It’s not every day that the head of the NIH makes time for Q&A on long COVID and ME/CFS.
An ME/CFS or long-COVID moment is an indication that something in the force has shifted – that these diseases are making headway in ways they have not before. As we go along in our day-to-day lives, it’s easy to forget that signs of significant shifts are occurring – and fairly regularly. Here are some recent ones.
- ME/CFS and Long COVID Experts Crash Time’s List of 100 Most Influential Health Leaders: It’s Another ME/CFS Moment
- Another ME/CFS Moment: ME/CFS is Much More Common than Thought, Says CDC
- A ME/CFS Just Occurred at…The Mayo Clinic!
The Bertagnolli Moment
The latest “moment” concerns Betsy Ladyzhets’s Q&A with NIH DIrector Monical Bertagnolli (“Q&A: NIH Director Dr. Monica Bertagnolli on next steps for RECOVER, future Long Covid research plans, and more“. NIH Directors have a lot on their plates and we rarely see them talk about long COVID, and even rarer, ME/CFS.
THE GIST
- An ME/CFS or long-COVID moment is an indication that something in the force has shifted – that these diseases are making headway in ways they have not before. As we go along in our day-to-day lives, it’s easy to forget that signs of significant shifts are occurring – and fairly regularly.
- The latest “moment” concerns Betsy Ladyzhets’s Q&A with NIH DIrector Monical Bertagnolli (“Q&A: NIH Director Dr. Monica Bertagnolli on next steps for RECOVER, future Long Covid research plans, and more“. NIH Directors have a lot on their plates and we rarely see them talk about long COVID, and even rarer, ME/CFS.
- Betsy Ladyzhets is an investigative journalist whose main effort, The Sick Times, is a relatively small specialist website; i.e. it’s not the New York Times, the Boston Globe, or even the Cincinnati Herald. – and that’s the thing – the new NIH Director took time out of her very busy day to speak to the cofounder of a small website about long COVID and ME/CFS.
- When asked about the RECOVER Initiative’s much-criticized clinical trials for long COVID, Bertagnolli acknowledged the disappointment, stated that each trial also used the intervention to understand the biology of long COVID, and then pointed to something very unusual for the notoriously closeted RECOVER Initiative – an open meeting from Sept 23-25th to discuss options for the upcoming round of trials. (You must register by Sept 6th.)
- Citing the “intense activity”, the “really serious, hard work to be done”, and its inclusive nature, Bertagnolli seemed to go out of her way to portray the new RECOVER as a fast-moving, receptive initiative – in short, everything it hasn’t been perceived of as yet.
- She stated that big Pharma needs to know more about the disease before jumping in but failed to acknowledge that the fact that the $1.15 billion RECOVER Initiative has contributed nothing substantial to our understanding of the disease and doesn’t appear likely to do so anytime soon. (It spent most of its money on a limited testing regimen.)
Thus far, RECOVER has proven to be a hugely expensive and decidedly uninformative undertaking. Even with the $500 million boost in funding, Bertagnolli, the initiative is still “struggling with balancing resources”. $1.65 billion hasn’t gone very far…
That provides clarity though. The only way ME/CFS and diseases like it will get their fair share is through the Long COVID Moonshot bill that’s making its way through Congress right now. The big push for the bill is coming up soon. Stay tuned.
As NIH Director Bertagnolli has a stake in seeing the RECOVER Initiative succeed. Right now, its critics abound. The NIH appears to have flubbed the chance to prove it could effectively launch an effort to understand a new disease.
She clearly has a lot of work to do. Time will tell whether she will take actions to right the ship or let the project bumble along Choosing to speak to Ladyzhets suggests, though, Bertagnolli is sincere about long COVID and ME/CFS and that’s potentially a big deal. An NIH director pushing for a long-term commitment to these diseases would, one would think, go far.
Words, of course, only account for so much. Former Director Francis Collins told the ME/CFS community that the NIH was now serious about ME/CFS and to watch them, only to drop the disease a year or two later.
Time will tell if this is a long COVID / ME/CFS moment or more talking points from the new Director. I’m hoping that it’s the former.
