USA: The RECOVER Initiative - Long Covid research

The studies claiming that have huge dropout rates.

 

There's a POTS clinic where i live. The head cardiologist insists that exercise is a treatment and has published studies on it. When patients say exercise makes them worse, they are told to take an SSRI and excluded from the study because he thinks PEM is a mental illness.
A local group of POTS patients (they don't even have a CFS diagnosis!) has been trying to tell him for years that exercise doesn't help them but all he shows is contempt.

I've been in that unit and it is sad because the younger researchers do not show any contempt at all. One of them was studying to become a neuroscientist and had a bright and empathetic personality, i enjoyed my time there because of that. But unfortunately, they learn the wrong things because their superiors keep hammering this nonsense into their skull and you can only question things so much, especially if every doctor is telling you the same thing. There is no doubt that this way of thinking is taught in med school. It reminds me of the very strict culture some Asian countries have.

 

There is a major issue here when we combine thinking like this - which I can see how they have convinced themselves of what they are saying not being fallacial - with NOT actively courting a programme of genuinely proper expert patients. And indeed spending just as much time and money and effort, probably needs more, coming up with protocols that mean they are actually measuring and monitoring effectively. They don't seem to 'get' that the first 2yrs of all this study is basically 'kiddery' including patients kidding themselves or their body kidding them and all the group stuff and social pressure stuff that will go around it. It's only when the body gives out you get the hindsight and I don't see the main measure being taken late enough in all of this: 1, 2, 3 years are far more important that all are taken rather than the first months (which are more about methods).

I think they also need to acknowledge to themselves that they might indeed be studying the decline due to 'treatment' over this period and for their design and methodology to be reflecting those measures not 'improvements' - it is tilted entirely the wrong way. Just like I'm still astounded that after PACE, that measured nothing to do with harm and didn't check safety - which should have been THE NUMBER ONE AND ONLY TEST those people had the gall to say 'pushing through on exercise is safe, it won't cause you harm'. And get GPs to push that message, that one answer to the only question most patients might have had (most of whom would love to exercise and do more again no matter how much it hurt, if it didn't make their situation worse), is beyond unethical.

So I don't know fully how this study will capture what many of us know will be in there which is patients who (whether in study or not might have done this either due to their own hope or their circumstances) can't rest enough and follow their own body and experience declines in weird 'terracing patterns' after the period that tends to actually be measured. Now the data in that period is useful in order to look back and see what harmed them, so future cohorts have that evidence once and for all, but I don't feel confident those later measures won't get hidden or not collected or not believed and I don't believe the design has been done to capture this.. partly because of the ethics of designing a trial focussed on watching the downhill impact of a 'treatment that can harm'. It is probably even interesting to see how 'in denial' or 'not noticed yet' people are in the first 6months who then end up looking back and seeing it very differently. Is that going to be annotated and studied?

I do not believe this is possible without training out 'CBT/sales-style communication', and indeed making sure it has been trained-in to actively guard against inadvertent pushing, rewording, pressure, manipulation and to find ways that can actually help patients to really tune-into early signs and not 'thinking positively' as it totally flaws their answers and ability to provide the very measure that is so important and key.

And that training out of all this ingrained, embedded behaviour from those who might be around patients as well as patients themselves, needs to be at every stage and reinforced given the world out there is trying to push all of this stuff too.

As @V.R.T. notes they've completely misheard on the PEM thing - they think it is 'just' the PEM after the over-exertion event which might be months, they really aren't hearing that there is an issue of pushing through this, or being slightly over threshold on adrenaline (which influences how someone feels - hence the need for absolute re-training of all these staff and patients), and then 'boom' at 6months and a decline for years after that. One which is both hard to imagine and hard to stablise.

We do need to begin to have a hierarchy of knowledge where it isn't based on 'who can speak loudest and crudest' but those who've been through the most and seen the most being treasured and their wisdom sought so hard people 'come to them' and really want to hear what they have to impart and understand it.

And the kicker is that I have discovered: patients who have not experienced this themselves directly often are incapable of advocating for or speaking for other patients, just like I don't think most of those who haven't experienced severe ME can talk for those who have - yet the other way around is absolutely needed given those with moderate or mild need and want to rely on the testimony of those who get worse as evidence of the consequences. That group being cut out, inadvertently even by the community who are trying hard (because they are taking on what has been left by professionals and 'are ill themselves') but 'throwing bones' based on assumptions of what they need is paternalism. And people are so dependent on the only thing being offered as a scrap of help they aren't going to answer back to say 'hey that isn't quite what I need', so it feels like there is a whol research project and area there for setting up centres and specialisms that aren't just patient-led, but led by those who are genuinely wanting to represent and proxy what they actually want to say.

