USA: NIH National Institutes of Health news - latest ME/CFS webinar 14 Jan 2025

Marketplace: "NIH got $1.6 billion for research into long COVID. Where are the treatments?"

'Roughly 20 million people in the U.S. are now estimated to have long COVID, maybe more. And that initial $1.15 billion NIH got for the RECOVER program — which stands for Researching COVID to Enhance Recovery — has yielded few answers and zero approved treatments so far'

There’s good reason for the focus on observational research, according to Dr. Serena Spudich, a neurologist and researcher at Yale who’s working with the RECOVER program.

“There has to be a very, very strong urgency for finding treatments,” she said. “And at the same time, we will only find treatments if we understand the condition properly.'

'Dr. Ziyad Al-Aly, director of the Clinical Epidemiology Center and chief of the Research and Education Service at the VA St. Louis Health Care System, said his team and others did similar research earlier in the pandemic, “for peanuts, a few hundred thousand dollars that generated evidence much more robustly, faster, years ahead of RECOVER, for a small, small, small, small fraction of the funds.”

'At this point, more than four years in, “NIH should be laser-focused, laser-focused on finding treatment for long COVID,” he said.'

This fall, it held a kickoff meeting for the next phase of the RECOVER program, called RECOVER-TLC, which stands for Treating Long COVID. Now, Joseph Breen at the National Institute of Allergy and Infectious Diseases at NIH said it’s in the process of soliciting ideas for drugs and other treatments to trial.

“We have every intention of getting started as soon as possible,” he said. “In reality, we’re probably into next year.”

“The NIH can do this right, they have to do this right,” he said. “And they need to do it fast, which we know is possible.”

'Some legislators are already pushing for additional funding. Sen. Bernie Sanders, a Vermont Independent, along with several Democratic senators, introduced the Long COVID Research Moonshot Act in the Senate, and a companion bill has been introduced in the House. The Moonshot Act would provide $1 billion a year for 10 years for long COVID research. It has yet to be brought to the floor for a vote.'
 
Yann04 said:
Is there any chance It’ll be voted on before the change in government. While the Democrats have a senate majority?
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As I understand it there isn't sufficient bipartisan support for it. So even if it were brought for a vote, the likelihood of passage is minimal at best. (Prove me wrong Congress!! I will celebrate if you prove me wrong.)
 
In my opinion, after Appropriations Committee (led by DEM leadership) cut LC funding out of the package in August (even with a letter from 17 Senate colleagues asking for LC funding to be included to Appropriations leadership), the LC Moonshot Act was DOA to me after that, even if D's got the trifecta in November (POTUS, Senate, House). There simply isn't enough support, from either side of the aisle, not just R's. Two LHHS leaders, Baldwin & Murray, two D leaders who in May had seemed like strong LC & ME advocates at the Senate LHHS FY NIH 25 Budget Hearing, had already essentially dropped their support by August (this is just my two cents, where I have collaboration with Baldwin's office and met with a clerk from the U.S. Senate Committee on Appropriations Subcommittee on Labor-HHS-Education).

The best case is a watered-down version somehow being absorbed into a larger bill (as someone else said on here), but even then I don't know the feasibility of that happening (I don't have enough policy experience to predict that).
 
Yann04 said:
Is there any chance It’ll be voted on before the change in government. While the Democrats have a senate majority?
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Almost none. As in maybe 0.001%.

Senate majority means nothing, in the US senate legislation has to pass a 60% threshold and there's basically zero chance it does.

The only viable chance is a complete turnaround in 2 years, if Democrats regain a majority in both chambers, and somehow muscle through a provision in an omnibus budget like what happened with RECOVER. Which did happen in a Republican trifecta so it's not entirely impossible. Just about close to lottery odds.
 
rvallee said:
Senate majority means nothing, in the US senate legislation has to pass a 60% threshold and there's basically zero chance it does.
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I think there’s a loophole for budget bills (which this would probably be part of) where a 51 vote majority is needed instead.
rvallee said:
The only viable chance is a complete turnaround in 2 years, if Democrats regain a majority in both chambers, and somehow muscle through a provision in an omnibus budget like what happened with RECOVER. Which did happen in a Republican trifecta so it's not entirely impossible. Just about close to lottery odds.
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There is near zero chances the democrats take back the senate before 2028. The 2026 map doesn’t allow the 4 flips needed without a crazy D+10ish environment. Though it’s very likely they will take the house back.
 
