Wanted: Volunteers to catch COVID in the name of science

 The world’s first medical trial authorised to deliberately expose participants to the coronavirus is seeking more volunteers as it steps up efforts to help develop better vaccines.

The Oxford University trial was launched last April, three months after Britain became the first country to approve what are known as challenge trials for humans involving COVID-19.

Its first phase, still ongoing, has focused on finding out how much of the virus is needed to trigger an infection while the second will aim to determine the immune response needed to ward one off, the university said in a statement on Tuesday.

Researchers are close to establishing the weakest possible virus infection that assures about half of people exposed to it get asymptomatic or mild COVID-19.

They then plan to expose volunteers – all previously naturally infected or vaccinated – to that dose of the virus’s original variant to determine what levels of antibodies or immune T-cells are required to prevent an infection.

“This is the immune response we then need to induce with a new vaccine,” said Helen McShane, Oxford University Professor of Vaccinology and the study’s chief investigator.

The trial’s findings will help make future vaccine development much quicker and more efficient, the statement said.

Global immunologists have been seeking to pinpoint the immune reaction that a vaccine must produce to shield against the illness, known as a correlate of protection. Once discovered, the need for mass vaccine trials is greatly reduced.

Scientists have used human challenge trials for decades to develop treatments against many infectious diseases, but this is the first known such research into COVID-19.

A drawback is the risk of harm to volunteers contracting the disease but the university is taking precautions.

Participants will need to be healthy and aged 18-30. They will be quarantined for at least 17 days and any who develop symptoms will be given Regeneron’s monoclonal antibody treatment Ronapreve.

https://wtvbam.com/2022/01/26/wanted-volunteers-to-catch-covid-in-the-name-of-science/

Psaki defensive when asked about Biden-Xi talk on COVID origins

 White House press secretary Jen Psaki bristled Wednesday when asked about President Biden’s claim that he pressed Chinese President Xi Jinping to be transparent about the origins of COVID-19 — growing flustered at what she interpreted as a suggestion he was lying about doing so.

Biden said at a press conference last week that he urged Xi to be transparent during a 3 1/2 hour virtual summit in November. Biden said his spokespeople gave reporters the opposite impression because they weren’t in the room for part of the summit.

“On COVID origins, you guys are talking a lot about sanctions for Russia if they dare to invade Ukraine. What about sanctions for China at any point for misleading the world about the early days of the global pandemic?” Fox News correspondent Peter Doocy asked Psaki at her regular press briefing.

Psaki deflected, saying, “We have used sanctions as a tool as it relates to our concerns about the behavior of a range of countries, including officials in China, but I have nothing to preview for you at this point.”

“Is it possible down the line though that … sanctions would be considered or some other form of punishment for their actions in the earliest days of the pandemic?” Doocy followed up.

“We strongly believe and the president has been clear and directly clear about the importance of them being transparent and providing data and information related to the origins of the pandemic, but I don’t have anything to predict for you in terms of additional actions,” Psaki replied.

Doocy then asked about the White House’s changing description of Biden’s communications with Xi. The issue of coronavirus origins was conspicuously missing from a White House readout in November of the Biden-Xi summit and Psaki told reporters afterward that Biden pushed for “transparency” more generally, giving a clear impression that he didn’t ask Xi to get to the bottom of the origins of the pandemic — a characterization she didn’t correct.

“The president said for months that he had not spoken directly to Xi about the COVID origins investigation. Now he says he did talk to Xi about it, but nobody else was there. If the president had that conversation, did it work? And is Xi now playing ball?” Doocy asked.

Psaki fired back: “What are you getting at there? Are you suggesting the president wasn’t being honest about his own conversation with Xi?”

Biden emphasized that he told Xi that he had an obligation to disclose any information on what exactly the origin of the virus was.

AP

“No, but the story did change,” Doocy said. “For months, he was asked about it and he said that he had not directly asked him about the COVID origins investigation.”

