30,000 people we serviced already. Prevention number 1 is that immediately I suggest within 30 days to have the CDC guidelines updated with co-infections that exist and with those symptoms that exist to be distributed to all hospitals and doctors. Because regardless, until we come to a solution, at least let them know to test for what symptoms, because they're oblivious to— they're letting people out without proper diagnostics, what they get sicker and sicker from. Number 2 is awareness campaigns, what we do, Life Align. I do billboards, spend tens of thousands of dollars a year, papers, awareness flyers all over the place. We focus on hospitals, doctors, and we focus on the public. If you have these symptoms, suicidal symptoms, if you have fatigue, if you have, you know, brain fog, if you have all these different symptoms, you know, get tested for not just for Lyme but for all our different co-infections. And we share that and we print out all the co-infections awareness. So there's two elements and the doctors and the hospitals have to be educated and the patients have to know what to look out for. That's going to save lives. At least know that people will be able to tap into what soon— and the third thing is insurances. Insurances, you know, it's killing families. We deal daily with families, breadwinners who are suffering from Lyme disease. Now it's called, you know, it mimics all different diseases. So people are running from doctor to doctor, different symptoms, and at the same time they can't provide to the families, and it's out-of-pocket because insurance only covers the first initial meeting. So with having said that, insurance should be addressed right away, and it should be, even this should be executive order that they have to cover extended care. My name is Stephen Phillips. Thank you very much for inviting me to speak today. Good afternoon. I'm a physician, researcher, and author. In 1996, I opened my medical practice, and from day one, we focused on chronic illness. And the goal was to identify and diagnose properly chronic infections that are known to cause a wide range of chronic and autoimmune illness, things like Lyme and others. And that's what we've done. And my practice has been exceptionally effective at getting patients off of disability and back to full lives.. And these results have been replicated over several decades, over more than 25,000 patients. My research areas have been fairly broad. I started out with microbiology and immunology work, went into innovative ways for direct detection tests, which are desperately needed. And my most recent research area has been in drug development, where I've worked with people at Stanford to formulate a new drug candidate, and it's been in the final throes of testing at Tulane University. And I'm really privileged to serve on the scientific advisory board for the Bayer Lyme Foundation, which has funded $40 million of research that's been some of the best in the field. It's the most patient-centric, most innovative, and really the most impactful. I'm also an author, a co-author of Chronic, which is a best-selling book on chronic illness, and it details my story and It's really a distillation of the decades of research and my medical practice and what I've accumulated knowledge. And I'm a best-selling author on Substack, and it's called Zero Spin. So like others here today, my family and myself have been devastated by these infections. I was motivated to open my practice not because I got Lyme in med school, but yeah. Oh, sure. Take after my dad with my soft-spoken. I said I was motivated to do what I do because of my father. I ended up getting Lyme in med school, and it was a chronic and relapsing course, but it was not disabling. And what I did learn through my studies, because I took all these electives in Lyme at Yale, and I realized my father was most likely suffering from undiagnosed Lyme for more than 20 years. So he had an insidiously progressive dilated cardiomyopathy. He was given 6 months to live. They were putting him on a heart transplant list. And I went to the cardiologist and I said, can we test him for Lyme? And the guy refused. And I was thrust in this very unfortunate position to try to have to desperately save my father's life. And fortunately, he responded really beautifully to antibiotics. And his heart function normalized. And he lived another 25 years. And in 2010, I came down with an absolutely devastating illness related to Bartonella, which I sustained from spider bites while sleeping in my bed. And just for the sake of brevity of these introductions, I won't go into the full details of all that, but I would like the opportunity during this roundtable to, you know, paint the four corners of the problems because after 30 years, they're pretty apparent to me now. And to hopefully present some potential paths forward of how we can get this situation taken care of. Thank you, Dr. Phillips. Hello, my name is Samuel Sophio. Hello, my name is Samuel Sophio. I'm from Cincinnati, Ohio. I'm a junior at Cedarville University. Secretary Kennedy, thank you for the honor of being at this table. Table, and thank you all for caring about those afflicted with Lyme disease. My story reflects many across this nation. In 2020, I became chronically ill. My parents who watched me sprint across the soccer fields now watched as I struggled to go on walks. I'm so, so sorry. All right, um, my story reflects many across this nation. In 2020, I became chronically ill. My parents, who watched me sprint across soccer fields, now watched as I struggled to go on walks, to take deep breaths, and even just to function without pain and fatigue. My parents drained their hard-earned money with doctor appointments, blood tests, heart monitors, and imaging. The medical system tosses back and forth, leaving us at the end of the road broken with misdiagnoses, little in our wallets, and no answers. If it wasn't for my relationship with Christ, I would have lost hope. I've been fighting Lyme disease for more than 5 years. Currently, I'm being treated by Lyme Light provider Carrie Hodges. I'm very thankful for just the blessing she's been in my life. She works with Long COVID doctor Jordan Vaughn. As you all know, patients need better and affordable testing. We need insurance to cover our treatments because we pay out of pocket. Thankfully, organizations like Limelight help patients with this. Lastly, one Lyme sufferer said, let me know if you find something that works. Some patients spend years sinking all of their money into treatment, but they don't get better. We are hoping for more research to know what works. Secretary Kennedy, I know that you understand the impact of Lyme disease, and I want to say thank you, and thank you all. I know that you all are fighting for us and are dedicated to gold standard care. Thank you.

Good afternoon. My name is Olivia Goodrow. I'm 21 years old and I have been battling tick-borne diseases for 14 years now.

It took—

yes, I can. Better? Wonderful. I'm 21 years old and I've been battling tick-borne diseases for 14 years now. It took 51 doctors and 18 months for me to just be diagnosed with Lyme disease. Then it took another 3 years and 4 more doctors to be diagnosed with 5 other co-infections. At 12 years old, I started the LiveLyme Foundation to give money to kids to afford their Lyme disease medication, to give funding, and to promote awareness. Starting at 13, I began developing apps, including Tick Tracker, the Long Haul Tracker, and Tickmojis, which I will talk about later. Through LiveLyme, I've hosted 6 scientific international summits that have had participants from over 50 different countries. I've also written my memoir, But She Looks Fine: From Illness to Activism, which details how I turned Lyme disease into LymeAid. Lastly, I am a junior at UCLA, and I am working with renowned scientists on rapid diagnostics for tick-borne diseases. Secretary Kennedy, thank you so much for inviting me here today, and thank you all here for the incredible work that you do, and I look forward to making history.