This is why a lot of us fought behind the scenes the last two (or three) omnibus bill cycles when D had control of Senate and the WH. We still couldn't get LC in that omnibus package with that dynamic. Many of us thought we could get it through. It was very telling, IMO. It's my personal opinion that we inflate D support (and I say this as someone who I'm sure you can tell I vote pretty liberally and have been pretty involved with Congressional advocacy over the last 7 years). It's just a different landscape in this current political climate.
 
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10/29/24, Interdisciplinary Women’s Health Research Advancements: NIH and White House Women’s Health Workshop

"The goal of the initiative is to fundamentally change how we approach and fund women's health research. Particularly over the last two decades, we have made meaningful progress in studying the health of women and clearly uncovered data that are practical benefit to women now. However, despite the evolution of our research and important contemporary findings, as well as other important knowledge that has accrued over the years, oftentimes through clinical observation, there is still much more for all of us to do, not simply to catch up on health data for women due to historical underrepresentation of women in clinical studies and the need to study sex as a biological variable, but to fully realize the opportunity we have before us to address health conditions that affect women uniquely differently than men and or disproportionately, as well as commonly co-occurring disorders such as heart disease and depression and chronic conditions such as pain syndromes, Long COVID, all more common in women."
 
'Discovering Hope in Science is a podcast presented by the Office of Communications and Media Relations at the NIH Clinical Center'

Sept. 2023: 'Episode 1: Navigating COVID-19 Breakthrough Infections featuring Dr. Julio Arturo Huapaya (Johns Hopkins)"

"The current thinking is that there could be reservoirs of virus in the body that are not replicating but are still causing low levels of inflammation...However, whether this more sustained immune activation has a relationship to the symptoms of long COVID, it's still under investigation"

https://open.spotify.com/episode/1E91SRnMgJE5qcHtF8rRHv?si=a-xBd3mtQ-GTzIB6m7oTFg

NIH Clinical Center link on interview: https://www.cc.nih.gov/podcast/2023/episode-1
 
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Dakota15 said:
Koroshetz (on RECOVER) :"Let me just start off by saying that as one of the co-leads in that program, I went into it you know four or five years ago, with the idea that what we're going to be dealing with is ME/CFS. And that it's going to be a hard problem, and that we need to get pristine data..

"The truth of the matter is you know these years later nobody has a cure for Long COVID, there are now some clues - it's very similar to what we see in ME/CFS - so if you look at Dr. Nath's work in the Intramural Studies in people with ME/CFS, he did studies in people with Long COVID and he sees a big overlap and what we're seeing most people are seeing is evidence of chronic inflammation which is not unexpected that's we had thought about in ME/CFS - we have people have published papers where they see certain patterns, and that's also happened in ME/CFS - the stage we're at now is where we have to validate those patterns to see if they stick - many of them were done in small groups of people but now with RECOVER we have samples from thousands and thousands of people so we can have really powerful validation studies. We can bring in AI to look at this data and develop the results of the biosamples, the MRI imaging - you know what have you in RECOVER.

I would say, the thing about RECOVER is that most of the studies are showing that there's persistent virus somewhere in the body and it's not totally clear....Ian Lipkin spent a lot of time trying to understand if there's a persistent virus in people with ME/CFS and he was not able to find it but this is not easy you know this is not easy to find we may have to go back and look again to see which virus this this could be if there persistent virus again in ME/CFS but most of the studies are showing that persistent virus occur"

"Then the issue of if you have chronic inflammation, if you have chronic virus, why do you have fatigue and PEM? That's a you know that's a problem for Long COVID, it's a problem for ME/CFS. So the hope is that we get some answers to these kind of mechanistic questions from the RECOVER people that we can then apply to people with ME/CFS"

"This is not a rare event now in the general theme of infection leading to these kind of symptoms that persist- that affect your immune system and persist for years so we know what happens - now we got to figure out..."

"We have 400 different diseases in our portfolio, that the future really is based on the creativity that's coming in but we don't pay, we don't in general, unless Congress tells us, we don't we don't favor one disease over the other - we're trying to solve all these. None of them are good. We're trying to solve all these diseases we really rely on this creativity coming up and the problem in ME/CFS has been the same problem with people getting care for it - that the the medical community has not really gotten behind the effort to understand and treat people with ME/CFS. The research community has not got behind ME/CFS to put in the creative ideas like you need and we have some really good people but we don't, I don't know how many, but it's not a lot of people who put their career into ME/CFS."

