September 20, 2022
Dear Friends and Family,
Completion of this segment puts us one-third into the COVID Pandemic Critique. So, I decided to reflect on what I have learned to date. I hope you elect to do so also.
Dear Friends and Family,
Completion of this segment puts us one-third into the COVID Pandemic Critique. So, I decided to reflect on what I have learned to date. I hope you elect to do so also.
- Our overall performance was poor. We had 16.0% of the Covid deaths worldwide and we are only 4.2% of the world’s population. Our death per capita ratio puts us in the bottom of the world comparisons, if not dead last.
- The CDC – the Public Health Organization charged with protecting us from health threats did not execute their duties effectively as expressed by their new Director, Dr. Rochelle Walensky on August 17, 2022, when she made this public statement.
For 75 years, CDC and public health have been preparing for COVID-19 and in our big moment, our performance did not reliably meet expectations.
- The White House Task Force adopted a mitigation strategy based on a flu model which treated everyone the same. This did not prove out with COVID as the virus hit the elderly much more severely than the young, yet we never altered course.
- The health care community collectively put little effort into developing or finding therapeutics to minimize the effects of the disease outside of Remdesivir which turned out to be a dud. [NOTE: Paxlovid was developed but very late in the pandemic – 12/22/2021 long after the vaccine was available].
- Accurate, comprehensive data was not available from the CDC to guide decision making. The CDC was fully funded for the development of such a comprehensive national clinical and laboratory data system since 2009, yet it was never developed. (Dr. Deborah Birx).
- The CDC failed to produce an effective diagnostic test for COVID at the onset of the pandemic which put the testing needed for mitigation behind 16 to 24 weeks behind the progress of the viral spread. Further, they did not elect to use diagnostic testing that was available from Japan or the World Health Organization (Dr. Deborah Birx and Sanjay Gupta, MD and medical reporter for CNN).
- Testing that was developed by the CDC could only be analyzed by Public Health Labs and not on commercial high-throughput systems (0.1% and 99.9% of the country’s laboratory capacity respectively). This resulted in significant delay in getting testing results and therefore the complete implementation of the mitigation strategy. (Dr. Deborah Birx).
- The CDC had no plan on how to effectively utilize the testing that was available which led to a disorganized state of testing throughout the U.S. for lack of a comprehensive national strategy (Dr. Scott Gottlieb, former FDA head).
The points above provide some insight into why our overall results as a country are so poor and for Dr. Walensky’s August 17 statement on the CDC. Our COVID-19 deaths total 1,043,171 as of 9/8/2022.
Happy Learning,
Harley
COVID PANDEMIC CRITIQUE – SEGMENT 6
CONTROLLING THE SPREAD -- DATA & TESTING – EXCERPTS
DATA
The Fictional Tale: The Pandemic fiasco started with a model developed by Neil Ferguson of the Imperial College of London which predicted that tens of millions of people would die due to the COVID – 19 infection. COVID – 19 was compared to the Spanish flu, which killed approximately 50 million people in 1918. Ferguson’s report stated that the only way to prevent massive deaths would be for the entire population of the planet to be locked down and for people to remain separated for 18 months until a vaccine was available.
Source: Covid Operation by Pamela A. Popper & Shane Prier (2020)
In 2002, Ferguson made his first highly publicized prediction. He suggested the mad cow disease might kill as many as 100,000 people in Britain, or 150,000 if it also proved to be transmissible from sheep to humans. Fewer than 180 Britons died. In 2005 he warned that an influenza called H5N1 could kill hundreds of millions of people. Only of 43 people died according to WHO.
On Monday, March 16, Imperial College publicly released the forecast that it previously shown only to policymakers. Over 2 million Americans and 500,000 would die in a matter of months if governments did not shut their countries immediately. The epidemic would peak quickly and sharply. By early June, about 50,000 Americans would die of Covid each day. Equally terrifying, an uncontrolled pandemic would case coronavirus patients to destroy the hospital system. Within a month, hospitals would be out of intensive care beds. By mid-May, more than two million Americans would need intensive care, more than 30 times the number of beds available.
Source: Pandemia by Alex Berenson (2021).
At the outset of the pandemic, Dr. Fauci used wildly inaccurate modeling that overestimated US deaths by 525%. Scammer and pandemic fabricator Neil Ferguson of Imperial College London was their author, with funding from the Bill & Melinda Fates Foundation of $148.8 million. Dr. Fauci used this model as justification for his lockdowns.
Source: The Real Anthony Fauci by Robert F. Kennedy, Jr. (2021)
CDC’S DATA SYSTEM: In the end, the flu bias in the CDC’s data system and the agency’s jurisdictional limitations exposed, once again, the rigidity in its thinking. The CDC had been fully funded for global health security and domestic health security since 2009. It had received millions upon millions of dollars in global health security funds every year for precisely the situation we were now in. They made decisions that resulted in the absence of a comprehensive national clinical and laboratory system. No one else is accountable for that.