Hi, thank you so much for convening this meeting. My name is Lyndon Hu. I'm an infectious disease physician at Tufts University. So I think I'm probably part of that ivory tower, but I will be the first to admit that we have not in the 25 years I've been doing basic science. Patient treatment and clinical science been able to come up with satisfactory answers for patients and cures. And I think we need to do better. I will say though that I am probably the most excited I've ever been during my career at the opportunities we have to actually solve this right now. That's thanks a lot to people in this room at this table and also in the audience here. In terms of bringing attention, focus, and funding to this problem. And I think we're at a very unique point in science where we now have the tools to do things. Traditionally, we've done science, you know, in very precise, elegant ways, looking at one potential hypothesis at a time. But now, with the technology that we have, we can do what's called unbiased science and look at all the hypotheses at once and have the patient and the patient data tell us what's the important thing to be looking at. So, um, to that end, I'll just mention two things that we're involved in at Tufts. One is an NIH-funded study to enroll 1,000 patients with Lyme disease so that we can put them through all these what are called multi-omic tests and come to some answers with that. But one of the unique things that we're doing with that about this study is that we are actually using clinicians on the front lines as our research centers. And so they're the ones who are involved in bringing the patients to us, enrolling them, and being involved in telling us what they're seeing. So we've learned a lot through that trial, and we're only in our first year in terms of how to work with clinicians, busy clinicians who are not prepared to do research and what kinds of support we need to give them. To be able to do the best kinds of research. The other thing I'll just mention quickly is that we're also involved in a drug repurposing study. We've just completed screening 50,000 compounds against Lyme disease, many of which we found active are actually very common, safe medications. I'm not sure where we're going to go with those eventually, but the idea is that we are now taking that— we're on our way to 100,000. And we are going to take that, feed that with our collaborators into a machine learning artificial intelligence model where we can then screen virtual libraries of hundreds of billions of compounds quickly to identify the parts of the ones that we actually screen physically that are the most active because repurposed drugs are not designed for treatment of Lyme disease. But if we can figure out what makes them active using machine learning, we can develop better drugs for that. So, I'll stop there. And thank you so much for convening this. Thank you, Dr. Hu. Thank you very much. I'm Morgan Griffith. I represent the 9th District of Virginia, which is southwest, western, and parts of central Virginia. Needless to say, we are a hotspot like so many others for tick-borne illnesses., and cases have been increasing. Lyme disease is devastating, and Virginia Tech in my district is doing some research to understand the prevalence and gather more information into Lyme disease and other tick-borne illnesses. I would be remiss, and I think we all agree, Chris Smith has just done amazing work, and I'm hopeful that we can get his Kay Hagan Tick Act through the Energy and Commerce Committee. As chairman of the health subcommittee, I will do everything I can to get it on there early. We got a little slowed down by the shutdown. But hopefully we'll get this done next year. That's important for those who want to use a vaccine. FDA is working on clinical trials on a vaccine for Lyme disease. For what that's worth, we'll see what the studies show. The repurposing of existing medical compounds, any way that I can help on that, that makes perfect sense. Use things that we already have tested on the human body as being safe. And let's go forward with that. I will tell you, and I'll switch gears just a little bit, you mentioned alpha-gal. I will tell you that that too, it's not, in most cases, it's not nearly as devastating. But good doctors out there in the field, people paying attention to what's going on. I have long had allergies. So I have my, at that time, infant, relatively young son in with me seeing the allergist. And my allergist, Dr. Saju Eapen out of Roanoke, Virginia, said to me, "Uh, have you been having any problems lately?" I said, "Well, I've been following my diet strictly. I'm not eating the things I'm not supposed to eat, but I keep getting an upset stomach and I can't figure out why." This would be about 2010, maybe 2011. He says, "Uh, let me do a test." Sure enough, I have alpha-gal syndrome. Now I have a very mild case. It causes some stomach upset. But as we had discussions over the years, he told me that there was a case that he was aware of, I'm not sure it was his, where a lady kept breaking out in hives, going into anaphylaxis, and it turned out to be dryer sheets with beef tallow. So some people have severe reactions. Mine, it's annoying, but it's not severe. I kept telling my other son, who's a teenager, that he needed to be careful going out in the woods. You mentioned that, Mr. Secretary. He's big on hunting and fishing and, you know, bow hunting, you name it, he does it. I said, "Don't wear your shorts. Wear long pants, you know, protect yourself." And so, I'm kind of excited that you mentioned we've got to get word out there on prevention as well for all of these tick-borne diseases. Fortunately, he has not contracted any of the diseases as of this date. But he wouldn't listen to dad, but when his best friend came down with Alpha-gal, all of a sudden— I haven't said anything, but I noticed he's wearing the long pants now, Mr. Secretary. Dad's experience didn't help him, but his best friend did. But these are things that we can work on as we go forward. And last but not least, since we've got a little bit of a platform here, I'm going to mention Revivacor. I'm kind of excited and I'm gonna— if a poor dog can't wag his own tail, I'm gonna wag my tail a little bit on this one. I have no interest in Verivacor, for those who worry about it. I don't own any stock. It's a company that does medicinal stuff. It does organs. In order to transplant organs from pigs and cows, they had to take out the alpha-gal protein genetically from those animals. And I suggested to them in early 2020 that they look into having their product that they, that they originally designed, the genetic work in my district, and look to the FDA to see if they could get it approved for food. In late 2020, they got it approved. There's an alpha-gal safe pig product out there, but no major supplier has picked up the license on it. But the— but it's out there for those people who suffer from that. So that, that's a minor one. But then I asked Davis Michaels, who does incredible work for me in my office, to come up with, you know, a list of all the different ones that we know about. Everybody knows about the big 3: Lyme, Alpha-gal, Rocky Mountain spotted fever. My goodness, there's close to a dozen, if not more, diseases, and I'm learning so much listening to all the co-infections and so forth that are going on here. That's why this hearing or meeting today is so important, Mr. Secretary. Thank you so much, and as Chairman of the Health Subcommittee of Energy and Commerce, I'll do whatever I can to help move these things along, not just Chris Smith's bill, which he's been the champion on for years and years, but anything else that we can do to improve situations on lots of diseases. But today, we'll focus on tick-borne illnesses. And thank you so much for doing this. And I yield. Thank you, Chairman. I asked Dr. Oz to come here to talk about some of the funding options for people, for Americans who may get sick. First off, let me make it clear to all of you, if you didn't already realize it, that this sentinel event, this roundtable online, would never have happened if it wasn't for Secretary Kennedy sitting calmly next to me, not being so calm all the time. Taking a— You know, he looks mild-mannered here, but you get him going on things like Lyme, and it gets them agitated for a very good reason. The massive ship that is HHS, even with a great captain, cannot change direction unless he's barking about it all the time. And I learned early on that when you mix medicine with politics, you know what you get? Politics. There's no medicine left. I learned this on the show when I began talking about chronic Lyme, and I've had many of the folks around this table either on the show or interviewed around it. Dr. Phillips and others have come and joined with blue chip pedigree, with great efforts to try to explain what's happening. They get no respect from academic centers frequently, but in general from the medical community. The question, why is that? There's a quote as you walked into this building from Hubert Humphrey. He says, "The moral obligation of government to take care of those living in the shadows." And folks who suffer from chronic Lyme are indeed living in the shadows. Many of you, have witnessed it, I certainly have. But when I began to recognize that the boards and the other groups that drive this process, and insurance companies of course are incentivized by these boards taking a strict stance with a limited amount of time for treatment and thus forcing people into diagnosis that might not truly represent them, you begin to realize you need powerful allies to make change happen. The Coens are friends of mine and Alex actually was born at my hospital many years, not that many a few years ago. But she has even been very supportive of this, but it takes people like that who appreciate this. But I'll tell you, going to those events, you realize there's a volcano of activity ready to erupt amongst people who are frustrated, angry that this has not been addressed. As Congressman Smith said, when you're talking to the wall and nothing happens, after a while you realize that it's not an accident. There's an active desire not to hear the story get loud. We began looking into this a little bit at the instruction of Secretary Kennedy and noticed a few things. First off, in the chronic disease categories, especially with Lyme, there's a general short-circuiting of the system. It becomes a condition that resembles other conditions, makes it hard to put it into a bucket. If you don't want to put it in a bucket, makes it that much easier to avoid managing it. There are about 90,000 cases of Lyme disease reported by the CDC. Now you heard a much larger number from Secretary Kennedy, didn't you? Others would probably reflect that. Well, we only know about 90,000 because only 90,000 fit into one of those buckets. That's data from 2023, by the way. It is still the most common tick-borne disease in North America, but it's not nearly what it truly represents and the impact it has, including economic impact on our country when college students can't show up in class, get educated, go to school, and become contributing members of society., which is one of the values of investing in healthcare. Of those people affected by chronic Lyme, in addition to memory loss problems, joint pain, debilitating amounts of discomfort often, you end up with destruction of families. People don't even know what to think about their relatives. My family is from the eastern part of Pennsylvania, there's a lot of Lyme disease. I can't even keep track of the number of relatives, relatives who have Lyme disease, much less my friends. And these people are not crazy. We talk about it in many different contexts, but that's how they're labeled. So Secretary Kennedy asked us to address funding issues. He asked me to run the Centers for Medicare and Medicaid Services. And the question is, will we pay for Lyme disease? So Medicare, which covers 68 million Americans, 90% over the age of 65, but chronic disease categories are often treated as well. It turns out, have a long list of ailments that they treat. And Secretary Kennedy, I brought you this list, but it includes things you might expect on a list like this: Alzheimer's disease, asthma, atrial fibrillation, autism is on this disease for treatment, some chronic ailments like cardiovascular disease and cancer when they're in that category. But it turns out that we can cover chronic Lyme disease. It's actually already covered and we've updated our website to make it clear that chronic Lyme disease is present because it's a disease that is— and I'll read these words to you because I want you to understand because this is what the statute says on the website right now. Clearly identifiable infectious triggers, that includes Lyme disease. Now when you get bitten by a tick, many things happen besides Borrelia. Other things can get infected, viruses sometimes which are hard to identify, but clearly identifiable infectious triggers and difficult to identify infectious Figures both belong in this management structure. So, we've updated the covered— the chronic care management category for Medicare, which are people whose chronic conditions, that they have to have at least 2, are expected to be lasting at least 12 months or until death. We don't want the latter. We want the former. So, we're going to pay for it. Secretary Kennedy, there's my homework assignment. And we announce this today because again, it wouldn't have happened without a person who's curious and courageous. And Secretary Kennedy said this at the very beginning, we should listen to patients. He listens. He listened to all of you and he wants us in the medical community to listen harder as well with this Medicare guidance. And because Lyme is quantified as infectious associated chronic disease, I think we can make America healthy again by making it easier to be healthy in America. In America by getting serious about the management of this terrible problem. Bless you for hosting this. Thank you very much, Dr. Oz. One of the reasons we wanted to host this meeting, as I made clear, is to announce to the world that the gaslighting of Lyme patients is over. And we now— oh. Lyme and COVID are the number 6 and 7 respectively chronic diseases in this country after diabetes, obesity, cardiac disease. So, it— the burden is enormous. And the economic costs have not been quantified anywhere, but as Dr. Haase said, there are all kinds of collateral costs when people can't work, when families are destroyed. And I've seen the pressure that it puts puts on families when you have a, when you have a child who's chronically ill, who has brain fog year after year. See, I, I think my son has seen more than 51 doctors, is— and that's what happens. That is the story. That is the odyssey of American kids who are motivated to change, to, to find a cure, to find a remedy, and who are relentless. They They're going to see doctor after doctor. And I'd like to do something in the short time that we have left, and I wish I could spend 2 or 3 hours with this panel. We have another panel coming up on innovation, but I'd like each of you maybe to go around and talk about the most exciting innovations that you're seeing right now that might give hope to people, to patients who have Lyme disease around this country. And maybe I could start with Dr. I think we are seeing an explosion in new diagnostics that are coming through. And as you mentioned, I think diagnostics are the start of all of this until we have a diagnostic that allows us to clearly separate out patients. Because I think the general— and is it okay if I do some non-scientific justified speculation? But I think many people think that Lyme disease is probably not just one disease, that people get there through different pathways, that there are different things that go on. And until we have tests that separate people into the different subgroups of Lyme disease, we won't be able to really test the treatments that are appropriate and going to work on them. And when we lump people together and test a treatment, it's not going to work in some, it's going to work in some, and— but it washes out, so you can't tell if anything's working. Work. So I think the new coming diagnostics are terrific. I think there's a lot of new coming things in prevention so that we can prevent some of the people from suffering the ways the people at this table have. So I think those are really exciting in terms of some of the new preventative things that are coming down the pipeline that are kind of innovative and not been tried before. So, you know, things in terms of our group is working on narrow spectrum antibiotics that can be taken for long periods of time to prevent disease, but could also be used to try, um, longer-term therapy because all of our tests for chronic Lyme disease have been done with pretty short-term antibiotics, like a couple of months. So, if we had something safe that we could use for longer periods of time, we could really test these hypotheses and see if they work. So, those are some of the exciting things that I see coming down and one of the reasons I'm really excited about this point in time for all of us.

