April 7, 2023
Over 2400 people have signed Long COVID Justice’s petition to the US National Institutes of Health about their secretive and troubling plans for Long COVID trials. We have just received NIH’s response, and ask our community to keep the pressure on. Here’s why:
Treatment, care and support for Long COVID requires addressing the complications of post-exertional malaise (PEM, also known as post-exertional neuroimmune exhaustion, or PENE) that affects all too many of us. (see “What is PEM” below for more information).
Sadly, we have seen decades of researchers ignoring and even worsening PEM in their ill-guided quests to study exercise as a treatment for ME/CFS. And now it seems like the NIH is intent on pursuing a potentially dangerous study of “exercise intolerance” for Long COVID, even though many of us have diagnosed or undiagnosed PEM!
In April 2023, two months after we first submitted our collective concerns, the NIH sent us a letter justifying their plans for the trial – the details of which remain off-limits to Long COVID and ME/CFS patients, advocacy organizations and the public. The excuses and omissions of information in this letter are complicated. But here’s the simple bottom lines:
– The three-page letter never once mentions PEM, still speaking only of “exercise intolerance.” This shows a dangerous ignorance of the specificity and potential severity of PEM, or an unwillingness to directly acknowledge its risks. It includes no specific information on how it would warn or protect people from the risks of PEM from the trial itself or from any misinterpretation of results.
– NIH has still not responded to the MEAction letter calling for immediate release of the study protocol. Without that, there is no way to ensure that “testing of physical therapy strategies would be done in the appropriate patient populations with careful safety monitoring, as well as adaptation and individual tailoring of the intervention.”
– The letter never acknowledges decades of research, experience, and recommendations in post-infection illness and recommendations– expertise that still remains at the margins of the RECOVER Initiative that can lead to repetitions of past mistakes. Too often, researchers who employ exercise interventions for rehabilitation lack awareness and understanding of the evidence found in years of ME/CFS research. For example, they cite WHO and NICE as sources, without referencing the very clear cautions from these same bodies against exercise for people with PEM or ME/CFS.
This is a matter of safety and a matter of priorities: Despite the complexities of Long COVID and over a hundred million people affected worldwide, we know there are likely only a few treatment trials being pursued at the moment. We continue to strongly oppose the inclusion of an exercise study as a top priority – especially without clear, specific and detailed recognition of the risks, the need to exclude many from participation, and a commitment to consistent and careful monitoring of all participants regardless of prior PEM status.
This letter confirms our suspicion that NIH has not yet fully acknowledged the potential harms and limitations of this secretive study. This is unsafe, unethical, and unacceptable.
Recent coverage of the RECOVER exercise trial controversy, with more in the works, are helping to shine a spotlight on this issue. Those close to the RECOVER Initiative have encouraged us to keep the heat on.
What you can do now:
- Please share our petition with friends and family. If you have PEM, let them know that this issue is directly related to your challenges with Long COVID. And if you do not, ask them to endorse in solidarity with the millions of us that do – and all those who may sadly join our ranks in a nation dropping all COVID-19 prevention efforts.
- Continue to speak out on social media, tagging @LongCOVIDNtwk and @NIH on Twitter and @LongCOVIDJustice on Instagram.
What is PEM?
Post-exertional malaise (PEM) is a worsening of symptoms or addition of new symptoms after exertion. It can happen a day or more after the exertion. PEM can come from any physical activity – not just exercise, and not just vigorous activity. It can also come from mental exertion or sensory overload.
For some of us, it seems like cumulative PEM early in our condition led to an ongoing state of disabling fatigue and other symptoms, even without continued exertion.
Resting and pacing are specific interventions that seek to address PEM – but we need many more, including those that find and address the underlying causes of PEM and other disabling symptoms.