From masks to tests to data collection to flu bias – the CDC made several very real and very consequential decisions that shaped the early months of the pandemic and are still shaping events today. To this day, the date is incomplete. Ultimately, the CDC’s greatest sin was not recognizing and acknowledging that it had sinned. Instead of fixing the issues, it hardened its belief that its approach was the best because they were the best. As difficult as it is for me to write this, it’s true that one of our nation’s finest medical/scientific institutions, one of the world’s leading public health entities, believed that the projections it had derived from its model of cases and hospitalizations were more accurate than the real, comprehensive data itself. This really stunned me. The same was true for vaccines and the durability of vaccine protection: we had to rely on the well-connected data from other countries to make decisions in this country, the United States, the country with the most advanced It and data collection capacity, which we could have tapped into from the private sector.
Source: Silent Invasion by Dr. Deborah Birx (2022).
CASE COUNTS, FATALITY RATES AND DEATHS REPORTED: Many presumed positive cases were being tabulated as positive cases when symptomatic people presented who had been to an area with high viral transmission. But the entire country was full of epidemiological spread, and it was still flu season. In the beginning, before testing was readily accessible, much of this predictive diagnostic criterion, was understandable, because it was better to be overly cautious and assume more people had the virus than not. However, by midsummer as cases were increasing across the U.S., according to the CDC, presumed positive cases were still being allowed into the official counts despite broader access to testing.
The incompetence continued, as not only were the cases being overinflated, but the number of tests being performed were as well. Antibody tests were being reported in addition to the PCR antigen tests when reporting how many tests were also being reported as new cases. If it was considered a positive case during the initial infection following an antigen test or even a presumed positive, and then it was again reported as a case by a later-obtained antibody test.
One important piece of information that became widely misused was from a report put forth by the CDC that stated only 6% of people who had reportedly died of COVID-19 had COVID-19 listed as their only cause of death on the death certificate. This tidbit of information immediately incited a conspiracy that most deaths being reported were not actually due to COVID-19, indicating the virus was not as deadly as portrayed, restrictions in place were for naught, and the pandemic was not what the government was telling people it was. People began rejecting the pandemic more than ever, claiming the death counts were grossly overestimated.
Source: Panic Attack by Nicole Saphier, MD (2021)
The CDC has done its part to ensure that as many deaths as possible are attributed to COVID – 19—even when it was not the actual cause of death. On March 2020 “The CDC issued new guidance that required doctors who complete death certificates to list COVID-19 on the certificate if it contributed to or caused the death. This was no different than what we did before. We are supposed to list all contributing causes. Then later in the fall of 2020, the CDC changed course dramatically, this time without bringing any attention to the new guidelines. “Without fanfare, the CDC acknowledged on another webpage that even if COVID was not listed by the doctor as the underlying cause of death, or the proximate cause of death, as long as it was listed as one contributing cause, it should be coded as the cause of death.” Indeed, the CDC website at the time of this writing reads “When COVID-19 is reported as a cause of death on the death certificate, it is coded and counted as the death due to COVID-19. All these machinations with the death certificates hide the fact that the death rate from COVID-19 for everyone except for those over 60 is significantly lower than the death rate for influenza.
Source: The Truth About COVID-19 by Dr. Joseph Mercola and Ronnie Cummins (2021)
Too often, Dr. Fauci was at the center of these systemic deceptions. The “mistakes” were always in the same direction – inflating the risks of coronavirus and the safety and efficacy of vaccines in order to stoke public fear of COVID and provoke mass compliance. The excuses for his mistakes ran from blaming the public (now blaming the unvaccinated), blaming politics, and explaining his gyrations by saying, “You’ve got to evolve with the science.” Dr. Fauci acquiesced to CDC’s selective protocol changes for completing death certificates in a way that inflated the claimed deaths from COVID, and thus inflated its infection morality rate.
Source: The Real Anthony Fauci by Robert F. Kennedy, Jr. 2021
WHITE HOUSE TASK FORCE AND DATA: At several COVID Huddles I showed charts documenting the true dates of cases. I took time to show the actual data, the discrepancies between trend shown by Birx and the accurate trends from Arizona, Florida, Texas, and elsewhere – a detailed analysis often provided by some outstanding analysts outside the government. These illustrated how the reported dates of deaths were at times tallying deaths from weeks or months prior. In turn, newly accurate assignment of dates changed the entire shape of the trend curve. That meant peaks on the charts were off by weeks, so if one designed a policy to the peak, or concluded an impact of a policy from the declines of a peak, it would be incorrect.
Source: A Plague Upon Our House by Scott W. Atlas, MD (2021)
TESTING
FAILURES FROM THE OUTSET: At least the Japanese had a reliable diagnostic test. The same could not be said for us. On the last day of January 2020, all seemed to be moving along nicely toward the development of a diagnostic tool that could be rolled out quickly and in large numbers. Over the first half of February though, it became clear that neither was true.
On February 8, we learned that contaminated testing materials had caused the test the federal agencies had created to result in false positives. This production issue was resolved, but the delay was costly. We should have been on the brink of having millions of test kits manufactured and shipped to the states. Now, rather than ensuring that those kits were deployed at the first sign of an outbreak, the CDC had to validate a new test. This general disregard for and mismanagement of testing, as compared with the rapid focus on vaccines at the NIH, would continue to haunt us throughout the spring and into the summer. We were no longer days behind; we were weeks behind. Early in a pandemic, days and sometimes even hours can be crucial. You are attempting to slow the spread before the curve become exponential. By the time the federal agencies had caught up to where they were before the testing debacle, they were actually 16 to 24 weeks behind the progress of the viral spread.
