Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Sometime seems forever lol Cw :)
But anyways sure you seen this but chit I would be very happy even with 1B even.
Bucillamine Phase 3 clinical trial (NCT04504734) for #COVID-19 💊
— BITCOIN | DATA | LONG COVID (@kamtraders) May 4, 2023
By Revive Therapeutics $RVV $RVVTF
▪️DSMB meeting on May 10th, 2023 and will assess the efficacy of Bucillamine
▪️Revive expects to announce the recommendation of the DSMB meeting by May 17th, 2023.$veru $pfe pic.twitter.com/sP6M9RSec7
It will be nice to finally see the results after all this waiting and speculation. Good or bad, either way I can move on.
May 17th can not come soon enough. There is no excitement, based on the pps, as the longs hold and the rest of the world remains nonbelievers.
ps.It will be nice to finally see the results of the patients who took the higher dosage of Buccy. We have been waiting for quite some time.
A significant amount of asymptomatic Covid infections result in #LongCovid.
https://twitter.com/JacobBAguilar/status/1653916482655453185
ps. not sure why he follow me lol
pps. wait Cw ok he follows about %50 :) lol
Olympic gold medalist Tori Bowie dies aged 32. Just saying The BusS is moving. You will require it for the remainder of your lifetime. Or you GET SIDS
https://www.cnn.com/2023/05/03/sport/tori-bowie-death-track-and-field-spt-intl/index.html
What to know about XBB.1.16, the 'Arcturus' variant
A new Covid variant is spreading in the U.S., but will it cause a surge in cases?
XBB.1.16 — dubbed “Arcturus” on social media — is another descendant of omicron. It was first detected in early January and the majority of cases have been seen in India so far. It’s been steadily rising in the U.S. in recent weeks, although it still made up slightly less than 10% of new confirmed Covid cases as of Saturday, according to the Centers for Disease Control and Prevention.
Last week, the World Health Organization deemed XBB.1.16 a “variant of interest” as it continues to spread and outcompete other variants.
Ali Mokdad, a professor of global health at the University of Washington, said it’s still too early to predict what XBB.1.16 will do. But what he’s seen so far has been reassuring.
“We haven’t seen an increase in hospitalizations, we haven’t seen an increase in any of the indicators that make us worry,” Mokdad said.
Is XBB.1.16 more contagious?
Mokdad said that XBB.1.16 is gaining ground on the previously dominant strain in the U.S., called XBB.1.5.
That increased transmissibility appears to be due to the subvariant’s ability to avoid immune detection in the body.
“It can’t be spreading so fast unless it has some immune escape,” Mokdad said.
The virus has two ways of surviving, Mokdad said. One way is to be more infectious and evade immunity from previous infections or vaccinations, “which this one is doing,” he said. The other one is to become really deadly. “We haven’t seen that yet.”
Dr. Peter Chin-Hong, a professor of infectious disease at the University of California, San Francisco, said that aside from the increase in transmissibility, so far XBB.1.16 is not too different from XBB.1.5.
That means that “hopefully, it’s not going to be too different” in terms of how sick it makes people and how well the vaccines work.
What are the symptoms of XBB.1.16?
XBB.1.16 doesn’t appear to be making people sicker than earlier omicron strains, according to Dr. Mike Ryan, the executive director of the WHO’s health emergencies program.
“To my knowledge, we’re not seeing a different spectrum of symptoms or severity associated with this variant of interest,” Ryan said during a media briefing last week.
Some news reports have mentioned that XBB.1.16 infection causes a “new” symptom — conjunctivitis, or pink eye — though the WHO noted that this symptom was already known to be associated with Covid. As early as the spring of 2020 there were reports of itchy, sore eyes in Covid patients. In May 2020, the American Academy of Ophthalmologists noted that mild conjunctivitis could be a symptom of Covid.
"It's not a new symptom," but it may be more common than previously thought, Chin-Hong said.
Do vaccines work against XBB.1.16?
Mokdad said that labs haven’t yet determined how well the Covid vaccines work against XBB.1.16.
Chin-Hong said he wasn't particularly concerned about the vaccines.
"Because it's so similar to XBB.1.5, we think that vaccines will be fine," he said.
Last week, the Food and Drug Administration and the CDC said that older adults and immunocompromised individuals could get a second dose of the updated booster shot, which protects against an earlier omicron subvariant.
Why are there always new variants?
XBB.1.16 certainly won’t be the last new variant that emerges. The subvariant is yet another offshoot of the growing omicron family tree.
XBB.1.16 is a descendant of the XBB subvariant, which itself formed when two strains of omicron subvariant BA.2 combined, according to the WHO.
Already, two other XBB strains, XBB.1.9.1 and XBB.1.9.2 are also rising in the U.S. Together, the two strains account for about 11% of new cases, according to the CDC.
On Wednesday, the WHO's technical lead for Covid-19, Dr. Maria Van Kerkhove, said the XBB.1.9 strains are likely similar to what’s been seen with previous XBBs.
“This just indicates to us that the virus continues to evolve and it will continue to evolve because the virus is circulating pretty much unchecked,” Van Kerkhove said.
nbcnews.com
Ecomike
Whiners are in general losers!
RVVTF is for winners.??
I am confident that bucillamine holds great promise in combatting COVID. However, I do have some reservations about the CEO's ability to deliver on this potential. I am optimistic that the efficacy data will be positive, paving the way for the global distribution of bucillamine to every single person on Earth.
What You Need to Know
There is strong scientific evidence that antiviral treatment of outpatients at risk for severe COVID-19 reduces their risk of hospitalization and death.
The antiviral drugs nirmatrelvir with ritonavir (Paxlovid) , remdesivir (Veklury) and {? Bucillamine?} are the preferred treatments for eligible adult and pediatric patients who are at high risk for progression to severe COVID-19.
