Despite more than a billion dollars in funding it received in December 2020 to study long COVID, the National Institutes of Health (NIH) has produced only disappointment in the eyes of many patients, their advocates, researchers, and even people inside the NIH.

‘A Slow-Moving Glacier’

Besides recruiting just 3% of the participants it needs to begin research, criticism leveled at the agency revolves around a lack of urgency and transparency with patient advocates and researchers, and investigating open-ended research questions instead of testing promising therapies.

Former long COVID patient Lauren Stiles, a research assistant professor of neurology at the State University of New York at Stony Brook, says the sluggish study “is a slow-moving glacier” and adds, “With a half-billion dollars, they could have run multiple clinical trials.”

Co-chair of the research initiative, Walter Koroshetz, who directs the NIH’s National Institute of Neurological Disorders and Stroke, says that everybody involved in the study is frustrated by its slow pace, and admitted that enrollment is taking “way too much time.” But he added that the research effort is actually “much faster” than any previous NIH initiative.

High Stakes

Unfortunately, the pace offers little consolation to the long COVID community, and there’s a lot at stake. The NIH’s research could play a large role in how the pandemic’s fallout on the healthcare system is addressed, and will affect the care of not only COVID-19 long-haulers but also the millions living with other post-viral illnesses. To succeed, however, the NIH has to conduct a large-scale study while avoiding excessive bureaucracy.

“The potential is huge,” said one anonymous researcher involved in the study. “With that kind of investment, if the money is used wisely, it could be a huge leap in knowledge of post-viral disease. I hope it’s still going to be possible.”

The RECOVER Initiative

Long COVID is among many post-viral illnesses, like ME/CFS, in which symptoms from an initial sickness linger or reappear. Congress’ massive monetary investment in understanding long COVID gives patients and researchers of post-viral illnesses newfound hope of that elusive breakthrough in knowledge. “If you can’t figure it out now,” said Koroshetz, “I think it’s going to be really hard to ever figure this out.”

The RECOVER Initiative is the NIH’s 4-year investigation into long COVID, where it will fund researchers to learn more about the long-lasting health impacts of SARS-CoV-2 infection. The NIH wants to establish who’s at risk for long COVID, how widespread it is, and its causes and symptoms, with a planned biobank of tissue samples. The current enrollment goal is 40,000 adults and children.

Too Broad in Scope?

Koroshetz fears that if the NIH didn’t take a “broad but engineered approach” to solving long COVID, the result could be numerous small trials that are never able to be validated, and so nothing is gained.

Juan Wisnivesky, co-director of the nation’s first long COVID clinic at Mount Sinai and a RECOVER site, says the slow pace will ensure consistent research methods for better outcomes. He believes the NIH is pushing as hard as it can. “If they were trying to do this faster, there might be more problems.”

Still, more people, including researchers, are voicing concerns that the NIH’s approach is too broad and lacks any treatment testing. 

Recruiting Woes

As of March 18, 2022, the NIH had only managed 1,366 adult and child study participants—far off its goal of 40,000 and after $470 million allocated for recruitment. This is in stark contrast to the recruiting pace of internal studies being launched by long COVID clinics across the country, such as Mayo Clinic and Mount Sinai.

The issues are many and varied. One patient says he never heard back when he inquired about signing up for RECOVER through the program’s website. He doesn’t even know if he qualifies for the study, and even if he does, he won’t know whether there’s a long COVID site recruiting near him, as they still aren’t listed. 

Some researchers have suggested that the Biden administration create a task force to keep agencies accountable, coordinate with current studies, and message the public to enroll.

Transparency Worries

Though the NIH claims high research standards in its desire to include input from patients, caregivers, and others, advocacy groups are doubtful. In November 2021, and again in February 2022, they cited:

• A lack of patient engagement structure 
• Not enough experts versed in other post-viral illnesses
• No scheduled meeting with the National Heart, Lung, and Blood Institute, and
• A lack of drafted guidelines for children’s long COVID studies. 

The NIH, they claim, is not taking patient recruitment seriously. In one instance, a meeting participation invitation was sent to the public with just a few days notice. The NIH has now been forming several long COVID committees, but only one includes members of the public and some say the advisory process has been chaotic and inefficient with too much overlap.

Additionally, in a low-profile move in 2021, the $1.15 billion allocated to the NIH for long COVID research was diverted to address unaccompanied migrant children at the U.S.-Mexico border. The agency says the funds were immediately replaced with funds from the COVID-19 testing and tracing program, and its research wasn’t at all affected, but there’s concern how the funds earmarked for long COVID research are actually spent.

Victim of Its Own Success?

Assuming no funding concerns, much work lies ahead for the NIH: finishing recruitment, creating child long COVID study parameters and, according to Koroshetz, launching newly formed clinical trials in addition to the observational research.

In the meantime, expectations will likely remain high of the NIH because of its prior success in speeding COVID-19 vaccines and medications. That success, says Body Politic patient advocate Allison Sbrana, showed us what the agency is capable of in a crisis situation.

*Cohrs, R. (2022, March 29). ‘A slow-moving Glacier’: NIH’s sluggish and often opaque efforts to study long Covid draw patient, expert ire. STAT News. https://www.statnews.com/2022/03/29/nih-long-covid-sluggish-study