Whistleblower: FDA and CDC both know, but won't admit, that 90% of covid patient hospitalizations are the fully vaccinated

Out of concern for the safety of her patients, Deborah Conrad, a physician's assistant, reportedly convinced the hospital where she works to start carefully tracking the Wuhan coronavirus (Covid-19) "vaccination" status of every patient admitted. What was discovered as a result is that upwards of 90 percent of all new hospital admissions for "covid" are occurring in "fully vaccinated" people. The area where Conrad works is about 50 percent vaccinated for the Fauci Flu, and yet nine out of every 10 new patients at her hospital are sick, and in some cases dying, despite having gotten jabbed in obedience to the government. Many of these sick and dying patients are young people who, prior to getting jabbed, were perfectly healthy. Now they have heart problems, blood clots and other health damage that will likely track them for the rest of their lives. Conrad was so horrified by this revelation that she attempted to reach out to health authorities at the U.S. Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA), only to be ignored by both of them. Conrad's hospital employer also barred her from filing reports into VAERS (Vaccine Adverse Event Reporting System) even after being asked to do so by doctors who work there. (RELATED: Read this to learn more about how the FDA and the CDC have been lying about covid numbers to push their plandemic agenda.) "That the CDC and FDA failed to respond is arguably not surprising – they have been cheerleading this vaccine for months," wrote Aaron Siri on his Injecting Freedom Substack blog. "Admitting almost any harm now would be akin to asking them to turn a gun on themselves."

Hospitals are overflowing with fully vaccinated patients while the unvaccinated remain healthy

In a letter to Rochelle Walensky and other top officials at the FDA and CDC, Siri explained on behalf of Conrad all the details and science surrounding what was discovered at the hospital facility in question, which is located in New York. One of the biggies is that the hospital facility is now busier and fuller than it ever was throughout the plandemic. Because of the injections, in other words, the hospital facility is now running out of beds. "Even more troubling is the fact that many individuals being admitted are presenting with complication months after vaccination and the hospital has more admitted patients now on average than it had last year during the pandemic," Siri writes. Furthermore, Conrad has been roadblocked at every turn in which she has attempted to get this truth out to the public, including by routing it through the FDA and the CDC, which are supposed to be looking out for public health. Siri explained that a large AHRQ-funded study by Harvard Medical School found that "fewer than 1% of vaccine adverse events are reported" to VAERS. This is a paltry figure that is only made worse by hospitals like the one where Conrad works that refuses to allow its employees to log covid vaccine-related injuries and deaths into it. "The underreporting of anaphylaxis by the CDC and VAERS is particularly troubling because it is mandatory for medical providers to report anaphylaxis after any COVID-19 vaccine to VAERS, most of these reactions occur within 30 minutes of vaccination, and there has been an intense campaign by health authorities to inform medical providers that they need to report anaphylaxis after COVID-19 vaccination to VAERS," Siri added. You can read his full letter with all the details at this link. The latest injury and death tolls for Chinese Virus injections can be found at ChemicalViolence.com. Sources for this article include: AaronSiri.substack.com NaturalNews.com

911 System in Jeopardy Amid ‘Crippling Labor Shortages’: Association President

An emergency medical service (EMS) group has issued a warning about a U.S.-wide shortage of workers that could imperil the 911 system in some places.

“This has been a problem that has that been developing over several years because of chronic underfunding shortfalls from Congress for ambulance services, but certainly during the pandemic, things have hit a crisis level,” American Ambulance Association President Shawn Baird told Fox News on Oct. 10.

In recent months, “we’ve seen a tremendous amount of workforce attrition and schools had shut down paramedic training institutions and stopped graduating new students for the last year, so we’re suddenly in a severe shortfall,” Baird said.

His organization sent a letter to the House and Senate leadership saying the EMS system is facing a “facing a crippling workforce shortage,” noting it’s a “long-term problem that has been building for more than a decade.” The labor shortage, the letter warned, may undermine the 911 emergency system and deserves congressional attention.

In a study released (pdf) by the group’s 2019 Ambulance Industry Employee Turnover Study, the turnover for paramedics and EMTs was 20 percent to 30 percent. That number has increased since the COVID-19 pandemic started last year, Baird told Fox News.

“When you take a system that was already fragile and stretched it because you didn’t have enough people entering the field, then you throw a public health emergency and all of the additional burdens that it put on our workforce, as well as the labor shortages across the entire economy, and it really has put us in a crisis mode,” Baird told NBC on Oct. 8, warning about the 911 system.

Vaccine Mandates May Contribute to Shortage

In some areas, vaccine mandates have contributed to the EMS labor shortage, officials said.

Julie Keizer, the town manager of Waldoboro, Maine, told NewsCenter Maine that “the vaccine mandate has contributed to the loss of first responders.”

