USA: Mount Sinai PACS clinic and Dr David Putrino

Twitter thread from Putrino explaining why they will not diagnose ME/CFS post-covid.

https://twitter.com/user/status/1723749843821023617
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"provide care and conduct research for people with infection-associated complex chronic illness, starting with #LongCOVID, #MECFS, #EDS and chronic #Lyme hoping to include more conditions over time. However, in the course of providing services to folks with these conditions, 2/"

"care will be taken to NOT diagnosis them with other conditions just because they meet diagnostic criteria and for no other reason. For instance, people with #LongCOVID at our center will not receive an #MECFS diagnosis just because they meet international consensus criteria 3/"

"for an #MECFS diagnosis. Why? Because making this diagnosis does not change the assessment or treatment options open to our patients, but it DOES limit our patients’ opportunities to participate in clinical trials. We have many interventional trials that are active or pending 4/"

"that have an #MECFS arm, a chronic #Lyme arm or a #LongCOVID arm. However, people with multiple diagnoses can’t take part. The reason for this is because if we’re presenting these data to the FDA, they won’t accept data to support an indication for #LongCOVID if half the 5/"

"patients in the trial have an #MECFS diagnosis as well. So we need to keep them separate. Since adding a diagnosis doesn’t affect treatment, we don’t necessarily see the need to add a diagnosis. Let’s also think about the opposite direction: you have symptomatic chronic #lyme 6/"

"or #MECFS, you go through an acute SARS-CoV-2 infection and 6 months later you still have not returned to pre-infection baseline. Do you have #LongCOVID? Or has your pre-existing #MECFS or #lyme been worsened by a new acute infection? The honest answer is that we don’t yet 7/"

"know the answer to this. In this case, a #LongCOVID diagnosis may be helpful to you in the future to access specific treatments that may become labeled for #LongCOVID, but should you be included in the #LongCOVID arm of a clinical trial? Probably not (and def not according to 8/"

"the FDA). Also, “mixing and matching” diagnoses without a thoughtful rationale will also affect our ability to conduct good-quality EHR research in years to come. If everyone who meets ICC ME/CFS criteria is given that diagnosis, it will skew #LongCOVID data because not all 9/"

"centers will do this and things will get messy fast. I know this is a delicate topic and I don’t want this thread to be misinterpreted, so let me say how much gratitude I personally have for the #MECFS, chronic #Lyme, #Fibromyalgia, #dysautonomia and #EDS communities. Thanks 10/"

Thread continues at link above.
 
Putrino said:
"for an #MECFS diagnosis. Why? Because making this diagnosis does not change the assessment or treatment options open to our patients, but it DOES limit our patients’ opportunities to participate in clinical trials. We have many interventional trials that are active or pending 4/"

"that have an #MECFS arm, a chronic #Lyme arm or a #LongCOVID arm. However, people with multiple diagnoses can’t take part. The reason for this is because if we’re presenting these data to the FDA, they won’t accept data to support an indication for #LongCOVID if half the 5/"

"patients in the trial have an #MECFS diagnosis as well. So we need to keep them separate. Since adding a diagnosis doesn’t affect treatment, we don’t necessarily see the need to add a diagnosis. Let’s also think about the opposite direction: you have symptomatic chronic #lyme 6/"
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That makes no sense. Criteria for interventional trials can include a time and/or suspected cause of onset, along with any other criteria they want to add. So, you can have a treatment arm of 'pre-Covid-19 onset ME/CFS'. And an arm of 'ME/CFS with onset attributable to Covid-19'. Long Covid is an umbrella term that means all sorts of things - from post-ICU symptoms, identified lung damage, ME/CFS...

Putrino is just adding to the mess with ideas like those in those tweets. And contributing to the disappearing of ME/CFS.
 
Amy Proal discussed this problem too. Personally I don't see why LC patients can't be diagnosed with ME/CFS (I've asked for both diagnoses to be recorded in my records). The symptoms and diagnostic criteria are the same (excluding lung fibrosis, PICS etc). Instead of swamping ME/CFS and replacing with a larger number of new LC patients, disappearing ME/CFS, politically it's stronger to say we now have many more ME/CFS patients - it's a major problem. No reason why studies can't simply look at different subgroups: pre-Covid, Covid-induced as Hutan says and Amy indicates at the end.

