Friday, April 07, 2023

Dr. Redfield’s Bombshell Testimony

Robert W Malone

Yesterday, we witnessed the ex-director of the Centers for Disease Control (CDC), under oath, directly blame Dr. Fauci and the U.S. government for the deaths of millions of people.

However, if you went to the headlines of Google News—there was nary a news story. I guess Google felt it wasn’t important enough to warrant above-the-fold status

The actual testimony of Redfield was explosive. Yet none of these headlines belie the gravity of Redfield’s testimony. Redfield directly linked gain-of-function research and the creation of SARS-CoV-WIV to Fauci, and to the U.S. government—including the Department of Defense (DOD). He absolutely believes and gives sworn testimony to the effect that Fauci and Jeremy Farrar, director of the Wellcome Trust and soon be the chief scientist at the World Health Organization, covered up the lab leak information. Redfield himself was excluded from the meetings when the processes, strategy, and tactics for covering up the lab leak were developed.

This winter, we had a high-level federal employee on the farm. He/she came to me anonymously to express concerns about what had happened in the execution of this corrupt and failed public health response, and in particular to how the vaccines were developed and implemented. She/he discussed how all of the high-level meetings on the clinical trials, the safety of the vaccine, and the public health response, were all done under complete secrecy. Recorders were turned off, plus cell phones and computers were not allowed in the meetings. So there are literally NO RECORDS of these meetings.

This person believes that finding evidence of the malfeasance in the meeting minutes or recordings is going to be difficult. So when the New York Times headliner (above) cynically states that the Republicans lack a “smoking gun,” I believe they know damn well why. The New York Times reporting and editorial staff are many things, but they are not stupid.

But here is the thing, I do speak to people working on these issues in Congress. I have been told that the federal government has a large paper trail that documents the corruption over the past three years.

Written Statement of Dr Robert Redfield Before the House Select Subcommittee on the Coronavirus Crisis. March 8, 2023

Chairman Wenstrup, Ranking Member Ruiz, and members of the Committee, my name is Dr. Robert Redfield. I am pleased to testify today in support of this subcommittee’s important work—to investigate the origin of the COVID-19 virus that resulted in the deaths of over one million Americans.

As I know this Committee is aware, from 2018-2021 I served as the 18th Director of the Centers for Disease Control and Prevention during the Trump administration. As CDC Director, I oversaw the agency’s response to the COVID-19 pandemic from the earliest days of its spread and served as a member of the White House’s Coronavirus Task Force.

But perhaps more relevant to the purpose of this hearing, my 45 years in medicine has been focused on the study of viruses. I am a virologist by training and practice. Prior to my time at the CDC, I spent more than 20 years as a U.S. Army physician and medical researcher at the Walter Reed Army Institute of Research where I served as the Chief of the Department of Retroviral Research and worked in virology, immunology, and clinical research at the forefront of the AIDS epidemic and other viral threats. In 1996, I co-founded the Institute of Human Virology at the University of Maryland School of Medicine in partnership with the State of Maryland, the City of Baltimore, and the University System of Maryland where I served as the Director of Clinical Care and Research and also served as a tenured professor of medicine, microbiology and immunology; chief of infectious disease; and vice chair of medicine at the University of Maryland School of Medicine. After my time at CDC, I served as the senior public health advisor to Governor Hogan and the State of Maryland.

As COVID-19 began to spread across the world, there were two competing hypotheses about the virus’s origin that needed to be vigorously explored. The first hypothesis is the possibility that COVID-19 infections in humans were the result of a “spillover event” from nature. This is a situation in which a virus naturally mutates and becomes transmissible from one species to another—in this case, from bats to humans via an intermittent species. This is what happened in previous outbreaks of SARS and MERS, earlier coronaviruses that emerged from bats and spread through an intermediate animal. The second hypothesis is the possibility that the virus evolved in a lab involved in gain-of-function research. This is a type of research in 2 which scientists seek to increase the transmissibility and or pathogenicity of an organism in order to better understanding the organism and inform preparedness efforts and the development of countermeasures such as therapeutics and vaccines. Under this theory, COVID-19 infected the general population after it was accidentally leaked from a lab in China.

From the earliest days of the pandemic, my view was that both theories about the origin of COVID-19 needed to be aggressively and thoroughly examined. Based on my initial analysis of the data, I came to believe—and still believe today—that it indicates COVID-19 infections more likely were the result of an accidental lab leak than the result of a natural spillover event. This conclusion is based primarily on the biology of the virus itself, including its rapid high infectivity for human to human transmission which would then predict rapid evolution of new variants, as well as a number of other important factors to include the unusual actions in and around Wuhan in the fall of 2019, all of which I am happy to discuss today.

Even given the information that has surfaced in the three years since the COVID-19 pandemic began, some have contended that there is no point in investigating the origins of this virus. I strongly disagree. There is a global need to know what we are dealing with in the COVID-19 virus because it affects how we approach the problem to try and prevent the next pandemic.

Understanding the origins of COVID-19 is critical for the future of scientific research, particularly as it affects the ongoing ethical debate around the conduct of gain-of-function research. Gain-of-function has long been controversial within the scientific community, and, in my opinion, the COVID-19 pandemic presents a case study on the potential dangers of such research. While many believe that gain-of-function research is critical to get ahead of viruses by developing vaccines, in this case, I believe it had the exact opposite result, unleashing a new virus on the world without any means of stopping it and resulting in the deaths of millions of people. Because of this, it is my opinion that we should call for a moratorium on all gain-of-function research until we can have a broader debate and come to a consensus as a community about the value of gain-of-function research. This debate should not be limited to the scientific community. If the decision is to continue gain-of-function research then it must be determined how and where to conduct this research in a safe, responsible and effective way.

Thank you again for inviting me to be here today as we explore these important topics. I look forward to answering your questions.


Omicron BA.5 Overpowers China’s Vaccines in Study: After 3 Months Sinopharm Useless Against Transmission

Researchers affiliated with Chinese academic medical centers including the University of Hong Kong, Xinjiang Medical University, Capital Medical University and the Urumqi Center for Disease Control and Prevention led by Shi Zhao, Ph.D., and Yaoqin Lu, Ph.D. sought out to better understand the transmission characteristics of SARS-CoV-2 Omicron BA.5 variants and whether inactivated vaccines used in China associated with a protective outcome against the transmission of these COVID-19 variants.

Designing a cohort observational study involving 1139 participants with COVID-19, the authors report that despite significant levels of contact tracing, high vaccination rates and other intensive control measures employed in Mainland China, Omicron BA.5 variants represent a high risk for transmission in household settings across all age cohorts.

When comparing persons vaccinated with a 2-dose inactivated vaccine versus those with primary series and a booster dose, the latter is associated with a more protective outcome against Omicron BA.5 transmission. While Omicron BA.5 represents a highly transmissible pathogen, the combination of vaccine and nonpharmaceutical interventions may be linked to some reduced transmission.

But the takeaway was stark. After three months, the authors found the vaccines afford absolutely no protection against transmission. 90.7% of infected cases were asymptomatic, demonstrating how mild COVID-19 has actually become—at least, for purposes of this study in this city of over 4 million in China’s far northwest.

Published recently in JAMA Network, this study was conducted in Urumqi, the capital of the Xinjiang Uyghur Autonomous Region in the far northwest of China. BA.5 was in heavy circulation during the time of this study—an outbreak in the region from August 7 to September 7, 2022. The study occurred before China dropped its zero-tolerance policy. The investigators sought out to evaluate the transmission characteristics of this particular transmissible form of Omicron known as BA.5 as well as the overall effectiveness of the Chinese inactivated vaccines, centering on BBIBP-CorV (Sinopharm) against transmission of the virus.