Clinicians should consider COVID-19 treatment in patients with mild-to-moderate COVID-19 who have one or more risk factors for severe COVID-19. Treatment must be started early to be effective.
https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-care/outpatient-treatment-overview.html
Yes it looks like it. The only concerned I have is why they didn't go in the first place. What's behind the back door? They didn't have confidence. I heard Johnson and Johnson might be their partner. It's a perfect fit. Both of the CEO can't get anything done. LOL
O $h!^ if this pop in May that would be great. May go away is here.
So in other words, the company is following the exact path that was delineated back in Oct 2022?!?
My word!!!!!!!!
Expect a fresh round of heehawing IF the dsmb recommends continuing the study.
Ghosted in 3...2..1. lololsss
Thanks, I have never been a whiner LOL.
$RVVTF may end up outperforming the market this summer
Agreed. Continuing the study with hospitalizations as EP is lighting cash on fire and sacrificing time.
no matter the decision, it's going to take time and $$$ - probably just a matter of getting the data to where they can get a potential partner to look at what they've got and decide whether they (potential partner) want to fund further trials.
Continuation of the study is a death march.
Big pharma's plan (who controls the FDA) has always been to slow down or ruin any medical trials that threaten their cash cow: the vaccine. I have no doubt the FDA is going to tell Revive that they have to finish the 1000 patient trial and resubmit data, at which point they will take another year to decide to look at it, then another half a year to make a decision, at which point there will be less confirmed cases of Covid per year than small pox. We've been f__ked, gents. Big pharma strikes again. Guarantee they were handing out duffel bags of cash to stifle any competition.
That's a good catch. Unfortunately, that is the outcome we most desire. I think it may have to do with the endpoint switch back to hospitalizations. Unlike McDonalds, the FDA is not lovin it.
ps. Good data opens the door to so many pathways that it is hard not to get excited. I like the addition of symptom data, but I think Revive didn't accumulate exactly what the FDA wants so there still needs to be negotiations and discussions. This is where we could use some expertise.
Did you notice that they're down to two outcomes? continue the study OR halt due to significance not likely to be met. No longer looking at halting due to efficacy.
I'm very impressed with the detailed communication to SH !
Yes sir, very pleased and hopeful
NEWS OUT.
https://www.globenewswire.com/news-release/2023/05/02/2658886/0/en/Revive-Therapeutics-Announces-Data-Safety-Monitoring-Board-Meeting-Date-on-Phase-3-Clinical-Study-of-Bucillamine-in-the-Treatment-of-COVID-19.html?fbclid=IwAR3hk1InFM3Kt6I--6ciptfu6KhhmK0pV1Gwf2tpGsBoi7BWj4gWSuolhoE
I am pleasantly surprised the the data has already been submitted and the timelines are very soon. Let's see.
I wish I had know about and been able to get NAC over 60 years ago. Yes it helps, but Long Covid is about way more that "lung Issues". It helps with a family of health issues that use up the active L-Glutathione in the body. It is super safe and better than many mild asthma OTC products. I started taking it for RA about 6 years ago, before Covid19 arrived.
There is long laundry list of key vitamins, and supplements that help with all of the long issues, but most people are looking in the wrong place, namely the Medical Business/practice (That is why the call it practice, LOL) that is great at testing and surgery, but sucks at nutrition, and supplementation of poor diet and lifestyle issue assistance, for answers to complex bio-medical problems that may need daily over-site and expertise and experimental tweaking of each persons unique health situation to get them back to an optimal health and live style. AI may end being part of the solution.
But part of the problem is people's mind sets, who want one diagnosis and one pill and a miracle, and want keep drinking and eating and smoking junk...
Health officials warn irritating symptom may be returning with latest COVID strain
BY WILL CONYBEARE AND ADDY BINK - 05/01/23 7:05 AM ET
(KTLA) – A new coronavirus subvariant is starting to spread in the U.S. and, according to health experts, it could be causing an annoying symptom to return.
According to the Centers for Disease Control and Prevention, roughly 10% of all COVID cases reported last week were determined to be from the omicron-related XBB.1.16 subvariant, being referred to by some as Arcturus.
After first being reported in January, the World Health Organization declared XBB.1.16 a variant of interest in mid-April, The Hill reports.
The Los Angeles County Department of Public Health is warning residents that this omicron sub-strain of COVID-19 may come with an irritating symptom: conjunctivitis
Pandemic 3 years later: Has the COVID-19 virus won?
Commonly known as pink eye, health officials also reported that pink eye could be linked to COVID early in the pandemic. Then again last year, experts warned there could be a connection between the then-new omicron variant and itchy, irritated eyes.
Now, some health officials are reporting an increase in conjunctivitis cases nationwide.
That includes Los Angeles County, where the health department has warned that pink eye may be the newest possible symptom of COVID.
“Observational data suggests that people infected with XBB.1.16 may be more likely to experience conjunctivitis as a symptom of their COVID infection, along with more traditional COVID symptoms, such as fever, cough and shortness of breath,” the LA County Health Department said in a statement. “Historically, conjunctivitis was reported in 1 to 3% of COVID-19 cases.”
Conjunctivitis occurs when the lining that covers your eyelid and eyeball, the conjunctiva, becomes inflamed, optometrist Dr. Melanie Dombrowski tells Nexstar’s WGHP. Symptoms include eyes becoming pink or red, increased tear production, discharge from the eyes, and itching, irritation, or burning, according to the CDC.
Hair suddenly falling out in the shower? This might be why
Pink eye is common with respiratory infections like the cold and flu.
However, with the limited data available, the department said it is “too early to know with certainty” if XBB.1.16 is truly associated with higher rates of conjunctivitis.
“Residents should be aware that itchy, watery or red eyes may be a sign of a COVID-19 infection and these symptoms should not be simply dismissed as a result of pollen or seasonal allergies, especially if someone more vulnerable to severe illness could be exposed,” the Health Department said. “The fact that we are seeing new strains, with possibly new and different symptoms, tells us that COVID continues to evolve and the way we think about our protections should reflect what we know.”