“I think part of the problem is everybody thought [workers] would conform because nobody wants to lose their jobs,” Keizer said. “But when you look at the rate of pay for emergency workers, they can make more delivering packages than patients.”

Earlier this month, meanwhile, nearly 900 firefighters in Los Angeles filed a notice of their intent to sue the city over the Los Angeles vaccine mandate slated to go into effect in the coming weeks.

“The claims will be filed in Superior Court as an unlimited civil case pursuant to California Code of Civil Procedure,” Kevin McBride, attorney for the firefighters, wrote in a notice.

Deborah Clapp, executive director of Western Mass Medical Services in Massachusetts, told local media that overworked crews and low wages may contribute to the high turnover rate and staffing shortages.

“What happens if there’s a disaster of some sort? And a disaster doesn’t need to be very big in western Massachusetts,” she told Fox6. “We need all these logistics to be able to step into place and handle these events and, meanwhile, 911 is still being called for the heart attack, the baby being born, the car crash. … We have one trauma center in western Massachusetts. One level one trauma center.”

The American Ambulance Association didn’t immediately respond to a request by The Epoch Times for comment on vaccine mandates.

Jack Phillips

BREAKING NEWS REPORTER

RED ALERT as America now just nine meals away from ANARCHY... massive civil unrest PROVOKED on purpose

Mass famine has been engineered into the coordinated takedown of the United States of America, and it's already too late to reverse it. Widespread food scarcity is already "baked in," so to speak, and now it's only a matter of time as the dominoes fall. IMPORTANT: Tomorrow's Situation Update podcast will reveal bombshell news about the coming food rationing across America (to be announced before Christmas) and Biden's takeover of the US supply chain with military troops. This is already in the planning stages at the highest levels of corrupt government. We have an exclusive interview with Steve Quayle on all this, also airing tomorrow on Brighteon.TV at 2 pm central tomorrow (Thursday). Tune in tomorrow for full details, and watch for the podcast to appear tomorrow morning at https://www.brighteon.com/channels/hrreport America is being deliberately plunged into a "Dark Winter" of famine, energy collapse, hyperinflation and medical martial law. Over the next several months, we are going to witness:

  • Food riots in democrat-run cities

  • Government-enforced rationing of food purchases at retail (welcome to Amerizuela)

  • Some sort of food rationing enforcement ID system, possibly a biometric / Mark of the Beast system

  • Aggressive public shaming of "hoarders" and possible criminalization of stockpiling food

I'll be covering these issues in more detail in tomorrow's Situation Update podcast, but even before then, we already know the following facts:

  • Public school systems are running out of food. One school system in Alabama is now urging parents to keep their children at home because the school has no more food to feed them.

  • All across America, people are seeing empty shelves with their own eyes now. The hashtag #BareShelvesBiden is trending across social media.

  • The mainstream media is acknowledging the worsening shortages, but they are trying to blame "hoarders" rather than the engineered supply chain collapse put in place by the treasonous Biden regime (as an act of war against America).

  • Food manufacturers across the country are announcing major price increases, and grocery store chains like Alberton's are declaring prices will rise aggressively for the foreseeable future.

  • Some grocery retailers are having to dispatch their own cargo trucks to food manufacturers just to pick up pallets of food that would otherwise not be delivered due to labor shortages (also caused by the Biden regime and its engineered lockdowns / covid bailout money scheme). From Breitbart.com:

Other supermarket chains are also having a difficult time stocking shelves, the Journal reported, due to receiving unfulfilled deliveries from suppliers. The lack of supply of food has many grocers “sometimes sending their own trucks to grab goods from manufacturing plants.”

