Fm1 Member
  • Member since Mar 28th 2016
  • Last Activity:
  • Forum

Posts by Fm1

    Is there a Correlation Between Mild COVID-19 & Previous Encounters with Coronaviruses? Stanford University Investigators Think Maybe


    https://trialsitenews.com/is-t…nvestigators-think-maybe/


    Stanford University School of Medicine investigators recently concluded that individuals infected with SARS-CoV-2 may actually experience a milder form of the illness if certain cells affiliated with the immune system “remember” previous encounters with seasonal coronaviruses, that is, those pathogens that trigger roughly a quarter of the common cold experienced often by children. Apparently, if this hypothesis is correct, those specific immune cells, assuming they encountered one of the previous older and milder coronaviruses, are essentially ready for mobilization against the novel coronavirus. Perhaps this could be the reason why some individuals, especially children, appear more resilient as compared to others infected with the virus. Could this be a way in the future to actually forecast who is more likely to develop severe SARS-CoV-2 symptoms? Could these immune cells represent a sort of biomarker for additional research? TrialSite introduces an interesting study, led by Mark Davis, PhD, professor of microbiology and immunology and director of Stanford’s Institute for Immunity, Transplantation, and Infection as well as a Howard Hughes Medical Institute Investigator. The investigators have filed for a patent to potentially commercialize what could become a way of predicting with more certainty who is at risk for severe COVID-19.


    The Killer T Cells

    Called Killer T cells, they circulate via the blood and lymph system and according to the published study in Science Immunology, those associated with the most severely infected with SARS-CoV-2 exhibit fewer signals of past encounters with those coronaviruses associated with the common cold.


    Dr. Davis went on the record, “Pathogens evolve quickly and ‘learn’ to hide their critical features from our antibodies,” said Davis, who is also the Burt and Marion Avery Family Professor. But T cells recognize pathogens in a different way, and they’re tough to fool. He continued, “Our cells all issue real-time reports on their inner state of affairs by routinely sawing up some samples of each protein they’ve made lately into tiny pieces called peptides and displaying those peptides on their surfaces for inspection by T cells.”


    The Key Question

    The Stanford authors found that as the pandemic intensified, “A lot of people get very sick or die from COVID-19, while others are walking around not knowing they have it. Why?”


    To find out, the study’s first author, postdoctoral fellow Vamsee Mallajosyula, PhD, first confirmed that some portions of SARS-CoV-2’s sequence are effectively identical to analogous portions of one or more of the four widespread common-cold-causing coronavirus strains. Then he assembled a panel of 24 different peptide sequences that were either unique to proteins made by SARS-CoV-2 or also found on similar proteins made by one or more (or even all) of the seasonal strains.


    The researchers analyzed blood samples taken from healthy donors before the COVID-19 pandemic began, meaning they’d never encountered SARS-CoV-2 — although many presumably had been exposed to common-cold-causing coronavirus strains. The scientists determined the numbers of T cells targeting each peptide represented in the panel.


    They found that unexposed individuals’ killer T cells targeting SARS-CoV-2 peptides that were shared with other coronaviruses were more likely to have proliferated than killer T cells targeting peptides found only on SARS-CoV-2. The T cells targeting those shared peptide sequences had probably previously encountered one or another gentler coronavirus strain — and had proliferated in response, Davis said. Many of these killer T cells were in “memory” mode, he added.


    “Memory cells are by far the most active in infectious-disease defense,” Davis said. “They’re what you want to have in order to fight off a recurring pathogen. They’re what vaccines are meant to generate.”


    Killer T cells whose receptors target peptide sequences unique to SARS-CoV-2 must proliferate over several days to get up to speed after exposure to the virus, Davis said. “That lost time can spell the difference between never even noticing you have a disease and dying from it,” he said.


    Testing the Hypothesis

    Davis and team analyzed blood samples from COVID-19 patients. Sure enough, the group uncovered COVID-19 patients with milder symptoms evidenced more killer-T memory cells directed at peptides SARS-CoV-2 shared with other coronavirus strains. Sicker patients’ expanded killer T-cell counts were mainly among those T cells typically targeting peptides unique to SARS-CoV-2 and, thus, probably had started from scratch in their response to the virus.


    Davis commented, “It may be that patients with severe COVID-19 hadn’t been infected, at least not recently, by gentler coronavirus strains, so they didn’t retain effective memory killer T cells.”


    The Stanford investigator shared that cold-causing seasonal coronavirus strains are rampant among children, who rarely develop severe COVID-19 even though they’re just as likely to get infected as adults are.


    “Sniffles and sneezes typify the daycare setting,” he said, “and coronavirus-caused common colds are a big part of the reason. As many as 80% of kids in the United States get exposed within the first couple of years of life.”


    File a Patent: Potential Commercial Value

    Davis and Mallajosyula have filed, through Stanford’s Office of Technology Licensing, for patents on the technology used in this study.


    Funding

    The work was funded by the National Institutes of Health (grants AI057229 and U01 AI140498); Stanford’s Institute for Immunity, Transplantation, and Infection; the Howard Hughes Medical Institute; the Bill and Melinda Gates Foundation; the Sean N. Parker Center and the Sunshine Foundation.


    Lead Research/Investigator

    Mark Davis, PhD, professor of microbiology and immunology and director of Stanford’s Institute for Immunity, Transplantation and Infection as well as a Howard Hughes Medical Institute Investigator.


    Note that Professor Davis is also a member of Stanford Bio-X, the Stanford Cardiovascular Institute, the Stanford Maternal and Child Health Research Institute, the Stanford Cancer Institute, and the Stanford Wu Tsai Neurosciences Institute.


    Other Stanford study co-authors are former undergraduate student Conner Ganjavi; postdoctoral scholar Saborni Chakraborty, PhD; former life science research professionals Alana McSween and Allison Nau; graduate student Ana Jimena Pavlovitch-Bedzyk; life science research professional Julie Wilhelmy; Monali Manohar, PhD, laboratory director and research scientist at the Sean N. Parker Center for Asthma and Allergy Research; and Kari Nadeau, MD, PhD, professor of pediatrics and director of the Sean N. Parker Center.


    Call to Action: Check out the release from Stanford Medicine News Center here.

    a little reading for the liers, deniers and trolls


    The Drug that Cracked COVID


    https://www.mountainhomemag.co…e-drug-that-cracked-covid


    On the morning of December 18, 2020, as the newscaster announced a grim New York record for COVID-19 deaths and the weatherman predicted a white Christmas for Buffalo, Judy Smentkiewicz drove home from a house cleaning job, excited about the holiday. But her back hurt bad, and she was unusually exhausted. “I thought it was my age, being eighty years old, working every day,” she said. “I never thought about COVID.”


    Judy’s small house in Cheektowaga, just east of Buffalo, was all set for Christmas. Daughter Michelle, who lives a few miles away and talks to her mother five times a day, put up the tree and the decorations and the snowman on the front lawn of grandma’s house with her daughter until it looked like a scene from It’s a Wonderful Life. Son Michael came up from Florida with his wife Haley to help his sister cook the family Christmas Eve dinner, usually for twenty-five, but now just immediate family with “COVID shaping everything,” Michael said. Michael, fifty-seven, hasn’t lived in Buffalo for close to thirty years, and relishes the trip home.


    But now he was worried. Mom was sleeping twelve hours a day. She couldn’t eat. She couldn’t lift the phone. “I’m fine, I’m just tired,” she kept saying. But Judy was always up with the sun. After raising two children as a single mother, working thirty-five years as an office manager for Metropolitan Life Insurance Company, she was still cleaning houses five mornings a week with her girlfriends to “keep busy.” On December 22, three days before Christmas, Judy tested positive for COVID-19.

    We were devastated,” Michael said. The family Christmas Eve dinner was cancelled, Judy spent Christmas in quarantine in her house, four days after Christmas she was taken by ambulance to Millard Fillmore Suburban Hospital, and on New Year’s Eve Michael and Michelle got a call from the hospital that their mother was being admitted to the ICU. It all happened so fast. “We can’t be with her,” Michael said. “We can’t hold her hand, we can’t sleep in the room with her.” He started keeping notes to make sense of it all. “Hearing her voice crack on the phone as she agreed to go on the ventilator was HEART-BREAKING,” he wrote.


    His mother was sedated and unresponsive, as if she were in a coma, as a ventilator mechanically breathed for her. The doctors said there was little more they could do, and her chances of survival were bleak. Judy was getting the global standard of COVID-19 care recommended by the World Health Organization, the National Institutes of Health, and all major public health agencies. It was called “supportive care.” Judy was told to stay at home since there was nothing the doctor could do for her anyway, it was best to keep patients away from doctors and everyone else, until she had trouble breathing in week two. That was the sign the disease had entered its potentially fatal stage and it was time to go to the hospital where doctors couldn’t do much but more supportive care. In other words, Judy would have to save herself. “There is no antiviral drug proven to be effective against the virus,” The New York Times said on March 17, 2020, under the headline “Hundreds of Scientists Scramble to Find a Coronavirus Treatment.” It was day seven of the pandemic, when the global death toll was 7,138. “When people get infected,” the Times said, “the best that doctors can offer is supportive care—the patient is getting enough oxygen, managing fever and using a ventilator to push air into the lungs, if needed—to give the immune system time to fight the infection.” The global death toll was more than 3.3 million as this story went to press, and scientists are still scrambling. The NIH and WHO are still recommending Tylenol and water in 2021. There is still no approved treatment for all stages of COVID-19.


    Even with the rollout of vaccines, they are “not the whole answer,” Dr. Francis Collins, director of the NIH, said recently on 60 Minutes, with variants that threaten to defeat vaccines in rich countries constantly sweeping the Earth after mutating in that majority of poor 7.9 billion humans who won’t get a big pharma jab any time soon. According to The Wall Street Journal, global deaths in 2021 will soon exceed 2020, and millions more are expected to die. “People are going to continue to get sick,” Collins said. “We need treatments for those people.”


    Michael was calling the doctors and nurses constantly, but “we heard nothing but bad, bad news. Mom wasn’t getting any better. It’s going to be a long haul, she’s in bad shape, prepare yourself.” The doctors and nurses said they had exhausted all treatment options, and like so many others Judy was highly likely to die. When an eighty-year-old COVID-19 patient goes on a ventilator, they said, it’s a highly likely death sentence—eighty percent of them don’t survive. The prolonged critical illness was typically about a month with little or no change until, surrounded by helpless doctors and nurses and goodbyes and cries of loved ones echoing from a Zoom call, they turned blue and suffocated to death.


    But as Judy lay dying in the small hospital eight miles northeast of Buffalo, almost six hundred miles south in Norfolk, Virginia, Dr. Paul Marik, sixty-three, the endowed professor at the Eastern Virginia Medical School and a world-renowned clinician-researcher, was unknowingly preparing to save her life with a “wonder drug” that obliterates COVID-19. Discovering the drug was one thing, but getting it to Judy’s doctors in time to save her, getting it to the many thousands of people who needed it, would be a harrowing journey to rival the Iditarod mushers’ 1925 serum run of 675 miles through ice and snow to Nome, Alaska so Dr. Curtis Welch could stop the diphtheria epidemic. But this “Great Race of Mercy” had far less chance of success, for the obstacles were not in nature but in the minds and hearts of other men.


    Marik was accustomed to beating the odds. The legendary professor, a 6-foot, 230-pound, balding, barrel-chested, bear of a man with a crisp native South African accent touched with the South after thirty years, is the second most published critical care doctor in the history of medicine, with more than 500 peer-reviewed papers and books, 43,000 scholarly citations of his work, and a research “H” rating higher than many Nobel Prize winners. Marik is world famous as creator of the “Marik Cocktail,” a revolutionary cocktail of cheap, safe, generic, FDA-approved drugs that dramatically reduces death rates from sepsis by 20 to 50 percent anywhere in the world—whether you’re in a hospital in Zurich or Zimbabwe, Chicago or Chengdu—down to near zero, when given soon after presentation to hospitals. Since he published what he calls the “HAT Therapy” (Hydrocortisone, Ascorbic Acid [intravenous Vitamin C] and Thiamine) in 2016 in the most prestigious peer-reviewed journal in the field, Marik has received worldwide publicity, is celebrated in James Bond Internet memes with the “Marik Cocktail” shaken, not stirred, and is seen in ICUs around the globe as a historic figure in medicine for improving care of sepsis, which last year passed cancer and heart disease as the world’s number one killer, according to Lancet. Marik, known as a quirky genius and an exceptionally kind-hearted doctor (his most published peer in the annals of medicine doesn’t see patients), has been searching for an effective treatment for COVID-19 since it began.


    Now, while Judy’s doctors were stumped, he was spending long days and nights at the Sentara Norfolk General Hospital, a large, 563-bed teaching hospital on the EVMS campus, where Marik, head of pulmonology and critical care, was treating hundreds of critically ill COVID-19 patients, many referred to him from all over the 1.8-million population Hampton Roads region.


    The pandemic had pushed him to nights doing Zoom grand rounds and making YouTube videos instructing doctors and hospitals all over the world on treating COVID-19, sending out a daily EVMS COVID-19 Management Protocol online for doctors worldwide, and hunting the literature for the “wonder drug” that would save Judy Smentkiewicz and bring the pandemic to an end.


    This was not something many people thought possible. But while the world was living the nightmare of the COVID-19 pandemic like a Michael Crichton sci-fi horror production where the planet is facing a plague apocalypse, millions die, and doctors can do nothing as brilliant pharmaceutical scientists race to develop vaccines to save the globe in the final scene, Paul Marik had a different movie in his head. He was startled and appalled that all the national and international public health agencies recommended that the most well-trained, well-equipped doctors in history stand down and wait on big pharma’s lab scientists while the worst pandemic in a century devastated the world. “It’s therapeutic nihilism to say that doctors can do nothing,” Marik said. “Supportive care is no care at all.” What Marik did was assemble four of his closest friends, who also happen to be four of the top academic critical care doctors in the world. He challenged them to join him in an expert panel to continually review the literature while treating their COVID-19 patients and developing treatment protocols—low-cost generic therapies that countless black and brown and poor people all over the world would need, he saw from the beginning, or face a coming catastrophe without treatments or vaccines.

