Erica Hayes, a 40-year-old long COVID patient, exemplifies the frustration felt by millions as federal research has yet to yield new, approved treatments. Despite the vast reach of long COVID, affecting an estimated 17 million adults in the U.S., the $1.15 billion investment in research has not resulted in any FDA-approved drugs.
This has led to disappointment and anger within the patient community, who argue that the National Institutes of Health (NIH) should prioritize finding ways to alleviate suffering rather than solely focusing on understanding the disease's mechanisms. Meighan Stone, executive director of the Long COVID Campaign, stated, "It's unconscionable that more than four years since this began, we still don't have one FDA-approved drug."
Criticism of RECOVER Initiative
Some doctors and researchers have voiced criticism of the NIH's research initiative, RECOVER (Researching COVID to Enhance Recovery). Dr. Ziyad Al-Aly, chief of research and development with the VA St Louis Healthcare System, noted that the absence of clinical trials forces physicians to rely on educated guesses when treating long COVID. "What [RECOVER] lacks, really, is clarity of vision and clarity of purpose," Al-Aly said, suggesting that the NIH has had sufficient time and resources to make more significant progress.
RECOVER has funded eight clinical trials, with only one having published results. The initiative has supported over 200 observational studies and 40 pathobiology studies, leading to insights on risk factors and interactions with pre-existing conditions. However, critics argue that the focus should have been on interventional trials from the outset.
New Funding Allocation
The NIH is now allocating an additional $662 million for long COVID research, with $300 million specifically earmarked for clinical trials over the next four years. RECOVER issued a request for clinical trial ideas in late October, seeking potential therapies, including medications, with the goal of rapidly advancing treatments for long COVID.
This shift suggests a response to patient concerns and has sparked cautious optimism. Stone described the $300 million as a "down payment," emphasizing that more funding is needed to help patients regain their health. The NIH acknowledges the urgency in finding treatments but stresses the importance of understanding the biological mechanisms underlying the condition.
The Importance of Clinical Trials
Ezekiel J. Emanuel, co-director of the University of Pennsylvania's Healthcare Transformation Institute, pointed out that only 15% of RECOVER's initial budget was allocated to clinical studies, calling it "a failure of having the right priorities." He suggested that preliminary clinical trials could have encouraged pharmaceutical companies to invest in further drug development and investigate the impact of existing drugs on immune responses.
Challenges in Treatment and Insurance Coverage
The absence of FDA-approved treatments means that physicians often prescribe experimental or off-label drugs, leading to insurance coverage challenges for patients. Promising treatments like intravenous immunoglobulin therapy, low-dose naltrexone, and hyperbaric oxygen therapy are sometimes used, but their effectiveness remains unproven, and costs can be substantial.
Amy Proal, president and chief scientific officer at PolyBio Research Foundation, is collaborating on a clinical study repurposing two HIV drugs to treat long COVID. She highlights the importance of clinical trials to evaluate potential treatments and develop new drugs specifically targeting long COVID.
Patient Perspectives
Long COVID patients like Erica Hayes express frustration with the current state of research and treatment. Hayes said she would volunteer for an experimental drug trial, highlighting the urgent need for effective therapies to improve the lives of those suffering from this debilitating condition.