The study

In this observational study known as a cohort study, the investigators embraced data from an Omicron-seeded COVID-19 outbreak in Urumqi during August 7 to September 7, 2022. Study participants had to have confirmed SARS-CoV-2 infections along with their close contacts so that the team could compare a booster dose to 2 doses of inactivated vaccine along with identified risk factors.

The study design factored in a range of data from demographic characteristics and timeline records from exposure to laboratory testing outcomes to contact tracing history and contact setting. The study team used models to estimate mean and variance of key time-to-event intervals of transmission. Categorizing and analyzing various disease-control measures across a variety of contact settings, the study team analyzed transmission risks and contact patterns. Employing use of multivariate logistic regression models, Zhao, Lu and colleagues estimated the effectiveness of the Chinese inactivated vaccines with a prime focus on Sinopharm.

What were the findings?

The study included 1139 people diagnosed with COVID-19 as reported by the authors in JAMA Network. 630 (55.3%) of the total were females while the mean [SD] age, 37.4 [19.9] years) and 51?323 close contacts who tested negative for COVID-19 (26?299 females [51.2%]; mean [SD] age, 38.4 [16.0] years), the means of generation interval, viral shedding period, and incubation period were estimated at 2.8 days (95% credible interval [CrI], 2.4-3.5 days), 6.7 days (95% CrI, 6.4-7.1 days), and 5.7 days (95% CrI, 4.8-6.6 days), respectively.

Zhao, Lu and colleagues wrote in JAMA Network that rigorous contact tracking, intensive control measures and nearly universal vaccination (86% received ≥2 doses of vaccine) in this region 980 persons were recorded with infections. The authors report, “High transmission risks were found in household settings (secondary attack rate, 14.7%; 95% CrI, 13.0%-16.5%) and younger (aged 0-15 years; secondary attack rate, 2.5%; 95% CrI, 1.9%-3.1%) and older age (aged >65 years; secondary attack rate, 2.2%; 95% CrI, 1.5%-3.0%) groups.”

The authors report a vaccine effectiveness rate against Omicron BA.5 booster dose vs. two doses at 28.9% (95% CrI, 7.7%-45.2%) and 48.5% (95% CrI, 23.9%-61.4%) for 15-90 days after booster dose. A troubling report—“no protective outcome was detected beyond 90 days after the booster dose.” Thus, the inactivated vaccines used in China against COVID-19 are essentially worthless after three months.

While the booster provided some protection it wasn’t that robust, meaning that Omicron BA. 5 spread rapidly even among vaccinated persons in households. Past three months the vaccine afforded no protection against transmission.


The study authors acknowledge a number of limitations.

Recall bias and underreporting during contact tracing may impact accuracy of identified transmission pairs, thus biasing the GI estimates

Vaccine effectiveness rates may not be generalizable to other vaccines, such as mRNA vaccines

7% of SARS-CoV-2 infections asymptomatic—this means that the findings may not be extendable to persons who are infected with severe COVID-19.




Thursday, April 06, 2023

Is the cost of living leap caused by excessive government spending?

It is conventional economics to say it is. If a government prints a lot of new money to finance a big increase in their spending, it must devalue each individual dollar. There will be more dollars chasing the same amount of goods and services so prices must go up to ration out the available goods and services. It's pretty simple logic.

But Leftists don't like that logic. They like to think that governments can spend as much as they like as long it is in a good cause. They just ignore the economics of the matter.

But a prominent Leftist economist has come to their rescue. Joseph Stiglitz is a Nobel prize winner and one of the many Jews who support Leftist causes.

I am referring to an academic article under the title "The Causes of and Responses to Today’s Inflation". It is here:

In it, economists Joseph E. Stiglitz and Ira Regmi argue that excessive government spending is NOT the cause of our current inflation. It is dated December 2022 so there should have been some critique of it by now but I can find none. So I thought I might note what I think is a basic problem with it.

For a start, nobody disputes that cost-push factors have had a significant role. Government lockdowns greatly disrupted supply chains and thus drove up shortage-driven prices. And the sanctions in response to Vladimir Putin's war were a further huge supply chain limitation.

But was that all that there was to it? Stiglitz & Co. say it was and they justify that by saying that consumption during the the recent inflationary period has not been high. They say: "Real personal consumption, even after recovering from the depths of the pandemic, was only slightly above trend and not commensurate with the level of inflation seen during the same time."

He is here using absolutes rather than relativities. The demand might have been subdued in absolute terms but that fails to take account of the already mentioned supply deficiencies and their price consequences. That demand remained at or a bit above previous levels DESPITE the higher prices and poor availability of some goods, shows that cost push pressures were not the only influence at work. We also have to look at people's RESPONSE to the cost push pressures. And when we do that we see that demand was in fact high in the circumstances. And what pressure kept that demand surprisingly high? Demand pull, that good old profligate government spending and its usual effect of creating high demand

Stiglitz tries to get government spending off the hook as a cause of inflation but we see that government spending did have an expansionary effect on demand if we look at demand in context.


COVID-19 Vaccine Injured: Left Alone, in Often, Dire Declining Health, Mounting Debt & Absolutely No Help from Government

Most recently, KOMO News, a Seattle-based ABC Television affiliate owned by Sinclair Broadcast Group, one of the largest and most diversified broadcast companies in America, drills into this crisis, covering some of the devastating challenges faced by individuals identified as COVID-19 vaccine injured. From debilitating injuries to mounting debt and the specter of bankruptcy, the government offers no real help.

Introducing local case stories of patients injured in the Pacific Northwest region and beyond, Brooke Conrad with the National Desk reports that out of 12,000 COVID-19 vaccine-related injury or death-related claims with the U.S. government under its horribly broken Countermeasures Injury Compensation Program (CICP), absolutely none have been compensated for as of March 1, 2023, while 23 have been deemed eligible for compensation but not paid. The reporter reminds the reader that 300 have been denied claims associated with the dysfunctional vaccine injury scheme used during the national public health emergency.

As TrialSite has reported since early in the pandemic, the Public Readiness and Emergency Preparedness Act (PREP Act) offers industry and the vaccine administration supply chain near universal immunity except for some extremely difficult-to-prove exceptions. It turns out, industry refused to develop vaccines unless elected officials years ago voted to include universal liability waivers.

So, despite the acceleration of novel mRNA and viral vector technology and the government’s absolute protection of industry, the only thing protecting consumers is the “deeply flawed” CICP, and the track record is awful. Conrad reports that from 2010 through 2021, the program only compensated 6% of all non-COVID-related claims, or 29 out of 491 claims totaling $6 million in payouts. Most of the claims involved the H1N1 vaccine.

Summarizing the program’s impact is Renee Gentry, Director of the Vaccine Injury Litigation Clinic at George Washington University Law School:

“The countermeasures program is basically a black hole. It’s your right to file and lose. I don't think it was ever anticipated to handle the number of vaccinations that have happened under COVID.”

Select COVID-19 vaccine injured stories

The recent piece from the mainstream media introduces a handful of COVID-19 vaccine injury stories such as Steve Wenger, who eventually became paralyzed from the waist down for a time from the Johnson & Johnson COVID-19 vaccine. Mr. Wenger now finds himself deep in a financial hole due to the circumstances. Only very expensive IVIg infusions twice per month plus Rituximab every six months has helped.

Another person injured by the Johnson & Johnson COVID-19 vaccine was introduced--Michelle Zimmerman. Vaccinated in March 2021, Zimmerman experienced severe pain shooting down her arm just five minutes after the jab. Her tongue and throat swelled up for about 20 minutes leading to a “harrowing cascade of other adverse events.” This COVID-19 vaccine-injured patient was ultimately diagnosed with hypoxic-ischemic encephalopathy (brain damage triggered by lack of oxygen or blood flow).