    These five doctors set out to save the world, with a better chance at it than most. Pulmonary critical care specialists often lead medical teams at hospitals in a crisis. “Lungs are the most common organ that fails in the ICU and in the context of many diseases,” says Dr. Pierre Kory, Marik’s protégé. “Pulmonary critical care physicians (are)...the most widely skilled, and the most knowledgeable and experienced in all facets of disease and all levels of severity to the extent that no other doctor comes close.” ICUs were getting hammered by the new respiratory plague all around the world, but Marik had assembled a group of intensivists with nearly 2,000 peer-reviewed papers and books and over a century of bedside experience in treating multi-organ failure and severe pneumonia-type diseases. If anyone could arrest the coronavirus in a living patient, they could.


    Marik turned to his dearest colleague in medicine in Houston, professor and doctor Joseph Varon, a Mexican American with academic appointments in both his countries that have included the University of Texas Health Science Center, and research innovations including a cooling cryo-helmet he used to save his own life when he had a stroke. He then recruited his comrade-in-arms in sepsis therapies, the renowned Dr. Gianfranco Umberto Meduri, an Italian, professor at the University of Tennessee Health Science Center in Memphis, the father of noninvasive intubation and world authority on steroid treatment of ARDS (Acute Respiratory Distress Syndrome) and COVID-19. He called on his longtime boon colleague and former resident Dr. Jose Iglesias, from Cuba, a highly published associate professor of medicine at Hackensack Meridian School of Medicine in Seton Hall, New Jersey, and director of one of that state’s largest dialysis centers. At age fifty, the youngest of the group was Pierre Kory, a big, passionate doctor-scientist like Marik, and his protégé. Kory was a highly published former associate professor and critical care service chief at the University of Wisconsin-Madison and the director of the Trauma and Life Support Center at University Hospital, one of the top academic medical centers in the world. If you go by the traditional measure of lives saved by research breakthroughs or bedside care, Marik, Meduri, Varon, Iglesias, and Kory—four brilliant immigrants from South Africa, Italy, Mexico, Cuba, and one brash New Yorker—are the finest COVID-19 clinician-researchers of the pandemic.


    They made their first major breakthrough in March 2020, by the third week of the pandemic when only 3,800 Americans had died. It was based on the idea that COVID-19 has one great weakness: the coronavirus doesn’t kill anybody. In a mechanism so diabolical Marik believes “human beings aren’t smart enough to have figured it out,” the trillions upon trillions of coronaviruses that overwhelm and sicken the host don’t kill it. But in the second week of the disease, all the coronaviruses die, and like suicide bombers flooding out of a Trojan Horse swamp the body with a “vast viral graveyard” that triggers a friendly-fire hyper-immune response that in turn unleashes monstrous multi-organ inflammation and clotting like doctors have never seen. A body dying of COVID-19 is a complex, terrifying sight. But its weakness is simple: “As pulmonary critical care doctors we know how to treat inflammation and clotting, with corticosteroids and anticoagulants,” Marik says. “It’s first-grade science.”

    From the beginning of the pandemic, the hospitals that Marik and Varon led had COVID-19 beat. They achieved remarkably high survival rates at their hospitals at a time when 40 to 80 percent of patients in the U.S. and Europe were dying from the disease. Their success was achieved with the group’s now-famous MATH+ protocol for hospitalized COVID-19 patients.


    The cocktail of safe, cheap, FDA-approved generic drugs—the steroid Methylprednisolone, Ascorbic Acid (Vitamin C), Thiamine (Vitamin B1), and the blood thinner Heparin—was the first comprehensive treatment using aggressive corticosteroid and anti-coagulant treatments to stop COVID-19 deaths. Both were novel approaches strongly recommended against by all national and international health care agencies throughout the world, but later studies made both therapies the global standard of hospital care. In addition, Kory, Marik, et. al published the first comprehensive COVID-19 prevention and early treatment protocol (which they would eventually call I-MASK). It is centered around the drug Ivermectin, which President Trump used at Walter Reed hospital, unreported by the press, though it may well have saved the president’s life while he was instead touting new big pharma drugs.


    The doctors published their breakthroughs in real time on the website of their nonprofit research group, the Front Line COVID-19 Critical Care Alliance (http://www.flccc.net), so doctors anywhere in the world could find them and use them immediately. Marik, Kory, Varon, Meduri, and Iglesias became heroes of the pandemic to intensivists around the globe who used their protocols to save thousands of lives, and to practitioners at many hospitals in the U.S., including the St. Francis Medical Center in Trenton, New Jersey, where Dr. Eric Osgood posted the MATH+ protocol on a private Facebook group for thousands of ICU doctors after it stopped the dying in his hospital, and talked it up with his colleagues around the nation. Marik and his colleagues receive more than five hundred emails a day from doctors and patients begging for help to beat COVID-19, and they answer all of them, comforting patients and their families, coaching other doctors, and saving lives. Emails like this (unedited):


    Dear Dr Marik I am from a remote place(Muzaffarpur,Bihar) in India.people are not that rich and can’t effort costly treatment.i used your MATH PLUS protocol in TOTO to save hundreds of life at very low cost.since there is limited govt facility I have managed pts with SPO2 of even 72% at room air with home oxygen,proning and MATH PLUS. I don’t have words to thank you for this.you deserve to get Nobel Prize for your protocol. Words are not supporting me enough to thank you. Dr Vimohan Kumar


    Many prominent doctors and scientists around the world believe that Marik, Kory, Meduri, Varon, and Iglesias deserve the Nobel Prize in medicine. Dr. Keith Berkowitz, director of the Center for Balanced Health on Madison Avenue in New York City and Dr. Robert Atkins’ former medical director, and Dr. Howard Kornfeld, founder of the Recovery Without Walls Clinic in Marin County, California, found Marik while looking in the literature for COVID-19 treatments for their patients, and convinced him to form the nonprofit FLCCC to get the word out to the world and save humanity.


    Emmy Award-winning publicist Joyce Kamen of Cincinnati and former CBS News correspondent Betsy Ashton of New York City set aside their lives and began working tirelessly to reach every famous TV newsperson, scientist, and public health expert you know and hundreds you don’t, the handful of science writers who have won Pulitzer Prizes, the five thousand science writers on a special news wire who haven’t, every science desk from CNN to NBC News to the Atlantic magazine, every governor and member of Congress, President Trump, Dr. Anthony Fauci, and, when the time came, President-Elect Biden. Nobody responded.


    Marik thought it might be a good idea if doctors who were actually saving lives with treatments that could save almost everybody could spend a few minutes on the podium sharing their knowledge with the world after Trump made his speeches and Fauci and Dr. Deborah Birx talked about flattening the curve and obeying lockdowns so millions wouldn’t die. “People are dying needlessly,” Marik said. “We’ve cracked the code of the coronavirus.” Nobody seemed to care.


    Kory even testified to the Senate on May 6, 2020, his first appearance before the committee seeking COVID-19 treatments, that steroids were “critical” to saving lives and received silence and scorn. Six weeks later, the publication of the Oxford University Recovery Trial proved that the FLCCC doctors were right, and corticosteroids became the accepted worldwide standard of care, changing the trajectory of the pandemic. Now, millions of deaths later, steroids remain “the only therapy considered “proven” as a life-saving treatment in COVID-19,” he says, and only in “patients with moderate to severe illness.”


    No approved treatment to stop the sick from getting sicker and overloading hospitals, where they face possible death, yet exists. All the non-vaccine big pharma designer treatments for COVID-19 have largely failed to show an impact on mortality, Kory says, including Remdesivir and monoclonal antibody therapy. The Holy Grail COVID-19 treatment remains elusive. On November 11, 2020, Dr. Fauci co-authored a paper for JAMA, the Journal of the American Medical Association, “Therapy for Early COVID-19, A Critical Need,” explaining that early treatments “to prevent disease progression and longer-term complications are urgently needed.”


    A month earlier, Dr. Marik had found exactly what Dr. Fauci was seeking. The discovery astounded him.


    In the professor’s continual review of “the latest (and best) literature,” he picked up a surprising “data signal” in October from emerging studies in Latin America. Ivermectin, a safe, cheap, FDA-approved anti-parasitic drug, was showing remarkable anti-viral and anti-inflammatory agency as a repurposed drug—the most powerful COVID-19 killer known to science.


    Marik had been keeping tabs on Ivermectin but hadn’t included it in his protocols. He knew the drug as a core medicine on the WHO Model List of Essential Medicines, and it is well-established in the literature as a “wonder drug” that won the 2015 Nobel Prize for its discoverer, Japanese microbiologist Satoshi Ōmura, for nearly eradicating two of the “most disfiguring and devastating diseases” in history, river blindness and elephantiasis, that had plagued millions of people in Africa countries, one of the great achievements in the history of medicine. The drug was also well known as a standard treatment for scabies and lice, from nurseries to nursing homes. A veterinary version keeps millions of family dogs and cats, farm animals, and cattle safe from worms and parasitic diseases. An over-the-counter medicine in France, Ivermectin is safer than Tylenol and “one of the safest drugs ever given to humanity,” Dr. Marik said, with “3.7 billion doses administered in forty years, that’s B for billion, and only extremely rare serious side effects.”


    An earlier Australian study, reported in the journal Antiviral Research, showed that Ivermectin, which blocked other RNA viruses like Dengue virus, yellow fever virus, Zika virus, West Nile virus, influenza, the Avian flu, and HIV1/AIDS in vitro, decimated the coronavirus in vitro, wiping out “essentially all viral material by 48 hours.” But more research was needed in human beings.


    But by October Marik’s concerns were answered. The studies were well-designed university trials that showed amazing anti-COVID-19 activity at the normal doses used to treat parasites. Though small and endlessly diverse by large, Western big pharma “one-size-fits all” random control trials, the Ivermectin studies were a mosaic of hundreds of scientists and many thousands of patients in trials all over the world, all showing the same remarkable efficacy against all phases of COVID-19 no matter what dose or age or severity of the patient. “Penicillin never was randomized,” Marik says. “It just obviously worked. Ivermectin obviously works.”


    Marik was astonished. “If you were to say, tell me the characteristics of a perfect drug to treat COVID-19, what would you ask for?” he said. “I think you would ask firstly for something that’s safe, that’s cheap, that’s readily available, and has anti-viral and anti-inflammatory properties. People would say, “That’s ridiculous. There could not possibly be a drug that has all of those characteristics. That’s just unreasonable. But we do have such a drug. The drug is called Ivermectin.”


    If it was universally distributed at a dose that costs ten American cents in India and about the cost of a Big Mac in the United States, he said, Ivermectin would save countless lives, crush variants, eliminate the need for endless big pharma booster shots, and end the pandemic all over the world.


    There were no effective, lifesaving, approved COVID-19 treatments that doctors had used to slow down or stop the coronavirus in the history of the pandemic, in any phase of the disease, except the one, corticosteroids, that Marik and company had discovered.


    Now they had discovered another treatment, even more powerful, that could save the world.


    Surely, Marik thought, the world would listen this time.


    As Judy lay dying in Millard Fillmore hospital, her doctors did not have Ivermectin in their treatment bag. But they did have Remdesivir, and they gave a dose to Judy. Manufactured by Gilead Sciences, one of the world’s largest pharmaceutical companies, Remdesivir costs $3,000 a dose. It is the only anti-viral treatment for hospitalized COVID-19 patients approved by the NIH COVID-19 Treatment Guidelines Panel, and as a result is a standard of COVID-19 care in many hospitals, even though many doctors say it doesn’t work, and the WHO recommends against it. It has been shown in studies to have no mortality benefit for COVID-19 patients. (Coincidentally, seven members of the NIH COVID-19 Treatment Guidelines Panel acknowledge in financial disclosures that they have received research support or consultant payments from Gilead, or sit on the advisory board of the $60 billion company). As The Washington Post reported, “Remdesivir may not cure coronovirus, but it’s on track to make billions for Gilead.”


    Remdesivir had “absolutely no effect” on his mother, Michael Smentkiewicz says. But Michael refused to accept the reality that nothing could be done. “I’m stubborn, I’m pushy, I’m the loudest guy in the room,” he says. Anguished that they couldn’t enter the hospital to see his mother and comfort her, Michael, Michelle, their families, and friends—eight of them in all—spent New Year’s Eve standing outside the hospital with their hands on the brick wall under her window, praying for her recovery. They linked arms and sang and called out her name to the high square window lit against the dark. “We felt we needed to be on that ground, blessing the doctors, blessing my mother, staking our claim for healing,” Michael says. “My wife said people live on love,” he says, “and they feel you.”


    New Year’s Day came. The calendar turned, but Judy was the same. In the morning Michael went by himself to the hospital parking lot and shouted into the cold gray air up toward his mother’s window. “We’re here for you!” he cried. “We’re not ready for you to go! We’re here fighting! We’re not leaving town until you get out of the hospital.”


    But by now the Smentkiewiczs believed they needed a miracle. Michael put out a wider appeal to the universe, calling upon some fifty of his “prayer brothers” around the country to pray for his mother’s life. Thoughts and prayers from a wide network centered on the room in the small hospital in Williamsville, New York.


    At 11:35 a.m. on New Year’s Day, with the annus horribilis of 2020 finally gone and buried, the universe delivered its answer. That was the morning Jan, Michael’s mother-in-law in Atlanta, who had also been praying for Judy’s life, picked up her phone and thought, “This is how the Lord works in my life. There on my phone is this video and the words ‘Ivermectin’ and ‘COVID.”’


    Jan clicked on the link. A large, intense physician, six-foot-one inches tall and lineman-wide with horn-rim glasses wrapping a bald head, was being interviewed on Fox 10 News Now, KSAZ-TV in Phoenix, Arizona. It was Pierre Kory, president and chief medical officer of the FLCCC, who had testified that morning to the U.S. Homeland Security Government Affairs Committee in Washington that he and his colleagues had discovered a drug that could swiftly end the global pandemic and return life on Earth to normal.


    Kory is a COVID fixer. He went to COVID-19-wracked hospitals during outbreaks, when patients were dying and doctors were overwhelmed, with the mission to stop the dying and restore order to the ICU. When the pandemic hit, Kory helped prepare the university hospital in Madison to handle a forecast surge. Then he went east to help save New York City when the death rate exceeded that of the medieval plague, taking over as the ICU attending chief at the main COVID ICU at Mount Sinai Beth Israel Medical Center.


    “I’m a lung specialist, I’m an ICU doctor. My city is being destroyed by the worst pandemic in a century, and it’s a lung disease, all my friends, the ICU chiefs who trained me and the ones I trained, they’re going out of their minds, people are dying. Are you kidding me? I went to New York to save lives.”