You should talk to your doctor if you have pink eye as well as pain in the eyes, sensitivity to light, blurred vision, intense redness, symptoms that aren’t improving or get worse, or a weakened immune system, according to the CDC.
Older adults and individuals with underlying health conditions are encouraged to take extra precautions to avoid infection, which includes staying up to date on vaccinations, frequent hand washing, and staying home when feeling sick.
Though officials say Arcturus may be more effective at escaping immune response than other subvariants, it doesn’t appear any more severe.
Those guys have quality control supply chain market share and location presence.
I don’t blame you for trying to make lemonade from lemons but MF couldn’t monetize anything if his life depended on it. He’s skilled in golf. It’s a fun hobby
Let’s see how many days pass before he does something for all those suffering shareholders and monetize anything at all??
Ecomike
Fine as wine!
Haha ya mmhmmm. What’s the one glaring difference here? McDonalds and burger king have CEO’s that know how to type an email that doesn’t look like a 1st grader wrote it and can also tie their shoes which I don’t know if Frank can do. Oh and they also can likely check their egos at the door and do what’s best for their companies and shareholders. Frank denies any help including from individuals who have 10x the experience he does.
Your responses are strong and to the point. :)
Burger King and McDonalds makes billions selling hamburgers.
Is there any evidence that NAC and probablty therefore Buci helps with long haul covid lung related problems? Maybe Ecomike--can you please provide any input?
Thank you ,
Eking
RSV is prevalent in the infant and toddler, as well as the elderly age groups. Both groups being at high risk, and in need
It's a very contagious virus, good point.
What about helping with RSV? Big market for that.
Exactly, the press just isn't reporting all the sickness and death covid is still causing.
Gio,
Hate to agree with Birx, of all people, but... https://t.co/nbeczybKvq
— Mehdi Hasan (@mehdirhasan) April 29, 2023
Patients walk out of a @StanfordMed #LongCovid trial after medical staff stop masking while tending to LC participants. 1/ pic.twitter.com/vhPQLbbaxg
— Laura (@lauragetsbetter) April 29, 2023
Only way anything comes of this is if Frank buggers off and lets someone with any knowledge take over. And the board of directors is less than useless. They have done nothing to help this company and only enabled frank to keep sucking at his job.
I like it, good analogy!
Scrub, rinse, soak, clean, sanitize, prepare and get this data to the DSMB so the big boys can swoop on in and finish this trial for long haulers. Get Buccy to market for several infectious diseases in the USA and let's move things along. The fat lady has not sung yet, but she is now standing on stage and the stage is a rockin.
ps. Revive has taken a couple of body blows, but it just takes one good left hook to get back in the game. Come on MF. Get er done.
I agree it’s promising I don’t see how it’s monetized as states and communities begin to decriminalize and legalize
If I’m wrong about that I’m wrong. Time will tell
There will always be a need for a drug that can combat an acute respiratory illness such as SARS-CoV-2. Someday it will happen again. So keep working on Bucillimine and get it approved. Psilocybin research is very important for PTSD sufferers and other mental disorders such as depression so don't give up on that either. IMO Revive stock will rebound soon and for those that want to just get your money back you'll have your chance..... I'm in this company for the long haul. Yes, like some of you, I had visions that I would be 500k richer but that didn't materialize yet.....
April 20, 2023
The NIH has poured $1 billion into long Covid research — with little to show for it
Written by Betsy Ladyzhets, Rachel Cohrs
Edited by Derek Kravitz, Erin Mershon
Why we're reporting on the National Institutes of Health's RECOVER initiative and how to republish this story
Long Covid affects an estimated 16 million Americans and the research work by the National Institutes of Health represents the federal government's most high-profile, and costly, attempt to understand and address the disease. This story explores the taxpayer spending and work thus far by NIH's RECOVER initiative. This article was co-reported with STAT News, a newsroom focused on health, medicine, and scientific discovery that is produced by Boston Globe Media. Funding for this project also came from Columbia University’s Brown Institute for Media Innovation. Our ongoing series on the Covid-19 pandemic can be republished under a Creative Commons license. For more information, click the republish button below.
Republish This Story
WASHINGTON — The federal government has burned through more than $1 billion to study long Covid, an effort to help the millions of Americans who experience brain fog, fatigue, and other symptoms after recovering from a coronavirus infection.
There’s basically nothing to show for it.
The National Institutes of Health hasn’t signed up a single patient to test any potential treatments — despite a clear mandate from Congress to study them. And the few trials it is planning have already drawn a firestorm of criticism, especially one intervention that experts and advocates say may actually make some patients’ long Covid symptoms worse.
Instead, the NIH spent the majority of its money on broader, observational research that won’t directly bring relief to patients. But it still hasn’t published any findings from the patients who joined that study, almost two years after it started.
There’s no sense of urgency to do more or to speed things up, either. The agency isn’t asking Congress for any more funding for long Covid research, and STAT and MuckRock obtained documents showing the NIH refuses to use its own money to change course.
“So far, I don’t think we’ve gotten anything for a billion dollars,” said Ezekiel Emanuel, a physician, vice provost for global initiatives, and co-director of the Healthcare Transformation Institute at the University of Pennsylvania. “That is just unacceptable, and it’s a serious dysfunction.”
Eric Topol, the founder and director of the Scripps Research Translational Institute, said he expected the NIH would have launched many large-scale trials by now, and that testing treatments should have been an urgent priority when Congress first gave the agency money in late 2020.
“I don’t know that they’ve contributed anything except more confusion,” Topol said.
Patients and researchers have already raised alarms about the glacial pace of the NIH’s early long Covid efforts. But a new investigation from STAT and MuckRock, based on interviews with nearly two dozen government officials, experts, patients, and advocates, and internal NIH correspondence, letters, and public documents, underscores that the NIH hasn’t picked up the pace — instead, the delays have compounded.
It’s difficult to pinpoint exactly why progress is so stalled, experts and patients involved in the project emphasized, because the NIH has obscured both who is in charge of the long Covid efforts and how it spent the money. The broader Biden administration has also missed opportunities for oversight and accountability of the effort — despite the president’s lofty promises to focus on the disease.
