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Waves on beach with white foam

Is the tide turning a bit for ME/CFS?

Is the tide turning a bit? Could long COVID be starting to lift some chronic fatigue syndrome (ME/CFS) boats? That was certainly our hope. We hoped the appearance of millions of long-COVID long haulers would spark interest in the really long haulers – the people with ME/CFS who’ve been dealing with this disease for 5, 10, 20, 40, or more years. It only makes sense that a pandemic of epic proportions might be enough for researchers and institutions to take a new look at ME/CFS.

That does appear to be happening – at least for an ME/CFS researcher and a prominent ME/CFS clinic. Both are busier than ever.

First, though, a brief stop at some things that haven’t happened – not yet, anyway.  If you’ve read my recent rants about the NIH you know what’s coming. I just can’t let go of it yet…

Big Miss!

What makes sense isn’t always what happens though. It was stunning to see, two years after long COVID came on the scene, a reduced lack of Institute support for the NIH ME/CFS research centers and no increase in funding.

Thus far, the NIH has missed a huge opportunity to cheaply and effectively study ME/CFS

That was peanuts, though, compared to what happened with the NIH’s congressionally funded long-COVID RECOVER project. The RECOVER project provided a golden opportunity to cheaply and easily bring ME/CFS into the research mainstream.

It seemed like a win-win situation. The NIH got the opportunity to live up to promises (“Watch us – we’re serious about ME/CFS now” – remember that?) in a cheap and effective manner. The hard work of the RECOVER project, after all, had been done: the protocols had been created and the researchers and clinics found. All the NIH needed to do was to insert 500 or so ME/CFS patients into its 40,000 people long-COVID study.

In one swoop, ME/CFS would have been embedded in a massive research network containing integrated databases and large, rigorously conceived studies – the kinds of studies this field has largely been missing for the past 30 years. The kinds of studies that don’t get dismissed, that aren’t too small, that don’t have methodological problems; in short, the kinds of foundational studies that can really move a field forward.

Dozens, if not hundreds, of researchers would have been exposed to ME/CFS. As the NIH uncovered similarities between ME/CFS and long COVID, treatment trials – a rarity for ME/CFS – would have been forthcoming. By itself, the RECOVER project could have turned our little niche field into a major research opportunity. With 1-2 or more million people with ME/CFS in the U.S. there are certainly plenty of people to study.

It was all there for the asking. All the NIH had to do was pony up a little money but that, astonishingly, was once again, a bridge too far.

We should note that the NIH has not had it easy with the RECOVER project. Even though (for it) it got the RECOVER network up and running in record time, it still managed to miss ALL the COVID peaks (ouch!) – thus losing its best chance to do what Congress wanted it to do – catch long COVID in the act. A year and a half later, it’s enrolled only a fraction of its estimated participants. Remarkably, only last week did it begin to provide links to some of the RECOVER research centers on its website. If I was Senator Tim Kaine – a long-COVID sufferer and supporter of the RECOVER initiative – I would not be pleased.

Is the National Institutes of Health (NIH) Going to Miss Out on Long COVID?

So the NIH has been pre-occupied for sure and it may change its tune in the future. I still find it hard to believe that when – I believe it’s a when not an if –  that when the NIH or other research efforts start to unravel long COVID that it  won’t finally step forward to extend a hand towards ME/CFS. The NIH is, after all, made up of humans, and morality – no matter how washed out morality can get in a big bureaucracy like the NIH – is still part of the human package.

The NIH’s unwillingness, thus far, to include ME/CFS in its RECOVER initiative, though means we’re largely back where we were – creating small, interesting studies that do move this field forward but can’t create the kind of “pop” needed to move this field forward quickly.

The NIH’s unwillingness to take advantage of the long-COVID opportunity to support ME/CFS aside, a wave – not a big one, for sure, maybe a 2-3 footer 🙂 maybe building – and that is good news.

Two important players in this small field – Dr. Benjamin Natelson and the Bateman Horne Center – are suddenly quite busy!

