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Gordo

Just curious, anyone have a plan, or preps for global pandemic?

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Ø   But did you look at the video itself? 

Yes, I started by watching the entire video and its style caused me to wonder if PV had an agenda.  Looking that up led to the numerous reports of previous falsehoods by PV. 

 

Ø  What's false and misleading about it?  

I wasn’t present on the five dates that “the staff member pretended to be a nurse on Tinder and went on five dates with Charlie Chester“ and so can not say what is distorted because I’m not privy to what was actually said.

 

I suspect there will be a number of lawsuits over this and will watch to see the outcome of those.

 

The quote above came from Project Veritas founder wants to sue Twitter for defamation over recent suspension

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5 hours ago, corybroo said:

led to the numerous reports of previous falsehoods by PV. 

 

This is a deflection attacking the source, so that the discussion changes from discussing the subject matter, to debating your source attack. You've done this before, as with the Great Barrington Declaration, I recall.

The point was the relentless amplification of fear relating to the coronavirus, by the media, and by CNN in this particular case.

The video speaks for itself. If you have any concrete evidence of fraud, please presented it. Otherwise, focus on the content presented.

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Hi Sibiriak!

Covid vaccine is available in the US -- so it appears that that crisis is coming under control.

Not so for illegal immigration -- it's at an all time high.  With the Drug cartels based in Mexico leading the onslaught -- migrants from Central America are paid money and provided with transport, in exchange for their bringing opioids across across the border; drugs that add to the severe addiction problem in this country.  And children and women in the caravans are often abused by the (combo human/drug) traffickers.

This is a problem that's growing worse, that appears to have no prospect of improvement without big changes in Washington.

  --  Saul

 

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On 4/21/2021 at 9:24 PM, Sibiriak said:

48%  of US respondents now believe illegal immigration to be  “a very big problem" versus 47%  for the coronavirus outbreak.

The left will continue to use use the fact that almost half of the population is still in fear of, and focused on, the coronavirus, to continue their unprecedented power grab and push through radical agenda, including open borders. This was why the pandemic was politicized and weaponized: When one's tribe supports indefinite lockdowns and wearing a mask starts defining one's identity,  one is also more likely to support other tribal policies that may have been unpalatable in "peacetime."

FDR used WWII similarly, and the Kenedy assassination and the civil rights movement were used to pass the 1965 immigration act, which dramatically changed US immigration by shifting preferences to family unification.

The US and the English-speaking world of liberal democracies will be much changed when this is over, and I am pessimistic about the results.

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It's horrible!  India has a facility that manufactures the oxford/astrozenica vaccine; it produces more vaccine than any other vaccine producing facility (including those manufacturing other Covid vaccines, such as Pfizer, Moderna, Johnson&Johnson), and, until the pandemic hit so overwhelmingly, exported some of it to the undeveloped world, including some African countries.  India is now keeping what they make-- but it isn't nearly enough.  The US, Australia, Russia and many other European countries are donating vaccine to India.

But it is all too little, too late.  There will be a horrible total death toll from this, before anything like normalcy returns.

  --  Saul

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7 hours ago, KHashmi317 said:

Short Video on India Situation: What does the Current Data Say?

This video is right on point, Thanks.

We should remember that the media has rolling coverage moving wherever infections are rising, with special emphasis on leaders the Left finds unpalatable. We've had Texas, then Florida, then Brazil, then South Dakota. Now it's Modi's turn. The Left hates Modi, so India is painted as hell right now, even though with four times the population of the US, it has one-third of the death toll. And this is the peak in India, which has so far been largely spared -- as recently as the middle of March a headline in the Economist proclaimed: "India seems to have suffered surprisingly few deaths from covid-19"

Does India have problems? Of course. But it's actually doing remarkably well, compared to many other countries, despite this being a holiday season with huge ongoing gatherings of revelers. And no masks.

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Science crazier than conspiracy theory...

Reverse-transcribed SARS-CoV-2 RNA can integrate into the genome of cultured human cells and can be expressed in patient-derived tissues

Quote

Prolonged detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) RNA and recurrence of PCR-positive tests have been widely reported in patients after recovery from COVID-19, but some of these patients do not appear to shed infectious virus. We investigated the possibility that SARS-CoV-2 RNAs can be reverse-transcribed and integrated into the DNA of human cells in culture and that transcription of the integrated sequences might account for some of the positive PCR tests seen in patients.