America is just nine meals away from anarchy

It is now crystal clear that the engineered food collapse is going to plunge the nation into extreme food scarcity -- Venezuela-style -- probably by Christmas. The food riots won't be far behind. Notably, this is all by design. The Biden regime criminals are seeking to plunge America into widespread civil unrest and anarchy so they can declare martial law and suspend the 2022 elections, preserving Democrat rule for the foreseeable future. This engineered plan for civil unrest is further accelerated by mass firings up police, firefighters, 911 operators and other first responders. "Crippling labor shortages" are leaving 911 emergency response call centers with skeleton crew staff, reports The Epoch Times. All across America, government and corporate leaders are firing those who refuse to take vaccines while facing a mass die-off of those who did take them. The result is the deliberate gutting of the entire infrastructure that runs a nation, including transportation and logistics, medicine, law enforcement, local government, food supplies, energy, air cargo and more. What you are watching is the systematic, planned dismantling of an entire nation. America is being gutted like the carcass of a hog in a meat plant, and the end result is inescapable: Mass starvation, destitution and anger resulting in a nationwide uprising revolt that the Biden regime will use to declare martial law. In essence, this is January 6th on a nationwide scale. The Biden regime is baiting the entire population into an armed revolt, then using the revolt to install itself into permanent power while cancelling elections and using food scarcity as a weapon. Entire crowds of protesters will of course be hit with aerosolized bioweapons, which DHS is testing right out in the open this week across New York City (and NYC subways and parks). These are practice runs for unleashing these deadly weapons against the American people in 2022. Make no mistake: Biden and his globalist controllers are waging all-out WAR against the American people, which is what every Marxist / fascist treasonous government regime eventually comes to. When you see the mass uprisings this winter, just remember it was all invoked by engineered food scarcity, and it's playing right into the hands of the anti-American traitors who are systematically dismantling this nation -- and its military -- through the forced injection of biological weapons that are fraudulently labeled "vaccines." A lot of Americans weren't ready to hear this truth until now. But at this moment, it's all undeniable. You can see the evidence right in front of you. The takedown of this nation has commenced, and it won't be long before America looks like Venezuela, complete with an engineered financial collapse and dollar reset that will be the final nail in the coffin of the American empire. Get full details in today's hard-hitting Situation Update: Brighteon.com/0b4d6eeb-425b-4c65-bd60-3f2a5765dd2cFind a new podcast each day at: https://www.brighteon.com/channels/hrreport

Breakthrough Infections are Killing People

The sad death of Colin Powell should bring much needed attention to the phenomenon of breakthrough COVID infections of the fully vaccinated. You can choose to believe the establishment that breakthrough infections are nothing to worry about. Or you can choose to believe that they are just a minor inconvenience because COVID vaccines are not and cannot be 100% effective. Or you can consider real-world data that show how serious breakthrough infections really are.

Department of Defense study

A recent release of data from an important study by the Department of Defense merits very serious attention. It is called the Project Salus study. One indication of how important the data are is that the official website giving the data was taken down. But it is available on this site. A logical interpretation is that the federal agencies running the pandemic, namely the NIH, CDC, and FDA, were upset with the data (I am about to give you). Why? It is because the data undercuts the establishment’s argument in favor of COVID vaccines and downplaying of breakthrough infections. It should be noted that this study has received no attention by the mainstream media.

The title of the report is “Effectiveness of mRNA COVID-19 Vaccines Against the Delta Variant Among 5.6 Million Medicare Beneficiaries 65 Years and Older,” dated September 28, 2021.

The DOD study got access to the medical data for those people who were fully vaccinated. Of that group, 2.7 million got the Pfizer shot and 2.9 million got the Moderna one.  Here are key findings:

–         There were 161,000 breakthrough cases.

–         There were 33,000 hospitalizations.

–         There were 10,400 intensive care unit admissions.

–         There were 3,381 deaths for a death rate of 2.1%.

The first reaction from establishment vaccine advocates is that all these numbers are very small percentages of the total sample of 5.6 million fully vaccinated people. That is correct. All this illustrates is the tyranny of small percentages when looking at health impacts of vaccines.

But there are reasons why the DOD data undercount the true negative impacts of breakthrough infections. The principal one is that the study followed the CDC procedure in not counting any negative health impacts occurring within 14 days of the last vaccine shot. This is important, because some analyses have found that high fractions of negative health impacts, such as vaccine induced blood problems, happen within a few days of vaccination. This omission is a deliberate deception aimed solely at undercounting negative health impacts of vaccines.

It should also be noted that this study did not examine serious adverse health impacts, including death, resulting from vaccines without any COVID infection long before and possibly long after breakthrough infections. This has been detailed by this author.

Another consideration is that the DOD study was on a cohort of about 10 percent of the entire Medicare population. It is reasonable to believe that the 65 and older demographic very likely was vaccinated to a very high degree. The New York Times said in August that at least 80 percent of people 65 and older are vaccinated in the US. Thus, the total number of deaths for this large group resulting from breakthrough infections could be large; perhaps over 10,000. Indeed, it has been widely reported that over 80 percent of COVID deaths are in that demographic. The tragic end to Colin Powell, age 84, who had two major underlying medical problems also pertains to the 65 and older population. The elderly population is especially vulnerable to having immune systems unable to block a breakthrough infection when the vaccine immunity seriously degrades. Powell surely had his initial vaccinations many months earlier.

Another cause of undercounting breakthrough deaths is that many are likely counted as only COVID deaths, and do not consider full vaccinated status. Taking all these factors into account, the total number of breakthrough deaths for the nation is likely in the 10,000 to 20,000 range.  This number is rising as more vaccinated people have declining vaccine effectiveness.