    Kory is the son of two New York intellectuals, one a Jewish radiologist who survived the Holocaust, the other a French PhD linguist. He is a New York liberal, renowned pulmonary critical care specialist, award-winning professor and researcher, and a big, brawling, blunt-spoken, and deeply idealistic physician whose lectures are famously a river of eloquence until he gets worked up. Then out comes a torrent of scientific data roiling with moral outrage against medical institutions that turn their backs on human suffering. “I’m a New Yorker,” he says. “I tell it like it is.”


    In an impassioned, nine-minute testimony, Kory implored the Senate and the NIH to read his scientific review, later published in the American Journal of Therapeutics, that presented a “mountain of data” showing that Ivermectin stopped all phases of COVID-19. The peer reviewers, including three senior career scientists, two at the Food and Drug Administration, supported Kory’s conclusion that Ivermectin “should be systemically and globally adopted...for both the prophylaxis and treatment of COVID-19.”


    It was Tuesday, December 8, and the news was bleak. On CNN Dr. Fauci asked the American people not to get together for Christmas or Hanukah to prevent “a surge upon a surge” after Thanksgiving. There were 286,189 deaths already and new cases and deaths were reaching a “frightening peak” and accelerating faster than ever, ABC News reported. “The end of the pandemic is in sight,” Fauci said. “The vaccine...will end the pandemic and return us to as near normal or normal as possible, but we have to do our part right now.”


    Then came the bright, confident voice of the big physician from the Midwest saying that science had discovered a way for schoolchildren to go back to school and workers to work, and for families to put a star on the Christmas tree and candles on the menorah with new hope.


    “We have a solution to this crisis,” he said. “There is a drug that is proving to be of miraculous impact,” Kory said. “When I say miracle, I do not use that term lightly. And I don’t want to be sensationalized when I say that. It’s a scientific recommendation based on mountains of data that has emerged in the last three months...from many centers and countries around the world showing the miraculous effectiveness of Ivermectin. It basically obliterates transmission of this virus. If you take it, you will not get sick.”


    The scientific evidence was overwhelming, he said. The data from twenty-seven studies, sixteen of them randomized controlled trials, demonstrated, with highly statistically significant, overwhelmingly positive, consistent, and reproducible rates, that people who got sick with COVID-19 were far more likely to quickly get better at home when they took Ivermectin. They didn’t go to the hospital. Housemates of people with COVID-19 who took Ivermectin didn’t get infected. People who got moderately ill in hospitals didn’t go to the ICU; they got better quicker and went home faster. Hospitals didn’t get overrun. The drug even saved elderly, critically ill COVID-19 patients from dying compared to those routinely dying elsewhere. Six prevention studies showed Ivermectin reduced the risk of getting COVID-19 by 92.5 percent, superior to many vaccines. Dr. Hector Carvallo, a professor of medicine at the University of Buenos Aires, gave 788 doctors and other health care workers in three medical centers weekly Ivermectin prophylaxis, with a control group of 407 doctors and others who didn’t get the drug. In the control group 236 people, or 58 percent, “had become ill with COVID.” Among the 788 who got Ivermectin, “no infections were recorded.”


    Kory had been working with a senior data scientist in Boston named Juan Chamie, who discovered that Ivermectin dropped case and death rates off the cliff in numerous regions around the world. The huge Indian state of Uttar Pradesh, which with 232 million people would be the fifth biggest country the world, mass distributed Ivermectin to 200 million people last fall and by winter was reporting few if any deaths in the country. The state is still not suffering as badly as its neighbors in that crisis-stricken country. In Peru, tens of thousands of rural residents in eight states often took animal-grade Ivermectin—some in the form of de-worming horse paste—through a large, door-to-door humanitarian mission because doctors and health ministers in the capital city of Lima refused to give the “peasants” the human medicine. But cases and deaths plummeted in the eight rural states to pre-pandemic levels, with no reported harm from the medicine’s impurities, while they soared in Lima, where Ivermectin was not dispensed amongst the ivory towers of medicine.


    Kory’s data was corroborated by Dr. Andrew Hill, a renowned University of Liverpool pharmacologist and independent medical researcher, and the senior World Health Organization/UNITAID investigator of potential treatments for COVID-19. Hill’s team of twenty-three researchers in twenty-three countries had reported that, after nine months of looking for a COVID-19 treatment and finding nothing but failures like Remdesivir—“we kissed a lot of frogs”— Ivermectin was the only thing that worked against COVID-19, and its safety and efficacy were astonishing—“blindingly positive,” Hill said, and “transformative.” Ivermectin, the WHO researcher concluded, reduced COVID-19 morality by 81 percent.


    Kory nearly broke down pleading with the NIH to review the “immense amounts of data that shows that Ivermectin must be implemented and implemented now,” and reverse its negative recommendation of August 27, when no data was available.


    “We have 100,000 patients in the hospital right now dying,” he cried out to the committee. “I’m a lung specialist, I’m an ICU specialist. I’ve cared for more dying COVID patients than anyone can imagine. They’re dying because they can’t breathe. They can’t breathe...and I watch them every day, they die....I can’t keep doing this. If you look at my manuscript, and if I have to go back to work next week, any further deaths are going to be needless deaths, I cannot be traumatized by that. I cannot keep caring for patients when I know they could have been saved by earlier treatment with a drug...that will prevent the hospitalization, and that is Ivermectin.”


    Kory’s testimony, titled “I can’t do this anymore” on YouTube, went viral and reached eight million views and counting before being censored by YouTube for “misinformation;” it was the Howard Beale speech that captured the gestalt of a new time. But unlike the fictional newsman in the movie Network who had thousands throwing open their windows with 1970s angst and shouting “I’m mad as hell and I can’t take it anymore!” this prophet was real, and many lives and the fates of nations were at stake.


    The reaction was explosive and hopeful all over the world, from doctors, nurses, scientists, and civil rights activists; from people watching their loved ones die from COVID-19 and begging for help. Eighty-five-year-old Nobel Prize winner Ōmura in Japan, a legend in microbiology, promptly asked his research team to translate Kory’s paper into Japanese to be placed on his institute website. Thousands of social media fans were moved by Kory’s bravery and the big heart of a doctor who cared about his patients, hailing him as a knight fighting big pharma, big media, big politics, big everything. “Never give up, Pierre Kory!” implored a young woman in Japan. Overnight, the American doctor was a folk hero to great masses of people weary of death and lockdowns and hungry for things not forgotten—the hush of the theater, the clatter of seats in the classroom just before the teacher started, the wonder of human touch—and a prophet to doctors who saw the Hippocratic Oath subsumed by regulators, politicians, and journalists picking COVID-19 drugs if they worked for Wall Street or Washington, whether the doctor thought they worked for the patient or not.


    In South Africa, where use of Ivermectin was criminalized, civil rights activists hung posters with Kory’s data urging revolt, and a group of physicians won permission from the Ministry of Health in Zimbabwe on January 27, 2021 to treat COVID-19 with Ivermectin; case fatalities dropped in one month from seventy a day to two a day, “and our hospitals are virtually empty,” said Dr. Jackie Stone, who was subsequently taken in for questioning for her use of a controversial drug. In Phnom Penh, Cambodia, a doctor trained in Milwaukee, Wisconsin, was using Kory’s data to persuade the Ministry of Health of Ivermectin’s efficacy and was making a personal appeal to the king. “Thank you for your amazing courage and love for humanity,” he wrote. “You’re a real doctor who is living up to the Hippocratic oath. All doctors need to follow your example!!”


    In Bath, England, Dr. Tess Lawrie, a prominent independent medical researcher who evaluates the safety and efficacy of drugs for the WHO and the National Health Service to set international clinical practice guidelines, read all twenty-seven of the Ivermectin studies Kory cited. “The resulting evidence is consistent and unequivocal,” she announced, and sent a rapid meta-analysis, an epidemiolocal statistical multi-study review considered the highest form of medical evidence, to the director of the NHS, members of parliament, and a video to Prime Minister Boris Johnson with “the good news...that we now have solid evidence of an effective treatment for COVID-19...” and Ivermectin should immediately “be adopted globally and systematically for the prevention and treatment of COVID-19.”


    Ignored by British leaders and media, Lawrie convened the day-long streaming BIRD conference—British Ivermectin Recommendation Development—with more than sixty researchers and doctors from the U.S., Canada, Mexico, England, Ireland, Belgium, Argentina, South Africa, Botswana, Nigeria, Australia, and Japan. They evaluated the drug using the full “evidence-to-decision framework” that is “the gold standard tool for developing clinical practice guidelines” used by the WHO, and reached the conclusion that Ivermectin should blanket the world.


    “Most of all you can trust me because I am also a medical doctor, first and foremost,” Lawrie told the prime minster, “with a moral duty to help people, to do no harm, and to save lives. Please may we start saving lives now.” She heard nothing back.


    In Charlottesville, Virginia, Dr. David Chesler, an internist/geriatrician for forty-four years with hundreds of COVID-19 patients in six nursing homes, wrote to Dr. Fauci, telling him essentially that he had found the early treatment Fauci was urgently looking for. Dr. Chesler explained that facing the choice with his elderly COVID-19 patients to “either provide my patients with the standard of care, basically first aid, with Tylenol, oxygen and monitoring, until they became sick enough to be sent to the hospital, or to try something more proactive with the hope of the patients not becoming so ill and then losing their lives,” he had since successfully treated “over 200 high-risk COVID patients” with Ivermectin, many over 100 years old, with none dying or needing “heroic” oxygen support. Fauci never replied.


    Everywhere the problem was the same, Kory said. The WHO, NIH, and other public health agencies were suddenly recommending only COVID-19 therapies proven by the “gold standard” of large randomized controlled trials of treatment and placebo groups, which were powerful but had several limiting flaws, including the fact that they took months to complete and cost ten to twenty million dollars that only big pharmaceutical companies could afford. They had thrown out all the other time-tested forms of clinical and scientific medical investigation still taught in all the medical schools, such as observational trials (which had eliminated widespread crib death), case histories, and anecdotes. They also restricted the use of essential off-label and generic drugs with blatant disinformation campaigns that reminded Kory of big tobacco’s efforts to hide the dangers of smoking. In effect, the public health authorities eliminated the full toolbox of essential scientific methods and drugs that doctors use every day, including the most effective early, prophylactic, and late-stage treatments for COVID-19, which were developed by frontline doctors, not pharmaceutical companies.


    Kory never tires of reminding critics that the modern Hippocratic Oath, the World Medical Association Declaration of Helsinki, makes it abundantly clear that all medical research is secondary to the doctor’s clinical judgement in the moment, whether the patient is dying of COVID-19 or giving birth. The doctor is morally compelled to use their best clinical judgement and the “best available evidence” in that instant, not tomorrow or next year when more data is published. As the WMA puts it: “The health of my patient will be my first consideration.” Clearly the medical establishment is now routinely violating that ancient oath, Kory says, and as a result he “feels estranged from most, but not all, of my colleagues.”


    In the new world of medicine, the COVID world, he says, “Only big randomized controlled trials by big pharma/big academic medical centers are accepted by big journals, while others are rejected,” while only studies in big journals are accepted by big public health agencies for drug recommendations, and only drugs recommended by big public health agencies “escape media/social media censorship.”


    “This leaves you with a system where the only thing that’s considered to have sufficient evidence or proven efficacy is essentially a big new pharmaceutical drug,” he adds. “If it doesn’t come from the mountaintop, it doesn’t exist,” Kory says. “The people on the ground, we cannot do any more science that’s considered credible. We’re discredited as controversial and as promoting unproven therapies and our Facebook groups are shut down, Twitter accounts are locked, YouTube videos are removed and demonetized. It’s really almost totalitarian what’s happening when we’re just well-meaning scientists trying to do the right thing by our patients.”


    As Kory left the Senate hearing room that morning in December after his Ivermectin testimony, his face was dark with disgust. The hearing was dead before it started. When Republican Senator Ron Johnson of Wisconsin (with whom Kory decidedly shares no political sympathies) called the hearing on early COVID-19 treatments, The New York Times ran an advance story eviscerating it as a panel of anti-science kooks promoting “fringe theories,” a “forum for amplifying dubious theories and questionable treatments pushed by President Trump,” including hydroxychloroquine. The hearing was boycotted by all seven Democrats (who have received a total of $1.3 million in big pharma bucks from Pfizer, AstraZeneca, Johnson & Johnson, Merck, Gilead, and others), and four of the seven Republicans, including Utah’s Mitt Romney (more than $3 million received from big pharma), Ohio’s Rob Portman ($542,400), and Florida’s Rick Scott (more than $1 million in stock in Gilead Sciences, maker of Remdesivir).


    Michigan Senator Gary Peters, the Democratic chairman, walked out after reading an opening statement saying the hearing was “playing politics with public health.” Kory was outraged. “I want to register my offense at the ranking member’s opening statement,” he said. “I was discredited as a politician. I am a physician and a man of science. I’ve done nothing, nothing, but commit myself to scientific truth and the care of my patients.”


    But the next day the assault continued. “All the gods of science and medicine” as Marik calls them, descended to crush the little Nobel-Prize winning pill. The New York Times headlined, “A Senate hearing promoted unproven drugs and dubious claims about the coronavirus,” slamming Ivermectin as unproven, but never mentioning Kory or his testimony. In subsequent days, the WHO guidelines committee, after promising a thorough review for months, quashed Ivermectin without a vote, as a lesser advising committee threw out all the strongest evidence first—including the WHO consultant’s own report—and “having thrown out most of the evidence,” Kory said, “they called the remaining few crumbs of very low certainty.”


    Ivermectin is the generic name for Merck’s Stromectol, which they developed in 1981. Though the drug went off patent in 1996, Merck still distributes millions of doses each year in Africa for free, with a statue honoring the drug and the great humanitarian eradication effort in its headquarters and one at the WHO in Geneva. But recently Merck issued a stern warning that seemed written by marketing, Kory says, “as it had no scientific data to support the conclusion,” that Ivermectin was suddenly dangerous. Another pharmaceutical company’s CEO privately noted that “People must think Merck knows what they’re talking about because it’s their drug,” but Merck has “tremendous disincentives” to say nice things about the generic pill, as it has already spent hundreds of millions of dollars developing an oral anti-viral COVID-19 treatment, rival to Ivermectin, that may be priced at $3,000 a dose.