ME/CFS was the diagnosis patients got after SARS1 and that virus was similarly novel, with unique proteins interacting with ACE receptors etc. I don't think it's logical to say that LC is not ME/CFS, but maybe I'm just not seeing the bagpipes and kilt.

No, I know what question you're asking though. Yeah, because I, I see it as well, like, I, I, I see people, you know, going through this is long covid, ME/CFS, how does this fit together?

I think that this is one thing I'll say. I, ME/CFS patients are extremely sick, and they're some of the most understudied patients who deserve the most comprehensive, amazing research that there is.

And they deserve to be validated and just studied again and again and again. And so I, and I think that, so I think that the study of MECFS cases is incredibly important. It's one of the reasons we started Poly Bioo Research Foundation. That being said, when people develop chronic symptoms after infection with the SARS COV two virus, which is a novel virus that creates proteins that have very unique capabilities like the spike protein that drive very specific kinds of illness.

And the SARS COV two virus can infect, you know, most human tissue types because of the ACE two receptor entry and get into, you know, body sites that are somewhat different than other pathogens. I mean, just give or take that there's, there's very little chance that the, that the patients who have, who meet a particular ME/CFS diagnostic criteria, but got to those set of symptoms from a SARS COV two onset, had the exact same thing happening as someone who got to those sets of symptoms due to another infection or another exposure.
And so I don't think that that, that long covid is ME/CFS, that that has not made sense to me from the beginning. I don't think any many research teams at all are studying long covid that way.

I think what people think though, is that the SARS COV two virus may be able to drive chronic symptoms, or there may be symptoms that manifest in patients with long covid that impact certain pathways, for example, the vagus nerve or the brainstem. And that those pathways may be similarly impacted in patients who end up with an ME/CFS diagnosis, but just via a different pathogen or a different route. And so what that doesn't mean, it doesn't mean then that long covid is ME/CFS, it means that there, there's separate, but there could be similarities.

And I think that it's okay that way, but I think that when it comes to research, we, we need to know if someone has a SARS COV two onset for a lot of our research. Because for a lot of what we're doing, we're looking for T-cell responses that could still indicate infection with SARS COV two, we're looking for spike protein associated abnormalities. We're looking for impacts on the blood vessels or the nerves that would be specific to what the SARS COV two proteins might be more likely to drive.

Right? So to us as researchers, if someone who got chronic symptoms after SARS COV two retains the diagnosis long covid, that is more helpful for us. Um, it that we keep those patients with a long covid diagnosis, even if they could meet MECFS diagnostic criteria.

And what we do then is to the greatest extent possible, and, and many teams are interested in this, we are trying to put in arms of pre covid MECFS patients.

So patients who, who meet MECFS diagnostic criteria, but before 2020, we're trying to integrate them and, and sometimes study them in concert with the patients, the long covid or SARS COV two onset patients. And, and we are doing that, but to call the long covid patients ME/CFS patients is, is actually muddies the groups a little bit more for us than it, than it helps.
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SNT Gatchaman said:
Personally I don't see why LC patients can't be diagnosed with ME/CFS (I've asked for both diagnoses to be recorded in my records). The symptoms and diagnostic criteria are the same (excluding lung fibrosis, PICS etc).
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I'm pretty much in agreement with you SNT, but are you sure the diagnostic criteria are the same? Last time I looked, the WHO criteria for Long Covid were ridiculously non-specific. Well, maybe not ridiculously non-specific when talking about the impact of Covid-19 on health systems. But ridiculously non-specific if you are an investigator trying to unravel the issue of ME/CFS-like Long Covid.

What diagnostic criteria of LC is the same as ME/CFS?
 
