#1 Patient Power: scientific and policy progress with Patient Led Research Collaborative (PLRC)

[Music] Welcome to Make Visible, the podcast shining a light on complex chronic illness. I am your host, Emily Kate Stevens, and I've been living with an energy limiting condition since 2020. Here, I will speak to the world's leading experts to bring you the latest science, research and insights into invisible illnesses, including MCFS, EDS, fibromyalgia, pots, long COVID, and more. [Music] Thank you so much for joining us for this the first episode of the Make Visible podcast. For those of you that don't know me, I am a journalist and broadcast producer, who's had long COVID since March 2020. And I have had the privilege of co-hosting the long COVID sessions podcasts for the past three years. Now, I have learned so much from my access to these experts, healthcare professionals, the scientists who are leading the charge in the space of long COVID. But I quickly started to realise that long COVID is not a stand-alone illness in this complex chronic illness space. And what the focus on long COVID has done is actually enable research into these illnesses that for decades have been overlooked. So I became really interested in this idea of looking more broadly at energy limiting conditions. We are talking about post-viral, associated conditions and genetic conditions. We're looking at the conditions that often have no specific biomarkers or no specific diagnosis. They are conditions that are difficult to treat and often contentious in whether they even exist. As a complex illness sufferer, I can tell you wholeheartedly they do exist. These are physiological illnesses and we need to do all that we can to research, to spread information and to try and reach a deeper understanding of what is going on in our bodies and in our minds. And this podcast is brought to you by Visible, who are working with 100,000 people to enable them to understand and manage their chronic illnesses. Together, what we're trying to bring you here is access to information. It is science distilled into a palatable form. It is conversations with people that the majority of us can't get appointments with. And it's trying to get some of that information that is out there because, whilst these are complex chronic illnesses, so many of the people that I have spoken to have said, they are not mysterious. We do know certain things about these conditions. We do have some ideas of perhaps not a cure, but of ways in which we can treat, be it symptomatically or trying to get to the root of these conditions, there are things that we can do to enable people to live. So what we're going to try and do in this series of conversations is bring you some of that information from these absolutely brilliant people. Conversations with scientists who look at things on such a micro level. Conversations with patient advocacy groups who look at things in a much broader context and everything in between. We would love to have you feeding back into this show, telling us what would be useful for you. What you feel is missing out there in terms of the information that is available to you, whether you're managing your own illness or you're a caregiver for someone with an illness, or perhaps you are a medical professional or a researcher yourself who is looking at these conditions. Please tell us what you would like to be included and we will endeavour to bring you a podcast that is informative, that is useful, and hopefully that is reassuring and comforting. So to kick us off, we're very excited this week to bring you a conversation with the Patient-led Research Collaborative. A fantastic organisation built from and as a response to complex chronic illness. The Patient-led Research Collaborative was established in 2020 by a group of patients with Long COVID and the other associated illnesses like ME/CFS and POTS that we are looking at in this programme. The aim of PLRC is to facilitate Patient-led Research into these conditions. And since their inception, they have published a raft of papers and articles, including a complete review of the Long COVID findings in January 2023 in nature, articles in life sciences, frontiers, they've worked with the NIH World Health Organisation and so many of the most progressive thinkers in the infection associated chronic conditions space from Eric Topel to Akiko Osaka. In today's interview with Lisa McCorkill and Hannah Davis, we discuss what PLRC have managed to achieve in the Patient-Avigacy Space over the past four years. Whether the Patient-Loyce has managed to gain recognition, the need for Patient-led Research. We discuss some of the 10 studies that they've funded, the Patient-Generated Hypothesis Journal that they launched in May 2023, and we talk about their Long COVID Mune Shot Bill, which since we recorded has been introduced by Senator Bernie Sanders to the US Government. Now the Long COVID Mune Shot Act would provide the NIH with a billion dollars of funding for Long COVID Research and Care for US Patients every year for the next 10 years, which is a major historic achievement in this area. And such an achievement really highlights the way in which Patient-Avigacy can actually have the potential to impact policy. I think that what the past four and a half years have really taught us is the power of Patient-led Advocacy and Care. You can see so many different doctors, but they, if they don't have the lived experience, if they don't have the day-to-day understanding of the