Covid-19 News

AP analysis doesn’t prove COVID-19 vaccines prevent deaths

https://trialsitenews.com/ap-a…-vaccines-prevent-deaths/

Dr. Ron Brown

June 30, 2021

Heralded across the media, pseudo-epidemiologists at Associated Press (I thought they were mostly journalists over there) apparently skipped the peer-review process and released findings from their flawed analysis claiming extraordinarily high COVID-19 vaccine effectiveness in preventing deaths. In their press release, the pseudo-epidemiologists/journalists removed any doubt that AP is yet another news agency spreading misleading public health information. Even Dr. Rochelle Walensky, Director of the Centers for Disease Control and Prevention, which provided data used in the AP analysis, appeared dazzled by AP claims of vaccine effectiveness, prompting her to pronounce that most deaths from COVID-19 are now entirely preventable.

On June 24, 2021, Carla K. Johnson and Mike Stobbe from AP wrote, “Nearly all COVID-19 deaths in the U.S. now are in people who weren’t vaccinated, a staggering demonstration of how effective the shots have been.” Nearly all COVID deaths in US are now among unvaccinated (apnews.com). Staggering demonstration, indeed! In reality, this claim is more likely a staggering demonstration of limitations and biases inherent in observational studies like the AP analysis.

Unlike randomized controlled trials, which analyze participant data from experiments or interventions organized by researchers, observational studies use data obtained from the real world, where conditions are not controlled by researchers. Observational Studies: Uses and Limitations | SpringerLink. Because observational studies cannot rule out unintended influences on the study results, known as confounding factors, a limitation of observational studies is that they cannot prove causation. The level of evidence from these studies is well below causation demonstrated in randomized controlled trials.

You might think that a lower standard of evidence in the observational AP analysis had little effect when compared to results of COVID-19 mRNA vaccine randomized controlled trials. After all, the AP analysis corroborated the exceptional results found in the randomized trials of very high vaccine efficacy (effectiveness under controlled conditions), which were approximately 95%.

The problem is that reported vaccine efficacy, or relative risk reduction measures in COVID-19 mRNA vaccine trials, did not include absolute risk reduction measures of approximately 1%, which is a more meaningful outcome for clinical and public health applications. Medicina | Free Full-Text | Outcome Reporting Bias in COVID-19 mRNA Vaccine Clinical Trials (mdpi.com). Furthermore, the vaccine trials’ clinical endpoints were laboratory confirmed infections with a mild symptom in otherwise healthy participants, not hospitalizations and mortality in participants with severe infections and underlying health conditions. If the vaccines aren’t really so efficacious after all, even for mild infections, what explains the “staggering demonstration” of vaccine effectiveness to prevent deaths claimed in the AP observational analysis? The answer lies within biases often found in observational studies.

World Health Organization had this to say about biases within observational studies used to assess vaccine effectiveness: “Due to lack of randomization of vaccination in real-world settings, all observational study designs are subject to bias because vaccinated persons often differ from unvaccinated persons in their disease risk, independent of vaccination.” Evaluation of COVID-19 vaccine effectiveness: interim guidance, 17 March 2021 (who.int)

Several critical differences in disease risk potentially affected vaccinated and unvaccinated persons in the AP analysis. People from lower socioeconomic groups have higher COVID-19 incidence and mortality, which they have had even before COVID-19 vaccines were made available to the public. Association of Social and Demographic Factors With COVID-19 Incidence and Death Rates in the US | Health Disparities | JAMA Network Open | JAMA Network. Perhaps due to environmental, economic, social, and lifestyle factors, people in these groups are more susceptible to diseases like COVID-19.

Furthermore, people with lower socioeconomic status are more likely to have vaccine hesitancy. Individual and social determinants of COVID-19 vaccine uptake | BMC Public Health | Full Text (biomedcentral.com). Of relevance, healthy vaccinee bias, the tendency for healthier people to seek out vaccinations, is concordant with the tendency of unhealthier people to avoid vaccinations, regardless of socioeconomic status. Frequency and impact of confounding by indication and healthy vaccinee bias in observational studies assessing influenza vaccine effectiveness: a systematic review (nih.gov)

The association of vaccine hesitancy with increased COVID-19 mortality in the AP observational analysis does not prove causation. The evidence is anecdotal—there is no proof that lack of vaccination had anything to do with higher disease mortality in lower socioeconomic groups and in people with compromised health conditions, within whom higher mortality rates were already evident before vaccination availability. Moreover, not only did the AP analysis confuse causation with correlation in assessing the association of vaccine hesitancy and disease mortality, the flawed findings of the AP assessment were overgeneralized to the entire population.

Experienced epidemiologists do not make these sorts of rookie mistakes. Unlike some journalists, fully trained epidemiologists account for differences in studied groups by adjusting results accordingly for each group. Estimating an accurate adjustment is a difficult task at best, even for the pros. Media reports on findings from the AP analysis make no mention of how limitations and biases in the AP observational analysis were managed and adjusted by the journalists, or even if they were managed at all.

