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

Abstract

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.

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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?

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W.H.O. Do You Trust?

By SCOTT W. ATLAS

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 naïve 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.

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Also see my other blogs. Main ones below:

http://edwatch.blogspot.com (EDUCATION WATCH)

http://antigreen.blogspot.com (GREENIE WATCH)

http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH) Also here

http://australian-politics.blogspot.com (AUSTRALIAN POLITICS)

http://snorphty.blogspot.com (TONGUE-TIED)

https://immigwatch.blogspot.com (IMMIGRATION WATCH) Also here

https://awesternheart.blogspot.com (THE PSYCHOLOGIST)

http://jonjayray.com/blogall.html More blogs

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