 

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3 hours ago, Todd Allen said:

Science crazier than conspiracy theory...

Well, not really. Retroviruses are well known to do this.

But the coronaviruses are not retroviruses, so if this is true, it'd be unusual. Until this is confirmed and replicated, nobody should get too excited.

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9 hours ago, Todd Allen said:

Science crazier than conspiracy theory

While hiking today, I was listening to the Paul Offit video that mccoy had posted, and it brought me back to the reverse transcription by RT that Todd linked above. The possibility of reverse transcription from the mRNA vaccines was adamantly rejected as impossible by Offit and this is the current view held by most. This is why anyone who suggests that the mRNA vaccines "change DNA" is ridiculed and laughed out of the room by most.

As I've pointed out repeatedly, SARS Covid-2 is not unique in leaving long-term effect in some who have recovered, as such effects are common after bouts with influenza and other viruses. While I personally think that another explanation will be found, the paper above is another reminder of why unpopular opinions should not be "canceled" or banned, but argued against with evidence. I should also note that even if there are real reverse transcription changes, they do not have to be significant, or adverse to one's health. Or be responsible for any of the observed long-tail effects.

If the paper had done exactly the same experiment with Pfizer's vaccine, with similar conjectures, it would have received a very different reaction.

It also strengthens the philosophical argument against Offit's push to force universal inoculations, as no matter how small the chance that the "crazies" might be right, there is still a chance and adults should be free to make their own choices, just as they do with the flu vaccine. I fail to see the logic in his "moral responsibility to others" claim, as those others are presumably free to choose to be vaccinated themselves, and as we know, the vaccines are very effective at preventing hospitalization and death, as well as transmission.

Finally, I am surprised that there was no mention of the long-tail immunity conferred by infection with SARS Covid-1 against SARS Covid-2, which would imply that D and T cell memory is likely effective for years to come in most people. I am sure that booster shots will be pushed, but it may be an over-precaution, at least in part driven by a profit motive.

One reason for the different outcomes in different regions, regardless of lockdowns, may well be that some populations had been exposed to similar viruses in the past:

"The team tested subjects who recovered from COVID-19 and found the presence of SARS-CoV-2-specific T cells in all of them, which suggests that T cells play an important role in this infection. Importantly, the team showed that patients who recovered from SARS 17 years ago after the 2003 outbreak, still possess virus-specific memory T cells and displayed cross-immunity to SARS-CoV-2.

"Our team also tested uninfected healthy individuals and found SARS-CoV-2-specific T cells in more than 50 percent of them. This could be due to cross-reactive immunity obtained from exposure to other coronaviruses, such as those causing the common cold, or presently unknown animal coronaviruses. It is important to understand if this could explain why some individuals are able to better control the infection," said Professor Antonio Bertoletti, from Duke-NUS' Emerging Infectious Diseases (EID) programme, who is the corresponding author of this study."

Edited by Ron Put

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On 5/7/2021 at 7:47 PM, Ron Put said:

Jeremy S. Faust, MD, MS; Chengan Du, PhD; Katherine Dickerson Mayes, MD, PhD; et al
JAMA. Published online May 21, 2021. doi:10.1001/jama.2021.8012
The initial COVID-19 outbreak in the US caused disruptions in usual behavioral patterns.1-3 To assess associated changes in external causes of death, we analyzed monthly trends from 2015 to 2020 in deaths resulting from drug overdoses, homicide, unintentional injuries, motor vehicle crashes, and suicide in the first 6 months of the pandemic.
Methods
We measured monthly excess mortality (the gap between observed and expected deaths) from 5 external causes using provisional national-level underlying cause death certificate data published by the National Center for Health Statistics (NCHS) through August 2020 (released March 2021). Data from March to August 2020 were aggregated by the NCHS into 5 groups: drug overdose (all intents), assault (homicide), unintentional injuries, motor vehicle crashes, and intentional self-harm (suicide) (see the Supplement for ICD-10 codes).4,5
To forecast all-cause and cause-specific expected monthly deaths from March to August 2020, we used seasonal autoregressive integrated moving average (sARIMA) models developed with cause-specific monthly mortality counts and US population data from January 2015 to February 2020. We plotted observed and expected deaths monthly with 95% CIs estimated from sARIMA models.
We estimated the contribution of individual cause-specific mortality to all-cause non–COVID-19 excess mortality by dividing cause-specific mortality by total non–COVID-19 excess mortality from March-August 2020 (see the Supplement). Confidence intervals for the percent contribution to non–COVID-19 excess mortality were determined by subtracting the observed number of deaths from the upper and lower 95% thresholds for the expected number of deaths. For excess mortality counts, any figure not crossing 0 was considered statistically significant. For observed-to-expected ratios (OERs) of cause-specific mortality, statistical significance was defined as a 95% CI that excluded the null value of 1.00.
Analyses were conducted using R version 4.0.2. This study used publicly available data and was not subject to institutional review approval per HHS regulation 45 CFR 46.101(c).
Results
From March to August 2020, there were 256 635 (95% CI, 161 450-351 823) all-cause excess deaths (1 661 271 observed; 1 404 634 expected) and 174 334 COVID-19 deaths (underlying cause). For the study period, OERs for 3 external causes of death were significantly higher than expected (drug overdoses, homicides, unintentional injuries), 1 unchanged (motor vehicle crashes), and 1 lower (suicides) (Table).
There were 10 443 excess drug overdoses (95% CI, 6115 to 14 771; Figure, A), accounting for 12.7% of non–COVID-19 excess mortality (95% CI, 7.4% to 17.9%); 2014 excess homicide deaths (95% CI, 1086 to 2942; Figure, B), accounting for 2.4% of non–COVID-19 excess mortality (95% CI, 1.3% to 3.6%); and 7497 excess deaths due to unintentional injuries (95% CI, 694 to 14 300; Figure, C), accounting for 9.1% of non–COVID-19 excess mortality (95% CI, 0.8% to 17.4%). There was no significant change in motor vehicle crash deaths overall (725; 95% CI, −1090 to 2540) but fewer than expected motor vehicle crash deaths occurred in April (−523; 95% CI, −815 to −231), and significant increases were recorded monthly from June to August (1550; 95% CI, 611 to 2489) (Figure, D). Suicide deaths were statistically significantly lower than projected by 2432 deaths (95% CI, 1071 to 3792 fewer deaths) (Figure, E).
Discussion
Provisional mortality data showed that deaths from some but not all external causes increased during the pandemic, representing thousands of lives lost and exceeding prepandemic trends.
Explanations for these changes are unknown. Drug overdoses and homicides may have been related to economic stress. Pandemic-associated changes in access to substance use disorder treatments may have exacerbated mortality from overdoses.6 Decreases in motor vehicle crash deaths in April coincided with less traffic, despite increases in drivers testing positive for drugs and alcohol and lower seatbelt use.3 Increases in motor vehicle crash deaths in June to August occurred as traffic increased (though still below 2019 levels), likely reflecting higher-risk behaviors.3 Lower than projected suicide deaths are paradoxical with reported increases in depressive and other mental health symptoms during the pandemic. Additional data are needed to understand the mechanism behind this finding.
This study has limitations, including death certificate accuracy and that 2020 data published by NCHS are considered preliminary. However, substantial changes to March to August 2020 data are unlikely. Also, the true number of non–COVID-19 medical deaths may have been lower than projected during the pandemic period, as evidenced by the observation that in May, the total excess deaths due to drug overdoses, assaults, and unintentional injuries exceeded the apparent number of all non–COVID-19 excess deaths.

Excess and External Causes of Death in the US, March 1-August 31, 2020

Edited by AlPater

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Hmmm....interesting. This subject was on my mind quite a bit. I thought about the consequences of overplaying the virus mania and it is interesting the significant increase in drug overdoses, but then again there was a decrease in suicides. IAC, the drug overdose is considerable compared to the suicide statistics. 28% vs 9%and over twice as many deaths!

Edited by Mike41

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19 hours ago, Mike41 said:

I thought about the consequences of overplaying the virus mania and it is interesting the significant increase in drug overdoses, but then again there was a decrease in suicides.

