COVID-19 long-haulers plead for government action

 COVID-19 long-haulers and advocates are stepping up their calls for state and federal officials to take action and dedicate funding to those who have endured the mysterious condition that stems from the coronavirus.

After months of sharing their stories of ongoing symptoms, long-haulers are appealing to elected officials for assistance and begging them to provide help.

“We need to have more legislation for survivors like ourselves and not just keep telling our stories because there's a bazillion stories out there now,” said Maya McNulty, a long hauler from New York. “We're not like some Netflix series that you can just binge watch and then the problem goes away. We are living with this … disease, and there is no hope.”

The grassroots, nonpartisan group COVID Survivors for Change launched a week of action on Friday, with delegations from all 50 states dedicated to illustrating how the virus has changed the lives of long-haulers and families who’ve lost loved ones.

Advocates said they plan to contact officials, including Michigan Gov. Gretchen Whitmer (D), Pennsylvania Gov. Tom Wolf (D), Montana Gov. Greg Gianforte (R), Kentucky Gov. Andy Beshear (D) and Alaska Gov. Mike Dunleavy (R), to push for initiatives to support COVID-19 survivors.

Their requests range from direct funding for long-haulers to a 9/11-style commission to investigate how the pandemic led to hundreds of thousands of deaths and potentially millions of long COVID-19 cases.

The delegations plan to photograph empty chairs to signify all of those who’ve died of COVID-19 and long-haulers who experience persisting symptoms. The chairs are meant to serve as a “powerful” symbol highlighting the community and calling on elected officials to listen to “what they need and respond accordingly,” said Chris Kocher, the executive director of COVID Survivors for Change.

“We really wanted to show the strength and power of the movement by taking action in all 50 states and communities all across the country to highlight just how many people have had their lives devastated by COVID and how important it is that we need our government to continue to step up and take action to support all those who have been impacted by COVID,” Kocher said.

The effort follows a temporary memorial that was erected on the National Mall last month, with one white flag representing every COVID-19 death in the U.S. Sunday is the last day of the memorial "In America: Remember."

Reuters reported that the U.S. exceeded 700,000 coronavirus deaths on Friday.

Rock Island, Ill., resident Jennifer Johnson, who has suffered from long COVID-19 for seven months, set up her chair to be photographed with medical equipment, a cane and medications that she now needs to use.

“It's one thing to see a chair with nobody in it, but then it's a whole different experience to have to see what people are dealing with on a daily basis,” she told The Hill.

Johnson, a 46-year-old single parent of two teenagers, said she has six providers for her various symptoms, including inflammation, muscle weakness, decreased lung capacity and memory problems. She said that immediately following a suspected stroke two months ago, “I couldn’t tell you my name.”

But she is worried about the financial costs of her extensive health care needs as “a full-time employee” who is “not able to work full-time” and expects to lose “significant income.”

“I don’t want to be carried financially for the rest of my life,” she said. “I want to work, I want to be productive. But this just isn’t a work issue. This is an entire quality of life issue.”

McNulty of Niskayuna, N.Y., has characterized long-haulers like herself as “a new breed of survivors” and launched Covid Wellness Clinic that’s dedicated to helping long COVID-19 patients. 

The 48-year-old long-hauler contracted COVID-19 in March 2020 and ended up hospitalized for 69 days, including 30 days in a medically induced coma. She spent months relearning to eat, walk and talk and has returned to the emergency room four times due to long COVID-19 symptoms.

McNulty is requesting “significant” and “dedicated” funding for long-haulers, although she said she worries that money will funnel to “people that don’t need it.”

“We demand more care for us because we're being forgotten,” she said.

As part of the week of action, certain delegations of COVID Survivors for Change are also planning to rally with teachers to back safe school reopenings, write letters to the editors of their local newspapers and set up and request memorials for COVID-19 victims, including long-haulers.

Junction City, Kan., resident Mary Snipes, 52, said she will send letters and emails to state elected officials this week calling for them to collaborate and spread more awareness about the potential outcomes of COVID-19.

