USA: NIH National Institutes of Health news

@Sean - I agree, which is why I wrote to NIHReform@mail.house.gov and first.opinion@statnews.com to clarify what is needed from this community's perspective (from my lens at least) from this agency. Hoping others will do the same too.

 

I am skeptical of the sincerity of this report, US Republicans have in plan to drastically reduce research funding if they could, but this criticism is surprisingly good. Although as pointed out above, jumping into trials is not a good thing, without a theoretical foundation or genuinely promising early results, they're pretty much completely wasted.

 

I’m skeptical too but surprised at the accuracy of the criticism, which to me indicates (to the leadership of this House Committee at least) that this issue of RECOVER is squarely on their radar.

Sent my testimony indicating that we need robust funding in this space, but highlighted where we could use help from their aims (a new IACCI Center restructure, help with transparency that would include meaningful patient engagement, etc.)

 

It's confusing - because clearly they see RECOVER as another stick to beat the NIH with, but their actual criticisms of RECOVER are very accurate as you say. Very difficult to work out what this means for Long Covid within the NIH. But the call for reorganisation is clearly bad news for the NIH.

 

Two possibilities:

a) One of the Republicans who attended the HELP hearing provided input here. I can’t remember which Republicans were at the hearing, but at least one of them has a close family member with Long Covid.

b) They lifted the paragraph on RECOVER from on of the Stat News articles because they saw RECOVER as another convenient way to bash the NIH

 

Neil Shapiro, Associate Director for Budget, NIH at ACD last week: "RECOVER Initiative has really been NIH's top priority in terms of advocating for a portion of those funds to be allocated by HHS for this type of research" (at 58:11)

Director Bertagnolli: "RECOVER. I want to touch on the program briefly because it is so important and so many people are counting on it. As you can see from this slide, we haven't been just sitting on our hands. RECOVER is one of world's largest and most diverse Long COVID cohorts and the only one that is deeply characterized. RECOVER has created a network of nearly 300 research sites...where hundreds of Long COVID researchers are working with nearly 90,000 participants.."

"Interventions not showing promise can be quickly terminated and the trials can quickly pivot to test new interventions as needed. In February, the project received an additional infusion of $515 million."

(starts at 27:18)

https://videocast.nih.gov/watch=54652

 

World Federation of Neurology: 'Neuro-ID Update [June '24]' by B. Jeanne Billioux, MD & Avindra Nath, MD

'For this Neuro-COVID-19 update, we review several recent articles on SARS-CoV-2 viral persistence, including Post-Acute Sequelae of COVID-19 (PASC), or Long-COVID'

'..the findings suggest that SARS-CoV-2 infection may lead to antigenic persistence in some patients, particularly those who were more ill, and may play a role in persistence of symptoms even in patients who were not ill enough to be hospitalised (Peluso 2024).'

'The concept of SARS-CoV-2 persistence and its association with PASC is quite intriguing, and an area of much-needed research, regarding both the nature of these potential viral reservoirs as well as in relationship to the treatment of PASC. Clinical trials are needed to stimulate the immune system or reverse immune exhaustion to see if this may help remove the viral remnants and alter the course of the illness.'

(Reading the tealeaves IMO, Nath [and Billioux of NINDS] makes another plea to his colleagues & to leadership to consider his clinical trial recommendations)

 

Just sharing from Day 2 of ACD last week now that the recording is up: https://videocast.nih.gov/watch=54654

(starts at around 1:03) Bertagnolli on RECOVER: "This is our interim progress, moving forward to a new stage of enhanced focus.."

Auchincloss: "About 17% of adults in this country have experienced Long COVID..it's a staggering number to realize..RECOVER was initiated in 2021 with the idea of understanding Long COVID and the long-term chronic illnesses associated with post-infection. From the very beginning we thought there would be overlap with this and the ME/CFS spectrum."

"The guiding principle from the beginning has to been engage the patients with representatives that are part of the process with developing scientific agenda and the research protocols. This has been true all the way through..."

Koroshetz: “I'm going to take actually a little bit of an objection to what was mentioned, that this is a new disease (Long COVID). I actually think this is an old disease, but we'll see. The reason for why I say that, is because NIAID, particularly Joe Breen, who was mentioned, and NINDS folks, have been working on Myalgic encephalomyelitis /chronic fatigue syndrome for a number of decades. And the symptoms that people with Long COVID have expressed say almost identical to what people with ME/CFS experience.

There are differences, not clear if the differences are related to the timeframes, most of the people with ME/CFS have been sick for years...with Long COVID people it's a year or two, or months. We'll have to see how that pans out. The neurologic symptoms, memory, word finding difficulties, concentration difficulties, executive functioning difficulties - these are the brain fog things that folks complain of and these also occur in ME/CFS."

"Now the big question - what is causing this problem? In ME/CFS, we've never been able to get to the bottom of it. However in ME/CFS, most of the evidence pointed to the fact that the condition started with what sounded like an infectious condition but people just never got better and it was impossible to figure this out because we would see people months or years after what the infection was.."

 

Koroshetz has been saying this since the beginning of the pandemic but this is such BS. They could have done prospective studies on EBV-triggered ME/CFS (or other strongly suspected infections). The Dubbo study did it, Leonard Jason did it, it is not rocket science and NIH has the money for such things. He is talking about it like they really wanted to do it, it was just "impossible". Give me a break...

 

STAT News: 'Readers respond to essays on long Covid...'

“NIH needs reform and restructuring, key Republicans committee chairs say,” by Cathy McMorris Rodgers and Robert B. Aderholt

"I agree with the authors that NIH needs reform. I was an athletic, otherwise healthy person who was struck down and disabled by long Covid in January 2022. For over two years, I’ve watched life pass me by as NIH has fumbled the $1.15 billion allocated to it by Congress to study and treat long Covid. This initiative, known as RECOVER, has failed to publish any research that furthers our understanding of the underlying cause of long Covid and the vast majority of clinical trials they’ve launched are for drugs that people have already tried and found unhelpful."

"Perhaps NIH would not have bungled the long Covid funding had it not completely ignored other post viral diseases, namely myalgic encephalomyelitis (ME) for the past 40 years. ME receives only $15 million a year — the most underfunded disease per patient burden at the NIH."

"NIH should reevaluate how it allocates funding to diseases and base allocations on objective patient burdens. HIV, a disease with treatments that allow people with it to live mostly normal lives, receives $3.3 billion annually through NIH. Meanwhile, ME patients are disabled, have no approved treatments, and suffer a higher patient burden. Covid long haulers are suffering the same fate, many struck down as first wavers in March of 2020 are still disabled and sick as ever over four years later. Despite this, there is still no yearly allocation for long Covid in NIH’s baseline budget, as funding has only ever come from one time appropriations. NIH should right-size funding for ME and long Covid and start taking these diseases seriously."

— John Bolecek, long Covid patient