Thus far RECOVER has turned out to be a snooze fest.
The kind of project that the RECOVER Long COVID Initiative is, with its massive funding, is beginning to emerge. It appears to be a slow-moving, highly conservative effort that is putting a premium on delivering reproducible results but which thus far lacks creativity and above all, abjures risk.
Despite the initiative’s enormous mass – it’s got oodles more money than any other long-COVID initiative – RECOVER feels restrained and cautious. One would think that a $1.15 billion budget would leave room for the initiative to take some high-risk, high-potential shots, but not so – not yet. Instead of lighting the long-COVID world on fire, thus far, RECOVER is putting it to sleep. It hasn’t produced a single finding of note.
Still, we’re still very early on with RECOVER. Creating RECOVER is more like building the Titanic than anything. It’s going to take longer than we want to launch but when it does it should be something else indeed. With its $1.15 billion budget, RECOVER has to deliver the goods on long COVID: anything else would be a huge fail.
The Clinical Trials Conundrum
RECOVER is in a bit of a tough spot with clinical trials. How do you mount clinical trials in a disease you’re still in the dark about? Do you take some educated guesses and start pouring money into clinical trials, most of which are probably not going to pan out – or do you wait until you know more about the disease and use your resources then?
RECOVER has clearly chosen the second path and that’s not going please the long-COVID community which has been clamoring for over a year for RECOVER to bring them a nice, meaty plate of clinical trials. Slate – which recently published a hit piece on long COVID – reversed gears, and highlighted the frustrations of one long-COVID patient:
“Long COVID is a vile disease that affects every bodily system. It affects your ability to live, eat, sleep, and work,” he said. “Many people have been struggling for two to three years, with no end in sight. Finding treatments makes humanitarian and economic sense. The lack of urgency is profoundly unethical and irrational.”
Eric Topol said he expected the NIH would have launched many large-scale trials by now. It hasn’t launched any and won’t launch its first until late summer – that is, if it finally meets its target. Even conservative scientists like Akiko Iwasaki have, in the face of all the suffering people, thrown out the standard playbook.
“I’m a basic scientist. I’d like to figure out the disease before treating anything. But at this point, I don’t think we have that kind of time or luxury. I think we have to start doing clinical trials and learning who benefits and how to improve these therapies,”
Going Slow
RECOVER’s slow but steady approach is not going to excite many, but it does appear to fit within its mandate – to provide definitive results by employing sizeable studies/trials that use a standard methodology. The downside of that approach is that is so resource-heavy that in the end, it may not explore as many corners of an issue as one might like.
The Five Clinical Trials
The long COVID community wants dozens of clinical trials – RECOVER gave it five. It was ironic hearing Dr. Hernandez acknowledge the community’s needs during RECOVER’s recent webinar, as it rolled out its minny package of clinical trials.
“Hey, we need answers now. We need interventions so we’ll improve someone’s health, their function, their quality of life,” how to do things in parallel? So having all this available to develop some of those answers is really critical because I don’t think anyone in this community is really excited about serial answers that take decades.”
The five trials are:
- Viral persistence – Paxlovid – 900 participants – late summer – It was good to see Paxlovid, but it was an obvious choice. Still it has potential. Grade- A
- Brain fog (cognitive dysfunction) – 315 participants – cognitive retraining – late summer – they didn’t say what kind of cognitive retraining but RECOVER is clearly thinking neuroplasticity which we all know can help some people and doesn’t help others. One website reported: a “2013 review suggests that CRT may be effective for mild cognitive impairment” but that “it can be an exhausting and time-consuming process.”…Ouch… Grade- C
- Sleep disturbance – hypersomnia (too much sleep) – 474 participants – drugs and behavioral training – fall – this was a surprise. While hypersomnia, of course, does happen in ME/CFS, unrefreshing sleep is much more common. (Is this a difference between long COVID and ME/CFS?). One study found hypersomnia in only 3% of long COVID participants (!). Behavioral techniques will surely play a large part and they should be helpful. We really need RECOVER’s data on hypersomnia. Grade- C-
- Autonomic dysfunction – 360 participants – immunotherapies and behavioral training – later this year. The fact that immunotherapies are involved was different and rather exciting. Other aspects of treating autonomic dysfunction will be involved. This trial should actually be quite helpful, as dysautonomia is not well-known or well-treated in the medical field, and positive results should be helpful in spreading the word. That said, dysautonomia is a large field with many potential treatments. Grade- potential A
- Exercise intolerance – 360 participants – exercise therapy – controversial, not needed, not particularly helpful even if it were to provide benefits. Grade- F (see below)
It’s not that these trials are all bad; it’s just that RECOVER stopped there. That it didn’t include low-dose naltrexone which is used widely across ME/CFS, FM, and long COVID and could really use a well-done trial was shocking.