The study emphasized that the above data represented a marked improvement of analogous data from March to December 2020 period when COVID was rampant and before vaccinations. Consider the example of the death rate of 2.1 percent for breakthrough infections of the vaccinated compared to 12 percent in the pre-vaccination period. That information is correct. But do consider that some 3,000 deaths for the 9/11 calamity was considered of enormous news media importance. So, why are the 3,381 deaths reported in the DOD study of little mainstream media interest?

State data

In Massachusetts, it was reported this month that the total number of breakthrough cases was 44,498, with 345 deaths (.8%). In South Carolina, it was reported this month that there had been 14,992 breakthrough cases with 350 deaths, showing a much higher death rate (2.3%). In Oregon, it was reported this month that out of 28,075 breakthrough cases there were 237 deaths (.8%). In Indiana, the reported number of breakthrough cases was 39,000 with 334 deaths (.8%). In Minnesota, the total cases reported were 32,796 with 185 deaths (.6%).

As of October 12, the CDC reported 7,178 breakthrough deaths, with 85% over 65. It no longer counts all breakthrough cases, but just deaths and hospitalizations. However, CDC data are notoriously unreliable. So, extrapolating the data for the above six states to the entire nation (using population data) results in 14,510 breakthrough deaths for 1.6 million cases and a death rate of .9%. This is lower than the 2.1 percent in the DOD study; this might be explained by many breakthrough infections happening in people younger than 65 and some under-reporting of breakthrough deaths probably because they are counted as COVID deaths.

Declining vaccine effectiveness

The deaths are important because they show the true limitation of current COVID vaccines. It is now recognized that the effectiveness of the vaccines quickly diminishes over time. After about six months they become ineffective. It was found in this study that breakthrough infection rates 5-6 months post-vaccination are twice as high as 3-4 months post-vaccination. Also noted was that the data showed that mRNA vaccine effectiveness falls short of what was predicted in the drug company studies that got them FDA sanctioned. It also showed that the Moderna vaccine was better than the Pfizer one in sustaining effectiveness.

An unpublished graph of CDC data (made available on a Rational Ground newsletter, October 14, 2021) showed a marked increase in COVID deaths in hospitals starting in April 2021, rising from 3.1 to 15.1 percent for vaccinated patients in May 2021. This corresponds to the five months since the onset of the mass vaccination program; a period when vaccines lose their effectiveness. As time goes on, more people lose protection from vaccines causing more breakthrough infections.

This serious decline in vaccine effectiveness should lead rational, objective people to conclude any vaccine that only provides just a few months of protection should not be described as a medical solution worthy of wide use and mandates. In terms of ineffectiveness against the delta variant, does it make sense to believe that requiring repeated booster shots of the same vaccines will produce better results? At best, they may only delay breakthrough infections.

The worsening of health outcomes after vaccination has been interpreted as resulting from damage to the immune system caused by vaccines. This is referred to as Antibody Dependent Enhancement in the medical research literature. It refers to immune system weakening from the vaccines.

As to declining vaccine effectiveness it should be noted that two studies from Israel and Qatar that were published in the New England Journal of Medicine supported this threat to the fully vaccinated. In Israel, the rise of COVID-19 cases in fully vaccinated people has been reported. According to Dr. Haviv, the vaccinated account for 85-90% of all new hospitalizations and 95% of “severe” cases at the Herzog Medical Center in Jerusalem.

Impacts of being vaccinated

There have also been reports that very high fractions of hospital admissions in the US are for fully vaccinated people. One whistle blower reported that where she worked that while the vaccination rate was less than 50% in the community, about 90% of hospital admissions had been fully vaccinated.

It has been reported from several states that 40% of hospitalized COVID patients had been fully vaccinated, including from New York. Since July 1, nearly 40% of all Onondaga County residents who tested positive for the novel coronavirus had been fully vaccinated.

Recently reported for Maryland was that over the past three months in Anne Arundel County, about 30% of the people hospitalized with COVID are fully vaccinated. In neighboring Howard County, health officials said roughly 30% to 40% of people hospitalized with COVID are fully vaccinated. That is a lot of breakthrough infections.

A recent report from Public Health England shows that 163 of the 257 people (63.4%) who died of the delta variant within 28 days of a positive COVID test between February 1 and June 21, had received at least one dose of the vaccine.

Natural immunity

A very important finding of the DOD study that deserved attention by mainstream media was that the one variable that explained substantial resistance to serious negative health impacts from breakthrough infections was natural immunity resulting from prior COVID infection.

If we want to face reality with honesty, then natural immunity must be viewed as the enemy of mass vaccination. That governments refuse to credential natural immunity as they increasingly mandate vaccination is a disgraceful rebuttal of medical science. Indeed, there is now indisputable medical evidence that natural immunity is more effective, especially against variants, and longer lasting than vaccine immunity.  All of this makes it a threat to mass vaccination.

