WASHINGTON — The federal government has spent more than a billion dollars reading Covid for a long time, an effort for the millions of Americans suffering from brain fog, fatigue and other symptoms after recovering from a coronavirus infection.
There’s nothing to show for that.
The National Institutes of Health has not hired a single patient to evaluate potential remedies, despite a transparent congressional mandate to examine them. they simply worsen some patients’ prolonged Covid symptoms.
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Instead, the NIH has spent most of its money on larger observational studies that might not possibly provide direct relief to patients. But it has yet to publish the effects of patients who joined this study, just two years after it began.
There’s also no sense of urgency to do more or speed things up. The company is no longer asking Congress to invest in prolonged Covid research, and STAT and MuckRock have received documents that appear to indicate the NIH refuses to use its own to replace the course.
“So far, I don’t think I’ve gotten anything for a billion dollars,” said Ezekiel Emanuel, M. D. , vice chancellor for global projects and co-director of the Healthcare Transformation Institute at the University of Pennsylvania. severe dysfunction. “
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Eric Topol, founder and director of the Scripps Research Translational Institute, said he expects the NIH to have introduced many large-scale trials to date, and that testing remedies has been a pressing priority when Congress granted cash to the company in late 2020. .
“I don’t know if they contributed to anything other than more confusion,” Topol said.
Patients and researchers have already sounded the alarm about the frigid speed of NIH’s first prolonged efforts against covid. Lawyers, as well as internal NIH correspondence, letters, and public documents, indicate that NIH has not increased speed; Instead, the delays have worsened.
It’s difficult to determine precisely why progress is so stalled, experts and patients involved in the task noted, because the NIH has hidden who is aware of the long Covid efforts and how they spent the money. The broader Biden administration has also missed opportunities for oversight and accountability for the effort, despite the president’s lofty promises about the disease.
The NIH’s mistakes have big ramifications for the more than 16 million Americans who suffer from covid long-term, in addition to those with other similar chronic diseases. As the largest government-funded study on this topic, the NIH initiative, called RECOVER, sets precedents for long-term studies and clinical guidelines. This will dictate how doctors across the country treat their patients and in turn affect people’s ability to access medical accommodations, disability benefits, etc.
“The NIH RECOVER study is futile,” said Jenn Cole, a longtime covid patient discovered in Brooklyn, New York, who sought to participate in the study but found the procedure inaccessible. The investigation is “a waste of time and resources,” he said. He said, and he doesn’t use taxpayers’ money to his advantage.
Reacting to questions from STAT and MuckRock, the NIH and a Duke University institute that administers clinical trials defended the initiative and offered a transparent explanation for the delays.
The NIH said it chose to fund a large-scale study program rather than small-scale studies to make certain knowledge and processes shareable among other patient groups, adding that clinical trials will soon be launched. In those trials, standardized screening designs will allow the company to verify remedies at sites. If there are signs that a drug is working, the company said it can pivot to devote more resources to it.
A spokesperson for the Department of Health and Human Services said the company has made progress over the past year in its reaction to the long Covid, and efforts are underway in addition to the RECOVER program.
“Management remains committed to addressing the long-term effects of the worst public health crisis in a century,” HHS said.
In 2020, Congress invested $1. 2 billion to learn more about the mysterious lingering symptoms that afflicted others infected with covid-19. This amount of money to fund studies on a chronic disease such as long covid is virtually unknown.
The money was explicitly intended to fund studies to detect the disease and clinical trials to test remedies that could bring relief to patients. But more than two years later, the company hasn’t begun testing a single treatment. There are also no plans to test many in the future. Instead, it focuses on observational studies, and that too has produced little information.
The NIH is planning five clinical trials, each of which will evaluate remedies that can only help with one main category of long-term covid symptoms. Some of those remedies will be medications, while others will be behavioral therapies, such as cognitive rehabilitation. Each trial will come with 300 to 900 patients, selected based on their symptoms, based on the main points shared in a webinar in mid-April.