At precisely the moment when we needed to be testing widely to see where and how the virus was spreading, we were flying almost totally blind. Tests should have been broadly available; instead, they became a precious commodity. While the failure of the tests was deeply disturbing, I was also concerned about some of the decision making at the CDC. When the tests were designed back in January, they were built mainly for use and analysis by our country’s Public Health Laboratories and their often unique equipment. These labs are more like research facilities than diagnostic labs that patient would access. They are not high-throughput (i.e., fast-processing, high-volume) clinical or commercial labs. Worse, most have been significantly understaffed for decades. And yet, the CDC had created a test that could be processed only at these low-throughput facilities. In comparison to the higher-throughput, commercial labs, the CDC versions could process 50 to 100 samples every four hours, far less than the 500 to 1,000 samples every four hours processed at the clinical and private diagnostic labs. With the CDC limited to about 0.1% of the country’s laboratory capacity, all those high-throughput systems, the 99.9% of our national laboratory capacity, were sidelined when they were needed most.
Source: Silent Invasion by Dr. Deborah Birx
TESTING: Testing, Testing, Failures 1-2-3: Testing too little, too late, was our original sin in the response. When COVID got stuck in a flu model early on, testing simultaneously suffered. “We don’t really diagnose flu,” Birx pointed out. “When you come down with a flu-like ailment during flu season and you call your doctor, you’ll likely be prescribed flu treatment without a flu test. With COVID, the situation was not like flu- it was like HIV, with a large volume of asymptomatic people perpetuating the virus’s replication and spread. For that you needed to have testing.”
Within the first ten days of knowing the virus’s genetic sequence, the CDC sent out test kits it had developed. But they didn’t work. Although the WHO had developed a test before the CDC, one that many countries were using, the U.S. chose not to use it and instead waited for its own testing system to become established. But that really never happened. As Birx put it to me, “We let perfect be the enemy of the good.” Instead of pushing to an impossible “perfect,” and therefore getting nowhere, we should have accepted “good enough” and at least gotten somewhere. Many things worth doing are worth doing badly – even, and especially, in a pandemic.
Source: World War C by Sanjay Gupta, MD (2021)
THE NEED FOR A COMPREHENSIVE APPROACH: Each type of diagnostic test has an important role when we take the time to understand the context in which each can be optimally used. A comprehensive approach to pandemic planning will take into consideration the different kinds of test, how they should be best used, and when they can be made available after a new pathogen emerges. We didn’t have a deliberate strategy to deploy different layers of testing. What you need is an all-of-the-above approach that sets in motion a deliberate effort to build four layers of testing needed in a crisis. First are laboratory developed tests that can be deployed quickly to allow you to get initial tests into the field. Next are manufactured test kits that are based on PCR and can be run on high-throughput testing instruments and can allow high-volume testing at clinical laboratories. Third are point of care molecular tests that many doctors already have in their offices and can be updated to test for SARS-CoV-2. Finally, inexpensive antigen tests can also be used at the point of care or deployed to schools and workplaces, and eventually can be used as at-home tests.
These are the four layers of a resilient system. A plan to develop each of these testing platforms should have been under way from the start. The part of the system that got short shrift for a long time was the non-PCR tests. We rely far too much on lab-testing in this country. Government payers like Medicare favor lab-based tests over point-of-care diagnostics because they’re accustomed to paying for services. This has created a healthcare system that is biased against tests that can be put into the hands of consumer, which is precisely what’s needed in a pandemic. No one agency, or public health official, owned this challenge. We needed an all-of-the-above approach to get the four layers of testing into the market. We needed a coordinated response that deployed the right test to the right patient at the right time.
When antigen tests finally reached the market in large quantities, the federal government initially cornered the entire supply with no detailed plan on how to use them. They shipped most of these tests into nursing homes, following a strategy to focus resources on preventing infection in the vulnerable elderly. But nursing homes found the tests a poor fit for their needs. Many nursing homes worried that the antigen-based tests were not sensitive enough to screen an asymptomatic population and the tests would miss positive cases – a problem in a nursing home, where there are many vulnerable residents. If nursing homes used the tests to screen their staff, and then missed workers who might have asymptomatic infection and be able to spread the virus, the consequences could be grave. It was well established that many outbreaks in nursing homes were triggered by infected staff members who didn’t know they were shedding the virus. Thus, many of the antigen tests went unused. A federal survey found that about 30% of thirteen thousand facilities that were provided the rapid tests hadn’t used the equipment.
Multiple reports circulated of situations where nursing homes tested a patient with an antigen test, got a positive result, and then moved the patient into a COVID-only ward, believing the patient was infected. Then, they would find out on a subsequent PCR test that was run to confirm the result that the initial finding from the antigen test was a false positive. In the meantime, the patient had become infected with SARS-CoV-2 after being placed alongside COVID patients. The federal government had sent the antigen tests to the one place where they shouldn’t have been used – nursing homes. Not only did we have a shortage of tests; we didn’t use the tests we had in an appropriate manner. It was another measure of the disorganized state of testing in the U.S. and the lack of a comprehensive national strategy.