St. Lukes University Hospital, in Pennsylvania has recognized natural immunity by offering their workers with it at least a one-year deferment to get vaccinated. With workers in many sectors refusing vaccination even with loss of their jobs, and a resulting huge impact on our economy and society, perhaps the federal government and major companies will be compelled to act in a similar fashion by recognizing natural immunity.

Vaccine immunity impacts

Finally, newly reported research is worth noting: High viral load found in “158 of 232 unvaccinated (68%…) and 156 of 225 fully vaccinated (69%…) symptomatic individuals.”  This indicates no difference between the symptomatic vaccinated and unvaccinated in terms of who was carrying, and therefore spreading, the virus. It also found high viral loads in “7 of 24 unvaccinated (29%…) and 9 of 11 fully vaccinated asymptomatic individuals (82%…).”  What this means is that among asymptomatic individuals, the vaccinated had a higher percentage with a high viral load.

A valid conclusion is that the unvaccinated that catch the virus are more likely to be at home in bed with symptoms, while the vaccinated that catch the virus (breakthrough infection) may often have no symptoms and hence continue their daily routine unknowingly spreading the virus. This is why many medical experts refer to the vaccinated as super spreaders. Indeed, the eminent Dr. Robert Malone, inventor of mRNA vaccines, has emphasized that vaccinated people in their normal activities are “going to be spreading the virus like crazy.”

As to breakthrough infections and deaths, what must be remembered is that there is likely to be a lot of COVID virus circulating, mostly the delta variant now. This is happening as fully vaccinated people have declining vaccine effectiveness. The booster shots just delay such a loss. All of this means increasing breakthrough cases, some of which result in death, especially in the most vulnerable; that is, the elderly, those with compromised immune systems (like Colin Powell), and those with serious comorbidities, including obesity.

Dr. Joel S. Hirschhorn, author of Pandemic Blunder and many articles on the pandemic, worked on health issues for decades. As a full professor at the University of Wisconsin, Madison, he directed a medical research program between the colleges of engineering and medicine.  As a senior official at the Congressional Office of Technology Assessment and the National Governors Association, he directed major studies on health-related subjects; he testified at over 50 US Senate and House hearings and authored hundreds of articles and op-ed articles in major newspapers.  He has served as an executive volunteer at a major hospital for more than 10 years.  He is a member of the Association of American Physicians and Surgeons, and America’s Frontline Doctors.

Biden Deputy Treasury Secretary: The Only Way to Transcend Supply Chain Challenges is 100% Worldwide Vaccination!

In the latest absolutely, outrageous—and bizarre claim out of the Biden administration, Deputy Treasury Secretary Wally Adeyemo, declared in an interview with ABC’s Stephanie Ramos that the only way that the American economy will transcend the current supply chain crisis, inflation, and all else is 100% vaccination. That’s right—let’s just forget natural immunity, lowering infection rates in many states, or any number of other factors the politicization of the COVID-19 vaccine has gone to great lengths to conceal.

Recently ABC News reported on mounting supply chain problems across America and beyond focusing on the Port of Los Angeles and Long Beach. To be expected, most experts acknowledge that current supply chain problems arose out of the pandemic shutdowns last year. Longshoremen and others involved with trade report severe shortages in truck drivers and other key labor.

While Biden recently announced measures to overcome supply chain issues, some news sources question out loud whether his regulatory actions may just make matters worse. In a recent piece in National Review Biden has secured 24×7 operations at the major ports of Los Angeles and Long Beach, yet Veronique De Rugy writes that “honestly that [POTUS] measure sounds like the equivalent of trying to rescue a sinking boat with a solo cup.”

A confluence of factors hampering the American supply chain hinder efforts to overcome the crisis. These include severe labor shortages, weakening infrastructure, and growing inflation. The Biden administration has attempted to prop up spending by providing a series of benefits via the American Rescue Plan, but those actions don’t stop these more foundational, structural problems at this point.

Blame the Vaccinated

If it couldn’t get any worse, well—it just did for the unvaccinated. In the ABC News interview, Deputy Treasury Secretary Wally Adeyemo essentially blamed the entire supply chain crisis on the unvaccinated. He declared that America was in a transitory economy, and POTUS’ stimulus was meant to help people make it through the tough times due to the pandemic.

But Mr. Adeyemo got right to his main agenda which was to reinforce on national media the vilification of the unvaccinated declaring that “the only way we can get to a place where we can work through this transmission is to ensure that everyone in America [and the world] is vaccinated.” 

TrialSite focuses on biomedical health research and by extension in the pursuit of transparency and accessibility may from time to time uncover political, economic, and social topics of concern. We suggest that something is terribly wrong if the main talking point of this administration is that the supply chain crisis is now due to unvaccinated people. Never mind natural immunity or challenges with the vaccines themselves—this comes after a handful of months where the vaccinated transmitted the virus along with the unvaccinated. This unreasonable, either-or false dilemma we believe is political suicide. POTUS won’t achieve his aims, and his party will be voted out en-masse next year. The supply chain problems may continue to persist if a change in leadership paradigm doesn’t happen, and soon.