WHO Eyes ‘Protecting’ Ivermectin from Use for COVID as It Plans to Emerge Out of Pandemic & Refocus on NTD Programs

https://trialsitenews.com/who-…-refocus-on-ntd-programs/

Recently, the World Health Organization (WHO) conducted its 14th meeting of the Strategic and Technical Advisory Group for Neglected Tropical Diseases (NTD), held virtually from June 22 to June 24, 2021. Known as STAG (Strategic and Technical Advisory Group), the group published a number of recommendations, including the potential implications of COVID-19 on Neglected Tropical Diseases. With so much health authority attention on COVID-19, the hundreds of millions of people at risk for NTD face greater risks as programs languished in the pandemic. That is, WHO’s STAG shared that the predicted and emerging empirical evidence suggests possibly profound impacts of the pandemic on the organization’s various programs dealing with NTD. Consequently, the STAG group suggested that first and foremost health systems in the various countries should prepare for not only greater numbers of NTDs, but also “more intense transmission of infection” followed by “accumulating disability” as a consequence of the pandemic and the associated intense focus on fighting COVID-19, to the detriment of other programs, such as leprosy and cutaneous leishmaniasis. WHO’s STAG positions that medicines such as ivermectin that are not proven must be “protected” from diversion, meaning used by health authorities, such as in Indonesia where the national drug regulator has authorized use of ivermectin to combat COVID-19 during this latest intense spike of the pandemic there. Interestingly, WHO anticipates the possibility that ivermectin will be deemed effective, declaring “and that even in the event of efficacy of such drugs against COVID-19 being established, the agreement of medicine donors for repurposing be obtained before the donations are used for that purpose.” Is the WHO preparing to control the distribution of the drug for targeted use against SARS-CoV-2?

The WHO STAG goes on with a recommendation for other urgent actions, such as the avoidance of expiry and “stock-outs” of particular medicines such as praziquantel due to delays in program implementation. That’s because WHO rightfully doesn’t want to lose ground against key NTDs and get back on track on reaching 2030 targets as defined in their 2021-2030 NTD road map.

For example, WHO has concerns of pandemic-related hits on funding impacting NTD programs generally and with specific concern for outbreaks of visceral leishmaniasis and dracunculiasis in East Africa and South Asia, for example.

It would appear, at least from the point of view of STAG, that the world is emerging out of the COVID-19 pandemic and it’s time again to focus on mission-critical NTD programs that represent a vital lifeline for hundreds of millions of people living in abject poverty.

And they have their eyes on ivermectin, whether it’s deemed efficacious or not for COVID-19.

What a Difference a Point of View Can Make: A Review of Roman et al. & the Case for Ivermectin as a COVID-19 Therapeutic Option

https://trialsitenews.com/what…id-19-therapeutic-option/

Recently, an eclectic group of authors based in the U.S. and Latin America authored a meta-analysis (Roman et al) incorporating ten(10) randomized controlled trials—out of a couple dozen possible ones—to assess the benefits and any harms of the use of ivermectin in COVID-19 patients. The team of authors found that based on their interpretation of the ten specific studies, the study drug failed to reduce all-cause mortality, length of hospital stay, or viral clearance in randomized controlled trials in COVID-19 patients with mostly mild, early-onset disease. They found the FDA-approved drug had no effect on adverse events or serious adverse events and concluded that ivermectin is not a viable option to treat COVID-19. But how could this interpretation differ so markedly from the multiple study groups tracking ivermectin-based studies? One group has accumulated all randomized controlled trials and prominent observational studies and reports on overwhelmingly positive data points. Then there’s the peer-reviewed, published meta-analysis from the Front Line COVID-19 Critical Care Alliance and the most recent peer-reviewed and published meta-analysis sponsored by the Bird Group indicating substantially positive evidence for the use of ivermectin as a therapeutic agent targeting COVID-19, and thus promotes its consideration as a public health tool during this pandemic. Published in the American Journal of Therapeutics, Lawrie et al. reviewed Roman et al. in a rebuttal, and TrialSite includes some of these details herein. Perhaps from the standpoint of global health authorities, the most authoritative ivermectin-focused meta-analysis, authored by Dr. Andrew Hill and a group of researchers, looked at 18 randomized controlled trials, finding that ivermectin was in fact associated with reduced inflammatory markers and faster viral clearance by PCR. Hill et al.detected that in six underlying clinical trials involving more moderate and/or severe SARS-CoV-2 that ivermectin was associated with a 75% reduction in mortality. But Hill et al. were not ready to declare the drug’s readiness for medicinal evidence due to questions about the underlying studies (e.g. not peer-reviewed, study size, etc.) and hence called for larger, controlled trials. Roman et al. completely deviate from this trajectory by declaring there’s no need to bother with any more studies as the evidence just isn’t there.

TrialSite notes that Roman et al. is not peer-reviewed but the study has elicited a number of critical responses and, again, the one prominent rebuttal we know of is summarized herein. From the vantage of the WHO, the Hill et al. meta-analysis would be a standard to at least refute.

Big Players Investigate Ivermectin

Apparently, the existing underlying evidence for ivermectin as a possible treatment for COVID-19 has sufficed for major governments, elite academic research centers, and major insurance companies as they now include ivermectin in costly clinical trials. For example, although they have discussed including ivermectin for half a year now, the University of Oxford finally formally moved forward including the approved generic drug in the PRINCIPLE trial.

Moreover, via the National Institutes of Health (NIH) Foundation, the United States government’s Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) now underwrites ivermectin research in its ACTIV-6 program.

And why would one of the largest health insurers in the United States, UnitedHealthcare, now sponsor a study that includes ivermectin unless there’s at least some modicum of evidence to merit such an investment? In fact, the COVID-OUT study in partnership with the University of Minnesota includes same-day shipment of the study product to the patient’s home.

That such primary players in the world of major research now invest considerable sums to investigate ivermectin suggest that underlying studies exhibit at least some degree of medical evidence. Otherwise, they wouldn’t bother.

Roman et al. POV

Roman et al. take a different direction than the NIH, University of Oxford and UnitedHealthcare and others. While the research authors look at the same data, they come to very different conclusions. An example would be the meta-analysis authored by Dr. Andrew Hill and co-authors and the interpretation of that data at the World Health Organization (WHO).