Yeah, absolutely. I think going on topic with the diagnostics, there are incredible diagnostic tools that are being developed. And one that I'm actually working on is through UCLA, and it is a rapid xBFA Lyme disease test that is a multiplex vertical flow assay. And to put this into layman's terms, today, They do not have time. They are very time sensitive. And this can be completed within 20 minutes. In our hopes, you could buy it at a Walgreens store. And I believe that this is a rapid test for tick-borne diseases that could really help people all over the world, especially in rural areas where they might not have access to clinics. Additionally, LymeSeq is also working on a multiplex immunoassay, which has AI learning as well. And it has a 94% sensitivity rate, which means that it is extremely capable of detecting tick-borne diseases and Lyme disease. So I think that a lot of universities and a lot of groups are creating incredible diagnostic tools. And I think what we can do is really just fast-track these innovations because once we get a diagnostic tool that can accurately detect tick-borne diseases, Lyme disease included, then that allows a lot more capabilities for getting proper treatments, medications, insurance companies cover these things. So those are some of the innovations that are out there.

I think, at least from a patient standpoint, there's a lot of uncertainty. You're waiting there day after day after day, you know, for me, 1,400 days, you know, with a lot of uncertainty. What's, what's wrong with me? And I think just having an accurate diagnostic tool would benefit us a lot. And of course, you know, like I said before, patients spend all their money and many years into treatments only to find at the end of the road that it didn't work and you're out of money now. So I think something that's a guideline or a focus that helps patients know, okay, this treatment is the best possible treatment for you based off of this best possible diagnostic tool. So I would hate to be a wet blanket on everyone's optimistic parade here, but to make better antibodies, we desperately need them because the current antibody testing on their best days is kind of abysmal. They miss more cases than they diagnose. However, on day 21 of doxycycline, those antibody tests, even when positive, fail to be useful. You really need direct detection tests. Now, Lyme bacteria have been extremely difficult to culture from infected hosts after a period of time. If you inject Lyme bacteria into a dog, you let the dog get sick for a couple of months, you know the dog is sick, the dog has Lyme, you did not treat the dog, you can't isolate Lyme bacteria from the blood of the dog. It's very difficult. Despite that difficulty, these organisms have been obtained alive from not only animals, multiple species, when they cut them up after therapy. They have been found in human tissues around the world. We know that the pathogen persists, and yet we don't have a good direct detection test on the market. We can't even kill Lyme bacteria in the test tube with the several antibiotics recommended by the Infectious Disease Society of America as the purported curative treatments for Lyme. The situation, if you explain this to Joe the plumber, they would say, what is wrong with this field? It is so messed up. How can this paradigm have persisted for so long? This is an easy to diagnose and easy to treat illness when the facts speak otherwise, and they have done so for decades. And when it comes to Bartonella, Bartonella is a beast. It's incredibly antimicrobial resistant. There's only one class of antibiotics that actively kills and effectively kills Bartonella, and that is aminoglycosides. And they are hamstrung by horrible pharmacokinetics. They don't get inside cells. Bartonella is an intracellular infection. They don't pass the blood-brain barrier. Bartonella does. They are horribly toxic. People only be on them for a couple weeks before developing, you know, ear toxicity and kidney toxicity. So when I say, you know, what's exciting going forward, I could tell you that I do think that in the next couple of years, there'll be the opportunity for AI-designed drugs and small peptides. I know that there's good research going on at Duke with a subset of screening, like high-throughput screening for small molecule, you know, finding that's, you know, funded by the Cohens and also by, originally by the Barry Alliance Foundation, so that's optimistic there. But the other thing I wanted to mention is that a couple people have said that Lyme can mimic this disease and mimic that disease and what have you. And when I opened the doors, one of the first things I noticed that people were coming in with diagnoses of fibromyalgia, and rheumatoid arthritis and lupus and multiple sclerosis and ME/CFS, and patients were getting better from these various conditions. So if it mimics a condition 100%, and Lyme and these other infections are known to be able to mimic these other conditions, then by definition it's causing these conditions. This is a broader issue than people, I think, realize. This is not just about Lyme in the way that people think of as Lyme, but I think that These other conditions, like there are over a dozen studies, randomized controlled trials on rheumatoid arthritis showing that antibiotics work and placebo doesn't. The critics of these studies will say, well, some antibiotics have anti-inflammatory effects. That's why they work. No, they've also done the studies in antibiotics that are completely devoid of anti-inflammatory effects. There are multiple open-label trials on multiple sclerosis showing that antibiotics help multiple sclerosis patients when standard MS therapies have failed. And I can tell you from my personal experience over 30 years, I've gotten quite a number of patients with these conditions to get better after standard therapies have failed. So that's the only thing I would like to add to the commentary. Pardon me, Duvey, we have a— just to add up, we have about 10 minutes or so, so we will have to keep the remarks short. Secretary Kennedy, I just want to acknowledge on the surface that you are the innovation. Recognizing Lyme disease today, what you've done made history. Without your recognition, all these solutions, doctors, and many doctors denied Lyme disease is a myth. Today, what you've done, put it out publicly, is the innovation. And Dr. Oz, you incorporating Medicare to cover extended care is innovation because this is the surface before we go down to all these solutions. And I want to applaud you for that. And I just want to ask you, how do we get other insurances to mandate them to follow in your direction? Private insurers will often cover Medicare decisions, and there's obviously a desire to treat chronic illness, but Dr. Phillips is really addressing the problem. If you don't know what you're paying for and you don't think it really works that well, you're not that incentivized to treat it because you don't get the benefit of a patient getting better. I actually did not realize that, that the, I mean, electric sides were the only way of getting to an intracellular organism, but that is mission critical because we argue about, you know, 21 weeks of IV, this or that, but if the patient is still sick afterwards and, you know, you go to any of the Lyme events, you'll see a large number of patients who claim that they've been through every treatment possible. Hyperthermia treatment, hyperbaric treatment. In surgery, there's an adage that if you have more than one operation to treat a disease, you don't have a good operation because if you had a perfect operation, you wouldn't need two. There's probably 25 Lyme treatments, which means none of them are really that effective, as much as we'd like. If you cobble them together, perhaps you can get the results, and anything's better than nothing. But the insurance companies need a bit more confidence that we have better approaches. That leads back to awareness.