RECOVER could have launched a series of small pilot trials. LDN, Guanifacine, gut enhancement therapies, many different kinds of immunotherapies, metformin, Abilify, anticoagulation/antiplatelet therapy, apheresis, stellate ganglion block, antihistamines for MCAS, herpes virus antivirals – the list of potential treatments goes on and on.
Michael Peluso and his colleagues at the Long Term Impact Infection with Novel Coronavirus (LIINC) hope to produce a series of small but intense clinical trials of immunotherapies to: a) see what works and b) to learn about what’s happening in long COVID.
The idea is that as you perturb the patient with a treatment, then study them intensely, and learn about the disease that way. That worked great in HIV and that’s the kind of work one might have expected the money-rich RECOVER Initiative to employ.
The Exercise Intolerance Trial
RECOVER’s mostly rather dull stabs at treatment were hardly exciting, but they made some sense. It’s with the exercise trial that one really starts to wonder. If RECOVER had to go back to the drawing board 6 months or so into the planning stages of its exercise trial because it realized – whoops – that exercise might produce some negative effects in some participants – it clearly hadn’t done its homework.
The way RECOVER clapped itself on its back for contacting post-viral disease researchers suggested it wasn’t too fond of the homework idea.
“We’ve had input from clinicians, those who are taking care of patients with long COVID every single day, as well as researchers who know things about design of clinical trials, for example, and who have had prior experiences with taking care of people with postviral syndromes and even researching postviral syndromes themselves..”
That was not a given? As we’ll see, apparently, it wasn’t. Dr. Hernandez started off with what will turn out to be a theme: we don’t know that long COVID is exactly like ME/CFS – so we’ll proceed as if it’s not.
“So I think these are examples where people are trying to translate what’s been the prior research scenario, but also noting that we may or may not know fully what the exact overlap is with long COVID, PASC, and MECFS.”
When exercise, gut, small fiber neuropathy, herpesvirus, cortisol, autonomic nervous system, blood vessel, coagulation, brainstem, results are similar – don’t we really know enough to conclude that the ME/CFS-like group of long-COVID patients is very, very similar to ME/CFS?
Say what? Long COVID “is in many ways different from ME/CFS?”
Dr. Eldrin Lewis – a Stanford cardiologist who specializes in heart failure – continued the theme, stating that the PEM in that the PEM in long COVID was “in many ways” different from that in ME/CFS.
That’s news. One study which directly compared PEM in both conditions found similar rates of the core symptoms of ME/CFS (fatigue, muscle and joint pain, infection and immune reaction, neurologic and gastrointestinal symptoms, and orthostatic intolerance) in both. Long-COVID patients did report more sleepiness, respiratory issues, depression and anxiety, irregular body temperature, and excessive thirst, but the core symptoms were the same as in ME/CFS. The study concluded that “People with Long COVID experience PEM that is the hallmark of ME/CFS”.
Lewis clearly isn’t so sure about this PEM stuff. As he backed away from having people with severe exercise intolerance participate in this exercise trial, his wording suggested that he clearly believed they would show up in later trials: “what we don’t want would be to have people who have severe PEM as an initial component of this trial”.
Lewis noted how the cardiology field started off low and slow with heart failure patients and exercise and worked their way up. In doing so, he negated the recommendations of the CDC, and in particular, the consensus of UK, and Dutch research establishments which poured millions of dollars and decades of effort into graded exercise therapy in ME/CFS – before abandoning it altogether.
THE GIST
- The RECOVER initiative for long COVID is on the clock! Patients have been clamoring for clinical trials – many clinical trials – for over a year. Eric Topol thought RECOVER would have launched many clinical trials by now. In a recent webinar RECOVER gave the long COVID community….five.
- RECOVER is a bit stuck. it doesn’t know what’s causing long COVID and appears to be wary of moving forward on the clinical trials front until it does. This isn’t necessarily a bad strategy. RECOVER may simply be hoarding its resources until it feels it has a better grasp on long COVID.