    A news blackout by the world’s leading media came down on Ivermectin like an iron curtain. Reporters who trumpeted the COVID-19 terror in India and Brazil didn’t report that Ivermectin was crushing the P-1 variant in the Brazilian rain forest and killing COVID-19 and all variants in India. That Ivermectin was saving tens of thousands of lives in South America wasn’t news, but mocking the continent’s peasants for taking horse paste was. Journalists denied the world knowledge of the most effective life-saving therapies in the pandemic, Kory said, especially among the elderly, people of color and the poor, while wringing their hands at the tragedy of their disparate rates of death.


    Three days after Kory’s testimony, an Associated Press “fact-check reporter” interviewed Kory “for twenty minutes in which I recounted all of the existing trials evidence (over fifteen randomized and multiple observational trials) all showing dramatic benefits of Ivermectin,” he said. Then she wrote: “AP’S ASSESSMENT: False. There’s no evidence Ivermectin has been proven a safe or effective treatment against COVID-19.” Like many critics, she didn’t explore the Ivermectin data or evidence in any detail, but merely dismissed its “insufficient evidence,” quoting instead the lack of a recommendation by the NIH or WHO. To describe the real evidence in any detail would put the AP and public health agencies in the difficult position of explaining how the lives of thousands of poor people in developing countries don’t count in these matters.


    Not just in media but in social media, Ivermectin has inspired a strange new form of Western and pharmaceutical imperialism. On January 12, 2021, the Brazilian Ministry of Health tweeted to its 1.2 million followers not to wait with COVID-19 until it’s too late but “go to a Health Unit and request early treatment,” only to have Twitter take down the official public health pronouncement of the sovereign fifth largest nation in the world for “spreading misleading and potentially harmful information.” (Early treatment is code for Ivermectin.) On January 31, the Slovak Ministry of Health announced its decision on Facebook to allow use of Ivermectin, causing Facebook to take down that post and removed the entire page it was on, the Ivermectin for MDs Team, with 10,200 members from more than 100 countries.


    In Argentina, Professor and doctor Hector Carvallo, whose prophylactic studies are renowned by other researchers, says all his scientific documentation for Ivermectin is quickly scrubbed from the Internet. “I am afraid,” he wrote to Marik and his colleagues, “we have affected the most sensitive organ on humans: the wallet...” As Kory’s testimony was climbing toward nine million views, YouTube, owned by Google, erased his official Senate testimony, saying it endangered the community. Kory’s biggest voice was silenced.


    But Jan heard him. After a few minutes of watching the interview with Dr. Kory on New Year’s Day morning, she’d heard quite enough. Her fingers flew on a text to her daughter, Haley: “This is the drug Michael’s mother needs to be on...now!!!!...You need to take charge of Nonnis healing.”


    Haley showed the text to her husband. But Michael Smentkiewicz wasn’t interested. He was skeptical. A doctor selling a “miracle drug” for COVID on the Internet sounded awfully fishy. “This channel is telling you, ‘You gotta take Ivermectin,’ but you got people like QAnon, conspiracists, telling you what to take,” he said. He and his sister returned to the hospital parking lot to pray, and floated a cluster of mylar balloons, including a pink heart, up to their mother’s window. But nothing was working. Finally, he watched the video, and thought Kory was “incredible,” with top credentials, “and his passion is crazy.” Within minutes, “I called the ICU and told the attending physician, ‘We want my mother to be on this medication.’”


    The doctor said no. Ivermectin wasn’t approved for COVID-19, and “we don’t experiment on our patients.” But Michael pushed harder. “I’m a bull,” he said. After several back and forths, a hospital administrator gave approval for one dose, 15 milligrams of Ivermectin. Less than twenty-four hours later, “Mom is off the ventilator.”


    The nurses were shocked. Michael was jubilant. The next day his mother was sitting in a chair talking to him on Zoom. But then Judy regressed. They moved her to a cardiac floor, her heart was racing, and “she was going downhill,” Michael says, and he asked the doctor for another dose of Ivermectin. This time the “no” from the doctor and administration was final. That day the family retained Buffalo lawyer Ralph Lorigo, who studied Kory’s video and the FLCCC website and sued the hospital to give their mother more Ivermectin.


    Judge Henry Nowak of the New York State Supreme Court agreed to hear the case on an emergency basis as “a matter of life and death.” He ruled that a woman was dying in the middle of a pandemic with no known treatment for COVID-19 and a safe, long-established drug had affected her “miraculous turnround,” and ordered the Millard Fillmore Suburban Hospital to immediately start Judith Smentkiewicz on four more doses of Ivermectin, per her family doctor’s prescription.


    The hospital refused to carry out the judge’s order. The hospital’s lawyer insisted on a hearing to make his case that no patient has the right to choose their own medicine. The debate ensued as Judy lay dying. “The world has gone mad,” Kory said. All over the world, people were fighting for their lives not only against the coronavirus but against their national public health societies, their most respected hospitals and long-trusted doctors for the right to use the little generic pill that cracked COVID-19.


    Dr. Manny Espinoza was dying of COVID-19 in his Texas hospital when his wife, Dr. Erica Espinoza, asked the doctors to try Ivermectin as a last resort, and was refused. Erica hired a life-flight helicopter to take Manny to the Houston hospital of FLCCC co-founder Joseph Varon for the cheap little pill that in four days had her husband sitting up smiling and telling their children about the “miracle” that saved his life. “We see this every day,” Dr. Varon says. “They say it’s a miracle, I say it’s the science, but it’s the truth.” In Atlanta, Georgia, eighty-four-year-old Lou Gossett Jr., the Oscar-winning black star of An Officer and a Gentleman, gravely ill with COVID-19, checked out of a hospital and was three days from his lungs failing, doctors said, when his son connected him with an FLCCC doctor in Florida who gave him Ivermectin. Gossett quickly recovered and made a very short film for the FLCCC doctors that ends: “I’m very grateful to all of you for literally saving my life.”


    In Cushing, Oklahoma (pop. 7,826), Dr. Randy Grellner saw Kory’s testimony and started giving his patients Ivermectin, which he’d used safely for years for parasites, for COVID-19 because he was “tired of the heartache...tired of the misery...I’ve seen enough death and despair.” In a few weeks the overwhelmed clinic dropped from twenty-five new COVID-19 cases a day to two. “The first thing that surprised me was how fast was the recovery in seventy-five and eight-five-year-old people,” Dr. Grellner said. “I know there’s controversy. I have no political motivation. I don’t have any desire except to put husbands and wives back together. If you’re getting problems from an organization that you work for that says you can’t use it, I would question that organization. If we’re not doing what is best for the patient, then we need to find another occupation.”


    In Buffalo, after a forty-minute hearing on the fate of Judy Smentkiewicz, the lawyer for the Millard Fillmore hospital agreed that she could take Ivermectin If the family doctor delivered the prescription, and after a lot of hassles (including the hospital couriering Ivermectin from another hospital, “At eleven o’clock that night she was administered the second dose of Ivermectin,” Lorigo says. She immediately started improving. With three more doses of Ivermectin, he said, “she’s off the cardiac floor, she’s back on the COVID floor, she’s cured of COVID, she’s released.”


    A week later, Natalie Kingdollar, whose sixty-five-year-old mother Glenna Dickinson was dying of COVID-19 on a ventilator in Rochester General Hospital—the doctors had exhausted all treatment options—read the Buffalo News story of Judy’s recovery, a life-saving flicker in the media blackout, and persuaded the ICU doctors to give her mother Ivermectin. Twelve hours later, after one 12 mg dose that her daughter picked up at Walgreens for eighty-three cents, Glenna’s vitals were much improved. She was “completely stable and doing much better,” Lorigo said. They reduced her ventilator 50 percent, no longer had to “flip” her from her back to her belly for better oxygen flow, and they moved her to a “step down ICU.”


    Glenna’s doctor, who prescribed the Ivermectin, is Thomas Madejski, internist and chief of medicine at Medina Memorial Hospital, former president of the New York State medical society, a clinical instructor in medicine and pharmacy at the University of Buffalo, who sits on the Board of Trustees of the American Medical Association as an expert in geriatric medicine. As medical director of a nursing home he says he has successfully used Ivermectin to quell COVID-19 among elderly patients in three New York counties.


    Now Dr. Madejski, who has treated Glenna for fourteen years, prescribed a full course of Ivermectin to complete the treatment, and was denied. The ICU doctors and Rochester General refused to administer the medication because Ivermectin isn’t approved to treat COVID-19 by the FDA (the budget of which, as it happens, is 75 percent funded by big pharmaceutical companies). Another state supreme court judge, relying on the science provided by Pierre Kory and the FLCCC, ordered the hospital to dispense a handful more of the pills, per the doctor’s script, and Glenna got off the ventilator and is now home, cured of COVID-19.


    A few days before Judy was released from the hospital, the writer of this story was interviewing her son Michael about the happy news that she was headed home, but he said the doctors were waiting a few more days because she was still a little “breathy.” Alarm bells went off in my mind after many interviews with Pierre Kory. I got word to Dr. Kory, who called Michael Smentkiewicz, who heard the doctor’s voice and became emotional. “It’s him, it’s the guy,” he said, holding his phone out for the family to hear. “Listen to his voice.” Kory walked the rehab center through the complicated step-down use of corticosteroids for elderly COVID-19 patients that is more attentive than the one-size-fits-all government protocols, which cause of lot of needless deaths when doctors treat on cruise control, Kory says. After a month in rehab, Judy went home, happy and healthy, to her children and her grandchildren.


    She was quite amazed to learn from her children that while she was lying unconscious and near death with COVID-19 she became a front-page story in The Buffalo News and a Joan of Arc figure in a new revolution, the grandmother who won the first legal fight in the battle of Ivermectin. It is an unprecedented civil rights uprising of doctors, nurses, scientists, Nobel-Prize winning biologists, billionaire health philanthropists, civil rights activists, and thousands of ordinary people across Europe, Asia, South America, Africa, Canada, and the United States fighting a global, big-data-driven medical establishment. They’re fighting for the lost little things, the little data—the sanctity of the doctor-patient relationship, the survival of the Hippocratic Oath, and the most important of civil rights, the right to life.


    Kory sometimes despairs at the forces against him. “Our little Ivermectin has so many big enemies,” he says. “It’s David versus ten Goliaths.” But word is getting out. More than twenty countries representing some 20 percent of the Earth’s population use Ivermectin, many in their national protocol. Every day it seems Kory hears from someone like the Toronto doctor, a Bulgarian, who used Kory’s data to convince the health ministers in his home country to sign on. Kory talks every day to his growing base of 17,000 Twitter followers, and his peer-reviewed paper on Ivermectin recently exploded online as one of the most-discussed scholarly papers ever posted out of seventeen million tracked by Altmetric.


    Every Wednesday night, Kory stars in an FLCCC webinar hosted by former CBS correspondent Betsy Ashton that is an Ivermectin 60 Minutes, with Kory talking to the public and answering their questions. Recently he reported that Mexico, the “light and model of the world,” solved an India-like COVID-19 crisis last fall by testing and treating the population with Ivermectin, and now has some of the lowest case and death rates on the globe. He also posted an interview with a prominent surgeon and hospital owner in Visakhapatnam, India, who treats many COVID-19 patients in the tragic current “COVID tsunami,” and passed on the hopeful news that the All India Institute of Medical Sciences in New Delhi has recently approved Ivermectin for early and home treatment, “a game changer for India and for the world,” the surgeon said. Ivermectin “saved India in 2020 after it got official permission in Uttar Pradesh in August followed by many other states,” he wrote, but starting in January with many political changes, it “has been getting BAD propaganda by big pharma and big scientists,” and many doctors stopped using it, collapsing prevention and home treatment and seeding the crisis of overloaded hospitals and many needless deaths.


    “We BEG health agencies and mainstream media in other countries,” the Indian doctor wrote, “NOT to give BAD PROPAGANDA of Ivermectin. Ivermectin is saving India and Africa.”


    As he reported the news that night, Kory expressed disgust with “the physician-scientists in the ivory towers and public health agencies” who are “just not getting it;” it was up to doctors now to save lives as the scientists are “completely disconnected to how to treat this disease and what to do.” His mentor takes the longer view. “The saddest thing for us is we know this can make a difference and save lives,” Marik says, “and it seems like nobody really cares and wants to listen to us.” But “we feel we can’t be silenced, we just can’t be, because you know the truth will ultimately prevail.”


    “This is how science always progresses,” says Dr. Berkowitz, who takes hope from the recovery of Judy Smentkiewicz. “This is what being a doctor is,” he said. “It says in the Talmud, if you save one life, you save the entire world

    Target of federal probe made key Ivermectin ruling


    https://trialsitenews.com/the-…de-key-ivermectin-ruling/


    A centerpiece of US policy on COVID-19 early treatment is the ACTIV-6 Ivermectin trial. As described in ClinicalTrials.gov, the trial will look at the effect of Ivermectin on COVID-19 symptoms, hospitalization and death. The trial is described by the director of the NIH, Francis Collins:


    ““ACTIV-6 will evaluate whether certain drugs showing promise in small trials can pass the rigor of a larger trial.”


    That statement is supported by the conclusion of the COVID-19 Treatment Guidelines statement on Ivermectin:


    “There are insufficient data for the COVID-19 Treatment Guidelines Panel (the Panel) to recommend either for or against the use of ivermectin for the treatment of COVID-19. Results from adequately powered, well-designed, and well-conducted clinical trials are needed to provide more specific, evidence-based guidance on the role of ivermectin in the treatment of COVID-19.”


    However, Collins’ statement and the supporting statement from the COVID-19 Treatment Guidelines are controversial. In their May/June 2021 issue, The American Journal of Therapeutics published the following statement about the use of Ivermectin in COVID-19:


    “In summary, based on the totality of the trials and epidemiologic evidence presented in this review along with the preliminary findings of the Unitaid/WHO meta-analysis of treatment RCTs and the guideline recommendation from the international BIRD conference, ivermectin should be globally and systematically deployed in the prevention and treatment of COVID-19.”


    The NIH does not have the final word on whether this clinical trial would be carried out. That decision is made by the designated institutional review board (IRB). The institution conducting the trial is the Duke University Health System (DUHS) but the ethics review was contracted to a commercial organization WCG IRB. WCG IRB approved that clinical trial on April 28. That organization is now the target of an investigation by the Government Accountability Office (GAO).


    The probe was requested by US Senators Sanders, Warren and Brown. Earlier they had found the WCG and a second for-profit IRB had provided inadequate responses to their own inquiry. As reported by Relias Media, the Government Accountabity Office (GAO) was expected to begin an investigation of for-profit IRB’s including WCG IRB. Our inquiry to the GAO has confirmed that that investigation is now underway.