For example, Roman et al. do share the WHO “living systematic review and network meta-analysis” concerning the use of ivermectin as a potential therapy for COVID-19. Hill et al. were the primary contributor to that WHO assessment and found that ivermectin was associated with a 75% reduction in mortality. In this case, both Roman et al. and WHO come to the conclusion that because of the nature and structure of at least some of the underlying studies, the evidence is actually deemed uncertain.

But Roman et al. markedly deviate from the others’ direction (except for the position of Merck) in this ivermectin discussion. While WHO recommends more clinical trials, which again is backed by the NIH, the University of Oxford and UnitedHealthcare actions as well as other prominent institutions, the Roman et al. authors conclude that because the quality of evidence is uncertain not only do they find no evidence for any efficacy but also they don’t even recommend larger trials.

TrialSite reached out to the corresponding author, Adrian Hernandez, MD, who is affiliated with the University of Connecticut, School of Pharmacy. In that outreach, the authors (Roman et al) were invited to provide their point of view to share with the rapidly growing TrialSite community. Moreover, Roman et al. were invited to a debate, where TrialSite would provide a forum for the different research perspectives.

The Rebuttal

In a formal Rebuttal to Roman et al. Dr. Tess Lawrie and co-authors offer a pointed response to this new, seemingly selective study. How could the group of authors come up with such a different result than even the conservative-minded WHO? Why would they not follow the lead of at least Hill et al.?

According to the Lawrie et al. rebuttal, first and foremost the group opted for a smaller sample size. Specifically, whereas the Lawrie meta-analysis covered 24 studies involving 3406 patients, Roman et al. covered only 10 studies with 1173 patients. Again, Hill et al., the meta-analyses used by WHO, looked into 18 underlying studies. The work of Roman et al. ignored a number of larger trials, especially ones with mortality as an endpoint.

The Bird Group (e.g. Lawrie et al) suggested that Roman et al. consider adding some of the larger studies with the same inclusion criteria and data and thereafter, reanalyze and then assess the conclusion. Lawrie and team otherwise believe that “this review is of no value as we know the conclusions are incorrect and the results are different when eligible trials are added to the analyses.”

But why would Roman et al “underpower” their study unless there was an inherent endpoint in mind, suggests Lawrie et al. In the rebuttal, they call out other material issues for scrutiny. For example, they share with the reader that Roman et al. inserted corrections but actually then ignored the corrections in their final conclusion. Why would Roman et al. make corrections and not update the corresponding conclusion?

Lawrie et al. declared in the rebuttal, “The article has an embarrassing history whereby treatment arms in the study of Niaee1 were reversed, attracting protest from Dr. Niaee himself. This egregious error has been corrected in the revised version, but with no change to the conclusion in spite of dramatic change in the evidence.”

In their negation, Lawrie et al. also point out in another section titled “Absurd Confidence Levels, errors not corrected” suggesting that Roman et al. make egregious “technical errors” concerning the Chaccour study, assigning “…a RR of unity with absurd Confidence Intervals [0.02 46.56] when the correct assignment for a study with zero deaths in both arms (mortality outcome) is “not estimable.”

Lawrie et al. declare that in their own peer-reviewed, published paper that they include careful investigations of “double-zero” studies. Lawrie et al. find a number of other errors identified by contributors in the comments section in the preprint server medRxiv, which haven’t been corrected as of yet.

Again, TrialSite has invited Roman et al. to participate in any discussion on this platform. TrialSite’s obviously tracked and chronicled the ivermectin journey since April 2020 and concludes that the majority of studies indicate positive outcomes but Roman et al. are afforded a place in this space for their analysis and point of view. That invitation remains continuously open.

It’s a Matter of Point of View

TrialSite recognizes that there are indeed varied points of view based on a number of factors and forces that can and, in fact, do sway and influence all human judgment. However, there is a scientific method and well-established pathways for the interpretation of medicinal evidence. This particular meta-analysis, that is Roman et al., appears to deviate from all the other meta-analyses reviewed by this platform’s analysts. Dr. Andrew Hill’s meta-analysis developed under the auspices of Unitaid, an affiliate of the WHO, didn’t come to the sweeping conclusion that there is not sufficient evidence to continue studies. Rather, Hill, an influential character in the ivermectin discussion internationally, found that the existing positive data, while compelling, wasn’t sufficient for recommendation. From statistical power to questionable quality of underlying study data, the critique’s been focused on these attributes—and the need for bigger, more standardized studies—not that there is so little conclusive data that study isn’t even merited anymore.

A Debate?

TrialSite perhaps could serve as a platform for the different groups to come together, discuss and debate the dissimilar interpretations to bring even more clarity to the ivermectin discussion. That invitation is extended ongoing.

Mass media censorship of I xxxxxxxxx + F + nonBigpharma..

LENR is well under the radar.. unfortunately..

If only it had the profile of I............

Quote from Fm1

WHO’s STAG positions that medicines such as ivermectin that are not proven must be “protected” from diversion, meaning used by health authorities, such as in Indonesia

Thohir ..New head of the Indonesian government -med organises for cheap supply of ivermectin..

to the people.. 34--48cents per tablet. 3 month trials have commenced following

good preliminary effectiveness

https://voi.id/ekonomi/62467/m…pok-hingga-semarang-timur

https://voi.id/en/berita/62648…ak-akan-jadi-beban-rakyat

"

It is planned that this drug will be priced between IDR 5.000 to IDR 7.000 per tablet.