Still, why would an interview with Director Bertagnolli be considered an ME/CFS/long-COVID moment? Because of who Betsy Ladyzhets is and who she is not.
Betsy Ladyzhets’s Q&A with Bertagnolli was a good sign.
The cofounder and managing editor of The Sick Times – a journalism-based website documenting the long COVID crisis – Betsy Ladyzhets has been laser-focused on COVID-19 and long COVID. A former journalism fellow at MuckRock, her 2023 STAT/MuckRock piece, “The NIH has poured $1 billion into long Covid research — with little to show for it“, made the news. Her work has appeared in the Science News, The Atlantic, STAT News, FiveThirtyEight, MIT Technology Review, TIME.com, and other national publications.
For all its good work, Ladyzhets’s main effort, The Sick Times, is a relatively small specialist website; i.e. it’s not the New York Times, the Boston Globe, or even the Cincinnati Herald. That brings up a really interesting question: why would the new Director of the $47 billion-a-year National Institutes of Health take time out of her busy day to talk to her?
The fact that she did do that may be more important than anything she said. When the head of the NIH takes the time to speak to the cofounder of a website devoted to long COVID – that’s potentially very good news.
Bertagnolli’s background doesn’t suggest she would have much interest in complex, poorly understood diseases like long COVID. She’s been immersed in a field – cancer – which with its diagnostic precision couldn’t be more unlike messy fields like long COVID and ME/CFS. (She does know about the Epstein-Barr Virus (EBV), though.)
She has quite a resume. The former Director of the National Cancer Institute (NCI), Bertagnolli was chief of the division of Surgical Oncology for the Dana-Farber Brigham Cancer Center, the former President of the American Society of Clinical Oncology and the chair of the Alliance for Clinical Trials in Oncology. She trained in surgery at Brigham and Women’s Hospital.
She’s not exactly a fresh face. In her mid-60s, she’s had plenty of time to take in the prejudices that have so hampered the ME/CFS field. That doesn’t appear to have happened, though. She became NIH Director not in the middle of the COVID-19 pandemic but of the long COVID “pandemic” and appears to be taking it quite seriously.
The Q and A
Ladyzhets first asked about the RECOVER Initiative’s much lamented first round of clinical trials and the new trials seeded by $500 million from the Biden Administration. First, there was some good news. Bertagnolli pointed out that while the long COVID community was “a little disappointed” (an understatement), each trial also used the intervention to understand the biology of long COVID.
While some of the interventions were so milquetoast (cognitive training, exercise, sleep hygiene) that one wonders how much help biological analysis will provide others (IVIG, transcranial stimulation, Paxlovid, Modafinil), they might provide some insights. In any case, RECOVER showed some creativity when it decided to dig into the biological effects of the trials.
It became clear that RECOVER got the message about speed as well. In contrast to the “old” RECOVER which kept pushing the starting date of the clinical trials back and back, Bertagnolli said RECOVER was moving “really fast” and pointed to an open Sept 23-25th meeting to discuss the new trials which she called “absolutely critical”. The fact that the meeting is taking place is a rather overt acknowledgment that RECOVER needs more help with creating clinical trials. (That meeting is open to the public and you must register by Sept 6th.)
Citing the “intense activity”, the “really serious, hard work to be done”, and its inclusive nature, Bertagnolli seemed to go out of her way to portray the new RECOVER as a fast-moving, receptive initiative – in short, everything it hasn’t been perceived of as yet.
Recognizing that big Pharma is still mostly standing on the sidelines Bertagnolli noted that until we “understand the fundamental pathobiology” of long COVID, they’re not going to join in. Then she said something that simply didn’t fly: that getting at the pathobiology was a “critical part of the cohorts, the specimens, the clinical trials…” in the RECOVER Initiative.
What happened with getting at the roots of long COVID?
That was ironic given that the single most disappointing aspect of the project has been its rather bizarre neglect of the pathobiology. Bertagnolli was right when she said we need to get at the pathobiology to find the right treatments, but RECOVER has spent most of its money carrying out a limited and hardly informative (at least for the ME/CFS-like subset) testing regimen in tens of thousands of participants.
On the plus side, it’s taking lots of samples. On the minus side, it doesn’t appear to have the funds to do anything with them.