    The senators recommended the investigation when WCG IRB provided an inadequate response to their inquiries. CEO Donald A. Deieso addressed the senator’s concerns:


    “Our practices make certain that we scrupulously adhere to all regulatory requirements, that no panelist has any financial interest in any study that they review, and that there are no conflicts of interest in our mission to protect human subjects.”


    However, the senators concluded:


    “WCG Clinical provided no details whatsoever on how they identify, address, and prevent undue influence from panel members’ conflicts of interest.”


    and further:


    “”Our preliminary investigation, opened in November 2019, raises questions about whether the commercial IRBs’ reviews of these studies have significant vulnerabilities that may leave patients exposed to unnecessary risks during their participation in clinical trials…”


    The controversy is further complicated by the question of whether the NIH held a vote to endorse its position statement on Ivermectin. Earlier reporting and a pending complaint in federal court suggests that no vote was held on the NIH position statement.


    There are reasons for profound concern about the ethics of the ACTIV-6 Ivermectin trial. The evidence of the safety and efficacy of Ivermectin in COVID-19 raises the question of whether the placebo patients in the trial are being unnecessarily deprived of care. The trial approval may also have a broader, immediate impact: the trial approval may be considered to be tangible evidence that the effectiveness of Ivermectin in COVID-19 is lacking. This perception is evident in a recent article in Medscape. A more accurate perception should be that there is seemingly no end to suspicious behavior when it comes to NIH’s handling of this drug in COVID-19.


    Note that views expressed in this opinion article are the writer’s personal views and not necessarily those of TrialSite.

    FDA Grants EUA to Roche’s Tocilizumab Despite Mixed Study Results


    https://trialsitenews.com/fda-…pite-mixed-study-results/


    The U.S. Food and Drug Administration (FDA) made yet another questionable decision by issuing an emergency use authorization (EUA) for Roche’s IL-6 inhibitor called Actemra/RoActemra (tocilizumab) for the treatment of COVID-19 in hospitalized adults and pediatric patients (two years of age and up) who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygen (ECMO). Roche declared that the EUA was based on the results from four randomized, controlled trials that evaluated the drug for the treatment of COVID-19 in over 5,500 hospitalized patients. The multinational pharmaceutical company headquartered in Basal, Switzerland, indicated that the result of these studies suggests that this drug “may improve outcomes in patients receiving corticosteroids and requiring supplemental oxygen or breathing support.” As TrialSite will discuss below, the study results are mixed at best. But the use of the four studies mentioned (RECOVERY, EMPACTA, COVACTA, and REMDACTA) led to FDA positive decisions leading to the EUA. As some of these studies generated questionable results, the FDA’s decision to accept the EUA based on the “totality of scientific evidence available to the FDA” is dubious, especially given narrow conditions for the treatment, the incredible societal need, and demand for early-onset care as well as the economics of this drug. Factoring in absolute risk reduction, the study findings become even more of a stretch. But with the EUA, the FDA only has to declare the drug “may” be effective for treatment in what are very specific circumstances declared here.


    The U.S. FDA letter of Authorization and Fact Sheets for patients and healthcare professionals are now ready for review containing the latest information on this EUA.


    The Case for Tocilizumab


    Roche declared that the recent positive decision was based on four randomized controlled trials as expressed in the company’s recent press release, which the company included in its EUA submission. In the RECOVERY Actemra/RoActemra study, investigators out of the United Kingdom studied the drug in over 4,000 hospitalized COVID-19 patients. Other Roche-sponsored global trials included the placebo-controlled EMPACTA, COVACTA and REMDACTA studies. Roche reports to the public that there were no safety signals detected from these clinical trials with the most common adverse reactions seen (incidence 3%) were constipation, anxiety, diarrhea, insomnia, hypertension, and nausea. As TrialSite shares below, a few of these studies failed to generate compelling results.


    RECOVERY Trial

    The core underlying thrust for EUA authorization resulted from the RECOVERY trial (NCT04381936). The results were published in May in The Lancet. Between April 2020 and Jan 24, 2021, this study team enrolled 4116 adults out of 21,550 total patients participating in the study, into the tocilizumab arm of the trial, including 3385 (82%) of the patients receiving systemic corticosteroids. Overall, 621 (31%) of the 2022 patients allocated tocilizumab and 729 (35%) of the 2094 patients allocated to standard of care died within 28 days (rate ratio 0.85; 95% CI 0.76-0.94; p=0.0028). As far as measuring the impact of discharge from hospital within 28 days, the tocilizumab group performed better than standard of care (57% vs 50%; rate ratio 1·22; 1·12–1·33; p<0·0001). Among those not receiving invasive mechanical ventilation at baseline, patients allocated tocilizumab were less likely to reach the composite endpoint of invasive mechanical ventilation or death (35% vs 42%; risk ratio 0·84; 95% CI 0·77–0·92; p<0·0001).


    Other Studies Cited by Roche

    Roche mentioned the EMPACTA trial as part of the rationale for the EUA. The results of that industry-sponsored trial (NCT04372186), including 379 patients, were published in the New England Journal of Medicine (NEJM). The study authors shared that with hospitalized patients with COVID-19 pneumonia who didn’t receive mechanical ventilation, the study drug “reduced the likelihood of progression to the composite outcome of mechanical ventilation or death” but did nothing to help with survival.


    Roche also mentioned the Phase 3 COVACTA study (NCT04320615), involving 438 participants. The study evaluated the efficacy, safety, pharmacodynamics, and pharmacokinetics of tocilizumab compared with a matching placebo in combination with standard of care in hospitalized patients with severe COVID-19 pneumonia.


    Conducted across 62 trial site hospitals in nine countries, ultimately 438 hospitalized patients with severe pneumonia were randomly assigned to participate in the study. According to Ivan Rosas (Baylor College of Medicine) and co-investigators, the results were not compelling as the primary outcome of clinical status on an ordinal scale measured at day 28 was not significantly different in either the study drug arm or the placebo arm, reported Clarie Barnard in Medicine Matters, Rheumatology. Moreover, 28-day mortality rates didn’t significantly differ among patients in the tocilizumab and the placebo.


    In the REMDACTA study, Roche itself reported that the drug failed to meet its endpoints as reported by TrialSite.


    What’s the Evidence for Tocilizumab using ARR?

    Ron Brown, PhD, a contributor to TrialSite, emphasizes the importance of the concept of absolute risk reduction (ARR) as actually necessary but an elusive topic for most in the clinical trials business. As the researcher emphasized in a published report titled Outcome Reporting Bias in COVID-19 mRNA Vaccine Clinical Trials, Relative risk reduction and absolute risk reduction measures in the evaluation of clinical trial data are poorly understood by health professionals and the public.


    The absence of reported absolute risk reduction in COVID-19 vaccine clinical trials can lead to outcome-reporting bias that affects the interpretation of vaccine efficacy. Dr. Brown’s emphasis on ARR concerns not only the risk for reporting bias but also for proper informed consent for subjects.


    In looking at Roche’s tocilizumab’s performance in Oxford’s RECOVERY trial, the experimental event rate (EER) for mortality is the percentage of COVID-19 deaths in the tocilizumab group, which is 31%.” Now the control event rate (CER) is calculated by the percentage of deaths in the group with standard care, which here equals 35%. To arrive at ARR, we calculate CER minus the EER, that is 35% minus 31%, or 4%. The relative risk reduction (RRR) equals ARR divided by the CER, which is 0.04 divided by 0.35 or 11.4%, which reduces mortality risk almost four times higher than the ARR.


    The risk or rate ratio is reflected in the EER divided by the CER which totals 88.6%, not 85% reported in the article summary. Thus confirming that RRR is 1 minus the risk ratio, that is 1 minus 0.886 or 11.4%.


    The study authors fail to mention the above derived absolute and relative risk reductions in mortality in the published article. Note that similar calculations must be applied for patient discharge, etc.


    So where does that put the basis of the FDA’s decision? It depends on one’s point of view. Considering the EUA for the mRNA-based COVID-19 vaccines were based on trials that produced data indicating an absolute risk reduction of approximately 1%, the 4% ARR of the tocilizumab trial is significantly higher.


    On the other hand, the relative risk reduction of the tocilizumab trial is 8.5 times lower than the 95% RRR of the mRNA trials. The point here is that as long as the drug (or vaccine) shows any amount of improvement over a control, it qualifies for EUA. Of course, unless it’s a generic drug tested in smaller studies, which regardless of outcome, will get ignored due to regulatory capture issues discussed on this objective media platform.


    Perhaps most critical, however, in the absolute and relative risk measures, is the importance of this subject in the context of informed consent, that is, the public has a right to know what the absolute risks are as well as relative risks for any drug or vaccine.


    Clinical Trial Program

    As Roche shared in its recent press release, the Swiss company’s clinical trial program evaluated the safety and efficacy of Actemra/RoActemra in hospitalized patients with COVID-19. Actemra/RoActemra is not approved for this use in any country and there is limited information known about the safety or effectiveness of using Actemra to treat people in the hospital with COVID-19, emphasizing the speculative nature of the FDA’s EUA.


    COVACTA and EMPACTA were the first two global phase III, multicenter, randomized, placebo-controlled studies of Actemra/RoActemra in patients hospitalized with COVID-19 associated pneumonia. COVACTA was conducted in collaboration with the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the United States Department of Health and Human Services (HHS). TrialSite emphasizes this is yet another example of public funding directed into industry research. Again, given the pandemic, that’s understandable but little was allocated to low-cost, generic alternatives.


    EMPACTA aimed to address research questions about the safety and efficacy of Actemra in underserved populations by emphasizing enrollment from minority patients often underrepresented in clinical trials. Both studies were published in the New England Journal of Medicine. Roche also partnered with Gilead Sciences, Inc., on REMDACTA, a phase III, randomized, double-blind, multicenter study to evaluate the safety and efficacy of Actemra/RoActemra plus Veklury® (remdesivir), versus placebo plus Veklury, in hospitalized patients with severe COVID-19 associated pneumonia. Roche itself shared in REMDACTA that the study failed to meet endpoints.


    The Study Drug

    As shared by Roche, Actemra/RoActemra was the first humanized interleukin-6 (IL-6) receptor antagonist approved for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have used one or more disease-modifying antirheumatic drugs (DMARDs), such as methotrexate (MTX), that did not provide enough relief. The extensive Actemra/RoActemra RA IV clinical development program included five phase III clinical studies and enrolled more than 4,000 people with RA in 41 countries. The Actemra/RoActemra RA subcutaneous clinical development program included two phase III clinical studies and enrolled more than 1,800 people with RA in 33 countries. Actemra/RoActemra subcutaneous injection is also approved for the treatment of adult patients with giant cell arteritis (GCA), for the treatment of patients two years of age and older with active polyarticular juvenile idiopathic arthritis (PJIA) or active systemic juvenile idiopathic arthritis (SJIA), and for slowing the rate of decline in pulmonary function in adult patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD). In addition, Actemra/RoActemra is also approved in the IV formulation for patients two years of age and older with active PJIA, SJIA, or CAR T cell-induced cytokine release syndrome (CRS). Actemra/RoActemra is not approved for subcutaneous use in people with CRS. It is not known if Actemra is safe and effective in children with PJIA, SJIA or CRS under two years of age or in children with conditions other than PJIA, SJIA or CRS. Actemra is intended for use under the guidance of a healthcare practitioner.


    Call to Action: Based on the results of the studies that Roche shares itself, the FDA EUA is, in fact, questionable. What are your thoughts? Learn more about absolute risk reduction vs. relative risk reduction. TrialSite reminds that for COVID-19, about 90% of the cases are either asymptomatic and/or mild-to-moderate cases necessitating the importance of early-onset care. Public pressure should build on the agency to center its attention on early-onset care in addition to continuous improvement on COVID-19 vaccine candidates.

    Most Cancer Patients Respond Well to mRNA-based COVID-19 Vaccines However Patients on Rituximab for Hematological Malignancies Generate No Response


    https://trialsitenews.com/most…ies-generate-no-response/


    An important, yet not well-publicized study led by investigators from Mays Cancer Center in San Antonio and Geneva University Hospital in Switzerland, recently showcased that 94% of cancer patients respond well to an mRNA-based COVID-19 vaccine. Funded partly by the National Cancer Institute’s funding of the Mays Cancer Center as well as grants from the American Cancer Society and the Hope Foundation for Cancer Research, the study indicates that a great majority of patients struggling with cancer can develop a solid immune response to the novel coronavirus (COVID-19) via mRNA-based vaccines within a matter of a few weeks to a month upon the second dose of the vaccine. However, a significant issue was discovered in this study in that a small group generated absolutely no response to the pathogen. Particularly those patients on the drug Rituximab, within six months of the jab, failed to generate an immune response.


    The Study

    The study involved 131 patients participating in the clinical trial between January and April 2021. By organizing a prospective cohort to investigate what is called “seroconversion rates” as well as anti-SARS-CoV-2 spike protein titers subsequent to two vaccine doses involving either Pfizer-BioNTech’s BNT162b2 or Moderna’s mRNA-1273.


    The median age of patients in the study was 63. Most of the patients (106) had solid cancers as opposed to hematological malignancies (25). The study population was 80% non-Hispanic white, 18% Hispanic, and 2% Black.


    Investigator Quotes

    Professor Shah pointed out, “We observed a significant difference in response when two doses were given,” Shah further noted. “At least for patients with cancer, two doses are very important for robust antibody response.” Moreover, the researcher declared, “In countries where there is lack of vaccination, there is talk that one dose might confer adequate protection, but this may not be true in the case of patients with cancer,”


    Finding

    Of the total study participants, 94% experienced seroconversion, developing a healthy antibody response. But the study raised some concerns. Notably among cancer patients diagnosed with hematological malignancies fared worse than those with patients diagnosed with solid tumors (77% versus 98%, p = 0.002). Out of the total patient population in the study, seven of them failed to develop any antibody response, reported Dimpy P. Shah, MD, PhD, with the Mays Cancer Center, UT Health San Antonio MD Anderson.


    Of note, the investigators found that cancer patients on a cancer therapy called Rituximab, a monoclonal antibody, used to treat hematological cancers as well as autoimmune diseases, within six months of the second jab developed no antibodies. Moreover, the San Antonio-based research team observed that the antibody response among those patients on chemotherapy was less strong as compared to the average study population.


    Published

    This study was published in the peer-review journal Cancer Cell.