Snipes, who was hospitalized for COVID-19 in December for almost two weeks, still uses oxygen to breath and has endured chest pain, headaches, brain fog, joint pain and high blood pressure.

“It gets frustrating because I am a type of person that would go, go, go, go,” she said.  “And now it's like I am at a standstill because I am so weak and fatigued and just [have] no energy.”

Doctors and scientists have been perplexed by the conditions of long COVID-19 as it’s developed throughout the pandemic. They’ve conducted research attempting to determine how often it occurs among COVID-19 patients, with a recent study saying 37 percent had at least one long-term symptom three to six months after infection, suggesting millions nationwide could have long COVID-19.

The National Institutes of Health announced last month that it dedicated almost $470 million to develop a national study population to investigate the long-term effects of the virus, with the hope of recruiting between 30,000 and 40,000 participants.

David Putrino, director of rehabilitation innovation for the Mount Sinai Health System, said it’s been “really challenging” as his clinic has cared for almost 1,600 long-haul patients throughout the pandemic. In a survey of patients, 60 percent said they had a change in employment status due to their symptoms.

“We're doing our best to manage their symptoms and provide good evidence-based care,” Putrino said. “But obviously with a novel condition, evidence-based care is tough. And obviously it's also just not easy to provide reassurance when you can't say in good faith that you know precisely what's happening to a patient.”

Janna Friedly, the medical director of University of Washington Medicine’s post-COVID-19 Rehabilitation and Recovery clinic, said she supports more government support for long-haulers as they deal with an “increasing burden” of costs. 

Friedly, who previously experienced long COVID-19 symptoms for nine months, said the clinic “desperately” needs more resources to care for patients, especially those with 10 or more different symptoms who require multiple specialists.

“I think we're just starting to really scratch the surface in understanding the financial and economic impact of long COVID on patients themselves, but also on the health care system and in the workforce,” she said.

https://thehill.com/policy/healthcare/574984-covid-19-long-haulers-plead-for-government-action

Biden presses companies to get ahead of vaccine mandate

 President Biden is pushing companies to get ahead of the federal COVID-19 vaccine mandate by imposing their own mandates amid simmering concerns that some employees will quit when the national requirement takes effect. 

Biden’s vaccine-or-test mandate for businesses with 100 or more workers is still being crafted by the Occupational Safety and Health Administration (OSHA), prompting the administration to fill that time by encouraging more employers to implement their own vaccination rules beforehand.

Companies taking that step are getting a shout-out from the White House.

“We’re touting companies as far reaching as United Airlines to Tyson’s Foods who are leading their industries on putting forth requirements that are going to help keep their workplaces safe and their business strong and consistent. Economists from across the board agree that requirements will help in our recovery,” a White House official told The Hill.

When asked why the administration would rather see companies come out now with their own mandates instead of waiting until the OSHA ruling, the official said, “There is no reason to wait to put forth these requirements and we encourage every company to do what will boost vaccinations.”

Some business groups, however, say employers have real concerns that workers may quit instead of rolling up their sleeves.

“The administration's stated goal is to get as many people vaccinated as possible. If employers mandate it before they are required to, that serves the overall goal. Employers have been able to do this for some time but many have been hesitant fearing the possible loss of employees,” said Marc Freedman, vice president of workplace policy at the U.S. Chamber of Commerce.

“The forthcoming OSHA rule is what is creating the anxiety for employers—they don't know how their employees will respond and are worried about employee departures,” he added.

Biden’s rule is expected to come out within the next month, and OSHA will publish an Emergency Temporary Standard to enact the mandate. It is expected to affect around 80 million workers. Businesses that fail to comply could face fines of up to $14,000 per violation.

Many members of the business community have argued that the Biden announcement about a forthcoming vaccine mandate has essentially frozen some companies in place because they might not want to put resources toward a vaccine program that might not align with the administration's eventual mandate. Some companies could also be worried about employee retention if they implement a program before they need to.

The CEO of South Motors, a group of Florida auto dealerships in the Miami-Ft. Lauderdale area, told The Associated Press about fears of losing workers over the federal vaccine mandate because of how difficult it’s already been to find employees and keep them. The CEO of Rhode Island-based VIBCO Vibrators, which makes industrial vibrators for dump trucks, predicted the vaccine mandate will be detrimental to 15 percent of employees.

