Redox imbalance links COVID-19 and myalgic encephalomyelitis/chronic fatigue syndrome

Abstract

Although most patients recover from acute COVID-19, some experience postacute sequelae of severe acute respiratory syndrome coronavirus 2 infection (PASC). One subgroup of PASC is a syndrome called “long COVID-19,” reminiscent of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). ME/CFS is a debilitating condition, often triggered by viral and bacterial infections, leading to years-long debilitating symptoms including profound fatigue, postexertional malaise, unrefreshing sleep, cognitive deficits, and orthostatic intolerance. Some are skeptical that either ME/CFS or long COVID-19 involves underlying biological abnormalities. However, in this review, we summarize the evidence that people with acute COVID-19 and with ME/CFS have biological abnormalities including redox imbalance, systemic inflammation and neuroinflammation, an impaired ability to generate adenosine triphosphate, and a general hypometabolic state. These phenomena have not yet been well studied in people with long COVID-19, and each of them has been reported in other diseases as well, particularly neurological diseases. We also examine the bidirectional relationship between redox imbalance, inflammation, energy metabolic deficits, and a hypometabolic state. We speculate as to what may be causing these abnormalities. Thus, understanding the molecular underpinnings of both PASC and ME/CFS may lead to the development of novel therapeutics.

Concluding Remarks

People with acute COVID-19 and people with ME/CFS share redox imbalance, systemic inflammation and neuroinflammation, impaired production of ATP and other abnormalities in common (Fig. 2), abnormalities that have bidirectional connections (169).

The syndrome of long COVID-19 that can develop in some COVID-19 survivors (people called “long haulers”) is very similar to ME/CFS, so it may well be that the group of abnormalities seen in acute COVID-19 and in ME/CFS also will be seen in long COVID-19. Presumably, redox abnormalities in COVID-19 are secondary to the infection with SARS-CoV-2. The same may be true among those ME/CFS patients whose illness began with an “infectious-like” illness.

Clearly, COVID-19–induced permanent damage to the lungs (chronic hypoxia), heart (congestive failure), and kidneys (fluid and acid-base abnormalities) could cause some of the persisting symptoms seen in long COVID-19. In both long COVID-19 and ME/CFS other symptoms (e.g., fatigue, brain fog) may be generated by neuroinflammation, reduced cerebral perfusion due to autonomic dysfunction, and autoantibodies directed at neural targets, as summarized elsewhere (170).

As many as 2.5 million people suffer from ME/CFS in the United States (6). The COVID-19 pandemic may generate a similar number of cases of long COVID-19 in the coming 1 to 2 y (5). It therefore is imperative that increased research be focused on both long COVID-19 and ME/CFS. Fortunately, the United States and several other countries have committed substantial funding to study chronic illnesses following COVID-19, one of which is long COVID-19. Two registries and associated biobanks of people with long COVID-19 and/or ME/CFS are available to aid research.* We suggest that the study of the connections between redox imbalance, inflammation, and energy metabolism in long COVID-19 and in ME/CFS may lead to improvements in both new diagnostics and therapies.

Microbial signatures in the lower airways of mechanically ventilated COVID-19 patients associated with poor clinical outcome

Microbial signatures in the lower airways of mechanically ventilated COVID-19 patients associated with poor clinical outcome - Nature Microbiology

Analysis of lower respiratory tract microbiome of mechanically ventilated COVID-19 patients rules out a role for secondary respiratory infections as drivers of…

www.nature.com

Abstract

Respiratory failure is associated with increased mortality in COVID-19 patients. There are no validated lower airway biomarkers to predict clinical outcome. We investigated whether bacterial respiratory infections were associated with poor clinical outcome of COVID-19 in a prospective, observational cohort of 589 critically ill adults, all of whom required mechanical ventilation. For a subset of 142 patients who underwent bronchoscopy, we quantified SARS-CoV-2 viral load, analysed the lower respiratory tract microbiome using metagenomics and metatranscriptomics and profiled the host immune response. Acquisition of a hospital-acquired respiratory pathogen was not associated with fatal outcome. Poor clinical outcome was associated with lower airway enrichment with an oral commensal (Mycoplasma salivarium). Increased SARS-CoV-2 abundance, low anti-SARS-CoV-2 antibody response and a distinct host transcriptome profile of the lower airways were most predictive of mortality. Our data provide evidence that secondary respiratory infections do not drive mortality in COVID-19 and clinical management strategies should prioritize reducing viral replication and maximizing host responses to SARS-CoV-2.

Discussion

The samples used in this investigation were obtained during the first surge of cases of COVID-19 in New York City, and management reflected clinical practices at that time. Among the differences with current therapeutic approaches in COVID-19 patients, corticosteroids and remdesivir, two medications that likely affect the lower airway microbial landscape, were rarely used during the first surge. Other medications, such as antibiotics and anti-inflammatory drugs, could affect our findings, and we therefore considered them as potential confounders. However, the use of these medications was not found to be associated with clinical outcome. Of note is that although our institutions were responding in ‘surge mode’, both the Long Island and Manhattan campuses did not suffer from shortages in medical staff, supplies or equipment and the decision to start MV did not differ from the standard of care. The cross-sectional study design precluded evaluation of the temporal dynamics of the microbial community or the host immune response in this cohort, which could have provided important insights into the pathogenesis of this disease. Performing repeated bronchoscopies without a clinical indication would be challenging in these patients, and other, less invasive, methods might need to be considered to study the lower airways at earlier time points and serially over time in patients with respiratory failure. It is important to note that there were no statistically significant differences in the timing of sample collection across the three outcome groups. Evaluation of microbial signals at earlier time points in the disease process might also be important to identify changes occurring prior to use of broad-spectrum antimicrobials. Also, the presented data from lower airway samples are restricted to those subjects for whom bronchoscopy was performed as part of their clinical care. Thus, the culture-independent data are biased towards patients who, while critically ill with COVID-19, were not representative of the extremes in the spectrum of disease severity. Investigations focusing on early sample collection time points may be warranted to include subjects on MV with early mortality or early successful discontinuation of MV.

In summary, we present here the first evaluation of the lower airway microbiome using a metagenomic and metatranscriptomic approach, along with host immune profiling, in critically ill patients with COVID-19 requiring invasive MV. The RNA metatranscriptome analysis showed an association between the abundance of SARS-CoV-2 and mortality, consistent with the signal found when viral load was assessed by targeted rRT–PCR. These viral signatures correlated with lower anti-SARS-CoV-2 spike IgG and host transcriptomic signatures in the lower airways associated with poor outcome. Importantly, both through culture and NGS data, we found no evidence for an association between untreated infections with secondary respiratory pathogens and mortality. Together, these data suggest that active lower airway SARS-CoV-2 replication and poor SARS-CoV-2-specific antibody responses are the main drivers of increased mortality in COVID-19 patients requiring MV. The potential role of oral commensals such as M. salivarium needs to be explored further. It is possible that M. salivarium can impact key immune cells, and it has recently been reported at a high prevalence in patients with ventilator-acquired pneumonia44. Critically, our finding that SARS-CoV-2 evades and/or derails effective innate/adaptive immune responses indicates that therapies aiming to control viral replication or induce a targeted antiviral immune response may be the most promising approach for hospitalized patients with SARS-CoV-2 infection requiring invasive MV.

Quote from Fm1

88,000 prescriptions written, no reports of overdose or deaths nor even a headache, and best of all no reports of prescribed ivermectin patients being hospitalized. Proof is in the patients recovering!!!

FM1

80,000 prescriptions: more people thatn this think homeopathy, or tin foil hats, help? But then I guess they have had longer to get good PR in place.

No overdose reports. Maybe not, if you look only at FLCC websites...

The Centers for Disease Control and Prevention (CDC) confirmed with the American Association of Poison Control Centers (AAPCC) that human exposures and adverse effects associated with ivermectin reported to poison control centers have increased in 2021 compared to the pre-pandemic baseline. These reports include increased use of veterinary products not meant for human consumption.

No ivermectin takers

end up in hospital?Policeman dies from COVID

A police captain who refused the vaccine and took the anti-parasitic ivermectin to combat COVID-19 dies from the virus

A Georgia police officer who frequently posted anti-vaxx messages on Facebook and took an anti-parasitic drug instead of a vaccine has died of COVID-19.