    Lead Research/Investigator


    Ruben Mesa, MD, FACP, executive director of the Mays Cancer Center.


    Dimpy P. Shah, MD, PhD, Assistant Professor


    Pankil K. Shah, MD, Ph.D., Mays Cancer Center, who served as co-lead author of the study w


    Alfredo Addeo, MD, senior oncologist at the Geneva University Hospital.


    Call to Action: More inquiry into these findings is necessary.

    At least her motivation is clear: Greed. Join our clinic! Please give us your money. We will not heal you to increase our share of your money. We will just cure one symptom and you then must tell everybody how great we are....

    The USA criminal health system at work - plain sight!

    Criminals and liers. Here in the US, we are lead to believe we have a world class health system. In reality we have the 37th ranked health care system in the world. Pay more for less!! It's always about the latest and greatest. Pure bullshit, yet the media eats it up and spits it out to the public.

    Researchers find potential path to a broadly protective COVID-19 vaccine using T cells


    https://medicalxpress.com/news…broadly-covid-vaccine.amp


    Gaurav Gaiha, MD, DPhil, a member of the Ragon Institute of MGH, MIT and Harvard, studies HIV, one of the fastest-mutating viruses known to humankind. But HIV's ability to mutate isn't unique among RNA viruses—most viruses develop mutations, or changes in their genetic code, over time. If a virus is disease-causing, the right mutation can allow the virus to escape the immune response by changing the viral pieces the immune system uses to recognize the virus as a threat, pieces scientists call epitopes.

    To combat HIV's high rate of mutation, Gaiha and Elizabeth Rossin, MD, Ph.D., a Retina Fellow at Massachusetts Eye and Ear, a member of Mass General Brigham, developed an approach known as structure-based network analysis. With this, they can identify viral pieces that are constrained, or restricted, from mutation. Changes in mutationally constrained epitopes are rare, as they can cause the virus to lose its ability to infect and replicate, essentially rendering it unable to propagate itself.


    When the pandemic began, Gaiha immediately recognized an opportunity to apply the principles of HIV structure-based network analysis to SARS-CoV-2, the virus that causes COVID-19. He and his team reasoned that the virus would likely mutate, potentially in ways that would allow it to escape both natural and vaccine-induced immunity. Using this approach, the team identified mutationally constrained SARS-CoV-2 epitopes that can be recognized by immune cells known as T cells. These epitopes could then be used in a vaccine to train T cells, providing protective immunity. Recently published in Cell, this work highlights the possibility of a T cell vaccine which could offer broad protection against new and emerging variants of SARS-CoV-2 and other SARS-like coronaviruses.


    From the earliest stages of the COVID-19 pandemic, the team knew it was imperative to prepare against potential future mutations. Other labs already had published the protein structures (blueprints) of roughly 40% of the SARS-CoV-2 virus, and studies indicated that patients with a robust T cell response, specifically a CD8+ T cell response, were more likely to survive COVID-19 infection.


    Gaiha's team knew these insights could be combined with their unique approach: the network analysis platform to identify mutationally constrained epitopes and an assay they had just developed, a report on which is currently in press at Cell Reports, to identify epitopes that were successfully targeted by CD8+ T cells in HIV-infected individuals. Applying these advances to the SARS-CoV-2 virus, they identified 311 highly networked epitopes in SARS-CoV-2 likely to be both mutationally constrained and recognized by CD8+ T cells.

    These highly networked viral epitopes are connected to many other viral parts, which likely provides a form of stability to the virus," says Anusha Nathan, a medical student in the Harvard-MIT Health Sciences and Technology program and co-first author of the study. "Therefore, the virus is unlikely to tolerate any structural changes in these highly networked areas, making them resistant to mutations."


    You can think of a virus's structure like the design of a house, explains Nathan. The stability of a house depends on a few vital elements, like support beams and a foundation, which connect to and support the rest of the house's structure. It is therefore possible to change the shape or size of features like doors and windows without endangering the house itself. Changes to structural elements, like support beams, however, are far riskier. In biological terms, these support beams would be mutationally constrained—any significant changes to size or shape would risk the structural integrity of the house and could easily lead to its collapse.


    Highly networked epitopes in a virus function as support beams, connecting to many other parts of the virus. Mutations in such epitopes can risk the virus's ability to infect, replicate, and ultimately survive. These highly networked epitopes, therefore, are often identical, or nearly identical, across different viral variants and even across closely related viruses in the same family, making them an ideal vaccine target.


    The team studied the identified 311 epitopes to find which were both present in large amounts and likely to be recognized by the vast majority of human immune systems. They ended up with 53 epitopes, each of which represents a potential target for a broadly protective T cell vaccine. Since patients who have recovered from COVID-19 infection have a T cell response, the team was able to verify their work by seeing if their epitopes were the same as ones that had provoked a T cell response in patients who had recovered from COVID-19. Half of the recovered COVID-19 patients studied had T cell responses to highly networked epitopes identified by the research team. This confirmed that the epitopes identified were capable of inducing an immune reaction, making them promising candidates for use in vaccines.


    "A T cell vaccine that effectively targets these highly networked epitopes," says Rossin, who is also a co-first author of the study, "would potentially be able to provide long-lasting protection against multiple variants of SARS-CoV-2, including future variants."


    By this time, it was February 2021, more than a year into the pandemic, and new variants of concern were showing up across the globe. If the team's predictions about SARS-CoV-2 were correct, these variants of concerns should have had little to no mutations in the highly networked epitopes they had identified.


    The team obtained sequences from the newly circulating B.1.1.7 Alpha, B.1.351 Beta, P1 Gamma, and B.1.617.2 Delta SARS-CoV-2 variants of concern. They compared these sequences with the original SARS-CoV-2 genome, cross-checking the genetic changes against their highly networked epitopes. Remarkably, of all the mutations they identified, only three mutations were found to affect highly networked epitopes sequences, and none of the changes affected the ability of these epitopes to interact with the immune system.


    "Initially, it was all prediction," says Gaiha, an investigator in the MGH Division of Gastroenterology and senior author of the study. "But when we compared our network scores with sequences from the variants of concern and the composite of circulating variants, it was like nature was confirming our predictions."


    In the same time period, mRNA vaccines were being deployed and immune responses to those vaccines were being studied. While the vaccines induce a strong and effective antibody response, Gaiha's group determined they had a much smaller T cell response against highly networked epitopes compared to patients who had recovered from COVID-19 infections.


    While the current vaccines provide strong protection against COVID-19, Gaiha explains, it's unclear if they will continue to provide equally strong protection as more and more variants of concern begin to circulate. This study, however, shows that it may be possible to develop a broadly protective T cell vaccine that can protect against the variants of concern, such as the Delta variant, and potentially even extend protection to future SARS-CoV-2 variants and similar coronaviruses that may emerge.

    COVID-19 Long-Haulers Turning to Ivermectin for Relief, But Questions Over Drug’s Effectiveness Linger


    https://news.wttw.com/2021/07/…-over-drugs-effectiveness


    Streeterville resident Valerio Cerron led an active lifestyle before testing positive for COVID-19 in late February.


    Before the pandemic, the 35-year-old ran up to 5 miles daily, had a busy social life and traveled regularly for work.


    While his coronavirus infection was mild, his symptoms lingered beyond the expected two to three weeks. “I was still experiencing shortness of breath symptoms, chest pain,” he said, adding that even long conversations took a toll. “Sometimes I have to catch my breath a lot. … It’s a disconcerting feeling because you expect you’re going to get better like everybody else.”


    Patrick McBriarty can relate. The 56-year-old author who lives in North Center used to be an avid cyclist, biking around 2,000-3,000 miles per year. But that changed when he contracted COVID-19 in March 2020. His case was also mild, but he has experienced symptoms for more than a year.


    McBriarty and Cerron are among those known as long-haulers, people whose COVID-19 symptoms linger well beyond their initial infections. In their quests to get better, they have each tried numerous remedies, including an antiparasitic medicine used to treat tropical diseases and scabies called ivermectin.


    READ: At What Point Does a COVID-19 Infection Become a Disability?


    The Food and Drug Administration has approved ivermectin for the treatment of several diseases, including parasitic worms and head lice, but the agency has not approved it for the treatment or prevention of COVID-19.


    Some doctors say it’s time for the drug to get a green light.


    “Ivermectin is one of the safest drugs known in history,” said Dr. Pierre Kory, a pulmonary and critical care specialist who notes that the scientists who discovered the compound that led to the drug’s development received the Nobel Prize.


    Testifying before the U.S. Senate in December, Kory advocated for the use of ivermectin for COVID-19 on behalf of the Front Line COVID-19 Critical Care Alliance, an international group of physicians and scientists that believes ivermectin is a “miracle drug” for COVID-19 and should be used immediately.


    But the drug is not a “one-size-fits-all medication” and should not be viewed as a treatment for COVID-19, says Dr. Sajal Tanna, an infectious disease specialist at Northwestern Medicine.


    “Like all medications, ivermectin has side effects,” Tanna said. “Ivermectin can interact with other medications. It can cause gastrointestinal symptoms like nausea, vomiting and diarrhea, low blood pressure and allergic reaction.”


    In the U.S., the drug is available only by prescription and doses are based on a person's weight, according to Tanna, who says it should be administered under the supervision of a doctor who is familiar with their patient’s full medical history.


    Other health agencies are undecided when it comes to using the drug for COVID-19.


    The National Institutes of Health says there is insufficient data on ivermectin to make any recommendations on its use for the coronavirus. The World Health Organization says ivermectin should only be used within clinical trials.


    But Kory and the Front Line COVID-19 Critical Care Alliance say the drug works.


    “There’s a lot of controversy as agencies say they need more data because that’s what they always do,” said Kory, who’s the president of the alliance. “There’s been lots of successes, lots of doctors are using it and saying it’s really effective.”


    The alliance has developed protocols for using the drug to prevent and treat COVID-19, including guidelines specific to long-haulers.


    McBriarty, who struggled for months with fluctuating fatigue, brain fog, dehydration and chest tightness, says his first treatment of ivermectin produced a noticeable change.


    “The brain fog and fatigue were mostly gone,” he said. “I was now able to work a whole day or two-thirds of a day and then do a walk and get in 10,000 steps a day four to five days a week. I can live a normal life without being forced into bed for a day or more at a time each week.”


    McBriarty still experiences tightness in his chest and throat and says he isn’t able to exercise like he used to before his COVID-19 infection, but he hopes his latest round of ivermectin will help.


    Cerron says he felt some improvement after taking ivermectin for about a week but decided to start a different treatment plan under a doctor’s supervision.


    “My biggest idea of recovery – my main goal – will be to get back to running outside daily, exercise daily and some sort of social activity that I had before,” he said.


    Dr. Tanna is not convinced.


    “I would not just jump to ivermectin,” she said. “We at Northwestern really focus on high-quality data, and in accordance with the World Health Organization and the FDA, we do not think ivermectin is an effective therapy for COVID-19.”


    Instead, she says long-haulers should seek treatment at one of the clinics dedicated to long COVID-19 — such clinics at Northwestern, Rush University Medical Center, UChicago Medicine and Shirley Ryan are not using ivermectin, according to spokespeople. Tanna also says patients with lingering symptoms should consider getting vaccinated against COVID-19, which has reportedly decreased symptoms for some long-haulers, she said.


    And while Kory advocates for the use of ivermectin to prevent and treat COVID-19, he doesn’t see it as a replacement for vaccines.


    “(Ivermectin) is complementary to and a safety net for vaccines. It shouldn’t be viewed as a competitor,” he said. “I know many people will not get a vaccine for months or years. Some people can’t get a vaccine for certain reasons.”


    Cerron is fully vaccinated against COVID-19. McBriarty is unsure whether he’ll get it, but he plans to continue using ivermectin, under Kory’s supervision, until all his symptoms are gone. Even then, he intends to keep the medication on hand.


    “We’re going to have some form of COVID for another 100 years from now, and the vaccines that we’re developing now may work but we don’t know for how long. We need to have as big a tool kit as possible to deal with it,” he said.


    Contact Kristen Thometz: @kristenthometz | (773) 509-5452 | [email protected]

    Reports of Growing Censorship Across Social Media Doesn’t Help Bring People Together to A More Rational Understanding of Vaccine Risk-Benefit Analysis


    https://trialsitenews.com/repo…ne-risk-benefit-analysis/


    Apparently, the censorship squads intensify their efforts on Twitter, Facebook, LinkedIn, and even Wikipedia as a uniform push to squash any negative discussion about COVID-19 vaccines increasingly trumps individuals’ First Amendment rights to communicate. Should government be at all communicating with the social media networks about what people can and cannot say, even indirectly, could be the basis for what could ultimately become a massive lawsuit. Most recently, a Cincinnati, Ohio-based 12-year old girl named Maddie de Garay was hospitalized a number of times after receiving the second dose of the Pfizer-BioNTech vaccine known as BNT162b2 (Comirnaty). The adolescent actually was a participant in a clinical trial testing the mRNA-based vaccine from December 2020 to January 2021. Apparently, what triggered the Twitter action was the fact that the mother, Stephanie, commenced sharing more details about the hospitalizations. This was all captured in a press conference sponsored by Wisconsin Republican Sen. Ron Johnson, reported Gabe Kaminsky with The Federalist. Ms. De Garay shared during the press conference that the family is both pro-family and pro-science, hence why they had their daughter and two other kids participate in the trial. Apparently, the sponsor’s response—the kid’s problems arise from preexisting conditions.


    The Family

    Apparently, this family is as patriotic and pro-science as they come. With the father working in the medical field and the mother an electrical engineer, they volunteered their children in the study involving children and adolescents in the spirit of “helping us all return to normal life.” Could this family be part of some menacing, anti-fax contingent, or are they simply distraught that their doctor was afflicted by a rare serious adverse event?


    The Hospitalizations

    But the adverse reactions are real, clearly connected to the study, and seemingly dangerous for this 12-year old. In the press release, the mother complained of painful electrical shocks up and down the spine and neck that impacted her posture and leading her apparently to the need for a wheelchair. With severe pain in both fingers and toes, both parts of the body apparently turned white and were ice bold to the touch.


    Moreover, with severe chest pain, she had a tube inserted to help her breathe. With the symptoms ongoing, Ms. De Garay shared that their daughter has now been hospitalized three times for a total of two months in the hospital. In tears, the mother asked Pfizer why hadn’t these challenges been detected. Fearing that this injury could be permanent, the mother declared she was perfectly normal before participating in the clinical trial. Maddie participated in the large nationwide trial involving children/adolescents between the ages of 12 and 15.