The most likely explanation for the reduction in suicides I have seen (I believe in Psychology, but can't search now) points to the wave of political polarization in 2020. Suicidal ideation has doubled in the last couple of years, based on what I've read, but among some groups, the political polarization may have reduced actual suicides, because the polarization channeled passions into activism, especially for the most volatile and vulnerable. Although statically white males 45-55 account for three-quarters of all completed suicides in the US and this is a less likely group to have been activated by political activism, the theory makes sense to me, as the "passion channeling" argument can still account for the slight overall drop. I should note that the wide expectations are that the 2020 reduction is viewed as a mere delay and the expectations are that the numbers will increase once the "passion channeling phenomenon" fades.

A much more important factor is the delayed treatment of CVD, which is more likely to explain the increase in "Covid deaths," if the numbers are ever revisited based in view of the inclusion of "probable" and the absurdly high 40-cycle PCR CDC guideline that would have significantly skewed the "Covid-deaths" estimates.

To illustrate, here is just one example:

Large decrease in hospitalized heart attack patients

During the COVID-19 pandemic, Kaiser Permanente emergency departments have remained fully open, available, and safe for those who need to receive care. Despite the availability of immediate emergency care, new research by Kaiser Permanente shows that the weekly number of patients admitted to Kaiser Permanente hospitals in Northern California for heart attacks after the onset of the COVID-19 pandemic fell to nearly half of what would be expected....

“Both elderly patients and those who had previously been diagnosed with heart disease repeatedly heard they were at high risk for COVID-19,” said lead author Matthew Solomon, MD, PhD, a Kaiser Permanente cardiologist in Northern California and a physician researcher at the Kaiser Permanente Northern California Division of Research. “We worry that our findings suggest these high-risk patients might have stayed home despite having concerning symptoms.”...

“Admissions for heart attacks started falling right after the time of the first reported death in California from COVID-19 on March 4 and continued to fall dramatically until they were nearly 50% lower by mid-April,” said Solomon.

Additional analyses showed that the heart attack hospitalization rate from March 4 through April 14, 2020, was also markedly lower than what was seen in Kaiser Permanente Northern California hospitals during the same time period in 2019.

The findings support anecdotal reports of physicians seeing fewer patients with acute medical conditions, including heart attacks. “Given how the COVID-19 pandemic and our societal response has been changing so quickly, it was important for us to let medical providers and governments know as rapidly as possible that the experiences physicians were reporting were true at the population level,” said senior author Alan Go, MD, associate director overseeing cardiovascular and metabolic research at the Kaiser Permanente Northern California Division of Research.

The declines were seen for both very severe and more mild heart attacks. The less severe type of heart attack, known as NSTEMIs, or non-ST-elevation myocardial infarction, are 4 to 5 times more common. They are less likely to result in death but can cause long-term heart problems.

“Patients who survive a heart attack but do not seek medical care are at risk for certain medical complications,” added Go. “These complications can include developing new or worsening heart failure, having a repeat heart attack, as well as experiencing dangerous heart rhythms — all of which could increase the risk of dying.”

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We interrupt this discussion for a important censorship announcement from Facebook:

“In light of ongoing investigations into the origin of Covid-19 and in consultation with public health experts, we will no longer remove the claim that Covid-19 is man-made from our apps.”

“We’re continuing to work with health experts to keep pace with the evolving nature of the pandemic and regularly update our policies as new facts and trends emerge."

Thank you for your cooperation.  Carry on.

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Are Fully Vaccinated People Who Get COVID At Risk For Long Term Symptoms?
Breakthrough coronavirus cases after getting the vaccine are extremely rare. Here's what we know about the symptoms.
By 
Catherine Pearson
05/27/2021 05:56pm EDT | Updated May 30, 2021
https://www.huffpost.com/entry/will-people-who-get-covid-post-vaccination-have-long-term-symptoms_l_60afda9be4b0ead279660672

>>>>>>>>>>>>>>>>

COVID-19 Vaccine Breakthrough Infections Reported to CDC - United States, January 1-April 30, 2021.
CDC COVID-19 Vaccine Breakthrough Case Investigations Team.
MMWR Morb Mortal Wkly Rep. 2021 May 28;70(21):792-793. doi: 10.15585/mmwr.mm7021e3.
PMID: 34043615 Free article.