“We don’t share every detail of every diplomatic conversation, you know that,” Psaki replied curtly. “The president answered a direct question just a week ago … and provided that information.”

The US intelligence community said in August that it’s possible the virus leaked from the Wuhan Institute of Virology, calling the theory one of two “plausible” explanations along with natural transmission from animals. With the exception of a written statement attributed to him in August, Biden said almost nothing publicly about the subject until last week.

The US intelligence community raised the possibility that COVID leaked from the Wuhan Institute of Virology.

AP

Biden smiled and walked away in December when The Post asked him on the White House lawn why he hadn’t done more to get transparency from China.

Last week, The Post asked Biden at his second solo White House press conference why he didn’t push Xi for transparency during the November summit and whether “that has anything to do with your son’s involvement in an investment firm controlled by Chinese state-owned entities.”

“The answer is, that we did — I did raise the question of transparency,” Biden replied, giving a starkly different answer than his own press team and side-stepping his son Hunter’s business interests in China.

“I spent a lot of time with him and he — the fact is they’re just not, they’re just not being transparent,” Biden said.

The Post pressed, “transparency on the coronavirus origins?”

“Yes,” the president said.

“And you did during the virtual summit?” The Post continued.

“Yeah,” Biden said.

“Is there a reason your press staff was unaware of that? And what did you say to the Chinese president?” The Post further pressed.

“They weren’t with me the entire time,” Biden said. “I made it clear [to Xi] that I thought that China had an obligation to be more forthcoming on exactly what the source of the virus was and where it came from.”

Hunter Biden divested a 10 percent stake in an investment fund controlled by Chinese state-owned entities, according to his lawyer.

WireImage

First son Hunter Biden’s attorney Chris Clark said less than a week after Biden’s November summit with Xi that he divested a 10 percent stake in an investment fund controlled by Chinese state-owned entities. Hunter Biden and the White House provided no further details. That firm, BHR Partners, was registered 12 days after Hunter joined Vice President Biden aboard Air Force Two for a 2013 trip to Beijing.

Documents published in September by The Intercept revealed that US health officials indirectly funded “gain of function” research at the Wuhan lab that sought to better understand viruses by manipulating them — including modifying three bat coronaviruses distinct from COVID-19 and discovering they became much more infectious among “humanized” mice when human-type receptors were added to them.

Psaki said in August that Biden does not support former President Donald Trump’s demand that China pay $10 trillion in reparations for allowing the virus to spread by concealing early data about the outbreak.

https://nypost.com/2022/01/26/psaki-defensive-when-asked-about-biden-xi-talk-on-covid-origins/

No exit from zero-COVID: China struggles to find policy off-ramp

 

China's "zero-COVID" stance has put it at odds with the rest of the world and is exacting a mounting economic toll, but an exit strategy remains elusive as authorities worry about the ability of the healthcare system to cope and adapt to new strains.

Chinese medical experts believed last year that higher vaccination rates would eventually allow China to relax tough rules on movement and testing as infection rates slow elsewhere.

The emergence https://graphics.reuters.com/world-coronavirus-tracker-and-maps/vaccination-rollout-and-access of the highly transmissible Omicron variant dashed those hopes.

While some analysts have branded China's approach as "unsustainable", many local health experts - and some from overseas - say the country has no choice but to continue given its less developed health system.

Some even argue China's economy could even emerge stronger than ever if it keeps Omicron at bay.

"For a large country with a population of 1.4 billion, it must be said that the cost effectiveness of our country's prevention and control has been extremely high," said Liang Wannian, head of the expert epidemic prevention group at China's National Health Commission, at a Saturday briefing.

Kristalina Georgieva, managing director of the International Monetary Fund, called on China last week to "reassess" its approach, saying it had now become a "burden" on both the Chinese and global economies.

But China is concerned the cost of lowering its defences could prove even higher, especially with a healthcare system that has lagged its broader development.

"With a large population and high density the government is rightly concerned about impacts for the spread of the virus," said Jaya Dantas, professor of international health at the Curtin School of Population Health in Perth, Australia.

