“Anthony Fauci needed to use all his moxie and all his esoteric bureaucratic maneuvers—mastered during his half-century at NIH—to win FDA’s approval for his vanity drug, remdesivir. Remdesivir has no clinical efficacy against COVID, according to every legitimate study. Worse, it is deadly poisonous, and expensive poison at $3,000 for treatment.1 In fact, remdesivir’s wholesale cost is roughly 1,000x more costly than hydroxychloroquine and ivermectin. The challenge required Dr. Fauci to first sabotage HCQ and IVM. Under federal rules discussed earlier, FDA’s recognition of HCQ and IVM efficacy would automatically kill remdesivir’s ambitions for EUA designation. And even if Dr. Fauci somehow finagled an FDA license for remdesivir, demand for the product, which doctors were administering late in the disease, as it had to be given through an IV in the hospital, would plummet if either HCQ or IVM stopped the COVID-19 infections early. Why would Dr. Fauci care to undermine any medicine that might compete with remdesivir? Might it have something to with NIAID and CDC having just spent $79 million developing remdesivir for Gilead, a company in which the Bill & Melinda Gates Foundation owns a $6.5 million stake? The BMGF is engaged in other large drug development deals with the company, including a cofunded $55 million investment in a malaria treatment being developed by Lyndra Therapeutics. Gates has also funded the promotion of Gilead’s Truvada in Kenya. Another Gilead partner, the US Army Medical Research Institute of Infectious Diseases at Ft. Detrick, Maryland (USAMRIID), where the drug was studied in monkeys, also contributed millions to remdesivir’s development. At the outset of the coronavirus plague, remdesivir was just another pharma-owned molecule that FDA had never approved as safe and efficacious for any purpose. In 2016, remdesivir demonstrated middling antiviral properties against Zika, but the disease disappeared before the expensive non-remedy got traction. After the Zika threat vanished, NIAID put some $6.9 million into identifying a new pandemic against which to deploy remdesivir. In 2018, Gilead entered remdesivir in a NIAID-funded clinical trial against Ebola in Africa. This is how we know that Anthony Fauci was well aware of remdesivir’s toxicity when he orchestrated its approval for COVID patients. NIAID sponsored that project. Dr. Fauci had another NIAID-incubated drug, ZMapp, in the same clinical trial, testing efficacy against Ebola alongside two experimental monoclonal antibody drugs. Researchers planned to administer all four drugs to Ebola patients across Africa over a period of four to eight months. However, six months into the Ebola study, the trial’s Safety Review Board suddenly pulled both remdesivir and ZMapp from the trial. Remdesivir, it turned out, was hideously dangerous. Within 28 days, subjects taking remdesivir had lethal side effects including multiple organ failure, acute kidney failure, septic shock, and hypotension, and 54 percent of the remdesivir group died—the highest mortality rate among the four experimental drugs. Anthony Fauci’s drug, ZMapp, ran up the second-highest body count at 44 percent. NIAID was the primary funder of this study, and its researchers published the bad news about remdesivir in the New England Journal of Medicine in December 2019. By then, COVID-19 was already circulating in Wuhan. But two months later, on February 25, 2020, Dr. Fauci announced, with great fanfare, that he was enrolling hospitalized COVID patients in a clinical trial to study remdesivir’s efficacy. For important context, this was a month before the WHO declared the new pandemic, a time that there were only fourteen confirmed COVID cases in the United States, most from the Diamond Princess cruise ship. These individuals were among the first wave of COVID-19 hospitalizations from whom NIAID recruited the 400 US volunteers for Dr. Fauci’s remdesivir trial. Dr. Fauci’s press release said only that remdesivir “has shown promise in animal models for treating Middle East Respiratory Syndrome (MERS).”It’s unclear, then, if NIAID informed these frightened souls that, less than a year earlier, a safety review board had deemed remdesivir unacceptably toxic. Its deadly effect on patients aside, remdesivir was a perfect strategic option for Dr. Fauci. Optics required that NIH devote some resources to antiviral therapeutic drugs; critics would complain if he spent billions on vaccines and nothing on therapeutics. However, any licensed, repurposed antiviral that was effective against COVID for prevention or early treatment (like IVM or HCQ) could kill his entire vaccine program because FDA wouldn’t be able to grant his jabs Emergency Use Authorization. Remdesivir, however, was an IV remedy, appropriate only for use on hospitalized patients in the late stages of illness. It would therefore not compete with vaccines, allowing Dr. Fauci to support it without compromising his core business. Furthermore, while HCQ and IVM were off-patent and available generically, remdesivir was in the sweet spot of still being on patent. The potential profit upside was impressive. Remdesivir cost Gilead $10 per dose to manufacture. But by granting Gilead an EUA, regulators could force private insurers, Medicare, and Medicaid to fork over around $3,120.00 per treatment—hundreds of times the cost of the drug. Gilead predicted remdesivir would bring in $3.5 billion in 2020 alone. Dr. Fauci did not suddenly get the idea that remdesivir might work against