David Putrino, a neurophysiologist at the Icahn School of Medicine at Mount Sinai, labored through his holiday last Christmas to write a grant application for urgently needed Long Covid research. With colleagues, he hoped to tap into $1.15 billion in funding that Congress granted the National Institutes of Health (NIH) in 2020, as Long Covid emerged as a major public health problem. NIH had solicited grant applications in December 2021, just weeks before their January due date. The agency said it planned to issue decisions by late March.

But as of today, Putrino was still waiting to hear whether NIH will fund his effort to discover whether microclots might be a meaningful diagnostic biomarker for many types of Long Covid. “Maybe they should hire people who are dedicated to accelerating these programs,” says Putrino, who specializes in rehabilitation medicine. “[Long Covid] is a national crisis. This does not deserve to be somebody’s second or third job. What we need from the NIH right now is their full attention.”

Putrino’s is not the lone complaint about NIH’s management of Long Covid research—an initiative dubbed RECOVER, for Researching COVID to Enhance Recovery. RECOVER’s flagship, an observational study of up to 40,000 people, has come under fire from patient advocates and some scientists who say it lacks transparency and is moving far too slowly—a ponderous battleship when a fleet of hydroplanes are what’s needed. As of 6 June, the study had signed up 3712 adults, or 21% of its adult enrollment target of 17,680. Among children, numbers are even lower: Ninety-eight children are participants in a study aiming to enroll 19,500 of them.

Critics note that other countries have been more nimble. By July 2021, the United Kingdom had funded 15 Long Covid research projects aimed at diagnosis and treatment. In contrast, a recent independent review published by the Rockefeller Foundation found that, as of February, NIH had funded just eight of 200 Long Covid trials listed in the U.S. ClinicalTrials.gov database.

NIH acknowledges the critiques and says it has already “obligated or committed” the $1.15 billion, slated to be spent over 4 years. But the scope of the project prevents it from sprinting, Walter Koroshetz, director of NIH’s National Institute of Neurological Disorders and Stroke and a co-chair of the RECOVER initiative, implied in a talk to a panel of advisers to the NIH director on 9 June. “You can’t believe what a big lift this has been,” he told the advisers. RECOVER “is engineered to really not leave any stone unturned … for what could be causing this trouble.”

NIH added in a statement that it expects to announce winners of the long-awaited January funding within 2 weeks. And the agency says it has dedicated multiple staff to RECOVER, reinforced by other NIH experts and the outside firm Deloitte. But given the growing concern about the condition—recent estimates are that one in five U.S. COVID-19 survivors is afflicted—U.S. researchers say more urgency is needed.

RECOVER’s longitudinal study aims to discover the biological roots of Long Covid and describe its prevalence, risk factors, and symptoms. It will also include clinical trials of treatments and preventives, which it hopes to launch by fall.

“Everybody is working as fast as possible but this is a monster of a study,” says immunologist Janko Nikolich-Žugich of the University of Arizona College of Medicine, Tucson, a principal investigator for a RECOVER arm in Arizona. “It has been a nightmare to both put together and to run … in part because Long Covid comes in so many flavors.”

NIH 1 year ago awarded New York University’s (NYU’s) Grossman School of Medicine a huge chunk—$448 million—of its Long Covid funding to run the longitudinal study, through subawards to more than 24 institutions. NYU declined to make RECOVER investigators available for interviews or respond to written questions about the study.

Related News

Abnormal immune response, lingering virus, and blood clots all under investigation

Meanwhile, extramural scientists not involved in RECOVER are finding other ways to fund research, because NIH has put out few additional requests for Long Covid work. Michael VanElzakker, a neuroscientist at Massachusetts General Hospital, was already using a rare, sophisticated brain scanner to run a battery of tests on cognitive function in people with myalgic encephalomyelitis/chronic fatigue syndrome when the pandemic descended. As a result, he says, “I have a whole neuroimaging pipeline that’s ripe for Long Covid people to go through.” But he’s relying on charitable donations, because “there’s not really a way to apply for [NIH] Long Covid funding per se.” He recently applied for a general NIH neuroscience grant but worries his proposal won’t fare well when “binned in with somebody who’s got a model of ALS [amyotrophic lateral sclerosis].”

Others complain about NIH’s opaqueness. For instance, the RECOVER website does not list award amounts to institutions subcontracted through NYU, nor tally how much has been spent. “I wish there was more transparency regarding instruments, enrollment, data, and where and when and with whom the money has been invested and what it has yielded so far,” says Harlan Krumholz, a cardiologist at the Yale School of Medicine. He co-authored Rockefeller’s policy briefing, which excoriated NIH’s Long Covid response. NIH says it is working to add grant funding and other details to its searchable public database, REPORTER.

Still others remain frustrated by NIH’s tight application deadlines. For example, on 27 April the agency announced a competition for funding for Long Covid clinical trials—with a preferred submission deadline of 19 May. “I decided not to apply because the deadline” was so short, one prominent immunologist says.

But Nikolich-Žugich says the agency is doing the best it can. “I have seen an incredible number of people from the NIH work incredibly hard on all of this on very compressed timelines,” he says.

Mady Hornig, a neuropsychiatrist at Columbia University who has Long Covid and is a patient representative in RECOVER, notes NIH must balance moving quickly without sacrificing rigor. The goal of the fast funding turnarounds “is a really laudable one: not to be slowed down by the usual NIH cycle and still allow for high-quality peer review.” Still, she agrees that when it comes to funding research on this mysterious condition, “There have been a few hiccups along the way.”

Koroshetz said yesterday that NIH is doing its all. “We’re hoping we can … really make a difference to people. And the sooner the better.”

Read More

Leave a Reply

Your email address will not be published. Required fields are marked *