Dr. Benjamin Natelson’s ME/CFS Moment

Dr. Natelson

After 2 decades of studying this disease, Dr. Benjamin Natelson is having an ME/CFS moment.

Dr. Benjamin Natelson has been getting after ME/CFS and fibromyalgia (FM) for a long time. A doctor, researcher, and author (“Your Symptoms are Real“), Natelson has been publishing in one form or another on ME/CFS for almost 20 years. Mt. Sinai’s entry for him states “he is the only neurologist on the East Coast expert in the diagnosis and care of patients with severe fatigue and/or body-wide pain for which there is no apparent medical explanation.”

Natelson’s had some dry spells but he has been able to get NIH grants fairly consistently. From 1995 to 2002, he ran one of three NIH-funded ME/CFS research centers. From 2010 to 2020, his NIH funding dried up a bit and he was able to score only three grants, but recently he’s been on a roll. Since 2021, he’s scored 3 NIH grants, has 5 NIH studies going, and is trying for two more: Natelson is clearly having an ME/CFS moment. If you watched his presentation at the recent NIH telebriefing, you could sense his excitement.

Please note that all these studies are open for enrollment, and the faster we get them filled, the more we will learn. Natelson is located in the Big Apple (New York). If you’re close by, please consider enrolling in one or more of them.

R21 Studies

Natelson currently has 3 smaller R2I (but still pretty darn big; i.e. $100K to $350K a year) grants going.

Cerebrospinal Proteome Spinal Fluid Study

John Hancock ME/CFS Brain signature

Natelson is attempting to find our brains “John Hancock” i.e. it’s unique proteome signature

Natelson’s been wanting to do this study since he teamed up with Lyme expert Stephen Schutzer to show, in another NIH-funded grant, that the proteins in ME/CFS patients’ cerebrospinal fluid were different in people with Lyme disease. (That is certainly an intriguing fact as we move into a new era of post-infectious disease research.)

The Gist

  • The National Institutes of Health (NIH) has thus far woofed on the easiest, cheapest, and most effective opportunity to study and understand ME/CFS – embedding people with ME/CFS in its huge RECOVER long COVID projection.
  • The NIH’s neglect of ME/CFS is not new but long COVID is and there are signs that the long COVID “wave” may be finally starting to wash up on the ME/CFS field’s shores.
  • Dr. Benjamin Natelson has been studying ME/CFS for many years but after quite a dry spell in the 2010s Natelson is now engaged in now less than 5 NIH-funded ME/CFS and long COVID studies and has applied for two more. They include brain imaging, exercise, sleep, mitochondrial supplementation and cerebral spinal fluid studies.
  • One of those trials, though – ironically the easiest one which simply requires that a person nap in a rocking bed for a period of time during two afternoons – is in danger of not being finished because of lack of patient participation. Women who are not obese, are not on brain-altering drugs, and are not depressed can participate in the study which is taking place in New York City. (See the blog for details).
  • Similarly, the Bateman Horne Center is often doing clinical trials – but almost always in fibromyalgia. At the present, though, it’s engaged in 4 ME/CFS and long COVID trials including a trial of the most exciting supplement to cross ME/CFS patients’ paths in quite some time – oxaloacetate, as well as the Pridgen protocol, endothelial cell and a mystery study (!)
  • The results from a Freedom of Information Action request to determine how many researchers are applying for ME/CFS grants should tell us if interest in ME/CFS has indeed begun to dramatically increase.

 

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There was a problem, though. Natelson and Schutzer had to pool all the samples together and then assess them – making the result a bit muddled. Skip forward ten years and the technology now exists – much of which they noted was developed by their team members – to assess protein levels patient by patient – and arrive at a more much precise look at what’s happening in ME/CFS patient’s brains. Plus, this time they’ll also have access to Dr. Peterson’s CSF (cerebrospinal fluid) samples and hopefully will come up with a unique brain proteomic signature that tells us much about what’s going on in our noggins.