Captain Joe Manning, 57, of the Wayne County Sheriff's Office died on Wednesday after a short battle with the virus, according to local news station WSAV.

Sheriff Chuck Moseley said, "Captain Manning was an integral part of our family and our hearts are broken. Our love and prayers go forward to his family," according to WSAV."

After the announcement of his death, Facebook posts made by Manning circulated on social media.

In one post, Manning shared an image that said, "I am not vaccinated by choice and that's my right."

In another, Manning encouraged people to stock up on the anti-parasitic drug ivermectin, frequently used to deworm horses, and increasingly being taken by people in a misguided attempt to treat or prevent COVID-19.

Here is a good no politics summary of evidence from non-pressure-group treatment advocates.

Reviews of ivermectin for COVID-19: evidence from RCTs is still needed | HTB | HIV i-Base

Unfortunately, the last two published RCTs did not report a benefit. This included a Columbian study that randomised 476 adults with PCR-confirmed mild COVID-19 disease to either ivermectin (300 μg/kg) or placebo for five days, given as an oral solution. [4]

There were no significant differences in the time to resolving symptoms between the two groups: 10 vs 12 days; HR: 1.07 (95CI: 0.87 to 1.32), p=0.53, with symptoms resolving in 82% and 79% in the active vs placebo groups respectively.

A second study from Argentina randomised 501 participants (1:1) to ivermectin or placebo in a staggered dose, according to weight, for 2 days. There was no significant difference on the primary endpoint of hospitalisation: 14/250 (5.6%) vs 21/251 (8.4%) in ivermectin vs placebo (OR: 0.65; 95% CI: 0.32 to 1.31), p= 0.227. [5]

So for evidence of ivermectin hospitalisations look at any of the trials, and note that in ig trials the ivermectin patients go to hopsital and die like the placebo ones.

Interestingly, there is some meta-analysis evidence (but of low prevision, unlike the high precision remdesivir evidence of the same) that ivermectin reduces hospitalisation a bit (I think HR ~ 0.66) which remains whether you take all trials, or only the high quality ones. Though not any of the other measured outcomes. My guess is that it provides symptomatic relief in many cases (with 5% gastrointestinal side effects as flip side of this).

You might ask why doctors are so much more positive about remdesivir: which has similar though much more accurate evidence on its effect reducing hospitalisation?

In absence of strong evidence from testing people tend to look for is the drug plausible. this can be wrong, but is a good starting point

An important complication, and a caution to any positive results – carefully explained in the paper from Andrew Hill – is that pharmacokinetic studies have shown that drug levels achieved with highest tolerable dosing remain too low to have a direct therapeutic effect reported in in vitro studies. Without PK support for a potential mechanism it is difficult to see how ivermectin could work.

https://www.nejm.org/doi/full/10.1056/nejmoa2007764

Remdesivir (GS-5734), an inhibitor of the viral RNA-dependent, RNA polymerase with in vitro inhibitory activity against SARS-CoV-1 and the Middle East respiratory syndrome (MERS-CoV),^5-8 was identified early as a promising therapeutic candidate for Covid-19 because of its ability to inhibit SARS-CoV-2 in vitro.⁹ In addition, in nonhuman primate studies, remdesivir initiated 12 hours after inoculation with MERS-CoV^10,11 reduced lung virus levels and lung damage.

Remdesivir and chloroquine effectively inhibit the recently emerged novel coronavirus (2019-nCoV) in vitro - Cell Research

www.nature.com

Notably, two compounds remdesivir (EC₅₀ = 0.77 μM; CC₅₀ > 100 μM; SI > 129.87) and chloroquine (EC₅₀ = 1.13 μM; CC₅₀ > 100 μM, SI > 88.50) potently blocked virus infection at low-micromolar concentration and showed high SI (Fig. 1a, b).

Good in vitro antiviral (EC50) vs cell toxicicity (CC50) ratio does not mean a drug will actually work for real, but it is a plausible starting point.

ivermectin has a poor starting point, and needs clear clinical evidence to counteract that:

Another important consideration relates to potency, relative selectivity and toxicity of ivermectin. Our evaluation of in vitro studies showed that ivermectin exerts selectivity for some viruses in ex vivo mammalian cell infection models utilizing Vero, Huh and BHK cells. However, the micromolar concentration range required to inhibit replication by 50% for most viruses may be a cause for concern. Clinically approved formulations of ivermectin can be administered orally, subcutaneously, intramuscularly or topically with a recommended dose range of 150–200 µg/kg in humans and 6–500 µg/kg in animals depending on species and formulation, and the indicated clinical applications. With this dose range, pharmacokinetic characterizations have shown that attainable peak plasma concentrations increase with dose and may range from 3–48 ng/mL in dogs, 21–82 ng/mL in horses, 7–40 ng/mL in pigs, 9–60 ng/mL in sheep, 12–133 ng/mL in cattle and 20–81 ng/mL in humans [38-40]. A study on safety and tolerability of escalating doses of ivermectin in healthy humans showed that a single dose (120 mg) that is 10-fold bigger than the clinically recommended dose (200 µg/kg) was well tolerated and it yielded a peak plasma concentration equivalent to 248 ng/mL with an elimination half-life of 19 hr [41]. Similarly, population-based pharmacokinetic modelling revealed that ivermectin administered orally for three days at 600 µg/kg would yield maximal median plasma concentrations of 105–119 ng/mL (0.12–0.14 µM) and an elimination half-life of 3–5 hr [42]. These data indicate that even with extremely high doses of ivermectin, attainable peak plasma concentrations would remain markedly lower than established EC₅₀ concentrations for most viruses in vitro, albeit significantly higher than 0.5–1 ng/mL that is optimal for the anthelmintic activity. The use of extremely high doses of ivermectin would increase the prospect of adverse drug-drug interactions in patients requiring polypharmacy, as is often the case in viral infections [2, 43].

None of this stops ivermectin from being a useful anti-viral COVID drug. It takes large high quality trials to determine that for sure. I keep on with this stuff because I feel the conspiracy theories about medical establishment out to prevent ivermectin are completely wrong. The PR has had an effect. It has been incorporated in a whole load of large clinical trials - if it were not for major pressure group activity I doubt that would have happened on evidence alone because of the above.

Quote from Fm1

New research found that natural immunity offers exponentially more protection than COVID-19 vaccines.

Other research shows the opposite. Most research shows that it is best to have both natural and vaccine immunity. Why wouldn't you want both? What reason would you have to not get a shot? Many patients have become severely ill after getting COVID the second time. Why risk that? Some number have also gotten severely ill after full vaccination, so a booster might be a good idea too.

Quote from Fm1

another blow to the vaccine warriors!Harvard Epidemiologist Says the Case for COVID Vaccine Passports Was Just Demolished

New research found that natural immunity offers exponentially more protection than COVID-19 vaccines.

FM1 this is a straw man.

I, presumably, would count as a vaccine warrior? But I've never been much in favour of COVID vaccine passports for lots of reasons. (Mainly - not clear would overall encourage vaccine take-up - which is what countries need to get through a high delta infection winter without severely unpleasant consequences on health systems).

This war imagery "vaccine warrior etc" is profoundly bad for science. The anti-vaxers are anti-science, so will use it. No-one else needs to do so!

EDIT - what Jed says above does remain a possible reason for demanding vaccine passports - it will add protection to everyone - but it might in some ways be fairer to look at antibody tests.

Quote from Shane D.

Good of you to have total trust in what the health care establishment tells you. Wish I were that way, life would be so simple if so, but am stubborn I guess.

Not total trust, but very high trust. I am sure you also have very high trust in the medical establishment. If you get severely ill with a heart attack or cancer, I am sure you will go to the hospital rather than use some cure that anonymous people on the internet claim will fix the problem.

Every educated person knows that medical science has made enormous progress in the last 200 years, and that doctors know far more than ordinary people about disease, and how to cure it. We all have trust in doctors, just as we all trust airplane pilots and air traffic controllers. We put our lives in their hands when we fly. That does not worry a rational person who understands the odds of an accident are low, and who understands that technical experts are usually right. If they were not usually right, civilization would collapse.

You are not stubborn. You are irrational. You seem to think that whatever the establishment claims, the opposite must be true. That makes no more sense than believing everything the establishment says.