coronavirus in January 2020. In one of his many extraordinary feats of uncanny foresight, beginning in 2017, Dr. Fauci paid $6 million to his gain-of-function guru, Ralph Baric—a University of North Carolina microbiologist—to accelerate remdesivir as a coronavirus remedy at China’s biosecurity laboratory in Wuhan. Baric used coronavirus cultures obtained from bat caves by Chinese virologists working with Peter Daszak’s EcoHealth Alliance, another recipient of Dr. Fauci’s funding. Dr. Fauci demonstrated his personal interest in those experiments by dispatching his most trusted deputies, Hugh Auchincloss in 2018 and then Cliff Lane in 2020, to negotiate with the Chinese government and to supervise Baric’s experiments at the Wuhan lab and elsewhere in China. Baric claimed that his mouse studies showed remdesivir impeded SARS replication, suggesting that it might inhibit other coronaviruses. Chinese researchers at the Wuhan Lab and China’s Military Medicine Institute of the People’s Liberation Army Academy of Military Science submitted their own patent application for remdesivir. China’s military brass said the joint patent application was “aimed at protecting China’s national interests.” Early in March 2020, the Gates Foundation bankrolled $125 million of tax-deductible grants to support drug makers to develop coronavirus treatments. Gates and/or his foundation had large equity stakes in many of the pharmaceutical companies that received these funds—including Gilead. On April 24, 2020, Gilead’s volunteer spokesperson Bill Gates declared: “For the novel coronavirus, the leading drug candidate in this category is remdesivir from Gilead.” For HCQ, Dr. Fauci demanded well-designed randomized double-blind placebo-controlled trials and he warned against the use of IVM for treatment. In contrast, Fauci green-lighted remdesivir following studies in which the control group did not receive a real placebo. Instead, Fauci’s researchers used no placebo in the more severely ailing patients and gave the remaining patients an “active comparator” containing the same treatment protocol agents as used in the remdesivir arm except for substituting sulfobutyl for remdesivir as the test agent. Utilization of so-called “toxic” or “spiked” placebos—also known as “fauxcebos”—is a fraudulent gimmick that Dr. Fauci and his drug researchers have pioneered over forty years to conceal adverse side effects of toxic drugs for which they seek approval. Dr. Fauci eventually recruited 400 US hospitalized volunteers for NIAID’s remdesivir trials, but despite this fauxcebo chicanery, Dr. Fauci’s researchers just couldn’t get remdesivir to show any improvement in COVID survival. Despite its disappointing performance, Dr. Fauci worked hand-in-hand with Gilead’s remdesivir team to guide the trial to a satisfactory outcome. According to Vera Sharav, the President and founder of the Alliance for Human Research Protection (AHRP), “The National Institute of Allergy and Infectious Diseases (NIAID) had complete control over the trial and made all decisions regarding trial design and implementation. Gilead Sciences employees participated in discussions about protocol development and in weekly protocol team calls with NIAID.” Sharav’s organization, Alliance for Human Research Protection (AHRP), monitors the quality and ethical performance of clinical trials. NIAID’s remdesivir trial’s original endpoint made sense: to win approval, the drug would need to demonstrate a “reduction in COVID mortality.” However, the drug didn’t show the hoped-for benefit. While fewer patients receiving remdesivir died, those receiving remdesivir were also a lot less sick than the placebo subjects when they entered the trial. So Dr. Fauci’s team decided to move the goalposts. The researchers, in fact, had changed the trial “endpoints” twice in an effort to create a meager appearance of benefit. Dr. Fauci’s new endpoints allowed the drug to demonstrate a benefit, not by improving the chances of surviving COVID, but by achieving shorter hospital stays. Yet this too was a scam, because it turned out that almost twice as many remdesivir subjects as placebo subjects had to be readmitted to the hospital after discharge—suggesting that Fauci’s improved time to recovery was due, at least in part, to discharging remdesivir patients prematurely. Altering protocols in the middle of an ongoing study is an interference commonly known as “scientific fraud” or “falsification.” UCLA Epidemiology Professor Sander Greenland explains, “You’re not supposed to change your endpoint mid-course. That’s frowned upon.” Vera Sharav agrees: “Changing primary outcomes after a study has commenced is considered dubious and suspicious.” But Dr. Fauci had little reason to worry that insiders would complain about the corruption of the study, since his trusted deputy, Cliff Lane, chaired the NIH Treatment Guidelines panel. Lane was doubly conflicted, since he had personally overseen the remdesivir trials in China, and stood, potentially, to share in patent rewards and royalties for the drug. In addition to Lane, seven of the panel members had financial relationships with Gilead—and eight additional panel members had had financial relationships with Gilead prior to the past eleven months, for which they were required to declare a relationship. “Is it any wonder remdesivir is the only drug recommended for COVID?” asks Vera Sharav, a Holocaust survivor who has devoted her life to advocating for ethics in the notoriously corrupt clinical trial industry.