The lack of accessible testing would contribute to the excessive spread of SARS-CoV-2 and to the disproportionate burden borne by Americans who worked in lower-wage jobs, where they came into contact with the virus but had no way to use testing to avoid unknowingly bringing COVID into their homes. We had no way to diagnose actual infections, let alone intervene to prevent those who were contagious from passing the virus on to others. So, we had to apply our measures to mitigate spread of SARS-CoV-2 to the whole population, since we couldn’t identify those who were carrying the infection. The plan that we had drilled for always envisioned the CDC taking the central role in developing a test and following a very staged process in deploying it across the nation. The system failed to do so.
Source: Uncontrolled Spread by Scott Gottlieb, MD
THE ROLE OF TESTING: The question about the role of testing was fundamental. It wasn’t simply surveillance for the purpose of knowledge – testing was the key to a strategic policy. Testing was the main tool in the epidemiology toolbox, their only tool, really. In this pandemic, a positive test was a major driver of the policy of quarantining and isolating healthy people with low-risk profiles – shuttering businesses, closing schools – in short, a key to locking down the country. That’s why health policy experts like myself with a broader scope of expertise than that of epidemiologists and basic scientists are needed. Because no one with a medical science background who also considered the impacts of the policies was advising the White House.
There were serious reasons to test, important reasons to actually increase testing, but in a strategic way. The question was how to leverage that testing capability to have the most impact – to save the most lives and to facilitate reopening the country. I thought my approach was obvious. Let’s focus testing on where it really matters and increase it. High-risk environments, where high-risk people lived and worked. Nursing homes, a tinderbox of risk for its elderly, frail residents, were an obvious target. Knowing that cases were brought in by the staff, they needed to be tested and tested far more frequently, perhaps every day. I also pushed for more point-of-care tests in places independent-living seniors frequented, like senior centers, visiting nurses taking care of seniors at home; and historically Black colleges and universities (HBCUs), where high-risk faculty members were more concentrated.
The Fauci-Birx testing strategy was not merely unfocused; their strategy bizarrely prioritized more testing to the lowest-risk people and the lowest-risk environments – students and schools – while letting the deaths continue in nursing homes and assisted living facilities, where a once-per-week schedule was assumed to be effective. Testing, though, was the way – the only way- to find infected people who had no symptoms. In high-risk contagious people with asymptomatic infections would be critical to find, no doubt. But the goal, the rationale for testing, became a key point of confusion and disagreement. We knew who was at risk, so there were two alternatives: 1) indirectly protecting the “vulnerable” by confining and locking down everyone else, or 2) doing everything to protect high-risk people directly. By the time I set foot in the White House the nation had been using the Birx-Fauci lockdown restrictions – the indirect strategy – for months. Why was there no admission that the lockdown strategy did not work? It undeniably failed to protect the elderly.
I then added what was known but never mentioned inside the White House – a positive test using the PCR technique in place does not necessarily mean someone is contagious. That had been well established. Fragments of dead virus hang around and can generate a positive test for many weeks or months, even though one is not generally contagious after two weeks. Moreover, PCR is extremely sensitive. It detects minute quantities of virus that do not transmit infection. This was a hugely impactful problem – that PCR tests were the basis of defining cases, and the basis for quarantines, but most were misleading. Using a PCR “cycle” threshold of 35 – lower than the 37 to 40 cycles used routinely to detect the virus -- fewer than 3% of “positives” contain live, contagious virus as reported by Clinical Infectious Diseases. Even the New York Times wrote in August that 90% or more of positive PCR tests falsely implied that someone was contagious. Sadly, during my entire time at the White House, this crucial fact would never even be addressed by anyone other than me at the Task Force meetings.
POLITICS OVERTAKES TESTING: The Vice President looked around the long oval table and verified that everyone concurred. He clearly wanted to be sure he had heard all objections, which was understandable, since testing was a main focus of his Task Force, not to mention a barometer of his own achievement. Everyone – Birx, Fauci, Giroir, Redfield, and I – again agreed to the new set of guidelines. It was a solid document. Days later, the CDC posted its new testing guidance.
The reality of the Washington political world took over the story. The New York Times wrote: “Democrats, including Speaker Nancy Pelosi and two governors – Mr. Cuomo and Gavin Newsom of California – were outraged by the changes. Mr. Newson said California would not follow the new guidelines. Cuomo was quoted, “We’re not going to follow the CDC guidance. I consider it political propaganda.” It would have been comical if it weren’t also deadly serious. These people had zero knowledge yet were overtly defiant of the authorities they used to swear by – the CDC, Fauci, and Birx. To me it was truly insane, more than just an embarrassment indictment of the entire country. These politicians are our leaders? The people in charge of the United States of America? Many friends from abroad – Switzerland, France, even Brazil – emailed me, saying, “What the hell is wrong with the United States?