If the RECOVER project has been focused on pathobiology, it’s hidden it very well. Of the 75 publications to come out of the RECOVER project thus far, I found only four that address the pathobiology of the ME/CFS-like subset of long COVID. Somehow, this hugely expensive project has hardly moved the needle in understanding the largest subset found in long COVID.
Since Bertagnolli said a major area RECOVER could improve on was communicating that perhaps there’s something we don’t know. (I’m still having trouble grappling with the idea that such an expensive project has produced so little of substance.)
So much money in – so few results out.
Despite the fact that the RECOVER has spent more – much more – on long COVID in five years than it ever spent on ME/CFS over 40 years (and knows much, much less about it), its big problem right now is funding. Bertagnolli said, “Even with the $515 million (boost)…we’re struggling with balancing resources”. $1.65 billion just hasn’t gone very far…
Not surprisingly, Bertagnolli tagged pathogen persistence and an aberrant immune response as the two chief hypotheses regarding long COVID and twice questioned whether we will either need new, stronger antivirals or use the current ones at higher doses.
Thankfully, Ladyzhets kept ME/CFS in the discussion and, in fact, Bertagnolli, without being asked about it, included ME/CFS in her first answer. Still, her reply to Ladyzhets when she talked about people who have had ME/CFS “for 20, 30, 40, years”, while positive, “We absolutely have to address that”, lacked substance.
Bertagnolli acknowledged the need to transition from the shot-in-the-arm type funding given by Congress with the RECOVER Initiative into a “long-term project” that illuminated long COVID “ME/CFS, chronic Lyme disease, all of these chronic conditions.” Her call for “A long-term program that’s really robust in these conditions”, and her support of the Long COVID Moonshot, was encouraging.
When it came to the big question for ME/CFS – what about more funding specifically for ME/CFS – her reply was typical, disappointing, and illuminating; i.e.
“We care a lot about ME/CFS but don’t look to us for more funding.” Instead, she encouraged the ME/CFS community to pin its hopes on long COVID – which, of course, we are.
“We want to be able to conquer ME/CFS and do it in the best possible way. I hope that the ME/CFS community will see much of the research that’s happening now, spurred on by Long Covid, to benefit them.”
Ironically, we are learning more about ME/CFS from long COVID – but not from the NIH. As to ME/CFS itself, Bertagnolli stated:
“we have a small but mighty team of long-term ME/CFS researchers who’ve been interested in this problem, some internal to NIH, that we intend to continue to fully support… The funding issues, that’s always a moving target. It’s difficult for me to speak to that other than to say, we’re going to do the best we can with what funding we receive.”
The funding “we receive” says it all: the NIH is not going to dig into its coffers to give ME/CFS a hand up. If Congress allocates more money for ME/CFS, fine…otherwise things will remain the same. At least that provides clarity regarding how important the Long COVID Moonshot bill is for both the ME/CFS and the long-COVID fields. Stay tuned on that – a major effort is coming up shortly.
As NIH Director Bertagnolli has a stake in seeing the RECOVER Initiative succeed. Right now, its critics abound. The NIH appears to have flubbed the chance to prove it could effectively launch an effort to understand a new disease.
She clearly has a lot of work to do. RECOVER’s open meeting on clinical trials is a step in the right direction, but major issues in the RECOVER program need to be addressed. Whether she will take an active role in addressing them or whether she will let the project bumble along remains to be seen.
Choosing to speak to Ladyzhets suggests, though, Bertagnolli is sincere about long COVID and ME/CFS and that’s potentially a big deal. An NIH director pushing for a long-term commitment to these diseases would, one would think, go far.
Words, of course, only account for so much. Former Director Francis Collins told the ME/CFS community that the NIH was now serious about ME/CFS and to watch them, only to drop the disease a year or two later. ME/CFS funding at the NIH today is lower than when Collins promised the ME/CFS community that the NIH was finally getting serious about the disease.
Time will tell if this is a long-COVID / ME/CFS moment or more talking points from a new Director. I’m hoping that it’s the former.
I searched The Sick Times, and was pleasantly surprised to see a decent number of search hits returned for “autonomic” and “dysautonomia”.
