Last week, a research symposium in Bethesda, Maryland kicked off RECOVER-Treating Long COVID, a new phase of the National Institutes of Health (NIH)’s flagship research program. The meeting included three days packed with research presentations and panel discussions aiming to advance clinical trials for the disease and capture feedback from people with Long COVID, many of whom have been critical of the $1.6 billion effort.
Following our live blog of the meeting, The Sick Times asked speakers and attendees to share reflections on the event. Most agreed that the meeting was a promising step forward for the criticized program. The NIH devoted significant time to people with Long COVID and scientists with expertise in post-infection chronic diseases — two groups of experts who had been shut out of decision-making in earlier phases of the program — and indicated that these groups will have a say in which treatments are tested and how trials are set up.
In addition to new commitments to engagement, the RECOVER-TLC meeting marked a shift for the program’s structure: into the National Institute of Allergy and Infectious Diseases (NIAID). Previously, the program sat between institutes and did not have clear oversight, as past reporting by The Sick Times, STAT News, and MuckRock has shown. Some meeting attendees expressed optimism that the clinical trials initiative could move more quickly at NIAID, which has previously directed HIV/AIDS research, and with the leadership of NIAID director Dr. Jeanne Marrazzo.
However, much work remains for the NIH to advance meaningful clinical trials, many said. At the end of the meeting, Marrazzo presented specific steps that the institute plans to take in RECOVER-TLC, such as including people with Long COVID in key advisory positions and making trials accessible to people with more severe symptoms. Long COVID advocates and researchers will be closely watching to track how NIAID follows through on those steps.
While the meeting’s content was promising, some people with Long COVID who attended or watched were disappointed by accessibility barriers for participation. Many of the scientists and government officials who spoke did not wear high-quality masks, increasing the risk of reinfection for the people with Long COVID present. Advocate JD Davids called the lack of masking a microaggression.
For the people watching remotely, the live stream was often low quality and difficult to follow, without public transcripts. To some advocates, these access challenges support skepticism about the program’s future progress.
Read on for reflections from people with Long COVID, scientists, and clinicians who attended the meeting. Meanwhile, NIAID and the Foundation for the National Institutes of Health have released a form for people to submit potential therapeutics for clinical trial consideration; video recordings of the meeting will later be posted on the same website.
Megan Carmilani, founder of Long COVID Families:
“During the RECOVER TLC conference, the minimal focus on children with Long COVID was striking and concerning. It’s well-documented that one in four people with Long COVID is a child, yet less than an hour in total of the 2.5-day event was spent discussing the unique immune systems, symptom profiles, and treatment needs of kids. While the pediatric presentation and panel by researchers were excellent, and caregivers shared impactful stories, the lack of structured time for pediatrics in conferences like this must change.
“A meaningful starting point would be to engage pediatric organizations, like Long Covid Families, in the planning process, as we are patient-and-caregiver-led and specialize in supporting children with Long COVID. And for everyone to remember, children are not just small adults.”
Alison Cohen, assistant professor of epidemiology and biostatistics at the University of California, San Francisco:
“It was great to have so many patient-researchers and patients involved in this symposium, and I hope that this is a harbinger of deep patient engagement and patient-driven research to come with the RECOVER-TLC initiative.
“It is clear that patients living with Long COVID are eager for treatments: we are now almost five years into the COVID-19 pandemic, and there are not yet any FDA-approved treatments for Long COVID. RECOVER-TLC has an opportunity to work in partnership with patients throughout the research process, using models from community-based participatory research and related research approaches, as they work to conduct the next round of trials for Long COVID and accelerate the pace of robust evidence generation.”
Long COVID Action Project (LCAP) activists:
Two activists from LCAP disrupted NIH Director Dr. Monica Bertagnolli’s remarks at the start of the meeting, holding up banners and chanting demands, which included research focused on antivirals and diagnostic tests.
One of the activists, going by the alias Corsi Rosenthal, said in a statement: “I’m here at the NIH as a Registered Nurse who has been maimed by Long COVID. I now live with my father as I am unable to keep a full or part-time job. It is absolutely critical NIH listen, understand, and act upon these demands. It’s past time for real science to be employed. There is no scientific reason for not having one single FDA approved treatment and we deserve better. The kids deserve better.”
The other activist, going by the alias Clean Air, said: “Early in the pandemic, we created vaccines at an unthinkable speed. Now, years later, we have two choices. That’s it. Years have passed and the pandemic rages on killing thousands weekly and disabling millions. 400M with Long COVID. Likely an undercount as with everything pandemic related. As a parent and former business owner now chronically ill and out of the workforce on disability – the NIH’s time to act passed long ago. I’m here to have my voice heard and ensure the powers that be recognize that we matter. Our children matter. The future won’t fix itself – we must take action. We must demand action.”