Facing mounting financial losses, over $400,000 as insurance repeatedly declined to cover many of her clinic visits, a combination of lost wages have led her parents, who were supposed to retire, to continue working to support their daughter. While Zimmerman filed a CICP compensation case in October 2021, she wasn’t assigned a case number until January 2023, when she received ongoing conflicting messages from CICP.

TrialSite has supported COVID-19 vaccine-injured group React19, the largest COVID-19 patient advocacy group in the United States if not the world. With over 20,000 identified members, Chris Dreisbach heads up the organization’s lead affairs department.

Himself injured by the Pfizer vaccine in March 2021, he since then struggled with a diagnosis including chronic inflammatory demyelinating polyneuritis which has led to involuntary muscle spasms, modified gait, back pain and a headache disorder called occipital neuralgia not to mention brain fog and electrical pulses from head to toe.

The React19 legal counsel went on the record with Ms. Conrad: “Without having their experts’ fees paid, the COVID vaccine-injured hands are absolutely tied behind their backs.” He concluded, “These cases often come down to the battle of the experts.”

On the prospect of CICP and its standard of proof to secure vaccine injury award—difficult to say the least, what with so much research still left essentially leading to that conflict among the experts. But the highly funded certainly have the advantage.

In another case covered by Conrad, just 30 minutes after Cody Flint received his Pfizer mRNA COVID-19 vaccine, the pilot experienced debilitating pain in the form of a “severe, stabbing headache.” Just two days later, Flint, who flies crop dusting missions, nearly blacked out in the air! He underwent two ear surgeries, and his physician has gone on the record that the injuries are likely linked to the COVID-19 vaccine. With no insurance at the time, Flint faces a mountain of debt.

Devoid of humanity

Flint’s claim was ultimately denied. Along the way, he provided testimony—at the year mark awaiting determination from CICP. His case was discussed during a Senate Appropriations subcommittee hearing: Sen. Cindy Hyde-Smith, R-MISS directly addressed the matter with Biden administration Health and Human Services Secretary Xavier Becerra, asking:

“Can you tell me what you’re going to do to address the thousands of claims currently in the backlog at HHS, and what you are doing to improve the transparency of the CICP process so that Americans like Mr. Flint are properly compensated in a reasonable time period?”

The response speaks for itself, as Becerra switched the topic, avoiding the issue at hand, declaring lots of Americans suffer from long COVID, and that fraudsters are misappropriating money designated for COVID-19 purposes. The Biden HHS head expressed absolutely no empathy, no real humanity—just a bureaucrat protecting the program despite the reality of his agency’s mission statement:

“The mission of the Department of Health and Human Services (HHS) is to enhance the health and well-being of all Americans, by providing for effective health and human services and by fostering sound, sustained advances in the sciences underlying medicine, public health and social services.”

Targeted transition

As reported by KOMO News a movement grows to push for the COVID-19 vaccines to be transferred from CICP to the primary vaccine injury program known as the National Vaccine Injury Compensation Program or “VICP.” Operating via a court process rather than an administrative one, VICP covers much of the routine scheduled vaccines reports Conrad. While compensation claim success is certainly higher than CICP, critics lament that VICP is a horribly broken system as well.

But with no real options COVID-19 vaccine injured advocates push on that something is better than nothing. For example, from 2006 to 2021, Conrad states that the program compensated almost three-quarters of all adjudicated petitions (7,418 out of 10,342) paying out about $4.9 billion since the program onset in 1988.

The largest COVID-19 vaccine injured organization network, React19 provides a breakdown comparison of the two programs.

KOMO News reports three “hurdles” faced by advocates that seek to transfer the COVID-19 vaccine injured from CICP to VICP, including 1) vaccine placed on routine CDC recommended schedule (this has been cleared), 2) Congress must pass an excise tax to fund the compensation program and 3) the standing Secretary of Health and Human Services needs to add the COVID-19 vaccines to the Vaccine Injury Table, delineating both injuries and conditions associated with the vaccines.




Wednesday, April 05, 2023

Risk Factors Associated With Post−COVID-19 Condition: A Systematic Review and Meta-analysis

Vasiliki Tsampasian, et al.

Yikes! Big study in a major medical journal shows that vaccination gave you virtually no protection against long Covid: Tiny OR of 0.57


Importance Post−COVID-19 condition (PCC) is a complex heterogeneous disorder that has affected the lives of millions of people globally. Identification of potential risk factors to better understand who is at risk of developing PCC is important because it would allow for early and appropriate clinical support.

Objective To evaluate the demographic characteristics and comorbidities that have been found to be associated with an increased risk of developing PCC.

Data sources Medline and Embase databases were systematically searched from inception to December 5, 2022.

Study Selection The meta-analysis included all published studies that investigated the risk factors and/or predictors of PCC in adult (≥18 years) patients.

Data Extraction and Synthesis Odds ratios (ORs) for each risk factor were pooled from the selected studies. For each potential risk factor, the random-effects model was used to compare the risk of developing PCC between individuals with and without the risk factor. Data analyses were performed from December 5, 2022, to February 10, 2023.

Main Outcomes and Measures The risk factors for PCC included patient age; sex; body mass index, calculated as weight in kilograms divided by height in meters squared; smoking status; comorbidities, including anxiety and/or depression, asthma, chronic kidney disease, chronic obstructive pulmonary disease, diabetes, immunosuppression, and ischemic heart disease; previous hospitalization or ICU (intensive care unit) admission with COVID-19; and previous vaccination against COVID-19.

Results The initial search yielded 5334 records of which 255 articles underwent full-text evaluation, which identified 41 articles and a total of 860 783 patients that were included. The findings of the meta-analysis showed that female sex (OR, 1.56; 95% CI, 1.41-1.73), age (OR, 1.21; 95% CI, 1.11-1.33), high BMI (OR, 1.15; 95% CI, 1.08-1.23), and smoking (OR, 1.10; 95% CI, 1.07-1.13) were associated with an increased risk of developing PCC. In addition, the presence of comorbidities and previous hospitalization or ICU admission were found to be associated with high risk of PCC (OR, 2.48; 95% CI, 1.97-3.13 and OR, 2.37; 95% CI, 2.18-2.56, respectively). Patients who had been vaccinated against COVID-19 with 2 doses had a significantly lower risk of developing PCC compared with patients who were not vaccinated (OR, 0.57; 95% CI, 0.43-0.76).

Conclusions and Relevance This systematic review and meta-analysis demonstrated that certain demographic characteristics (eg, age and sex), comorbidities, and severe COVID-19 were associated with an increased risk of PCC, whereas vaccination had a protective role against developing PCC sequelae. These findings may enable a better understanding of who may develop PCC and provide additional evidence for the benefits of vaccination.


Does NIH’s RECOVER Trial Planning (long COVID) Deviate from Emerging Science?

While the community of long COVID patients were supportive of the National Institutes of Health (NIH) RECOVER (Researching COVID to Enhance Recovery) initiative with an aim of finding effective treatments for the condition, patient communities have been actively challenging the NIH on approach.

With a recent petition from an organization Long COVID Justice and multiple letters sent by Santa Monica, CA-based #MEAction USA, long COVID patient advocates are concerned about the extensive levels of exercise trials involved in the program, a problematic issue given emerging scientific evidence suggesting a large percentage of the long COVID cohort struggles with “post-exertional malaise” (PEM). Long COVID patient advocates are rightly concerned. Involving a worsening of symptoms from fatigue to difficulty regulating body temperature and cognitive dysfunction after even a light exercise session, the long COVID patient advocacy groups point out a significant delta between the reality of this common condition associated with long COVID and imminent NIH study protocols that introduce the potential for outright danger to the participants at least in some cases.

