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COVID-19

NIH Documents Show $1.6 Billion Long COVID Initiative So Far Falls Short of Goals

Congress more than three years ago allocated $1.6 billion to the NIH to define, understand, and treat long COVID—and there’s largely nothing to show for it.

It’s been more than three years since Congress directed the National Institutes of Health (NIH) to investigate the long-term effects of COVID-19—and there are still no answers for the millions of Americans suffering from long COVID.

The NIH launched the $1.15 billion RECOVER initiative in early 2021 to understand, prevent, and develop potential treatments for long COVID. The NIH set deadlines for certain goals to be met when it allocated funding.

But according to documents obtained by The Sick Times, MuckRock, and STAT through the Freedom of Information Act (FOIA), the goals outlined in contracts between the NIH and the institutions tasked with leading the research have not been met despite passing the deadline, and nearly all of the initial funding has already been allocated.

“It’s a waste of money,” Dr. Darrel DeMello, a COVID-19 specialist, told The Epoch Times in an email. Dr. DeMello believes there should be a solution or a series of solutions for treating long COVID by now.

Congress allocated more than a billion dollars to the NIH in December 2020 and recently signed off on an additional $515 million to bolster research efforts. However, the documents show the majority of the funding has been used for observational research to collect data instead of clinical trials that test therapies or treatments.

NIH Recruited Data Experts, Not Long COVID Experts

According to NIH documents, RECOVER relied on three central institutions for its long COVID research initiatives: New York University (NYU), Massachusetts General Hospital, and Research Triangle Institute.

Collectively, these three contracts account for a significant portion of the $1.15 billion that Congress allocated to the NIH for long COVID research in 2020. The contract documents offer insights into how the NIH established its long COVID research initiative, the scientific expertise that the NIH prioritizes in its research teams, and RECOVER’s initial goals and timelines.

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The NIH did not choose scientists with established expertise treating COVID-19 or independent physicians currently seeing long COVID patients in the clinical setting. The agency largely chose personnel in the research field who have been or are presently funded by other NIH grants and specialize in data collection and information systems.
According to the contract between NYU and NIH, experts with “key personnel experience” have backgrounds in biostatistics, data collection, and cardiac therapeutics. Key personnel working on the Massachusetts General RECOVER initiatives have backgrounds in biostatistics, epidemiology and environmental health, pharmacoepidemiology, pulmonology, rheumatic disease, information systems, cloud computing, and developing and implementing analytic tools for large data.

Selecting researchers who have never treated acute COVID-19 infections will yield results, as those who treat COVID-19 infections are the ones who understand the actual underlying disease process, according to Dr. DeMello.

Although the NIH has an expert list of investigators and clinicians providing oversight to working groups with expertise and clinical experience treating post-infection syndromes, myalgic encephalomyelitis, chronic fatigue syndrome, and other illnesses, only one expert is currently part of RECOVER’s listed leadership and its clinical trial leadership team.

RECOVER Initiative Still Hasn’t Defined Long COVID

An initial goal of RECOVER was to better define long COVID and the risk of developing the condition after a SARS-CoV-2 infection. This goal has not been met.

Around 10 percent of adults who have had COVID-19 continue to experience long-term symptoms, commonly referred to as long COVID or post-acute sequelae of SARS-CoV-2 infection (PASC). This translates to millions of Americans, considering that over 100 million people in the United States have been infected with SARS-CoV-2.
According to the NIH’s contract with NYU, its observational study aimed to recruit 85 percent of its cohort by spring 2022 and to have a working research-based definition of long COVID within the same timeframe. They did not reach 85 percent recruitment in 2022 and no working definition for long COVID has been provided.
In a paper published more than a year ago in the Journal of the American Medical Association, RECOVER researchers sought to develop a long COVID definition based on self-reported symptoms that could be used in future studies.
They found 37 symptoms across multiple pathophysiological domains present more often in SARS-CoV-2–infected participants at six months or more after infection compared with uninfected participants. Of these, the NIH said 12 symptoms best distinguished between those with and without long COVID, including post-exertional malaise, fatigue, brain fog, dizziness, gastrointestinal symptoms, heart palpitations, issues with sexual desire or capacity, loss of smell or taste, thirst, chronic cough, chest pain, and abnormal movements. This led experts and lawmakers to criticize the prioritized symptoms for diagnosis as more than 200 symptoms have been reported in those with long COVID. The NIH, in response, posted a Q&A to address concerns.