The only officially announced trial to date will focus on Paxlovid, to test whether the drug relieves symptoms by alleviating any ongoing viral infections in patients’ bodies. The studio is scheduled to begin recruiting in January.
But as of April, RECOVER had enrolled all patients in any of those clinical trials. And the timeline slid back and forth.
Initially, in a letter to members of Congress requested by STAT’s March 2022 report on the initiative’s slow start, the NIH told lawmakers that the company plans to publish clinical trials until this fall. But by August, the estimated publication had been whittled down to “until the end of 2022. “Then the delay became public in December, when one of the NIH officials in charge of RECOVER told advisors that clinical trials would begin in the first quarter of 2023. Now, Duke University, which oversees clinical trials infrastructure, has told STAT and MuckRock that it expects the first patients to sign up for trials this summer.
Emanuel said the speed shows little urgency in the NIH component.
“If you haven’t understood pathobiology, you check things out. You’re just slowing down, slowing down, slowing down, walking,” he said.
All five clinical trial protocols are undergoing protection reviews, and the Food and Drug Administration is reviewing trials that will control Paxlovid and other drugs, the Duke Clinical Research Institute said. The institute plans to share those protocols publicly when exams are completed, but has yet provided an estimate of when this will happen.
Faster progress is possible. A similar study at Stanford, which won an investment directly from Pfizer, was also announced in October 2022 and has already begun enrolling patients. This trial “was more flexible and started the study faster” compared to RECOVER because it is smaller. said Upinder Singh, the study’s lead researcher. Singh and his colleagues are only testing Paxlovid in one place, rather than comparing other treatments.
Duke also intended to create a patient registry to collect data on Covid patients for a long time, but that initiative was not launched either.
“A patient registry is still planned, but the scope is being reevaluated to fully comply with the wishes of the Initiative,” Duke said.
Instead of prioritizing remedies from the start, the NIH used much of its long-standing investment in large-scale Covid to track prolonged Covid symptoms and be informed about how the disease works. This selection has frustrated patients, as thousands of other studies have already answered many primary questions about the disease.
“We didn’t want to recreate” existing studies that already answered those questions, said Cole, the longtime Covid patient. Researchers have been compiling lists of non-unusual symptoms since the summer of 2020, he said. For Cole, fatigue and brain fog are the most debilitating aspects of the disease.
And even the study of symptoms is slowly progressing, partly because the initiative has failed to attract other healthy people who might be compared to long-standing Covid patients. RECOVER temporarily filled its spaces for other people who had Covid more than 30 days ago. were hired, but it’s still for other people who have recently become inflamed, study leader Leora Horwitz said in a statement. Most study sites shut down recruitment of long-term covid patients at the end of August 2022.
Most of the clinical discoveries that have emerged from RECOVER so far have been based on small patient teams or electronic fitness records, rather than the thousands of others who have signed up to participate.
The breakneck speed of the government’s long covid efforts contrasts with the government’s hugely successful partnership with the pharmaceutical industry to bring covid-19 vaccines to market in less than 12 months. There are no ongoing efforts to help the independent personal sector. With corporations or researchers seeking to examine long-term remedies for COVID-19 through the NIH, some have shown promise. This month alone, the White House has long left covid-19 out of a $5 billion effort to study next-generation covid-19 remedies and vaccines.
Long Covid researchers wish there was greater urgency. Singh compared to the stress she is under lately with the stress many scientists experienced earlier in the pandemic when reading vaccines and treatments. “As a clinical community, we want to focus on the long Covid. and locate answers for the long Covid,” he said.
Topol echoed this sentiment and mentioned a recent op-ed in Scientific American calling for a Warp Speed operation for prolonged covid treatments. “That’s what happened,” he said.
That’s almost saying where the NIH’s $1. 2 billion pot of long-term Covid cash went.
