covidAs we grapple with the third year of the COVID-19 pandemic, a lingering specter has emerged as an unwelcome companion to millions: Long COVID. Characterized by persistent and often debilitating symptoms experienced long after their initial recovery, this condition has affected over 15% of adults across the U.S., who contracted COVID.
With roughly 5.8% (some 15 million!) battling the condition, we cannot simply overlook Long COVID as an individual, one-off, health problem; it's an ongoing, widespread, public health emergency with no end in sight. Yet, Long COVID remains distressingly under-acknowledged, under-researched, and under-funded—despite the recent National Institutes of Health’s (NIH) nationwide research program, NIH RECOVER, designed to “understand, treat, and prevent long COVID.”
Clearly, news of the RECOVER initiative and the formation of the Office of Long COVID Research and Practice are (truly) promising; regrettably, though, the announcement leaves several important transparency questions unanswered. Most primary? The lack of patient input across various research priorities and trial designs, as observed in various proposed and published documents.
Given its $1.15 billion budget and scope—to identify strategies to prevent and treat the long-term effects of COVID, including Long COVID—once the rush to launch these trials began in the fall of 2022, the clinical trial planning process itself often resulted in patient input being relegated to the periphery. Had the patient community been more fully included and respected (for their time, treasure, and talent) in this process, we would have anticipated a different set of priorities and clinical trials.
Additionally, there is concern that the NIH has not provided a timeline for publication of results. Currently researchers are scrutinizing some 60 million electronic health records from some 24,000 trial participants, while also conducting more than 40 pathobiology studies to determine how COVID-19 impacts various body tissues and organs. Information obtained from these investigations has been vital in shaping the design of phase 2 clinical trials. (Phase 2… in this the third year of COVID-19?!)
So, while “only” 1.5% of Americans are experiencing daily activity (of living) limitations, that means over 3.88 million people are already life-bucketed into the Long COVID cohort (CDC, 2023). With enrollment to start over the next few months, results are probably still a year away. By that point, Long COVID will have plagued us for over four years—a warp-speed slowdown for patients awaiting results and relief. (I recall a similar stay with HIV in the early 1980s)
The proposed House appropriations further complicate matters once treatments do come out. But the House is under the assumption that user-fees from bio, device, and the pharmaceutical industry can subsume public cuts. This short-sighted reliance is so dominant that in 2021, those fees accounted for three-quarters—or $1.1 billion—of the agency’s drug division budget. To top it off, nearly half of the FDA’s budget bankrolls some 6,500 jobs at the agency.
The benefits of leveraging big pharma aside (a score indeed), the FDA plays a critical, gold-star role in protecting public health by ensuring the safety, efficacy, and security of drugs, biological products, and medical devices. While these fees can provide a substantial source of revenue, overreliance on them could potentially influence the agency's priorities or decisions and can create a potential conflict of interest. They also affect the agency’s capacity to fulfill its mission, potentially jeopardizing public health in their cost-containment efforts.
In many regards, it feels that the country has already marched on, leaving behind many of us in immunocompromised situations, at the risk stratification of others. Case-in-point. A vital tool in both treating COVID-19—and thereby preventing Long COVID in the first place—is monoclonal antibodies (mAbs). mAbs are tiny laboratory-made molecules that can mimic the immune system's ability to fight off harmful pathogens, but as of January 26th, we no longer have any in our Treatment as Prevention (TasP) arsenal.
And while there have been calls in the halls of Congress for “investments in platform technologies and mAbs,” support for Rep. Trahan’s (D-MA) proposed bill, Disease X Act—that strengthens the Biomedical Advanced Research and Development Authority’s (BARDA) capacity to facilitate public-private research and develop countermeasures for viral threats—hasn’t (yet) moved.
This against the backdrop of a 12% rise in hospitalization for the week ending July 22. Often preceded by an increase in wastewater levels, surveillance efforts, too, have waned. And with it, correlative or causative questions linger. Like how much of that is asymptomatic spread?
Resiliency, immunity, or ignorance aside, still there were 494 deaths the week of July (only now being reported by the CDC). As we’ve all learned, deaths are traditionally a lagging indicator.
Long COVID—let alone COVID—is not a condition we can afford to marginalize, or simply move-on from. And vaccine fatigue also shouldn’t dictate governmental resolve to properly fund the RECOVER initiative and re-configure its research priorities to reflect real-world issues.
And above all, we need 2020 empathy for those affected. Each individual incapacitated by Long COVID is a loss to our community, workforce, and families. It's time to confront and rid ourselves of Long COVID.
Scott D. Bertani, MNM, PgMP, with over 25 years of experience in the field of HIV and syndemics, is currently the Director of Advocacy at HealthHIV.