I occasionally do this same search on the larger newspaper and media outlet websites, and often there are no hits, even for organisations that have reported on Long COVID.
So that’s good to see.
I think this information is a lot more interesting and potentially helpful than yet another review of the government “maybe” finally acknowledging ME/CFS.
“Advancing Research and Treatment: An Overview of Clinical Trials in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) and Future Perspectives”
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10816159/
Some interesting highlights include:
‘Herpesvirus is considered the main cause of up to 80% of ME/CFS cases, making antivirals a logical treatment option.’
Immunological disturbances have been found in ME/CFS patients, including changes in cytokine profiles [51], increased numbers of B-cell subsets [52,53,54,55], and decreased cytotoxicity of natural killer (NK) and T cells [56,57,58], which play a role in the immune defence against viral infections [59]. Furthermore, an autoimmune aspect of ME/CFS has been implicated, with autoantibodies detected in 4 to 95% of ME/CFS, including antinuclear antibodies, antibodies to neurotransmitters and neurotransmitter receptors, and antibodies formed by oxidative and nitrosative stress (O&NS) (reviewed in [23,60]). Additionally, decreased levels of immunoglobulin G (IgG) subclasses IgG3 and IgG4 have been reported in subsets of patients [61]. Inflammatory, autoimmune, and immunodeficiency problems reported in ME/CFS patients justify the need for treatments targeting these disturbances.
There is a lot of other important information in this review which is best read in small sections since it is dense. This was published in the Journal of Clinical Medicine in January 2024. Cort, maybe you already covered this, but even if you did, I think it warrants revisiting.
The only remedy is to facilitate the immune system to identify and kill the offending neuro-viruses. NOT to treat the symptoms only.
Indeed, it is difficult to understand that over seventy years ago Dr. Jonas Salk was able to invent a means to instruct the immune system to kill the polio neuro virus. But since then, nothing has been accomplished to kill other neuro-viruses?? If only Moore’s Law applied to medical/viral research and kill remedies instead of to just über-profitable treatment remedies.
Randy, I totally agree with you that facilitating the immune system in its battle against herpes viruses is the only option. (Polio is not a herpes virus.) Once you have a herpes virus, it lives in your body forever and, as far as I know, they have never developed a “cure” for any herpes virus. There is some interesting research, however, done at Baylor. https://hhv-6foundation.org/transplant-complications/937 Baylor College of Medicine’s Center for Cell and Gene Therapy has demonstrated a way to quickly generate antiviral T cells for the treatment of opportunistic viral infections, and recently reported success in a small clinical trial. This research has been ongoing for a while and I am not sure why larger studies have not been done. Here is the full paper: https://pubmed.ncbi.nlm.nih.gov/24964991/
Hello, Betty
Thank you for your reply.
I meant that the polio-virus is just that; not a herpes virus.
My wife has long-haul Covid with ME/CFS symptoms thus my interest in the subject matter.
To date, the only prospective remedy to kill offending herpes virus is Ultraviolet Blood Irradiation treatment that was successfully used in the 1930s, 40s and 50s before establishment medicine abandoned it for antibiotics. She has yet to try it since only a relatively few naturopathic practitioners offer the treatment, of which, there are none locally.
My knowledge of the treatment was derived from Dr. William Douglass’ book Into the Light.
Do you have any patient experience/results with the treatment?
Dear Randy,
First, I am so sorry that your wife has Long Covid with ME/CFS symptoms. I have had ME/CFS since 1984 and confirmed Covid twice last year after I attended a national conference and again after travelling to Maui to visit our daughter. In my case, the symptoms of Long Covid were more serious with a sudden increase in high blood pressure and heart A-fib after walking only a short bit. Sometimes, it is hard to separate which symptoms are from Long Covid and which from ME/CFS. I am being treated with an anti-viral called Nexavir which you can buy without a prescription from the Nexaco Company. Dr. Paul Cheney first recommended it for ME/CFS and it also seems effective (not a cure) for Long Covid. Nexavir is the latest version of a very old medicine called Kutapressin which is made out of pig’s liver. It is in cream form. It is not inexpensive, but worth a try.