In reality, the critics are pointing out the possibly detached nature of clinical research planning at the NIH and academic medical center partners—a delta between the academic researchers’ assumptions and the real-world conditions, needs and demands on the ground.

What is the RECOVER initiative?

As TrialSite has chronicled, the RECOVER initiative was announced by the NIH in early 2021. The program was made possible by a Congressional injection of $1.15 billion for over four years to the NIH to support research into the prolonged health consequences of SARS-CoV-2 infection, announced the NIH’s director at the time.

The NIH organized a team of mostly academic-based researchers to identify the most pressing research questions plus areas of what they deemed greatest opportunity to address what the NIH identifies as an emerging public health propriety.

The research first started with the “NIH PASC Initiative” in a bid to learn more about how COVID-19 may lead to widespread and lasting symptoms in addition to developing ways to treat or even prevent such symptoms.

Out of the total funding from U.S. Congress, $172 million has been allocated to conduct clinical trials at Duke Clinical Research Institute. The NIH wasn’t forthright with the journal Nature as to how much of those funds would be used to fund exercise trials.

A real problem

Fast forward a couple of years, and the problems have only worsened. Recently, Rachel Fairbank addressed this matter in a recent entry in the journal Nature. Introducing that up to 23 million people in America alone struggle in one way or another with long COVID, TrialSite has chronicled that across multiple populations the rate appears to range from 10% to as high as 30% during different periods of the pandemic. According to one report associated with an analysis of long COVID workers’ compensation claims in the State of New York between January 1, 2022 and March 31, 2022, 18% of persons with long COVID have yet to return to work over a year after recovering from COVID-19.

What’s the issue?

At least some of the long COVID clinical trial protocols developed by the NIH as part of RECOVER involve extensive exercise as part of the study. Yet given the incidence of PEM, patient advocates have heightened concern that long COVID trial participants won’t be appropriately informed about possible risks, nor will the participants be properly screened for PEM nor will the monitoring be adequately directed to monitor patients for the harm that too much exercise can introduce.

Succinctly summarizing the issue, Lisa McCorkell, a co-founder of the Patient-Led Research Collaborative for long COVID, a Washington D.C.-based research and advocacy group calls the whole problem out:

“In a world where there’s hundreds of things to trial, why are we choosing this one thing that we know has the potential to cause harm to a substantial portion of patients?”

What’s RECOVER’s response?

According to the recent piece in Nature, Duke Clinical Research Institute serves as the RECOVER Clinical Trials Data Coordinating Center, sending a statement to Nature on behalf of the NIH declaring, “Trials being planned for RECOVER — which stands for Researching COVID to Enhance Recovery — have not yet launched and that the agency is working with patient representatives in shaping the exercise trial protocol.”

Interestingly, while the communication assured the journalist that the study investigators are in fact, meeting with the long COVID patient representatives to discuss the matters raised in the letters and petition, the NIH failed to make any such representatives available to the prominent publication for an interview in time for the published entry. The full protocols for RECOVER research studies haven’t been reviewed by an institutional review board meaning no research has commenced. Only after that point will the NIH share the protocol which is strange—this is a publicly funded research affair. Why the secrecy?


W.H.O. Do You Trust?


Trust in public health has been shattered—half of America has lost faith in the scientific community altogether. Apparently blind to that loss of trust and the urgent need for transparency, our current government is doubling down on World Health Organization (WHO) decrees that directly circumvent public oversight.

The WHO has drafted a new global Pandemic Accord. Before seeing anything final in what will be legally binding, the U.S. ambassador to the WHO, Pamela Hamamoto, on February 27 imprudently promised “The United States is committed to the Pandemic Accord.”

This comes immediately after the exposure of yet another disgrace undermining trust in public health institutions. It turned out the February 2020 Lancet article calling the lab origin of the SARS-CoV-2 virus a “conspiracy theory” was itself the true conspiracy, contrived behind closed doors contemporaneously with a March 2020 publication in Nature. If that coordinated media campaign was designed to conceal malfeasance by Drs. Francis Collins and Anthony Fauci—who, as leaders of America’s National Institutes of Health, reportedly sent American tax dollars to fund China’s dangerous gain-of-function research and circumvent Obama administration-introduced restrictions—we may be witnessing the deadliest cover-up scandal in history.

News media are also beginning to acknowledge facts that refute the original reasons behind lockdowns. Those facts shouldn’t be partisan. Both the Trump and Biden administrations rejected the science—D.A. Henderson’s classic 2006 review of pandemic data clearly demonstrated lockdowns were not effective, and were extremely harmful. Both administrations rejected the alternative—targeted protection—that had been recommended since March 2020. And the lockdowns failed to stop the death (see evidence presented by Christian Bjornskov, Eran Bendavid, Virat Agrawal, Jonas Herby, and Phil Kerpen).

Truth seems to be prevailing, but being proven right is not sufficient. We have a crisis of trust that threatens the credibility of all future health guidance.

Americans should be concerned that the latest WHO agreement-in-progress is not classified as a treaty. America’s treaties require congressional approval. That’s key to a representative government—the public gets input into how they are governed. But executive-signed “accords” circumvent the authority of the people. After all the public has endured in this pandemic at the hands of government, is there any doubt that health emergency powers must have full, public vetting?

Despite protestations to the contrary, all signers of the Pandemic Accord clearly relinquish critical autonomy to the WHO. Most ominous is that WHO defines “public health emergency” on its own terms—giving it full leeway to determine the fundamental justification for public restrictions. We already know there is ambiguity within the U.S. on that definition. When you’re going to invoke emergency measures, there must be clarity on the terms and time limits of the emergency. Why should any sovereign nation allow a third party to legally define and impose such a critical state?

WHO’s accord also explicitly claims oversight over intellectual property, including patent limits and drug prices. And far beyond the purview of a pandemic agreement, it imposes WHO’s preferred social policies, enforceable by law. For instance, the nebulous term “equity” appears 10 times in the accord, as it does in WHO Director-General Tedros Adhanom Ghebreyesus’ January report on health emergencies. Isn’t that the responsibility of autonomous nations, rather than global organizations, to determine for themselves?

Just as the truth about COVID-19 is prevailing, are we going to simply ignore the WHO’s record? The WHO has had major successes in its 75-year history, including the eradication of smallpox, but a series of missteps in emergencies prior to COVID cannot be disregarded—its overreaction and lack of transparency in the 2009-10 H1N1 flu pandemic, its delayed response to the 2014 Ebola crisis in West Africa, and its flawed response to the Zika virus, for example.

What about the COVID-19 pandemic? Tedros began the pandemic by backing China’s early cover-up. On January 28, 2020, he said, “we appreciate the seriousness with which China is taking this outbreak, especially the commitment from top leadership, and the transparency they have demonstrated”—despite China’s broadly reported efforts to block information access and punish those who disobeyed. Tedros further proclaimed, two days later, that “the speed with which China detected the outbreak, isolated the virus, sequenced the genome, and shared it with WHO and the world are very impressive, and beyond words. So is China’s commitment to transparency.” He also backed China‘s false claim that COVID exhibited no human-to-human transmission. And, of course, he failed to strongly protest China’s consistent stonewalling a full lab inspection.

Beyond supporting China’s false narratives, WHO disregarded evidence for guidelines on mitigation, censored its own staff for acknowledging the limits of asymptomatic spread, and erratically changed fundamental definitions like “herd immunity” to influence behavior.