condition, it's not necessarily helpful, and it's not necessarily understanding what we're going through. So could you give me an overview of where you PLRC have got to at this stage in the summer of 2024? We continue to do a lot of internal research. We're working on a Re-Infections project right now, looking at the impact of re-infections on people with Long COVID. We are doing a phenotyping project, so I think we probably know a lot of the restrictions and obstacles we're facing in. Research designed, but especially at clinical trials, is getting accurate phenotyping of Long COVID. So we did a big machine learning project trying to distinguish clusters on that. We continue to do a lot of collaborations with external organizations. So a couple of our members, including one of our leads, Latisha Sores, collaborated with a team in Brazil to look at the quality of life in resilient patients with Long COVID. There was another study looking at return to work, obstacles, and return to work with Long COVID. We did a mental health-centered paper looking kind of at what patients with Long COVID care about in relation to mental health. So not just you have anxiety, you have depression, but looking at stigma, how medical stigma, and how doctors treating you poorly influences mental health outcomes and how financial insecurity and other necessities can impact mental health outcomes. And these are all papers that you have gone out and gained the funding for. Have you done that on an individual basis per study, or have you done that out of your centralized part of funding that you've received as an organization? That's actually a good question. We have a lot of project-based funding, so a couple of those were funded by Conroe Foundation a couple years ago, and we just made the money last kind of a while, but a lot of our projects are still unfunded. A lot of the projects are still falling tier-based and people are taking an interest in it for personal reasons or academic reasons and work on it on a volunteer basis. So it's still kind of a mixed system organization in that regard. Some of the collaborations we have, like we work very closely with N3C, which is the US's EHR Center, the Center for Long COVID Electronic Health Record Data. So that's a funded project and we put out a lot of papers with them pretty regularly. But for the most part, a lot of the research we do hasn't been entirely funded. You are creating a huge amount of output and you're involved in a lot of different things. How large is the organization now? Can you just describe that growth in terms of your actual infrastructure? At least say you tell me. Yeah, so we now are around 65 members in terms of paid staff. I think we have around 10 total potentially that are paid in the rest of our volunteers or have like one-off projects contributing to the papers and that kind of thing. Right. Yeah. And we do, in addition to the papers, we have our hypothesis journal and we have our advocacy work and a few other projects that we're working on and then consulting on a lot of studies. We also have our patient-led research fund which funded 10 different long COVID infections associated chronic condition research studies and we have patient reps on each of those. So we have a kind of like smaller projects that some folks are able to get some funding for. But in terms of actual kind of staff like we enhance our the only full time folks and then we have a few other part-time leads and then a few other folks who help with administration and harms and that type of stuff. And you mentioned just then I think the phrase that you use is long COVID and infection associated chronic conditions. When you were actually launched and were naming yourselves as an organization, I think you were quite conscious by you to not limit what you do to long COVID. And in your most recent patient-led hypothesis, actually quite heavily focusing on some of the other conditions. Under that umbrella of infection associated chronic conditions, can you just detail some of those conditions because our audience is not only long COVID sufferers. We are trying to reach those people who have possibly for many, many years had these underfunded under researched conditions and actually through the money and through the awareness that has gone into the UK, but are now able to access a little bit more information and hopefully a little bit more future research. So if you could just detail the umbrella term and what you include within your organization. Within our organization we have it's largely like majority of people with long COVID, but then we also have folks with conditions that can develop after a COVID infection, but they developed them from a different type of infection or in some other way. So that includes ME/CFS and dysautonomia. A lot of our work and research is really focused on long COVID and then the associated conditions with long COVID. But in terms of what we advocate for and are in community with, we are one of the lead organizations of the infection associated chronic condition patient advocacy coalition, which is a group of all of the ICCs and infection associated chronic conditions really trying to come together and identify similarities and differences between each other and really push the field forward because there are so many barriers that we all share. Many of these ICCs have been neglected, but we can all learn from each other in terms of both like resources shared and education, but also even the biology of all of our