TESTING SUMMARY: It goes without saying that determining if someone is contagious is the fundamental reason for testing. The overwhelming majority of positive PCR tests, though, show virus fragments in people who are not contagious. This fact was widely known and reported in great detail in scientific studies as well as in newspapers. That meant that most tests, using the extremely sensitive techniques in place, were detecting dead virus or such minute quantities of virus that a positive test was worse than meaningless: it was mis-categorizing someone as contagious, thereby necessitating home confinement, isolation and even quarantining others around him. This pitfall – a sensitivity so high that the test was essentially detecting false positives – was widely known to every person closely following the pandemic. Yet, The White House Task Force doctors – Birx, Fauci, Giroir, Redfield – literally never discussed this critical error during the meetings I sat through in Washington.
What stunned and saddened me was the realization that the Task Force had not thought critically about the specifics of testing in this pandemic. This was all part of the puzzle of the Task Force doctors. There was a lack of scientific rigor in meetings I attended. I never saw them question the data. The striking uniformity of opinion by Birx, Fauci, Redfield, and Giroir was not anything I had seen in my career in academic medicine, and I took that as an absence of independent thought. And that’s not science.
Source: A Plague Upon Our House by Scott W. Atlas, MD
The unabbreviated version of the above can be found in the pdf document below.
CONTROLLING THE SPREAD -- DATA & TESTING – EXCERPTS
DATA
The Fictional Tale: The Pandemic fiasco started with a model developed by Neil Ferguson of the Imperial College of London which predicted that tens of millions of people would die due to the COVID – 19 infection. COVID – 19 was compared to the Spanish flu, which killed approximately 50 million people in 1918. Ferguson’s report stated that the only way to prevent massive deaths would be for the entire population of the planet to be locked down and for people to remain separated for 18 months until a vaccine was available.
Source: Covid Operation by Pamela A. Popper & Shane Prier (2020)
In 2002, Ferguson made his first highly publicized prediction. He suggested the mad cow disease might kill as many as 100,000 people in Britain, or 150,000 if it also proved to be transmissible from sheep to humans. Fewer than 180 Britons died. In 2005 he warned that an influenza called H5N1 could kill hundreds of millions of people. Only of 43 people died according to WHO.
On Monday, March 16, Imperial College publicly released the forecast that it previously shown only to policymakers. Over 2 million Americans and 500,000 would die in a matter of months if governments did not shut their countries immediately. The epidemic would peak quickly and sharply. By early June, about 50,000 Americans would die of Covid each day. Equally terrifying, an uncontrolled pandemic would case coronavirus patients to destroy the hospital system. Within a month, hospitals would be out of intensive care beds. By mid-May, more than two million Americans would need intensive care, more than 30 times the number of beds available.
Source: Pandemia by Alex Berenson (2021).
At the outset of the pandemic, Dr. Fauci used wildly inaccurate modeling that overestimated US deaths by 525%. Scammer and pandemic fabricator Neil Ferguson of Imperial College London was their author, with funding from the Bill & Melinda Fates Foundation of $148.8 million. Dr. Fauci used this model as justification for his lockdowns.
Source: The Real Anthony Fauci by Robert F. Kennedy, Jr. (2021)
CDC’S DATA SYSTEM: In the end, the flu bias in the CDC’s data system and the agency’s jurisdictional limitations exposed, once again, the rigidity in its thinking. The CDC had been fully funded for global health security and domestic health security since 2009. It had received millions upon millions of dollars in global health security funds every year for precisely the situation we were now in. They made decisions that resulted in the absence of a comprehensive national clinical and laboratory system. No one else is accountable for that.
From masks to tests to data collection to flu bias – the CDC made several very real and very consequential decisions that shaped the early months of the pandemic and are still shaping events today. To this day, the date is incomplete. Ultimately, the CDC’s greatest sin was not recognizing and acknowledging that it had sinned. Instead of fixing the issues, it hardened its belief that its approach was the best because they were the best. As difficult as it is for me to write this, it’s true that one of our nation’s finest medical/scientific institutions, one of the world’s leading public health entities, believed that the projections it had derived from its model of cases and hospitalizations were more accurate than the real, comprehensive data itself. This really stunned me. The same was true for vaccines and the durability of vaccine protection: we had to rely on the well-connected data from other countries to make decisions in this country, the United States, the country with the most advanced It and data collection capacity, which we could have tapped into from the private sector.
Source: Silent Invasion by Dr. Deborah Birx (2022).
CASE COUNTS, FATALITY RATES AND DEATHS REPORTED: Many presumed positive cases were being tabulated as positive cases when symptomatic people presented who had been to an area with high viral transmission. But the entire country was full of epidemiological spread, and it was still flu season. In the beginning, before testing was readily accessible, much of this predictive diagnostic criterion, was understandable, because it was better to be overly cautious and assume more people had the virus than not. However, by midsummer as cases were increasing across the U.S., according to the CDC, presumed positive cases were still being allowed into the official counts despite broader access to testing.