"We need that to happen in ME/CFS and that I think been the big problem - we can't fund if people don't apply - we don't hardly get any applications in ME/CFS research - so we need the applications - the applications come when people get passionate about doing something about a disease and that's something the government, no matter how much money we put out, is not going to do it - it's like people want to do what they really feel passionate about.."

"The good news for ME/CFS is Long COVID completely changed the ball game so people can't say well there's no such thing as chronic post-infectious condition - they did that for years to patients - but they can't do that anymore - and so there you're right out in front and not only that but now you have primary care physicians who are seeing you know lots of Long COVID cases which there's lots of them and they look just like ME/CFS, so I think they're going to get better at that and then the big question for us, for you and I, is can we convert these Long COVID researchers to ME/CFS researchers but I think we have a golden opportunity to do that now we can't squander that - well there's a lot of activity in Long COVID -and at NINDS, we put out calls for grants to study Long COVID and the neurologic effects of Long COVID and you know those people are the people we hope are going to be studying the the ME/CFS cases and in our grants we encourage kind of mixing and looking at ME/CFS and Long COVID together because they're basically chronic infection associated conditions so we have an opportunity now to change things, we we got to make this work that we've got to convert the Long COVID research effort which is you know lots of money, hundreds and hundreds of people you know 15,000 people volunteered for these studies uh so it's an opportunity to make a difference."
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Vague, superficial, bland. I can't help but feel like Koroshetz is chiefly "making the right noises" while he awaits the progress of the NCCIH project unfolding under his supervision.

As long as he is funding and supporting the unit on "interoceptive disorders" he opened on his department, directed by Walitt (his second unit), where Long Covid and ME/CFS are "researched" as "as avoidant behaviour after an infection", and as long as he is supporting the NCCIH-initiated interoception project, then personally I do not consider Koroshetz a serious or safe person to lead any effort into Long Covid or ME research.

Link on some of Koroshetz' questionable activities "regarding the NCCIH's interoception project, its links to ME/CFS, and an incomplete list of worrying NIH developments here.
 
From the rumblings (the few contacts in HHS willing to share from inside those walls) I’m gathering I’d be very hard pressed for any promotions coming from NIAID-NHLBI-NINDS, but I hear you. For better or for worse (worse), he’s attached to NINDS. Of course we’ll see how it all shakes out since everything is conjecture until then.
 
https://twitter.com/user/status/1858911979584246101


Bertagnolli: 'But we still have work to do. Families across the country are grappling with new cancer diagnoses, managing chronic diseases, or struggling with ill health from Long COVID, among many other challenges."

Long COVID:

"For many, symptoms of COVID-19 persist long after the initial, acute phase of COVID19 infection has ended. To address this growing public health concern, NIH’s National Heart, Lung, and Blood Institute (NHLBI), the National Institute of Allergy and Infectious Diseases (NIAID), and the National Institute of Neurological Disorders and Stroke (NINDS), along with several other NIH Institutes and the Office of the Director (OD), are leading NIH’s Researching COVID to Enhance Recovery (RECOVER) initiative,3 a national research program to understand post-acute sequelae of SARS-CoV-2 (PASC), commonly known as Long COVID. In 2023, the NIH RECOVER initiative launched and opened enrollment for phase II clinical trials to evaluate at least four potential treatments for Long COVID, with additional clinical trials planned. These trials were informed by findings from earlier RECOVER research and focus on several of the symptoms described as most burdensome by people experiencing Long COVID.

With its complementary research efforts, RECOVER has positioned NIH to design and conduct trials that have the potential to provide Long COVID patients who experience varying symptoms with relief sooner than any individual study can alone. The Administration has dedicated an additional $662 million of COVID supplemental appropriations to RECOVER over the past year, on top of the original $1.15 billion, to support a second wave of clinical trial activity, long-term patient follow-up, and further pathobiology and mechanistic studies, as well as electronic health record research and overall research infrastructure."
 
For any that watched the hearing today, things got pretty contentious at different points (specifically with Rep. Andy Harris, R-MD). To me, this feels like is a different time with NIH and Congressional relations. This was not the sleepy-type of NIH budget hearings that I tuned into when Collins was there from 2017 - 2019 (when I first started to track). Feels like there's a lot of fluid nature right now with this partnership.
 
Medill on the Hill, Northwestern: “Lawmakers Spar With NIH Director Over Vaccine Rhetoric, Racial Equity”

“Lawmakers sparred with Dr. Monica Bertagnolli, Director of the NIH…at a House Appropriations Committee Hearing on Tuesday”

“And that’s why nobody trusts the NIH,” Harris responded.

https://t.co/2dEzWpLkez
 
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