different conditions. So when I say ICCs, I mean ME/CFS forms of dysautonomia, chronic Lyme disease, all of these chronic conditions that can be sparked after an infection. So it includes like PANs pandas. It can include fibromyalgia. So it's, yeah, it's a wide range of conditions and the coalition is kind of building itself out right now. There's an effort currently from like a subset of a coalition of these groups that's working to get an office of infection associated chronic conditions within NIH to help coordinate the research because both we understand that there is similarities and there's power in studying these illnesses together while also identifying their differences and additionally like researchers and clinicians also are identifying this. Yeah, I think we've seen a QJ overlap having me in terms of the clinicians that have actually turned their expertise from ME/CFS or from some of those other conditions that you've mentioned to treating non-cabin. And some of that is to do with the symptomatology. So a lot of the people who were dealing with POTS are able to help non-cabin patients. But just to clarify, you're not suggesting by looking at them together, you're not lumping them all in to being one thing. No, it's more about the coordination of this research and ensuring that learnings are shared across these conditions because of the similarities, but also there's value in distinguishing between the conditions because they have shared symptomatology. If we can identify the biological differences between them, that could help us understand a lot more about these different conditions. So no, it's not about lumping them together or making them have the same name. It's really actually important to still keep them separated and identify what infection caused each of these conditions, but separating by phenotype and coordinating that research learning from each other is really, I think, going to help us get to answers faster because a lot of the research that we've seen in long COVID, that has been really the most ingenious and giving us the most answers, has been based in research from other infectious disease and chronic conditions. And it's building upon that historical context is really critical. Yeah, absolutely. And it's a little similar, isn't it, the way that we are saying, can we look at repurposing drugs that could help almost repurposing some of that, the research methodologies or some of the studies that have previously been done is helpful, rather than having to set up things from scratch and trial the actual methods that we're using with long COVID. One thing that I find quite exciting, I love the patient advocacy. I love the way in which you are making voices heard. But one thing I really, really appreciate is this patient-generated hypothesis journal that you started doing. I think May 2023 that the first issue is released in May 2023. Yeah, and then this summer 2024. Could you just explain for our audience the theory behind what you've done here? Yeah, so the patient-generated hypothesis journal was created to give patients and caregivers a platform to share their hypotheses on their conditions or the person that they care for is conditioned. A lot of it is based in what we've seen online sharing and our own experiences is that patients and caregivers are often the first to have a deeper understanding of what's happening to their body, they're doing their own research to have the biological understanding of what's going on, and then they also have the hypothesis just based off what is physiologically happening. We wanted to give a platform for these folks to share what their hypotheses are because two often journals are really focused on academics and only platforming people who have certain degrees and you have to write it in a certain way and you have to have certain credentials in order to be taken seriously by the academic community. But we felt like there was too many hypotheses that are high quality within the patient and caregiver community to not have those be shared. So, we created the journal what happens is patients and caregivers submit their hypotheses. We have a panel of patients who vote on which ones to include and then once the ones are chosen, then we work with the patient or caregiver on building up their hypothesis and really ensuring it is of strong high quality. And then we also occasionally bring in external reviewers and so folks who are experts in the field of that hypothesis to also give feedback and really make sure that it is of sufficient quality, quote unquote, for academics to take seriously. And then we compiled on together and published them and we have had a really great response to both of the issues, interest from researchers who think that the hypotheses are good ideas and make consider studying them. I think it is just so critical given how much expertise is within the patient community to really provide that platform for them to share their ideas and connect them to researchers who can execute those ideas. Yeah, because it goes back to what we said before about as patients we have this intimate knowledge of what's going on in our bodies or perhaps we've been reading research papers or as patients who have that awareness of what's going on in the scientific field you don't stay in your lane necessarily the way that a cardiologist stays in their lane or a specific researcher who looks at one type of cells stays in their lane. So as patients we have this more overarching view and either