China had 4.7 million registered nurses at the end of 2020, or 3.35 per 1,000 people, official data showed. The United States has around 3 million - around 9 per 1,000.

China is also wary of the risk of new variants, especially as it refuses to import foreign vaccines. Studies suggest China's vaccines are less effective against Omicron and it has not yet rolled out its own mRNA version.

Wu Zunyou, chief epidemiologist at the Chinese Center For Disease Control and Prevention, warned the "insidious" Omicron could still lead to a rise in the absolute number of deaths even if it was proven to be less deadly, and China must remain patient.

"China's medical capacity and standards are not as good as Britain or the United States, but the results of China's coronavirus prevention and control are far, far superior," he said in a weekend interview with the Beijing News.

'PREMATURE OPTIMISM'

China has stepped up its health warnings, urging citizens to ignore claims that Omicron is no more serious than the 'flu and to stay vigilant.

On Wednesday, the Global Times, published by the official People's Daily, also lashed out at overseas media for "mocking" China's policies, saying they saved lives.

Foreign criticism was "based on unfounded or premature optimism regarding the end of the pandemic", it added.

Experts in China and overseas have also cast doubt on the hope that Omicron represents the final stage of the pandemic.

"SARS-CoV-2 will not magically turn into a malaria-like endemic infection where levels stay constant for long periods," said Raina MacIntyre, head of the Biosecurity Research Programme at the University of New South Wales' Kirby Institute.

"It will keep causing epidemic waves, driven by waning vaccine immunity, new variants that escape vaccine protection, unvaccinated pockets, births and migration," she told Reuters.

END-GAME

China's economy is expected to slow as a result of COVID related supply disruptions, while lockdowns to douse domestic outbreaks weigh on travel and consumption.

Hong Kong's "zero-COVID" approach has put the Chinese-controlled city out of step with other global finance centres and is battering its economy.

Still, China's economy has remained resilient, with GDP growth at 8.1% last year, far exceeding expectations.

MacIntyre of the Kirby Institute said it wasn't a "binary choice" between opening up and remaining isolated, adding there was "no need to surrender to the virus, as Australia is doing at the moment."

China could still emerge from the crisis in the strongest position, especially if COVID leads to widespread cognitive impairment, organ damage and other long-term conditions in other countries, she said.

"If China keeps the virus largely under control, their population will be fit and healthy into the future, while the United States and Europe will be groaning under an unprecedented burden of chronic disease."

https://www.marketscreener.com/news/latest/No-exit-from-zero-COVID-China-struggles-to-find-policy-off-ramp--37654291/

Doctor's Organization Has Treated Over 150,000 COVID-19 Patients With 99.99% Survival

 by Meiling Lee via The Epoch Times (emphasis ours),

A doctor who has been offering free telehealth services to COVID-19 patients during the pandemic says that early treatment for COVID-19 works, claiming that he has a 99.99 percent survival rate.

“We have a team of volunteer free doctors that donate their time to help treat these patients that come to us,” Dr. Ben Marble, the founder of myfreedoctor.com, an online medical consultation service, said at a roundtable discussion hosted by Sen. Ron Johnson (R-Wis.) on Jan. 24.

Marble was answering Johnson’s question about what people can do if they or their loved ones have COVID-19.

People can visit the website myfreedoctor.com, create an account, and fill out a patient intake form if the doctors are accepting new patients for that day. One of the doctors will then reach out in less than 24 hours. With a huge demand for their services, the physicians say they can only “accept a certain number of patients each day.”

Marble says that he and his small team of volunteer doctors prescribe [Dr. Peter] McCullough’s treatment protocol, which consists of hydroxychloroquine, ivermectin, monoclonal antibodies, prednisone, and other low-cost generic drugs. They also prescribe vitamins D and C, and zinc.

McCullough, a cardiologist, and epidemiologist, along with several physicians put together an early treatment protocol to provide outpatient care for COVID-19 patients. Their paper was published in The American Journal of Medicine in August 2020.