    Social Listening’s Ominous Tone

    A review of the chatter across social media harkens to scary times ahead—in what seemingly becomes a new kind of McCarthyism for this age. TrialSite cannot confirm if true, but there are allegations that Twitter immediately blocks any mention of Maddie’s name.


    Other Vantage: The Committee to Protect Health Care

    A liberal-leaning group called The Committee to Protect Health Care, however, challenged this press conference, declaring it was a misinformation campaign. Apparently, a day after the press conference, a few doctors from this organization declared the event was contributing to mounting vaccine hesitancy across the country.


    Emphasizing a rationale risk-benefit analysis, that vaccination is key to overcoming COVID-19, a Dr. Madelaine Tully from Milwaukee, WA, declared, “Let’s be clear, serious side effects of the COVID-19 vaccines are extremely rare. The chances of dying from COVID-19 is many, many times greater than the chance of serious side effects of the COVID-19 vaccine.”


    The Math

    But is that true? Does that add up? The death rate for children involving COVID-19 is incredibly low. The American Academy of Pediatricians provides a near up-to-date count of pediatric COVID-19 cases, including mortality. As of June 24, children were 0.00%-0.24% of all COVID-19 deaths, and 8 states reported zero child deaths. In states reporting, 0.00% to 0.03% of all child COVID-19 cases resulted in death. The point here is that both sides must start using actual figures based on real underlying data, not just hurling around assumptions.


    Mainstream Starts Reconsidering?

    TrialSite reported recently that MedPage Today’s Editor-in-Chief Martin Makary, MD, MPH, came out and declared that of course there are cases where kids should be vaccinated, however, at least for healthy kids, there is no pressing need. That the risk-benefit analysis doesn’t add up to vaccine healthy kids. MedPage Today isn’t some fringe group of radicals but a very mainstream online publication. The World Health Organization also came out recently declaring kids don’t need to be vaccinated but they quickly updated their edict to include 12 to 15 year old, the very age range from the recently FDA emergency use authorization (EUA) on March 10, 2021.


    Holistic Risk-Benefit Analysis

    Many Op-Ed contributors in the TrialSite have raised concerns about vaccinating children. Granted, few studies articulate the risks associated from all sides of the equation. As TrialSite emphasized of late, a Cleveland Clinic study indicated that of all of those 4,000+ hospitalized, 99% were unvaccinated. The point from the federal government health authorities centers on the risk of not getting vaccinated. Now children face far less risk as exemplified by the American Academy of Pediatricians data.


    But as TrialSite has conveyed, the overall total number of cases are dramatically dropping as the CDC reported that for March and April 2021, a total of zero deaths in an entire cohort investigated.


    But Pfizer is now conducting a study for kids under 12, investigating the optimal dose for this cohort. TrialSite suggests that a comprehensive analysis be done before there are broad-based vaccinations of children under 12 with what is still an investigational product. However, there are exceptions based on risk-based analyses. For example, immuno-compromised children could fit in the more at-risk category.


    Conclusion

    American and other societies are facing challenging times while the pandemic appears on the wane, millions around the world are still infected and another variant-driven surge is a real possibility. There’s no easy way out of this crisis as, increasingly, people appear to take sides, as a balkanized, tribal sort of fragmentation trumps a more orderly and calm discourse factoring in the real risks as opposed to benefits of vaccination, especially for low-risk cohorts such as children. Covering up the issue only serves to create more distrust and angst, which can lead to even more extreme stances.


    Somewhere, somehow, soon leadership must emerge from all different vantages, based on a common, rational understanding of the actual underlying risks associated with the vaccines across various age groups.

    Canadian Researcher Analyzes CDC VAERS Data for COVID-19 Vaccine Safety POV—But is the Other Side of Risk Calculated?


    https://trialsitenews.com/cana…-side-of-risk-calculated/


    Recently published in the journal Science, Public Health Policy, and the Law, Jessica Rose, PhD, MSc, BSc, authored a report titled, “A Report on the U.S. Vaccine Adverse Events Reporting System (VAERS) of the COVID-19 Messenger Ribonucleic Acid (mRNA) Biologicals,” reminding the reader of the importance of safety associated with any “technologically novel” biologic therapy or vaccine still in some form of the experimental stage. The COVID-19 vaccines developed in the United States and Germany transcended any vaccine development efforts before—their compelling, effective, and according to health authorities, safe vaccines now help nations around the world combat COVID-19. The author analyzes the VAERS database and compares the number of COVID-19 versus flu vaccine safety reports. Using vaccine data up to April 10, 2021, Dr. Rose shares with the reader that by the end of March, about 100X more COVID-19 vaccinations occurred as opposed to flu vaccinations. Hence perhaps not surprising that 380 times more safety reports were generated due to COVID-19 inoculations. Thus 99% of all adverse events (AEs) recorded in VAERS are associated with the mass COVID-19 vaccination program. The researcher brings a methodical approach to the review of the VAERS database and identifies significant safety signals. On the other hand, not factored in are the risks of no vaccination—e.g. the scenario if there were no vaccinations. How many more deaths, illnesses, and long-term COVID cases would accrue? TrialSite reminds all of the Cleveland Clinic study, indicating that 99%+ of those hospitalized from January to mid-April 2021 were unvaccinated. The point is that all of the risks must be considered, analyzed, and ultimately calculated for a true depiction of actual risk that will gain public policy attention.


    Dr. Rose slices and dices the U.S. Centers for Disease Control and Prevention (CDC) VAERS COVID-19 vaccination data first by describing the research methodology employed to generate the data. By using the statistical language and environment for statistical computing known as “R,” the author elucidates her particular statistical methodology, then shifting the result of the data analysis.


    Describing how to establish statistical causation, she emphasizes the need to determine the association, time ordering, and spuriousness. She furthermore explains how the association is depicted in incidence rate data combined with heatmaps—corroborated with Chi-Square tests. The author depicts vaccine association with AE or death via time ordering series. However, non-spuriousness is extremely difficult to prove in the real world. Thus, merely showing deaths in close time proximity to the jab doesn’t necessarily prove a statistical connection because other factors could be at play such as underlying health conditions. That can be overcome by factoring in third variable factors and employing tests for skewed data distribution.


    On May 21, Rose posted a summary of her VAERS study on YouTube. The Canadian research reports on three (3) major findings, including 1) CDC VAERS-based reporting data overview, 2) Evidence of causation, and 3) breakthrough infections.


    Conclusion

    Rose’s work in this published piece summarizes VAERS data to April 9th, 2021. She reports while “it may appear that AEs are not currently imposing a significant burden on the fully vaccinated population, however, the weekly releases of VAERS data do not include all of the reports made to date — they are all the reports the CDC has processed to date — and the backlog is likely to be staggering. Thus, due to both the problems of under-reporting and the lag in report processing, this analysis reveals a strong signal from the VAERS data that the risk of suffering an SAE following injection is significant and that the overall risk signal is high.”


    Rose suggests from her analysis that at least a percentage of the reported deaths, spontaneous abortions and anaphylactic reaction as well as cardiovascular, neurological and immunological adverse events are associated with the vaccines.


    In taking a cautious view, this researcher reminds that the mRNA-based vaccines are new, experimental, and “extreme care should be taken when making a decision to participate in the experiment.” She emphasizes that her data involving short-term analysis is in fact limited based on underreporting.


    What about Risks Associated with No Vaccine?

    On the other side involve the risks of no vaccination. Studies such as Cleveland Clinic reveal that the COVID-19 vaccines have greatly reduced hospitalization, for example. Put another way, that study reveals that 99% of COVID-19 hospitalized patients were in fact unvaccinated. TrialSite notes, to date, few if any studies truly factor in both the emerging safety signals in VAERS in combination with the risks associated with no vaccine.


    So TrialSite reminds all that when viewing the vaccine safety data, which this platform is committed to, the alternative scenario must also be factored into the algorithm. That is what if there’s no vaccination—how would that worsen the public health situation. Again, the Cleveland Clinic study reveals out of 4,300 COVID-19 admissions from January through mid-April, approximately 99% of these patients were not fully vaccinated. Among 2,000 hospital workers who were hospitalized for COVID-19, 99.7% of the infected failed to get fully vaccinated. This has implications for death and long-term health challenges as up to 20% of COVID-19 patients end up with long-COVID.


    The point here is that models of risk ultimately must look at all sides of the multifaceted, dynamic equation. Follow the link for the study.


    Lead Research/Investigator

    Jessica Rose, PhD, MSc, BSc

    NIH mounts defense in federal ivermectin deception case


    https://trialsitenews.com/nih-…vermectin-deception-case/


    On March 29, 2021 plaintiff Jin-Pyong Peter Yim (myself) filed a complaint in federal court in the District of New Jersey claiming that the National Institutes of Health violated the Freedom of Information Act. Yim had made the following request to the NIH:


    “All updates to the Coronavirus Disease 2019 (COVID-19) Treatment Guidelines that were endorsed by a vote of the Panel. (Date Range for Record Search: From 01/01/2021 To 01/28/2021)”


    The intent of the request was to not, in fact, to obtain any document since all of the Guidelines are publicly available, but to determine if a vote had been held on the current recommendation which was updated in that time period. The FOIA request was a question about the integrity of this federal agency.


    The receipt date of the FOIA request was January 28, 2021. By law, the NIH has 20 days excluding weekends and federal holidays to respond to such a request either by providing the requested documents or stating the relevant exemption to FOIA that prevents the documents from being provided. In unusual circumstances, the federal agency may extend the deadline for administrative reasons such as the challenge of assembling “voluminous” records etc. When the agency cannot meet the deadline for providing records, it must notify the requester that the request must be modified or offer an alternative deadline. In this case, the NIH did none of the above. Instead, on March 8, the NIH stated:


    “ Your request is being processed and is in the queue behind all other requests received ahead of yours, following HHS FOIA ‘first-in, first-out’ guideline. Once review begins on any records responsive to your request, the NIH will provide an estimated completion date.”


    NIH’s violation of FOIA was flagrant and the complaint against NIH was simple:


    “… despite the passage of more than 20 business days since NIH received the

    above request, it has failed to provide the statutorily required response …including failing to seek a permitted extension; determine and communicate to Yim the scope of any responsive records it intended to produce or withhold and the reasons for withholding; or inform Yim of right to appeal.”


    On April 23, the NIH responded to the FOIA request:


    “All approved updates to the guidelines are posted online and can be found at

    https://www.covid19treatmentguidelines.nih.gov/whats-new/. The documents posted on this website respond to your request in full.”


    Then, on June 30, in its “Answer” to the complaint, the NIH stated that the complaint is now moot; that it has properly responded to the FOIA request, albeit after the deadline. NIH also provided emails and testimony in support of their argument.


    Judge Brian R. Martinotti denied a request earlier to discuss mooting of the case based on the same data set. However, for reasons that are not clear, Judge Martinotti has since been removed from the case. His replacement is Judge Zahid N. Quraishi who is likely to see the argument in the same way but that remains to be seen.


    NIH remains in violation of FOIA for the following reason: the statement provided by the NIH is ambiguous as to whether the requested document exists. By law, the FOIA response must notify the requester of adverse determinations including when a document does not exist. The type of statement provided by the NIH is not consistent with FOIA. Examples of acceptable responses to this FOIA request are:


    “We have located the document that is responsive to your FOIA request: https://files.covid19treatmentguidelines.nih.gov/guidelines/archive/statement-on-ivermectin-01-14-2021.pdf”

    “There are no documents that are responsive to your FOIA request.”

    Ultimately, NIH must provide a response that will show whether a vote was held on its ivermectin recommendation. More to the point, the response will show whether the NIH has been deceiving the American public on a safe and effective treatment for COVID-19.

    Study ties milder COVID-19 symptoms to prior run-ins with other coronaviruses


    https://medicalxpress.com/news…-covid-symptoms-prior.amp


    A study by Stanford University School of Medicine investigators hints that people with COVID-19 may experience milder symptoms if certain cells of their immune systems "remember" previous encounters with seasonal coronaviruses—the ones that cause about a quarter of the common colds kids get.

    These immune cells are better equipped to mobilize quickly against SARS-CoV-2, the coronavirus responsible for COVID-19, if they've already met its gentler cousins, the scientists concluded.


    The findings may help explain why some people, particularly children, seem much more resilient than others to infection by SARS-CoV-2, the coronavirus that causes COVID-19. They also might make it possible to predict which people are likely to develop the most severe symptoms of COVID-19.


    The immune cells in question, called killer T cells, roam through the blood and lymph, park in tissues and carry out stop-and-frisk operations on resident cells. The study, published online July 1 in Science Immunology, showed that killer T cells taken from the sickest COVID-19 patients exhibit fewer signs of having had previous run-ins with common-cold-causing coronaviruses.


    Discussions about immunity to COVID-19 often center on antibodies—proteins that can latch onto a virus before it's able to infect a vulnerable cell. But antibodies are easily fooled, said Mark Davis, Ph.D., a professor of microbiology and immunology; director of Stanford's Institute for Immunity, Transplantation and Infection; and a Howard Hughes Medical Institute investigator. Davis is the study's senior author.


    "Pathogens evolve quickly and 'learn' to hide their critical features from our antibodies," said Davis, who is also the Burt and Marion Avery Family Professor. But T cells recognize pathogens in a different way, and they're tough to fool.


    Our cells all issue real-time reports on their inner state of affairs by routinely sawing up some samples of each protein they've made lately into tiny pieces called peptides and displaying those peptides on their surfaces for inspection by T cells.


    When a killer T-cell's receptor notices a peptide on a cell's surface that doesn't belong there—for example, it's from a protein produced by an invading microorganism—the T cell declares war. It multiplies furiously, and its numerous offspring—whose receptors all target the same peptide sequence—fire up to destroy any cell carrying these telltale-peptide indications of that cell's invasion by a pathogenic microbe.

    Some of the original killer T cell's myriad daughter cells enter a more placid state, remaining above the fray. These "memory T cells" exhibit heightened sensitivity and exceptional longevity. They persist in the blood and lymph often for decades, ready to spring into action should they ever cross paths with the peptide that generated the wave of T-cell expansion that begat them. That readiness can save valuable time in stifling a previously encountered virus or a close cousin.


    As the pandemic progressed, Davis mused, "A lot of people get very sick or die from COVID-19, while others are walking around not knowing they have it. Why?"