pick up on patterns or see things that perhaps are not visible when you're looking at things at a much more microscopic level. And I think what's really wonderful about it is that because I know that you work with the horses of the papers and you make it look super professional and slick but it is really refreshing to read these papers that are comprehensible. And I'm someone who reads a lot of scientific papers but there's just something say like the person that's written it actually has this concrete understanding of what the condition is and what they're saying. Rather than it feeling a lot of the time in the scientific community and I'm not berating anything that they do it feels somehow so abstracted from the human side of the illness and I think that's what's wonderful about these hypotheses is that they feel human. An example of a couple of the hypotheses that are in the current issue of the journal that's out now. There are hypotheses in there that could potentially join multiple of the major hypotheses so the effect on dopamine in long caveats and in the other and post-infection conditions. That ties into so many of the other different studies that have looked at glucose activation in the brain or looked at hormone levels. So I think that what's really nice is just taking that element of it and looking specifically at that. It still also fits into the overview. Is that one of the ways in which you selected these hypotheses the way that they tie into the rest of the research? I think one of the the benefits kind of like what you were saying about how the patient community is not in just one field of study right they're not just like only cardiology and so I think having from a patient's perspective if you're doing all of this research on your own looking up all these articles about your condition and you're seeing different research coming out of different fields but all kind of like semi-related you're able to put the puzzle together a little bit easier than someone who's just in their own lane. So I think a lot of these hypotheses happen to do that and we elevated that because it was you know a really solid hypothesis but there were like various criteria that went into choosing them and I think it just was the stronger hypotheses happen to do that. I find that platform for patients is really interesting. I think there's still a lot of scientists who say that you and I shouldn't have a voice because I don't have a medical degree. I do have four and a half years of living with a condition and I know what it's like to actually live through it rather than what the doctors see on a blood test or on an appointment once every two years. So to have that patient power, to have that patient voice on paper in a form that is essentially the same as the scientific papers I think is really quite remarkable. I think that's one of the things we're trying to change the most. I think one thing people might not know about us is that the majority of our members are not academics, don't have PhDs, didn't necessarily ever write a paper before joining PLRC and it really is not a huge learning curve to do that within a new group of people and it's really empowering and the research we put out is I think equally high quality and would like to see that changed. So I know I was just wondering if you feel like we have in the last since you started, have we made raids into having the patient voice more readily heard by the scientific community? I think so absolutely and I think not just us but across fields. The patient-led research has increased in legitimacy and it has become apparent that including patient involvement strengthens the design and speeds up research generally, it leads to asking more interesting and relevant questions. It aids in recruitment, it overall is only a positive. I definitely feel like we're seeing more researchers go out of their way to include patients in all parts of the design process and some you know our true allies now and go kind of above it beyond to shout from the rooftops about patient-led research but then of course there are still many people who don't quite get it yet and who are skeptical and to think that patients being involved means they're biased but that's silly to me because all research is biased in some way if you're not aware of the biases in your research that's really what the problem is but yeah I think it's increased quite a bit. Are you saying that right down to the actual design of some of the studies or trials because two and a half years in I had an appointment with a long-over clinic and I was kept there for four and a half hours? I think there was so much that needed to be listened to in terms of the patients and I think that's from the people that I've spoken to it does feel like more recent studies have taken that into consideration, have tried to make it easier and less stressful, less tiring on the patient although actually there's still that bias in terms of the patient has to generally be well enough to go and attend an appointment even to be part of the study. That's actually a really complicated question I think because I agree I think there are a lot of people taking into consideration, ham for instance, and setting aside little rooms or gravity chairs or places patients can lay down during the study to improve the likelihood that they can make it through but there's a small side note there that a lot of these studies need to be studying patients when they're tired and when they're in that crashy