"With cheap and affordable drug prices, I'm sure people will be able to get them easily and won't be a burden. Especially for the prevention of COVID-19, you don't need to always take it and only take 2-3 tablets. Likewise for healing", said Erick in his written statement quoted on Tuesday, June 29.

Quote from Fm1

AP analysis doesn’t prove COVID-19 vaccines prevent deaths

https://trialsitenews.com/ap-a…-vaccines-prevent-deaths/

Dr. Ron Brown

June 30, 2021

Heralded across the media, pseudo-epidemiologists at Associated Press (I thought they were mostly journalists over there) apparently skipped the peer-review process and released findings from their flawed analysis claiming extraordinarily high COVID-19 vaccine effectiveness in preventing deaths. In their press release, the pseudo-epidemiologists/journalists removed any doubt that AP is yet another news agency spreading misleading public health information.

Dr. Brown goes on describe some finer points of why the AP is getting it wrong. But I think he is missing what to me is the probable elephant in the room.

The original AP article is here :

https://apnews.com/article/cor…3d9731c76c16e7354f5d5e187

Here's the pertinent extract, my bold:

The AP analyzed figures provided by the Centers for Disease Control and Prevention. The CDC itself has not estimated what percentage of hospitalizations and deaths are in fully vaccinated people, citing limitations in the data.

Among them: Only about 45 states report breakthrough infections, and some are more aggressive than others in looking for such cases. So the data probably understates such infections, CDC officials said.

Reading between the lines, the above may imply that hospitals are not compelled to check for vaccination status of those admitted to hospital with Covid symptoms. Alarming if true.

I suspect that hospitals are often neglecting to report vaccination status.

In a nutshell I believe what the AP is doing is this: It is lumping people whose vaccination status was not checked into the unvaccinated group. In other words, if a person isn't confirmed as vaccinated, she is regarded as unvaccinated.

This, I believe, is why the CDC itself is not on top of this data and shouting it from the rooftops. They know the hospitals are not properly recording vaccination status. So they leave it to the AP to jump to vaccine - exalting conclusions, while news outlets over the world drink it up like drunken sailors.

Quote from Fm1

Unlike some journalists, fully trained epidemiologists account for differences in studied groups by adjusting results accordingly for each group. Estimating an accurate adjustment is a difficult task at best, even for the pros.

This virus/disease simply is over the head of journalist and also of 99.999% of all doctors with 1% math background...

Quote from Fm1

Again, TrialSite has invited Roman et al. to participate in any discussion on this platform.

Would nice to see a criminal FUD'er in a discussion.

Quote from Mark U

The CDC itself has not estimated what percentage of hospitalizations and deaths are in fully vaccinated people, citing limitations in the data.

Again: maximally 5% of the reported people die from COV-19. And also maximally 1/3 tested positive had CoV-19. With such nonsense data it simply is not possible to get to the bottom of truth.

Now we have UK data where more vaccinated die, than unvaccinated. But here again we have no detail data. Death reason for both, comorbidity etc.. Even the PCR data is not available. Somebody with PCR >28 (Counts positive) certainly did not die from CoV-19. Even much lower PCR cycles do not confirm death from CoV-19. But in USA all these cases go to death from CoV-19.

Best you can do: Simply do not believe any figure of vaccine efficiency if you are a member of a risk group. Buy your ivermectin. Especially Pfizer/Astra completely fail for most new variants. Already basic delta is 9x less protected in lab test where usually (if paid by Pfizer..) blood is used from specially selected people with 10x antibodies. So this tells, if you have minimal antibodies, this factor is 90x...= 90x less protection.

COVID-19 and HIV/AIDS: more in common than you think

https://trialsitenews.com/covi…in-common-than-you-think/

Paul Elias Alexander, PhD

From very early on in the COVID-19 pandemic, the US Task Force and similar such entities globally conspired to commit one of the most devasting falsehoods and we argue ‘lies’ to the American people. As a consequence, Task Force members in nations such as Canada, UK, France, Australia etc. were very lazy, academically sloppy, very cognitively dissonanced to anything averse to their ‘biased’ politicized narrative, and seemingly did not read the data or science or did not understand it. Maybe they were just blinded to it in the era of highly politicized hatred and attacks and smears on then President Trump and his administration. Extraneous nations to the US and its leaders seemed to jump onto the anti-Trump train and the more you take time now to look back on what they did and said, the more illogical, irrational, hysterical, nonsensical, absurd, and plain mendacious and specious they all were. All these medical advisors. All of these government leaders. They were flat wrong then in all they said and flat wrong today, for their lockdowns, school closures, shelter-in-place, mask edicts, mask mandates, and school closures did nothing to curb the spread or reduce deaths. In fact, it worsened it and now they are trying again with falsehoods about the Delta variant that up to now, based on current data, is infectious but non-lethal. Infections have gone up but hospitalizations and deaths which is the key indicator of lethality, have gone down and remained flat. Up to now. Delta, despite the hysterics and nonsense by the media and their talking head experts, is emerging as one of the weakest variants and non-consequential. While we have no control on mutations, we have no reason up to now, to think otherwise on this variant. What the US Task Force did as it battled a President trying to right a public health ship and address the crisis, will go down as the greatest public health disaster in history and the US led the way with the insanity. A real clown car daily we were treated to. We still are.