In his most alarming failure of all, Tedros backed China’s reckless lockdowns and massive human rights violations, stating “the Chinese government is to be congratulated for the extraordinary measures it has taken to contain the outbreak” as Beijing used pseudoscience to justify imprisoning its citizens. Tedros insisted that “WHO continues to have confidence in China’s capacity to control the outbreak” until May 2022, more than two years too late. How would one explain that praise, given the director-general’s explicit warning in March 2020 that he had “never before seen a pandemic that can be controlled?” We must hope Tedros was incorrect when he said “China is actually setting a new standard for outbreak response.”

Allocating authority to the WHO requires being na├»ve about its financial backing. More than 80 percent of its $6.1 billion 2022-2023 budget comes via voluntary donations often earmarked for specific initiatives. For instance, the Bill & Melinda Gates Foundation alone is responsible for over 88 percent of the philanthropic donations to the WHO—that may or may not be in the best interest of any nation’s citizens, especially considering the outsized legal authority of WHO agreements.

The WHO does not deserve public trust, yet Americans are about to be newly bound by its decrees. At what point are transparency and accountability to the people required of America’s leaders? Rep. Tom Tiffany (R-Wisc.) and Sen. Ron Johnson (R-Wisc.) have appropriately introduced a bill to reclassify the Pandemic Accord as a treaty. Now is the time to demand WHO reform and ensure stricter oversight, not to further relinquish authority to such an untrustworthy institution.




Tuesday, April 04, 2023

Have we militarised medicine?

Julie Sladden

‘In the absence of information, we make up stories.’ These words remind me we need truthful, unhindered, and accurate information to build understanding. The way to get information is to ask questions. And the way to get good information is to ask good questions.

Plenty of questions have been raised over the past three years, even with all the censorship. But things have taken off in recent weeks with ‘corker’ questions being asked in the US Government, the UK Parliament, and even our Australian Senate.

It’s made for some popcorn-worthy viewing.

Questions… Over the Covid era I’ve had plenty of them. Some answered, but most are not.

Questions like:

Why did our governments propagate so much fear during the pandemic?

Why wasn’t there any effort dedicated to exploring early treatment options?

Why were possible early treatment therapeutics banned from use in Australia despite widespread use overseas?

Why did AHPRA feel the need to tell medical professionals to effectively ‘fall in line’ with the vaccine rollout?

Why were healthy populations forced to vaccinate, or lose their jobs, access to education, or essential services?

Why does the provisional approval of the Covid so-called ‘vaccines’ continue despite data clearly showing alarming rates of significant adverse events? Rates that have seen previous vaccines suspended.


Thankfully, I’m not the only one asking questions.

Renowned US cardiologist, Dr Peter McCullough, has been asking questions and has not stopped since the pandemic began. For the past three years McCullough, and doctors like him, have dedicated their lives to researching, treating and ultimately saving the lives of Covid patients around the globe.

I had the opportunity to ask Dr McCullough a few of my questions on his recent visit to Australia. He started with an interesting comparison between Australia and Texas.

‘Texas has 29 million people, Australia, 26 million people. Texas has great cities, like Australia has great cities. It’s the same virus, we’re largely the same people… Texas and Australia would be a fair comparison.

‘Our hospital made its own decisions about the closure of operating rooms and catheterisation laboratories and when to reopen them. Quickly, in Texas, many different doctors and clinics began to learn how to treat the illness. And that took a lot of anxiety away from people and they felt like there was a way in which the problem could be managed and avoid hospitalisation and death. That was really the critical feature.’

He added:

‘Texas was not perfect. We certainly had hospitalisations and deaths. But we had strong advocates. We had a senator, from the very beginning, who reached out to many of us – Senator Bob Hall. And he said: “I want to know what’s going on. I want to have town halls. I want the doctors to get on calls and tell me what’s going on in your ERs in your health systems. Are you learning how to treat it? Are there innovations?”’

In Australia, it was a different story. The ‘top-down’ flow of information involved very little consultation from coal-face doctors who were faced with managing the disease. As Australian doctors watched the pandemic unfold around the world, we had the advantage of learning from doctors abroad who were gaining extensive experience in early treatment. It wasn’t all sunshine and roses. Watching McCullough testify to the Texas Senate Committee in late 2020, his frustration at the lack of focus on treatments for patients with Covid was clear. Undeterred he, and others like him ,including Dr Pierre Kory who joined McCullough on his visit to Australia, have been instrumental in providing information to the world about how to treat the infection. Their protocols included drugs like hydroxychloroquine, ivermectin, and repurposed drugs known for their pharmaceutical abilities to address various stages of the disease.

Meanwhile, Australia banned hydroxychloroquine for the treatment of Covid on March 2020. March! Ivermectin followed later in September 2021, curiously around the time many mandates came into effect as people were funnelled down the ‘vaccine or bust’ route.


‘I have the same question,’ mused McCullough, who says hydroxychloroquine and ivermectin are currently used as first-line treatment in two dozen countries around the world.

I asked McCullough what his thoughts were on the role of medical boards and medical regulation.

‘You’re referring to AHPRA,’ McCullough deduces. ‘The role of that body, in my view, is clinical competence. And then, being sure that the doctor or the professional is free of major behavioural issues, drug abuse, etc. That’s their role. That is the role. Prior to Covid, they had no special stake in any disease… The aberration was Covid. And we saw, both in the United States and Australia, these bodies take a particular interest in Covid. That they were going to determine what can be said and what couldn’t be said they weren’t going to determine what drugs could be used and not used. This is the first time in medicine that these bodies took on this very unusual aberrant behaviour.’

Aberrant is one word for it.

We explored the other ‘aberrant’ behaviours of the pandemic response along with The Spectator Australia’s Alexandra Marshall and historian John Leake. Leake co-authored Courage to face Covid-19 with McCullough. Soon we arrived at one of my biggest ‘why’ questions: why had we been funnelled down a ‘vaccine or bust’ path?

One word: countermeasures.

Countermeasures are devices and strategies used to eliminate an attack by an enemy force.

I first heard this term back in December 2022 thanks to the work of Katherine Watt and Sasha Latypova, who researched the legislative framework that enabled the ‘warp speed’ response to the virus. A framework that had its foundations laid decades ago. Indeed, it’s the only explanation I’ve heard that helps make sense of the ‘aberrant’ behaviours we’ve witnessed over the past 3 years.

‘The military has biological threat programs. There’s one for smallpox, monkeypox, there’s one for anthrax,’ explains McCullough in a recent presentation. ‘The military came up with the idea of messenger RNA vaccines, not Pfizer or Moderna, and NOT operation warp speed.’

Turns out the military has been playing with mRNA vaccines for over a decade. And the combination of three legislative items – Emergency Use Authorisation (EUA), Other Transaction Authority (OTA), and the PREP Act – enabled what many suspect could be the origins of the first worldwide military operation in medicine. The EUA gets rid of the FDA ‘safety and efficacy’ regulations under EUA so the FDA has no oversight; the OTA enables the Department of Defence to order undisclosed ‘military prototypes’ from pharma; and the PREP Act, which enables the plan to be rolled out.

‘A military program was announced by Health and Human Services … and the Department of Defence, who ushered us into this vaccine era,’ continues McCullough. ‘The military emergency use authorisation is a mechanism to get rapid new technology into the military. It’s not a mechanism for the public. Its first application broadly to the public was the Covid pandemic. That’s the reason why the FDA doesn’t seem like they have any ownership over this. They can’t seem to respond to it. Because it’s a military program. This has a military origin to it. And the program is executed like a military program. No one will be spared. There are no exceptions.’

Think about it. If a virus emerged (from a US-funded lab, no less) and was interpreted as an act of ‘bioterrorism,’ what would a response to that look like?

Would it look like a single-minded, fear-fuelled, authoritarian-style military operation to get every man, woman and child ‘countermeasured’?

It might just look like that.

I have more questions.