Dr. Pierre Kory, a pulmonologist and the President at the Frontline COVID-19 Critical Care (FLCCC) Alliance, says that the public is not aware that there are doctors across the country who will provide telehealth and early treatment for COVID-19.

“On our website, we have a button, which says find a provider. We’ve tried to collect as many telehealth providers that treat all states in the country,” Kory said.

“We are trying to let that message be known because that message is being suppressed that this disease is treatable,” he added.

Kory also claims that there is corruption at the federal level in suppressing early treatment with repurposed cheap drugs and their availability and that the Centers for Disease Control and Prevention (CDC) has been “captured by the pharmaceutical industry.”

“The corruption is because they don’t want you to use off-label, repurposed generic medicines. It does not provide profit to the system,” Kory said, adding that, “you know what’s going on in this country right now, is that the CDC has been captured by the pharmaceutical industry.”

“They sent out a memo in August of 2021, they sent out a similar memo back in the spring 2020, telling the nation’s physicians and pharmacists not to use generic medicines.”

The Epoch Times has reached out to the CDC for comment.

Early treatments were and continue to be discouraged by the CDC, whose guidance since the beginning of the pandemic up until January 2022, only focused on people self-quarantining for 14 days, keeping hydrated, taking analgesics, and only seeking hospital care when they can’t breathe or turn blue. They also warned people to not take any medications not approved for COVID-19.

“People have been seriously harmed and even died after taking products not approved for use to treat or prevent COVID-19, even products approved or prescribed for other uses,” the CDC wrote on its potential treatments webpage.

The weblink provided for the alleged harmful product was related to a March 2020 health alert warning of a serious health effect from ingesting non-pharmaceutical chloroquine phosphate used to clean fish tanks. This alert came after an Arizona man and his wife took the non-pharmaceutical drug in an attempt to self-medicate for COVID-19.

For the past two years, the U.S. Food and Drug Administration (FDA) has only authorized limited early outpatient treatments for COVID-19 that include monoclonal antibodies for high-risk patients and antiviral pills from Merck and Pfizer. However, the FDA on Jan. 24 announced it was limiting the use of Eli Lilly and Regeneron monoclonal antibodies only to patients “likely to have been infected with or exposed to a variant that is susceptible to these treatments.”

Johnson held the roundtable discussion to offer a different perspective on the response to the pandemic, including on “the current state of knowledge of early and hospital treatment, vaccine efficacy and safety, what went right, what went wrong, what should be done now, and what needs to be addressed long term.”

The discussion panel consisted of renowned health experts and scientists that included McCullough, Dr. Robert Malone, and Dr. Paul Marik.

According to a press release, Johnson also invited over a dozen prominent figures involved in developing, promoting, and leading the pandemic response, including the CDC Director Dr. Rochelle Walensky and White House Coronavirus Response Coordinator Jeffrey Zients. All of the individuals declined to attend the forum.

https://www.zerohedge.com/covid-19/doctors-organization-has-treated-over-150000-covid-19-patients-9999-percent-survival

Fat injections could treat common cause of foot pain, plantar fasciitis

 A novel technique that transplants a patient's own fat into the sole of their foot could offer relief to those suffering from a common and painful condition called plantar fasciitis, according to University of Pittsburgh School of Medicine researchers.

In a pilot study, published today in Plastic and Reconstructive Surgery and led by a wife-and-husband team, the fat injection procedure improved symptoms of plantar fasciitis in patients, laying the groundwork for a larger clinical trial.

"We developed this procedure to harness the regenerative properties of fat," said Jeffrey Gusenoff, M.D., professor of plastic surgery at Pitt. "In this proof-of-concept study, we showed that fat injections into the foot reduced heel pain, helped patients get back to doing sports and activities and boosted quality of life."

Plantar fasciitis, or PF, is one of the most common causes of heel pain, affecting about 2 million people in the United States. It's caused by inflammation of the plantar fascia, connective tissue that runs from the heel to the toes and supports the foot arch.