I refer particularly to the one lie that hobbled the US pandemic’s response (which I continue to argue that this was never the ‘emergency’ they reported it to be and subjected the nation and world to), this being that we were all at ‘equal risk’ of severe outcomes and death if infected with SARS-CoV-2. This was a flat duplicitous statement and we knew very early on, certainly by summer of 2020, who the at-risk group was and who was at most risk. The median age of death globally remains approximately 82, and with severe underlying medical conditions. We knew very early on that COVID-19 was amenable to risk stratification and one’s baseline risk was prognostic on hospitalization and mortality. It was clear. Like how we knew that asymptomatic spread and recurrent infection and the very flawed inaccurate RT-PCR test with its near 100% false positives above a cycle count of 35 or so, was all based on falsehoods. None of what these inept television medical experts and these Task Force people were saying made any sense and they could never back anything up with data or evidence. Just their assumptions and flawed models led by the most failed and irresponsible public health persons from Imperial College. What a sheer inept, incompetent, person this Ferguson emerged to be. Moreover, the public health agencies with CDC in the lead, were always wrong and have now been regarded as CDC365, always 365 days behind the science. When combined with the greatest threat, ‘triple F’ we have come to know him as (FFF), also known as ‘flip-flop Fauci’, then no wonder the US response was no chaotic and nonsensical and devastating. And continues to be. When you come to think of it, it was horrendous and perverse, especially the ravages subjected to the poor in the society (ies) who were least able to afford this unsound and unscientific absurdity. So, we were never at ‘equal’ risk of severe outcomes and death and we could have used a more focused ‘age-risk’ stratified approach to managing the pandemic and the response. We could have ‘targeted’ the response to those at risk and not suffer the entire society. Always with the elderly properly, double and triple down protected. First!

As a result of this ‘equal risk’ lie, 20-year-old Johnny in the prime of his life with no medical conditions and of regular body weight (as excess body weight and obesity emerged as a principle risk factor in predicting severe outcome), continues to hide under his bed in fear, thinking he is at the same risk as his 90 year old grand mother who has 3 grave medical conditions. And this has stuck in Johnny’s head and this one deceit by the public health leaders in the CDC, the NIH, the FDA and governments with the media medical cartel and the illogical sloppy television medical advisors, severely damaged the response. This is why Suzie is running still in the forest with no one around for 10 miles with double masks and gloves!

Importantly, we have early outpatient drug treatment (1, 2, 3, 4) that we knew very early on was saving lies. It was reducing hospitalization, this multi-drug sequenced ‘cocktail’ approach using hydroxychloroquine, favipiravir, ivermectin, colchicine, budesonide, methylprednisolone, high dose aspirin, low molecular weight heparin etc. under doctor supervision, dosed and time in line with the three phases of COVID disease (early viral replication, inflammation florid pneumonia ARDS, and the thrombotic phase).

So how is COVID tied to HIV/AIDS? Well, the same duplicity, the same lie of ‘equal risk’, the same effort to provide falsehoods to the public, emerged in the 1980s as a result of the emergence of HIV in 1981 in the gay community (New York and Los Angeles). The scientists then and the public health and research agencies such as the CDC and NIH/NIAID knew that the risk was greatest and focused on the homosexual community and among injecting drug users and principally anyone who engaged in high-risk behavior. So they lied to us, they lied to the entire world and sought to tell a public health story that also focused on non-homosexual communities e.g. heterosexual persons, and the CDC etc. put out lies that para ‘we are all at risk…everyone is at risk’. The result was for decades, persons at no risk or very low risk e.g. heterosexuals and heterosexual women, monogamous partners etc., were frightened livid. There remained confusion on how best to manage the infection and this drove stigma and mischaracterizations that hurt good people, homosexual and heterosexual. This was a pure flat lie by the CDC and all involved. For whatever reasons. These so-called public health leaders did not want to face the inconvenient truth or the truth, and as such did not want to have the necessary honest debate with the public. This is where COVID and HIV is intertwined. Both emerged and for both, a very serious lie was predicated on the public basically claiming para ‘we are all at equal risk’. This was then for HIV, as it is now for COVID, a flat lie and dangerous falsehood for it has shaped the response and it has even costed lives!

Yes, we did not want to tell the truth about COVID as we did for HIV, and this causes more suffering and lives. We did not tell African-Americans 16 months now that it is imperative to get sunlight on their skins and dietary supplements of Vitamin D given Vitamin D’s key immunomodulatory role and in T-cell immunity and immunity in general as it relates to COVID risk and sequelae. We refused to even mention the dramatically escalated risk of severe COVID outcomes if very overweight or obese. We had data from France and the UK that clearly showed the increased risk due to obesity especially for those admitted to ICU with COVID, relative to the general population, and there is greater mortality in such persons with COVID (references 1, 2, 3, 4). These are modifiable risks but we have refused to bring to the public. Why? A public service message running daily for the last year to reduce body weight and adjust food intake, along with the need for Vitamin D supplementation would have saved thousands of lives, especially in the minority populations. We lied for 16 months now to the world that there is no viable therapeutic option and this has cost hundreds of thousands of American lives, likely millions of lives across the world. There were always cheap, effective, safe, and available therapeutic options (1, 2, 3, 4) for the public and we did not have to lose so many lives, especially among our precious elderly and minority communities. We could have treated millions early with established repurposed drugs. We can still do this to close out this pandemic as we are better poised to treat our way out of this pandemic, and not rely on vaccines that are showing evidence of adverse effects and even deaths. Shame on public health for treating us to a second showing of the GREAT LIE that ‘we are all at equal risk’. Shame on them for many died needlessly. Shame on what they did to HIV and now to COVID. Hopefully, the lies would stop and we can have the honest, open debate that the public desperately needs! Hopefully, honesty can for once, prevail!