COVID-19 Vaccine Developed in Spain Authorized by European Medicines Agency

Yet another COVID-19 vaccine was recently authorized in Europe. This time, a COVID-19 vaccine developed in Spain and plagued by delays has been recommended for authorization by the European Medicines Agency (EMA). Bimervax (previously COVID-19 Vaccine HIPRA). It is now authorized in Europe as a booster in people aged 16 years and above who have been vaccinated with an mRNA COVID-19 vaccine.

Developed by HIPRA Human Health S.L.U., Bimervax contains a protein produced in the laboratory that consists of part of the SARS-CoV-2 spike protein from the Alpha and Beta virus variants.

The CHMP concluded that sufficiently robust data on the quality, safety and immunogenicity of the vaccine are now available to recommend its marketing authorization in the EU.

What’s the basis for the decision?

Bimervax is approved based on an immunobridging trial, which compared the immune response triggered by this new vaccine with that triggered by the authorized mRNA vaccine Comirnaty that targets the original (Wuhan) SARS-CoV-2 spike protein.

The study involved 765 adults who had previously completed primary vaccination with 2 doses of Comirnaty and who were subsequently given a booster dose of either Bimervax or Comirnaty. Although Bimervax triggered the production of lower levels of antibodies against the original strain of SARS-CoV-2 than Comirnaty, it led to higher levels of antibodies against the Beta and Omicron variants and comparable levels against the Delta variant.

Supportive data were provided from an ongoing study that included 36 adolescents aged 16 to 17 years old, with immune response data available for 11 of them. The study found that Bimervax given as a booster produced an adequate immune response in these adolescents, with antibody production comparable to that seen in adults who received Bimervax.

The CHMP, therefore, concluded that a booster dose of Bimervax is expected to be at least as effective as Comirnaty at restoring protection against COVID-19 in people aged 16 years and older.

What about the safety profile?

The safety profile of Bimervax is comparable to that of other COVID-19 vaccines. The most common side effects seen with Bimervax were pain at the injection site, headache, tiredness and muscle pain. These were usually mild to moderate and cleared within a few of days after vaccination.

The safety and effectiveness of the vaccine will continue to be monitored as it is used across the EU, through the EU pharmacovigilance system and additional studies by the company and European authorities.

Final risk-benefit analyses

Based on the available evidence, the CHMP concluded that the benefits of Bimervax outweigh its risks and recommended granting a standard marketing authorization in the EU. See the product information for the vaccine product plus a package leaflet for members of the public and details of the vaccine’s authorization.

How Bimervax works

Bimervax works by preparing the body to defend itself against COVID-19. It contains part of the SARS-CoV-2 spike protein from the Alpha and Beta virus variants, which have been combined into a single protein in the laboratory. The spike protein is found on the surface of SARS-CoV-2 (the virus that causes COVID-19) and is used by the virus to enter the body’s cells. The vaccine also contains an ‘adjuvant’, a substance to help strengthen the immune responses to the vaccine.

When a person is given the vaccine, their immune system will identify the combined protein in the vaccine as foreign and produce natural defenses — antibodies and T cells — against it. If, later on, the vaccinated person comes into contact with SARS-CoV-2, the immune system will recognize the spike protein on the virus and be prepared to attack it. The antibodies and immune cells can protect against COVID-19 by working together to kill the virus, prevent its entry into the body’s cells and destroy infected cells.

A booster injection of Bimervax is given into the muscle, usually of the upper arm, at least 6 months after the last dose of an mRNA COVID-19 vaccine.




Monday, April 03, 2023

Australia recorded relatively more ‘excess deaths’ during the Covid-19 pandemic than Sweden

Australia recorded relatively more “excess deaths” during the Covid-19 pandemic than Sweden, which chose not to lock down its populations, new analysis from the OECD reveals.

As the world approaches the three-year anniversary of the start of lockdowns this week, top academics say data showing Sweden’s success in keeping mortality rates down brings years of civil liberty restrictions and billions of dollars in government spending in other nations into question.

New OECD analysis comparing excess deaths in 2020 and 2021 – the two worst years of the pandemic – for 36 developed nations reveals Australia had the fifth lowest increase in excess deaths, but came in behind Sweden, which attracted global scorn for resisting closing businesses, schools and ordering citizens to stay at home.

Including excess deaths – defined as those over and above what was expected – for 2022 as well puts Australia even further behind Sweden with an 8.2 per cent increase over the three-year period compared with Sweden’s 3.1 per cent.

Stefano Scarpetta, the director of employment, labour and social affairs at the OECD, said: “If you control for population growth (higher in Australia), Australia’s excess deaths rate over the three-year period as a whole was 2.1 per cent and in Sweden it was -0.6 per cent, that is no excess mortality. The reason why we use excess mortality (instead of Covid-19 deaths) is because in practice counting the number of deaths because of Covid is very difficult.”

Dr Scarpetta said there were variations in classification and testing across countries, and it was difficult to determine whether elderly victims had died with or from Covid-19.

The OECD report, Ready for the Next Crisis? Investing in Health Care Resilience, found half of all Covid-19 deaths occurred among people aged 80 across 22 OECD countries with comparable data, and one third occurred in nursing homes.

Mexico and Colombia, which did impose lockdowns, endured the greatest increases in excess deaths of about 50 per cent. Japan and Sweden, the only two OECD nations to resist them, prompting international condemnation at the time, had among the lowest increases, ranking 4th and 8th, respectively.

Two US public health experts who in 2020 recommended the Swedish approach – Stanford University’s Jay Bhattacharya and Harvard’s Martin Kulldorff – said they felt vindicated but ­despaired at the lack of appreciation of the findings and feared the same policies would be followed again.

“The thing to emphasise is that Sweden has had one of the lowest excess mortalities in all Europe during the pandemic no matter how you cut the data,” Professor Bhattacharya said. “If lockdowns were necessary to prevent death it should have had one of the worst. Sweden served as a control group for the world in ethical pandemic management and it was a rousing success.”

He said the success Australia had in having “little Covid on the island for a full year came at tremendously high cost: 270 days of lockdown in Melbourne, ­essential imprisonment of the population”.

The underlying health of a country’s population (including rates of obesity), vaccination levels against Covid-19, and the capacity and quality of the available health care system best explained the widely different rates of excess deaths across countries, the OECD found.

Former US president Donald Trump in April 2020 said Sweden was “suffering badly” from its decision to follow its pandemic plan, but the US, where lockdowns pushed the jobless rate above 15 per cent in 2020, ended up with five times as many excess deaths as Sweden and the sixth worst outcome, according to the OECD data.

“Extended quarantining of healthy populations, the closing of schools, and massive violation of civil rights: these were never part of any pandemic plan that I’m aware of for respiratory viruses,” Professor Bhattacharya said.

Epidemiologists at the UK’s Imperial College, whose dire forecasts early in the pandemic convinced the UK and US to impose lockdowns in March 2020, forecast Sweden would endure 96,000 Covid-19 deaths by July 2020 if it didn’t follow China and then Italy in imposing lockdowns. After three years, Sweden has experienced 23,777 deaths from or with Covid-19, compared with Australia’s 19,477, according to the World Health Organisation.

Sweden’s population is older than Australia’s, with a median age of 41, compared with Australia’s 38.

“The principle of public health is that you can’t just focus on one disease; you have to look at cancer, cardiovascular disease and mental health,” Professor Kulldorff said.

He said Australia’s lockdowns had caused “huge collateral damage in public health, even if you ignore the impact on the economy and government finances”.

According to the IMF, Australia’s gross public debt as a share of GDP surged from 47 per cent to 59 per cent between 2019 and 2022, mainly as a result of federal and state stimulus programs that accompanied lockdowns, while Sweden’s public debt declined from 39 per cent to 31 per cent.