    To find out, the study's first author, postdoctoral fellow Vamsee Mallajosyula, Ph.D., first confirmed that some portions of SARS-CoV-2's sequence are effectively identical to analogous portions of one or more of the four widespread common-cold-causing coronavirus strains. Then he assembled a panel of 24 different peptide sequences that were either unique to proteins made by SARS-CoV-2 or also found on similar proteins made by one or more (or even all) of the seasonal strains.


    The researchers analyzed blood samples taken from healthy donors before the COVID-19 pandemic began, meaning they'd never encountered SARS-CoV-2—although many presumably had been exposed to common-cold-causing coronavirus strains. The scientists determined the numbers of T cells targeting each peptide represented in the panel.


    They found that unexposed individuals' killer T cells targeting SARS-CoV-2 peptides that were shared with other coronaviruses were more likely to have proliferated than killer T cells targeting peptides found only on SARS-CoV-2. The T cells targeting those shared peptide sequences had probably previously encountered one or another gentler coronavirus strain—and had proliferated in response, Davis said.


    Many of these killer T cells were in "memory" mode, he added.


    "Memory cells are by far the most active in infectious-disease defense," Davis said. "They're what you want to have in order to fight off a recurring pathogen. They're what vaccines are meant to generate."


    Killer T cells whose receptors target peptide sequences unique to SARS-CoV-2 must proliferate over several days to get up to speed after exposure to the virus, Davis said. "That lost time can spell the difference between never even noticing you have a disease and dying from it," he said.


    To test this hypothesis, Davis and his colleagues turned to blood samples from COVID-19 patients. They found that, sure enough, COVID-19 patients with milder symptoms tended to have lots of killer-T memory cells directed at peptides SARS-CoV-2 shared with other coronavirus strains. Sicker patients' expanded killer T-cell counts were mainly among those T cells typically targeting peptides unique to SARS-CoV-2 and, thus, probably had started from scratch in their response to the virus.


    "It may be that patients with severe COVID-19 hadn't been infected, at least not recently, by gentler coronavirus strains, so they didn't retain effective memory killer T cells," Davis said.


    Davis noted that cold-causing seasonal coronavirus strains are rampant among children, who rarely develop severe COVID-19 even though they're just as likely to get infected as adults are.


    "Sniffles and sneezes typify the daycare setting," he said, "and coronavirus-caused common colds are a big part of the reason. As many as 80% of kids in the United States get exposed within the first couple of years of life."


    Davis and Mallajosyula have filed, through Stanford's Office of Technology Licensing, for patents on the technology used in this study.


    Davis is a member of Stanford Bio-X, the Stanford Cardiovascular Institute, the Stanford Maternal and Child Health Research Institute, the Stanford Cancer Institute and the Stanford Wu Tsai Neurosciences Institute.

    I looked up The lot number of the vial and it was produced in April 27th and was distributed in Europe.


    Today I got to know, unexpectedly for me, who was the person that retrieved the vial submitted to analysis and it was a Spanyard called Rafael Navarro (I don’t know,

    but I suspect he is either a policeman or a retired LEO in Spain). As these vaccines are not for sale to the public he literally had to steal one vial to which he admits he is ashamed of having had to, but there was no other way. He says that for the official record he claims “he found it on the street”.

    With the lot number one can find the EU authorization code.

    Rafael Navarro is a Spanish entertainer, I'll wait for a more reputable names

    Ok but is unlisted as ingredient and also the measured amount of mRNA was a 6% of the official value. It should have 100 micrograms/mL and it was found 6 micrograms/mL and wasn’t even diluted to the same degree.

    I'm just now looking at this and have no good explanation for discrepancy other than manufacturing errors and I'm just guessing but here in the united States, a major manufacturing vaccine plant was closed due to lack of quality control. They were manufacturing J&J, but we're under investigation before Covid.

    To many idiots have hijacked the medical system. We told it too a months ago...It is something (why??) you already did ask the doctor at age 5....

    Again, the latest and greatest. Modern medicine is so full of itself. Aspirate before you vaccinate. Pretty friggin simple. Let the vaccine warriors spin that!!!

    Myocarditis Following Immunization With mRNA COVID-19 Vaccines in Members of the US Military


    https://jamanetwork.com/journa…ology/fullarticle/2781601


    Key Points

    Question Should myocarditis be considered a potential adverse event following immunization with messenger RNA (mRNA) COVID-19 vaccines?


    Findings In this case series of 23 male patients, including 22 previously healthy military members, myocarditis was identified within 4 days of receipt of a COVID-19 vaccine. For most patients (n = 20), the diagnosis was made after the second dose of mRNA COVID-19 vaccine; these episodes occurred against the backdrop of 2.8 million doses of mRNA COVID-19 vaccines administered.


    Meaning Vigilance for rare adverse events, including myocarditis, after COVID-19 vaccination is warranted but should not diminish overall confidence in vaccination during the current pandemic.


    Abstract

    Importance Myocarditis has been reported with COVID-19 but is not clearly recognized as a possible adverse event following COVID-19 vaccination.


    Objective To describe myocarditis presenting after COVID-19 vaccination within the Military Health System.


    Design, Setting, and Participants This retrospective case series studied patients within the US Military Health System who experienced myocarditis after COVID-19 vaccination between January and April 2021. Patients who sought care for chest pain following COVID-19 vaccination and were subsequently diagnosed with clinical myocarditis were included.


    Exposure Receipt of a messenger RNA (mRNA) COVID-19 vaccine between January 1 and April 30, 2021.


    Main Outcomes and Measures Clinical diagnosis of myocarditis after COVID-19 vaccination in the absence of other identified causes.


    Results A total of 23 male patients (22 currently serving in the military and 1 retiree; median [range] age, 25 [20-51] years) presented with acute onset of marked chest pain within 4 days after receipt of an mRNA COVID-19 vaccine. All military members were previously healthy with a high level of fitness. Seven received the BNT162b2-mRNA vaccine and 16 received the mRNA-1273 vaccine. A total of 20 patients had symptom onset following the second dose of an appropriately spaced 2-dose series. All patients had significantly elevated cardiac troponin levels. Among 8 patients who underwent cardiac magnetic resonance imaging within the acute phase of illness, all had findings consistent with the clinical diagnosis of myocarditis. Additional testing did not identify other etiologies for myocarditis, including acute COVID-19 and other infections, ischemic injury, or underlying autoimmune conditions. All patients received brief supportive care and were recovered or recovering at the time of this report. The military administered more than 2.8 million doses of mRNA COVID-19 vaccine in this period. While the observed number of myocarditis cases was small, the number was higher than expected among male military members after a second vaccine dose.


    Conclusions and Relevance In this case series, myocarditis occurred in previously healthy military patients with similar clinical presentations following receipt of an mRNA COVID-19 vaccine. Further surveillance and evaluation of this adverse event following immunization is warranted. Potential for rare vaccine-related adverse events must be considered in the context of the well-established risk of morbidity, including cardiac injury, following COVID-19 infection.

    Dr. Campbell vinticated and the good doc is pissed off. Aspirate before you vaccinate!


    External Content youtu.be
    Content embedded from external sources will not be displayed without your consent.
    Through the activation of external content, you agree that personal data may be transferred to third party platforms. We have provided more information on this in our privacy policy.

    Possibly Pfizer did - clandestine - at it later as it now is allowed to store the vaccine at normal fridge temperature for some days...

    I don't think they added it later, both MRNA vaccines probably had to use graphene to stabilize the spike. As I said, until January 2020 the reason MRNA vaccines were never used were related to an unstable spike coding .

    I will post this directly to the clearance items as the nature of this video is inflammatory and probably will be considered highly questionable. It can be considered highly speculative and to a certain point, paranoic. Nevertheless I think the presence of Graphene in a vaccine vial, officially denied, has been proven by these people to a level with a certainty enough to warrant and, even demand, further enquiry, and for that alone I deem this “delusional” video not entirely baseless.


    Watch at your own peril, is with English subtitles. You will probably not hear this anywhere else.


    https://rumble.com/vj25zh-covi….html?mref=lveqv&mc=48pz1

    I posted an article explaining the use of graphene in stabilizing the coding in cancer mRNA treatments. This is not a conspiracy nor is it crazy. Read about the problems up until January 2020 and the main reason for not using was a spike coding was unstable. So they took the cancer research which attacks thru the N pathway and used graphene gel to stabilize the spike code. here is a more UpTo date article from Feb.


    Graphene Hydrogel Could Help mRNA Vaccine Target Cancer More Effectively


    https://www.clinicalomics.com/…-cancer-more-effectively/

    CD8+ T cells specific for conserved coronavirus epitopes correlate with milder disease in COVID-19 patients


    https://immunology.sciencemag.org/content/6/61/eabg5669


    Abstract

    A central feature of the SARS-CoV-2 pandemic is that some individuals become severely ill or die, whereas others have only a mild disease course or are asymptomatic. Here we report development of an improved multimeric αβ T cell staining reagent platform, with each maxi-ferritin “spheromer” displaying 12 peptide-MHC complexes. Spheromers stain specific T cells more efficiently than peptide-MHC tetramers and capture a broader portion of the sequence repertoire for a given peptide-MHC. Analyzing the response in unexposed individuals, we find that T cells recognizing peptides conserved amongst coronaviruses are more abundant and tend to have a “memory” phenotype, compared to those unique to SARS-CoV-2. Significantly, CD8+ T cells with these conserved specificities are much more abundant in COVID-19 patients with mild disease versus those with a more severe illness, suggesting a protective role.


    DISCUSSION

    Antigen-specific T cell responses are known to be essential for an effective immune response against many infectious diseases but defining specific benchmarks for what is protective versus what is not has been challenging, especially in human studies (50, 51). This is due to many factors, including the low frequency of disease-relevant T cells, particularly when clinical samples are limiting, as they typically are. Consequently, some methods used to investigate T cells necessitate expansion of cells in culture which may alter the relative abundance and phenotype of some T cell clonotypes. Also, the TCR repertoire cannot be studied with some of these methods due to their incompatibility with sequencing techniques. The development of tetramer technology partially addressed this limitation and enabled the direct measurement and characterization of T cells ex vivo. Subsequent advances, both in terms of reagents and methods, have widened the scope of applications (17–19, 49, 52–56). However, the detection of low-affinity T cells is still lacking in many cases (18).


    Here, we report the development of a multivalent ‘spheromer’ system built on the scaffold of a self-assembling maxi-ferritin nanoparticle. As shown, the system has been engineered to be compatible with current pMHC (both MHC-I and MHC-II molecules) and SAv reagents that allows ease-of-use. The optimized spheromer assembly pipeline resulted in a very consistent reagent across multiple batches of synthesis with a relative ease of production, unlike the dodecamer (19). The defined geometry of the scaffold facilitated precise site-directed conjugation of pMHC, leading to a relatively homogenous reagent as assessed using a size-exclusion column. The spheromer bound cognate TCRs with a significantly higher avidity when compared to the tetramer, for both MHC-I (>50-fold) and MHC-II (>20-fold) molecules. Also, the low background contributed to the better signal-to-noise ratio observed in comparison to other pMHC-formulations tested. The improved TCR-binding properties of the spheromer may also be in part due to better 2D binding kinetics owing to its larger diameter. This may provide a better surrogate than either the tetramer or dextramer for membrane-embedded pMHC molecules that engage TCRs in vivo. This increased avidity and specificity can potentially enable the detection of more disease relevant, low-affinity T cells. Using the HLA-A*02:01-restricted influenza-M1 and HCMV-pp65 epitopes, we demonstrated that a significantly higher frequency of antigen-specific CD8+ T cells with a much more diverse TCR repertoire could indeed be detected with the spheromer. These results demonstrate that our engineered scaffold can be readily adapted with currently available reagents without a time-consuming systemic overhaul.


    We further applied the spheromer technology to delineate the CD8+ T cell response to SARS-CoV-2 using a panel of peptides derived from multiple proteins (ORF1ab, S, M and N) that were validated for HLA-A*02:01 binding. Studies have shown that a T cell response can indeed be generated against multiple SARS-CoV-2 proteins (7–13). We observed a relatively higher frequency of T cells against a few epitopes in the ORF1ab (P5, P10, P12, and P13) and S (P17 and P18) proteins in naïve, unexposed individuals. The high sequence similarity of these epitopes to hCoVs and the predominant memory phenotype of these T cells suggests that exposure to seasonal coronaviruses could contribute to the expansion of potentially cross-reactive T cells. Importantly, the frequency of T cells against a subset of these cross-reactive peptides (P5, P10, P12 and P17) was significantly higher in COVID-19 patients with mild symptoms. In contrast, T cells to unique ORF1ab derived peptides (P1 and P8) were higher in severely ill COVID-19 patients. These peptides (P1 and P8) have low sequence similarity to hCoVs. Overall, our data indicate that mild and severe COVID-19 patients elicit distinct T cell responses to particular SARS-CoV-2 epitopes. Also, the preferential recruitment of memory CD8+ T cells to cross-reactive epitopes likely contributes to their mild symptoms. These cross-reactive T cell responses need to be investigated in children as they may contribute to their milder clinical symptoms when compared to adults (57) since seasonal hCoVs infections are more frequent in children than adults (58). This study suggests that in addition to pre-existing cross-reactive memory CD4+ T cells reported previously (10), dissimilar SARS-CoV-2 epitope-specific CD8+ T cell responses could also contribute to divergent COVID-19 clinical outcomes. The observation of CD8+ T cell responses to multiple SARS-CoV-2 proteins is consistent with previous studies. Accordingly, the data presented here suggests that the incorporation of additional non-spike epitopes into a vaccine could further bolster anti-viral T cell immunity. This can be important given the emergence of several SARS-CoV-2 variants of concern (https://www.cdc.gov/coronaviru…illance/variant-info.html). Sequence analysis of SARS-CoV-2 epitopes found to be associated with mild symptoms in our study across variants indicates that one of the two spike protein epitopes (P17: VLNDILSRL) has mutated (S®A) in the B.1.1.7 lineage variants circulating in Europe. In contrast, none of the non-spike protein epitopes associated with mild symptoms were mutated across the analyzed variants (59, 60).


    Overall, this study demonstrates the potential of the spheromer technology but is limited in terms of the specificities and samples used for comparing the different pMHC-multimer platforms. Extending these results to other class I and class II HLA alleles will be important in the future, but the results shown here are consistent across different antigens complexed to HLA-A*02:01 and in our experience it would be surprising if it wasn’t advantageous to use this platform for other HLA alleles as well.