Did Dr. Fauci’s NIAID Support China’s Bio-Weapons Program?

Once known as a hawkish foreign policy think tank, the Center for Security Policy is perhaps now more of a right-wing biased organization. While we at TrialSite harshly disown any bias—from right to left—and take care to ensure a balanced point of view–we could not ignore the Center’s August 2021 article, “NIH Funded China’s Gain-of-Function Research at the Wuhan Institute of Virology,” by Gordon G. Chang. Given that the facts presented are well-footnoted, this may be a case where an important message comes from an otherwise questionable source. As has been well shown, the Obama administration ordered a moratorium on gain-of-function research in 2014. Also well documented is that Dr. Fauci’s NIAID provided funds to the New York-based nonprofit EcoHealth Alliance which studied infectious diseases. In turn, EcoHealth transferred some of these funds to the Wuhan Institute of Virology through the end of the moratorium. Papers published by researchers at Wuhan, “make clear that the researchers were using NIAID funds for research that can be described as ‘gain-of-function.’” Chang’s article focuses on two of these papers.

Gain-of-Function Work Put on Pause

Based on the two papers, Chang argues that Fauci knew or should have known that his agency’s grant money was being used for dangerous research that in fact met the definition of the prohibited work. So, his testimony in both May and July before the US Senate’s committee was not true. Gain-of-function research involves changing a pathogen to make it more contagious or more deadly. While this can be done in order to advance treatments, it is inherently a dual-use activity as it lies, “at the heart of biological weapons programs.” Back in 2011, US scientists had altered the genes of the H5N1 “bird flu” so it would spread between ferrets, and a controversy ensued. Many researchers urged a ban. On October 17, 2014, DHHS and the Office of Science and Technology Policy issued, “U.S. Government Gain-of-Function Deliberative Process and Research Funding Pause on Selected Gain-of-Function Research Involving Influenza, MERS, and SARS Viruses.” The document ended federal money for “for gain-of-function research projects that may be reasonably anticipated to confer attributes to influenza, MERS, or SARS viruses such that the virus would have enhanced pathogenicity and/or transmissibility in mammals via the respiratory route.”

Reverse Genetics and Humanized Mice

The 2014 directive also called for both federally-funded and other researchers to follow a “voluntary pause” on research. Then, in 2017 the White House Office of Science and Technology Policy issued a “Recommended Policy Guidance for Departmental Development of Review Mechanisms for Potential Pandemic Pathogen Care and Oversight;” On his way out of office, President Obama had lifted the moratorium. Back in 2014, NIH announced a five-year grant to EcoHealth. The Fauci-led NIAID was listed as the administrator of the grant, entitled, “Understanding the Risk of Bat Coronavirus Emergence.” The award was for a total of $3.75 million with $666,442 funded for the 2014 fiscal year. The award documents note that the researchers would look at, “the risk of future coronavirus (CoV) emergence from wildlife using in-depth field investigations across the human-wildlife interface in China.” The paperwork also noted, “Predictive models of host range (i.e. emergence potential) will be tested experimentally using reverse genetics, pseudovirus, and receptor binding assays, and virus infection experiments across a range of cell cultures from different species and humanized mice.” This grant was made five months before the alleged “pause,” and, “NIH continued to fund it, and EcoHealth Alliance transferred to the Wuhan institute $133,000 per year through 2019,” and also $66,000 in 2020.

Bat Woman and the ORFX Gene

Peter Daszak, the British zoologist who is EcoHealth’s president, “did not hide the dangerous nature of his work in Wuhan.” In February 2016 he publicly noted that his, “colleagues in China” were creating “killer” viruses. Two papers that Daszak co-authored offer key insights. The first one, “Bat Severe Acute Respiratory Syndrome-Like Coronavirus WIV1 Encodes an Extra Accessory Protein, ORFX, Involved in Modulation of the Host Immune Response.” One co-author was Shi Zhengli, who is known as the “Bat Woman” of the WIV. The paper was based on work done at Wuhan and looked at the creation of new types of WIV1 virus along with testing in human cells. Using complex reverse genetics and bacteria-based man-made chromosome methods to make, “recombinant SARS-like CoVs.” Some would call the work, “loss-of-function” since it involved the deletion of the ORFX gene. Yet, “the deletion of a gene or genes does not necessarily lead to the loss or diminution of the function of a virus. On the contrary, gene deletion can end up increasing function.” As an example, H5N1 was seen to be enhanced by a 15-nucleotide deletion. The Wuhan researchers could not know which functions in the rWIV1-DeltaX virus might be strengthened. The MIT Technology Review noted that two of the newly created chimeras, “replicated well in human cells [and] were, for all intents and purposes, brand-new pathogens.”