But some state-level mandates have not led to the kinds of worker shortages initially feared. In New York, a mandate for health workers to get vaccinated against COVID-19 has boosted the industry's vaccination rate, and has not resulted in widespread facility closures and mass resignations.

White House chief of staff Ron Klain has praised United Airlines, AT&T and other companies for their vaccine mandates. He tweeted an article that said United had less than one percent of employees refuse to get the vaccine following its mandate.

“Lots of talk about threatened resignations in the face of vaccine requirements, but the reality? ‘At Novant Health ...in North Carolina, 375 workers were suspended ... [but] the vaccination rate [hit] over 99 percent of its more than 35,000 employees,’” he said this past week. 

“There have been — some of these companies have been much bigger, larger companies, where they have effectively implemented these mandates and requirements. And for the most part, we have not seen a mass exodus of employees,” White House press secretary Jen Psaki told reporters on Wednesday. “Yes, individuals have decided not to get vaccinated and then have therefore not, no longer been employed. That’s nobody’s preference.”

But, she said the increases in vaccinations for the companies that have mandated it is a “good sign” and “a model” for how the mandates the federal government will impose will be treated.

A former OSHA official under President Obama said that in most cases of forthcoming workplace standards, companies typically comply ahead of the ruling.

“If employers know OSHA is going to issue a standard requiring certain safety measures, employers start to comply ahead of the requirement. You see this with most OSHA standards — that often by the time it is issued, many employers have complied or are on their way,” said Debbie Berkowitz, chief of staff and senior policy adviser for OSHA during the Obama administration.

Some GOP governors have threatened legal action over the Biden administration's mandate, including Georgia Gov. Brian Kemp, Arizona Gov. Doug Ducey, and South Dakota Gov. Kristi Noem. 

Republican Sen. Roger Marshall of Kansas attempted to block Biden’s vaccine-or-test mandate for businesses on Thursday through an amendment on the Senate floor. Senators were split down the middle on the vote and it fell short of the 60 votes needed for adoption.

While other Republican lawmakers and governors have denounced the federal mandate, health experts have praised it as a way to get more Americans vaccinated.

When the White House first announced the forthcoming rule, it said it expects more companies to require vaccines while OSHA is in the rulemaking process.

“Given that the White House has made it clear that the President stands behind OSHA issuing this standard, employers know it is coming,” Berkowitz said. “And what we found when I was at OSHA, most employers want to do the right thing and they will comply.” 

An Axios-Ipsos poll in September found that 60 percent of the public supported the vaccine-or-test mandate for businesses.

Psaki on Twitter this past week shared a list of companies that yielded positive results from their vaccine mandates, including Henry Ford Health System in Detroit, which went from 68 to 98 percent of its workforce vaccinated after they required it.

She also cited a Goldman Sachs estimate that “the new requirements will boost the number of vaccinated individuals by 12 million people, and create a net positive impact on employment.”

https://thehill.com/policy/healthcare/574986-biden-presses-companies-to-get-ahead-of-vaccine-mandate

Vaccine mandate for federal workers can be enforced next month

 The U.S. Office of Personnel Management (OPM) said in a memo issued Friday that President Biden's vaccine mandate for federal employees can be enforced beginning on Nov. 9 for employees who have not yet been inoculated.

In the memo from Director Kiran Ahuja, OPM advised against waiting to the last minute to get vaccinated as "other events often interfere with even well-laid plans."

"Employees who refuse to be vaccinated or provide proof of vaccination are subject to disciplinary measures, up to and including removal or termination from Federal service," Ahuja stated. "The only exception is for individuals who receive a legally required exception pursuant to established agency processes."

Federal agencies were advised to require their employees to get fully vaccinated by Nov. 22, with their second dose of a vaccine to be received "no later than November 8." The Nov. 8 deadline also applies to getting a dose of Johnson & Johnson's one-dose COVID-19 vaccine.

"Given this timeline, agencies may initiate the enforcement process as soon as November 9, 2021, for employees who have not completed their vaccination dose(s) by November 8," Ahuja added.