https://www.cdc.gov/mmwr/volumes/70/wr/pdfs/mm7021e3-H.pdf
Abstract
COVID-19 vaccines are a critical tool for controlling the ongoing global pandemic. The Food and Drug Administration (FDA) has issued Emergency Use Authorizations for three COVID-19 vaccines for use in the United States.* In large, randomized-controlled trials, each vaccine was found to be safe and efficacious in preventing symptomatic, laboratory-confirmed COVID-19 (1-3). Despite the high level of vaccine efficacy, a small percentage of fully vaccinated persons (i.e. received all recommended doses of an FDA-authorized COVID-19 vaccine) will develop symptomatic or asymptomatic infections with SARS-CoV-2, the virus that causes COVID-19 (2-8).

Edited by AlPater

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Interesting summary of the 1957 pandemic and how it compares to SARS Covid-2. I believe that the 1969 pandemic was actually a bit deadlier than 1957, not that anyone paid much attention to it, either.
 

 

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POLL: Most Americans now believe the coronavirus originated from a laboratory in China

Quote

24% think it was created in a laboratory and was released on purpose, 18% think it was lab-created and escaped by accident, while a further 12% think it was a naturally occurring disease that was being examined in a laboratory but was released by accident.

Only 13% agree  [...] that it occurred naturally in the wild and mutated to a human infection.   

 

 

 

Edited by Sibiriak

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Global trends in clinical studies of ivermectin in COVID-19

http://jja-contents.wdc-jp.com/pdf/JJA74/74-1-open/74-1_44-95.pdf
 

Quote

6. Conclusion:

The effective concentration of ivermectin against SARS-CoV-2 in an in vitro experiment by Caly et al. is as high as 2 μM; in clinical practice, it is necessary to administer tens of times the normal dose in order to obtain such a blood concentration. Therefore, there are opinions from the IDSA98) and others that the therapeutic effect of COVID-19 cannot be expected by the administration of the normal dose of ivermectin. However, in actual medical practice, there are many study reports demonstrating that the administration of a normal dose does indeed show a clinical response. As of the 27th of February 2021, the results of 42 clinical studies worldwide have undergone meta-analysis and concluded that ivermectin is effective in the treatment and prevention of COVID-19. In the UK, a consensus-based recommendation by 75 healthcare professionals from 17 countries around the world has been carried out and submitted to the WHO to further encourage the issuance of guidelines for the use of ivermectin in the treatment and prevention of COVID-19. We must consider why such a discrepancy is occurring.

The first consideration should be focused on the setting of the sensitivity of the SARSCoV-2 infection for experimental systems in vitro. By use of Vero/hSLAM cells, the antiviral activity of the test drug is reliably measured. The sensitivity setting is set to be as low as possible, because it is necessary to eliminate false-positive samples. If the sensitivity is set high, the number of test drugs (noise) that give a positive reaction increases. Furthermore, if the setting is high, it becomes necessary to set secondary and tertiary tests to exclude false-positive samples. It  seems that the sensitivity of the IC50􀊹2 μM set by Caly et al. was appropriate because neither false positives nor false negatives occurred. If the sensitivity of this test is set to 10 or 50 times higher, then changes in the IC50 (IC50􀊹0.2 μM, IC50􀊹0.04 μM, respectively) might be expected.  Depending on the test cells, viral load, medium composition, and culture conditions, the experimental system in vitro can be set in different ways. Therefore, the paper by Caly et al. merely indicated that ivermectin was found to have anti-SARS-CoV-2 activity in vitro—no more, no less.  Extrapolating the results to evaluate clinical effects is too much of a leap.

There are in vivo infection experiments that can be used to connect in vitro experiments to clinical studies. In an in vivo infection experiment158) conducted at the Pasteur Institute in France, they employed the olfactory abnormality in hamsters as an index, along with dosage, in order to determine the equivalent dose that would be needed in humans. It was confirmed that the amount of SARS-CoV-2 virus did not change between groups administered ivermectin and the control.  However, a significant decrease in the ratio of IL-6/IL-10 in the lung was observed in the ivermectin group. It has been suggested that ivermectin might be effective on COVID-19 by acting to regulate host inflammatory reactions. As shown in Fig. 1, ivermectin has a macrolide structure. Like other macrolide compounds, it is known to exhibit extremely wide diverse actions159). Regulation of the host's inflammatory response is one of those diverse effects.