I am glad there are more and more people in the ME/CFS community who think that the research into the herpes viruses in ME/CFS should be the question that should get the most attention. Simply because it is the only hypothesis where researchers have already been successful at finding proof in small studies of excellent quality that herpes viruses seem to be at the core of the explanation of the pathomechanism.
I am not worried that the pharmaceutical industry will not begin to work on new treatments as soon as there is a full insight into the pathomechanism of ME/CFS.
What is worrying now is that there are still way too many “health experts” in the top ranks of institutions like the NIH who continue to resist the fact that ME/CFS is a somatic illness. Or, because they don’t want to understand the catastrophe the medical system has produced for people with ME/CFS over the last century they simply don’t want to know the somatic pathomechanism of ME/CFS.
Hello Betty, thank you so much for making us aware of this important review. I also missed it.
Until February 2024 the British ME Association did weekly systematic research updates which was very helpful. I am sure that this paper would have been discussed there. Unfortunately, they stopped. Probably because they had to reallocate their resources. Such a service is now missing for ME/CFS.
Having just scrolled down that paper, I feel relief and hope. In the last years too many researchers showed up especially in Long Covid who are not able to do proper research. Namely to first teach themselves the state of the research and then starting from there to formulate testable hypotheses and then do a study or run a trial.
The half of a billion invested in Long Covid through the RECOVER initiative was thrown out of the window exactly because of these simple reasons.
Watching this was very stressful for me, and I had times, where I needed to stop following the online discussions because it instilled hopelessness and despair in me.
I am glad that the projects in the EU, like this simple review that you made us aware of, seem to show more of a good understanding for what are the required characteristics of good research, and go at a slower and more careful pace. Do the necessary work step by step.
Hi Cort I didn’t receive this through the email but went directly to your sight. Maybe that it why there are only a few comments.
Thanks, Sandra – just about to send the email blast out 🙂
I appreciate the interview which forced Bertagnolli to consider her accountability to mecfs, but I’m unimpressed with her responses. Very disappointed that they will not look to redirect funding from AIDs since it now has multiple treatments (and which fundamentally requires certain personal actions rather arising from nowhere). Also, MECFS patients cannot be seen at the RECOVER clinics unless they also have long Covid so I think counting us as part of that umbrella is a fail. Can we somehow keep up the pressure on the press to continue to interview her to keep us top of mind?
ME/CFS and Long-Covid symptoms are caused by one of several neuro-viruses, perhaps herpesvirus-6A or 6B or herpesvirus-4 aka Epstein-Barr/ Guillain-Barre viruses or similar.
As soon as the NIH’s Monica Bertagnalli understands this, she will stop the madness of spending tens of millions of taxpayer dollars on pharmaceutical research and instead recommend a means to kill the offending neuro viruses. Namely, facilitating the adaptive immune system to kill the viruses using proven oxygen treatment such as IV-Ozone and/or Ultra Violet Blood Irradiation treatment that was so successful in the 1930s and 1940s. Both, BTW, obviate the use of pharmaceuticals and subsequent years of frequent doctor visits at $300 to $500 each.
However, considering the immense political power of for-profit oligarchical Big Pharma, I doubt the latter treatments will even be considered or even recommended to the medical establishment.
You can bet that by now, she’s already been informed of the six- or seven-figure salaries waiting for her for when she decides to exit the the NIH. But only if her decisions favor members of both Big Pharma and Big Medicine.
We know as many as 45% of people with Long COVID fit the case definition for ME/CFS. The RECOVER Initiative should be studying ME/CFS as well. #NotJustFatigue has been lobbying for its inclusion.
Sure we’ll see …meanwhile those of us who have suffered now for only a couple of years with post COVID type of ME/CFS are to do what? I just received what I consider to be my Neurologist’s final Kiss off as all of my bloodwork came back OK, and I believe he just wants to be rid of me! I believe anyone “in the know and not in denial” can see that there may already be potential cures or at least potential new drugs like for instance “Inspiritol” and others , but those holding the reigns of power seem unwilling to expedite the same for a quick pathway for FDA or any kind of EUA. Will these potentials be bought out or placed on the back burner and never see the light of day, or will someone able to do so and with a sense to help suffering humanity fight with fervor through the fog to give finality that can change our fate for the better and bring immediate resolution ?