The NIH’s blunders have massive ramifications for the more than 16 million Americans suffering from long Covid, in addition to those with other, similar chronic diseases. As the biggest government-funded study on this topic, the NIH initiative, dubbed RECOVER, sets precedents for future research and clinical guidelines. It will dictate how doctors across the country treat their patients — and, in turn, impact people’s ability to access work accommodations, disability benefits, and more.
“The NIH RECOVER study is pointless,” said Jenn Cole, a long Covid patient based in Brooklyn, N.Y., who wanted to enroll in the study but found the process inaccessible. The research is “a waste of time and resources,” she said, and fails to use patients’ tax dollars for their benefit.
In response to STAT and MuckRock’s questions, the NIH and an institute at Duke University managing the clinical trials defended the initiative, without providing a clear explanation for the delays.
The NIH said it chose to fund a large-scale research program instead of small-scale studies to make sure data and processes could be shared across different groups of patients, adding that clinical trials will be launching soon. In these trials, standardized study designs will allow the agency to test multiple treatments across multiple sites. If there are signals a drug works, the agency said it can pivot to devote more resources there.
A Department of Health and Human Services spokesperson said the agency has made progress over the last year in responding to long Covid, and that there are research efforts underway in addition to the RECOVER program.
“The Administration remains committed to addressing the longer-term impacts of the worst public health crisis in a century,” HHS said.
NIH RECOVER's spending
The NIH has spent the majority of its funding for long Covid research on observational studies of patient symptoms, with a smaller amount going to clinical trials.
Clinical research studies ($767.7M)Administrative coordination and communications ($17.3M)Research management services ($35M)Data management and repositories ($156.5M)Clinical trials ($171.5M)
Data via an NIH spokesperson, in response to questions from STAT and MuckRock.
Chart: Betsy Ladyzhets Source: NIH Get the data
In 2020, Congress made an investment of $1.2 billion to learn more about the mysterious ongoing symptoms that were afflicting some people infected with Covid-19. That sort of money to fund research into a chronic condition like long Covid was virtually unheard of.
The money was explicitly earmarked to fund both research to understand the disease and clinical trials to test treatments that could bring patients relief. But more than two years in, the agency hasn’t started testing a single treatment. Nor is it planning to test many in the future. Instead, it’s focused on observational research — and that, too, has produced few insights.
The NIH is planning five clinical trials, each of which will test treatments that may help with a major category of long Covid symptoms. Some of these treatments will be drugs, while others will be behavioral therapies, such as cognitive retraining. Each trial will include 300 to 900 patients, selected based on their symptoms, according to details shared during a webinar in mid-April.
The only trial to be formally announced so far will focus on Paxlovid, testing whether the drug alleviates symptoms by mitigating any ongoing viral infection in patients’ bodies. The study was supposed to start recruiting in January.
But as of April, RECOVER hasn’t signed up a single patient for any of those clinical trials. And the timeline has slipped over and over again.
Initially, in a letter to members of Congress prompted by STAT’s March 2022 reporting on the initiative’s slow start, the NIH told lawmakers that the agency expected to launch clinical trials by that fall. But by August, the estimated launch had slipped to “by the end of 2022.” Then, another delay became public in December, when one of the NIH officials leading RECOVER told advisers that clinical trials would begin by the first quarter of 2023. Now, Duke University, which is overseeing the clinical trial infrastructure, told STAT and MuckRock it expects the first patients to sign up for trials this summer.
Emanuel said the pace of trials shows little urgency on the part of NIH.
“If you don’t have the pathobiology figured out, you try things. You don’t just slow, slow, slow, walk it,” he said.
All five clinical trial protocols are going through safety reviews, and the Food and Drug Administration is reviewing the trials that will test Paxlovid and other drugs, the Duke Clinical Research Institute said. The institute plans to share these protocols publicly when reviews are complete, but did not provide an estimate for when that will happen.
Timeline for NIH's RECOVER initiative
More than two years after the NIH received initial funding from Congress to study long Covid, it has yet to begin clinical trials.
MISSING: summary MISSING: current-rows.
Date Event
December 2020 Congress allocates $1.15 billion to the NIH
February 2021 NIH announces the RECOVER initiative
June 2021 First grants provided to academic institutions
September 2021 NYU announces observational study, begins recruitment
April 2022 Biden issues presidential memo on long Covid
April 2022 NIH requests proposals for clinical trials
June 2022 NIH tells some members of Congress clinical trials will begin in fall 2022
August 2022 Duke Clinical Research Institute announces clinical trials coordination
October 2022 Duke announces Paxlovid study, estimates trials will begin in early 2023
August 2022 Observational study fills all slots for long Covid patients
December 2022 Patients begin sounding alarm on potential exercise study
February 2023 NIH tells patient advocates it doesn't plan to ask for more RECOVER funds
March 2023 Biden administration budget does not include RECOVER funding
April 2023 Duke estimates trials will begin in summer 2023
Source: STAT / MuckRock Get the data
Faster progress is possible. A similar study at Stanford, which received funding directly from Pfizer, was also announced in October 2022 but has already begun recruiting patients. This trial was “able to be more flexible and get the study started faster” in comparison to RECOVER because it’s smaller, said Upinder Singh, the study’s principal investigator. Singh and her colleagues are only testing Paxlovid and doing so at only one location, rather than comparing different treatments.
Duke was also supposed to create a patient registry to collect information about long Covid patients, but that initiative hasn’t been launched, either.
“A patient registry is still planned, but the scope is being reassessed to most effectively meet the needs of the Initiative,” Duke said.
Rather than prioritizing treatments from the start, the NIH used much of its long Covid funding on a large-scale study to track long Covid symptoms and learn how the disease works. This choice has frustrated patients because thousands of other studies have already answered many major questions about the condition.