Before his study was completed or peer-reviewed, much less published, Dr. Fauci learned that The Lancet had just published a placebo-controlled Chinese study that showed remdesivir utterly ineffective at keeping hospitalized patients alive OR reducing the duration of hospitalizations. Even more importantly, remdesivir did not reduce the presence of the virus in the blood. Worst of all, the Chinese study confirmed remdesivir’s deadly toxicity. The Chinese regulators and researchers shuttered that trial because of potentially lethal side effects. Remdesivir caused serious injuries in 12 percent of the patients, compared to 5 percent of patients in the placebo group. Unlike Dr. Fauci’s trial, the Chinese study was a randomized, double-blind, placebo-controlled, multi-center, peer-reviewed study, published in the world’s premier scientific journal, The Lancet. All the underlying data was available to the incurious press and the uninformed public. In contrast, Dr. Fauci’s NIAID-Gilead study was at that point, still unpublished, not peer-reviewed, its details undisclosed. It employed a phony placebo and had suffered a sketchy mid-course protocol change. In April, the Chinese cancelled two ongoing clinical trials with NIAID in China because the Chinese had succeeded in ending the COVID epidemic in the country, and researchers could no longer identify enough COVID patients to enroll in the study. In any event, the Chinese study spelled certain doom for remdesivir. It was now D.O.A. at FDA—a poem title? But Dr. Fauci never accepted this. The inimitable maestro of regulatory combat responded to the crisis with savvy and bold action that would miraculously salvage his sinking product: He appeared at one of his regular White House press conferences, this one in the Oval Office. Seated on the couch next to Deborah Birx and opposite President Trump, Dr. Fauci made a surprise announcement. From that lofty platform, Dr. Fauci, with great fanfare, declared victory. The data from NIAID’s clinical trial for remdesivir shows “quite good news,” he said, glossing over the drug’s failure to demonstrate any mortality advantage. He boasted that the median time for hospitalization was eleven days for patients taking remdesivir, compared to fifteen days in the placebo group. He told the credulous press: “The data shows that remdesivir has a clear-cut, significant, positive effect in diminishing the time to recovery.” He claimed that his study had therefore proven remdesivir so remarkably beneficial to COVID patients that he had decided that it would be unethical to deny Americans benefits of this wonder drug. He was, he declared, unblinding and ending the study and giving remdesivir to the placebo group. Remdesivir would be America’s new “standard of care” for COVID. It was, of course, all a lie.
On May 1, the FDA granted the pandemic’s first Emergency Use Authorization for a COVID drug, allowing remdesivir treatments for patients hospitalized with severe COVID-19. Based on Dr. Fauci’s representation, President Trump purchased the world’s entire stock of remdesivir for Americans. The European Union signed a “joint procurement agreement” with Gilead to queue up in the pipeline for 500,000 treatment courses. The day after Dr. Fauci’s announcement at the White House, the University of North Carolina issued a press release headlined: “Remdesivir, developed through a UNC-Chapel Hill partnership, proves effective against COVID-19 in NIAID human clinical trials.” Dr. Fauci’s gain-of-function wizard, Dr. Ralph Baric, called this “a game changer for the treatment of patients with COVID-19.” Vera Sharav points out that in a rational universe, a poison like remdesivir would have no hope of winning regulatory approval—unless, of course, the company could somehow distract attention from the overwhelmingly catastrophic scientific evidence by getting the world’s most powerful health official—the man who conducted the clinical trial—to pronounce the drug a “miracle cure” at a globally attended press conference while lounging on an Oval Office divan beside the president of the United States. Says Sharav, “What better free advertisement?” Sharav adds, “Dr. Fauci had a vested interest in remdesivir. He sponsored the clinical trial whose detailed results were not subject to the peer review he demanded for the drugs he regarded as rivals, like hydroxychloroquine and ivermectin. Instead of showing transparent data and convincing results, he did ‘science’ by fiat. He simply declared the disappointing results to be ‘highly significant,’ and pronounced remdesivir to be the new ‘standard of care.’ Fauci made the promotional pronouncement while sitting on a couch in the White House, without providing a detailed news release, without a briefing at a medical meeting, or peer review for publication in a scientific journal—as is the norm and practice, to allow scientists and researchers to review the data.”