The incompetence continued, as not only were the cases being overinflated, but the number of tests being performed were as well. Antibody tests were being reported in addition to the PCR antigen tests when reporting how many tests were also being reported as new cases. If it was considered a positive case during the initial infection following an antigen test or even a presumed positive, and then it was again reported as a case by a later-obtained antibody test.
One important piece of information that became widely misused was from a report put forth by the CDC that stated only 6% of people who had reportedly died of COVID-19 had COVID-19 listed as their only cause of death on the death certificate. This tidbit of information immediately incited a conspiracy that most deaths being reported were not actually due to COVID-19, indicating the virus was not as deadly as portrayed, restrictions in place were for naught, and the pandemic was not what the government was telling people it was. People began rejecting the pandemic more than ever, claiming the death counts were grossly overestimated.
Source: Panic Attack by Nicole Saphier, MD (2021)
The CDC has done its part to ensure that as many deaths as possible are attributed to COVID – 19—even when it was not the actual cause of death. On March 2020 “The CDC issued new guidance that required doctors who complete death certificates to list COVID-19 on the certificate if it contributed to or caused the death. This was no different than what we did before. We are supposed to list all contributing causes. Then later in the fall of 2020, the CDC changed course dramatically, this time without bringing any attention to the new guidelines. “Without fanfare, the CDC acknowledged on another webpage that even if COVID was not listed by the doctor as the underlying cause of death, or the proximate cause of death, as long as it was listed as one contributing cause, it should be coded as the cause of death.” Indeed, the CDC website at the time of this writing reads “When COVID-19 is reported as a cause of death on the death certificate, it is coded and counted as the death due to COVID-19. All these machinations with the death certificates hide the fact that the death rate from COVID-19 for everyone except for those over 60 is significantly lower than the death rate for influenza.
Source: The Truth About COVID-19 by Dr. Joseph Mercola and Ronnie Cummins (2021)
Too often, Dr. Fauci was at the center of these systemic deceptions. The “mistakes” were always in the same direction – inflating the risks of coronavirus and the safety and efficacy of vaccines in order to stoke public fear of COVID and provoke mass compliance. The excuses for his mistakes ran from blaming the public (now blaming the unvaccinated), blaming politics, and explaining his gyrations by saying, “You’ve got to evolve with the science.” Dr. Fauci acquiesced to CDC’s selective protocol changes for completing death certificates in a way that inflated the claimed deaths from COVID, and thus inflated its infection morality rate.
Source: The Real Anthony Fauci by Robert F. Kennedy, Jr. 2021
WHITE HOUSE TASK FORCE AND DATA: At several COVID Huddles I showed charts documenting the true dates of cases. I took time to show the actual data, the discrepancies between trend shown by Birx and the accurate trends from Arizona, Florida, Texas, and elsewhere – a detailed analysis often provided by some outstanding analysts outside the government. These illustrated how the reported dates of deaths were at times tallying deaths from weeks or months prior. In turn, newly accurate assignment of dates changed the entire shape of the trend curve. That meant peaks on the charts were off by weeks, so if one designed a policy to the peak, or concluded an impact of a policy from the declines of a peak, it would be incorrect.
Source: A Plague Upon Our House by Scott W. Atlas, MD (2021)
TESTING
FAILURES FROM THE OUTSET: At least the Japanese had a reliable diagnostic test. The same could not be said for us. On the last day of January 2020, all seemed to be moving along nicely toward the development of a diagnostic tool that could be rolled out quickly and in large numbers. Over the first half of February though, it became clear that neither was true.
On February 8, we learned that contaminated testing materials had caused the test the federal agencies had created to result in false positives. This production issue was resolved, but the delay was costly. We should have been on the brink of having millions of test kits manufactured and shipped to the states. Now, rather than ensuring that those kits were deployed at the first sign of an outbreak, the CDC had to validate a new test. This general disregard for and mismanagement of testing, as compared with the rapid focus on vaccines at the NIH, would continue to haunt us throughout the spring and into the summer. We were no longer days behind; we were weeks behind. Early in a pandemic, days and sometimes even hours can be crucial. You are attempting to slow the spread before the curve become exponential. By the time the federal agencies had caught up to where they were before the testing debacle, they were actually 16 to 24 weeks behind the progress of the viral spread.
At precisely the moment when we needed to be testing widely to see where and how the virus was spreading, we were flying almost totally blind. Tests should have been broadly available; instead, they became a precious commodity. While the failure of the tests was deeply disturbing, I was also concerned about some of the decision making at the CDC. When the tests were designed back in January, they were built mainly for use and analysis by our country’s Public Health Laboratories and their often unique equipment. These labs are more like research facilities than diagnostic labs that patient would access. They are not high-throughput (i.e., fast-processing, high-volume) clinical or commercial labs. Worse, most have been significantly understaffed for decades. And yet, the CDC had created a test that could be processed only at these low-throughput facilities. In comparison to the higher-throughput, commercial labs, the CDC versions could process 50 to 100 samples every four hours, far less than the 500 to 1,000 samples every four hours processed at the clinical and private diagnostic labs. With the CDC limited to about 0.1% of the country’s laboratory capacity, all those high-throughput systems, the 99.9% of our national laboratory capacity, were sidelined when they were needed most.