Since the establishment never speaks with one voice, and you can always find mainstream experts who disagree with other experts, it makes no sense to say you always believe what they say. You cannot agree and disagree at the same time. I know better than most people that the establishment is sometimes wrong, since I know a lot about cold fusion. I also know more than the CIA and State Dept. Far East experts about some obscure aspects of Japan. (I know because I went to college with those people, and I got better grades. My professors were also part of that establishment. Generally speaking, CIA research is pretty good, but they make mistakes, and I know for a fact they put on their pants one leg at a time.)

Quote from THHuxleynew

The Centers for Disease Control and Prevention (CDC) confirmed with the American Association of Poison Control Centers (AAPCC) that human exposures and adverse effects associated with ivermectin reported to poison control centers have increased in 2021 compared to the pre-pandemic baseline.

May be they mixed up IVR paste with a tube of meat paste....I guess increased means from 0 --> 1. This is an infinite increase 1/0....

But even an 8x dose is not harmful but if your weight is 50kg then its 16x....I would not take it. The max I would give is 6x.

Quote from JedRothwell

Other research shows the opposite

No only pharma marketing says otherwise.. lets say .. money research...

Quote from THHuxleynew

The anti-vaxers are anti-science,

The vaccine terrorists talk of vaccines because these gen therapies have a similar effect. But the gen therapy is not a vaccination that strengthens your immune system. The gen therapy just produces more or less monoclonal antibodies. This was also the original name for this therapy in cancer. Mono clonal antibody therapy.

So THH's arguments are fake and based on mediocre understanding what science is.

So we can only warn most not to undergo a mono clonal antibody therapy. Just for the vulnerable this might be OK if they can afford to get CoV-19 in the next 4-5 months.

Quote from THHuxleynew

(but of low prevision, unlike the high precision remdesivir evidence of the same)

Come now...this is exactly why many here take exception to such posts.

Remdesivir is even dismissed by the WHO. If it had "high precision" evidence, surely they would endorse it. Yet they officially removed it from the approved list.

And as W would say (probably)... the one unsubstaniated case you site above overrides the millions of successful cases in India? Really? You deny India success yet believe one completely factless (no medical facts provided) case of a self nedicated person?

If so I can then ascribe that I personally took Ivernectin after a positive test. Within 24 hours all symptoms where gone. Therefore Ivermectin works.

It is true in my case. I did take it. But I do not say it is proof. Your fact void report of a death is no more meaningful than my above "assertion".

This is truly a tribal argument for most here and more so for the "vaccine warriors". Most pro-ivermectin posters here have been vaccinated. They simply state the vaccines are failing and other tactics should be employed in conjunction. (Perhaps not vaccinating the young with an untested mRNA for long term effects)

Vaccine warriors however are absolutely enamored. There is no other solution other than vaccines and anything "better" than vaccines must be dismissed. That is why renedisivir us not dismissed. Not because it works, but because it's horrible price and ineffectiveness poses no threat to vaccines.

Ivernectin and other low cost alternatives pose a threat and that cannot be tolerated...... as has been stated here..... ivermectin may convince many not to get the shot. That is why you dismiss it, not because of faulty studies.

There is zero long term safety studies for the vaccine, yet you repeatedly state it is very likely long term safe. Yet you have no scientific basis for that claim. You strongly dismiss Ivermectin even though there is evidence it works. CERTAINLY more evidence than mRNA long term safety.

This is evidence of strong bias clouding reason.

Ivermectin in South Africa

Ivermectin in South Africa

Note that views expressed in this opinion article are the writer’s personal views and not necessarily those of TrialSite. Albert Buhr questions the

trialsitenews.com

Note that views expressed in this opinion article are the writer’s personal views and not necessarily those of TrialSite.

Albert Buhr questions the “insufficient evidence” narrative.

Anyone following the ivermectin story will be aware of the widespread erosion of public trust in regulatory agencies and public health authorities worldwide (except perhaps in countries where access is unhampered, with promising results).

In the context of financial conflicts of interest and extensive regulatory capture, it is reasonable for curious individuals to reserve their trust and attempt to assess for themselves the studies upon which public health recommendations are based. History is littered with public health advisories that were eventually overturned – often despite considerable institutional resistance, psychological gaslighting and disdain towards those who would question sponsored “consensus”.

This dismissive attitude provoked me to penetrate the review by a South African government sub-committee that recommends “not to use the option” of ivermectin. As current South African guidelines effectively barricade access to a potentially life-saving drug with a superb safety profile, one would expect it to be of sizeable scope and impeccable standard. But instead I see a dog and pony show.

THE STUDIES THEY LIKE

Of the 15 studies included for consideration, comparing ivermectin to placebo, 6 show almost no significant effect, while 9 have cautiously optimistic conclusions. Already I’m curious how the authors decided that such a balance of the scale inclines away from ivermectin.

Under the mortality heading, the author highlights 4 studies by name, devoting a short paragraph to each. The methodological limitations in 3 of the optimistic studies are pointed at, while the zero-efficacy study (Beltran-Gonzales) seems to be given a pass. Putting aside for a moment that all the studies can be shown to have significant methodological limitations (for medical research is indeed a messy business), the Beltran-Gonzales study actually looks quite poor. For example:

1. The trial was stopped early and did not enrol enough subjects to meet its own initial power calculations.

2. Single dose ivermectin is not the recommended regimen.

3. The ivermectin arm had the highest d dimer (p 0.01) and there appears to be no discussion of anticoagulation beyond thromboprophylaxis.

4. Absorbtion of ivermectin with food rises roughly 4-fold. Was it given on an empty stomach or with food?

5. The authors claim this is the first trial of ivermectin vs placebo. At the time there were already 5.

6. Most importantly, it is a study with late-stage, severe-condition, high-co-morbidity patients, while it has been well established that there is a clear treatment delay response relationship, with late-stage treatment not expected to be nearly as effective as early treatment.

None of those issues seemed to concern the author, as only “weaknesses in the randomisation process and the reporting of the trial outcomes” is mentioned.

At random, I next looked at Kishoria et al., one of the studies that found no benefit for ivermectin use. Problems proliferate:

1. The patient population was biased because the study recruited patients that did not respond to standard treatment.

2. The authors did not specify the treatment delay, but it was likely very late because the patients had already undergone standard treatment.

3. Criteria for discharge were not provided.

4. The time of discharge status was not specified and may not have been an equal time since treatment initiation for all patients.

5. Authors indicated 19 treatment and 16 control patients, but the results only showed 13 control patients. Authors did not indicate why the other 3 were missing.

6. Randomization in this very small sample resulted in very large differences in the groups, with over twice as many in the ivermectin group with age >40, and the only 2 patients with age >60 both in the ivermectin group. Authors did not adjust for these differences.

Highlighting the methodological limitations of 3 of the optimistic studies, while including this study in its consideration without any mention of its methodological limitations, seems suggestive of bias. Or am I missing something?

Most of the studies suffered from very small sample sizes, so my next deeper dive was guided by this enthusiastic description: “By far the largest trial of the group was conducted by López-Medina et al., in a study of 400 patients with mild or moderate disease in Columbia.” As a study widely cited for its conclusion of ivermectin’s lack of efficacy, I thought I would finally have something substantial to give clarity.

But alas. That this study was included, compared to some of the excluded studies, quite boggles the mind. This study has been widely criticized within the medical community (see some comments here: https://jamanetwork.com/journals/jama/fullarticle/2777389). The study authors also received institutional grants and “personal fees” from vaccine manufacturers and distributors, like Janssen! An open letter, signed by more than 170 physicians, has concluded that this study is fatally flawed: https://jamaletter.com/

THE STUDIES THEY DON’T LIKE

So much for the included studies. Frankly, I had seen enough to get the idea. It was time to check the list of 36 excluded studies.

The first study on the exclusion list is Bryant et al., which has arguably become well known for indicating a 68% reduction in mortality. The rationale provided for its exclusion is given as “Preprint, currently under review and later RCTs have been published.” It has since been published in the American Journal of Therapeutics, and is a systematic review and meta-analysis, using rigorous Cochrane methods, that included 21 RCTs with 2,741 patients (so much for our review’s lament of “small sample sizes”).