No single NIH official is guilty of leading RECOVER, and the initiative has failed to share the critical information that would be needed for a government investigative task of this magnitude.
Unlike Operation Warp Speed and other Covid efforts, the NIH has outsourced much of RECUPER’s execution work to outside organizations. New York University, RTI International, Mayo Clinic, Massachusetts General Hospital and Duke University are guilty of parts of the initiative.
Many RECOVER-related study projects have been funded through these organizations and not directly through the NIH. This procedure makes it tricky to track how decisions are made or how money is spent through public databases, said Michael Sieverts, a longtime Covid member. Patient-led study collaboration that has experience in the federal budget for clinical trials.
Public records requests that MuckRock submitted to the company in late 2022, aimed at answering questions about RECOVER’s funding, are still incomplete as of mid-April. Sieverts also asked NIH officials questions and got no response.
The RECOVER organization itself is intricate and difficult to understand, even for patient advocates who are directly involved, they said. This is a complex series of committees, some of which are not even published on the initiative’s website. There is no user in the end guilty of coordination between the other institutes – and requests for data on the hierarchy of leaders have been ignored.
“After more than two years, they don’t have an organizational chart for everything,” said Diana Güthe, founder of Survivor Corps and advisor to RECOVER, who has requested almost every assembly she has attended.
Lauren Stiles, patient advocate and president and CEO of Dysautonomia International, which serves on several RECOVER committees, shared her concerns.
“There is a general lack of transparency. When we asked who made that decision. . . they may not tell us,” Stiles said.
As a result, when RECOVER says it lacks funding, it is difficult to identify who is to blame for the primary decisions.
In response to questions about the initiative’s budget, the NIH said it had no cash for other programs. The firm said $811 million had been legally committed to various activities and the rest was earmarked for long-term study activities.
Budget cuts are already having an impact.
A RECOVER advisory committee tasked with rating and comparing potential remedy features was halted “due to lack of funding,” the committee leader told members in late January, via an email exchange shared with STAT and MuckRock that was not previously reported.
The NIH told STAT and MuckRock that the committee was suspended because drugs, devices and remedy systems were chosen for clinical trials. However, the firm said RECOVER’s clinical trials are “adaptable platform trials,” meaning they are designed with the goal of reducing shutting down and adding remedies as new data becomes available.
This existing budget cut didn’t come without a caveat: The NIH was well aware last summer that the company wouldn’t have enough money to conduct clinical trials that aligned with the initiative’s goals of recruiting patients with a variety of symptoms.
One of RECOVER’s co-chairs wrote to Congress in June that “additional resources are needed” for the full diversity of remedies needed.
But Biden’s management is not taking steps to secure more investment within the firm or lawmakers.
Acting NIH Director Lawrence Tabak told patient advocates that the company has no plans to direct further investments for RECOVER within the company. The company said such a request could undermine a failed request for more investment that Congress ignored last year.
The Biden administration did not request a new budget for RECOVER in its 2024 budget, a largely ambitious document that reflects the administration’s monetary priorities.
The budget included $130 million in lengthy Covid-related requests for other agencies, adding for the Health Resources and Services Administration for the care of long-term Covid patients with complex desires and to teach number one care providers, and for the Agency for Healthcare Research and Quality. to study the provision of Covid long-term care and identify Covid long-term care facilities.
NIH officials also have no duty to disclose how the budget is spent or deal with other considerations with RECOVER, as an entity has been created to oversee lengthy Covid studies across the federal government.
In April 2022, President Biden issued a presidential memorandum urging federal agencies to “realize the full potential” of government, in partnership with industry partners, to respond to prolonged Covid.
There is a lack of follow-up to the maximum high-profile objective of the initiative.
In August, in a long-term national covid curriculum mandated by Congress, the Biden administration announced it would create a series of long-term covid studies and practices at HHS. This month, HHS released a fact sheet touting management’s progress toward its goals: and overlooked any mention of theArray.