Thank you. Some of the exciting aspects that I've seen, you know, in my practice and also listening to all of you speak is, you know, the possibility of having better diagnostics and research, money going into research, that is going to help legitimize this, you know, disease, this diagnosis. The aspect of that that will impact me and therefore impact my patients is lifting the barriers to the clinicians. I think the biggest problem that that I saw when I worked in internal medicine is I was given 15 minutes to talk to a patient, and that's not enough time to take care of anything, really. I started working with Lyme patients, and I was afforded the ability to spend an hour, if not longer, with these patients, and that is critical because this is a disease that affects every system of the body, and you have to systematically go through those systems to support the body so that that it's in the best condition possible to treat. You know, I, in my practice, you know, have approaches from both Eastern and Western medication or medicine to help holistically treat the patient, which I think is incredibly important. You know, I also feel that, you know, there's a lot of limitations on utilization of long-term antibiotics. We, at my practice, use pulsed antibiotics in hopes of reducing resistance as well as giving the body time to detox and not create further issues down the road in regards to gastrointestinal problems. But I think the innovations that will occur hopefully from this roundtable and future roundtables will allow me to do my job that much better.

So thank you. All right, thank you. I'll be, I'll be brief. 2 things. One, tissue analysis. Oftentimes in patients, Lyme disease is not flowing through the blood, but that's the only place that we typically test. And so, a lot of research done by Dr. Amy Peral in the audience is looking at tissue reservoirs to seeing how the pathogens may be harboring there that we can understand the etiology as well as a potential diagnostic tool. And then second, I think just for everyone here as well in the audience, we've been talking a lot about Long Lyme, Chronic Lyme, and Jumping into the Deep End. If you need a good summary, I would recommend the award-winning documentary, The Quiet Epidemic. It goes through a lot of the history of Lyme and all the difficulty of patients, some of the innovations. So, I think that'll be a really great place for folks to start. Thank you. Mr. Chairman, Mr. Secretary, thank you so much again. Duvy, thank you for your great work in Lakewood and around that area, which is in my district. And Morgan, We now have a chairman of the Health Committee who is totally committed to Lyme disease. In the past, when our bill would come before that subcommittee, it was killed each and every year. The gentleman from my own state of New Jersey, Frank Pallone, he was chairman. I lobbied him, asked him, appealed to him, and he would not bring up the bill. And that one— the mainstay of that bill was the Blue Ribbon Commission, the task force to finally look at all of these in a very dispassionate way. Having your leadership, Mr. Kennedy, is just— and you too as well— is extraordinary. We always had like a civil, okay, thank you, go on, have a nice day, from the top people at NIH, CDC. I mentioned that '82 meeting, that '92 meeting I should say, was unbelievable. They were the best of the best, top people. And they basically said, no thank you. There's the door. Chronic Lyme does not exist. There needs to be something to be done with the infectious disease side of America. They lobbied aggressively against our bill. And when last time we got the bill passed on looking into what we may have weaponized the ticks, the big story in the Washington Post mocking the heck out of me for offering that. And I asked the reporter, have you read Bitten? Have you looked at any of this stuff? No, no, no. And yet they carry the story like we have a, you know, a tinfoil hat on our head. I was very incensed at that because who gets hurt? All of those people, you know, Megan Bradshaw is here.

Megan told her story recently.

She should be on television talking about not only her courage but her overcoming spirit. And she is just one amazing former patient. She still deals with obviously these issues. And Olivia, when she talked about her tick, Tracker. What an amazing thing that is. I've had hearings on my Foreign Affairs Committee. I've had hearings on how this is global. You know what the pushback was on that, Mr. Secretary? Oh, if you're in Canada, you probably have visited the United States at some point. And I had a senator there tell me that that's what he was told by officials there. I think that's changing. But this is a global issue that needs to be treated as such. Again, can't thank you too. Great leaders enough. Well, thank you very much, Chairman, and I want to thank all the panelists for being here. I want to thank my partner and friend Dr. Haase for joining me, Ken Callahan, and, uh, stay tuned, we'll be back in about 20 minutes with the next panel. Thank you all very much, and thank you, the audience, for coming. Welcome back, everybody. Uh, this morning, or I think Earlier this afternoon, we had a panel of physicians and patients, and we focused on those issues. This afternoon, this session, we're going to focus on innovators. And I want to thank all of the panelists for being here. I'm very excited to hear some of what you're going to tell us about what is on the horizon. And I want to start by introducing Senator Suzanne Collins from Maine. Who's had a long, long history of leadership on Lyme disease, and she was one of my inspirations for getting this panel up and going. So, I want to start out by allowing you to introduce the group.

Thank you. Well, first, Mr. Secretary, let me thank you for shining a spotlight on this disease and convening this— this roundtable and inviting so many people who care so deeply about being here. It's also wonderful to see one of my constituents, Dr. Honey, who is part of this effort as well. We've talked many years ago, and it's wonderful to see her today. The state of Maine had a record number of diagnosed Lyme cases in 2024. It was 3,218. And I mentioned the word diagnosed cases because the actual number of cases is undoubtedly much higher. The projections are that this year's total will be even greater. We know that early and accurate diagnosis can reduce costs and improve prognosis. The problem, however, is that there are still few effective diagnostics on the market. The Lyme Innovation Accelerator, or LymeX, is an essential tool to help identify and develop next-generation diagnostics. So, I commend HHS for its commitment to reenergizing LymeX, accelerating the research on tick-borne illnesses. I also want to salute the Steven and Alexandra Cohen Foundation, the largest public-private partnership to combat tick-borne disease, because they augment the federal efforts and accelerate the discovery of diagnostic tools, testing, and implementation. The fiscal year '26 Senate version of that funds the Department of Health and Human Services, maintains $5 million in funding for the LymeX program. Funding will be used for exciting new developments in Lyme disease diagnostics and treatment. It is also very important that the Kay Hagan Tick Act, which I first introduced in 2019, be reauthorized. She was a colleague of mine who sadly died of a tick-borne illness. Currently leading the Kay Hagan Tick Reauthorization Act with me Senator Tina Smith. The bill has 22 bipartisan cosponsors. It passed out of the Health Committee by a vote of 20 to 1. Unfortunately, it's being held up by one senator. I'm still working on him. But the original Kay Hagan Tick Act, which President Trump signed into law in 2019, has led to some measurable successes. It had 3 components. First, it required HHS to develop a national public health strategy to prevent and control vector-borne diseases. It identified 4 outcomes to help guide public health activities toward measurable and meaningful impact. And one of these outcomes, eliminating deaths from Rocky Mountains of spotted fever has been achieved. The national strategy also calls for the number of laboratory-confirmed Lyme disease cases to be reduced by 25% by the year 2035. It's important to set that kind of, of goal. The Tick Act also reauthorized Regional Centers of Excellence in vector-borne diseases. And taken together, these centers have supported more than 225 vector-borne disease prevention and control research projects and contributed to the scientific evidence base with more than 600 publications. It's also trained healthcare professionals, and I think that that is really important. Finally, the Tick Act funds CDC grants to state and local departments. That was $19 million across 65 jurisdictions. Thanks to the Tick Act, the number of jurisdictions able to report tick surveillance data increased from 6, only 6 health departments in 2019, to 44 in 2025. It's very important that this bill be reauthorized so we can continue our work. I do want to mention with a bit of pride some work that the state of Maine is doing, and then I will conclude, I promise. First of all, the University of Maine has a tick lab. It is And that's so important because we have so many people who work in the woods each day. Think of our loggers, think of our game wardens, for example. And the University of Maine has developed this little tick case that they can send a tick to the lab where it can be analyzed for pathogens. I think that's really important. They also do a lot of education. Education, teach people how to check themselves for ticks. Although, I will admit that my husband and I still have not figured out how to easily identify ticks on our black lab, who is very fond of bringing them into our house and transmitting them to us. Just to give you an idea, the tick lab at the University of Maine tested nearly 5,000 ticks from all 16 of Maine's counties and 398 towns. So, it has been extremely effective. In addition, one of the most important tools that I hope we'll continue to research to combat Lyme disease is a vaccine. We did have a Lyme disease vaccine on the market in the early 2000s, but it was pulled. As Lyme disease cases have skyrocketed, I think that this is something that we need to continue to investigate with clinical trials that are currently underway at Maine Medical Center's Institute for research. So I look forward to continuing to work with HHS, and again, I'm grateful to the Secretary for inviting me to participate today.