This seems an odd rationale for exclusion when other studies in preprint format were included in the review. Is added justification warranted? Apparently not. It opens the door for cynical minds to wonder whether its exclusion could be due to its conclusion that “ivermectin could have an impact on the SARS-CoV-2 pandemic globally. Ivermectin is not a new and experimental drug with safety concerns; it is a WHO ‘essential medicine’ usually used in different indications. It may be useful for more health professionals to get access to this medicine for use against Covid-19 during the ongoing pandemic.”

Preprint format appears to be a regular exclusionary justification, as are studies focussed on prophylaxis, a pilot or in vitro study, a phase 2 trial, and any reviews that included observational studies. Also of note is another study by South African Dr Tess Lawrie, a rigorous review based on Cochrane methods, excluded on the singular basis that it had not yet been peer reviewed.

POT, MEET KETTLE

These may all be standard reasons for exclusion, but one can’t help wonder why the design would so blatantly exclude all the most compelling data for ivermectin use. And why many others (like Gómez-Hernández, et al. as but one example) are not even mentioned. I’ll go out on a limb and call it exactly what it looks like: cherry picking camouflaged in industry speak.

On 30 July this review was “updated” by extensively lamenting the poor quality of studies supporting ivermectin, and choosing only one more anti-ivermectin study (Popp et al.) for inclusion. No surprise there. By protesting too much, it gives away its hand: call anything that runs counter to your prior conclusions poor science, and prop up your previous pronouncements with anything that will do.

The Popp study is an outdated, biased retrospective meta-analysis that splits up studies in order to dilute effects and avoid statistical significance. A more comprehensive critique can be found here: https://c19ivermectin.com/popp.html

Much more could be written in assessment of these South African reviews, but one tires of the project when the problems are already so apparent, and I hate to abuse a reader’s patience when they’ve already got the point. For a deeper dive into studies on ivermectin, these seem like fulsome resources: ivmmeta.com and c19ivermectin.com

DANGEROUS DISSENT

The resistance to prescribing repurposed medicines that have been proven safe, for fear they might eventually turn out to have little benefit (besides a welcome deworming), stands in stark contrast to the daily doling out of drugs with extensively documented risk of serious harm. Repeatedly citing insufficient evidence (in the face of compelling exhibits that seem all too easy to ignore), appears as entrenched and obstinate, especially to those in the early phase of illness who are blocked from access by dismissive doctors. Anecdotes abound.

Growing numbers of people are questioning their trust in undoubtedly sincere but fallible professionals trained to convey confidence, whose livelihoods, reputations – and even sense of self-identity – depends on towing the industry line. Indeed, doctors who dissent are painted as dangerous, at best,, as those who drafted the Great Barrington Declaration can attest.

As the Church discovered during the Dark Ages, fear and moral righteousness are the top tools of manipulation, and are so at home in the human mind that populations are even prone to propagandise themselves. “The science” has replaced “the Lord” in monolithic expressions of faith.

The current climate seems predicated on a naive regard of science – as if medical science (and public opinion) are not for sale to those who can afford it. It’s no hardship to follow the money.

letter | doctor letter

Ivermectin for preventing and treating COVID‐19

Outdated very biased retrospective meta analysis selecting a small subset of studies, with a majority of results based on only 1 or 2 studies, showing positive…

c19ivermectin.com

Ivermectin for COVID-19: real-time meta analysis of 63 studies

Ivermectin for COVID-19. Early treatment - 72% improvement, p < 0.0001. All studies - 68% improvement, p < 0.0001. 1 in 1 trillion probability results of the…

ivmmeta.com

The bomb is ticking louder...

Breakthrough COVID-19 cases accelerate in Minnesota

Severe COVID-19 in fully vaccinated Minnesotans remains rare even as more breakthrough infections are identified.

www.startribune.com

Already 1/3 of cases are breakthrough cases in MA...

As the CDC statistics shows the "vaccine power" decreases by about 10%/month.

How the vaccine effects wanes:

Anti-SARS-CoV-2 immunity induced by Pfizer/BioNTech vaccine may decline after 6 months

A team of scientists from Israel has recently claimed that antiviral immunity induced by the mRNA-based coronavirus disease 2019 (COVID-19) BNT162b2 gradually…

www.news-medical.net

Disease severity

Among people aged 60 years or above, the rates of severe COVID-19 were 0.29, 0.23, 0.15, and 0.10 per 1000 people for those who received the vaccine in January, February, March, and April – May, respectively.

The rate tripled in 4 months after 12 months expect it to be the same as of unvaccinated.

What vaccine terrorists hope....

Breakthrough cases won't stop vaccines from ending the pandemic

3 questions about how well COVID-19 vaccines work, answered. 3 questions about how well COVID-19 vaccines work, answered.

www.popsci.com

FDA Approval of Pfizer Puts Consumers in Ultimate Squeeze: PREP Act Liability Shields Ongoing While Fed/State & Local Authorities Now Force Vaccinations

FDA Approval of Pfizer Puts Consumers in Ultimate Squeeze: PREP Act Liability Shields Ongoing While Fed/State & Local Authorities Now Force Vaccinations

With the recent Food and Drug Administration (FDA) “approval” of the mRNA-based vaccine Comirnaty came the assumption that the liability shield protecting

trialsitenews.com

With the recent Food and Drug Administration (FDA) “approval” of the mRNA-based vaccine Comirnaty came the assumption that the liability shield protecting the drug and vaccine manufacturers, in this case Pfizer, would be lifted as the emergency use authorization (EUA) is no longer needed. But this isn’t the case at all with this most recent authorization under the Biden Administration. No, the reality is very different today for the healthcare consumer. Of course, one frequently discussed policy driver for the FDA approval of Pizer’s mRNA-based vaccine was to reduce vaccine hesitancy. That’s because the general public would perceive the vaccine to be permanently approved instead of an emergency use scenario. Not widely broadcast to the public is the support the approval provides to back up widespread vaccine mandates at the federal, state, and local employer level to the private sector. The recent approval was unorthodox, involving two distinct letters, one to Pfizer continuing the EUA and the other to BioNTech granting full approval to Comirnaty. Most healthcare consumers don’t realize that the recent FDA approval does nothing to protect their interests should injury or death result from an inoculation. That’s because both the approval and the EUA fall under what’s called the Public Readiness and Emergency Responsiveness Act, also known as PREP Act or PREPA. Now those pharmaceutical companies that have approved products such as Pfizer benefit on both sides, while they maximize revenue thanks to mandates and minimize legal risks thanks to all-encompassing liability shields under the PREP Act. Moreover, TrialSite suggests the duration of this coverage could run until 2024. What is the PREP Act, and why hasn’t the liability shield been lifted? What are the implications?

Vaccine-Centric Strategy & ‘Rushed’ FDA Approval

Vaccine hesitancy persists as a challenge in the United States (and beyond) as various demographic cohorts, or subsegments within, resist succumbing to the jab. This occurs for a variety of reasons. Historical injustices and health inequity in the African American community, including unethical and illicit experimentation such as Tuskegee, leads to residual fear and concern passed down the generations.

In other segments of society, people who have already been infected believe in the staying power of natural immunity. Still, others are susceptible to ideological “camps,” that is, groups of people that buy into a certain narrative, from the somewhat rational (those concerned about big pharma liability protection) to the irrational (vaccination is a plot to insert microchips in unsuspecting people). Another segment prides itself on organic, natural living and expresses concerns about new vaccines with no long-term testing. Yet, others have comorbidities, say perhaps immunocompromised, and fear adverse events. Finally, others lament the loss of individual rights perceived in growing mandates. Of course, there are many more examples, and no category or stereotype can appropriately box in those who have opted for vaccination.

Consumers have little protection, despite the recent high profile approval thatTrialSite indicated was potentially improperly rushed, and the actual process led to a bifurcated, non-standard outcome. That is, the FDA’s actions kept intact both the EUA and introduced the formal approval. In this way, existing EUA products (and rules) are enforced. At the same time, the force of full approval was to instill confidence in the public, perhaps, and provide serious backing for mounting mandates at places of employment—universities, governments, and health systems, etc.

But why is the liability shield not lifted?