“We didn’t need to recreate” existing studies that already answered these questions, said Cole, the long Covid patient. Researchers have been compiling lists of common symptoms since summer 2020, she said. For Cole, fatigue and brain fog are the most debilitating aspects of the condition.
And even the symptom study is moving slowly, in part because the initiative has failed to bring in healthy people who could be compared against long Covid patients. RECOVER quickly filled its slots for people who had Covid more than 30 days prior to their recruitment, but is still looking for people who were infected recently, study lead Leora Horwitz said in a statement. Most study sites closed enrollment for long Covid patients at the end of August 2022.
NIH RECOVER's enrollment
As of April 13, 2023, RECOVER is behind on its enrollment goals for adults, pregnant people, and children. The study is recruiting both long Covid patients and healthy people who will serve as controls.
EnrolledGoal
Adult
12,001
15,039
Pregnant
1,671
2,451
Pediatric
3,669
6,000
Chart: Betsy Ladyzhets Source: NIH RECOVER Get the data
The majority of the scientific findings to emerge from RECOVER so far have been based on small groups of patients or on electronic health records, rather than on the thousands of people who signed up to participate.
The crawling pace of the government’s long Covid efforts stand in stark contrast with the government’s wildly successful partnership with the pharmaceutical industry to get Covid-19 vaccines to market in less than 12 months. There are no ongoing efforts to support independent private-sector companies or researchers trying to study treatments for long Covid through the NIH, even though some have proved promising. Just this month, the White House left long Covid out of a $5 billion effort to research next-generation Covid-19 treatments and vaccines.
Long Covid researchers feel there needs to be greater urgency. Singh compared the pressure that she’s currently under to the pressure many scientists faced earlier in the pandemic when studying vaccines and treatments. “We as a scientific community need to focus on long Covid and find solutions for long Covid,” she said.
Topol echoed this sentiment, citing a recent opinion piece in Scientific American that called for an Operation Warp Speed for long Covid treatments. “That’s what should have happened,” he said.
It’s almost impossible to tell where the NIH’s $1.2 billion pot of long Covid money has gone.
There is no single NIH official responsible for leading RECOVER, and the initiative has failed to share basic information that would typically be available for a government research project of this scale.
Unlike Operation Warp Speed and other Covid efforts, the NIH has outsourced much of the work of running RECOVER to outside organizations. New York University, RTI International, Mayo Clinic, Massachusetts General Hospital, and Duke University are responsible for various parts of the initiative.
Many of the research projects associated with RECOVER have been funded through these organizations rather than directly from the NIH. This process makes it hard to track how decisions are made or how money is spent through public databases, said Michael Sieverts, a member of the long Covid Patient-Led Research Collaborative who has a background in federal budgeting for scientific research.
Public records requests that MuckRock filed to the agency in late 2022, intended to answer questions about RECOVER’s funding, are still incomplete as of mid-April. Sieverts has similarly asked questions to NIH officials and received no responses.
NIH RECOVER locations for adults in observational study
53 research centers across the U.S. are participating in NIH RECOVER's adult cohort study, which aims to understand long Covid by tracking patient symptoms.
One site, located in San Juan, Puerto Rico, is not shown.
Map: Betsy Ladyzhets Source: NIH RECOVER Get the data
The organization of RECOVER itself is convoluted, and difficult to figure out even for patient advocates who are directly involved, they said. It’s advised by a complex series of committees, some of which aren’t even posted on the initiative’s website. There’s no one person ultimately responsible for coordinating among the different institutes — and requests for information about the leadership hierarchy have been ignored.
“They don’t have an org chart for the entire thing that exists, after two-plus years,” said Diana Güthe, the founder of Survivor Corps and a RECOVER adviser who has asked at nearly every meeting she’s attended.
Lauren Stiles, a patient advocate and president and CEO of Dysautonomia International who serves on several RECOVER committees, shared similar concerns.
“There’s a complete lack of transparency. When we ask who made this decision … they won’t tell us,” Stiles said.
As a result, when RECOVER says it’s running out of funds, it’s hard to identify who is responsible for major decisions.
In response to questions about the initiative’s budget, the NIH said it has no money available for additional programming. The agency said $811 million has been legally committed to various activities, and the rest is earmarked to support future research activities.
The budget restrictions are having practical impacts already.
A RECOVER advisory committee responsible for ranking and evaluating potential treatment options was put on hiatus “due to a lack of funds,” the committee’s leader told members in late January, per an email exchange shared with STAT and MuckRock that has not been previously reported.
The NIH told STAT and MuckRock that the committee was paused because the clinical trial medicines, devices, and treatment programs have been chosen. However, the agency said that the RECOVER clinical trials are “adaptive platform trials,” which means they are designed with the intention of removing and adding treatments as new information becomes available.
This current budget squeeze didn’t come without warning: The NIH was well-aware last summer that the agency wouldn’t have enough money to run clinical trials that matched the initiative’s goals of reaching patients with diverse symptoms.
One of RECOVER’s co-chairs wrote to Congress in June that “additional resources are necessary” to test the full range of treatments needed.
But the Biden administration isn’t taking any action to get more funding within the agency, or from lawmakers.
NIH acting Director Lawrence Tabak told patient advocates that the agency isn’t planning on directing any further funding for RECOVER within the agency. The agency said that such a request would potentially undercut a failed request for supplemental funding that Congress ignored last year.
The Biden administration didn’t request any new funds for RECOVER in its 2024 budget, a largely aspirational document that reflects the administration’s financial priorities.
The budget did include $130 million in long Covid-related asks for other agencies, including for the Health Resources and Services Administration to support care for long Covid patients with complex needs and to educate primary care providers, and for the Agency for Healthcare Research and Quality to research the delivery of long Covid care and to establish long Covid care hubs.
There’s also little accountability for NIH leaders to disclose how funds are spent or respond to other concerns with RECOVER because an entity intended to oversee long Covid research across the federal government hasn’t been created.
In April 2022, President Biden issued a presidential memorandum calling on federal agencies to “harness the full potential” of the government, in partnership with private sector partners, to respond to long Covid.