Thank you. Thank you very much, Senator Collins. Senator Collins has to leave, has a hard out. Thank you. She has a hard out at 4:10, so we're going to have to let her go. I'm going to turn this over now to my Deputy introduce the panelists. Thank you very much, Mr. Secretary, and I'd like to echo the thanks for Senator Collins for her longtime leadership on this issue, which has had tremendous value and given a lot of momentum and encouragement to many of the other people in this room. All Americans deserve to be healthy and happy and prosperous, of course, including Americans with Lyme disease. People with Lyme disease also deserve respect and acknowledgement that they are truly suffering from real disease, and we are all working to make that happen as well. As the Secretary said in the first panel, many of us were in Martha's Vineyard in September, including Jay and me and the Secretary for Tribal Advisory Council, and we learned— we heard from the Wampanoag Tribe. In Martha's Vineyard about the explosion of Lone Star ticks in Martha's Vineyard. So, tick-borne illness are very much on our mind this autumn and in our hearts. Also in September, in this very room, the 3 of us and some others issued the Maha Strategy Report. All of us at HHS are working hard to fulfill all 120 commitments from that report. One of those directives calls on HHS to use artificial intelligence to reduce the economic burden of chronic disease. And this event shows that we're not waiting for the new year to act. I would now like to ask our distinguished panelists to introduce themselves with name and title and what you're doing to work on Lyme disease. And we'll start on my far left with Dr. Bransfield. All right, I'll start over again. Okay. All right. I'm Dr. Robert Bransfield. I'm a psychiatrist in New Jersey, and, uh, when a healthcare system fails someone, they often are referred to psychiatrists, and that's one of the reasons why I'm here. I've been treating thousands of Lyme patients over a span since 1973 when I saw my first Lyme patient. And in treating thousands of patients, I've learned from my patients, and a good part of my research has been based on that. Some of the articles that I've done have focused on some of the areas that have been overlooked. There's right now 650 peer-reviewed journal articles on the psychiatric manifestations of Lyme disease., and also some with cognitive impairments, with dementia. That's on the table there if you want to read it. So, there is a strong amount of evidence, goes back to 1952. Now, in working with these patients, I found there were some neglected areas. One area is trauma related to being lost in the healthcare system, post-traumatic stress. Another thing I worked on is substance abuse. People with chronic Lyme who were inadequately treated, 12-fold increased risk of substance abuse. I've also worked with autism, done 8 articles on Lyme-related autism. It's not just Lyme, but there's 20 infections that I see associated with autism. It's an infection-genetic susceptibility interaction that's immune-mediated. Then, I've also worked with people with suicide. That was an overlooked area, and That comes up a lot. People don't die with, from Lyme disease, from arthritis. They die from suicide or drug overdoses. I've also worked with patients who are violent. That's been a big issue, and homicides, dealt with homicides, tried to prevent them as best I could. Wasn't always able to do that. And then, a big thing in looking at Lyme disease is that It's a clinical assessment is more critical. Right now, these are complex interactive infections. There isn't a simple lab test. And in psychiatry, we don't make a diagnosis of depression or anxiety with a lab test. We make it with a thorough clinical exam. Sir William Osler said, "If you listen long enough, the patient will give you the diagnosis." And that's what we have to do. And we really can get that. So I've developed a clinical diagnostic system that anybody can use. I've also developed some educational videos that are on the internet that anybody can listen to to learn about that. It's good to educate other mental healthcare workers in this area. Now, my recent journal articles, one is, was looking at the entire connection between infectious disease and mental illness, and that, that was one article. Another article which I did with the Lyme biobank out of the Bay Area Lyme. In that case, we had a patient who was on my waiting list, and he was a case where he was inadequately diagnosed, inadequately treated, and then he went on to chronic disease, and he got lost in the system, couldn't get help, turned towards substance use, that made things worse, became psychotic, He killed his best friend and killed himself. And then we did an autopsy. We found evidence of persistent infection in his brain and body that helped explain why he acted in the way he did. Another article that I did is looking at this interaction of, with COVID My concern was that it contributed towards greater violence in the world., and I looked at proving that, how that occurred. But it also looked at the model of the role of infectious disease and violence on a regional and global level. And if you look at the map, where there's more infectious disease load, there's more violence. And you see that in different conflict zones. In higher equatorial areas and higher altitude and higher latitude areas, there's you see less vector-borne disease and less violence. Particularly in equatorial areas where there's compromised environments, you see more violence. So, a lot of it is an ecosystem problem where we have to look at the whole pattern of how that ecosystem involves the pathogens, the vectors, and how the disease evolves. And I think that's very critical. That's not exactly Lyme disease, but it's related, but my work looking at infection with these patients brought me to that. And I think we have to also look at the fact that this is not just an American problem, it's a global problem. And other countries follow the lead of American healthcare, but they also follow our mistakes. And that's been a big problem. I've seen it with, in going to other countries and talking with people there. It's a problem in Australia and Poland, in Eastern Europe and France, where they have this very restrictive criteria. And I think if we can be more clear in broadening out the definition of Lyme disease, it won't just help here, but it would help in other parts of the world. And I think it would help with global stability as well. So, it's very difficult dealing with this, but I think we can make some progress. But I think we have to look at diagnostics, not just as blood work. We have to do it. Clinical diagnostic systems where there can be screening, you can do rapid screening, and then you do more detailed screening. The most detailed screening I do takes 2 hours to do, and I look at 280 different symptoms, but you don't start out that way. You start out more with a screener and then you expand from there. And I think that's, we have to help people today. In my past week, I had 2 people that were homicidal, 2 that were suicidal, one that was psychotic with an autoimmune encephalitis. We have to help these people today. We can't wait till these things evolve. There's a great urgency. So, on behalf of my patients, and one other thing I get involved with is the legal, the forensic, the legal aspect of Lyme disease on various levels. That's a significant thing that comes up a lot. And on behalf of my colleagues with ILADS, I also organize I organize other psychiatrists and other doctors. I've done that since the '90s. And my colleagues are here from ILADS, and that's an organization where we help to promote and educate. And we also have to develop these biobanks, like the, the Bay Area Biobank where there's 28 Lyme disease brains. It helps us with a lot of these studies. The gold standard is really with autopsy and brain tissue. Tissue studies, and that's where we really are going to move forward and truly understand this. And I thank you very much for— and on behalf of my colleagues and my patients and myself— for bringing attention to this critical issue. Thank you so much, Dr. Mansfield. Dr. Patterson. Yes, I'm Bruce Patterson. I'm a viral pathologist. I've been doing pathology for over 30 years, so I've had my share of diagnostics and what we call pathogenesis, which is exactly how do bugs create disease. And, you know, I wrote an op-ed, Lyme: The Pandemic That COVID Uncovered, 4 years ago as we were using machine learning and AI to develop a diagnostic long COVID. And along the way, we found some aberrant patterns in the immune system that were intriguing, that had very signature markers of Lyme disease: interleukin-8, interleukin-4, TNF-alpha. These are all inflammatory proteins that we've been talking about and have been published. And we finally developed an algorithm-based system to diagnose Long COVID and distinguish it from chronic Lyme. Because as a clinician seeing thousands of patients, they all come in and say, oh, I have fatigue, I have brain fog, I have exercise intolerance, I must have Long COVID. Well, 4 years ago when we were first going through those iterations, a lot of these patients ended up having Lyme. And so, they probably weren't even adequately treated at the time. And I still think that is a huge issue right now with clinical trials starting with long COVID, clinical trials hopefully in Lyme. We're about to submit one in January. Is proper stratification of patients in these clinical trials. It's a very simple ask, but it's very difficult to come by. Come by. When people use the term diagnostics, diagnostics is a very, very broad term. There's diagnostics that say yes or no, you have something. There's diagnostics that say how much of something do you have. There's diagnostics that say you have this versus you have that. Or most importantly, in the Lyme context, the need for a diagnostic to say Is the bug active? Is it actively replicating? Or is there evidence of past infection? And I'll add a third condition that we just discovered, that much like in long COVID, there's retention of the pathogen's protein in white blood cells called monocytes that are nothing more than fragments of protein and nucleic acids. We just found the same thing in Lyme. In other words, we found that there were fragments of Borrelia protein in monocytes, and we show that those, uh, those white blood cells are pro-inflammatory. They're producing all the inflammatory proteins that cause these extensive symptoms— brain fog, fatigue, joint muscle pain, etc. We all know what those symptoms are, but the fact remains that there may not even be a replicating bug to treat with an antibiotic in certain cases. And that could be another potential mechanism for chronic Lyme that we have to look at. It may not be all about antibiotics, but immune modulation. We've been using one in particular called Miravaroc, which reprograms these white blood cells away from a pro-inflammatory phenotype. These cells also are able to migrate through the blood-brain barrier and cause neuroinflammation. So we have to think of this differently as organism, disease, treat the organism, the disease goes away. What I tend to approach Lyme as doing is treating the bug and treating the chronic inflammation that results from the bug, and that could be due to mere fragments of the bacteria in some cases, but it may be the bug in other cases. And we need to be able to distinguish that. So, thank you for your time, Secretary Kennedy. I think by looking at Long COVID and Lyme, we've identified from some of the reports that I've seen that these are in the top 7 of chronic diseases in the United States impacting our population. And again, the population worldwide.. And these are also ones that haven't been adequately addressed from a funding level. So, thank you, and I appreciate being here.