Last month, Biden issued an executive order requiring that federal employees get vaccinated against COVID-19.

"The health and safety of the Federal workforce, and the health and safety of members of the public with whom they interact, are foundational to the efficiency of the civil service," Biden wrote in his order. "I have determined that ensuring the health and safety of the Federal workforce and the efficiency of the civil service requires immediate action to protect the Federal workforce and individuals interacting with the Federal workforce.

https://thehill.com/homenews/administration/575049-opm-says-vaccine-mandate-for-federal-workers-can-be-enforced-next

US Stem Cell Clinics Boomed While FDA Paused Crackdown

 Hundreds of clinics pushing unproven stem cell procedures caught a big break from the U.S. government in 2017: They would have three years to show that their questionable treatments were safe and worked before regulators started cracking down.

But when the Food and Drug Administration's grace period expired in late May — extended six months due to the pandemic — the consequences became clear: Hundreds more clinics were selling the unapproved treatments for arthritis, Alzheimer's, COVID-19 and many other conditions.

"It backfired," says Leigh Turner, a bioethicist at the University of California, Irvine. "The scale of the problem is vastly larger for FDA today than it was at the start."

The continuing spread of for-profit clinics promoting stem cells and other so-called "regenerative" therapies — including concentrated blood products — illustrates how quickly experimental medicine can outpace government oversight. No clinic has yet won FDA approval for any stem cell offering and regulators now confront an enormous, uncooperative industry that contends it shouldn't be subject to regulation.

Although emerging research suggests stem cells could someday have broad use for a number of medical conditions, experts say they should not be used outside of well-controlled studies or a handful of established uses. For instance, stem cells collected from blood or bone marrow have long been used to treat leukemia and other blood diseases.

Many clinics use so-called adult stem cells collected from tissue like fat or bone marrow — not the more versatile but controversial stem cells from embryos used in research.

Turner and other experts have tracked the growth of the clinics for nearly a decade. Clinics charge between $2,000 to $25,000 for adult stem cell injections and other infusions which they advertise for an assortment of diseases, including diabetes, autism, cancer, multiple sclerosis and vision problems. Some clinics use stem cells derived from fat, harvested via liposuction then reinjected into patients, aiming to repair joints or fight disease. Others use bone marrow or blood taken from umbilical cords after birth.

There is no government tally of how many clinics operate in the U.S. But Turner counted more than 1,200 of them in 2019, up from the 570 clinics he and a co-author identified in 2016. He's working on an update but says the number has consistently grown.

The FDA has repeatedly warned Americans to steer clear of unapproved and unproven stem cell therapies, which have occasionally caused blindness, bacterial infections and tumors. During FDA's three-plus years of "enforcement discretion," the agency sent formal warning letters to more than a dozen businesses performing the riskiest procedures. Regulators also prevailed in a Florida court case to shutdown a major clinic offering unproven treatments. Another case against a similar prominent company is pending in California.

"It's time to actually get the data we need," to assess clinics' stem cell procedures, FDA's Dr. Peter Marks said at an industry conference in June. He pointed to a multiyear effort by FDA to help clinics through the review process.

Many stem cell doctors continue to argue that their in-office procedures are outside FDA's purview. But FDA has concluded that processing stem cells and giving them to patients with serious diseases amounts to creating a new drug, which the agency regulates.

The FDA hasn't disclosed how many clinics sought approval since 2017, but public comments suggest it was troublingly low.

"We have been very disappointed in the number of clinics that have come in," FDA's Dr. Wilson Bryan said at the same conference.

Bryan, who directs FDA's cell therapies division, added that he is "extremely concerned" by how many stem cell and related offerings remain available.

Tracking injuries from the procedures is difficult. Drugmakers and hospitals are required to report drug-related complications to the FDA, but no such requirements exist for individual doctors. And patients often don't know where to report problems.

David Stringham of Provo, Utah, says undergoing a procedure for joint pain at a local clinic was "the worst decision of my life."