Source: Silent Invasion by Dr. Deborah Birx
TESTING: Testing, Testing, Failures 1-2-3: Testing too little, too late, was our original sin in the response. When COVID got stuck in a flu model early on, testing simultaneously suffered. “We don’t really diagnose flu,” Birx pointed out. “When you come down with a flu-like ailment during flu season and you call your doctor, you’ll likely be prescribed flu treatment without a flu test. With COVID, the situation was not like flu- it was like HIV, with a large volume of asymptomatic people perpetuating the virus’s replication and spread. For that you needed to have testing.”
Within the first ten days of knowing the virus’s genetic sequence, the CDC sent out test kits it had developed. But they didn’t work. Although the WHO had developed a test before the CDC, one that many countries were using, the U.S. chose not to use it and instead waited for its own testing system to become established. But that really never happened. As Birx put it to me, “We let perfect be the enemy of the good.” Instead of pushing to an impossible “perfect,” and therefore getting nowhere, we should have accepted “good enough” and at least gotten somewhere. Many things worth doing are worth doing badly – even, and especially, in a pandemic.
Source: World War C by Sanjay Gupta, MD (2021)
THE NEED FOR A COMPREHENSIVE APPROACH: Each type of diagnostic test has an important role when we take the time to understand the context in which each can be optimally used. A comprehensive approach to pandemic planning will take into consideration the different kinds of test, how they should be best used, and when they can be made available after a new pathogen emerges. We didn’t have a deliberate strategy to deploy different layers of testing. What you need is an all-of-the-above approach that sets in motion a deliberate effort to build four layers of testing needed in a crisis. First are laboratory developed tests that can be deployed quickly to allow you to get initial tests into the field. Next are manufactured test kits that are based on PCR and can be run on high-throughput testing instruments and can allow high-volume testing at clinical laboratories. Third are point of care molecular tests that many doctors already have in their offices and can be updated to test for SARS-CoV-2. Finally, inexpensive antigen tests can also be used at the point of care or deployed to schools and workplaces, and eventually can be used as at-home tests.
These are the four layers of a resilient system. A plan to develop each of these testing platforms should have been under way from the start. The part of the system that got short shrift for a long time was the non-PCR tests. We rely far too much on lab-testing in this country. Government payers like Medicare favor lab-based tests over point-of-care diagnostics because they’re accustomed to paying for services. This has created a healthcare system that is biased against tests that can be put into the hands of consumer, which is precisely what’s needed in a pandemic. No one agency, or public health official, owned this challenge. We needed an all-of-the-above approach to get the four layers of testing into the market. We needed a coordinated response that deployed the right test to the right patient at the right time.
When antigen tests finally reached the market in large quantities, the federal government initially cornered the entire supply with no detailed plan on how to use them. They shipped most of these tests into nursing homes, following a strategy to focus resources on preventing infection in the vulnerable elderly. But nursing homes found the tests a poor fit for their needs. Many nursing homes worried that the antigen-based tests were not sensitive enough to screen an asymptomatic population and the tests would miss positive cases – a problem in a nursing home, where there are many vulnerable residents. If nursing homes used the tests to screen their staff, and then missed workers who might have asymptomatic infection and be able to spread the virus, the consequences could be grave. It was well established that many outbreaks in nursing homes were triggered by infected staff members who didn’t know they were shedding the virus. Thus, many of the antigen tests went unused. A federal survey found that about 30% of thirteen thousand facilities that were provided the rapid tests hadn’t used the equipment.
Multiple reports circulated of situations where nursing homes tested a patient with an antigen test, got a positive result, and then moved the patient into a COVID-only ward, believing the patient was infected. Then, they would find out on a subsequent PCR test that was run to confirm the result that the initial finding from the antigen test was a false positive. In the meantime, the patient had become infected with SARS-CoV-2 after being placed alongside COVID patients. The federal government had sent the antigen tests to the one place where they shouldn’t have been used – nursing homes. Not only did we have a shortage of tests; we didn’t use the tests we had in an appropriate manner. It was another measure of the disorganized state of testing in the U.S. and the lack of a comprehensive national strategy.
The lack of accessible testing would contribute to the excessive spread of SARS-CoV-2 and to the disproportionate burden borne by Americans who worked in lower-wage jobs, where they came into contact with the virus but had no way to use testing to avoid unknowingly bringing COVID into their homes. We had no way to diagnose actual infections, let alone intervene to prevent those who were contagious from passing the virus on to others. So, we had to apply our measures to mitigate spread of SARS-CoV-2 to the whole population, since we couldn’t identify those who were carrying the infection. The plan that we had drilled for always envisioned the CDC taking the central role in developing a test and following a very staged process in deploying it across the nation. The system failed to do so.
Source: Uncontrolled Spread by Scott Gottlieb, MD
THE ROLE OF TESTING: The question about the role of testing was fundamental. It wasn’t simply surveillance for the purpose of knowledge – testing was the key to a strategic policy. Testing was the main tool in the epidemiology toolbox, their only tool, really. In this pandemic, a positive test was a major driver of the policy of quarantining and isolating healthy people with low-risk profiles – shuttering businesses, closing schools – in short, a key to locking down the country. That’s why health policy experts like myself with a broader scope of expertise than that of epidemiologists and basic scientists are needed. Because no one with a medical science background who also considered the impacts of the policies was advising the White House.