I highly doubt that the right cohort has been recruited in so that this informs such research because basically most studies don't 'do' severe ME patients. If they did we'd have really good methodology protocols to make that possible: because those with severe ME need people to make the effort to 'attend to/hear them' and yet the level of illness seems to inspire a human reaction where the opposite happens and people who struggle with their slow sentences just guess and fill with their own presumptions rather than appreciating how much nuance is being said. And that every word is 100% meant and accurate, it just needs effort from the listener to make sense of it, and believe it (and yes those less ill have preconceived ideas and assumptions a lot and can often not believe what is being said which undermines things). SO it needs highly trained history takers/researchers and very clever and creative designers of what methods they could use to make it not just accessible to contibute but allow people's brains to be 'on' and feel they've had opportunity to give their meaningful answers in as energy-efficient a way as possible and check that someone has got it down right.

 

Yep. Harms are reformulated as another diagnosis or reframed as the patient being mentally ill. Voila, my treatment is harmless and has a 100% efficacy rate.

Recall how Crawley rediagnoses severe/very severe ME patients who get worse with activity as pervasive refusal syndrome.

My local neurologist who is a “POTS specialist” also said exercise was curative after spending half an hour telling me how the condition was “real” and may be mediated by autoantibodies. Lol

 

It is just insane that someone can report the symptoms of ME to a doctor for almost four years, not be warned off excercise, worsen themselves to housebound from excercise, finally receive a diagnosis and be prescribed...excercise!

I almost think there must be some fatal evolutionary flaw in the human brain that prevents people from seeing the harm. I genuinely have no idea how we can stop this culture of denial but it is perhaps the most important issue we face.

 

Something can be very effective for some patients while being ineffective or harmful to others. I guess this paper is foundational for the claim of effectiveness: The International POTS Registry: Evaluating the Efficacy of an Exercise Training Intervention in a Community Setting (SciHub)

Drop out rates in many treatment regimes are high - people stop taking medications because they feel better even though a longer course would be more effective, people stop exercising, go back to poor eating patterns, stop monitoring their peak flow blood pressure etc and clearly adherence to a programme is a measure of how good the programme is however it isn't gross measure of potential benefit to adhering patients. There are no perfect community setting interventions that deliver 100% compliance.

PASC is a 100+ plus symptom set which in some people amounts to ME/CFS but PASC is not ME/CFS, there are clearly many people with PASC who don't have ME/CFS but do have POTS. If 40% of POTS sufferers find a community delivered programme helpful then it is not unreasonable to suggests that those who have post Covid POTS might also find benefit in the same proportion.

 

And don't seem any better than the ME ones. I keep hearing that about POTS but the evidence just isn't there. It's pretty clear that wherever actual POTS is concerned, not dysautonomia or orthostatic intolerance, time is the only factor and otherwise nothing really works, at least not any better than eating more salt. Just like with ME, it's built on fake positives and charlatans hyping their business, but isn't supported by data at all.

 

Can you expand on this?

My understanding is that POTS is a syndrome that falls under both of those umbrella terms - dysautonomia and orthostatic intolerance.

Two examples:

https://www.hopkinsmedicine.org/hea...ostural-orthostatic-tachycardia-syndrome-pots

https://www.ninds.nih.gov/health-information/disorders/postural-tachycardia-syndrome-pots

I know that a lot of these terms overlap and are used differently by different patients. And doctors may have different diagnostic criteria.

But I have never heard someone say "actual POTS." So I'm curious about what that means. (and hoping my brain can read and understand your answer!)

EDIT: Just for completeness sake I'm adding a link that talks about different types of hypotension.

https://www.mayoclinic.org/diseases-conditions/low-blood-pressure/symptoms-causes/syc-20355465

I have been diagnosed with both POTS and NMH, neurally mediated hypotension. I don't have the common type of orthostatic hypotension where blood pressure drops in the first couple minutes of standing. It's a delayed, sudden drop that happens after 20-30 minutes.

 

Adding a link to another article that criticizes this exercise trial:
Why is the medical community still ignoring long COVID?

https://thehill.com/opinion/healthc...-medical-community-still-ignoring-long-covid/

(some line breaks added)

PS. A link to this article was also posted here:

https://www.s4me.info/threads/long-...d-social-media-2023.31490/page-34#post-476233

EDIT: Just noticed that this was written by Vox Jo Hsu who was one of the speakers at the Millions Missing 2023 event in Washington, DC.

 

I thought the Washington Post article was well reported—pretty rare in this field.

reporter bio


Amanda Morris
Washington, D.C.
Disability Reporter
Education: New York University, BS in Journalism and Media, Culture and Communications

Amanda Morris is a disability reporter for The Washington Post who has trailblazed on this beat. Before joining The Post in 2022, she was the inaugural disability reporting fellow for the New York Times and previously covered science, politics and national news for outlets like the Arizona Republic, the Associated Press and NPR. She uses her experiences as a hard of hearing woman with two deaf parents to inform her coverage.

 

I just mean meeting the arbitrary threshold of 30BPM increase. I'm not sure where the differences are, but there is a group of people whose heart rate just jumps like mad, I mean 150+ at the slightest exertion, can even stay there for hours.

From what I've seen, this typically improves over months, but not necessarily the rest of the symptoms. So over time people drop below the threshold of 30, but don't necessarily improve. Some resolve entirely after a while.