Quote from Fm1

Up to now. Delta, despite the hysterics and nonsense by the media and their talking head experts, is emerging as one of the weakest variants and non-consequential. While we have no control on mutations, we have no reason up to now, to think otherwise on this variant.

Delta is the last chance for the FM/R/J/B mafia to generate money from vaccines because after delta no more vaccines will be needed. Delta gives you a free immunization for all other variants.

Hospitals are drained here and best: The vaccines do not protect you against death from delta. You should no believe this last mafia commercial. In case of strong symptoms get your ivermectin ready! Please also the vaccinated folks!

So we should celebrate: With delta we see the finally mild end of the COV-19 saga. Thus let it spread.

Quote from Wyttenbach

Delta is the last chance for the FM/R/J/B mafia to generate money from vaccines because after delta no more vaccines will be needed. Delta gives you a free immunization for all other variants.

Hospitals are drained here and best: The vaccines do not protect you against death from delta. You should no believe this last mafia commercial. In case of strong symptoms get your ivermectin ready! Please also the vaccinated folks!

So we should celebrate: With delta we see the finally mild end of the COV-19 saga. Thus let it spread.

Just recently we had a kids summer camp outbreak of the delta virus. 80 kids and staff tested positive. 74 were asymptomatic, while 6 adults showed only mild symptoms. All 6 adults were fully vaccinated. Breakthrough cases should be a major concern yet we keep hearing breakthrough cases are extremely rare. NONSENSE !!!

safety of ivermectin

Healthy People Medicating: The 18mg-Dose Ivermectin Clinical Trial

https://trialsitenews.com/grou…vermectin-clinical-trial/

Safety and pharmacokinetic profile of fixed-dose ivermectin with an innovative 18mg tablet in healthy adult volunteers

Jose Muñoz, Conceptualization, Formal analysis, Investigation, Methodology, Supervision, Writing – original draft, Writing – review & editing, Maria Rosa Ballester, Data curation, Formal analysis, Investigation, Methodology, Validation, Writing – original draft, Writing – review & editing, […], and Alejandro J. Krolewiecki, Conceptualization, Formal analysis, Funding acquisition, Investigation, Methodology, Project administration, Writing – original draft

This study was conducted in healthy adult volunteers in which we

compared 3 treatment regimens: the weight-based reference standard

versus 2 experimental regimens of fix-dose 18 and 36 mg using 18 mg

tablets. All 54 volunteers received the 3 treatments sequentially. The

results confirmed that the fixed-dose regimen (both 18 mg and 36 mg) are

as safe as the standard dosage and could justify the use of fix dosing

regimens rather than the current weight based strategy…

These findings contribute to further understand the pharmacokinetic

characteristics of ivermectin, highlighting its safety across different

dosing regimens. They also correlate with known pharmacokinetic

parameters showing stable levels of AUC and C_max across a wide range of body weights, which justifies the strategy of fix dosing from a pharmacokinetic perspective…

The study adhered to the updated Declaration of Helsinki [28] and was conducted according to rules of Good Clinical Practice [29].

Prior to initiation, the study protocol was approved by an independent

ethics committee (Clinical Research Ethics Committee of the Hospital de

la Santa Creu i Sant Pau, in Barcelona, Spain) and the national

competent authority (Spanish Agency for Medicines and Health Care

Products, AEMPS, Spain). All subjects provided written informed consent

to participate in the study after the nature and purpose of the study

was fully explained to them and received stipends for their

collaboration…

Safety

All subjects receiving at least one dose of study drug were included in the safety analysis (n = 57). No abnormal result or significant differences were found between biochemistry at baseline and after the administration of IVM in any of the three study arms…

This study provides the first pharmacokinetic and safety data of a formulation of IVM in 18 mg tablets […]

Safety data was consistent with previous studies regarding the lack of

significant adverse events even at the highest doses uses in this study

(36 mg) which in the lowest weight group (51 to 65 kg) providing doses

of up to 700 mcg/kg…

Although IVM was very well tolerated, 14 participants received treatment

to control adverse events that were mostly to improve mild headache,

common in participants of phase I trials after deprivation of caffeine

and other substances. At the same time that fixed and higher doses of

IVM proved to have an excellent safety profile in our study […]

[…] differences in systemic exposure among participants having different

weights might have implications on the efficacy of ivermectin,

potentially achieving higher cure rates in those patients with lower

weight…

The limitations of this study include the healthy, non-infected status of the volunteers; although this limitation might not be relevant based on a previous study showing no differences in PK parameters between O. volvulus infected individuals and controls [35]. Whether the same applies for individuals infected with gut-dwelling parasites is currently unknown. Another limitation is the use of a different IVM for the reference group rather than the widely used Mectizan donated by Merck, which is used in the large majority of MDA programs. However, the Abbott labs IVM used in this study is the reference IVM product in Brazil [23].

In conclusion, the administration of IVM in a fixed dosing strategy with 18 mg or 36 mg is as safe as the reference product adjusted by weight, adding a potential benefit due to the increased systemic exposure to the drug particularly in low weight adult individuals. Moreover, the fixed dose regimen offers a logistical advantage for the deployment of large MDA interventions aiming at the control and interruption of transmission of NTDs, and facilitates the co-administration with other antihelmintics prescribed this way, like albendazole or mebendazole. Further studies evaluating these concepts in pediatric populations and infected individuals, as well as clinical trials with efficacy endpoints are warranted.

Funding Statement

The study was funded in full by Exeltis France. Grant # 2015-005690-20. The funders participated in study design and decision to publish through the co-authors SG and EC.

Data Availability

All relevant data are within the paper and its Supporting Information files.