The follow-through has been lacking on the initiative’s highest-profile goal.
In August, in a congressionally mandated national long Covid research plan, the Biden administration said it would create an Office of Long Covid Research and Practice at HHS. This month, HHS put out a fact sheet touting the administration’s progress in reaching its goals — and omitted any mention of the office.
An HHS spokesperson said that the department is working to develop the office, and requested funding in next year’s White House’s budget for the Office of the Assistant Secretary for Health to coordinate response efforts to long Covid.
“It seems to have been like, well, if we don’t do anything, maybe no one will notice,” said Güthe. “It’s so important to do an evaluation of what was promised. What’s been accomplished, and what hasn’t?”
A huge chunk of funding to study a chronic illness like long Covid is rare, so any clinical trials that the NIH chooses to run are crucial choices — and some doctors and advocacy groups have voiced serious concerns about the selection of one clinical trial in particular.
That trial would test exercise as a potential long Covid treatment, despite years of research suggesting that exercise could harm patients and set back further study.
Diagnosing Myalgic Encephalomyelitis/Chronic Fatigue Syndrome.
Many people with long Covid have similar symptoms to people with myalgic encephalomyelitis or chronic fatigue syndrome (ME/CFS), a debilitating condition that often follows viral infection. The defining feature of ME/CFS is intense fatigue and worsening of other health issues after physical or mental activity. This symptom, known as post-exertional malaise, often occurs with a lag, which can make it tough for doctors to diagnose — and even for patients to recognize themselves.
“What often happens is, people will go for a walk, they may not feel it for a day or two, and then suddenly, they feel ill on the third day,” said Adam Lowe, an ME/CFS patient and one of the founders of MEAction UK, the U.K. branch of the Myalgic Encephalomyelitis Action Network. Patients might suddenly become bed-bound and have trouble focusing, he said.
This worsening of symptoms happens because a patient isn’t producing and using energy in the same way as a healthy person, said Todd Davenport, a professor at University of the Pacific who has studied exercise and this condition. It’s an internal change similar to the whole-body exhaustion that a marathon runner might experience at the finish line of their race.
A number of past studies and surveys of patients have demonstrated how dangerous exercise can be for people with ME/CFS. Many patients told to exercise by their doctors later dropped out of studies or treatment regimens, citing worsening symptoms. One infamous trial that pointed to exercise as a potential treatment was later discredited as deeply flawed.
Studying exercise as a treatment could “frame long Covid as something that can be overcome with grit and hard work,” said Jaime Seltzer, the director of scientific and medical outreach at MEAction, arguing that such framing is “unsound and ethically troubling.”
Not all patients with long Covid experience post-exertional malaise, and those who don’t could find exercise helpful, Davenport said. In those cases, slow and careful exercise through a rehabilitation or physical therapy program might help repair energy systems that have fallen out of shape.
But it may be difficult to distinguish between these different groups of patients, unless a clinical trial is set up with the utmost caution. “Ideally, what you would want is a very coherent, very specific set of inclusion and exclusion criteria,” Davenport said. Otherwise, the study would risk producing results that oversimplify long Covid, he added, leading doctors to widely prescribe a treatment that doesn’t work for some or many.
Scientists and patient advocates responsible for advising RECOVER have warned that an exercise trial could harm patients, but received mixed responses. Patients involved in the study sent emails and social media posts demanding that RECOVER stop the planned trial, while MEAction sent a public letter to NIH leaders.
Scientists and clinicians on an NIH advisory committee focused on rehabilitation similarly suggested that post-exertional malaise could be a dangerous result of the trial, according to internal emails shared with STAT and MuckRock. In response, NIH program officer Antonello Punturieri pushed back on the concerns. Punturieri cited clinical guidelines from the World Health Organization and a U.K. agency, even though both recommend against exercise for people with ME/CFS.
In response to these concerns, RECOVER set up internal meetings including researchers in charge of the exercise study, patient representatives, and the initiative’s top advisory committee. “Work is now underway to further revise that protocol” based on these meetings, the Duke Clinical Research Institute said.
The study’s planned revisions will address concerns about patient safety, such as monitoring for post-exertional malaise after exercise. But it’s unclear how the researchers will do this screening, or whether ME/CFS doctors will be involved.
Even with revision, experts and patient advocates remain concerned that the exercise study takes resources away from other research and could lead to harmful recommendations from doctors. If RECOVER finds exercise is helpful for some patients, asked JD Davids, an advocate with Long COVID Justice and author of a petition asking the NIH to stop this trial, “What are the chances that doctors would correctly understand how limited this recommendation is? I think it’s very low.”
It’s not like there aren’t plenty of potential treatment options worth studying.
Topol and other researchers compiled a full table of other treatment candidates for a review paper published in Nature in January. Experts on one of RECOVER’s advisory committees compiled a similar list, for a paper published in March.
Given “the number of other candidate treatments out there, I can’t imagine why you would choose graded exercise therapy,” said Julia Moore Vogel, a researcher at the Scripps Translational Institute living with long Covid, and co-author of the Nature review paper. Vogel is leading a study of wearable devices for long Covid, which will start with about 500 participants despite planning for up to 100,000.
One study has even reported results already, via a preprint shared by The Lancet in early March. The trial found that metformin, a common treatment for diabetes that also has antiviral properties, lowered Covid patients’ risk of developing long-term symptoms by about 42%.
This research group actually didn’t set out to study long Covid, said David Boulware, one of the scientists and an infectious disease physician at the University of Minnesota Medical School. The initial goal was to evaluate potential treatments for acute Covid-19, but the team added long Covid tracking partway through the trial.
And it’s unlikely to get further study without some kind of government assistance. The initial study relied on philanthropic funding, and additional grants would be needed to keep studying this generic drug.
“It’s a great drug, it’s cheap, it’s available worldwide,” Boulware said, “but there’s no profit margin for anyone to study it.”