“Sampling and Lab Capacity” Only

The publishing of this paper in 2016, with Shi Zhengli’s name attached, in the Journal of Virology, “guaranteed wide attention in the scientific community.” So we need to be wary of various denials of NIAID funding, such as NIH’s statement that, “NIH has never approved any grant to support ‘gain-of-function’ research on coronaviruses that would have increased their transmissibility or lethality for humans—-The research proposed in the EcoHealth Alliance, Inc. grant application sought to understand how bat coronaviruses evolve naturally in the environment to become transmissible to the human population.” So, NIH must have known that its, “money was used for” dangerous research. Clearly, the research did create two brand-new pathogens, “the essence of gain of function.” EcoHealth’s spokesman Robert Kessley has told the Washington Post that, “The NIH has not funded gain-of-function work—-EcoHealth Alliance was funded by the NIH to conduct a study of coronavirus diversity in China. From that award, we subcontracted work with the Wuhan Institute of Virology to help with sampling and lab capacity.” But with Daszak listed as an author, obviously NIH money did not only go to, “sampling and lab capacity.”

“Chimeric Viruses Based on a Bat Virus”

The second paper that is significant is “Discovery of a Rich Gene Pool of Bat SARS-Related Coronaviruses Provides New Insights into the Origin of SARS Coronavirus,”  by authors Ben Hu, Lei-Ping Zeng, Xing-Lou Yang, et al. in 2017. It was this paper that led Senator Rand Paul to cite a Rutgers University molecular biologist to the effect that the “research matches, indeed epitomizes the definition of gain-of-function research.” This paper also lists NIH as a funder and has the project number from the May 2014 funding of EcoHealth with a note, “NIAID.” 14 of 17 co-authors are listed as tied to the WIV, and once again Daszak is a co-author. While not describing standard gain-of-function work, this research paper shows evidence of dangerous gene-splicing. Dr. Li-Meng Yan has said that Dr. Shi’s team, “made chimeric viruses based on a bat virus, WIV1.” Shi had moved spike proteins from various novel bat viruses to WIV1, and the created viruses were able to bind to human ACE2 receptors. Yan who is a Chinese virologist living in the US who studies coronaviruses notes, “This shows that WIV1, as engineered, can potentially infect humans.” And Yan argues that creating new viruses is just as dangerous as gain-of-function work.

China’s Top Biowarfare Expert

The Washington Post’s fact-checker has said, “the EcoHealth funding was not related to the experiments, but the collection of samples.” This statement from an important newspaper cannot readily be squared with the May 2014 grant terms and the two papers under discussion. Another key issue is the People’s Liberation Army. Dr. Yan had fled Hong Kong in 2020 to reveal information about China’s coronavirus experimentation, and he asserts that the bat virus samples collected by Shi and her experiments advanced Chinese bio-weapon efforts, regardless of whether it involved a technical gain-of-function. According to Chang,  “Chinese military researchers for at least a decade have published numerous articles and books describing the bioweapons China needs and will use.” Also, China has a notion of civil-military fusion, “meaning the military has access to, among other things, any technology it wants.” Major General Chen Wei’s job of heading the BSL-4 unit at WIV is also disturbing, as she is “China’s top biowarfare expert,” according to Foreign Policy magazine. Author Chang asks, why would she be at WIV if it was not, among other things, a practical bio-weapon laboratory?

Who is Author Gordon G. Chang?

According to his website, Chang is the author of The Great U.S.-China Tech War and Losing South Korea. His other books are Nuclear Showdown: North Korea Takes On the World and The Coming Collapse of China, both published by Random House. In Hong Kong, he was a partner at the Baker & McKenzie law firm. His work has been in The New York Times, The Wall Street Journal, The National InterestThe American Conservative, Commentary, National Review, Barron’s, and The Daily Beast. He is also a columnist for Newsweek. He has provided briefings at the National Intelligence Council, the Central Intelligence Agency, the State Department, and the Pentagon.  Chang has also testified before the House Committee on Foreign Affairs and the U.S.-China Economic and Security Review Commission.    

Large RWE Study: Famotidine (Pepcid) May Have Saved Hundreds of Thousands of Lives During COVID-19 Pandemic

A cutting-edge federated technology-powered network known as TriNetX powered an impressive real-world evidence study involving approximately 400 million patients across 30 countries. Based on a federated, distributed model the system pulls electronic medical records—that is from diagnoses and procedures to medications and more—in an aggregated format supporting deep analytics of the de-identified patient data. American and German researchers represent the University of Virginia at Charlottesville and Charité–Universitätsmedizin Berlin analyzed a cohort of 22,560 COVID-19 patients receiving H1/H2 receptor antagonists, with a special focus on 1,379 severe cases requiring respiratory support. Establishing mortality as a primary endpoint the researchers explained they hoped to mitigate cofounder by employing propensity-score matching with a goal of “stratified and balanced sub-cohorts across age and gender.” What they found was stunning. Among other benefits famotidine provided what the authors declared was “an immense benefit” to COVID-19 patients.