Article information

PLoS Negl Trop Dis. 2018 Jan; 12(1): e0006020.

Published online 2018 Jan 18. doi: 10.1371/journal.pntd.0006020

PMCID: PMC5773004

PMID: 29346388

Jose Muñoz, Conceptualization, Formal analysis, Investigation, Methodology, Supervision, Writing – original draft, Writing – review & editing,^#¹ Maria Rosa Ballester, Data curation, Formal analysis, Investigation, Methodology, Validation, Writing – original draft, Writing – review & editing,^#² Rosa Maria Antonijoan, Data curation, Formal analysis, Methodology, Project administration, Supervision,^2,³ Ignasi Gich, Data curation, Formal analysis, Methodology,^2,³ Montse Rodríguez, Investigation, Project administration, Resources,² Enrico Colli, Funding acquisition, Methodology,⁴ Silvia Gold, Conceptualization, Methodology, Resources,⁵ and Alejandro J. Krolewiecki, Conceptualization, Formal analysis, Funding acquisition, Investigation, Methodology, Project administration, Writing – original draft^6,^*

Roger K. Prichard, Editor

¹ Barcelona Institute for Global Health, ISGlobal-CRESIB, Universitat de Barcelona. Barcelona, Spain

² CIM-Sant Pau. IIB Sant Pau. Institut de Recerca de l’Hospital de la Santa Creu i Sant Pau. Barcelona, Spain

³ Pharmacology and Therapeutics Department, Universitat Autònoma de Barcelona (UAB), Bellaterra, Spain

⁴ ExeltisPharma, Chemo group. Madrid, Spain

⁵ Fundacion Mundo Sano, Buenos Aires, Argentina

⁶ Instituto de Investigaciones en Enfermedades Tropicales, Universidad Nacional de Salta/CONICET, Oran, Argentina

McGill University, CANADA

^#Contributed equally.

Yes. I have read the journal’s policy and the authors of this manuscript have the following competing interests: EC and SG are members of Chemo Group, which includes Liconsa, the manufacturer of the study drug and Exeltis France, the funding source.

This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

https://www.ncbi.nlm.nih.gov/p…/PMC5773004/#!po=0.632911

Pet owners urged to avoid their cats and dogs if they have Covid

https://amp.theguardian.com/wo…rs-study-domestic-animals

Cat or dog owners who have Covid-19 should avoid their pets while infected, experts have said.

Scientists in the Netherlands have found coronavirus is common in pet cats and dogs where their owners have the disease. While cases of owners passing on Covid-19 to their pets are considered to be of negligible risk to public health, the scientists say there is a potential risk that domestic animals could act as a “reservoir” for coronavirus and reintroduce it to humans.

Dr Els Broens, from Utrecht University, said: “If you have Covid-19, you should avoid contact with your cat or dog, just as you would do with other people.

“The main concern, however, is not the animals’ health – they had no or mild symptoms of Covid-19 – but the potential risk that pets could act as a reservoir of the virus and reintroduce it into the human population.

Fortunately, to date no pet-to-human transmission has been reported. “So, despite the rather high prevalence among pets from Covid-19 positive households in this study, it seems unlikely that pets play a role in the pandemic.”

The research led by Broens was presented at the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) but has not yet been published in a journal.

Broens and his colleagues analysed the PCR test results of 156 dogs and 154 cats from 196 households. Six cats and seven dogs (4.2%) had positive PCR tests and 31 cats and 23 dogs (17.4%) tested positive for antibodies.

Eight cats and dogs that lived in the same homes as the PCR-positive pets were also tested for a second time to check for virus transmission among pets. None of the animals tested positive, suggesting the virus was not being passed between pets living in close contact with one another.

But researchers said their findings show Covid-19 is highly prevalent in pets of people who have had the disease.

Meanwhile, separate research, also presented at the ECCMID meeting, suggests cats that sleep on their owner’s bed may be at particular risk of getting Covid-19 from their owners.

Dorothee Bienzle, a professor of veterinary pathology at the University of Guelph in Canada, who presented the findings, said: “If someone has Covid-19 there is a surprisingly high chance they will pass it on to their pet.

“Cats, especially those that sleep on their owner’s bed, seem to be particularly vulnerable. So, if you have Covid-19, I’d advise that you keep your distance from your pet – and keep it out of your bedroom.”

Bienzle also recommends keeping coronavirus-infected pets away from other people and pets. She said: “While the evidence that pets can pass the virus on to other pets is limited, it can’t be excluded. Similarly, although pets have not been shown to pass the virus back to people, the possibility can’t be completely ruled out.”

UK scientists find evidence of human-to-cat Covid transmission

Commenting on the findings, Prof James Wood, the head of the Department of Veterinary Medicine at Cambridge University, said both studies were consistent with “a growing number of studies that are suggesting that a substantial proportion of pet cats and dogs may catch Sars-CoV-2 virus (which causes Covid-19) from their owners”.

He added: “Cats and dogs may commonly be infected with the virus, but most reports are that this infection appears to be asymptomatic. It also seems that the virus does not normally transmit from dogs and cats to either other animals or their owners.

“These studies need to be differentiated from earlier work that has reported a very small number of individual cats and dogs to be unwell after they caught Covid-19 from their owners.”

Quote from Fm1

Cat or dog owners who have Covid-19 should avoid their pets while infected, experts have said.

Wow!! We already did recommend this (avoid contact with your cat if somebody internal has it..) march 2020 for a real case!

Quote from Shane D.

