On Dec. 21, Congress passed the Consolidated Appropriations Act, 2021 (H.R. 133). Among many other measures, the embattled COVID-relief package included $1.15 billion for the National Institutes of Health (NIH) for long-term studies of COVID-19.
This significant amount of funding is vital and must be spent both wisely and expediently. And as we’ve seen in the substantive research successes in HIV/AIDS, that means consistent, deep, and respected involvement of members of affected communities.
The history of the early AIDS epidemic reveals that uncoordinated efforts at the National Institutes of Health made it impossible to ensure accountable, strategic use of funds.
That’s why AIDS activists demanded and won an Office of AIDS Research in 1993, with the first significantly coordinated effort coming in 1997 upon implementation of the Levine Panel’s recommendations of 14 top research priorities, including coordination of clinical trials.
And thus, it is vital from the start that NIH and federal partners establish and implement an integrated long-COVID strategic research plan in and across the post-viral conditions seen in long COVID/post-acute COVID-19 syndrome (PACS)—explicitly including myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS)—and including long-term COVID sequelae such as heart damage. In addition, we’ve learned in the global HIV effort the importance of integrating implementation science to determine the best and most accessible ways to disseminate findings for those in need.
In a recently published report I authored for the COVID-19 Working Group of New York, I argue that discussions about “returning to normal” post–COVID-19 mask an emerging, difficult truth: COVID-19 itself can become a chronic condition, a trigger of subsequent conditions, and the cause of long-term or permanent illness or disability that will impact millions in the United States, affecting many who already live with health challenges as well as those newly facing chronic illness. It will strain already-fragmented chronic care systems, and rates will likely echo or even exceed the disproportionate burden of acute disease in Black and Brown communities.
Anthony Fauci, M.D., director of the National Institute of Allergy and Infectious Diseases at the NIH, estimates that 25% to 35% of those with COVID-19 will face long-term effects, and he recognizes myalgic encephalomyelitis (ME, also known as ME/CFS, referencing the former name of chronic fatigue syndrome) as a likely post-viral syndrome, among other post-acute COVID sequelae.
Fauci affirmed at February’s International AIDS Society conference that “what we’re finding is that there’s a certain percentage of people … who have varying degrees of duration, anywhere up to several months or more, where they have a constellation of syndromes, some of which [are] quite similar to what has been referred to as myalgic encephalitis/chronic fatigue syndrome. And it is rather consistent: profound fatigue, muscle aches, temperature dysregulation like dysautonomia, sleeplessness, and then something that people refer to as brain fog.”
Indeed, many people with long COVID are approaching or have exceeded a six-month threshold of symptoms that can lead to an ME diagnosis. Many had milder experiences with initial COVID infection and were not hospitalized, but now face chronic, complex, and disabling multi-system issues from which they are not recovering.
As so often is the case, it took mobilization and research leadership by affected communities to counter disbelief about the scale and scope of long COVID.
The Patient-Led Research Collaborative for COVID-19—a now-central group in long COVID/PACS research discussions—published the first report on long COVID in early May, having found each other in the Body Politic support group for COVID “long-haulers.” (I have been a minor contributor in this effort, assisting with the wording of research questions and the editing of the initial report.)
Their extensive second study—involving 3,762 respondents from 56 countries—released as a pre-print in December 2020 while awaiting journal publication, concludes that “patients with long COVID report prolonged multisystem involvement and significant disability. Most had not returned to previous levels of work by six months. Many patients are not recovered by seven months and continue to experience significant symptom burden.”
As the report I authored for the COVID-19 Working Group of NY states, “The symptoms of their study participants crossed over an average of over nine organ systems; the most frequent after six months included fatigue, post-exertional malaise (a key characteristic of many cases of ME), and cognitive dysfunction.”
Integrated, Strategic Research
The COVID-19 Working Group of NY—which includes among its membership many HIV advocates, researchers, and clinicians—recommends a dedicated office within the federal government to coordinate all aspects of the COVID-19 response from research to public health implementation. It will also be imperative to have an accountable coordination structure across NIH itself (with significant and visible community representation) in order to ensure best use of these specific funds.
In addition, advocates and appropriators must be ready to fight for, and provide, additional funding over time: In some cases, subsequent conditions or syndromes can appear well after the initial illness or infection. For example, post-polio syndrome can occur 30 to 40 years after the original polio illness.
The pressure is heightened by the unique and long-overdue opportunity to learn from and build the knowledge base on post-viral illnesses and complex chronic conditions like ME/CFS. We’re seeing for the first time how these syndromes unfold in millions of people, even as we race to determine ways to remedy them.
Recognizing the success of cross-disciplinary HIV research coordinated by NIH with deep community engagement from both experts and scientists, the trans-NIH teams that will build out this research must insure that it is designed and conducted in deep consultation with people with long COVID who are members of communities most affected by COVID-19, including Black and Latinx people, immigrants, Native Americans and Alaskan Natives, as well as people living with complex chronic conditions and post-viral illness like ME/CFS, fibromyalgia, and postural orthostatic tachycardia syndrome (POTS).
Ensuring leadership by scientists from underrepresented communities, potentially using models like the Minority HIV/AIDS Research Initiative (MARI), will be vital to begin to address longstanding patterns leading to medical mistrust and low rates of participation in research.
The COVID-19 Working Group of NY has also called upon NIH to work with Department of Health and Human Services partner agencies to develop a coordinated COVID-19 implementation-science research agenda with specific funding. Implementation science studies the translation of scientific findings into “real-world” use, which will be essential in long COVID interventions that must take place in a complicated landscape of health care and social determinants.
In addition, research should not be limited to those with positive COVID-19 test results. Instead, data can be stratified by test results (including non-testers) to look for any findings, without restricting the participation of many people who were unable to access testing or for whom testing was inaccurate.