An HHS spokesperson said the branch is running to expand and requested investments in next year’s White House budget for the Office of the Assistant Secretary of Health to coordinate efforts to respond to the long covid.
“It turns out to have been like, well, if we don’t do anything, maybe no one will notice,” Güthe said. “It is very important to make an assessment of what was promised. What has been completed and what has not been done. “? »
A large portion of the investment to examine a chronic disease like long covid is scarce, so each and every clinical trial NIH chooses to conduct is a selection, and some doctors and advocacy teams have expressed serious considerations about settling on a specific clinical trial.
This trial would evaluate exercise as a possible long-term treatment for covid-19, despite years of studies suggesting that exercise alone can harm patients and delay further studies.
Many other people with long-standing covid have symptoms similar to those of myalgic encephalomyelitis or chronic fatigue syndrome (ME/CFS), a debilitating condition that follows a viral infection. The defining feature of ME/CFS is severe fatigue and worsening of other fitness disorders after physical or intellectual activity. This symptom, known as post-exertional malaise, occurs with a delay, which can complicate doctors’ diagnosis and even patient recognition.
“What happens often is that other people go for a walk, they may not feel it for a day or two, and then they feel bad health on the third day,” said Adam Lowe, an ME/CFS patient and one of the founders of MEAction UK, the British branch of the Myalgic Encephalomyelitis Action Network. Patients may remain bedridden and have trouble concentrating, he said.
This worsening of symptoms occurs because a patient doesn’t produce and use energy in the same way as a healthy person, said Todd Davenport, a professor at the University of the Pacific who has studied exercise and this condition. It is an internal replacement for the total frame exhaustion that a marathon runner may feel on the finish line of his career.
A number of previous studies and patient surveys have shown how harmful exercise can be for others with ME/CFS. Many patients who were told by their doctors to exercise subsequently dropped out of the studies or treatment regimens, causing worsening of symptoms. A notorious trial that indicated training was a potential remedy was later discredited as deeply flawed.
Studying exercise as a remedy may simply “yearn for Covid as something that can be beaten with courage and hard work,” said Jaime Seltzer, MEAction’s director of clinical and medical outreach, saying such framing is “unhealthy and ethically concerning. “
Not all long-term covid patients revel in post-exercise discomfort, and those who can’t find exercise helpful, Davenport said. In those cases, slow, careful exercise as part of a rehabilitation or physical therapy program can help repair energy systems. that have been deformed.
But it can be tricky to distinguish between those other patient teams, unless a clinical trial is set up with the utmost caution. “Ideally, what you would need is a very consistent and very explicit set of inclusion and exclusion criteria,” Davenport said. Said. Otherwise, the study would threaten to generate oversimplified effects throughout Covid, he added, leading doctors to widely prescribe a remedy that doesn’t work for some or many.
Scientists and patient advocates tasked with advising RECOVER warned that a training trial could harm patients, but they got mixed responses. NIH executives.
Scientists and doctors on an NIH advisory committee focused on rehabilitation also warned that post-exercise discomfort may just be a harmful end result of the trial, according to internal emails shared with STAT and MuckRock. In response, NIH program officer Antonello Punturieri dismissed the concerns. . Punturieri cited the clinical rules of the World Health Organization and a U. K. agency, or did not propose any training for other people with ME/CFS.
In response to those concerns, RECOVER has organized internal meetings that come with exercise evaluation researchers, patient representatives, and the initiative’s main advisory committee. “Lately work is underway to further revise this protocol” at those meetings, the Duke Clinical Research Institute said. .
Planned revisions of the questionnaire will address patient protection concerns, such as follow-up of post-exercise discomfort. But it’s not clear how researchers will conduct this assessment, or whether ME/CFS doctors will be involved.