The NIH reiterated that there is no definition of long COVID researchers can use to identify the disease, nor should insurers, disability agencies, or physicians use the study’s findings to clinically define or rule out long COVID. Additionally, the NIH acknowledged a working definition is evolving, but more research is needed before a definition can be used in clinical practice.

RECOVER Has Not Started Clinical Trials

The RECOVER website states that the NIH has finished planning the “full research protocols” for RECOVER observational studies, but clinical trial protocols have only been finalized for two of the five RECOVER clinical trials, and none of the clinical trials have completed enrollment.

“I know everybody has been frustrated with how slow things are moving, but good science takes time,” Dr. Michelle Harkins told The Epoch Times.

Dr. Harkins, a pulmonologist and critical care specialist, said she’s involved in three of the five RECOVER clinical trials.

“It has taken longer than I would like to get them up and running, but there are some clinical trials in progress,” she said.

“In the RECOVER-VITAL study, we are looking at Paxlovid, and two-thirds of the enrolled population is already in the study. We are going to be doing a sleep study at the University of Mexico to look at light therapy and other treatments, and we will be taking some of our patients from the observational cohorts for the clinical trial,” Dr. Harkins said.

In a randomized clinical trial published June 7 in JAMA Internal Medicine, researchers from Stanford found that a 15-day course of Paxlovid was generally safe but did not show significant benefit in a group of 155 mostly vaccinated participants with long COVID. The clinical trial was funded by Pfizer and coauthored by experts on RECOVER’s post-infection illness expert list.

“In the ENERGIZE study, researchers will look into transcranial direct current stimulator to assess neuro-component, and another study will look at POTS [Postural orthostatic tachycardia syndrome] disease and IVIG [intravenous immunoglobulin],” Dr. Harkins added.

In response to concerns that most of the funds went to data collection and observational research instead of clinical trials that could provide potential treatments for long-COVID patients, Dr. Harkins said observational cohorts will not provide specific answers but will provide “biobanking specimens” that scientists and researchers can learn from, which is especially important for the pediatric cohort.

As to why it has taken so long for the clinical trials to get underway, Dr. Harkins said the enrollment process can take a while because participants have to be screened to ensure they qualify for the trial.

“We want to make sure we put them in the right trial. If you put everyone with long COVID into a trial, you may not get answers, but if you put the person into the right trial based on their symptoms, we might be able to understand what treatments work for which group of patients. So, it is a little more detailed than just putting people into trials,” she explained.

“Long COVID is very complex, and it affects multiple organ systems—so really finding one pill to fix long COVID is not going to happen, so we are trying to understand how people with certain symptoms respond to certain treatments,” she said. “I wish it were as easy as the vaccine, believe me. It is taking a long time, and that’s frustrating, I’m sure, for all of us—on the study side of things, too. I wish it were going faster, but we are making some progress.”

At the same time, Dr. Harkins said some things could be done to speed things up. For example, faster clinical trials could be set up to test treatments that some patients and doctors are already using with some success, like low-dose naltrexone.

“Can we set up a rapid clinical trial network like we had during COVID times, where we have a little less red tape and can push things through faster? There needs to be another arm that looks into a rapid clinical trial,” she said.

Dr. Harkins said they’re close to finishing enrollment for the clinical trials she’s working on, but they will still need to perform the trial and follow participants for 120 days afterward.

“I think we are going to have some answers on some of the clinical trials in the coming months, and hopefully, they’ll be causative answers so that we know how to help patients. In the meantime, the observational studies do still give us good information that we can use,” she said.

“But I do think we could have a faster turnaround for all of the things that need to get done. Perhaps having a central entity to help fast-track and really study this so that we can move things forward, because we need to have these mechanisms in place for the pandemic or health crisis,” she added.

Dr. Harkins said Sen. Bernie Sanders (I-Vt.) is working on a “moonshot bill,” which would provide $10 billion in funding over the next decade to establish a long COVID research program at the NIH. This funding would be in addition to recent funding allocated for the continued RECOVER trial and may help speed up the process. 
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This article has been archived by Conspiracy Resource for your research. The original version from Epoch Times can be found here.

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