Doubtful but hopeful !
Cort, I think you may have covered this in previous articles about the NIH but I am wondering if you could review who the ME/CFS researchers Bertagnolli refers to are? Also on the one hand I understand the NIH wanting to take a fresh look at the issue of post infectious diseases like long covid but it always sounds like they are starting from scratch and reinventing the wheel. Do they talk to Ron Davis, Klimas, Bateman, Jarred Younger? Sometimes it seems like the money could be better spent funding existing researchers that actually have an interest in post infectious diseases rather than what seems like a “we’re interested but not that interested” attitude at the NIH. Or at the very least a feeling that they don’t really want to engage with patients and outside researchers in a collaborative way. I do have to remind myself that the focus should be congress, not the NIH, since congress is the one really in charge (of the money at least).
Perhaps the NIH will eventually change. The CDC has come along way, both on their website and in terms of research. Speaking of which their recent study showing that patients with “acute infection like symptoms” had similar rates and severity of ME/CFS symptoms whether they tested positive for covid so maybe it’s time to just end this ME/CFS vs Long Covid thing and go with “Post Acute Infectious Syndromes”.
How much total funding has MECFS received from the the NIH in the last 40 years?
Would be nice to be able to cite a specific figure to highlight the absurdity of the funding disparity
I think that the complete eradication of viruses holds a lot of promise. I will reiterate an experience of mine that I think supports this contention. I have had CFS/Fibro since age 30 – in the late 80’s. In the mid 90’s I took a trial regimen of bismuth (pepto-bismol) for a week or two, then added minocycline (or perhaps tetracycline) and Biaxin (clarithromycin) – taking all 3 meds for another two weeks. This was a regimen commonly used at the time to treat H.Pylori (a bacterial infection in the stomach known to cause ulcers in some people). I took it on a trial prescription from my GP even though I tested negative for H.Pylori – as my symptoms strongly suggested some kind of ongoing infection. The bismuth was taken for at least a week before (and during) the abx, as it somehow enhances the killing (or cell penetration) capacity of the abx/anti-virals.
The first week on bismuth and the second week on all 3 meds – left me with “floor hugging” fatigue – which made me basically give up hope on this regimen. But then, on the start of the 3rd week while taking all 3 meds – I unexpectedly experienced a 100% resolution of all of my symptoms, and I felt better (with more energy) than I had ever remembered experiencing in my entire lifetime. At that point I thought that I was finally cured! Unfortunately, after I completed the final (glorious) week on the 3 meds, my symptoms slowly returned.
I have explained this here because I later did some research to find that all of the meds of this regimen (the bismuth, the cycline, and the biaxin) – all have some degree of anti-viral properties (as well as their anti-bacterial properties). In fact, intracellular bacteria (like viruses) have no cell walls. They are very small and live inside other human cells. Their similarities to viruses can be so great that there is controversy amongst scientists as to whether some species are bacteria or viruses.
H.Pylori in the stomach is considered a bacteria – but it takes a regimen of multiple meds (like the one I described above) to eradicate it. This makes me wonder if new, more effective anti-virals, or combinations of current anti-virals/abx with meds that enhance them – might get rid of a viral root cause of CFS/Fibro/Long Covid – so the symptoms do not slowly return (along with the virus) after an anti-viral regimen is stopped?
Because of the incredible but temporary 100% (+) recovery that I experienced on the bismuth + 2 antibiotics (that were all also anti-virals) combination described above – I consider anti-viral research (especially in combinations) to be extremely promising. That being said, I have been waiting for decades to see it researched so I am not holding my breath.
Luckily not everyone is as useless as the NIH! Interesting German study on PEM:
https://link.springer.com/article/10.1007/s15010-024-02386-8?fbclid=IwY2xjawFI2JtleHRuA2FlbQIxMQABHTxGxliRv9uN9QprIy23yCSZ86rwtrWY3Jx0SMQtokwM7FyM1gx_TigQhA_aem_Nu_VQLJ30f80U5LFXK6wzg
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