The OECD report found the number of in-person doctor consultations fell by an average of 17 per cent across OECD countries in 2020, and more than one in five people reported having forgone a needed medical examination.

Japan, whose then prime minster, the late Shinzo Abe, was also criticised for resisting a European-style lockdown of the densely populated island nation, had the lowest level of reported population sadness in 2020 (11 per cent), according to the OECD report, while Mexico and Colombia reported the highest, each above 30 per cent.

This new OECD analysis reflected the findings of the UK statistical agency, which found Sweden had the second lowest excess death rate in Europe.


Human rights advocates and bills of rights did nothing to stop goverment abuses during the pandemic

Former UK Supreme Court judge Jonathan Sumption argued from near the start of the Covid pandemic that what democratic governments were doing to their citizens in the way of lockdowns, mandates, closing businesses, restricting travel and visiting sick relatives, weaponising the police – the list goes on and on – constituted the greatest infringements on civil liberties in the West in the last 300 years. I mention that because from March 2020 I was on the record in this newspaper, in The Spectator Australia and in outlets around the world, arguing precisely the same thing. Now readers can agree or disagree. Likewise, readers might think the costs were worth it for the benefits (though I think not, not with the data out now, including Sweden having the OECD’s lowest cumulative excess deaths from the start of the pandemic to now while we in Australia are currently running at 15-17 per cent excess deaths).

But one thing that is beyond debate is that the self-styled human rights lobby said not a peep about this government heavy-handedness. Nada. Nothing. Zero. Not the usual lawyerly caste that finds rights-infringements everywhere, many of microscopic proportions. Nor any of the eight members of the Australian Human Rights Commission (AHRC) who made not a single condemnatory comment about Dan Andrews’ authoritarianism, about former Prime Minister Morrison’s preventing citizens from leaving their own country, about any of the myriad intrusions into our civil liberties over two years. And for what it’s worth all eight, the President and the seven Commissioners, were appointed by the Coalition – even the so-called Freedom Commissioner. All of them.

I start this article with that background because the AHRC has recently decided to wade yet again into the bill of rights debate in this country. (Did I mention that all eight were appointed by a political party that claims to be overtly against a bill of rights?) Actually, ask around and you learn that the seven Commissioners and President are not unanimous on this initiative. It is mostly being pushed by President Rosalind Coucher. It recycles all the tired and wrong-headed old arguments in favour of handing power via a bill of rights to unelected judges over our elected Parliamentarians; all of them churned out back when Labor was last in power under Rudd-Gillard-Rudd. They were wrong then and they are wrong now. Buy a bill of rights, statutory as well as constitutionalised, and all you are buying is the druthers and policy-preferences of the lawyerly caste from which the judges are chosen. This model even moots social and economic rights. The proposal is as bad as you’d expect under Rudd and Gillard, though possibly your expectations of what AHRC Commissioners appointed by a Liberal/Coalition government might desire would be different from this. (Remember Douglas Murray’s criticism of all anglosphere conservative political parties, that they are congenitally unable to appoint anyone who shares the views of their core voters to anything.)

But here is where it gets galling to the point of rank hypocrisy. In the position paper announcing this initiative and its launch at the law firm Gilbert and Tobin (where else I muse?) the Commission (or perhaps just the President of the AHRC) had the gall to suggest a bill of rights might have helped protect civil liberties during the pandemic. Are you kidding me? First off, look at all anglosphere countries with potent and even constitutionalised bills of rights – so Canada, America, and Britain (with a strong statutory model). There is not one single example anywhere of a bill of rights being used by the judges to lessen or eliminate any of the myriad governmental pandemic inroads on civil liberties. Not one example anywhere! To suggest that a bill of rights would have helped flies directly in the face of what is known in the philosophy of science as ‘the facts’. (There are a few examples in the US of state courts using old-fashioned administrative law principles to say that some executive actions taken during the pandemic were ultra vires or beyond the power of the conferring statute.) That line of attack has a chance because it leaves the elected Parliament with the option of passing a new, more delegatory statute. But in times of panic (especially when the judges are panicking at least as much as anyone else) it is folly to think a bill of rights will help. I repeatedly doled out that advice throughout the pandemic to those against lockdowns who thought a trip to court would be a magic bullet and help. It didn’t in any jurisdiction with a bill of rights.

So this suggestion by the AHRC is as audacious as it is wrong on the facts – ‘during the Covid pandemic, there was a lack of clarity about rights of Australians and how to balance them with public safety measures. A Human Rights Act would have helped navigate those challenges’. No, it would not have helped. What would have helped was an AHRC President who could summon up the courage to speak up about the many inroads on our civil liberties in the way Lord Sumption did in Britain. But instead of the slightest criticism of the police thuggery in Victoria, of the idiocy and heartlessness of many of the pandemic rules, of anything or anyone, we get this after-the-fact attempt at redemption. The problem is that a bill of rights would not have helped (again, see every democratic country on Earth) and meantime it brings it with a massive empowerment of the judiciary and of the lawyerly caste.

This is hypocrisy on steroids I’m afraid. And it’s combined with the tired old prescription of a bill of rights so beloved by the lawyerly left of the Labor Party. ?




Sunday, April 02, 2023

'Unacceptable incompetence': CDC made dozens of basic data errors on COVID, epidemiologists find

The CDC found itself hoist with its own petard by making 25 basic statistical and numerical errors related to COVID-19, particularly with regard to children, while purporting to expose COVID vaccine misinformation, according to an analysis led by University of California San Francisco epidemiologists.

The preprint, which has not yet been peer-reviewed, documented 20 errors that "exaggerated the severity of the COVID-19 situation" and three that "simultaneously exaggerated and downplayed" severity, while one each was neutral or exaggerated vaccine risks.

More than half were from 2022, but nearly as many were made in the first two months of 2023 as in all of 2021, they found. Several errors were related to the agency's COVID data tracker, which failed to align with its National Center for Health Statistics (NCHS), and the CDC corrected at least in part 13 of the 16 errors brought to its attention.

The paper emphasizes how widely CDC errors can spread even if they are later corrected, with YouTube and Spotify linking its website on videos and podcasts that discuss COVID and the wide deference to CDC guidance in schools, businesses and healthcare facilities.

"The errors are damning," coauthor Vinay Prasad, a former National Institutes of Health fellow, said on Twitter. "Basic counts of dead kids, causes of childhood death. Unacceptable incompetence."

UCSF's Alyson Haslam, a former CDC fellow who works in Prasad's lab, made the final call on CDC errors that Prasad, Tracy Beth Hoeg and independent Georgia COVID analyst Kelley Krohnert collectively agreed "were indisputable and incorrect, as a matter of fact, and not preference or opinion."

The trio conducted "real time" review of news sources, Advisory Committee on Immunization Practices (ACIP) meetings and materials, the agency's Morbidity and Mortality Weekly Report and the Twitter accounts of the CDC and its director, as well as reports sent to them by others, going back to 2021.

The errors were heavily weighted toward exaggerating COVID's risk to children. Fifteen of the 16 pertaining to children's data "enhanced the perceived risk" of the virus and more than half the total errors involved mortality statistics, with the CDC data tracker "consistently" reporting higher deaths for children and adolescents than did NCHS.

Perhaps the most consequential error was the CDC's repeated promotion of a preprint that deemed COVID a "top 5" cause of death in children, which the agency only corrected in one place months later.

That paper compared 26 months of COVID deaths, where the virus was "one of several contributing causes to deaths," to 12 months of deaths from other causes that were "identified as the single underlying cause of death ... which by design exaggerates" the COVID risk to kids, the paper says.