Todd Davenport, professor in physical therapy at University of the Pacific:
“I appreciated the chance to share about post-exertional malaise/post-exertional neuroimmune exhaustion (PEM/PENE) at the RECOVER-TLC workshop. It was a surprise that PEM/PENE was not a focus of the original RECOVER studies, but it was an even bigger surprise that PEM/PENE was hardly discussed in any substantive way for the upcoming RECOVER reboot. How NIH handles PEM/PENE will predict the success of the remaining RECOVER efforts. I will be watching what they do. In the meantime, I give the RECOVER-TLC workshop the grade of ‘incomplete.’”
Jermaine Greaves, founder of Black Disabled Lives Matter:
“I liked that it was patient and doctor-centered, and they asked us what we thought. As a Black disabled person, I wanted them to know that because of what you haven’t done, I caught COVID twice. I was bed-bound, and it took me a very long time to recover to the capacity I am now.
“I feel like the meeting was a good step and a good faith first step. But what I would like to see next is including us in the study, including our experiences in the study, referencing us and even go a step further, having us on the advisory board. It’s cute to have us speak at these conferences and do a presentation. And I’ve already done that. I know what that looks like. It’s a cute disability inclusion box, which I’ve already done more than enough times in my life.
“[Instead:] Pay us, have us on the advisory board, have us visit these meetings accessibly. Another issue I had with the meeting was that lots of people in there weren’t masked. That bothered me.”
Seth Lederman, founder of Tonix Pharmaceuticals:
“RECOVER TLC looks to have a great future and the full support of NIH Director Monica Bertagnolli who gave opening remarks and who stayed for the entire first day. Not only did Dr. Bertagnolli participate, but she was truly “present” and available for informal conversations during the breaks.
“The progress reports at this meeting mostly provided information from observational studies that are ongoing or were completed in the RECOVER network. While those were informative, I hope the next steps with RECOVER TLC will be to fund and enroll patients in double-blind, randomized, placebo-controlled studies with sufficient power to achieve statistical significance on pre-specified endpoints that are acceptable to FDA to support registration.”
Ian Lipkin, professor of epidemiology and long-time ME/CFS researcher at Columbia University:
“I’m cautiously optimistic that there will be some inclusion [of people with myalgic encephalomyelitis or chronic fatigue syndrome (ME/CFS)] as this plan goes into effect. Jaime Seltzer and I tried to make the case as strong as we could that we needed to have at least a control group associated with well-characterized patients with ME/CFS. Whether that occurs or not, as you know, is more difficult…
“There’s a lot that can be learned about Long COVID from studies that have already been done in ME/CFS. It’s important to have people who have experience with these long-term debilitating illnesses to have a seat at the table. … At this point, they’ve received more than $1.5 billion. The total budget for ME/CFS is a fraction of that. We had three centers, each with $1.2 million in direct costs seven years ago, and now we have two centers with the same annual budget. And with inflation, it means that we have roughly half the investment that we had seven years ago. There’s only so much we can do [without further funding].”
It’s important to have people who have experience with these long-term debilitating illnesses to have a seat at the table.
Ian Lipkin
Andrea Martell, ME/CFS advocate:
“I didn’t hear Dr. Jeanne Marrazzo acknowledge that Long COVID needs diagnostic blood tests for each subset of Long COVID to make clinical trials successful. I didn’t hear Marrazzo acknowledge that she needs to call for funding grants for ME/CFS and Long COVID diagnostic blood tests in order to create successful clinical trials.
“We are discussing clinical trials for Long COVID right now because everyone wants treatments — what we are not discussing is the diagnostic blood tests that have to happen in order to make them successful.”
Lisa McCorkell, co-founder of the Patient-Led Research Collaborative:
“I am hopeful and optimistic about RECOVER-TLC, largely because it is under Dr. Marrazzo’s leadership who seems dedicated to solving Long COVID and other infection-associated chronic conditions and has been responsive to community feedback. What comes next will be critical — how meaningful and diverse the patient engagement is, what interventions are chosen to be studied first and why, how transparent the process is, who has the opportunity to provide input, how well we learn from each other — but I felt the meeting was an important step in having some of the necessary conversations to ensure better clinical trials for our community.”