In Japan, in 1994, ahead of the rest of the world, a 􀁬Research Group on Novel Action of Macrolides􀁺 was established. It was done for the purpose of clarifying actions160) other than the antibacterial activity of macrolide compounds, such as clarithromycin. The clinical use of several
effective macrolide antibiotics for the management and treatment of patients with diffuse lung disease (previously designated as refractory diseases) was established. One such disease is diffuse panbronchiolitis (DPB). DPB causes an obstructive respiratory dysfunction similar to cystic fibrosis (CF) (which occurs frequently in Westerners) and has been observed in Japan and East Asia. Although it is a fatal and intractable disease, the long-term administration of low-dose macrolides161) has made it possible to treat and reduced the mortality rate. In elucidating the mechanism of action of macrolides on DPB, novel actions such as chlorine ion channel regulation162) and anti-inflammatory actions163,164) were confirmed one after another. Following the elucidation of erythromycin's suppressive actions on the infiltration of macrophages into the endothelium, there were studies that investigated the prevention and treatment of diabetic nephropathy, as well as the treatment of active stage Crohn􀁠s disease. Several studies have also been conducted investigating the inhibitory effects of clarithromycin on the production of cytokines. One such study involves  the suppression of excessive inflammatory reactions caused by influenza and other chronic otolaryngology diseases. Prior to this, effects such as these that go beyond the antibacterial activity of the macrolide antibiotics could never have been imagined. Additionally, for example, it has been found that erythromycin exhibits prokinetic effects for gastroparesis in diabetic patients.

This was discovered to be due to the motilin-like action of a metabolite. A metabolite derivative165) (which exerted no antibacterial ctivity) was found to enhance motilin-like activity. By taking advantage of such derivative165) side effects, a new treatment for constipation in patients with severe diabetes was discovered. The biological reactions of macrolide compounds have been shown to be extremely diverse. Even though some have been elucidated, it is difficult to estimate how many other actions may have not yet been elucidated.

Although clinical trial results have been and continue to be accumulated showing that ivermectin is effective in the treatment and prevention of COVID-19, basic in vitro findings that can
reasonably explain its effectiveness have not yet been obtained. It is considered that a wide variety of biological activities exhibited by macrolide compounds, such as the above-mentioned actions, at multiple stages could possibly serve to exert an overall and more comprehensive action/
effect. Although it must be further elucidated by future studies, clinical efficacy can be determined by investigation of any of the following parameters: (1) antiviral activity, (2) inhibition of the relationship between the virus and the host cell, and (3) actions related to the regulation of
host reactions. It is necessary to prove that other effects are being exerted, and it seems that such investigations could be suitable research topics for basic researchers, pharmacological researchers,and clinical researchers to collaborate and elucidate on.

When the effectiveness of ivermectin for the COVID-19 pandemic is confirmed with the cooperation  of researchers around the world and its clinical use is achieved on a global scale, it could prove to be of great benefit to humanity. It may even turn out to be comparable to the benefits achieved from the discovery of penicillin—said to be one of the greatest discoveries of the twentieth century. Here, one more use for ivermectin, which has been described as "miracle" or "wonder"166) drug, is being added. History has demonstrated that the existence of such natural product-derived compounds with such diverse effects is exceedingly rare.

However, in order to pass on to posterity the fact that ivermectin has become widely used to control the world-shattering COVID-19 pandemic, only one simple action is required: the addition of only one word, COVID-19, to the 9th item (of the 11 listed) under the  " Antiviral" category in the "Ivermectin: The Future" section of the Nobel Lectures record167) entitled "Splendid Gift from the Earth".

