Since she first became ill with COVID in November 2020, 40-year-old Erica Hayes has not felt well.
Hayes has been spending most of the last four years sitting on her beige couch, frequently curled up under an electric blanket, because she is too ill to work.
My hands and feet are chilly since my blood flow is terrible right now. Hayes, a resident of Western Pennsylvania, stated, “My toes are cold even if I’m sweating.” She misses being able to go to her son’s baseball games at the age of 17 or play with her 9-year-old kid.
In addition to killing 1.2 million Americans, the COVID-19 pandemic has been called a crippling epidemic. Millions of Americans, including Hayes, suffer from protracted COVID. Among many other symptoms, the illness might cause memory loss, autonomic nervous system disruption, or energy deprivation, depending on the patient. Hayes’ constellation of symptoms includes recurrent hives and migraines in addition to brain fog and persistent exhaustion. Her tongue is also dry and swollen all the time.
Regarding her tongue, Hayes stated, “I’ve had a number of doctors examine it and tell me they don’t know what’s going on.”
Depending on how researchers define long COVID in a particular study, prevalence estimates vary greatly; nonetheless, the Centers for Disease Control and Prevention estimates that 17 million adults have the virus.
The federal government has spent $1.15 billion on COVID research as of December, despite the disease’s extensive reach, yet no novel medicines have been successfully introduced to the market.
The patient community is upset and disappointed by this, claiming that rather than merely attempting to understand why they are suffering, the National Institutes of Health should concentrate on finding solutions to end their suffering.
The fact that we still don’t have a single FDA-approved medication when this started more than four years ago is unacceptable, according to Meighan Stone, executive director of the Long COVID Campaign, a patient-led advocacy group. At an NIH-hosted session in September, Stone was one of several individuals with long COVID who shared their concerns and grievances regarding the agency’s long-COVID research approach with patients, physicians, and researchers.
The agency’s study project, RECOVER, or Researching COVID to Enhance Recovery, has also drawn criticism from certain medical professionals and researchers. According to Ziyad Al-Aly, chief of research and development at the VA St. Louis Healthcare System, doctors who specialize in treating long-term COVID patients are forced to make clinical judgments based on intuition in the absence of clinical trials.
Al-Aly acknowledged that the NIH has had enough time and funding to make more significant progress, but he stated that what (RECOVER) actually lacks is clarity of vision and clarity of purpose.
With $300 million of that amount designated for clinical trials, the NIH is now beginning to decide how to distribute an additional $662 million in funding for long-term COVID research. Over the following four years, these money will be distributed.With the stated objective of working quickly, cooperatively, and openly to improve treatments for Long COVID, RECOVER released a call for clinical trial ideas at the end of October to examine possible remedies, including drugs.
This development implies that the NIH has started to listen to patients. Those who argue that the agency’s approach to extended COVID has lacked urgency in the hunt for new treatments have expressed cautious hope in light of this.This $300 million, according to Stone, is a down payment. She cautions that helping people like Hayes restore some degree of health will require a lot more funding. Stone stated that it is truly a hardship to make up for this missed time.
The NIH acknowledged the necessity of developing cures, in an email to KFF Health News and NPR. However, doing so requires a grasp of the underlying pathways causing illness, which is challenging to achieve in post-infectious situations.
For this reason, it has provided funding for studies that aim to determine how long COVID impacts lung function or why the illness exclusively affects certain people.
Good science takes time
The community of long-term COVID patients has hope after Congress allocated $1.15 billion for the NIH to launch RECOVER in December 2020.
Clinical trials of possible treatments would follow, according to then-NIH Director Francis Collins, who clarified that RECOVER’s objective was to gain a better understanding of long-term COVID as a disease.
Eight clinical trials have been financed by RECOVER to evaluate the efficacy and safety of experimental treatments or interventions, according to the organization’s website. Results from only one of those trials have been published.
Conversely, more than 200 observational studies have been funded by RECOVER, including investigations on the most prevalent symptoms and the duration of COVID’s effects on pulmonary function. Additionally, over 40 pathobiology research that concentrate on the fundamental cellular and molecular causes of extended COVID have been financed by the program.
According to the RECOVER website, this research has produced important new information about the risk factors for long-term COVID and how the illness interacts with previous diseases.
It points out that observational studies are crucial for assisting researchers in creating and starting evidence-based clinical trials.
According to Leora Horwitz, co-principal investigator for the RECOVER-Adult Observational Cohort at New York University, good science takes time. She added that COVID is a very complex disease that seems to impact almost all organ systems.
Compared to many other diseases, this makes it more challenging to investigate. It is more difficult to pinpoint specific therapeutic targets for COVID since it damages the body in so many ways and has such a wide range of symptoms.
Horwitz added, “I’ll also remind you that for the majority of us, this pandemic is only three or four years old.” For thirty to forty years, we have been spending a lot more money on other conditions each year than this.
In 2021, NYU got roughly $470 million in RECOVER monies, which the university is utilizing to lead the effort to gather biospecimens and data from as many as 40,000 patients. According to Horwitz, there are currently close to 30,000 enrolled.
