News from the USA, United States of America

BrightCandle said:
I heard a lot of overconfidence and unevidenced claims of diagnostics and treatments and only a few of them seemed to pour proper cold water on their lack of biomarker and work towards one and their inability to really engage private drug companies without them
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The sad thing is this is the state of things in the field in general as well. It’s not as if the field was misrepresented.
 
Updates from the Sept. 19th ACIP (Advisory Committee on Immunization Practices) meeting. Fair warning, a lot of detail:

CDC advisory panel recommends keeping COVID-19 vaccine prescription-free

(if your browser has reader view this web page is easier to read)

The panel voted against recommending a prescription for COVID-19 vaccines - apparently this passed by only one vote.

And they reversed their decision on the MMRV vaccine.

Update: more coverage from Stat News:

Federal vaccine panel remade by RFK Jr. votes to maintain insurance coverage for Covid shots
 
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Some excerpts from the 2nd half of the HHS LC Roundtable (just getting to now):

Jason Roos, ARPA-H Director: "This is a problem we all have to tackle together...I'm here today to listen...how do we maximize the use of our resources? We are committed to moving the needle..."

Bhattacharya: "The need of patients that I heard from is just tremendous...it's the heart and soul of everything we're working at the NIH on this...there's a lot to learn from patients...we've spent $1.7 billion on this and we've been way too slow at evaluating (therapeutics)...for all the Long COVID patients out there, we're going to have an answer for you."

Sen. Young: "I wanted to assure you that members of Congress are engaged in a bipartisan way on this issue, are very interested in the development of therapeutics..."

Jim O'Neill, DHH Deputy Secretary: "I would like to add one symptom...alienation. So many are suffering, people around them don't believe them, don't take them seriously...I'm hoping it will provide validation..putting more facts on the table..."

Al-Aly: "These people need answers yesterday...it's not beyond us, it's not beyond the might of the U.S to solve this...people are hurting, they want treatment yesterday..we are in a race against time, we must make progress...we can and must solve this..."

Sen. Young: "Are there more ways to get pharmaceutical companies involved at the table to solve this problem? Perhaps a Pharma Roundtable at some point to bring stakeholders to the table and figure out collectively how we can accelerate US Long COVID Research through FDA reforms?"

RFK: "That is the question I asked - how do you bring in a public-private partnership? How do we incentivize private companies to get involved?"

Bhattacharya: "It really is a tragedy that we've spent so much money and time and not gotten those validated biomarkers. But I don't want to wait. I want those randomized trials happening now as fast as we can. We can't do hundreds, but we can do a lot...private-public collaborations....I think that's one way to accelerate things..."

Roos: "We've already begun this discussion, coordination with the Secretary's Office (on launching Long COVID work at ARPA-H)...we felt this forum was vital to helping inform that..I'm very confident in saying that in short order, after this forum, we can come up with a plan, work that through the Secretary's Office and get that out to the community to react to. We're talking weeks, not months, years. Speed is our middle name. Our job is to accelerate better health outcomes and we are very committed to doing this quickly. One key question for me, clearly money is required here. So, I don't want to dismiss that. But what are the barriers right now? Why can't we be sitting in this room next year and have that validated panel of biomarkers or have the mechanisms of action well-articulated, so we can move to the next step in the game? What are those things that are going to give us that exponential gain?"

Peluso: "I think this can be solved through resources....I'd like to see dedicated review panels that are experts in these conditions...I'd like to see an accelerated timeline for these grants in these agencies...18 months is not the speed we need to be going at..."

O'Neill: "This is a priority for this administration."
 
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i may be biased but I think there’s some sort of light with ARPA-H. Of course my faith in anything bureaucratic is exceedingly low, but I’m curious to see this strategic plan that will be going out to the community in a few weeks time (allegedly).

Also Sen. Young seems determined to move mountains for this, so at least there’s one high-ranking official who seems eager to stay on this (just my opinion, but I felt Sen. Sanders jumped ship when we couldn’t really really get Biden’s or Becerra’s buy-in, so even before the ‘24 election). So hopefully that doesn’t hurt
 
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Dakota15 said:
i may be biased but I think there’s some sort of light with ARPA-H. Of course my faith in anything bureaucratic is exceedingly low, but I’m curious to see this strategic plan that will be going out to the community in a few weeks time (allegedly).

Also Sen. Young seems determined to move mountains for this, so at least there’s one high-ranking official who seems eager to stay on this (just my opinion, but I felt Sen. Sanders jumped ship when we couldn’t really really get Biden’s or Becerra’s buy-in, so even before the ‘24 election). So hopefully that doesn’t hurt
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I have an indirect but real connection to Sen. Young, which could allow some direct communication with the man himself beyond the usual emails and phone-calls to his office (sorry that's so vague, basically I work with someone who is a longtime friend of his). His interest in helping does seem to be genuine, but his allegiance to the current regime is a significantly limiting factor, as are the with whom he (and, well, all of us) are forced to work with on this matter - to say nothing of the "results this quarter" mindset that seems actively hostile to long-term planning. Given all of this, what sort of non-technical information do people here feel would be most important and useful to get into his hands?