- it will not please long COVID patients, though, some of whom have been suffering for years, and who see plenty of possible, if unproven treatment options.
- RECOVER’s five clinical trials – which it expects to launch starting in the end of summer include Paxlovid, neurocognitive retraining, drugs and behavioral treatments or hypersomnolence, drugs and other therapies for dysautonomia and graded exercise for exercise intolerance.
- Paxlovid was an easy and good choice. So was attempting to treat dysautonomia – which few doctors know how to treat. Hypsomnolence seemed like a strange choice as it hasn’t been identified as a major problem in long COVID yet. Neurocognitive retraining (employing neuroplasticity) will probably not wow people who want their brain fog solved but it may help around the edges. The exercise study was the one big boner – it was a huge fail.
- RECOVER’s choices were conservative indeed and tended to focus on behavioral adjustments to long COVID. The exclusion of low-dose naltrexone, which is widely used by many doctors to treat ME/CFS and FM, was disappointing. Many other potential treatments – anticoagulants/antiplatelets, Guanifacine, immunotherapies of all types, metformin, herpesvirus antivirals, apheresis, stellate ganglion blocks were discarded.
- RECOVER’s extreme conservatism is highlighted by the small but intense trials of immunotherapies Michael Peluso and his colleagues at UCSF hope to get underway. Their goal is to use these trials to a) find treatments that help and b) to understand what’s going on in long COVID. The idea is to perturb that patient with a treatment and then study them intensely to see what happens. That’s a creative approach to long COVID – the kind of approach one hopes we’ll see at some point from RECOVER.
- A central theme that ran through the webinar was that long COVID is in important ways not like ME/CFS, and that RECOVER shouldn’t rely on ME/CFS studies – particularly regarding exercise – to inform the RECOVER initiatives approach.
- This contradicts everything we know about long COVID and ME/CFS thus far – including the results of the exercise studies. Ignoring the decades of work that have explored the exercise issue in ME/CFS and which culminated in the field abandoning the idea of graduated exercise, one RECOVER representative likened the exercise issue in long COVID to that of beta-blockers or exercise in heart failure. Both were believed to be harmful but studies later found them to be helpful.
- We just don’t know, he said, that ME/CFS is exactly like long COVID – so we have to give exercise a try. All indications including cardiopulmonary tests – indicate that it is, of course,very much like long COVID but never mind that – RECOVER is going to spend its time and money reinventing the wheel.
- The decision to exclude those with severe exercise intolerance from the exercise studies means RECOVER is not going to address deconditioning – a primary reason for exercise trials. So what is RECOVER going to address? One of the few factors left are anxiety and depression – suggesting that RECOVER believes the exercise intolerance is a result of anxiety and depression.
- RECOVER’s go-slow approach is not going to sit well with many but it has its advantages. Theoretically RECOVER’s enormous purse means it has the resources to explore long COVID thoroughly. Once it settles on some core findings it can then bring more resources to bear on them with potential treatments. At some point, though, it needs more creativity to bear on this condition.
- RECOVER’s slow as mud approach is generating some flack leading a powerful Congresswoman to ask RECOVER for answers.
- It’s getting tiresome repeating this but we’re still early in the game and this huge initiative is still getting its feet off the ground. We should know much more about it over the next year.
The difference, of course, is that we’re not relying on educated guesses with ME/CFS. The exercise studies have been done – some of them much bigger than what RECOVER is planning – in ME/CFS and exercise therapy was an active feature of ME/CFS research for decades. Unless long COVID is fundamentally different than ME/CFS, the results – which were mediocre at best – are going to be the same.
Hernandez echoed Lewis’s skepticism that the ME/CFS-like cohort of long COVID is going to react to exercise therapy like ME/CFS patients did. “Should we” he asked, “just assume something on this way that it won’t work or it will work or this and that?”
It depends. If you have unlimited amounts of time and money. the answer might be yes, you make sure everything is tightly wrapped up and has a little bow on top before you take a step forward. If resources are limited – and we know they are – and people are suffering – maybe it’s time to make some educated guesses rather than reinvent the wheel.
Does RECOVER Believe Long COVID is Depression?
The exercise issue brings up a disturbing question: Do Hernandez and Lewis believe the exercise intolerance found in long COVID is actually depression? Exercise, after all, is helpful with depression. Is that what they’re actually trying to treat?