Thank you, Dr. Patterson. Dr. Tell. I'm Micky Tell. I'm an engineer. I'm an immunoengineer, and I've been working on infectious disease immunology for the last 20 years. And the reason that chronic Lyme is an invisible illness is because We don't have the test to measure it. People are often still told that they're fine while their bodies are breaking down, and I think one of the real tragedies is that we wait for their bodies to break down to really try to step in and help. And so some of the big innovations that we need are we have to be able to measure what's happening, and we have to be able to measure it to see what trajectory are you on? Is your illness on track to recover or is your illness on track towards catastrophic breakdown of your body? So at MIT, we're rooted in engineering and rather than looking at this as a mysterious syndrome, we're looking at this as a set of problems, solvable problems. And so I lead a clinical study at MIT. It's actually MIT's largest clinical study. It's called MIT MAESTRO, and I've left a handout on the back table as well as I've given each of you guys to show you some of these features that we can measure. And we are running thousands of tests. We have over a million data points per participant. We've looked now at— we're looking at hundreds of people who have Long COVID or chronic Lyme or acute Lyme and trying to see if they are on track to recover or not, comparing them to recovered controls. Um, these diseases are complex and clinicians can't exactly ask their patients, is your connective tissue damaged? Is your connective tissue recovering? Is your blood-brain barrier integrity compromised? Um, what about You know, are you getting enough blood flow to your brain? But these are things that we can measure and we need to be measuring so that we can really understand the different impact. I've brought you just for an example, this is a capillaroscope. You can look at the blood flowing through your smallest microvasculature, your capillaries. You can wear all sorts of different— there's all sorts of different wearables available to look at blood flow. There are different wearables and different trackers that you can look at eye tracking, you can look at voltage, you know, brain voltage, you can through EEG. And so we have all these different measures that we can very finely measure and put hard numbers on different features of neurological dysfunction. So we don't need to say, oh, brain fog, that's a subjective symptom. We don't have a way to measure that. Well, we do, we do have ways to measure neurological dysfunction, and we need to be doing that. And so, um, we're in, in Maestro, our concept is measure absolutely everything. But the reason we're doing that is so that we can identify the tests that are the most impactful, the tests that we need to move to move forward with. And while we're not done yet, I do want to tell you that I think, you know, at the very least, measuring blood flow, measuring, you know, eye tracking and neurological dysfunction, those are really critical and important and could really help us see, you know, what is on track. And the other thing that I want to mention is one of the other things that we're doing is instead of asking the immune system a yes or no question. Have you ever seen this bug before? Yes or no. We're really trying to look at the features of the immune response so that we can ask it an open-ended question. If you saw this bug, how did you respond? Was it in a way that was protective and you're clearing this infection, you're never going to think about this again, or was it in a way that was catastrophic, bring the house down? And those are, those are really important to identify because then maybe we could help people before all of the ongoing damage and suffering. And so with that, I just—

I really want to thank you for your invitation today and for this open discussion. Thank you, Doctor. Thank you, Doctor. So we've already learned a lot of useful information about Lyme from our first 3 scientists. Fortunately, this meeting is being livecast and other people are learning from it. Our next 4 scientists are all people who work here at Health and Human Services. And before I turn it over to Dr. Jackson, I just want to go ahead and announce that because we have so much information today, we've launched a special dedicated page on the HHS website that is going to be a hub for news and data and policy around Lyme. So, the website is hhs.gov/Lyme. It launched today, and I hope it will be a resource for everyone. And now I will ask Dr.

Jackson for an introduction. Thank you. There we go.

Hi, everyone.

I'm Dr. Alicia Jackson. I am the director of ARPA-H, which is an agency within HHS designed for just these types of problems, problems that seem nearly impossible to solve, and we can bring the best innovators around the world who have new approaches They have new paths that we can go down. And also, we can bring together the groups, the datasets, all the AI tools that we need and build those for the community. And so, I'm thrilled to be here to make Lyme disease nothing that seems impossible, but actually possible to solve and probable that we can do it, not just in 2035, but within the next 5 to 10 years. And I do believe that is possible if we bring the right people and resources resources and committees together. Already, we've started to build an effort around these invisible diseases. And while it sounds quite simple, it's actually quite complex, which is to take not only all the clinical trial data that's being produced around Lyme, but also each individual patient's record, the depth of that record, the clinical notes, and bring them all together in one place. In place so that we can study them as a whole, make them available to researchers so we can understand what are the common patterns that we're seeing here, what's working, what's not working, why do some people recover when others do not, and get the, the kind of insights that we need. And we're building this for the community because if we can build that foundation for the community, we can allow a bunch of folks to come on top of it and find those insights, ask the questions that need to be be asked, and that will speed up the community as a whole. The second big area of innovation that we're quite interested in is around immunology and immune reset, and we're really looking to the community on this, which is what are those new ideas that you have? What are the big ideas that haven't been tried before or maybe go against dogma that we can put resources and funding in to actually go make a dent here. I'm happy to talk more with all the folks here. I'm so happy that all of you have come here to share your experiences, what you're digging into, what you're funding as well, so that we can partner and make a difference.

Thank you so much, Alicia. Next, we have our distinguished director of NIH, Jay. Hi, I'm Dr. Jay Bhattacharya. I'm the director of Director of the NIH. Thank you, Jim. I want to start by echoing something that Dr. Patterson said, which I think is incredibly important. The way forward on Lyme, on ME/CFS, on long COVID, so many other of these conditions that for the very longest time, patients have been gaslit to say, well, it's not real. Well, first, it is real. But also, when you think about addressing it, you have to— you can't just think about the pathological agent that initiated the condition. You have to think about the patient as well. It's the interaction between the patient and the pathological agent that is at the heart of making progress on each of these conditions. And, you know, the philosophy of the NIH has been and will be to think about those paradigms. We're not just going to be thinking about Borrelia. Although that's a very important thing to think about when you think about Lyme disease, but about the patient's reaction. Why is it that you have this long-term mean reaction? Why is it so sometimes difficult to find evidence of Borrelia in the chronic conditions, but sometimes you can find it? These are mysteries that are solvable, and the investments that we're making at HHS, including at the NIH, are going to be the heart of solving it. Let me just give you some items from this. Actually, you heard earlier in the earlier panel about this TUSC study funded by the NIH, this Prospective Study of Symptoms, Events, and Clinical Outcomes for patients with Lyme disease. It's a very large study comparatively for looking at how Lyme— it's a prospective study for how the symptoms evolve over time, how biomarkers evolve over time, and how clinical outcomes respond to treatments. There are several teams looking at the potential role of peptidoglycans and other bacterial proteins and the antibodies they generate for a possible role in persistent Lyme. We're supporting an ongoing clinical study using neuroimaging and blood markers after treatment to assess mechanisms of neurological symptoms associated with Lyme. We support several studies seeking to identify serological markers, antibodies that predict patient outcomes after treatment. And we are about to launch at the NIH Clinical Center, with a lot— in partnership with the Children's National Hospital in Washington, D.C., a new clinical study that will improve our understanding for pediatric Lyme disease, which is an increasingly important problem. In fact, this is one of the commitments that we made in the Lyme disease framework to do, and we're going to launch that in early 2026. The NIH has multiple ongoing initiatives and studies on Long COVID, ME/CFS, and other infection-associated chronic illnesses that may have similar underlying mechanisms. And studying these conditions together, finding what's in common and what's different, will help make advances in all of them. Again, Dr. Patterson, I think this is one of the things you're thinking along the same lines. While there's investments we've made in identifying new antibiotics that potentially could have a lot longer, better effects, as well as potentially protective monoclonal antibodies that can be used as a treatment strategy evaluated in the usual rigorous NIH way. We just— I've gone on long enough, so let me just say the NIH is committed to contributing to the overall Lyme strategy that the HHS and Secretary Kennedy has launched. And as I said, we've already committed to— we'll be launching this new pediatric Lyme initiative, as well as convening the new national NIH Lyme workshop to update federal research priorities on Lyme. I entirely agree with Dr. Jackson. We are— the idea that Lyme is an intractable condition, that patients are just making things up, those days are long gone. Those are long gone. At HHS, we are absolutely committed to making sure we do the gold standard science to address your condition. And within— with the advances we're seeing, there's a real potential within a few short years that we'll have much, much better early predictive biomarkers, much better treatments, and real cures, maybe even ways to prevent it that we don't currently have. But we're headed in that direction. Thank you so much, Jay.