Mostly I'm not sure if POTS really is a separate thing, rather than a matter of degree. But medicine being how it is, it's 30BPM by the 10 minute mark or bust that is the only true POTS.

Frankly I think we'd be much better off just starting over from scratch without trying to make sense of the old labels and definitions. But that's not happening soon.

 

Post copied and further posts moved from News from the USA

HHS Announces the Formation of the Office of Long COVID Research and Practice and Launch of Long COVID Clinical Trials Through the RECOVER Initiative
Current analysis estimates that 7.7 million to 23 million Americans have developed Long COVID.

https://www.hhs.gov/about/news/2023...inical-trials-through-recover-initiative.html


Biden administration opens new office to study long COVID response, NIH begins clinical trials
An estimated 7.7. million to 23 million Americans have long COVID.

Video that goes with the article has the following caption at 1.30:

https://abcnews.go.com/Health/biden...ew-office-study-long-covid/story?id=101873413


Biden administration announces launch of HHS office focused on long Covid research

https://www.cnn.com/2023/07/31/health/long-covid-research-office/index.html

The CNN article uses a picture from the Millions Missing protest in front of the White House.

Edited to add first quote box. It was temporarily lost in my executive function!

 

Biden administration announces launch of HHS office focused on long Covid research
https://edition.cnn.com/2023/07/31/health/long-covid-research-office/index.html

On Monday, HHS announced the formation of the Office of Long COVID Research and Practice to lead the federal government’s response to long Covid, a sometimes-debilitating condition marked by symptoms of Covid-19 that last weeks or months beyond the initial infection. It’s estimated that up to 23 million people in the United States have developed long Covid​

Also: https://apnews.com/article/long-covid-brain-fog-virus-treatments-d5ac01c9f4209691ddcd7a1b5c78353e

That’s why so far the RECOVER initiative has tracked 24,000 patients in observational studies to help define the most common and burdensome symptoms –- findings that now are shaping multipronged treatment trials. The first two will look at:

— Whether taking up to 25 days of Pfizer’s antiviral drug Paxlovid could ease long COVID, because of a theory that some live coronavirus, or its remnants, may hide in the body and trigger the disorder. Normally Paxlovid is used when people first get infected and for just five days.

— Treatments for “brain fog” and other cognitive problems. They include Posit Science Corp.’s BrainHQ cognitive training program, another called PASC-Cognitive Recovery by New York City’s Mount Sinai Health System, and a Soterix Medical device that electrically stimulates brain circuits.

Two additional studies will open in the coming months. One will test treatments for sleep problems. The other will target problems with the autonomic nervous system — which controls unconscious functions like breathing and heartbeat — including the disorder called POTS.

A more controversial study of exercise intolerance and fatigue also is planned, with NIH seeking input from some patient groups worried that exercise may do more harm than good for certain long COVID sufferers.
...
“We can rapidly pivot,” Dr. Amy Patterson with the NIH explained. A failing treatment can be dropped without ending the entire trial and “if something promising comes on the horizon, we can plug it in.”

The flexibility could be key, according to Dr. Anthony Komaroff, a Harvard researcher who isn’t involved with the NIH program but has long studied a similarly mysterious disorder known as chronic fatigue syndrome or ME/CFS. For example, he said, the Paxlovid study “makes all sorts of sense,” but if a 25-day dose shows only hints of working, researchers could extend the test to a longer course instead of starting from scratch.​

 

Saw someone with a list of RECOVER trials so this is convenient, although not super encouraging:

Viral persistence

• Paxlovid (currently starting and busy recruiting)

Brain fog

• home-based transcranial direct current stimulation developed by Soterix Medica (starting in 2-3 weeks)

Sleep issues / insomnia

• modafinil (starting in 2-3 months)
• solriamfetol (starting in 2-3 months)
• melatonin (starting in 2-3 months)
• light therapy (starting in 2-3 months)
• educational coaching (starting in 2-3 months)

Heart problems / orthostatic problems / autoimmunity

• immunoglobulin therapy (IVIG) (starting in 2-3 months)
• ivabradine (starting in 2-3 months)

 

NIH begins long-delayed clinical trials for long Covid, announces new research office

Not much to get excited about IMO

https://www.statnews.com/2023/07/31/long-covid-nih-clinical-trials-research-office/

 

WAPO article
NIH announces long covid treatment studies with hundreds of patients

https://wapo.st/3QgT6XR

 

NIH launches long COVID clinical trials through RECOVER Initiative, opening enrollment

https://www.nih.gov/news-events/new...through-recover-initiative-opening-enrollment
(line breaks added)

They mention the use of "platform protocols" and describe four of the RECOVER platforms on this page: RECOVER-VITAL, RECOVER-NEURO, RECOVER-SLEEP and RECOVER-AUTONOMIC.

There's also this brief statement - "A fifth platform protocol, focusing on exercise intolerance and fatigue, is under development with input from the patient community and scientific experts."