A logical fallacy is present. If RECOVER is trying to reverse deconditioning – the only physiological reason for an exercise study that I can think of – it would logically focus on the deconditioned segment of long COVID i.e.; people with severe PEM. That is the very group of people, though, who are being excluded from the study.
If RECOVER is going to focus on people with mild PEM, who are likely not deconditioned, how do they expect them to benefit? It’s true that exercise can benefit many diseases (diabetes, asthma, arthritis, back pain, anxiety, depression, osteoporosis, heart disease), but the only diseases in that list which regularly occur in long COVID are depression and anxiety. In none of those diseases have multiple studies found evidence of a metabolic dysregulation that interferes with energy production.
Is RECOVER hoping that exercise will produce some sort of psychological boost? Is that why they’re doing this study?
It wouldn’t be that surprising. Despite the fact that there’s no hint of cardiac problems in ME/CFS-like group of long-COVID patients and lots of evidence of autonomic nervous system problems, RECOVER is top-heavy with cardiologists and very light on autonomic nervous system specialists.
That doesn’t make sense in a disease where the biggest subset of long-COVID patients have dysautonomia but it does make sense if you look at the RECOVER Initiative as a kind of big boy network where people already in the network get first preference, whether they fit the bill or not.
Take Lewis. He’s well-published in the cardiology field – hasn’t published anything on the autonomic nervous system, apparently doesn’t know or care about the exercise trials in ME/CFS – and thinks the two diseases are radically different anyway. Lewis noted how helpful exercise is in heart failure as a justification for using it in long COVID. Could it be as simple as Lewis thinks – well it works in heart failure, why not long COVID? Let’s hope not.
Time will tell. If the PEM in long COVID is fundamentally different from that of ME/CFS, RECOVER may be right. Nothing thus far suggests that, though.
Pushback
RECOVER is getting pushback from Congress over its go-slow approach. STAT News reported yesterday that Rep. Anna Eshoo – an ME/CFS supporter – who sits on the committees that oversees the NIH (House Energy and Commerce Committee) sent a letter to NIH acting Director Lawrence Tabak asking what the heck is going on with clinical trials, among other things.
Conclusion
A case can be made for the RECOVER Initiative’s go-slow approach to clinical trials. In this scenario RECOVER investigates a few things that might modestly help long-COVID patients now and saves its resources for when it has more insights into the pathophysiology of the disease.
That’s an understandable strategy. People in the ME/CFS community know no magic bullets exist right now. Yes, some people are helped mightily by some things, but they tend to be in the minority. The really effective treatments probably lie in the future.
Theoretically, RECOVER should bring us more closely to that future than any other effort, but doing so will require more creativity and a greater tolerance for risk than it’s shown to date.
Cort, thanks for your excellent summary of the RECOVER project, which obviously is helping no one who suffers from ME/CFS/LONG COVID. What are your thoughts about the clinical trials at the Bateman Horne Center regarding oxaloacetate?
Thanks – I am so glad that this supplement – while extremely expensive – is getting a real trial 🙂
Any knowledge on when the trial results might be published Cort?
Has anyone tried it?
Interesting trial, but I keep thinking, why not just dose with acetyl coA in that case?
Interesting….do you know of any trials? Have you tried it?
I probably shouldn’t admit in public that I do, since AFAIK there aren’t any trials, but it’s a godsend. There is a company in Texas that sells it in capsules; I take two a day and I went from being flat at 1 PM to being good till 6 PM; I was actually able to work myself up to 8-9 pm and 2 miles of walking a day, till I eventually developed POTS and things went downhill again.
You say in the article we really need the data on hypersomnia, how do you feel it can be applied?
Along with LDN and guanfacine, I’m surprised to not see nattokinase as that seems to be everywhere I look….
Given that there doesn’t seem to be much out there on hypersomnia and long COVID I’d love to see their data showing that’s it a major problem. I don’t what the treatments there are for hypersomnia are other than behavioral treatments. There must be something, though.
Maybe they could stop at the rationale and save the $$ for a different trial!!
Its notable we know so little about how $1.15 billion has been spent. We have 5 trials but where is the rest going? 3 of the trials is basically a waste of time and the Paxlovid trial will come after we expect results from 6 trials already underway in the EU. Immunology trials have been happening for a while in the EU as well, I don’t anticipate RECOVER getting anything out first.