There were serious reasons to test, important reasons to actually increase testing, but in a strategic way. The question was how to leverage that testing capability to have the most impact – to save the most lives and to facilitate reopening the country. I thought my approach was obvious. Let’s focus testing on where it really matters and increase it. High-risk environments, where high-risk people lived and worked. Nursing homes, a tinderbox of risk for its elderly, frail residents, were an obvious target. Knowing that cases were brought in by the staff, they needed to be tested and tested far more frequently, perhaps every day. I also pushed for more point-of-care tests in places independent-living seniors frequented, like senior centers, visiting nurses taking care of seniors at home; and historically Black colleges and universities (HBCUs), where high-risk faculty members were more concentrated.
The Fauci-Birx testing strategy was not merely unfocused; their strategy bizarrely prioritized more testing to the lowest-risk people and the lowest-risk environments – students and schools – while letting the deaths continue in nursing homes and assisted living facilities, where a once-per-week schedule was assumed to be effective. Testing, though, was the way – the only way- to find infected people who had no symptoms. In high-risk contagious people with asymptomatic infections would be critical to find, no doubt. But the goal, the rationale for testing, became a key point of confusion and disagreement. We knew who was at risk, so there were two alternatives: 1) indirectly protecting the “vulnerable” by confining and locking down everyone else, or 2) doing everything to protect high-risk people directly. By the time I set foot in the White House the nation had been using the Birx-Fauci lockdown restrictions – the indirect strategy – for months. Why was there no admission that the lockdown strategy did not work? It undeniably failed to protect the elderly.
I then added what was known but never mentioned inside the White House – a positive test using the PCR technique in place does not necessarily mean someone is contagious. That had been well established. Fragments of dead virus hang around and can generate a positive test for many weeks or months, even though one is not generally contagious after two weeks. Moreover, PCR is extremely sensitive. It detects minute quantities of virus that do not transmit infection. This was a hugely impactful problem – that PCR tests were the basis of defining cases, and the basis for quarantines, but most were misleading. Using a PCR “cycle” threshold of 35 – lower than the 37 to 40 cycles used routinely to detect the virus -- fewer than 3% of “positives” contain live, contagious virus as reported by Clinical Infectious Diseases. Even the New York Times wrote in August that 90% or more of positive PCR tests falsely implied that someone was contagious. Sadly, during my entire time at the White House, this crucial fact would never even be addressed by anyone other than me at the Task Force meetings.
POLITICS OVERTAKES TESTING: The Vice President looked around the long oval table and verified that everyone concurred. He clearly wanted to be sure he had heard all objections, which was understandable, since testing was a main focus of his Task Force, not to mention a barometer of his own achievement. Everyone – Birx, Fauci, Giroir, Redfield, and I – again agreed to the new set of guidelines. It was a solid document. Days later, the CDC posted its new testing guidance.
The reality of the Washington political world took over the story. The New York Times wrote: “Democrats, including Speaker Nancy Pelosi and two governors – Mr. Cuomo and Gavin Newsom of California – were outraged by the changes. Mr. Newson said California would not follow the new guidelines. Cuomo was quoted, “We’re not going to follow the CDC guidance. I consider it political propaganda.” It would have been comical if it weren’t also deadly serious. These people had zero knowledge yet were overtly defiant of the authorities they used to swear by – the CDC, Fauci, and Birx. To me it was truly insane, more than just an embarrassment indictment of the entire country. These politicians are our leaders? The people in charge of the United States of America? Many friends from abroad – Switzerland, France, even Brazil – emailed me, saying, “What the hell is wrong with the United States?
TESTING SUMMARY: It goes without saying that determining if someone is contagious is the fundamental reason for testing. The overwhelming majority of positive PCR tests, though, show virus fragments in people who are not contagious. This fact was widely known and reported in great detail in scientific studies as well as in newspapers. That meant that most tests, using the extremely sensitive techniques in place, were detecting dead virus or such minute quantities of virus that a positive test was worse than meaningless: it was mis-categorizing someone as contagious, thereby necessitating home confinement, isolation and even quarantining others around him. This pitfall – a sensitivity so high that the test was essentially detecting false positives – was widely known to every person closely following the pandemic. Yet, The White House Task Force doctors – Birx, Fauci, Giroir, Redfield – literally never discussed this critical error during the meetings I sat through in Washington.
What stunned and saddened me was the realization that the Task Force had not thought critically about the specifics of testing in this pandemic. This was all part of the puzzle of the Task Force doctors. There was a lack of scientific rigor in meetings I attended. I never saw them question the data. The striking uniformity of opinion by Birx, Fauci, Redfield, and Giroir was not anything I had seen in my career in academic medicine, and I took that as an absence of independent thought. And that’s not science.
Source: A Plague Upon Our House by Scott W. Atlas, MD
The unabbreviated version of the above can be found in the pdf document below.
| covid_6l_data_--_segment_6.pdf |