The PREP ACT

As indicated by a Pfizer executive, the answer to this question is the Public Readiness and Emergency Responsiveness Act, also known as PREPA. Enacted in 2005 by Congress during the tenure of George W. Bush, this new law authorized the Secretary of the U.S. Department of Health and Human Services to issue the PREP Act declaration in response to a declared public emergency such as an epidemic, pandemic, or bioterrorism for example. The law introduced the product liability shield for pharmaceutical companies developing what was classified as “countermeasures” during a declared emergency.

PREPA represented a controversial tort liability shield granted to the vaccine producers to consumer health advocacy groups, protecting them from financial risk during an emergency. However, pharmaceutical companies lobbied intensely for key provisions, indicating the great financial risks of rapid vaccination programs.

Codified at 42 U.S.C section 247d-6d, this provides pharmaceutical and biotech companies the immunity from the standard liability associated with the commercialization of vaccines, from the manufacturing, quality and commercialization activities required to deliver product in association with the use of “countermeasures against chemical, biological, radiological and nuclear agents of terrorism, epidemics, and pandemics.”

Thus, since the pandemic and declared emergency, PREPA ensures immunity from tort liability claims, with an exception for “willful misconduct” to individuals or organizations involved in the production and commercialization of so-called “medical countermeasures.”

PREPA was embraced, and some could argue over-used by the previous POTUS (Trump). By December 2020, the Trump Administration has already issued four amendments to the initial HHS.

COVID-19 Timeline

TrialSite reviewed the timeline of events that have led to unprecedented liability shields for not only key vaccine producers (pharmaceutical companies) but also the complete ecosystem involved with the delivery of “countermeasures” from local and state government and health systems to every kind of conceivable device, test and the like. This was accomplished under the Trump Administration via the initial HHS Alex M. Azar DE clarion invoking PREPA and unprecedented use of amendments to extend and enhance government, industry, and medical professional liability shields.

In fact, the previous POTUS fully embraced the PREP Act to shield all sorts of private and public sector acts from any liability. Frankly, the Trump Administration made far broader use of the PREP Act than ever before. Of course, the underlying premise wasn’t negative—that there is an unprecedented health emergency and that consumers will need access to potentially life-saving countermeasures. What follows, TrialSite outlines a brief chronology of amendments to the PREP Act reported by U.S. HHS Office of the Assistant Secretary for Preparedness and Response.

Date Event

January 31, 2020 HHS secretary Alex M. Azar II declared a public health emergency as defined by section 319 the PHS Act, 42 U.S.C. 247d effective as of January 27, 2020 for the entire nation to support the nation’s health care community in the context of the emerging COVID-19 outbreak.

March 10, 2020 Azar invoked the PREP Act for medical countermeasures (e.g. vaccines, therapeutics, etc.) targeting COVID-19 as described in the Federal Register (85 FR 15198, Mar. 17, 2020) known as “the Declaration.”

April 10, 2020 Azar introduced the first amendment to the PREPA Declaration, extending liability immunity to “covered countermeasures authorized under the CARES Act (85 FR 21012, April 15, 2020). June 4th, the Trump Administration via HHS Azar’s actions further amended the PREPA Declaration “to clarify that covered countermeasures…include qualified countermeasures that limit the harm COVID-19 might otherwise cause.” (85 FR 35100, June 8, 2020).

August 19, 2020 The HHS Secretary triggered an amendment declaring additional categories of Qualified Persons and offered further amendments involving categories of disease, health condition or threat for which Azar “recommended the use of the Covered Countermeasures. (85 FR 52136, August 24, 2020).

December 3, 2020 Azar introduced even more pervasive liability shields leaving the health care consumer ever more vulnerable. That’s because the former Secretary further “amended the declaration to incorporate Advisory Opinions of the General Counsel interpreting the PREP Act and the Secretary’s Declaration and authorizations issued by the Department’s Office of the Assistant Secretary for Health as an Authority Having Jurisdiction to respond; added an additional category of qualified persons under Section V of the Declaration; made explicit that the Declaration covers all qualified pandemic and epidemic products as defined under the PREP Act; added a third method of distribution to provide liability protections for, among other things, private distribution channels; made explicit that there can be situations where not administering a covered countermeasure to a particular individual can fall within the PREP Act and the Declaration’s liability protections; made explicit that there are substantive federal legal and policy issues and interests in having a unified whole-of-nation response to the COVID-19 pandemic among federal, state, local, and private-sector entities; revised the effective time period of the Declaration; and republished the declaration in full.”(85 FR 79190, December 9, 2020).

February 2, 2021 Now with a new POTUS (Biden), then Acting Secretary Norris Cochran continued the Trump pattern of continued aggressive use of this law. Cochran Acting “amended the Declaration to add additional categories of Qualified Persons authorized to prescribe, dispense, and administer COVID-19 vaccines that are covered countermeasures under the Declaration (86 FR 7872, February 2, 2021).

February 16, 2021 Just a couple weeks later by February 16, 2021, Cochran further “amended the Declaration to add additional categories of Qualified Persons authorized to prescribe, dispense, and administer COVID-19 vaccines that are covered countermeasures under the Declaration.”(86 FR 9516, February 16, 2021).

February 22, 2021 February 22, 2021, the Department filed a notice of correction to the February 2 and February 16 notices correcting effective dates stated in the Declaration, and correcting the description of qualified persons added by the February 16, 2021 amendment. (86 FR 10588, February 22, 2021).

March 11, 2021 Under the Biden Administration the Acting Secretary moved to amend “section V of the Declaration to revise subsection (f) to clarify that observers should be experienced in administering intramuscular injections; delete subsection (g), change the prior subsection (h) to subsection (g) and add a new subsection (h) to add additional categories of qualified persons covered under the PREP Act, and thus authorized a number of further clarifications.

Rationale

The PREP Act was designed, among other things, to incentivize accelerated vaccine production in the case of a public health emergency, such as the COVID-19 pandemic. The liability shield remains the centerpiece of the law. Put simply, the pharmaceutical industry wouldn’t agree to commit resources, capital, and talent to accelerate vaccine development unless sufficient protections were in place to protect them against waves of litigation, such as the type that drove the tobacco industry to mass settlements.

Public Health Emergency vs. PREPA

Note that when the HHS Secretary invokes the PREP Act, this action is distinct from their power to proclaim a public health emergency under Section 319 of the Public Health Service Act. The suite of legal terms and conditions is distinct and different, as are the implications. More tailored and specified to a pandemic or bioterror, for example, in the latter case, the HHS Secretary must publish the PREPA edict in the Federal Register, identifying select information associated with each countermeasure.

Key Features of PREPA

The law supersedes or trumps state vaccine law, hindering attorney general actions against potential industry wrongs. The US HHS secretary oversees decision-making as to the definition of what constitutes an emergency offering an executive administration branch considerable powers as experienced in the current pandemic.

The concept of “program planners” also falls under covered entities in the Act, meaning a range of organizations from Native American tribal governments to state governments and local governments involved with the oversight and management and dispensation of vaccines, for example, also fall under the protected category.

Moreover, “qualified persons” from licensed health care providers and other health care or government professionals authorized to participate in the countermeasure response, as promulgated by the HHS Secretary, enjoy the liability shield, along with the employees and agents associated with this ecosystem of organization involved with a pandemic response.

Under PREPA, gone is the constitutional right to a jury trial. Although jury trials in civil cases are rarely used, this still remains a 7th Amendment right further stripped by PREPA in cases where a vaccine injures a consumer. There are exceptions for “willful misconduct” resulting in death or serious physical injury, which, not surprisingly, is incredibly difficult to prove.

Tight parameters govern all lawsuits under PREPA. For example, the plaintiff can file a lawsuit only in the United District Court for the District of Columbia. Making matters more complex, the plaintiff is subject to strict, customized pleading requirements.

Furthermore, PREPA showcases growing executive branch power, given the HHS secretary has the authority under the Act to create rules and regulations “that further restrict the scope of actions or omissions by a covered person” involving willful misconduct. While the law applies to vaccines and any drug, device, or diagnostic product that HHS secretary classifies as a “covered countermeasure,” the HHS secretary has been authorized thanks to PREPA to determine that a situation could become a health emergency in the future regardless of the specific connection to a pandemic, for example.