That's true in terms of published clinical guidelines, which are overly broad, particularly in the summary. They can expand to be a bit more helpful, eg CDC below. Though from a practical perspective, a doctor diagnosing LC (ME/CFS-like) could alternatively or cumulatively diagnose with ME/CFS.

CDC: Long COVID or Post-COVID Conditions

CDC said:
DEFINITION
Long COVID
Some people who have been infected with the virus that causes COVID-19 can experience long-term effects from their infection, known as Long COVID or Post-COVID Conditions (PCC). Long COVID is broadly defined as signs, symptoms, and conditions that continue or develop after acute COVID-19 infection. This definition of Long COVID was developed by the Department of Health and Human Services (HHS) in collaboration with CDC and other partners.

People call Long COVID by many names, including Post-COVID Conditions, long-haul COVID, post-acute COVID-19, long-term effects of COVID, and chronic COVID. The term post-acute sequelae of SARS CoV-2 infection (PASC) is also used to refer to a subset of Long COVID.
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CDC then said:
General symptoms (Not a Comprehensive List)

Tiredness or fatigue that interferes with daily life
Symptoms that get worse after physical or mental effort (also known as “post-exertional malaise”)
Fever
Respiratory and heart symptoms

Difficulty breathing or shortness of breath
Cough
Chest pain
Fast-beating or pounding heart (also known as heart palpitations)
Neurological symptoms

Difficulty thinking or concentrating (sometimes referred to as “brain fog”)
Headache
Sleep problems
Dizziness when you stand up (lightheadedness)
Pins-and-needles feelings
Change in smell or taste
Depression or anxiety
Digestive symptoms

Diarrhea
Stomach pain
Other symptoms

Joint or muscle pain
Rash
Changes in menstrual cycles
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In the review papers, eg Long COVID: major findings, mechanisms and recommendations (2023, Nature Reviews Microbiology) —

Many researchers have commented on the similarity between ME/CFS and long COVID 99; around half of individuals with long COVID are estimated to meet the criteria for ME/CFS 10,11,29,100, and in studies where the cardinal ME/CFS symptom of postexertional malaise is measured, a majority of individuals with long COVID report experiencing post exertional malaise 7,100.
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Characterizing long COVID in an international cohort: 7 months of symptoms and their impact (2021, Lancet: eClinicalMedicine)

Chronic Fatigue and Postexertional Malaise in People Living With Long COVID: An Observational Study (2022, Physical Therapy)

Endothelial dysfunction and altered endothelial biomarkers in patients with post-COVID-19 syndrome and chronic fatigue syndrome ME/CFS (2022, Journal of Translational Medicine)

A prospective observational study of post-COVID-19 chronic fatigue syndrome following the first pandemic wave in Germany and biomarkers associated with symptom severity (2022, Nature Communications)

Long COVID and Myalgic Encephalomyelitis/Chronic Fatigue Syndrome ME/CFS—A Systemic Review and Comparison of Clinical Presentation and Symptomatology (2021, Medicina)
 
It's still looking like a grab bag of all sorts of things though. For a researcher trying to find a causal mechanism to talk of 'Long Covid' as it is currently defined as a useful category makes no sense to me. Maybe the loss a sense of smell and the meeting of ME/CFS diagnostic criteria and persistent cough and depression are all caused by exactly the same mechanism in everyone. But assuming they are not and using more homogenous disease cohorts seems a safer start point for research.

I thought we would have moved past the idea of Long Covid by now, to more precise definitions of various LC pathologies, but we haven't. I assume the stigma of ME/CFS has something to do with that.
 
SNT Gatchaman said:
but maybe I'm just not seeing the bagpipes and kilt.
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Um I think I need the 3rd grade definition of this (from Wiki):

No true Scotsman, or appeal to purity, is an informal fallacy in which one attempts to protect their generalized statement from a falsifying counterexample by excluding the counterexample improperly.[1][2][3] Rather than abandoning the falsified universal generalization or providing evidence that would disqualify the falsifying counterexample, a slightly modified generalization is constructed ad-hoc to definitionally exclude the undesirable specific case and similar counterexamples by appeal to rhetoric.[4] This rhetoric takes the form of emotionally charged but nonsubstantive purity platitudes such as "true", "pure", "genuine", "authentic", "real", etc.[2][5]
 
Anecdotally, this kind of attitude towards an ME/CFS diagnosis is quite common in the UK, and is part of why DecodeME has struggled to recruit more post-Covid ME/CFS patients than we have. I suspect that a large part of it comes from the clinician knowing the stigma around the ME/CFS diagnosis - we can give them the same care without inflicting that on them - but obviously they then contribute to the stigma themselves with that attitude.
 