"Plantar fasciitis is exceptionally painful," said Beth Gusenoff, D.P.M., clinical assistant professor of plastic surgery at Pitt. "When you get up from a sitting position or from sleeping, it's a sharp, searing pain that some people describe as being like a nail going right through their heel."

The acute form of PF can be treated with stretching, shoe orthotics or cortisone injections. But about 10% of patients progress to the chronic form in which the foot's collagen degenerates and the plantar fascia thickens. For these patients, surgical release of the plantar fascia with a small cut can help, but this surgery comes with risks, according to Beth Gusenoff.

"Recently, there has been a plea among podiatrists to stop cutting the plantar fascia because some people get a lot of scar tissue, which causes pain," she explained. "And if too much is cut, the foot can become destabilized, so people end up with almost like a floppy foot."

Inspired by the regenerative properties of fat stem cells, the Gusenoffs developed a technique that uses fat harvested from a patient's belly or other body area.

"In fat, there are stem cells and growth factors that help bring in fresh blood supply, which drives a mode of wound healing with reduced scarring," explained Jeffrey Gusenoff. "We use a blunt needle to perforate the plantar fascia, which makes a small injury to stimulate the healing process. Then, when we pull the needle back, we inject a little bit of the patient's fat."

To test this method, the team recruited 14 patients with chronic PF and split them into two groups. Group 1 participants received the procedure at the beginning of the study and were followed for 12 months, and their Group 2 counterparts received the procedure after a six-month observation period and were followed for an additional six months.

"We found that Group 1 had improvements in quality of life and sports activity, decreased plantar fascia thickness and reduced pain levels," said Jeffrey Gusenoff. "And a lot of the measures that were improving six months after the procedure got even better by 12 months."

Similarly, Group 2 showed decreased plantar fascia thickness and increased sports activity six months after the procedure, and there was a slight, but not statistically significant, improvement in pain levels. With a larger sample size and a longer follow-up time, the researchers said it's likely they would have seen stronger improvements in this group.

According to the Gusenoffs, this study provides proof-of-concept that fat injections can treat PF, and they now are planning a larger clinical trial to validate these findings. With enough evidence, they hope that the procedure will be deemed a medical necessity so that it can be covered by insurance and become more widely available in the future.

In previous work, the Gusenoffs showed that fat injections can help solve another type of foot pain caused by loss of the fat pads that cushion the ball of the foot and heel.

This research was supported by the Virginia Kaufman Pain Research Challenge.

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Story Source:

Materials provided by University of Pittsburgh. Note: Content may be edited for style and length.

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Journal Reference:

1. Beth R. Gusenoff, Danielle Minteer, Jeffrey A. Gusenoff. Perforating Fat Injections for Chronic Plantar Fasciitis: A Randomized, Crossover Clinical Trial. Plastic & Reconstructive Surgery, 2022; 149 (2): 297e DOI: 10.1097/PRS.0000000000008765

https://www.sciencedaily.com/releases/2022/01/220125133737.htm

Non-mutated Apolipoprotein E linked to dementia in aging brain

 Researchers exploring dementia-related proteins in the brain identified Apolipoprotein E (ApoE) as a key misfolded protein. About 25% of individuals, and 50% of individuals with Alzheimer disease, have a genetic mutation, the APOE ε4 allele -- a known risk factor for the disease. The researchers were surprised to find that even in the brains of patients without the disease-driving APOE ε4 allele, ApoE proteins were strongly enriched in dementia. Their findings appear in The American Journal of Pathology, published by Elsevier.

"Dementia is very complex, but you can simplify it: the disease is caused by 'gloppy proteins' in the brain," explained lead investigator Peter T. Nelson, MD, PhD, Sanders-Brown Center on Aging and Department of Pathology, University of Kentucky, Lexington, KY, USA. "I'm not making light of it -- these 'sticky' misfolded proteins often end up destroying the brain, the mind, the memories and everything else for millions of people who suffer from dementia. We want to understand specifically which proteins are the problem."