Enactment of PREP Act During COVID-19

As described in the aforementioned table, the HHS Secretary Alex Azar, under the previous POTUS, invoked the PREP Act at the start of the pandemic for a period of four years, which means that until 2020, consumers would essentially have zero protection against vaccine injuries, for example.

As vaccine clinical trials showed results by the end of the year, some mainstream media were surprisingly frank about the situation. For example, MacKenzie Sigalos writing for CNBC, declared on December 17, 2020, that due to the PREP Act, “You can’t sue Pfizer or Moderna if you have severe COVID vaccine side effects. The government likely won’t compensate you for damages either.”

CNBC educated the reader as to the new reality as most mainstream media, politicians, and government bureaucrats in the HHS were not going to inform consumers of their rights or the lack thereof appropriately. That is, thanks to the enactment of the Act:

According to the CNBC journalist, pharmaceutical companies for four years would enjoy “total immunity from liability if something unintentionally goes wrong with their vaccines.”

The compensation pathway, limited and highly prescribed, included a little-known government fund.

Winning any money from this government fund for a civil wrong has been incredibly rare—with only 29 claims over the last ten years.

The Mainstream Media Fact-Checkers

There has been much confusion throughout society about the implications of the Pfizer (Comirnaty) formal approval. There has been much speculation that this action will prompt an uptick in vaccination and put health care consumers more at ease that the vaccine product is safe, effective, and fully vetted.

TrialSite and many other prominent medical and research scholars have challenged the accelerated pace of the approval. Importantly, in a recent Washington Post “Fact Check,” Glen Kessler fact-checked Robert Malone, challenging a claim made on the Steve Bannon show that the “approved vaccine would no longer have liability protections so Pfizer would simply keep distributing in the United States the product that had been authorized for emergency use.” Billed as a “little trick” by Malone, the prominent critic was correct that the FDA issued “two separate letters for two separate vaccines. The Pfizer vaccine, which is currently available, is still under emergency use authorization and it still has the liability shield,” yet indicated that the liability shield for Comirnaty, the approved product, would be lifted.

The Washington Post’s Kessler acknowledged that the use of the accelerated approval correlated with both policies to encourage more vaccinations and offer companies and government employers the backing for widespread vaccine mandates.

Pfizer’s ‘Complete Immunity’

The recent Washington Post piece authored by Kessler clarifies for all that Pfizer got the best of both worlds from the recent FDA approval. That’s because they will continue to enjoy the benefit of an all-encompassing liability shield while federal, state, and local government employers, not to mention the private sector, can now enforce uniform mandates for vaccination. Pfizer will produce tens of billions of dollars per annum for the foreseeable future and enjoy essentially complete product liability protection—even if the product maims or kills.

Kessler noted, “The Comirnaty vaccine has the same liability protection as the vaccine approved under the EUA.” But why is this the case? Well, we have the answer—PREP Act. Kessler informed the readers that the triggering of the PREP Act “covers all vaccines that might be produced to combat the coronavirus, whether fully authorized or not.”

What recourse does a consumer have?

As indicated in the Washington Post and above, pharmaceutical companies are completely shielded unless willful misconduct can be proven, and that’s difficult, time-consuming, and very expensive. Regardless, the PREP Act involves the Countermeasures Injury Compensation Program (CICP), which represents a government fund (taxpayer money) used to pay out claims associated with vaccine injury. The government has stepped in and committed limited taxpayer dollars offering full coverage to the vaccine producers. Remember, the government also allocated enormous sums (tens of billions) to subsidize the vaccines’ development, clinical trials, and manufacturing.

What kinds of restrictions does the CICP introduce?

Unlike the National Vaccine Injury Compensation Program, which offers the potential for traditional tort damages such as pain and suffering, emotional distress, or other comparable damages under PREPA’s CICP, any claims are seriously capped. Meaning any payout is limited to $50,000 per year. So if someone is making $250,000 annually and they lose their ability to work due to an adverse event associated with the vaccine, their actual recourse is severely limited.

How many people have claimed injury with the CICP thus far?

From 2010 to August 2, 2021, the CICO website reveals the total number of claims stands at 2,186.

How many claims are associated with experimental COVID-19 vaccines and therapies?

According to the CICP website, by August 2, 2021, there were 1,693 COVID-19 countermeasure claims, 686 alleged injuries/deaths from COVID-19 vaccines, and 1,007 alleged injuries/deaths from other COVID-19 countermeasures.

TrialSite notes that even though Hydroxychloroquine has been deemed not effective and thus not part of any EUA, the federal government still includes that drug under a countermeasure, thus mitigating any liability risk.

What’s Pfizer’s Official Statement?

Sharon J. Castillo, Pfizer’s Senior Director of Media Relations, Latin America & US Government Relations, went on the record with the Washington Post to clear the air and let all know about Pfizer’s near-universal immunity from liability. That is, although the formal FDA approval has occurred, most consumers that read up on these matters would assume the pharmaceutical company would lose some liability protection and the consumer gain protection. This is not the case at all.

Ms. Castillo declared, “The liability protections afforded under the PREP Act are tied to the declared public health emergency and not whether the vaccine is sold under an EUA.” She continued, “Therefore, both Comirnaty and the Pfizer-BioNTech covid-19 vaccine receive the same liability protections as medical countermeasures against covid-19.” The Washington Post’s Kessler elicited an HHS spokesperson’s confirmation declaring, “There are no liability or compensation differences between a countermeasure approved under an EUA or one that has received full FDA approval,”

Are there any lawsuits occurring at all under PREPA?

Yes. PREPA is invoked in several lawsuits. Notable among them is skilled nursing or assisted living facilities where COVID-19 countermeasures, including the administration of vaccines, are said to have resulted in resident deaths, as reported in the National Law Review.

Call to Action: Think about the implications of the current situation. The benefits or costs depend on one’s point of view. For those who believe the vaccine-centric strategy marks life or death, perhaps this configuration of law and commerce is a godsend. On the other hand, for those civil libertarian types, this configuration represents a dangerous confluence of executive branch power, industry, and erosion of workplace rights and civil liberties. What do you think? Share in the comments.

Quote from Bob#2

Remdesivir is even dismissed by the WHO. If it had "high precision" evidence, surely they would endorse it. Yet they officially removed it from the approved list.

On the other hand, the FDA has approved it for use with COVID. See:

Remdesivir Injection: MedlinePlus Drug Information

Remdesivir Injection: learn about side effects, dosage, special precautions, and more on MedlinePlus

medlineplus.gov

Evidently, the FDA and WHO disagree. Experts often disagree when the data is ambiguous.

Quote from Bob#2

You deny India success

Anyone familiar with health care in India will have doubts about their success.

Ivermectin use in india

More depressing news from Georgia.

GDPR Support

The Jolt: Anti-vaxxers shut down vaccination event, harass state health workers

POLITICAL INSIDER

By Patricia Murphy - The Atlanta Journal-Constitution

Greg Bluestein - The Atlanta Journal-Constitution

The headlines out of Gov. Brian Kemp’s latest press conference focused on the thousands of Georgia National Guard troops he’s preparing to deploy to help hospitals fight the pandemic.

But it was Dr. Kathleen Toomey who stopped us in our tracks when she revealed that anti-vaxxer protesters had disrupted several vaccination drives -- and forced one to shut down.

We asked aides to Toomey, the state’s top health official, to elaborate. Her office promptly detailed how public health staff “have been harassed, yelled at, threatened and demeaned by some of the very members of the public they were trying to help.”

In one south Georgia county, the anti-vaxxers tracked down public health employees through social media and harangued them with messages of hostility and misinformation about vaccines.

And the event that was canceled was a north Georgia mobile vaccination event, where an organized group of people showed up to harass and name-call public health workers. . . .

Quote from Fm1

With the recent Food and Drug Administration (FDA) “approval” of the mRNA-based vaccine Comirnaty came the assumption that the liability shield protecting the drug and vaccine manufacturers, in this case Pfizer, would be lifted as the emergency use authorization (EUA) is no longer needed.

This is how the criminal states of USA work since WWII. Money money money. They sold eastern Europa to the Russians for money they never got back...Conclusion. USA is ruled by outraging stupid individuals (mostly Free masons).

Quote from JedRothwell

The Jolt: Anti-vaxxers shut down vaccination event, harass state health workers

USA is a mad house. May be thanks to CoV-19 you will get rid of some of the worst GOP (tea party) members.