In 2018, Stringham was looking for an alternative to surgery for chronic pain in his right shoulder and elbows after years of weightlifting. He paid $2,400 for injections of so-called platelet-rich plasma at a clinic. It doesn't involve stem cells but the procedure is similar: doctors take a blood sample, process it to concentrate the platelets and then reinject them into the patient's problem areas in an attempt to speed healing.

The procedure went smoothly, but within hours Stringham was wracked by pain in his back, shoulder and arms.

"It was a crazy amount of pain and I kept calling them saying 'something is not right,'" said the 51-year-old. "And to this day I'm not right."

The clinic gave Stringham medication for the pain and told him to be patient. But things didn't improve, even after months of physical therapy. Since then, a neurologist has told Stringham he probably suffered nerve damage at the places where he was injected.

His case was included in a Pew Charitable Trusts review of 360 reported injuries from stem cell and other regenerative procedures between 2004 and 2020. Nearly all the reports came from medical journals, government publications, social media or news reports. Just five came from FDA's database for medical injuries.

"There are a lot of holes in the safety system," said Liz Richardson of Pew, who led the project.

The FDA didn't clearly assert its authority over such clinics until 2017. The next year, it began sending form letters to some 400 clinics, warning that they may be violating FDA rules. But the names of the clinics haven't been publicized, and such warnings are often ignored.

Traditional medical researchers welcome the FDA actions but say it's impossible to gauge their effect.

"The business model is this: 'We can keep offering these products until things get serious with the FDA — and then we can just take down our website'," said Laertis Ikonomou, a stem cell researcher at the University of Buffalo who also heads a task force on the topic for the International Society for Cell and Gene Therapy.

He and other specialists say the clinics have damaged the reputation of legitimate stem cell research while also siphoning off patients who might otherwise enroll in studies.

Lawyers representing stem cell clinics say they have no choice but to resist FDA regulation.

"FDA is pushing them into this drug development pathway, which nobody is adopting because it requires a million dollars' worth of toxicology and animal studies just to show something is safe for human use," said Marc Scheineson, a former FDA attorney.

For now, people on both sides are waiting to see what FDA does.

"We shouldn't feel too confident that the FDA has this wrapped up" said Turner, the bioethicist. "They really have invested some resources and they are trying to do something here but I think they're just outmatched and overwhelmed."

https://www.medscape.com/viewarticle/960049

Fast-food chains close some indoor seating as U.S. cities mandate vaccine checks

 As New York, San Francisco and a few other U.S. cities and counties require restaurants to check proof of COVID-19 vaccination to dine indoors, some fast-food chains are simply shutting their seating areas altogether - a move that may dent their sales.

The burger chain White Castle shut the seating sections in its more than 20 New York City locations in September, after New York City began asking customers over the age of 12 to prove they received at least one does of the vaccine in order to eat indoors.

By eliminating dine-in options, restaurants are forced to rely entirely on carry-out, drive-thru and delivery orders – which are generally more profitable. That also means they can eliminate costly labor required to clean seating areas and check customers' proof of vaccination, and perhaps have an extra employee work the kitchen or counter instead.

White Castle Chief Operations Officer Jeff Carper said the chain was "able to redeploy some labor to focus on drive-thru, delivery and pick-up," for instance.

Taco Bell, a unit of Yum Brands Inc (YUM.N), said it encouraged customers to place digital orders for pickup and delivery, adding that "our restaurants comply with federal, state and local regulations and guidelines to keep our team members and customers safe." Two Taco Bell locations that Reuters visited had closed their indoor seating.

At McDonald's Corp (MCD.N), franchisees consider multiple factors when deciding to close indoor seating, including COVID case counts, local regulations and staffing levels, the company said. On Sept. 16, 3 of the 8 McDonald's locations in New York City visited by Reuters had closed their indoor seating.

"We continue to monitor the Delta variant closely and, as we have throughout the last 18 months, remain able to adapt quickly while maintaining our safety standards," the company said.

Overall, consumer spending at U.S. restaurants has rebounded from last year's mid-pandemic lows, up 9% to $440 billion in the 12 months ended in August, according to data from The NPD Group/CREST.