The FLCCC has their "I-MASK+" protocol for COVID preventative, and early outpatient care. Their "MATH+" is for those hospitalized. Ivermectin is listed as the "core medicine" for both. I just got this flyer in the mail:

https://doctorsstudio.com/i-mask-covid-19-protocol/

They are advertising phone consultations to prescribe Iver for $249 (add their Vitamins to the order for only an extra $318 ) .

Not sure if this is a scam capitalizing off the FLCCC's popular I-MASK+ protocol, or legit, but thought it was interesting. Goes to show, if you make it hard for someone worried about their health to get a safe, probably effective drug, someone else will find a way to make money off of it.

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While not an exhaustive search, I could find no connection between "doctors studio" and FLCCC. Neither FLCCC nor DoctorsStudio websites reference the other nor members associated. The IMASK protocol has been freely published so, it looks as if an unrelated group has latched on and is using it.

For good intent or money? Who knows.

Quote from Shane D.

They are advertising phone consultations to prescribe Iver for $249 (add their Vitamins to the order for only an extra $318 )

The two best and most powerful human drugs Praziquantel & Ivermectin have been removed from public use. To much damage to Big pharma chemo/cancer income...

E.g. the legal price (Europe) for Praziquantel 2 dose to treat Chlonorchis sinensis is 250..300 euro.

If you are a cow then you can divide it by 100....

The same for Ivermectin. Its just about replacing one blood sucker with an other...

India price for 12mg tablet (60 kg one 1 dose) is 10 cents. Worst case treatment is 12..16 dose...

But at least - if you are wealthy enough - you now have an option to survive....

Ask your horse then you get 8 100kg dose for 6-8$. We get the bird version - 5 dose 10kg - for 8 euro.

Quote from Wyttenbach

That's why I post since months that we will have a second Nürnberg trial.

This is inline with FM/R/J mafia taking full control over western states. Money = power.

This explains some things: I guess somebody delivered fake vaccines to Chile buying original ones and doing the same as is done with cocaine and other drugs. You should inform the police -only if they are independent from the FM/R/J greedy mafia people ...

Great news from UK. Cases surpassed the India ones by miles now. But deaths are only up by 2x. So delta is really harmless. No need for vaccines.

All UK data can be found on:: https://www.ons.gov.uk/peoplep…ndwalesprovisional/latest

Only drawback 2 weeks late.

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Deaths are up so little in the UK because nearly all of the at risk population has been vaccinated - amongst those most at risk vaccination uptake has been very very high. This is partly outreach from doctors, and partly that in the UK the deadly anti-vax memes present everywhere are not so strong - at least amongst elderly (more at risk) people.

You might also like this noddy (for people who do not automatically distinguish between correlation and causation) explanation for why in the UK:

(1) more vaccinated people die in hospital then unvaccinated in the UK

(2) the vaccines in the UK are very highly protective, reducing risk of death by a large factor.

https://www.bbc.co.uk/news/health-57610998

Quote from Bob#2

For good intent or money? Who knows.

For that amount of money, it's mostly for the money!

Quote from THHuxleynew

Deaths are up so little in the Uk because nearly all of the at risk population has been vaccinated

That's why we all, here agree on vaccines for people age >65!!

With a proper calculation we can show that for people below age 45 the vaccine damage today is far higher than the benefit.

As said here (CH) nobody died in this age group from CoV-19. Most death age < 45 we see - world wide - are chemo patients or really sick individuals.

The real problem is that the vaccine protection is magnitudes overrated at least for people age >65. For the others CoV-19 vaccines have more ore less no benefit. As said with delta+++ we get a more or less free immunization and possible this will be the virus that will stay for a long time.

Quote from THHuxleynew

You might also like this noddy (for people who do not automatically distinguish between correlation and causation) explanation for why in the UK:

You should tell this to Pfizer. They sell natural immunity/protection for vaccine protection. ...

Quote from Wyttenbach

Delta is the last chance for the FM/R/J/B mafia to generate money from vaccines because after delta no more vaccines will be needed. Delta gives you a free immunization for all other variants.

Hospitals are drained here and best: The vaccines do not protect you against death from delta. You should no believe this last mafia commercial. In case of strong symptoms get your ivermectin ready! Please also the vaccinated folks!

So we should celebrate: With delta we see the finally mild end of the COV-19 saga. Thus let it spread.

Agree. Also this reminds me of a 'second opinion' CBC article, which describes that in the UK, a covid tracking app has people reporting more traditional cold like symptoms like headache, fever and congestion, and much less of the traditional symptoms like loss of smell. This is the Delta variant at work in the UK, in all probability. Delta is (likely) much more transmissible and also more infectious in the airways, so even the young are getting some cold symptoms. Yet it is not as nasty as the original.

Extract from the article at

https://www.cbc.ca/news/health…ported-symptoms-1.6069831

The most-reported symptoms of COVID-19 are now a headache, sore throat, and runny nose, according to the research team behind a U.K. symptom tracking app, and medical experts here in Canada say various factors could be causing the illness to feel more like a common cold.

The findings come from the ZOE COVID Symptom Study app, which allowed U.K. residents to report their daily symptoms throughout most of the pandemic, with scientific analysis provided by King's College London.

"Since the start of May, we've been looking at the top symptoms for the app users, and they're not the same as they were," said the team's lead researcher, Tim Spector, a professor of genetic epidemiology at King's College London, in a video statement released last week.

Headache, sore throat, runny nose and fever are now the top four reported symptoms, all while the more-infectious delta variant, also known as B1617, is sweeping mainly through people under 40 in the U.K.

"It's more like a bad cold in this younger population," Spector said.

Having a cough clocked in as the fifth most-reported symptom — less common than before, he said — while loss of smell is no longer in the top ten.