Dr. Natelson said he was particularly excited by this study, which was ready to go the moment it got funding. They already have the samples, as well as “leading pioneers in mass spectrometry and proteomics, experts in statistics and bioinformatics, experience with the methods”.

This is a one-year grant and it looks like it will actually get done in one year. A successful outcome and they’ll apply for a big RO1 grant application, which I imagine the NIH would find very hard to turn down.

Structural and Metabolic Neuroimaging of ME/CFS Occurring With and Without COVID-19 Infection

No subject may be more important in ME/CFS than blood flows – and if that’s true, no place may be more important to investigate them than the brain. If you can’t get good flows to the big computer in the skull, it’s likely nothing is going to work well.

This study is using advanced 7 Tesla MRI neuroimaging techniques to examine the structure of the cerebrum and a most interesting part of the brain – the brainstem – a possible center of autonomic nervous system dysfunction. The study is also assessing oxygen utilization; i.e. energy production in the brain overall in both people with ME/CFS and people with long COVID. (Take that, RECOVER program…).

  • Contact the Pain and Fatigue Study Center at Mt. Sinai, New York at 212-844-6665 or painandfatigue@mountsinai.org for more information on this study.

Rock a Bye Baby Nap Study On the Brink!

Warning Will Robinson

Danger Will Robinson! (:)) The rocking bed study is in danger of not being completed. (Image from Wikimedia Commons).

In what’s surely the most fun sleep study ever devised, Natelson is trying to give people with ME/CFS something many of us crave – deep sleep! Swiss sleep researchers devised something called a “rocking bed” that rocks back and forth like a baby cradle that helps you get to sleep more quickly and increases the time you spend in deep sleep. It appears that interactions between the amygdala, hypothalamus, and brainstem – three potentially crucial parts of ME/CFS patients’ brains – may be involved.

This study is in danger of not being completed! I know of two excellent studies – a Viagra study that sought to increase blood flows to the brain ME/CFS and an iron infusion study in POTS – that never made it to the finish line apparently because they couldn’t recruit enough patients. One thing we DON”T want is for the NIH to give us funding that gets wasted – particularly in a study that is so easy. All you do is take a nap in the rocking bed for two days

Dr. Natelson said that COVID was the first disruptor, but lately, the study criteria have been getting in the way. This study needs non-obese women who are not on brain-active meds and do not have active depression.

Beds, by the way, can be retrofitted to rock. 🙂

If you can get to New York to take naps for two days, contact Benjamin Natelson at (212) 844-6665 or email his team at painandfatigue@mountsinai.org 

Benjamin Natelson Wants You – To Take a Nap! (And Help Him Understand if ME/CFS and FM are Different)

The RO1 Study

A Cardiovascular Analysis of Post-exertional Malaise

Finally, there’s the big study – the multimillion-dollar, 4-year RO1 study on exercise in ME/CFS. Natelson and Cook threw a bit of a twist into our understanding of what happens during exercise with a big 2-day exercise study which suggested that it wasn’t energy production (VO2 max at anaerobic threshold) that was inhibited in ME/CFS but that something strange was happening with the breathing.

That study – which Health Rising will cover in a future blog – found that oxygen consumption at the ventilatory threshold (VO2VT) was significantly reduced. Importantly, the study found that people with ME/CFS still entered into anaerobic energy production early but at a different physiological point.

Natelson believes that some deep breathing during exercise may be reducing blood volume and exercise capacity. They’ll be closely measuring blood volume levels and replenishing the blood volume between exercise bouts, and measuring how much blood the heart is pumping out, as well as taking other CPET measures in 2-day exercise tests in 120 people.

Measuring Blood Volume in Chronic Fatigue Syndrome – the Daxor Way

The Oxaloacetate Trial

brain imagine oxaloacetate

Natelson will do brain imaging to determine if oxaloacetate increases glutathione levels

Natelson apparently has room for more as he’s also recently got funded to do an oxaloacetate trial. (The trial has not started yet it’s in the last stages of getting IRB approval) Oxaloaceta.te is surely the most exciting supplement to come across ME/CFS patients in years. The sterling results this mitochondrial supplement produced in his ME/CFS patients got Dr. David Kaufman – who isn’t used to such things happening in ME/CFS – so excited that he even created his own small clinical trial.