Frustrating. I have a close family member in the UK (newly on our forum) also with LC, who could otherwise have qualified for DecodeME. We also share an ME/CFS-affected ancestor from 100 years ago. It would have been ideal to have our family's genes represented in the study. I have to assume that evidence of vulnerability in our family tree across time (as opposed to any shared viral or environmental factors) could only have strengthened the chance of meaningful data.
 
More 'clarification' from Putrino

https://twitter.com/user/status/1723808644616044765
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An MD, Azola Alba, replying to him
"I disagree with withholding a diagnosis of ME from a LC patient. There is clear diagnostic criteria established and we should be building on the decades of work and not reinventing the wheel. Not all Long COVID patients meet MECFS criteria, but those who do need to be identified."

Putrino
"Not withholding! Just not blanket diagnosing!"

Alba
"So MECFS is a blanket dx but LC is not a blanket dx ? Lumping all pw LC in studies without clinically phenotyping them will continue to muddy the science. My clinical lens may be skewing my view. I leave the science to you. I guess we can agree to disagree(;"

Putrino
"Not what I am saying. Happy to have a conversation since my words here aren’t cutting it. You have my email!"

I'm not sure I am any the wiser about how his approach is a good one.
 
Braganca said:
https://twitter.com/user/status/1724024460867494300
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It's an attempt by Putrino to explain himself further. This seems to be the core of his argument

"The intention of this tweet was not to suggest that we would WITHHOLD a diagnosis from anyone, rather to say that we will not be automatically diagnosing everyone with #LongCovid who meets #MECFS diagnostic criteria with ME/CFS. If a patient"

"meets diagnostic criteria and the diagnosis serves them in some way (decided by an open discussion with their clinician), they get that diagnosis. I also want to clarify that this discussion ONLY applies to syndromic diagnoses: i.e. diagnoses that we make by checking off lists"

"of symptoms. This does not apply to diagnoses such as dysautonomia, diabetes, etc where we use clinical data to make the diagnosis. The reason the conversation matters for syndromic diagnoses is because with the right checklist you can diagnose anything. My original thread was"

thread continues

Personally, I am underwhelmed with the logic.
 
Andy said:
I also want to clarify that this discussion ONLY applies to syndromic diagnoses: i.e. diagnoses that we make by checking off lists"

"of symptoms. This does not apply to diagnoses such as dysautonomia, diabetes, etc where we use clinical data to make the diagnosis. The reason the conversation matters for syndromic diagnoses is because with the right checklist you can diagnose anything. My original thread was"
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Not sure why Lyme is in the mix then. Well, chronic Lyme as they are referring to it. A good portion of whomever they see with a history of Lyme will still clinically present as Lyme, e.g, CDC-positive Bb IgG's.

But, eh, it's nice to be included.
 
There's some legitimate concern with leaving people with multiple diagnoses and how healthcare professionals perceive them (and I guess with having any such diagnosis at all, and how some HCPs badly react to them). But I think on the whole the benefits outweigh those concerns. The issues are clearly with how those illnesses have been poorly defined, and the way forward is to fix those problems, not tiptoe around them.

So it's more about protecting patients from the screw-ups of medicine than anything else. And it's not as it fixing medicine will be easy or happen soon, so you can understand the reasoning here. But I think that making the problem more visible is the fastest way to force change.

It's not as if the behavior of the quacks pushing psychosomatic ideology will change, they will keep doing what they do no matter what. Or as if the bad attitudes towards the illness change significantly whether the diagnosis is applied at all.
 
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