The money doesn’t appear to be going into hard hitting biological research that is cranking out findings and digging deep into the disease because so far they haven’t published anything. Its certainly not gone into trials.
Where did all the money go?
I think much of the funding so far has been put toward research trying to determine the various mechanisms of the disease, but there have thus far only been a small handful of published findings (is that right, Cort?)
Fifteen studies so far – 14 of which are electronic health record studies. We haven’t seen anything from clinics – from the results of the first couple tiers of testing. They will help characterize long COVID. Next, they will presumably use those results to go after mechanisms.
RECOVER did fund around $40 million dollars of outside mechanistic research as well. 🙂
You are as always a font of knowledge – thank you, Cort!
We have no idea – which is kind of amazing in itself -my worry is that a lot of money went into building the infrastructure, getting the clinics in place, getting the patients in there and tested with not much money is left over to actually dig into the illness. Did RECOVER only start five trials because it doesn’t have the money for more?
It’s all conjecture – RECOVER says they are fine – and hopefully they are. THus far RECOVER has published 15 studies, 14 of which are electronic health record studies and 1 review.
We’re still waiting for anything from the clinics themselves. First we should get the results from the patient testing. Then they will use those to create hypotheses from the results and dig deeper.
On RECOVER’s side not since HIV/AIDS has the medical profession been hit with a widespread new disease like this. I’m sure there have been plenty of growing pains.
I will continue to be deeply perturbed that the Mount Sinai RECOVER study didn’t build in money for patient travel. A very urban-centric attitude, although even the cost of a round-trip Metrocard is a lot for city folks who are unemployed and/or on disability, let alone providing gas or train money for those in the outskirts of the city. This feels like a very basic thing to include.
NOW I’m depressed. Basically, they’ve got nothing, and certainly nothing new, and half their researchers don’t even know the basics.
My husband said it would take at least five years for any of this to produce anything – I think it’s going to be MUCH longer unless someone has an epiphany and STUMBLES on THE SOLUTION by total ACCIDENT.
Why do I even bother telling long-time ME/CFS sufferers to hang in there because we finally have some hope? That’s now looking like it’s condemning them to many more years of misery (not that we have any other choices).
I just got my third booster. Maybe that’s the best I can do for now: a booster every four months.
Thanks for your accurate descriptions. Shame on them.
It’s starting to look like your husband may be right. Thus far we have electronic health record studies and that’s about it.
https://recovercovid.org/publications
RECOVER does say that DOZENS of manuscripts are in preparation, though, – so maybe it will four years instead of five (:))
I keep hoping there’s an intelligent grownup in charge – against all realistic expectations. That’s a LOT of money. MY tax money.
Too many of us have already lost too much.
Thanks for your persistence, and thanks to those like Jennie Spotila and many others who keep chipping away at this monolith, because I have nothing to give – I was a plasma physicist working on fusion, and am now (the slowest on the planet) a novelist writing about ME/CFS as a subtext, and will never get anything back from over three decades of misery.
And still holding out the begging cup.
I really hope you will participate in our Lives Interrupted program, Alicia. From being a plasma physicist to this – it’s quite a story. We’re just getting some hosting things sorted out and we will post it.
There are SO many of us with these stories, including physicians!
I actually think that stress compounds anyone’s risk of catching something and not getting over it, and stress comes in many forms – maybe that’s quantifiable (not the it will help – try telling people not to take on too much stress; it’s almost a badge of accomplishment).
I’d be honored to be asked – but I don’t think I’m that different; I’ll look for the announcement and the details.