state. So like Dr. Nancy Climus who's at the Neuroimmune Institute in Florida talks about how she basically arranges all the tests so that the first ones don't need to be capturing the crash but then the ones toward the end like processing speed and and some of the cognitive stuff she does toward the end when she knows that patients are going to be crashy I think that that's another difficult component generally about being a patient with a fatigue illness in study design as you have to set yourself up to be tired but yeah there are also absolutely a lot of ways to accommodate that. So true they because I think about any blood test that I've had I can't get to a blood test on a day that I'm in a real crash say my blood tests are always on a day when I'm able to at least get out of bed and get to the hospital. Absolutely which is possibly why we spent so long not finding anything in people's blood. I really think that's the case in a lot of parts in and then of course eliminates moderate to severe and especially very severe patients from being included in these studies so almost all studies are biased toward people who are on the better end of the spectrum. Yeah that's a very interesting point. In terms of actually influencing public quality government you guys have done a huge amount I noticed that you've given testimony various times to the government there in the US tell me about the Long COVID Moonshot project. The Moonshot came out as an op-ed or comment that Dr. Michael Pluso from ECSF and I wrote in October of last year in nature in that article we called for a Moonshot for Long COVID at least a billion dollars in research funding for Long COVID every year for the next 10 years and that was we were trying to ensure that we could sustain the momentum that we've had within Long COVID research and I age does that have a line item for Long COVID research and so we wanted to make sure that this researcher is going to be funded and make sure that researchers can rely on this as a career and really dedicate the resources necessary so we could find answers we can look more deeply into mechanisms and ultimately find treatments for Long COVID and so that was an idea we put out in October of 2023 shortly after a group of patients really felt mobilized around that call and formed Long COVID Moonshot and they helped facilitate calls to Congress around the idea that we meet at least a billion dollars in research funding. Then there was the Senate hearing in January that was led by Senator Bernie Sanders, that really called attention to the crisis of Long COVID and following that hearing, Senator Sanders decided to make Long COVID one of his priorities and came out with the draft proposal of the Long COVID Moonshot Act. And so they've been working on finalizing that act potentially by the time this podcast is released, the Long COVID Moonshot Act will be introduced. And it's really a comprehensive bill that is like nothing we've seen in Congress before. It really meets the needs that we have for Long COVID research. And yeah, I'm very hopeful about it. We're going to need a lot of support within the US and patients and caregivers and family and friends, clinicians, researchers, everyone calling their representative and trying to get this passed in Congress. But it's just even so exciting and hopeful for me to have something like this in Congress right now, because it really just draws attention to how big a problem Long COVID is and that our government needs to step up and really take a bigger role in the response. So you have to actually get that bill passed. But for it to even reach this stage, that it is being drawn up into an act, that is something that's very remarkable in terms of this kind of proposal in this health space, is it not? Yeah, it takes a lot of mobilizing and drawing attention to the problem and ensuring that even especially a senator that's a high profilist and a nurse Sanders, like really understands this is a huge issue that needs to be addressed in that he wants to champion it. It takes a lot of effort and the mobilizing that the patient community did, especially like end of last year and around early this year around the Senate hearing was instrumental in making that happen. If patients didn't make their voices heard, we wouldn't be where we are with this. It takes a lot of effort to get to this stage. And just to give some detail of what is included in that in terms of what the funding would go towards, you are talking about clinical trials, you're talking about an expedited grant process, you are talking about education for medical providers. I think one of the major things was that you were quite insistent that the funding does not just get to recover, that you want to have this in a separate lane, essentially, from other NIH or government funding. Is that correct? Yeah, so the way that Sanders helped committing staff proposed it and what we have also supported in appropriations language as well is creating a separate long COVID research program outside of the recovery initiative and having all of this billion dollars going towards that research program. That's kind of to give a clean slate and have a leader of that program be someone who has expertise in long COVID, has a commitment to long COVID, another infection associated chronic conditions, and is really someone who can steer us in the direction we need to go. So one of the issues that we have found with the recovery initiative is that at the beginning, the folks who were running