Not only was the claim made in ACIP and FDA Vaccines and Related Biological Products Advisory Committee meetings, but also at a White House briefing by CDC Director Rochelle Walensky and by ACIP's chair in a subsequent meeting "after the errors were identified." Only ACIP's page on "vaccination evidence for young children" includes the correction.

The agency was plain sloppy in other errors, the authors allege. It listed pediatric deaths as 4% of COVID deaths when it meant to write 0.04% and gave a lower estimated rate of pediatric infections than symptomatic illness, with some errors remaining live for seven months.

"These errors have been made repeatedly and were likely to have affected discussion of pandemic policies," particularly the CDC's guidance calling for "school closures, mask mandates, and strong recommendations for vaccinations and multiple boosters even among children who have recovered from the virus," the authors conclude.

The CDC did not respond to queries for its response to the paper.

The FDA's evidence for full approval of Pfizer's COVID antiviral Paxlovid, shared with its advisory committee on antimicrobial drugs, also came under scrutiny.

The advisers voted in mid-March to approve the two-drug treatment for high-risk adults while warning that many patients could have harmful drug interactions, CNBC reported. The agency will make the final decision in May. (Pfizer long ago acknowledged Paxlovid is not useful against household transmission.)

While the FDA's briefing packet emphasized the infrequency of Paxlovid "rebound" infections — which hit the president, his COVID adviser, first lady and both FDA and CDC commissioners, all up to date on COVID jabs — its cited evidence only applies to a sliver of potential Paxlovid patients.

The Pfizer studies gave five-day treatments to unvaccinated high-risk patients (EPIC-HR) and vaccinated high-risk or unvaccinated low-risk patients before and after the Omicron variant wave (EPIC-SR). Only EPIC-HR found "any meaningful difference" compared to a placebo, a 5.6% absolute reduction and 86% relative reduction.

The FDA emphasized the "symptom rebound" rates were similar between Paxlovid and placebo arms across both studies, around 10-16%. This shows that for a "subset" of infections, regardless of Paxlovid, "virologic and/or symptomatic rebound may occur as part of the natural progression and resolution of COVID-19 disease."

A different graph on "viral RNA rebound," however, found notably higher rates in the Paxlovid arm in EPIC-HR and EPIC-SR's Omicron period.

In a lengthy review of the FDA evidence, University of Minnesota infectious disease researcher David Boulware said it actually shows Paxlovid is "likely near zero benefit" for under-60s with a "normal immune system" and vaccine- or infection-induced immunity.

Before the Paxlovid vote, National Institutes of Allergy and Infectious Diseases scientist Margery Smelkinson questioned its emergency use authorization starting at age 12 in spite of dramatically different COVID risk by age. She noted Pfizer ended EPIC-SR early after finding no "statistically significant evidence of benefit."

A member of the Norfolk Group of scientists, physicians and policy experts that recently published a "blueprint" for a potential COVID truth commission, Smelkinson pointed to the Paxlovid section of their report, which emphasizes the lack of rigorous data on who actually benefits from the treatment.

Prasad also questioned the quality of evidence for Paxlovid, including a Lancet Infectious Diseases observational study that found "the curves already split" between treatment and placebo groups at "Day 0," which he said indicates immortal time bias.

"Non randomized evidence will forever be plagued by differences in people who get pax and those who do not (likely being rich, health literate and well connected gets you more pax!)," he wrote in his newsletter in February.

The FDA declined to comment on the criticism of its proffered evidence. "We can’t comment on pending applications," press officer Chanapa Tantibanchachai wrote in an email.


Pfizer COVID-19 Vaccine Trial Whistleblower Case Dismissed by Judge

The legal case brought by a whistleblower from Pfizer’s COVID-19 vaccine trial has been dismissed by a judge.

Brook Jackson, who worked for Pfizer contractor Ventavia Research Group, did not prove violations of the False Claims Act, U.S. District Judge Michael Truncale ruled.

Jackson sued Ventavia, Pfizer, and another organization involved in the vaccine trial in 2021, alleging that trial violations she uncovered meant the government was defrauded when it paid for doses of Pfizer’s vaccine.

Internal records showed Ventavia officials acknowledging patients were unblinded, adverse events were not recorded, and vaccine doses were kept unlocked in “disorganized” rooms.

Under the False Claims Act, the government or a party suing on the government’s behalf—Jackson in this case—can recover money for false claims made by parties to secure payment for the government. Parties are liable if they knowingly present a false claim for payment or intentionally use a false record or statement material to make a false claim.

While Jackson presented evidence that violations occurred, the government’s prototype agreement with Pfizer only conditioned payment on delivery of a vaccine that had been authorized or approved by the U.S. Food and Drug Administration (FDA), Truncale ruled. The payment section states, “the Government will have no right to withhold payment in respect of any delivered doses, unless the FDA has withdrawn approval or authorization of the vaccine.” The FDA, which Jackson alerted to the violations, has not withdrawn approval or authorization.

“In sum, Ms. Jackson has failed to plead that the Government conditioned payment on Defendants’ certification of compliance with regulatory provisions or clinical trial protocol,” Truncale said in the new ruling.

While Jackson argued that the false record portion of the False Claims Act (FCA) was violated because of the trial violations, the defendants said that false records and statements alone did not create liability without a false claim seeking payment from the government.

“The upshot is that there is no liability under the FCA for making or using a false record or statement where the claimant is entitled to the payment,” Truncale said. “Pfizer was entitled to its claims for payment. Therefore, Ms. Jackson has not stated a claim for false record liability.”

The judge quoted a different ruling, which found that the False Claims Act was enacted by Congress “to vindicate fraud on the federal government, not second guess decisions made by those empowered through the democratic process to shape public policy.”

“When the government, at appropriate levels, repeatedly concludes that it has not been defrauded, it is not forgiving a found fraud—rather, it is concluding that there was no fraud at all,” the ruling stated.

Attorneys for Pfizer offered that argument during a recent hearing in the case.

“So if the FDA gets it wrong, they just get it wrong, and we live with it?” Truncale asked. “Exactly,” said Pfizer attorney Carlton Wessel.

“The Government has been aware of Ms. Jackson’s allegations for several years, has granted Emergency Authorization multiple times, and to this day continues to authorize and provide Pfizer’s vaccine at no cost,” the judge said in the new ruling.

He acknowledged the evidence Jackson offered but said her complaint did not “identify any safety risk that was hidden from the FDA in the data from the Ventavia sites, any symptomatic participants who Ventavia did not properly test for COVID-19 infection, or any COVID-19 infections in vaccinated participants that Ventavia falsely reported to have occurred in the placebo group.”

Retaliation Claim

Jackson was hired in September 2020. She reported problems with the trial to Ventavia management shortly after starting at the company. Dissatisfied with the response, she went to the FDA on Sept. 25, 2020. Ventavia fired Jackson that same day.

The False Claims Act protects whistleblowers from harassment, retaliation, and threats. The person must be engaged in protected activity, defined in a previous ruling as “motivated by a concern regarding fraud against the government.” Additionally, the employer must know the person was engaged in protected activity, and the punitive action or actions must be because of the activity.

Jackson’s activity does not meet the standard because she has not alleged she was concerned about potential fraud against the government, Truncale claimed.

“Rather, she alleges that she complained about participant safety and regulatory, protocol, and HIPAA violations,” he said, referring to the Health Insurance Portability and Accountability Act. “But that is not protected activity under the FCA’s retaliation provision—internal complaints about patient safety, or protocol and regulatory violations, are not the same thing as complaining about defrauding the Government.”

Even if Jackson was engaged in protected activity, the judge said that she did not show that Ventavia knew she was involved in such activity.

He dismissed the False Claims Act claims with prejudice, which means they cannot be brought again. The retaliation claim was dismissed without prejudice.