All of this garbage with comparing long covid to MECFS is OBVIOUSLY getting MECFS absolutely nowhere, just like it has been for the last several DECADES!!! Nothing is going to change on the MECFS front because I FULLY BELIEVE that scientist Judy Mikovits was 1000000000% CORRECT with everything she discovered with our disease aka the XMRV and how all of us contracted this etc and if anyone actually has done their research on all of what happened with her and that whole situation which can EASILY be done by either reading her books or watching a few of the THOUSANDS of videos where she is being interviewed about everything that happened and discovered and what the NIAID NIH etc did to her because she discovered it which at first they FULLY went along with but when she discovered HOW everyone had got this disease is because the ENTIRE blood supply and vaccine supply is CONTAMINATED (she goes into great detail about that if anyone still doesn’t these things then they NEED to be researching deeply into all of this), still to this very day she 10000000% stands by it because she will NOT let anyone in this world FORCE her to lie or change her work or be dishonest in ANY way because she has morals, values, a conscience, has Jesus in her life, integrity, honesty, loyalty to the people of the WORLD that she has so desperately been trying to SAVE from this beyond horrible miserable disease that she had dedicated her life’s work to and had switched her career path from the science she did on cancer all those years until she found out what MECFS was and was asked to switch from cancer to MECFS and she did because she saw how NEEDED scientist are in the MECFS field and how desperately we all need help and like she said she will NEVER back down from telling the truth no matter what they do to her or take from her (AGAIN) they smeared her name and reputation among many many things, just like “they” do to everyone who discovers something that is HIDDEN FOR A REASON that would destroy the entire system and America would go completely broke having to pay all of us billions along with the rest of the population who still has the XMRV but it hasn’t been ACTIVATED yet!!! Everyone like her who finds the facts and try’s to share them with the world and SAVE HUMANITY literally ALWAYS instantly gets discredited as a person and loses their career, loses their stability and their home and goes bankrupt, is made out to look like some crazy psychotic person because they smear them so bad with all the lies they tell about them and the death threats on them and their families and friends and the murders that happen etc etc it goes very deep but that’s what happens to people that expose the secrets of what “they” don’t want the population to know IF THAT SCIENTIST/or whoever it is DOESNT COME OUT PUBLICLY AND LIE AND SAY their work was flawed or their were mistakes etc etc THATS HOW THIS WORLD WORKS unfortunately but a HARD FACT!!! We could have easily been fixed just by simply giving us a medicine that of course was taken away from all the people of the world because they simply don’t want anyone to get better, and they most definitely don’t want to admit that they are the ones who caused this to happen and then offer the people the medication and like I said it would be 95% of America and who knows about wherever else. I love Ron Davis BUT they will never let him figure it out and fix us…. Nobody will be allowed to help reverse our disease and save us. That’s why like I’m sure most of you know by now, you have to be your own doctor! The whole entire medical community doesn’t know anything at all about MECFS other than the five minutes of training they got in medical school on MECFS saying that it’s all in our heads and it’s a psychiatric disease, and they won’t update their curriculum or offer for continued education to be mandated for all doctors and hospitals and nurses etc with the FACT that it’s PROVEN it’s not A psychiatric issue and it is physiology with multiple body systems being affected so basically our whole body. Bottom line I wish all of you luck and what I can tell you is do your research about everything, be your own doctor and help yourself and make your number one treatments to be detoxing in all different types of ways seeing which ones work for you and then vitamins and supplements GOOD ONES and most importantly as Judy Mikovits personally told me you have to number one focus on your gut because if you don’t heal your gut then you will never be able to get better, once your gut is healed then you need to focus on inflammation in the whole body. Blessings to everyone and I wish you luck in your research and detoxing. When using a search engine it’s a proven fact you can test it out for yourself or just trust me don’t use Google because they hide things and only put up the links to articles that lie, so you need to use something other than that such as DuckDuckGo which has been my favorite. Good luck to all of you.
People with, “Jesus in their life,” continue to bring us Trump, so please don’t tell us a Christian doctor is better than another type of doctor, or that they lie less than other doctors. That is so bad nutrient, not to mention offensive.
*That is so untrue…
Pathetic.
The more money goes into one single thing the more money is wasted. Taking all this time to just figure out what trials to make?
Anywhere else, if an organisation asks for funding a very precise plan has to be presented which obviously was not the case here.
Cort I wish they gave you just 1/4 of this budget so you could hire staff that would put all world wide research results into a solid presentation from which allocation of money could be decided.
More smaller, better functioning units with constant exchange of information world wide.
If part of that money would be invested in simple, basic respectful care, wellness centers ecc. , financial support, depression, anxiety and PEM could be reduced and a lot of people would not become that ill in first place.
What I observe here is typical North American acting. Big, powerful, useless.
To those who attached any hope on this “elephant” : study all the smaller trials, and deduce your knowledge from there.
There is a lot to learn from those.
Western medicine is ONLY one -and a very ignorant(ignores everything else and is a exclusive approach (does not look at the whole person).
I have yet to see another healing discipline that is as agressive towards other disciplines as our western medicine. In my eyes it has lost its path since it got “married” to pharma.