Jackson Riso, person with Long COVID:
“The second level problems of not listening to patients or subject matter experts seem to have been solved. Only time will tell for sure.
“However, the first level problems that led to these issues remain: Who is in charge? What is their plan? Without a dedicated leader or goals, there will continue to be no accountability.”
Meighan Stone, executive director of Long COVID Campaign:
“I found the NIH’s approach to the RECOVER-TLC meeting to be productive and positive. I think they did include patients and advocacy groups in important ways. I left really heartened and hopeful about those in leadership at NIAID.
“Advocates were calling on the NIH for some time to potentially streamline the clinical trials infrastructure and process by housing it at one institute. I think it is important to recognize that the NIH did do that… And it’s important to see how Dr. Marrazzo is already approaching this differently.
“The Long COVID Campaign approach out of this meeting will be, ‘trust, but verify.’ Dr. Marrazzo did a good job summarizing in the closing session where she spoke about, what did the NIH hear, and what does that look like in terms of action? We are going to take those last few slides, the NIH and NIAID commitments to action, and track those commitments. We’ll try to work collaboratively and call out where there are delays or where the funding portfolio for clinical trials isn’t reflecting patient needs.
“The very real constraints on so many of us who are advocating, because we’re living with Long COVID, were visible in the room. There were very few people [with Long COVID] that could actually make it to the meeting… The NIH is forbidden by federal guidelines to require masking on campus. But it still, at the end of the day, practically presents a real risk for people who already lost so much to this illness, and that would get so much worse if they were reinfected. And I think they did try to integrate those who were participating virtually, but it was clunky at times.”
The very real constraints on so many of us who are advocating, because we’re living with Long COVID, were visible in the room.
Meighan Stone
Lauren Stiles, president of Dysautonomia International:
“The meeting was a positive step in the right direction, although there is still a lot of work to do. NIAID Director Dr. Marrazzo seemed genuinely interested in hearing and solving concerns raised by patient advocates, and she made commitments to take several specific actions in response to our concerns at the end of the meeting.
“For the tens of millions of people who have POTS, dysautonomia, or ME/CFS not caused by COVID, there is a growing acknowledgement within NIH and other agencies that these diseases should be studied in tandem with Long COVID, because they are the most common diagnoses within the Long COVID population, and because they share many symptoms and pathology findings with Long COVID.”
Michal Tal, immunoengineer at the Massachusetts Institute of Technology:
“One of the things I personally thought was most impactful was the point about determining symptom range in surveys. What would this be on a good day, what would this be on a bad day, and where is an average day? Then you can see if you’ve shifted the range with an intervention.
“I also felt like we were having a very important and much needed discussion about how you weigh best scientific practices (slow as molasses) with the urgent need for diagnostics and therapies for the patients. We’ll have to find a middle ground.”
Angela Meriquez Vázquez, former president of Body Politic:
“The agenda was clearly created with extensive patient expertise and it was incredible to see researchers on the cutting edge of infection-associated chronic diseases like ME and Long COVID present to an audience that included NIH researchers and HHS [Department of Health and Human Services] staff.
“I’m cautiously optimistic that this meeting will lead to further opportunities for the NIH and HHS to share power with patients and leverage the deep expertise that patients and researchers in the ME community have cultivated since before 2020 with little to no public investment or attention.”
Julia Moore Vogel, program director at Scripps Research*:
“I was pleasantly surprised by the extent of genuine partnership with patients. A few examples — when I saw there were no people with Long COVID on the executive committee I asked for two people with lived experience to be added, and Jeanne Marrazzo committed to doing so in her closing comments. This means the patient community will have a share of the decision making authority — a sign of true collaboration. Dr. Marrazzo was also engaged throughout the meeting — listening, nodding, taking notes — and that along with her closing comments left me with the impression that she is committed to making the most of this opportunity. And when Meighan asked for more time for our panel, it was granted. Taken together, I observed showing, not just telling, that patients are partners in this work.
“I was also pleased that through repetition from the patient community, we conveyed two crucial points: 1) we must bring trials to participants’ homes so that we can include the most severely affected patients and 2) trials must address PEM, as Lisa [McCorkell] said ‘design for it, measure it.’
“I’m looking forward to hearing more about how NIH will act quickly, including the timeline for starting and completing these trials.”
Mike Z., person with Long COVID:
“One improvement, RECOVER-TLC will be led by the NIAID. There was discussion of a true partnership & collaboration with patients. This needs to happen, and time will tell if it is a reality.”
*Editor’s note: Julia Moore Vogel is also on our advisory board at The Sick Times.
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