Next we have Dr. Herodopoulos. Well, good afternoon, everyone, and thank you, Secretary Kennedy, for your initiative on this very important issue that affects so many Americans. I'm the Chief of Staff of the Office of the Surgeon General, and I am a family medicine physician, practiced in Florida for 2 decades. I have diagnosed and treated patients with Lyme disease, so I do bring some real-world experience to the Office of the Surgeon General. Part of what we do is want to communicate with the Americans how do we live healthier, how do we have disease prevention and harm reduction. So this— in this space we are going to be very active in educating the public on preventing as well as awareness to clinicians on how to diagnose Secretary Kennedy, you gave us our marching orders earlier this year, and Dr. Honey and I put together a briefing for you with your subject matter experts within the department. In one of those takeaways, you said, "I would want a livestream roundtable so patients and innovators of researchers and clinicians are seen and heard." And this is what we've executed today with your leadership Sir, and so many people around the world are cheering for you today because of this. So what I could tell you is that, I don't know if you remember, I put poppy seeds on the table for you because I said these are the size of the nymphs. And people don't understand it's not just the adult tick that spreads the Borrelia bacteria. It could be the nymphs too. 2, and those are the size of a freckle. So as we talk about primary prevention, we want— obviously Secretary Kennedy wears jeans in the— when he goes hiking for a reason, so he doesn't get Lyme disease and for others. And so we want to cover up. We want to make sure that we are not getting it in the first place, but taking it off. Research recently showed that the Borrelia bacteria actually— it doesn't have to be 48 hours. It can happen within hours that the bacteria is spread. And it's a very smart bacteria that quickly gets out of the blood and into the tissue. Unfortunately, that's why we have such a hard time with the biomarkers. And it develops a biofilm and hides. And so that's why even antibiotics are so hard to penetrate into the biofilm and get to it. So clinicians need to understand that Just because a patient doesn't live in the Northeast doesn't mean you're not thinking of it as a differential diagnosis. Making sure that if you are not totally able to understand why they're experiencing it, maybe you need to test or maybe you need to treat. Just educating yourself. Let's take down those barriers. This is a paradigm shift for patients with Lyme disease but also for clinicians to be aware to test. No longer will you be gaslighted. I want you to know your opinion, your experience matters, and you are valued. So, the wisdom we get from you, the patient-centered approach is warranted, ensuring that the voices and experiences that are affected by Lyme disease directly shape program development. And we listen at events like this. And you get real-world insights from patients and clinicians, and then you communicate how your stakeholder input could shape a program and then launch initiatives that, like ARPA-H is very much working on possibly novel antibiotics, as well as preventing maybe tick population expansion and also some anti-inflammatories that very much help with the immune dysregulation with the cytokine pathway that is expanding the disease state. So, we've learned so much, but there is so much more to be done with Secretary Kennedy's leadership and all the internal stakeholders that are here with your influence. So, yes, we have the Lyme disease site on the HHS website, but also there's going to be a fact sheet that's released today with some wins. I think it's a really big deal that the chronic care management guidelines with the G codes help the physicians to see that with the MLN that they can actually get reimbursed to see patients with chronic illnesses and that Lyme disease is listed on that. Active as of just 2 weeks ago. That is a big deal for the Lyme community. You are being seen, you are being heard, and we are doing things at HHS for you. And this is the beginning of the journey. This is not the end. So we are going to continue this communication, and I promise there are going to be more wins throughout this administration because of the wonderful leaders that we have here. So I'm going to let Dr.

Honey who has been my counterpart on putting this together, proceed.

Thank you, Stephanie. Dr. Honey. Thank you so much. And it's been a great team effort. I'm Kristen Honey, and I'm the Chief Data Officer at HHS and also the LymeX lead with our public-private partnership. But folks here probably know me as a Lyme patient because I was recruited by a tick in 1999 and went through many misdiagnoses. For over a decade until I completely collapsed. And if I had followed the guidelines, I would be dead today. Fortunately, the patient community shared their wisdom, and I am here on the shoulders of giants like Lorraine Johnson, who founded LymeDisease.org and the MyLymeData registry with over 20,000 crowdsourced records for— from patients. Who are trying to find answers, and the late Pat Smith, and people who shared what got them well. So after trying many things over 3 years, I finally biohacked my way out. But, you know, no one should have to be the FDA of their own body and take such extreme risks. So we need a new approach that puts the patient at the center and that is truly precision health Because there is no average American, and what works for me may not work for you. And with these complex conditions, we really have to look at the individual and the host response. And I think of myself now as really a data-driven problem solver who loves the science, loves the nerdiness, but give me a wicked problem, let's unleash all the data we can with radical transparency, and then have the courage to follow the data wherever it leads.

Us. Thank you so much, Kristen. Dr. Gould is the person on the panel that I think I've known the longest. I think we met at a scientific conference around 13 or 14 years ago. It's always lovely to see you.

Please proceed. Thank you very much, Deputy Secretary O'Neill and Secretary Kennedy, for hosting such an amazing— am I audible? For convening such a great gathering. I think it's a critical moment in the history of our health and wellness here in this country that this convening is happening. My name is Dr. Anita Goel. By training, I'm a physicist and physician from Harvard and MIT. I'm the chairman of the Nanobiosim Research Institute and Nanobiosim Diagnostics, which is a company in Cambridge, Massachusetts. I've been on a lifelong journey to bring fundamental physics and biomedicine together. My institute has been working with agencies like DARPA, NASA, DOD, and recently with FDA and HHS and Dr. Honey on really bringing together physics, bio, nano, and even AI tools to unleash quantum leap innovations in healthcare. And specifically, I feel like I'm hearing my echo. Specifically, we built a vertically integrated tech stack that enables real-time, high-resolution data collection and diagnostics in a decentralized way. So the idea is that you could diagnose with high resolution. So we, my initial background is building nanobiophysics-based detection systems, next-generation diagnostics at the single-molecule level. But we really harnessed all of that into a tech stack, most recently demonstrated with the FDA in a contract project we did with them, where we quantified the viral load. We have one of the most sensitive FDA-approved ways to detect low viral loads of COVID in saliva, and we quantified the viral load of these patients, and we ran a decentralized clinical trial, and we went— we focused on collecting multimodal data. And Secretary Kennedy, you mentioned it's important to listen to the patient, so I see our technology stack as a way of technologically listening to one patient at a time by recording all kinds of data, their past medical history, their electronic health records, their biomarkers, and quantifying them with very high resolution in real time, so temporally resolving this. Most of our clinical trials are done in a low-resolution way where we do cross-sectional studies.. But if we can measure in high resolution in real time at an individual level, we get a lot more data because each individual story— and this is that personalized precision medicine— there's a lot of environmental factors that are influencing the biology of that organism on many layers. And so what we're trying to understand is not only the background information, but that interplay of the information of that biological organism with different layers of information in the environment, and that when you mathematically try to put all that data together and extract patterns with tools like AI, you start to get novel insights. And the point is we can learn from patients in real time, as opposed to taking 5 to 10 years for certain kinds of clinical trials before therapies become available. So I'm advocating this kind of new technological infrastructure that makes it possible to collect high-resolution data in real time and then collect it on individuals, but then aggregate it over many popu— over a population of individuals to start to build patterns. It's the way Facebook learns from its users. That's how we can advance our tech infrastructure to learn from every patient, except use it for the benefit of advancing therapies faster, getting them to the bedside faster, being smarter in our triage of patients, earlier detection of patients, value-based care, delivering better care at a cheaper cost because we can allocate our medical, our $4 trillion in annual spending budget more efficiently if we understand not just the detection and the quantification of the disease, but how that fits into a bigger pattern of how all these parameters fit together. And so I think what I would advocate is that we're at a pivotal moment right now where with your leadership we can make major investments into really bringing the convergence of things like physics, nano, bio, and AI together to unleash a quantum leap in our capabilities in terms of not only diagnosis, but this enables, in my view, a platform to accelerate novel therapies for many kinds of diseases, including chronic diseases. For example, we need to understand the interplay of infection and inflammation, and this is true in Lyme disease as well as long COVID and many other diseases, or even if you look at other chronic diseases of inflammation. And if you can time resolve, let's just take Lyme and long COVID, if you can start to time resolve the infectious phase and the inflammatory phase of each patient and some of the things we saw in our clinical trial data is that no patients are the same. Some patients have high viral load and their inflammation and their symptoms end when the viral load ends. Other patients, their symptoms end but they continue silently carrying a persistent viral load. And a third group of patients have no viral load but they keep having symptoms. In some sort of inflammatory framework. And just really trying to understand that and tease that out, and we can learn from cohorts of patients in real time with this kind of tech infrastructure, and then use that to then more intelligently tailor therapies. And then the therapies themselves have to be holistic. You could take the best of medications, but you can also try, you know, if somebody is trying acupuncture or Ayurvedic medicine on the side, that should be part of the data input that then informs the trajectory of that patient. And with these kinds of tools, you can start to see all of that in real time. And then thanks to AI, you can really start to make sense of that.