One ME/CFS oxaloacetate trial is already underway at the BHC (see below), but this one would be more extensive – involving brain scans of ME/CFS patients before and 6 weeks after taking the oxaloacetate twice daily. Since oxaloacetate appears to be able to raise brain glutathione levels, and Shungu and Natelson have definitively demonstrated low brain glutathione levels are found in ME/CFS, Natelson is going to see if oxaloacetate is going to raise the levels of that important antioxidant in the brain.

Oxaloacetate: the Best Mitochondrial Supplement for ME/CFS (and Long COVID?)

More…

You thought that was all? Dr. Natelson is also applying to add long COVID patients to the ME/CFS exercise study and to use brain scans in acute COVID patients to try and figure out how long COVID begins. He is having a moment indeed.

The Busy, Busy Bateman Horne Center 

Bateman Horne Center

The Bateman Horne Center is busy – this time with ME/CFS and long COVID studies

The Bateman Horne Center (BHC) in Salt Lake City, Utah is no stranger to clinical trials – it’s doing them much of the time, but they’re almost always done in fibromyalgia. Things have changed lately, though. Noting “the growing awareness the pandemic has caused”, the BHC recently reported they’re currently engaged in no less than four ME/CFS and long-COVID clinical trials and research studies.

The RESTORE ME Oxaloacetate Trial

A long COVID oxaloacetate trial quickly got underway, but the BHC reported that Terra Biologicals is also funding a 90-day ME/CFS trial. I can’t remember a possible treatment moving so quickly into treatment trials in ME/CFS.

There’s one in-person visit to the Bateman Horne Center for a physical exam, assessments, blood collection, and to be fitted with a device to measure daily steps and upright position. In a nice touch, the people getting the placebo will receive a 90-day trial of oxaloacetate. Each in-house visit also garners a $50 gift certificate.

Pridgen Goes After Long COVID 

Dr. Pridgen’s large 2-viral treatment study for fibromyalgia is wrapping up shortly, but confident as always, he’s already moving on to long COVID. The BHC is conducting the Virios pilot trial with a twist; instead of Famvir, the lead antiviral will be Valtrex (valacyclovir). (Celebrex remains the other drug.)

This 60-person, 14-week trial requires several in-person visits to the BHC. This trial was slated to begin in May. It’s either filled or has not started enrolling yet.

The Blood Vessels: “The Endothelial Function and Upright Activity in ME/CFS and Long COVID” Study

Once again – blood flows. With the Visser team finding reduced blood flows to the brain in everyone with ME/CFS, and David Systrom’s finding suggesting that blood flows are either being diverted from the muscles or not being used by them, and David Patterson focused on the blood vessels in long COVID – blood flows are center stage.

This nice big 100-person study is going to compare blood flows between the long, long haulers in ME/CFS and the newer long haulers – people with long COVID. It’s going to use something called the EndoPAT device to assess endothelial function, and the BHC’s unique ankle device to measure “up-time”, and will include cognitive testing and a blood draw. After the initial 2-hour visit, the rest of the 7-day study will be done at home. Each participant will receive $50.

The Mystery Long-COVID Trial

Another clinical trial should begin recruiting soon. Watch the BHC’s Research Studies page or click their subscribe button on the top of their website to subscribe to their newsletter.

ME/CFS renewal

Signs of life in the ME/CFS field as one researcher gets really, really busy and a clinic embarks on new ME/CFS and long COVID studies and trials.

Conclusion

The NIH missed a big opportunity to vault the ME/CFS field forward but with a longtime ME/CFS researcher and an ME/CFS clinic having quite a moment it may be that a long COVID wave is starting to lift some ME/CFS boats.

We’ll find out how broad that wave is when the results from a Freedom of Information Act (FOIA) which requested how many grant applications the ME/CFS program at the NIH has received over the past two years come back.

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