The investigators used mass spectrometry to characterize the complete set of proteins, or proteome, from the amygdalae of 40 participants from the University of Kentucky Alzheimer's Disease Center autopsy cohort. The amygdala is vulnerable to mis-aggregated proteins associated with dementia and is often affected even at the earliest stages of disease. The subjects ranged from cognitively normal to severe amnestic dementia. Although previous studies have examined the human amygdala proteome, none have reported on a sample of this size with dementia subjects and control subjects for comparison.

As anticipated, portions of proteins previously associated with neurodegenerative diseases were found in the brains of patients with dementia, including proteins called Tau (associated with neurofibrillary tangles), Aβ (associated with amyloid plaques), and α-Synuclein (associated with Lewy Body disease). Aβ and α-Synuclein correlated strongly with clinical diagnosis of dementia. Tau and Aβ proteins, but not α-Synuclein, were occasionally detectible in cognitively normal subjects and those with mild cognitive impairment. Overall, Dr. Nelson observes, the findings for these proteins were in line with expectations.

The data also revealed a close correlation between dementia diagnosis and the detection of ApoE peptides in the brain. The correlation with dementia for ApoE was even stronger than that seen for Tau, Aβ, or α-Synuclein. Moreover, the ApoE peptides were significantly enriched even in dementia patients who lack the APOE ε4 allele. The results emphasize the relevance of the ApoE protein as an aberrantly aggregated protein in its own right, rather than just an "upstream" genetic risk factor.

"Our study adds to an evolving appreciation of multiple misfolded proteins in the human brain and moves the field forward by emphasizing that ApoE may be a stong contributor to the dementia prototype, even in individuals who do not have the disease-driving version of the APOE gene," said Dr. Nelson. "Even in persons lacking the APOE ε4 allele, ApoE may indeed be among the most impactful 'gloppy proteins' in aging brains."

Story Source:

Materials provided by Elsevier. Note: Content may be edited for style and length.

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Journal Reference:

1. Jozsef Gal, Yuriko Katsumata, Haining Zhu, Sukanya Srinivasan, Jing Chen, Lance Allen Johnson, Wang-Xia Wang, Lesley Renee Golden, Donna M. Wilcock, Gregory A. Jicha, Matthew D. Cykowski, Peter Tobias Nelson. Apolipoprotein E Proteinopathy Is a Major Dementia-Associated Pathologic Biomarker in Individuals with or without the APOE Epsilon 4 Allele. The American Journal of Pathology, 2021; DOI: 10.1016/j.ajpath.2021.11.013

https://www.sciencedaily.com/releases/2022/01/220126122408.htm

Vertex Pharmaceutical 4Q Profit Rose on Higher Sales of Trikafta

 Vertex Pharmaceuticals Inc. reported profit increased in the fourth quarter after sales of its Trikafta cystic fibrosis medication rose.

The Boston-based pharmaceuticals maker said net income rose to $770.1 million from $604 million in the same period a year earlier. Earnings per share reached $3.00 from $2.30 a year earlier and adjusted earnings per share rose to $3.37 from $2.51. Net product revenue increased to $2.07 billion in the quarter, from $1.63 billion a year earlier.

Revenue from Trikafta, by far the company's biggest seller, rose to $1.69 billion from $1.09 billion a year earlier. Revenue from the company's next-biggest seller in the fourth quarter, Kalydeco, fell to $152 million from $193 million.

The company reported full-year 2021 product revenue of $7.57 billion, beating its guidance from the third quarter earnings report of $7.4 billion to $7.5 billion. For 2022, Vertex issued product revenue guidance of $8.4 billion to $8.6 billion.

https://www.marketscreener.com/quote/stock/VERTEX-PHARMACEUTICALS-11321/news/Vertex-Pharmaceutical-4Q-Profit-Rose-on-Higher-Sales-of-Trikafta-37652480/