There is so much to learn from the countless other ways to heal body AND mind.
Thank you, Cort, for this brilliant presentation. I would not have been able to stay that objective.
Maybe they should try some of the supplements that have given some people on this blog some reduction of symptoms. If the researchers need ideas, perhaps they should ask ChatGPT for direction. Providing relief for long Covid sufferers may take a lot more than some type of cognitive behavior therapy.
There are really no end – or almost no end – of possibilities. They just chose not to explore them. It’s a very, very conservative approach.
Even though, its compounded, and the NIH has blocked every attempt to fund LDN trials, I really thought they would give low dose naltrexone a go. I’m sure every ME/CFS expert associated with
RECOVER promoted, It’s widely used, it can be quite helpful. It certainly had a better chance of doing something that cognitive retraining or exercise therapy. It would be great to hear why they didn’t give it a shot – along with other things.
It would be soooo nice if RECOVER could get in touch with the concerns of the community and respond to them. They had to with the exercise study but what about such a short slate of trials when everyone is demanding more, why not LDN? Why not anticoagulants? Why not gut manipulations? Why not stimulants?
Not responding to these question leaves us frustrated. It’s communication 101 – respond to the concerns of your constituency! It would be such a breath of fresh air and would allow people to get behind them .
In the short term I’m much more interested in what Peluso is trying to do than RECOVER. He and LIINC are, by the way, on the RECOVER but apparently couldn’t convince them to go the small, intensely studied, immunotherapy route.
Karen, your comment about asking ChatGPT for direction made me curious. So I asked this question. Note that it is pulling from information that still recommends CBT and graded exercise therapy, although at least there was a caution with that one.
Q: The NIH RECOVER program for Long COVID is not funding many reported treatments that have been shown to have an impact on recovery in Long COVID and ME/CFS. What are some suggestions for trials that might include other types of approaches?
A: While I don’t have access to the most up-to-date information beyond my September 2021 knowledge cutoff, I can provide you with some general suggestions for potential trials that could include alternative approaches for Long COVID and ME/CFS. It’s important to note that the decisions regarding funding and trial design are made by organizations such as the NIH based on various factors, including available evidence and scientific merit. Nonetheless, here are some suggestions for alternative approaches that could be considered for future trials:
Mind-body interventions: Investigate the effects of mindfulness-based stress reduction, cognitive behavioral therapy (CBT), or other mind-body interventions on symptom management and overall well-being in Long COVID and ME/CFS patients. These approaches have shown promise in managing symptoms and improving quality of life in various chronic conditions.
Complementary and alternative medicine (CAM): Explore the potential benefits of CAM therapies, such as acupuncture, herbal medicine, homeopathy, or naturopathy, as adjunctive treatments for Long COVID and ME/CFS. While the evidence base for some of these therapies is limited, they may offer potential avenues worth exploring.
Exercise and physical therapies: Conduct trials to assess the impact of tailored exercise programs, graded exercise therapy (GET), or other physical therapies on symptom severity, physical function, and overall recovery in Long COVID and ME/CFS patients. Careful consideration should be given to individualized approaches and the potential for post-exertional malaise.
Immune-modulating therapies: Investigate the effects of immune-modulating drugs or therapies, such as low-dose naltrexone (LDN), immunoglobulin therapy, or immunomodulatory agents, in managing symptoms and promoting recovery in Long COVID and ME/CFS patients. These approaches aim to address potential dysregulation of the immune system.
Nutritional and dietary interventions: Explore the impact of specific diets, nutritional supplements, or dietary modifications on symptom management and overall well-being in Long COVID and ME/CFS patients. Some potential areas of interest include anti-inflammatory diets, gut microbiome-targeted interventions, or nutrient supplementation.
Novel pharmacological interventions: Investigate the efficacy and safety of novel pharmacological agents specifically targeting the underlying mechanisms and symptoms of Long COVID and ME/CFS. Examples could include drugs targeting mitochondrial dysfunction, autonomic dysregulation, or neuroinflammation.
Remember, these suggestions are not exhaustive, and each potential trial would require careful consideration of the scientific rationale, study design, patient selection criteria, and potential risks and benefits. It’s essential to consult with medical professionals, researchers, and relevant funding organizations to evaluate the feasibility and potential impact of these suggestions.
