Effie SeibergDec 23, 2022

ACTIVISM ALERT:

The NIH is making its RECOVER trials for #LongCovid test therapies that are actively harmful for these patients and have long been debunked: graded exercise therapy and cognitive behavioral therapy. (Therapy's great to manage feels about this disease, not a way to cure this.)

Add your name to this petition to tell them to redirect energy into things that we don't already know will do harm:

https://actionnetwork.org/petitions/tell-nih

#NEISvoid #covid #mecfs #MyalgicEncephalomyelitis #GET #CBT

NIH must stop Long COVID trials on debunked, damaging therapies and fund strategic therapeutic research.

As the year draws to a close, I am contacting you on an urgent matter. Please sign our petition to demand that the US National Institutes of Health block plans for Long COVID research studies on debunked, harmful methods and step in to ensure a strategic, well-funded effort to find real answers. Here's what's going on: The RECOVER Initiative was funded by the US Congress to find answers on how to treat Long COVID. But we've learned that RECOVER's plans for their first wave of clinical trials includes studies of exercise therapy and cognitive behavioral therapy. We are, frankly, horrified. Patient advocates and our loved ones are speaking out: Approximately half of people with Long COVID meet the diagnostic criteria for myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). Research studies and patient reports have shown that exercise therapies often cause harm for people with ME/CFS and cognitive behavioral therapy is not an effective treatment. Given this, it is neglectful that RECOVER would choose to focus on exercise and forms of CBT when there are dozens of drugs available waiting to be tested that could lead to better outcomes and/or more clues as to the pathophysiology of Long COVID. It is a waste of taxpayer money, limited resources, and crucial time to be testing harmful, debunked hypotheses. Please sign our petition to demand that NIH immediately step in to right this situation, and commit to greater leadership and resources on Long COVID and associated diseases (LCAD). NIH failed to secure any new funding for RECOVER this year, so these misguided trials might be among the only ones funded for at least a year. As one of millions of people now living with both ME/CFS and Long COVID, I thank you for your help. JD Davids co-founder Long COVID Justice

Show threadBrian VastagDec 23, 2022
@effies Effie, do you have any links to RECOVER including GET/CBT?
Show threadEffie SeibergDec 23, 2022
@brianvastag ah here we go https://twitter.com/loscharlos/status/1606035530000408576/photo/1
charlos on Twitter

“And last week, RECOVER laid out plans for clinical trials at EU-US Conference, which included "Rehabilitation & Cognitive Behavioral Therapy (CBT)" — If funds are so limited, why aren't we prioritizing the hundreds of repurposed medications waiting to be trialed for #LongCovid?”

Twitter
Show threadBrian VastagDec 23, 2022
@effies ok, thanks, although that one slide isn't enough to convince me there's a trial of CBT/GET being planned.
Show threadEffie SeibergDec 23, 2022
@brianvastag It seems to me like it's at the top of their priorities list. I'm hoping the activism links make them change direction.
Show threadLaura J Mixon
@effies @brianvastag I looked through the protocols. Here’s what I learned. First, the RECOVER Protocol includes exercise =testing= rather than =therapy=; however, the real risk is that that will be a distinction without a difference. Here’s why.
Dec 24, 2022 at 12:03amWeb
Show threadLaura J MixonDec 24, 2022
@effies @brianvastag RECOVER has three primary sets of long Covid protocols: one for adults, one for children and young adults, and one for autopsies.
Show threadLaura J MixonDec 24, 2022
@effies @brianvastag In both cases, they use three tiers for participants, and in both cases, multiple occurrences of a complete cardiopulmonary exercise test is called for. Here’s a link to what a C-PET consists of: https://stanfordhealthcare.org/medical-tests/c/cardiopulmonary-exercise-test.html
Cardiopulmonary Exercise Testing

Cardiopulmonary exercise test, or CPET, uses exercise to evaluate the heart and lungs.

Show threadLaura J MixonDec 24, 2022
@effies @brianvastag Note that patients undergoing this test are supposed to push themselves to their maximum endurance. Even if the testing is done by a professional knowledgeable about ME/CFS, that criterion alone puts a person with ME at substantively higher risk than someone else would be.
Show threadLaura J MixonDec 24, 2022
@effies @brianvastag OK, with that background in mind, onto the protocols themselves.
Show threadLaura J MixonDec 24, 2022
@effies @brianvastag Here you go:
https://recovercovid.org/docs/PediatricProtocol.v2.3.pdf
Protocols for pediatric Tier 3 subjects (~10% off the cohort): requires graded cardiopulmonary exercise testing monthly from months 3-15, and again 1 year after the final monthly test. See pp. 9, 12, 25, 42, 60, 88.
Show threadLaura J MixonDec 24, 2022
@effies @brianvastag In this protocol they identify C-PET as only a minor elevation of above minimal, their lowest risk designation.
Show threadLaura J MixonDec 24, 2022

@effies @brianvastag Here are the adult protocols/

https://recovercovid.org/docs/Adult.Protocol.v6.0.pdf
Protocols for adult Tier 3 subjects: full cardiopulmonary exercise testing 7 times over a 48-month period (baseline, 3mo, 6mo, 12mo, 24mo, 36mo, 48mo). See pp. 19, 43, 52, 60. Note, CPET is =not= flagged as having greater than minimal risk, which is =not true= for ME/CFS patients.

Show threadLaura J MixonDec 24, 2022
@effies @brianvastag Tier 3 testing to be done on approximately 20% of subjects.
Show threadLaura J MixonDec 24, 2022
@effies @brianvastag Even in the hands of experienced ME/CFS pros, these tests pose risks. And that’s the rub: statistically speaking, there =aren’t= any ME/CFS pros out there. There are only two C-PET testing centers that I know of (those this may have changed in months since I looked it up): one in FL and one in CA.
Show threadLaura J MixonDec 24, 2022
@effies @brianvastag my big concern here is not that they included the tests, per sé; however dangerous it can be to people with ME, it’s one of the few tests that shows our bodies’ pathological reason response to exertion, and it’s more uncommon to be listed. My concern is that those who designed the protocols didn’t have the requisite knowledge regarding its risks to note it in the protocols.
Show threadLaura J MixonDec 24, 2022
@effies @brianvastag How, then, can we trust them to properly vet the host of researchers who will respond?
Show threadLaura J MixonDec 24, 2022
@effies @brianvastag (minor note, at the top of the thread, mentally insert “of the two protocols with living subjects” before “both protocols include exercise testing…”)
Show threadLaura J MixonDec 24, 2022
@effies @brianvastag (also insert “in the US” after the mention of two testing centers. Bleargh; ME cheesebrain definitely setting in…)
Show threadLaura J MixonDec 24, 2022
@effies @brianvastag@sciencemastodon. com another correction: “it’s one of the few tests that shows our bodies’ pathological reason response to exertion, and it’s =not= uncommon to be listed.” Apologies for all the typos. I probably should’ve put them in a doc for a quick edit instead of writing them on the fly.