There may be similar concerns for research into low-dose naltrexone, an off-label use of the addiction drug that has become common for long Covid and other chronic diseases. In low doses, naltrexone can help reduce inflammation in the immune and neurological systems, potentially alleviating long Covid symptoms.
But because the drug has been widely available for decades, pharmaceutical companies aren’t motivated to fund large trials. A few small clinical trials are underway, according to reporting by Rolling Stone.
The lack of help from NIH has left biotech executives frustrated.
“You have to understand what you’re trying to tackle, so we support that, of course. But as patients will tell you, we want intervention, not observation,” said Axcella CEO Bill Hinshaw. His Massachusetts-based company has gone all in on testing a drug candidate to treat long Covid symptoms, without any help from NIH.
Tonix Pharmaceuticals, which is developing a fibromyalgia medication that the company is hoping could be an effective treatment for long Covid symptoms, didn’t receive any funding from NIH either, despite putting in an application.
“I hope there are more therapeutics trials. And I think that the therapeutics trials can go hand in hand with the natural history kind of studies like RECOVER,” Tonix CEO Seth Lederman said.
Patients and experts fear that if RECOVER is the extent of federal effort to study long Covid, the condition could fall into the longstanding pattern of apathy and lack of urgency that has made breakthroughs in chronic illness treatment challenging.
“It’s clear that there are a lot of people at the NIH who are dedicated and determined, trying to figure this out,” said Charlie McCone, a patient representative at RECOVER. As a result, “patients are confused” why only a handful of clinical trials have been planned and none of those have launched yet, he said.
As the NIH initiative drags its feet, patients are left largely on their own to research potential treatments, said Cole, the Brooklyn-based patient, who has been struggling with symptoms since April 2020. “Because we’re not funding these promising treatments, and we’re not disseminating them through the medical system, it’s left to me to figure out how to make that happen for myself,” she said.
Cole, like many others in the long Covid community, feels abandoned by the federal government and health care system at large. If her symptoms worsen to the point that she can no longer work, she said, “the system’s not going to be there to pick me up.”
Infectious Disease
>
Long COVID
Patients Living With Long COVID Offer Insight to FDA
— Agency sought feedback on outcomes that matter most to patients
by Shannon Firth, Washington Correspondent, MedPage Today April 28, 2023
Patients with long COVID and their caregivers shared how the illness has impacted their lives, the treatments they've tried, and their hopes for clinical trials during a virtual public meetingopens in a new tab or window on Patient-Focused Drug Development for Long COVID hosted by the FDA on Tuesday.
Impacts on Daily Living
Jill Anderson, a patient participant, works for a behavioral health community services board in Virginia. Before developing long COVID, she had never had vertigo. Today, she's dizzy all the time.
"I would get up in the middle of the night and take a step out of bed and fall to the floor. It was terrifying how my world was spinning and out of balance," she said.
She has also experienced significant "brain fog," fatigue, and loss of appetite. Anderson currently works remotely on a reduced schedule and is worried she might lose her job.
Another patient participant, Heather Elizabeth Brown, a chaplain and corporate trainer in Detroit, said COVID impacted every major system in her body. "That includes my nervous system ... my reproductive system, digestive, lymphatic, endocrine -- any system you can name has pretty much been affected," she said.
She has had blood clots, lymphedema, fatigue, a stroke, COVID-induced diabetes, high blood pressure, and significant brain fog. During her initial infection, she developed pneumonia in both lungs and had to be on a ventilator for 31 days.
As a corporate trainer, her entire job is built around teaching and communicating, she said. "So having moments of not remembering what I was talking about could be very challenging."
Hopes for Treatment
During the panel discussion focused on treatments, Tammy Wilshire, a patient from the Appalachian Mountains of Pennsylvania, said she had "limited success" with a range of supplements -- vitamins C, D3, B12, and magnesium -- as well as beta blockers for tachycardia, and gabapentin for tremors and worsening fibromyalgia.
Physical therapy showed promise at first, she said, but as its intensity increased, she experienced "crippling fatigue" and a relapse of myalgic encephalomyelitis-chronic fatigue syndromeopens in a new tab or window, a debilitating multi-systemic illness, which forced her to stop.
Angela M. Vasquez, president of Body Politic, a grassroots health justice organization, takes 15 medications, receives weekly infusions of diphenhydramine (Benadryl) and saline, and takes supplements to support "mitochondrial health."
After being reinfected with COVID, she took 15 days of nirmatrelvir-ritonavir (Paxlovid) and found that despite an "extended flare," the medication minimized, to a degree, her cognitive dysfunction and gastrointestinal problems.
Her symptoms also improved following her first vaccine, Vasquez said, and she's come up with a "strict pacing routine" that enables her to work full-time from home, though she has little energy for much else.
A third patient, Daniel Lewis, takes a beta blocker and midodrine for post-orthostatic tachycardia syndrome, and bupropion (Wellbutrin) for fatigue, but each has helped only "a tiny bit."
Asked about their ideal treatments, Wilshire said it would need to reduce her pain and fatigue. Vasquez urged scientists to focus on post-exertional malaise. And Lewis said his "most disabling symptoms" relate to exertion.
Lewis urged FDA officials to expand access to approved drugs that he argues appear promising based on early research, including antivirals, Janus kinase inhibitors, anticoagulants, antiplatelets, metformin, and others.
Other patients described success with Pilates (given the opportunity for strengthening muscles without being physically upright), methylphenidate (Ritalin) for brain fog, supplements, acupuncture, meditation, and other supports from functional medicine doctors.
Shaping Clinical Trials
"Anything that is in person is extensively more difficult, than anything that can be ... done on online," said Liza Fisher, a flight attendant and part-time yoga instructor. In-person clinical trials also add to the cost for participants, many of whom have lost employment and healthcare coverage.
Costs of participating in general are always a factor, Fisher said. In 2021, she contemplated participating in a stem cell trial, but was told by the Houston-based company running the trial that she would have to biobank her stem cells first, which would set her back somewhere between $3,000 and $10,000. Fisher, who was unemployed and receiving disability at the time, quickly dropped the idea.