ME/CFS patients suffer most from unrefreshing sleep, not hypersonia. I’ve had ME/CFS for over 30 years and Long Covid for 9 months. The similarities are extensive, but there are also differences. Long Covid has made me significantly worse. It exacerbated all underlying conditions and lessened the efficacy of my medications. I am extremely disappointed by the Recover study as I, like many of my fellow patients are housebound/couchbound/bedbound and need immediate assistance. I strongly believe they should take a post viral chronic illness approach as my CFS/ME is post EBV/Mono. What do these viruses do in some patients so that they don’t recover? Why us? Is there a common genetic mutation amongst us? I wish experienced well informed patients could be a part of the Recover team as we the patients are the experts of our own bodies but not the experts of the scientific explanations. Shortness of breath and chest pain to the point where many long haulers either can’t or find it difficult to take a hot (or cold shower). Why? Chest xray, CT scan, pulsox and EKG are normal. Why do I have shortness of breath and why does a shower exacerbate it? Why does eating hot food exacerbate it? I’m eating room temperature foods so I can breathe better! Why? That’s the science I want help with. Do that with the other symptoms and then connect the dots. Severe fatigue is not deconditioning. Is it lactic acid as some suggest, is it mitochondrial damage? I’ll point the way and let Recover research the answer.
Cort, all 5 trials sounds awful.
1) Why do we need forth Paxlovid trial? Stanford, Yale and Karolinska university will give us enough data on Paxlovid. It is a waste of resources.
2) Retraining?? Is it a joke? Brain fog has an organic cause.
3)Studying hypersomnia?? Do they know anything about long covid? The majority of people suffer from insomnia!
4) behavioral trainings of all sorts should be excluded cause LC is organic. We are fed up of it. What kind of immunotherapy?
5) Exercise intolerance studying. I can`t believe. We have already had it in ME/CFS.
Overall there is nothing what can help millions of people. All these stupid trials will be comleted in years. How many people will become homeless, commit sicide or get organ damage due to LC waiting for these pseudoscientific efforts? If you have any accsess to NIH or Recover officials, please advocate for a new prudent road map. We need to understand why tissues don`t uptake oxygen during CPET. We need precise proofs of viral persistence, more data on herpes viruses reactivation, more data on autoimmunity and mitochondrial dysfunction. Many drugs to trial. We are observing a failure.
I wonder if Dr. Eldrin Lewis – a Stanford cardiologist has been in touch with Stanford ME/CFS clinic to coordinate? https://med.stanford.edu/chronicfatiguesyndrome.html
Stanford MECFS clinic puts patients on LDN, and Abilify and potentially anti viral treatments. I was not offered any cardiology opinions/options or tethered cord/CCI assessments. Nor any testing associated with mitochondrial disjunction or any research coming from Stanford labs. I think there is more cross functional offer there for Covid patients.
I would like to see more treatment trials. MCP-1 has been shown to be elevated in CFS. Elevated MCP-1 results in the recruitment of more monocytes to the brain, resulting in neuroinflammation and sickness behaviours (fatigue etc).
So why not trial a MCP-1 inhibitor like bindarit?
NIH are being two faced and frankly walking all over the ME community. In reality they are treating LC as Potentially different, doing observation stuff , seemingly starting from scratch, excluding studying ME alongside. They have told newspapers that they are going to look at long covid first And throw resources at it in the early stages where they think it will be easier to treat, saying A longer term ME is going to be harder. I think they have said they will *then* look at ME . We have only been waiting 20, 30,40 years in extremis. Then, when they talk to the ME community, they sell it to us that we should look to this research and they hope it “might help us too”. All whilst Essentially freezing the NIH ME/CFS budget.
I would like to see ME advocacy go back to working exclusively for those who identify as /have the ME label and start challenging what to me is gross unfairness from the NIH. I would have like this to be the MEAW focus.
Cort, just when things are depressing… are you aware of the VERY interesting and impressive new study ‘Suppressed immune and metabolic responses to intestinal damage-associated microbial translocation in myalgic encephalomyelitis/chronic fatigue syndrome’. Suzanne Vernon amongst a number of authors
Eagerly looking forward to reading it and blogging on it 🙂
It’s fascinating. Look forward to your coverage
Thanks for writing this up, Cort. This is depressing, but your blog from January (https://www.healthrising.org/blog/2023/01/13/long-covid-clinical-trials-big-drugs-big-studies-and-much-more/) is what gives me hope!!