Famotidine Background

Known for its trade name Pepcid, this drug is a histamine H receptor antagonist medication reducing stomach acid production. Used to treat peptic ulcer disease, gastroesophageal reflux disease, and Zollinger-Ellison syndrome, the drug can be administered orally or intravenously.

The TrialSite advisory committee member Dr. Michael Goodkin recently educatedTrialSite readers about the significant progress associated with this economical, widely available treatment. Can famotidine help treat COVID-19?

Early in the pandemic another TrialSite advisory committee member, Dr. Robert Malone identified famotidine as a potential inhibitor of SARS-CoV-2, the virus behind COVID-19.  In fact, Dr. Goodkin notes at least some scientists have wondered why some people became very ill with COVID-19 while others didn’t. Could this observation be associated with the responses of individuals’ mast cells to infection?

Drs. Malone, Goodkin, and many other prominent investigators suspect that “Therapies to blunt their response appear to be effective, most commonly the over-the-counter H2 blocker famotidine (Pepcid).” Goodkin argues, “numerous observational studies suggest its [famotidine] benefit, yet the medical establishment has paid little attention.”

This RWE TriNetX study led by researchers from the University of Virginia and Charité–Universitätsmedizin Berlin sought to investigate this question further.

The Study

In this study, the author shared results in the form of a letter published in Nature. Led by corresponding authors Cameron Mura and Saskia Preissne, the investigators sought to tap into and capitalize on the massive TriNetX data set in a bid to identify if there are any “beneficial effects of famotidine detectable on population-wide international scales.”

The authors ask other important questions:

  • Is it synergistic to treat with famotidine in conjunction with aspirin or general-purpose anti-inflammatory?

  • Does famotidine use correlate with any measurable parameters that may serve as biomarkers, perhaps offering mechanistic clues (e.g., serum C-reactive protein [CRP] levels a proxy for inflammation and the cytokine storm

The American and German team worked first with the following data set:

TotalDescription257,864Total COVID-19 cases7,479Deaths18,624Famotidine8,335Cetirizine3,928loratadine23,148Aspirin5,955Aspirin and Famotidine

The research team ran a series of statistical analyses such as quantifying association, risk ratios (RRs) as well as odds ratios (ORs) as reported in Nature.  The study team established respective 95% confidence intervals (CIs) in addition to Kaplan-Meier survival curves.

Conducting a series of statistical analyses involving “(i) the H1RAs loratadine (e.g., Claritin®) and cetirizine (e.g., Zyrtec®), (ii) the H2RA famotidine, (iii) aspirin, and (iv) a combination of famotidine and aspirin, the authors found that famotidine treatment reduced fatality risk in cases needing respiratory support (OR 0.73, CI 0.57-0.94). 

The authors didn’t find an observable benefit using dual-histamine receptor blocker targeting H1 and H2 receptors versus famotidine alone (OR 0.75, CI 0.39-1.46). To the authors’ surprise, “the combination of famotidine and aspirin (344 severe cases before matching) did exhibit a significant synergistic survival benefit (OR 0.55, CI 0.39-0.78).”

Benefits associated with fatalities became even more pronounced. With a decreased Risk Ration of 32.5% the authors declare, “An immense benefit, given the more than 3.8 million COVID-19-related deaths thus far.

Limitations

The study team shared some limitations they shared: they didn’t use sub-cohorts categorized by disease severity as they declared “a limitation of our work stems from the distribution of such severities almost certainly being related to the efficacy of any therapeutic intervention.” For other limitations follow the link at source to the journal.

What is TriNetX?

TrialSite’s InvestorWatch has profiled TriNetX. Founded by an ex-Microsoft technology executive in 2013, the Boston-based global health research network has raised tens of millions in at least four venture capital rounds.

In 2020 the company was acquired by the prestigious private equity group called Carlyle Group.

TriNetX positions itself as connecting the world of drug discovery and development from pharmaceutical company to study site, and investigator to patient by sharing real-world data to make clinical and observational research easier and more efficient. The company’s federated technology combines real-time access to longitudinal clinical data with state-of-the-art analytics to optimize protocol design and feasibility, site selection, patient recruitment, and enable discoveries through the generation of real-world evidence. The TriNetX platform is HIPAA and GDPR compliant. 

Lead Research/Investigator

Cameron Mura, Ph.D. Assistant Professor, Chemistry