[edited for clarity and greater neutrality]
 
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DHagen said:
Given all of this, what sort of non-technical information do people here feel would be most important and useful to get into his hands?
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My opinions:

Randomly trialing treatments without good mechanistic plausibility is very likely to lead nowhere and cost enormous amounts.

Long COVID is not homogeneous and subtyping is very important.

ME/CFS literature should be built upon for ME/CFS subtype.

Basic Biomedical research is always important.

Maybe a nudge in taking a look at dara? wasf3? Decode?
 
@DHagen

Off the top of my head:

These were actions committed to at the Roundtable:

- ARPA-H LC program
- Pharma roundtable

How can patient advocates be involved in this? How can we collaborate and be centered in this strategic plan that the ARPA-H Director said would be formulated immediately?

If NiH Director is passionate about clinical trials, then being partners in that process in a fast fashion (versus RECOVER-TLC taking a year to pick 4 options) is something I’d encourage. Or having the top LC/ME research names leading that effort, in a public way, versus the secrecy that surrounds nearly every decision.

Also agree on mechanistic studies being so important, but I don’t really know the solutions to that right now. A part of me thinks just fund the UCSF team / VIPER study, Ron Davis, etc and just let them do their work, but that probably sounds too simple in theory.
 
Yann04 said:
My opinions:

Randomly trialing treatments without good mechanistic plausibility is very likely to lead nowhere and cost enormous amounts.

Long COVID is not homogeneous and subtyping is very important.

ME/CFS literature should be built upon for ME/CFS subtype.

Basic Biomedical research is always important.

Maybe a nudge in taking a look at dara? wasf3? Decode?
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Thank you!

I fear, unfortunately, that most of these are precisely the points that those involved least want to hear - they do not want to spend money on anything that isn't going to bring results by the next election, they do not want Long COVID to have anything to do with ME/CFS (which they either don't believe in or which they see, quite correctly, as an indication of how intractable the problem really is, a fact they don't want to face), and they are pretty allergic to complexity of any sort. Of course, this has been true everywhere for a long time, so I suppose the matter is how to present the advice in a manner that won't result in immediate dismissal...

Dara (perhaps expanding this to the larger class of drugs / potential mechanism of action) seems like a real possibility; at the very least, it's the type of thing they want to hear. I don't know much about the funding structure wrt the NIH, but getting the name(s) in his ear in case an opportunity comes up absolutely seems worthwhile. It probably won't be much, I will see what I can do.
 
DHagen said:
Thank you!

I fear, unfortunately, that most of these are precisely the points that those involved least want to hear - they do not want to spend money on anything that isn't going to bring results by the next election, they do not want Long COVID to have anything to do with ME/CFS (which they either don't believe in or which they see, quite correctly, as an indication of how intractable the problem really is, a fact they don't want to face), and they are pretty allergic to complexity of any sort. Of course, this has been true everywhere for a long time, so I suppose the matter is how to present the advice in a manner that won't result in immediate dismissal...

Dara (perhaps expanding this to the larger class of drugs / potential mechanism of action) seems like a real possibility; at the very least, it's the type of thing they want to hear. I don't know much about the funding structure wrt the NIH, but getting the name(s) in his ear in case an opportunity comes up absolutely seems worthwhile. It probably won't be much, I will see what I can do.
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Thank you for planning to make this effort. Hopefully it might be a nudge that changes things. Grateful to you for trying in any case.
 
Dakota15 said:
Also agree on mechanistic studies being so important, but I don’t really know the solutions to that right now. A part of me thinks just fund the UCSF team / VIPER study, Ron Davis, etc and just let them do their work, but that probably sounds too simple in theory.
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I suspect that passing on specific names (of drugs, researchers, and programs) may have the best chance of "sticking" - so, as long as the decision makers can find a way to claim credit, I think the simpler the better, maybe? It would also make it easier to pass on to constituents and other pwME who could reinforce the message.
 
DHagen said:
I suspect that passing on specific names (of drugs, researchers, and programs) may have the best chance of "sticking" - so, as long as the decision makers can find a way to claim credit, I think the simpler the better, maybe? It would also make it easier to pass on to constituents and other pwME who could reinforce the message.
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Targeting CD38 or Dara. Either would do. People are getting nowhere because they have no leads. Dara is a credible lead.
 
Passing along.

'The University of Florida in United States invites applications for vacant Postdoctoral Positions’ (posted 7/15/25)

'An NIH-funded postdoctoral position is available in the Fatigue and Underlying Neurobiology (FUN) Lab, directed by Dr. Agostina Casamento-Moran within the Department of Applied Physiology and Kinesiology at the University of Florida. The successful candidate will join a dynamic, interdisciplinary team investigating the neurobiological mechanisms of fatigue and post-exertional malaise in Long COVID, ME/CFS, and other syndromes.’

Separate link here.
 
Apparently RFK Jr will announce the "cause of autism" today

Spoiler - he doesn't know the cause of autism

He's gonna make something up to push his agenda
 
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