it really did not have expertise in MECFS and Dysautonomia and these conditions that we often see after a COVID infection and that have researched historical research and that really should have been built off of when we're studying long COVID. And I think it was a steep learning curve for a lot of these folks, some of which they're still learning and patient reps are trying to teach, but also, you know, not great patient engagement at the beginning, a lot more like tokenizing and just dismissive of our experiences. And so a big part of the moonshot bill will be to do this the right way and have people leading and being consulted who are experts in long COVID and infection associated chronic conditions. There's places for people with lived experience and really just trying to do this in a way that's going to get us the answers that we need and just create a program and a research agenda that's based in research and other ICCs based in the research in long COVID state and based in the lived experience of people with these conditions. Anything like that that brings this condition and the research into such high profile position is surely only going to be a good thing. There's quite a heavy focus on the US because you have so much research going on there and you actually relative to other places have funding and the size of your university systems and medical systems is pretty much bigger than anywhere else. But do you think that this patient led approaches filtering out into other countries as well? Have you got involvement from other countries? I think that's one of the areas we've been best at I think is kind of international collaboration. We have a lot of the heads of, for instance, in long COVID India and long COVID chili and we've worked with people really all around the world on various projects and things like that and we've also been able to fund some international studies. That's fabulous and do you see a massive disparity in the treatment? It's not as if the treatment of don't care if patients in the UK or US has been particularly good but do you see a massive disparity in those countries that are less wealthy? I think there are some nuances with how the LMIC countries are treating long COVID. It's hard to generalize across all of them. Some in particular, with long COVID chili, I was learning that they have laws that guarantee high quality healthcare treatment for specific illnesses. So long COVID chili is trying to get long COVID covered by that type of legislation. There are others where there are more available treatments like in Tunisia. Some people are on celudic side, which is not available here but it seems like a safer form of blood thinner that was in a small clinical trial that showed improvements in long COVID patients and I think the medical education problem is terrible everywhere, obviously including the US and the UK and there are disparities in who get drugs and that is an issue across countries as well. Like I learned recently that in India you might not be able to get a prescription for something as a patient but a patient in the US could order almost anything from India and it would be considered like an export and so you wouldn't necessarily need to go through the same obstacles. So I think yeah, there are a lot of nuances but there is also just a ton of excellent research coming out of some of those countries. I'm what about obviously aside from your wealth in terms of medical research, you obviously live in a country where you do not have universal healthcare. Are there any models that you have seen where there is universal healthcare that has actually been fair or favoring long COVID patients? But I'm just really interested if there is anyone who's getting it right. I'm not sure anyone's getting it right. There's kind of, I feel like there's grows and cons of so many different structures. There might be like Brazil has good healthcare infrastructure but then they have like their own issues with medical education and knowledge about long COVID. Yeah and some countries are good about getting generic drugs available or putting caps on drug prices but then they may not have access to everything. But I think just generally infectious onset chronic conditions were just not known about universally. That's probably the biggest issue that we're facing from a medical or a clinician care standpoint. Well, I have to thank you and I applaud you for the very least raising awareness of this amongst the medical community and making patients feel like there are people who value their voice, value their opinion and value their lived experience because I know a lot of people will say it's very very early days for a disease but for the people who have been living similar diseases for the past 30 years, it's not particularly early days. So shining a light on it is hugely important and hugely welcomed I'm sure by all people who are suffering from these conditions. So thank you. Thank you. Thank you for listening. to make visible. Please do like, follow or subscribe to listen to our next episode where we'll be uncovering more insights into complex chronic illness. This was brought to you by the team at visible, a group of scientists and engineers whose lives have been affected by energy limiting health conditions. We're building wearable technology that's helping 100,000 people measure and manage their complex chronic illness. To find out more about what we're working on and how visible could help you, visit our website at makevisible.com