Fisher also found she was ineligible for another trial because she is currently taking off-label steroids. She also noted that other exclusionary criteria included "activity ranges for vitals," which she said aren't sensitive enough for the long COVID patient population.
As for trials of medications with potential side effects, Fisher said, "To be perfectly honest ... every time I was read a list of side effects, I thought, 'oh, that's my Saturday.'"
When she hears of an intervention or medication in a trial that she thinks could potentially trigger an increase in her symptoms, Fisher considers micro-dosing and slow titration schedules to more carefully assess her reaction, rather than opt out.
As to whether she'd be willing to enroll in a trial in which she might be given a placebo, she said she would, as long as she knew that if the experimental drug or intervention was successful, then she would also have access after the trial was completed.
Another patient participant, Ryan, who chose not to share his last name, said he views a control arm as the most important part of a clinical trial. "Sometimes I'll see a study that's been trialing a medication for 6 months and they've seen moderate improvement, but that's my experience without medication," he said.
Ryan also stressed the need to track biomarkers, such as those measuring micro-clotting, endothelial cell dysfunction, and T-cell disturbances or cytokines, which are tied to immune dysfunction more broadly.
As a logistical matter, Ryan also avoids clinical studies that would require him to drive, because of his brain fog
He is currently enrolled in the RECOVER programopens in a new tab or window at Mount Sinai Hospital in New York City, which is accessible by public transportation.
Asked by FDA officials about outcomes that matter most to patients, Michelle, whose daughter has long COVID and who did not share her last name, said that "being able to tolerate returning to school would be the most meaningful improvement for us."
Other patients, some of whom phoned into the webinar, called for more specific studies of long COVID and women's reproductive health. Others expressed concern over the loosening of mask requirements in healthcare settings, and the number of long COVID patients taking supplements, suggesting that more oversight was needed.
In closing the discussion, Michael Iademarco, MD, MPH, deputy assistant secretary for science and medicine in the Office of the Assistant Secretary of Health, noted that there was a great deal of diversity in the perspectives shared.
"It's a lot to pull together ... but at the end of the day, we have to pull it together, and make some steps forward in the right direction," he said. "And we may not always get it perfectly right, but that's what we're aspiring to do in HHS."
author['full_name']
Shannon Firth has been reporting on health policy as MedPage Today's Washington correspondent since 2014. She is also a member of the site's Enterprise & Investigative Reporting team. Follow
1 Comment
For the most part that seems true--for now
But even now--in the S2C area--there is only 1 approved drug that is partially effective and that was EUA just couple weeks ago
The application for Psilocybin is mostly beneficial to therapists doing PTSD and End of Life and other therapies. The dosages have to be accurate, it's science, not just me tripping out at Coachella on the shrooms I grew in the backyard. The results of these therapies are phenomenal and I think Psilocybin is a potential goldmine.
This has ALWAYS been about COVID and obtaining EUA for Bucillamine. Everything else is pretty much a joke IMO. And the need for a new COVID treatment has dramatically subsided....I'm sorry to say. There are lots of 'once promising' COVID small biotechs in the COVID graveyard now.
That’s the problem. What are they going to offer that’s differentiated? Anyone can buy or grow shrooms and micro dose they don’t need any pharma. Besides some here continue to say the fda is corrupt and won’t approve anything from small players.
It’s really a pity and a sham at this point in my opinion
Does anybody have a perspective on Revive's progress with Psilocybin? At this point, this industry is expecting legalization in various States to grow. It is legal Statewide in Colorado and legal in Oregon for medicinal use. I think there will be a strong push over the next three years to legalize Psilocybin and perhaps get corporate control over it. In the meantime it will stay mostly underground, but make no mistake, Psilocybin is magic medicine. How can RVVTF benefit here?
Revive was a long shot since the get go about 3 years ago. Now with covid in the rear-view mirror, it's an even bigger longshot. I would be happy just breaking even at this point but it's highly unlikely.
So I just want to ask all of you something. What the hell are we all doing here?
Making $$ of course......whether it comes in singles, or stacks, its still $$.
Progress forward is my hope
Followers
|
337
|
Posters
|
|
Posts (Today)
|
0
|
Posts (Total)
|
36642
|
Created
|
02/23/17
|
Type
|
Free
|
Moderators Classic Warrior |
Scientific Rationale of Bucillamine
Preclinical and clinical studies have demonstrated that reactive oxygen species contribute to the destruction and programmed cell death of pulmonary epithelial cells.1 N-acetyl-cysteine (NAC) has been shown to significantly attenuate clinical symptoms in respiratory viral infections in animals and humans, primarily via donation of thiols to restore antioxidant and to reduce the activity of cellular glutathione 2,3,4,5. Bucillamine (N-(mercapto-2-methylpropionyl)-l-cysteine) has a well-known safety profile and is prescribed in the treatment of rheumatoid arthritis in Japan and South Korea for over 30 years. Bucillamine, a cysteine derivative with two thiol groups, has been shown to be 16 times more potent as a thiol donor in vivo than NAC 6. The drug is non-toxic with high cellular permeability. The basis of the clinical study will analyze if Bucillamine has the potential, via restoration of glutathione activity and other anti-inflammatory activity, to lessen the negative consequences of SARS-CoV2 infection in the lungs.
| Psilocin Pharma Corp. has developed production solutions for the active compound Psilocybin. Our process encompassed with our intellectual property cover methods of production of Psilocybin based formulations. Psilocin Pharma Corp’s range of products have been engineered to work synergistically with the body's own natural pathways of absorption while offering a contemporary approach to consumption. Psilocin Pharma also has strong relationships with specific lab partners in certain areas like Brazil, where these formulations are legally approved and plan to sell products in these jurisdictions. | |
| |
Mental Health (Depression, PTSD & Anxiety)
|
Supplements for Brain Health & Cognitive Enhancement
|
Volume | |
Day Range: | |
Bid Price | |
Ask Price | |
Last Trade Time: |