Even with the review, experts and patient advocates remain concerned that the exercise study takes resources from other studies and may lead to destructive advice from doctors. If RECOVER finds that exercise is helpful for some patients, asked JD Davids, an attorney for Long COVID Justice and of a petition asking the NIH to block the trial: “What are the chances that doctors will kindly perceive how limited this advice is?I think it’s very low. “
It’s not as if there are many features of possible remedies to investigate.
Topol and other researchers compiled a comprehensive table of other candidate remedies for a review article published in Nature in January. Experts from one of RECOVER’s advisory committees compiled a list for a paper published in March.
Given “the number of other treatment candidates, I can’t believe why I would choose a graded training therapy,” said Julia Moore Vogel, a researcher at the Scripps Translational Institute who has been living with covid for a long time and co-author of the journal Nature. paper. Vogel is leading a study on wearable devices for prolonged Covid-19, which will start with around 500 participants, despite planning up to 100,000.
One study has even already reported results, via a preprint shared through The Lancet in early March. The trial found that metformin, a common diabetes remedy that also has antiviral properties, reduced the risk of long-term symptom onset in Covid patients by around 42%.
This study organization didn’t set out to examine covid-19 for long, said David Boulware, one of the scientists and an infectious disease physician at the University of Minnesota Medical School. The initial purpose was to compare possible remedies for acute covid-19, but the team added lengthy Covid follow-up halfway through the trial.
And it is unlikely that he will be able to continue his studies without some kind of help from the government. The original study was based on philanthropic investments and more grants would be needed to keep reading this generic drug.
“It’s a wonderful drug, it’s cheap, it’s available all over the world,” Boulware said, “but there’s no profit margin for anyone to examine it. “
There could be similar considerations for studies on low-dose naltrexone, an off-label use of the addictive drug that has long been not unusual for covid and other chronic diseases. In low doses, naltrexone might help reduce inflammation of the immune and neurological systems. systems, potentially alleviating prolonged Covid symptoms.
But since the drug has been widely available for decades, pharmaceutical corporations are not motivated to fund giant trials. Some small clinical trials are underway, according to Rolling Stone.
The lack of NIH has frustrated biotech executives.
“He has to realize what he wants to address, so we, of course. But as patients will tell you, we need an intervention, not an observation,” said Axcella CEO Bill Hinshaw. His Massachusetts-based company went to wonderful lengths to test a drug candidate to treat prolonged Covid symptoms, without any help from the NIH.
Tonix Pharmaceuticals, which is developing a fibromyalgia drug that the company hopes will be an effective remedy for long-term covid symptoms, also did not receive investment from the NIH, despite filing an application.
“I hope there will be more healing trials. And healing trials can go hand-in-hand with herbal history studies like RECOVER,” said Tonix CEO Seth Lederman.
Patients and experts worry that if RECOVER is the scope of the federal effort to screen Covid for a long time, the condition may fall into the long-standing trend of apathy and lack of urgency that has hindered advances in treating chronic diseases.
“It’s transparent that there are many other people at NIH who are committed and determined to resolve this,” said Charlie McCone, RECOVER patient representative. As a result, “patients are confused” why only a few of the clinical trials have been planned and none of them have started yet, he said.
As the NIH initiative moves forward, patients are largely left with their own devices to search for potential treatments, said Cole, the Brooklyn patient who has been suffering symptoms since April 2020. “Because we’re not investing in those promising treatments, and we’re not spreading them through the medical system, it’s up to me to figure out how to do it on my own,” he said.
Cole, like many others in the long Covid community, feels abandoned by the federal government and the health care formula in general. If her symptoms worsen to the point that she can no longer work, she says, “the formula probably wouldn’t be there to pick me up. “
This article was co-reported with MuckRock, a nonprofit newsroom that brings together journalists, researchers, activists, and citizens to request, analyze, and percentages of government documents. Sign up to receive your newsletters here.
Funding for this task came from Columbia University’s Brown Institute for Media Innovation.
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