According to Horwitz, this extensive library facilitates continuing observational studies, which assist researchers choose which clinical trials for therapies are worthwhile by enabling them to comprehend the biological processes of individuals who do not recover from an initial infection.
According to her, merely attempting treatments because they are available without any proof of their efficacy lowers the chances of successful trials and could endanger patients.
Delayed hopes or incremental progress?
According to the NIH, patients and caregivers have been at the heart of RECOVER since its inception. They have been helpful in the design of studies and clinical trials, survey responses, governance and publication group participation, and initiative direction. However, patient advocacy organizations generally agree that RECOVER ought to have done more to give clinical trials a priority right away. Additionally, patients claim that while choosing which studies to support, RECOVER leadership disregarded their desires and experiences.
According to JD Davids, co-director of Long COVID Justice, RECOVER has made some progress. This includes research on the variations in long-term COVID between children and adults.However, Davids argued that since the endeavor wasn’t intended to be a streamlined attempt to produce medicines, the NIH shouldn’t have called it RECOVER.
He claimed that the moniker was a little deceptive and nasty.
According to Ezekiel J. Emanuel, co-director of the University of Pennsylvania’s Healthcare Transformation Institute, RECOVER’s initial $1.15 billion budget was likely insufficient to discover a new drug to treat long-term COVID.
However, he stated that the outcomes of early clinical trials might have encouraged pharmaceutical firms to support additional research on drug creation and examine the ways in which current medications affect a patient’s immune response.
One of the authors of a COVIDroadmap report from March 2022 is Emanuel. He points out that one issue with RECOVER was its lack of emphasis on novel therapies. Clinical research accounts for just 15% of the expenditure. He emailed KFF Health News and NPR to say, “That is a failure in itself, a failure of having the right priorities.”
Even though the NYU biobank has had a significant impact, Emanuel stated that more attention should be paid to the ways that current medications affect the immune system.
He said some clinical trials that RECOVER has funded are ridiculous, because they ve focused on symptom amelioration, for example tostudy the benefitsof over-the-counter medication to improve sleep. Other studies looked at non-pharmacological interventions, such as exercise andbrain trainingto help with cognitive fog.
People with long COVID say this type of clinical research contributes to what many describe as the gaslighting they experience from doctors, who sometimes blame a patient s symptoms on anxiety or depression, rather than acknowledging long COVID as a real illness with a physiological basis.
I m just disgusted, said long-COVID patient Hayes. You wouldn t tell somebody with diabetes to breathe through it.
Chim re L. Sweeney, director and founder of theBlack Long COVID Experience, said she s even taken breaks from seeking treatment after getting fed up with being told that her symptoms were due to her diet or mental health.
You re at the whim of somebody who may not even understand the spectrum of long COVID, Sweeney said.
Insurance battles over experimental treatments
Since there are still no long-COVID treatments approved by the Food and Drug Administration, anything a physician prescribes is classified as either experimental for unproven treatments or an off-label use of a drug approved for other conditions. This means patients can struggle to get insurance to cover prescriptions.
Michael Brode, medical director forUT Health Austin s Post-COVID-19 Programsaid he writes many appeal letters. And some people pay for their own treatment.
For example, intravenous immunoglobulin therapy, low-dose naltrexone, and hyperbaric oxygen therapy are all promising treatments, he said.
For hyperbaric oxygen,two small, randomizedcontrolled studiesshow improvements for the chronic fatigue and brain fog that often plague long-COVID patients. The theory is that higher oxygen concentration and increased air pressure can help heal tissues that were damaged during a COVID infection.
However, the out-of-pocket cost for a series of sessions in a hyperbaric chamber can run as much as $8,000, Brode said.
Am I going to look a patient in the eye and say, You need to spend that money for an unproven treatment ? he said. I don t want to hype up a treatment that is still experimental. But I also don t want to hide it.
There s a host of pharmaceuticals that have promising off-label uses for long COVID, said microbiologistAmy Proal, president and chief scientific officer at the Massachusetts-basedPolyBio Research Foundation. For instance, she s collaborating on a clinical study that repurposes two HIV drugs to treat long COVID.
Proal said research on treatments can move forward based on what s already understood about the disease. For instance, she said that scientistshave evidencepartly due toRECOVER researchthat some patientscontinue to harborsmall amounts of viral material after a COVID infection. She has not received RECOVER funds but is researching antivirals.
But to vet a range of possible treatments for the millions suffering now and to develop new drugs specifically targeting long COVID clinical trials are needed. And that requires money.
Hayes said she would definitely volunteer for an experimental drug trial. For now, though, in order to not be absolutely miserable, she said she focuses on what she can do, like having dinner with her family.At the same time, Hayes doesn t want to spend the rest of her life on a beige couch.
RECOVER s deadline to submit research proposals for potential long-COVID treatments isFeb. 1.
— Sarah Boden, KFF Health News
This article is from a partnership that includesNPRand KFF Health News.
KFF Health Newsis a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF an independent source of health policy research, polling, and journalism. Learn more aboutKFF.