Excerpt:

Quote

Kitasato University, based on the judgment that it is necessary to examine the clinical effect of ivermectin to prevent the spread of uncertain COVID-19, asked Merck & Co., Inc. to conduct clinical trials of ivermectin for COVID-19 in Japan. This company has priority to submit an application for an expansion of ivermectin􀁠s indications, since the original approval for the manufacture and sale of ivermectin was conferred to it. However, the company said that it had no intention of conducting clinical trials. As a result, Kitasato University decided to conduct a doctor initiated clinical trial, the decision of which was published81) on the 12th of May. Following the decision to start clinical trials in Japan, the status of clinical trials overseas was extensively investigated. It was then found, somewhat surprisingly, that 14 trials were already registered on ClinicalTrials.gov by the 25th of May. Among them, except for two trials in the United States, all studies were conducted in developing countries with a large number of poor patients. It was also then understood that the use of inexpensive ivermectin to treat COVID-19 could potentially yield significantly great benefits.

However, looking closely at the protocols of the trials in these developing countries, all of them are doctor-initiated. The scales of the trials are small due to a lack of funds. Even if the target patients could be randomized, complete blinding would not be possible due to a shortage of manpower. There are strong tendencies not to employ methods that involve multiple expensive PCR tests. Judgements were made to utilize methods of low cost, such as changes in oxygen demand  and the number of days required to improve symptoms. In the case of new drug development conducted by a pharmaceutical company, the cost of clinical trials can be recovered from the sales profit of the new drug after marketing. So, even if it is a costly and labor-intensive investigation,  it is actively adopted.

However, in doctor-initiated trials it is not possible to hope for  cost recovery and the trial is performed in the cheapest possible manner. Although these doctor-initiated trial results may appear at first glance to be of a poor quality and biased (to eyes familiar with the results of company-oriented clinical trials in the clinical development of traditional anti-infective  agents), physicians involved in these trials are enthusiastic about avoiding bias and need  to understand the attitude of seriously assessing the efficacy and safety of a study drug. It must be appreciated that they are truly striving to treat and prevent the onset of COVID-19 in patients, for non-profit motives.

As already mentioned above regarding the FDA's view on the clinical use of dexamethasone for COVID-19, the use of existing drugs such as ivermectin for diseases other than its approved indications in clinical practice is permitted as "off-label use". As many clinicians are well familiar with clinical responses (real-world evidence) and understand  the actual possibility of off-label use, they naturally wish for approval to be granted for a given disease. However, a particular public law requiring regulators to consider measures for off label use was enacted in the United States in 2016. In this Act (82,83) named the "21st Century Cures Act",  "Real world evidence" is stipulated in Section 3022 of Chapter 3 ("Development") as a quasi-Chapter C "Modern Trial Design and Evidence Development" section. A provision of Section 3021 requires that a "Novel clinical design" be devised to justify real world evidence. Thereafter, real world evidence obtained from such trials can be aimed at" repurposing" existing drugs. This stipulation warns that one should not disregard evaluations or reviews that adhere to old-fashioned evidence-based medicine (EBM) that integrates clinical experience. Unfortunately, the law was not enforced due to the change of government in the United States and it is now too late due to the COVID-19 pandemic. This would have otherwise been the most appropriate proof of its legislative significance.

 

See also:

“I Don’t Know of a Bigger Story in the World” Right Now Than Ivermectin: NY Times Best-Selling Author  (May 25, 2021)

 

It’s Time To Talk About Ivermectin (March 30, 2021)

 

Edited by Sibiriak

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14 hours ago, Sibiriak said:

POLL: Most Americans now believe the coronavirus originated from a laboratory in China

Count me in the 13% who think Covid-19 jumped from an animal to a human (or, less likely but possible, was being studied in the Wuhan lab, and accidentally escape

For sure, it wasn't created, or modified, in a lab in Wuhan or anywhere else (it's genome does not show the signs, easily identifiable by virologists, of lab genome fiddling).

  --  Saul

 

 

 

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1 hour ago, Saul said:

Count me in the 13% who think Covid-19 jumped from an animal to a human (or, less likely but possible, was being studied in the Wuhan lab, and accidentally escape

Here are the results from the YouGov poll Sibiriak linked to:

Screenshot_20210605-141651_Chrome.jpg

What baffles me is why only 33% of people answer "not sure". It seems to me that people are far too convinced of the veracity of their own beliefs and the narratives they've been told. Epistemic humility appears to be in very short supply these days.

--Dean

 

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Basically, I agree with you.  But the virologists (who know their stuff better than we do), are almost unanimous in ruling out the possibility of having come from modification in a lab.

About public opinion:  Humans are evolved monkeys.

😉

  --  Saul

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