As said without any treatment ready and with a totally corrupt medical system the vaccination of people age >65 with comorbidity is the only solution - the same for younger obese/diabetes II high blood pressure age < 65!

Not so here in Switzerland/Europe. Here you can buy Ivermectin without prescription if you know how to sing.

But the fascist terror is growing all over here too. Inclusion with a green pass is like exclusion with a "J"" during WWII. Vaccinated have higher viral load than unvaccinated according UK data. Why should they get a free (green) pass??? And people with antibodies get none despite these are protected up to 40x better?

The real danger of CoV-19 is fascism. It is more real since ever!

As of August 20th Update summary for Pfizer/Astra crap:

Covid Vaccines: The Good, The Bad, The Ugly

The latest data from Israel and the UK on covid vaccine effectiveness.

swprs.org

Israel:: Importantly, in people who got vaccinated already in January 2021 (primarily the elderly), protection against infection and mild disease has already dropped to just 16% (see chart above). Moreover, since the Delta covid outbreak is still accelerating in Israel, the effectiveness against hospitalization and severe disease may further decrease (due to lags in hospitalizations).

(Update: The latest official MoH data confirms that protection against severe disease has already dropped to 55%; compared to the original 96%, this results in a tenfold increase in residual risk.)

The same is reported from UK data where Astra Zeneca (Oxfford vaccine) is even worse...

In the UK, which has primarily used the AstraZeneca DNA adenovector vaccine, the latest estimate by researchers at University College London indicates an effectiveness against infection of only 8% and a total effectiveness against severe disease of about 60%. In very senior citizens, the effectiveness against severe disease may be even lower (due to a weaker immune response).

Interestingly, the British government hasn’t updated its data on AstraZeneca vaccine effectiveness since June 13. Update: New data from PHE confirms that effectiveness against infection has dropped below 20%.)

‘Get Sicker’: Anatomy Of A Failed Policy

‘Get Sicker’: Anatomy Of A Failed Policy

Note that views expressed in this opinion article are the writer’s personal views and not necessarily those of TrialSite. By Mary Beth Pfeiffer

trialsitenews.com

‘Get Sicker’: Anatomy Of A Failed Policy

Note that views expressed in this opinion article are the writer’s personal views and not necessarily those of TrialSite.

By Mary Beth Pfeiffer

Twenty-seven-year-old Ankit Dubey was sick and terrified. He could hear sirens blaring across Lucknow, his home in northern India. He had been warned away from hospitals. People in his middle-class neighborhood were dying.

This second COVID wave was nothing like the first in 2020. This was Armageddon, “a horror movie,” he said, that lasted through April and May of 2021. He had thought lockdowns had spared India the chaos he had seen on TV from New York and Rome. He was wrong. “We went through hell,” he said.

Dubey told me his story because he wants the West to understand, to know. He, his parents, 56 and 65, and brother, 30, all four sick, were spared death, thankfully, but also painful and prolonged illness. How? They got treated early with a combination of safe generic drugs: azithromycin, doxycycline, and another he had never heard of: ivermectin. Other Indians tell similar stories.

India has been cast as a COVID failure with a struggling health-care system and spotty access to vaccines. But despite those two realities, India quelled a vicious Delta wave by making a key choice. Most of its states, led by 240-million population Uttar Pradesh where Dubey lives, opted to treat COVID early. The United States, Canada, the United Kingdom and most of Europe have not. They can learn from Ankit Dubey’s story.

“I don’t want to see more humans suffer like we did,” he said.

This article – my twentieth on COVID treatments in 18 months — was prompted by the contrasting experiences of success and suffering, of the Dubey family in India that beat back a virus at its doorstep to two patients in the United States who were never given the chance.

First, here is how the supposed greatest nation on earth practices COVID care.

Late, Pricey, Pointless

Sick with COVID and seeking help, Laurie Sharr, 62, in Nevada and Stephen Tyrrell, 51, in Florida were offered nothing to treat their escalating infections. This, of course, is standard operating procedure in America. Sharr was sent home with an antibiotic for pneumonia from a doctor who did not bother to test her or her husband. Tyrrell went to an emergency room with a dangerously low blood oxygen reading, and was told, “Go home and take Tylenol and rest.”

Within 48 hours, both were sick enough for a ticket into a hospital, with Laurie Sharr telling a doctor she was doing OK. “Don’t worry,” the doctor said, “it’s going to get a lot worse.” Indeed, ahead lay the “cytokine storm” – the dreaded cascade of illness that claims many COVID patients. It almost killed them both.

Three significant parallels emerged from my talks with these patients 2,500 miles apart.

Both had hospital staff members whispering to them that ivermectin worked but their hands were tied; one doctor had even used it to treat himself. Both had ivermectin smuggled into the hospital for them – in a pajama bag and in Gatorade. Both in no uncertain terms were denied safe, FDA-approved ivermectin – as many patients are — but somehow, eventually, both got the hospitals to give it.

For Tyrrell, the change was “180 degrees…it saved my life.” Sharr said the drug got her “over the hump.” It can be argued that each would have lived anyway. But the point is that damage was done. What would COVID have been for them if, like Dubey, they had been treated early and at home?

In all, Tyrrell spent 104 days in two hospitals and a rehab facility. For his first 38 days alone, Tyrrell’s insurance company paid $385,000. That six-figure prize won him the Cadillac of USA COVID care – high-priced remdesivir, state-of-the-art tocilizumab antibodies, inhalers, steroids, BiPAP treatments and blood-thinners.

‘I’m Terminal’

After eight days of this, and despite all efforts, Tyrrell was suffering severe oxygen deprivation and moved to ICU. “The patient has a critical and tenuous respiratory status,” a doctor wrote in his chart. Tyrrell was told 10 to 15 percent of patients like him survive 30 days.

Facing intubation next, Tyrrell had had enough. “I’m terminal, if you unplug that [oxygen] machine, I’m going to die,” he told a doctor. “I asked him, after he’d already given me everything else, if I could take ivermectin.”

“You might as well drink bleach,” the doctor responded.

Such hostile and dismissive responses – “witchcraft,” one hospitalist called ivermectin – are common from doctors who themselves appear traumatized by medical impotence and loss. Fearful and constrained, they watch helplessly as patients like Tyrrell and Sharr – once robust and healthy — are withered by COVID.

A fit and active man before COVID who took only baby aspirin, Tyrrell lost 84 pounds – a third of his body weight — and spent weeks on his back and then in a wheelchair. He struggles now to walk the length of his home. Sharr, a thrice-weekly aerobics instructor and choir singer, lost 27 pounds in two weeks and is haunted by her experience. “This thing eats your body,” she said. “It just eats it away.”

All of this — the suffering, trauma, disability and expense — might have been avoided if these two patients had been treated early. Yet we are told there is no early treatment.

That is a lie.

Complicit, ‘Catastrophic’

These two cases are not unique, as I’ve learned in 18 months of COVID research, including many talks with doctors, patients and scientists. At this point in our global pandemic, it is clear to me: People have died needlessly, and government is complicit. I’m not alone in believing this.

“It embarrasses me for what we have done in the U.S. in terms of this management,” Dr. Mobeen Syed, a medical educator with 395,000 YouTube subscribers, told me when we spoke of ivermectin for this article. “It embarrasses me that even though we have drug that is safer than Tylenol, we have made people resort to taking horse paste or animal products. We have done this to Americans.”

Juan Chamie, a data analyst who researches pandemic trends, made a prediction about the unfolding U.S. Delta wave as the weather cools; people move indoors, and school reopens. “Fall and winter in the highly vaccinated states in the north,” he said, “is going to be catastrophic.” Only early treatment can stop it, he told me.

Time and again, Chamie has documented ivermectin’s impact on dozens of outbreaks: In Delhi, Uttarakhand, Haryana and Uttar Pradesh in India; in parts of Peru, Paraguay, Colombia, Argentina and Brazil; and in Panama, Namibia, Zimbabwe, Slovakia and Indonesia. Ivermectin reduced hospitalizations in Mexico City up to 76 percent, while a door-to-door campaign obliterated it in the state of Chiapas. These trends, just after organized efforts, are no coincidence.