“Standard of Care”: FDA’s recognition of remdesivir as the new “Standard of Care” for COVID meant that Medicaid and insurance companies could not legally deny it to patients and would have to fork over Gilead’s exorbitant price tag on a product US taxpayers had, by then, spent at least $85 million to develop. Improving Gilead’s business even more, doctors and hospitals that failed to use remdesivir could now be sued for malpractice, leading some medical experts to believe that coercing the use of this worthless and dangerous drug on COVID patients almost certainly cost tens of thousands of Americans their lives. As we shall see, Dr. Fauci copied the choreographed script for winning remdesivir’s EUA from the worn rabbit-eared playbook that he developed during his early AIDS years, and then used repeatedly across his career to win approvals for deadly and ineffective drugs. Time and again, he has terminated clinical trials of his sweetheart drugs the moment they begin to reveal cataclysmic toxicity. He makes the absurd claim that his drug-du-jour had proven so miraculously effective that it would be unethical to deny it to the public, and then he strong-arms FDA to grant his approvals. This time only, the brazenness of the fraud earned Dr. Fauci some rare criticism even in mainstream science and press, and from academic institutions that customarily maintain silence about his shenanigans, given their addictions to whopping NIH and BMGF funding. On October 24, 2020, Umair Irfan noted that “The FDA is once again promoting a Covid-19 therapy based on shaky evidence.” The British Medical Journal pointed out, “None of the randomized controlled trials published so far, however, have shown that remdesivir saves significantly more lives than standard medical care.” Eric Topol of Scripps Research Translational Institute scolded that, “This is a very, very bad look for the FDA, and the dealings between Gilead and EU make it another layer of badness.” Angela Rasmussen, a virologist at Columbia University Mailman School of Public Health, told a reporter: “I was really surprised when I saw that news.” Science Magazine said Dr. Fauci’s move had, “baffled scientists who have closely watched the clinical trials of remdesivir unfold over the past 6 months—and who have many questions about remdesivir’s worth.” University of Oxford Professor of Clinical Therapeutics Duncan Richard scathingly observed that, “Research based on this kind of use should be treated with extreme caution because there is no control group or randomization, which are some of the hallmarks of good practice in clinical trials.” Professor Stephen Evans in Pharmacoepidemiology, at the Gates-funded London School of Hygiene & Tropical Medicine, offered a particularly scathing assess-ment—“The data from this paper are almost uninterpretable. It is very surprising, perhaps even unethical, that the New England Journal of Medicine has published it. It would be more appropriate to publish the data on the website of the pharmaceutical company that has sponsored and written up the study. At least Gilead has been clear that this has not been done in the way that a high-quality scientific paper would be written.” “
Excerpt from “The Real Anthony Fauci”, Robert Kennedy Jr., Skyhorse Publishers, Kindle Edition
Yes, as of the 14th of January 2022, Italy is STILL using Remdesevir to treat Covd19 patients, which would explain why we continue to witness so many deaths.
#NOVITÁ (From the Tuscany Health Library Network)
• WHO aggiorna la Living guideline on drugs for Covid-19 (14 gen 22)
• Molnupiravir e Remdesivir: OK di AIFA per trattamento dei pazienti non ospedalizzati ad alto rischio di malattia grave (30 dic)
• Molnupiravir: ok dell’FDA in alcuni gruppi di persone (23 dic)
• Anticorpi monoclonali e variante Omicron: FDA sospende bamlanivimab ed etesevimab insieme, etesevimab da solo e REGEN-COV (23 dic)
• Paxlovid: FDA autorizza uso di emergenza (22 dic)
• Molnupiravir: studio fase 3 per trattamento precoce e ambulatoriale (16 dic)
• Paxlovid (PF-07321332/ritonavir): il parere di EMA e l’avvio della rolling review (16 dic)
• Xevudy (anticorpo monoclonale sotrovimab): EMA raccomanda autorizzazione (16 dic)
• Kineret (anakinra): EMA raccomanda approvazione (16 dic)
• Aggiornate raccomandazioni AIFA sui farmaci per la gestione domiciliare di COVID-19 (14 dic)
• Anticorpi monoclonali: FDA approva tixagevimab + cilgavimab come prevenzione in alcuni individui (8 dic)
• RoActemra (tocilizumab): EMA approva uso nei casi di COVID-19 grave (7 dic)
• Plasma convalescente: OMS sconsiglia l’uso nei pazienti COVID-19 non gravi (7 dic)
• WHO aggiorna la Living guidance for clinical management of COVID-19 (23 nov)
• Monitoraggio anticorpi monoclonali per Covid-19: Report Aifa settimanali