So I'll stop right here. Thank you so much, Anita. I can say all of these opening statements have answered most of the questions I was planning to pose, which is excellent because they're us consuming a fair amount of time we allocated, and I bet we'll get all the rest of the answers from our final panelists. So, please go ahead. That's a very tough act to follow. Hi, my name is Dr. Ben Nemzer at Steven Alexander Cohen Foundation. As the largest nonprofit funder in the space, we fund research into Lyme diagnostics, therapeutics, biorepositories, prevention, etiology, epidemiology. This includes, of course, is the $10 million LymeX Diagnostic Prize Competition. Currently, there are 7 scientific teams developing new diagnostic tools with the ultimate goal of FDA approval in the next 2 years. Over the last 40 years, unfortunately, as we've heard so much about today, the status quo has failed Long Lyme patients. There's no consensus diagnostics for Long Lyme, no consensus treatments, no consensus on etiology, and of course, the patients and their families suffer tremendously. We often— so our portfolio is geared towards innovative ideas to break through that deadlock. We often attract innovative researchers who have grown frustrated with NIH's peer review process. While NIH peer review process has some strengths to slowly incrementally progress a research field, the primary weakness is valuing new and innovative theories or approaches. While innovative ideas may be financially risky, The slow incremental approach can take decades. A whole generation of patients suffer and the current taxpayer gets no benefit. Our foundation is positioned as a counterbalance to this grantmaking status quo by leaning into innovations. Of course, some projects are higher risk and higher work because it's what we feel is the best for Lyme patients and their families in the short and long term. Thank you. Thank you to all the panelists. I have a question that comes from my own anecdotal experience. In this panel, the last panel, there were several references to co-infections with other rickettsial tick-borne diseases and other diseases that compounds the complexity of diagnostics and of treatment. As I said, in my own anecdotal experience, I've met a number of Lyme patients or Long COVID patients who also have mold sensitivities that appear to, to amplify the impacts. Are any of you running into that problem? That's a really interesting observation because I think one of the things that's confounded our analysis and now has come out with a large number of patients, is mold and mycotoxin. We're working right now on an immune signature. Obviously, we have a test that can do 14 different biomarkers at one time, or 89 billion combinations, and we're enrolling patients to figure out— we think we have some early data to show that there is indeed mold mycotoxin signature that separates it from long COVID, Lyme, and ME/CFS. But I think that is another invisible hidden source of chronic inflammation and chronic disease that needs to be looked at. I think it's far more prevalent than we could, we could ever imagine.

I'll just add one point to that. I think that there's a complex constellation of infection and host immunity and inflammation, and which includes the microbiome. And so different people have different starting immune systems, and then with the infectious insult, their immune system reacts in different ways, and each person's Journey is a little bit different. And so to understand that, I think the idea of individualized precision detection and tracking helps us then dial in the parameters for that one patient. And the way you would do it for one patient may differ a little bit than how you do it for the other patient. And that's why, you know, instead of the one-size-shoe-fits-all, having the ability to real-time track, in my opinion, helps you tease out why, because For example, one patient might be co-infected because of a baseline immunocompromised situation, whereas another patient may have a post-infectious inflammatory reaction that might then modulate their immune system in such a way that they become more prone to certain infections. And so you really have to kind of understand that interplay, as well as the environmental exposures, to really answer your question, in my opinion.

And thank you, Doctor. The last question I would ask is, particularly from those who are academics, the two of you who work at MIT and Dr. Patterson, are there things that we should be doing at HHS that can support your work? You know, I think that's such an important question because I think at the end of the day, on our parts, it's always bandwidth and funding. I would love to collaborate with ARPA-H, expand these databases that we use as a source for machine learning and AI, but even the smallest things such as having the proper scientists and bioinformatics people to pull together all that data and deposit it, even that takes some resources. So, I think, you know, at the end of the day, especially in Lyme and Long COVID, which are two excellent examples, I think funding is critical. But the other critical thing is what we're doing here right here if I were here today. I would never have known what other people are doing in this space. We live in a little bit of a vacuum sharing these ideas. I think, as I've shared with you, Secretary Kennedy, in the HIV days, we didn't do this. In fact, the immunologists and the virologists rarely spoke to one another. But what we're doing today, we kind of get a feel for what everybody's doing. And a lot of us have similar ideas, maybe approached in a different way, that's what will get to real solutions and real outcomes.

So I think this is what we should be doing. I want to chime in there that, you know, I'm surrounded by colleagues who are trying to build tools that could really change this, some novel alternative methods, you know, these SNAMs to humans on chip, as well as different ways of looking at the human in their own body and developing new computational methods to really do systems medicine. And there's so much happening in, you know, with AI developing the way it is. I think one of the things that we really need is there's still data that doesn't yet exist in the way that we need it to exist in order to analyze it. And the funding mechanisms that exist today aren't in a way that really allow us to develop these tools that we need and to collect the data the way that we need to have it. And so I think having funding structures that allow for these really critical developments that can leap us forward would be Incredible. And I would just add to my colleagues here, I think this is an era of convergence. In the last century, a lot of our biggest innovations were in silos. So I think a great convergence across agencies, across disciplines, physics, nano, AI, bio coming together. I think the ability— you mentioned this idea of centers of excellence. I think those would be great places to set up where we could set up tech infrastructure to listen to patients at scale by recording, like almost having a place where we could record high-resolution data on a certain set of volunteer patients in exchange for however we set it up. And that becomes— because our AI is only as good as the data we use to train it. So if we can get high-resolution data, we can build next-generation algorithms to really start to predict where things are going to go. And so I think leveraging some of your vision of setting up these centers, which can be places where we envision the future of medicine and healthcare with the latest convergence of tools to get information, but also where we can try new therapies. Accelerate by recording and quantifying the response to the therapy. So it's all data-driven. We can accelerate how new therapies, including suppressed therapies, get to market and how we can think more holistically about health and wellness and even aging and chronic disease reversal.

Thank you very much. That's exactly what we're envisioning with these Centers for Excellence. I'm glad to hear you validate that. Do you— I I'm just curious, Dr. Goel and Dr.

Tahal, do you actually treat patients?

No, I'm full-time research.

So then how do you get your data? So we run clinical trials in partnership with the FDA where we— I partnered with several academic centers that recruited the patients, and then we collected all the data, built all the tech. I trained as a physician, but we work with a lot of others to actually recruit their patients.

I'm surprised you aren't working with Dr.

Patterson, 'cause he's got a lot of patients.

Well, now that we've met. Yeah, I've actually sat in front of some 12, 13,000. So it's interesting that you say that, but it's also interesting we've actually sat in front of them and heard their story. It makes you even more committed to find answers because It's gut-wrenching sometimes. So there's been a lot of mentions of data, and using data more efficiently is one of our priorities here at HHS. So we have around the department access to a lot of datasets, each of which has a very different structure. So CDC has disease surveillance data, FDA has clinical trial data, CMS has payment reimbursement data. NIH has research data. States have a lot of longitudinal health data. Other outside partners have electronic health records. And we're using AI to find ways to look for even weak signals across all these differently structured datasets. And that is one of the potential benefits of AI that we are all excited about., and a lot of the HHS people on this panel are working hard on that.

Alicia. One thing I wanted to address that goes directly to this point of what we're talking about is we've started launching this model of bringing new tools into ongoing clinical trials so we can broaden what's being measured.

I agree with Dr.

Tall quite a bit that we are sometimes limited to where the technology has been versus where it's going. Growing. And so being able to bring these new— we call it basically diagnostic markers, not necessarily bio, but a lot of other data inputs that we can get to enrich those datasets and seek new insights, I think is quite powerful and a model that we could expand even further.

We're applying it with our mental health for veterans clinical trials right now. Okay, wonderful. We're out of time. This has been a really wonderful discussion. As I said, it's been livestreamed, and we're going to— we've created this portal for more information. We're very grateful to the Steven and Alexandra Cohen Foundation, which is an amazing LymeX partner and has devoted really significant resources to helping us treat Lyme. Mr. Secretary, do you have any final thoughts? I'm very, very grateful for all of you participating. I hope it's the beginning of a major national effort to solve this problem and to finally give some relief and recognition to these patients who have been invisible for so long. Thank you very much, everyone. If there are ways the Department can help, please reach out to us, and please continue to validate Patience with Lyme.

Thank you so much.