But rather than support actual outpatient care, this is what we get from alleged protectors of U.S. public health, including the Food and Drug Administration, National Institutes of Health, and Centers for Disease Control:

Willful ignorance of the science supporting ivermectin – or any early treatment for that matter.

Demonization of this safe FDA-approved drug, used on 250 million people annually, as fit only for animals.

Speedy acceptance of drugs like woefully ineffective remdesivir in a system rife with conflicts of interest.

A fantastical supposition that there is one way out of COVID: Vaccines.

Greatly enriched pharmaceutical companies thanks to taxpayer largesse and something called the Emergency Use Authorization.

That statute in U.S. law allowed millions to be inoculated with a hot-off-the-presses, unapproved vaccine, as long as one explicit caveat was met: “there are no adequate, approved, and available alternatives.”

Of course, we know there were alternatives all along. Drugs to treat COVID have been sacrificed to vaccines.

Message and Media

Throughout COVID, the media has stepped into line like good soldiers in a war on disease, failing, in the process, to do its job. It gave government a pass on the dearth of outpatient care. It fostered the fiction that aggressively treating COVID is a right-wing construct. It dismissed vaccine side effects as rare. It enabled vast censorship.

News outlets might be excused for initially minimizing falling vaccine efficacy in this dynamic situation. But it cannot be excused for its politicization of and disdain for generic early treatments. As a mainstream community journalist for decades, with two books and many awards, I am appalled at what this profession has become.

Existing drugs could have relegated COVID to a manageable outpatient disease by the first half of 2021.

We have promising generics: ivermectin primarily but also fluvoxamine, hydroxychloroquine, budesonide and protocols that employ them with zinc, Vitamin D and the like. They have been suppressed around the globe, as countries – mainly, but not all, in the first world — have caved under pressure to conform to the U.S.-hatched strategy.

In the white-hot frenzy of pack journalism, doctors’ licenses have been threatened, and reputations imperiled, including of a prison doctor who used ivermectin and kept inmates out of hospitals. Will nursing home practitioners, who told me of their own ivermectin success, be next in this witch hunt? Indeed, somehad used it to control scabies and found a remarkable drop in COVID.

As the globe is buttressed by new variants, vaccine efficacy is being tested and so is that of ivermectin. Leading proponents are adjusting doses and adding to treatment cocktails as part of a logical ongoing effort: Use emerging science and clinical experience to learn what works. Although off-label use of approved drugs is well established — accounting for 21 percent of office prescriptions and half of oncology drugs – doctors have instead been told to follow only a few, patented, government-sanctioned treatments, available only in hospitals.

Who could blame them, in this heated environment, for not practicing medicine but following orders? Nonetheless, the forces of commerce and incompetence that have pushed a false narrative and demonized treatment for COVID must be held to account.

‘Walked Out Alive’

Laurie Sharr in Nevada was traumatized by 16 inpatient days in which her oxygen level plummeted so low that a doctor once looked at her readings and summarily told her she was minutes from death. Her husband, Weldon, fighting COVID in another hospital room, was wheeled in to say goodbye. Instead, he helped her onto her stomach and brought her back from the brink. At least for the moment.

For days, a nurse had told Sharr about ivermectin. “When we used to prescribe it,” the nurse had said, “everybody was walking out alive.” Though Sharr asked and was denied ivermectin, someone apparently intervened. All Sharr knows is that she got the drug for the last five days of her stay. “I started getting better.”

Sharr is grateful, but she is also angry and shaken: By her treatment like a “leper” who was checked through a window or doorway; by her nightmares of three to four calls of code blue each night; by her doctor’s callous announcement of impending death.

“If you don’t figure out how to live,” she said in a conversation punctuated by tears and memories of trauma, “you do not live.”

Helped From Afar

Three weeks into COVID, Stephen Tyrrell was maxed out on oxygen and breathless. “Help my wife bury me,” he texted his friend of more than 20 years, Sam Guirguis. Alarmed, Guirguis found a doctor in Idaho, Ryan Cole, who told him about an ivermectin protocol.

As with Sharr, administrators refused Tyrrell’s pleas, even under Florida’s “right-to-try” law for dying patients. After he threatened to bring in a high-powered law firm, Tyrrell got ivermectin on day 27 of infection. The change was dramatic. “I got my husband back,” said his wife, Rebecca Tyrrell. To Guirguis, Tyrrell went in three days from “basically dead” to making plans for a part-time business. “This was a man with a future.”

(I’d note here that the smuggled ivermectin may have made the dosing difference for one of these patients. We will never know.)

The article you are reading will undoubtedly be labeled “misinformation,” along with millions of Facebook posts that disagree with the government’s pronouncements. That single word and its embrace by the media has enabled anti-treatment COVID dogma. It keeps the press on message. It instills fear. It tows the line, even as the line moves and the government narrative shifts — on infectiousness of the vaccinated, how well vaccines work, where the virus originated and herd immunity.

Vaccines no doubt are a necessary weapon against infectious disease. But in the case of COVID, they have impeded actual care of those who are already sick, vaccinated or not.

I.F. Stone Knew

“All governments lie” was the mantra of investigative reporting legend I.F. Stone. As a journalist, I have exposed some serious lies in my career. But my reporting on the management of COVID-19 has transformed my view of government, and my profession, in a way that 25 years of investigative reporting did not.

It was a lie when the FDA trotted out a six-month-old web post recently, warning of “serious harm,” “seizures, coma and even death” from ivermectin. The March post was spurred, it said, by “multiple” reports of people harmed by an animal formulation. In response to my question – how many is “multiple”? – the agency told me four, with some “lost to follow-up.” This is how governments obfuscate, confuse and, yes, lie when discussing a drug that the Journal of Drugs in Dermatology said in 2016 “continues to provide a high margin of safety for a growing number of indications.”

FDA-sanctioned remdesivir, meanwhile, was associated with more than 500 deaths in its first year of use. Ivermectin was linked to 20 deaths in 19 years of WHO VigiAccess record-keeping. You won’t find that on the FDA web site.

In the same vein, on Aug. 26, the CDC reported a “three-fold increase…from the pre-pandemic baseline” in ivermectin calls to poison control centers. I asked the CDC press office four times: How many calls were received, and what was the baseline?

It finally answered, gave no figures, and referred me to the American Association of Poison Control Centers. I’m waiting.

Back to India

Ankit Dubey lives in a white stone house with first and second-floor terraces adorned by greenery, like many houses in America. He is happy to be alive and healthy, knowing what it is like to struggle for breath. A 2019 university graduate, he hopes to work in journalism.

When we spoke, we compared notes. In India, ivermectin is now a “household name” and easily available for about 150 rupees ($2) at the nearest drug store. People no longer fear COVID in Uttar Pradesh, with just 300 active cases on Aug. 28. Instead, he said, they treat it. Life goes on.

In the U.S., meantime, I told Dubey of shortages of ivermectin and of pharmacists refusing to fill prescriptions. He knows well the propaganda campaign being waged against ivermectin here because he follows Twitter, which is how we made contact.

“I feel sorry for you all, Miss,” he wrote in a text. “People should use India’s example.”

If only they did. The promise and merits of vaccines aside, treatment matters.

“We are even more at the mercy of virus,” said Dr. Syed, who supports vaccines except in select risk groups. “The virus is not leaving any stone unturned to hurt us. We should also not be leaving any stone unturned to protect us.”

***

Mary Beth Pfeiffer is an investigative journalist. Find links to her COVID articles here.

READ MY ARTICLES — The First Epidemic

PFEIFFER, COVID-19, IVERMECTIN

www.thefirstepidemic.com

https://www.medrxiv.org/content/10.1101/2021.04.22.21255913v1.full.pdf

A first paper of vaccine induced CoV-19

One finding:

Ct values (inversely related to viral load) of new infections increased with increasing time from first
vaccination and number of doses (Figure 1; Supplementary Table 4). The highest Ct values were in those who had received two vaccine doses, with a similar distribution to those not vaccinated but previously PCR/antibody-positive. Ct values were lowest in those not vaccinated and not previously PCR/antibody-positive.

The important detail is hidden in Table IV (at end) and not commented. The odds ratio for vaccinated severe cases ct < 30 is much larger post vaccination up to 28 days than for unvaccinated.