But the first mandate to check for proof of vaccination went into effect in New York City on August 17, and the city began to enforce the requirements as of Sept. 13.

Inspectors for New York City visited 18,182 establishments by Thursday, giving out 2,211 warnings and 6 violations of $1,000 for failing to check vaccination cards.

King County, Washington, home to Seattle, will require restaurants to check proof of full vaccination or a recent negative COVID-19 test beginning Oct. 25. San Francisco began requiring indoor diners to show proof that they had been fully vaccinated on Aug. 20.

https://www.reuters.com/world/the-great-reboot/fast-food-chains-close-some-indoor-seating-us-cities-mandate-vaccine-checks-2021-10-01/

Longeveron: Biomarker Analysis From Mid-Stage Study Of Anti-Aging Cell Therapy Candidate

Longeveron Inc. 

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 (Get Free Alerts for LGVN) announced Wednesday positive biomarker analysis data from the mid-stage study of its lead cell therapy candidate in aging frailty subjects.

What Happened: Florida-based Longeveron said ongoing biomarker analysis from the Phase 2b study of Lomecel-B investigational cell therapy in aging frailty subjects showed that administration of the investigational therapy was associated with a significant reduction in serum levels of soluble TIE-2 in a dose-dependent fashion at Day 270 compared to placebo.

Reductions in sTIE-2 correlate with anti-inflammatory and pro-vascular effects, while elevated levels of sTIE2 have been observed in patients with peripheral arterial disease and are an indication of poor vascular health, the company said.

Since poor vascular health and endothelial dysfunction are associated with the onset and development of frailty in older adults, the finding that Lomecel-B can reduce sTIE-2 suggests that improving vascular and endothelial function may be a potential mechanism of action of this product.

"This is the first time that a cell therapy has been associated with a reduction in sTIE-2 in the bloodstream," the company said.

What's Next: Longeveron plans to further explore the Tie-2 changes in additional subject populations with Aging Frailty.

The study's lead investigator Jorge Ruiz is scheduled Wednesday to present results from the trial at the 2021 11th Annual International Conference for Frailty & Sarcopenia.

Longeveron announced in mid-August data from the study that showed all cohorts showed mean increases in six-minute walk test distance from the baseline, at 180 days post-infusion, although statistically significant difference was not demonstrated.

https://www.benzinga.com/general/biotech/21/09/23153787/exclusive-longeveron-announces-biomarker-analysis-data-from-mid-stage-study-of-anti-aging-cell-th

Exscientia: $304.7M Upsized IPO Priced + $160M Concurrent Private Placements

 Exscientia plc (Nasdaq: EXAI), an AI-driven pharmatech company committed to discovering, designing and developing the best possible drugs in the fastest and most effective manner, today announced the pricing of its upsized initial public offering in the United States of 13,850,000 American Depositary Shares (“ADSs”) representing 13,850,000 ordinary shares at an initial public offering price of $22.00 per ADS, for total gross proceeds of approximately $304.7 million. All ADSs sold in the offering were offered by Exscientia. The ADSs are expected to begin trading on the Nasdaq Global Select Market on October 1, 2021 under the ticker symbol “EXAI.” In addition, Exscientia has granted the underwriters a 30-day option to purchase up to an additional 2,077,500 ADSs at the initial public offering price, less underwriting discounts and commissions. The offering is expected to close on or about October 5, 2021, subject to customary closing conditions.

In addition to the ADSs sold in the public offering, the Company announced the concurrent sale of an additional 7,272,727 ADSs at the initial offering price of $22.00 per ADS, for gross proceeds of $160.0 million, in private placements to SVF II Excel (DE) LLC, or Softbank, and the Bill & Melinda Gates Foundation. The sale of these ADSs will not be registered under the Securities Act of 1933, as amended, and will be subject to a 180-day lock-up agreement.

Goldman Sachs & Co. LLC, Morgan Stanley & Co. LLC, BofA Securities and Barclays Capital Inc. are acting as joint book-running managers for the offering.

https://www.biospace.com/article/releases/exscientia-announces-pricing-of-304-7-million-upsized-initial-public-offering-and-160-0-million-concurrent-private-placements/