This critique is interesting and shows the reason why scientists are cautious and want
a proper study of ivermectin. Main take away is that many of the studies of ivermectin has
not gone through a proper scientific process and e.g. there is a big risk of publication bias. I
still think that it may be good and should be ok to administer, on the other hand I do not see
that ivermectin is a wonder drug comparable to vaccine.
In a RCT Lancet study I fond interesting as the positive effect is seen by ivermectin although a low number of people indicating that Ivermectin has a significant positive effect But I agree with the authors that this is an indication only and a good motivation for a larger study. Statistically they use non-parametric analysis which for these small sample sizes is needed and indicates that they are competent. On the other hand it is unclear how many tests and comparisons is done and small sample size means that there can be confounding factors so, yes as they state in the paper a larger study is well called for.
There is a debate on the usefulness of p-values and the reason is that this value is not reflecting how large the effect is, just that it is an effect. That's why a confidence intervals is also
needed. But I would not recommend that one removes the P-values as they are a useful tool to compensate for the number of tests made e.g. bonferroni. If only a confidence interval is presented the P-value is less obvious and it is more demanding to analyze the effect of multiple comparisons.
mRNA vaccine inventor speaks out on 'Tucker' after YouTube deletes video of him discussing risks
'The government is not being transparent with us about what those risks are,' said Dr. Robert Malone
https://www.foxnews.com/media/…mrna-vaccine-inventor.amp
As colleges issue controversial mandates that students be vaccinated or not attend classes, and reports surfaced of numerous deaths potentially caused by the various coronavirus vaccines, the inventor of the mRNA technology that went into some of the vaccines told Fox News on Wednesday that Google-owned YouTube deleted a posting of a podcast during which he discussed his concerns and findings.
As "Tucker Carlson Tonight" host Tucker Carlson noted, Dr. Robert Malone is "the single most qualified" expert on mRNA vaccines, but that the Big Tech companies are asserting themselves as more informed than him on the topic.
"A Norwegian study conducted of 100 nursing home residents who died after receiving Pfizer's Corona shots. They found that at least ten of those deaths were likely caused by the vaccine. 10%," said Carlson.
Meanwhile, the New York Post reported that researchers found a link between rare cases of juvenile heart inflammation and vaccines from Pfizer and Moderna, which utilize the mRNA route.
"Young adults in the prime of their lives are being forced to take the vaccine because Tony Fauci said that," Carlson said, adding that Malone "has a right to speak," given his expertise.
"[O]ne of my concerns are that the government is not being transparent with us about what those risks are. And so, I am of the opinion that people have the right to decide whether to accept vaccines or not, especially since these are experimental vaccines," Dr. Malone said, pointing to the fact the vaccines are not formally approved but instead being administered under Emergency Use Authorization.This is a fundamental right having to do with clinical research ethics," he said. "And so, my concern is that I know that there are risks. But we don't have access to the data and the data haven't been captured rigorously enough so that we can accurately assess those risks – And therefore … we don't really have the information that we need to make a reasonable decision."
Malone said that in the case of younger Americans, he "has a bias that the benefits probably don't outweigh the risks in that cohort."
But, he noted there is no substantive risk-benefit analysis being applied to the vaccines.
That is one of my other objections, that we talk about these words risk-benefit analysis casually as if it is very deep science. It's not. Normally at this stage, the CDC would have performed those risk-benefit analyses and they would be database and science-based. They are not right now," said Malone.
"I can say that the risk-benefit ratio for those 18 and below doesn't justify vaccines and there's a pretty good chance that it doesn't justify vaccination in these very young adults."
Students at Indiana University in Bloomington, Ind., retained counsel to sue the school this week over its vaccine mandate, while in Annapolis, Md., students in the University of Maryland system protested last month against a blanket vaccine mandate there.
Overall, our study does not provide evidence that remdesivir is of benefit in patients hospitalised with severe COVID-19.Aavßßbsa,
Evaluation of the effectiveness of remdesivir in treating severe COVID-19 using data from the ISARIC WHO Clinical Characterisation Protocol UK: a prospective, national cohort study
https://www.medrxiv.org/conten…6.18.21259072v1.full-text
Abstract
Background Remdesivir was given UK early-access approval for use in COVID-19 in people aged 12 years and older on 26th May 2020 on the basis of unmet clinical need. Evidence on the side effects, complications of therapy and effectiveness of this therapy is lacking or conflicting.
Methods Adults with severe COVID-19 treated with remdesivir were compared with propensity-score matched controls, identified from the ISARIC WHO Clinical Characterisation Protocol study of UK hospitalised patients with COVID-19. Remdesivir patients were matched to controls according to baseline underlying 14-day mortality risk. The effect of remdesivir on short-term outcomes was investigated (primary outcome: 14-day mortality). Effect sizes were estimated and adjusted for potential confounders using multivariable modelling.
Results 1,549 patients given remdesivir and 4,964 matched controls were identified satisfying inclusion and exclusion criteria. The balance diagnostic threshold was achieved. Patients had symptoms for a median of 6 days prior to baseline; 62% were male, with mean (SD) age 63.1 (15.6) years, and 80% categorised as ‘White’ ethnicity. Fourteen-day mortality was not statistically significantly associated with treatment (9.3 % remdesivir vs. 11.9% controls, odds-ratio 0.80, [95% CI 0.60-1.07], p=0.116, adjusted for age, sex, number of key comorbidities, dexamethasone use, and diagnosis of viral pneumonia.
Findings Treatment with remdesivir was not associated with a reduction in mortality in our primary endpoint at 14 days.
Interpretation Remdesivir did not significantly improve mortality in this study. The findings are subject to the limitations of an observational study. Balance was achieved for measured baseline factors, but unmeasured confounders may account for observed treatment effect sizes.
Funding Medical Research Council UK & National Institute of Health Research
Evidence before this study At the time of designing this study, two clinical trials measuring the efficacy of remdesivir as a therapeutic in treating SARS COV-2 had published results: ACTT-1 and SOLIDARITY. ACTT-1 suggested that for those who required supplemental oxygen but not ventilation at baseline, remdesivir reduced time-to-recovery (rate ratio 1.45, [95% CI: 1.19-1.79]), improved clinical status at 15 days (proportional odds ratio 1.6 [1.2-2.3]), and improved mortality by both 15 days (hazard ratio 0.28 [0.12-0.66]) and 29 days (0.30 [0.14-0.64]) compared with a placebo. SOLIDARITY did not find any evidence of benefit for remdesivir in these same types of patients – it reported on time-to-recovery, and 28-day mortality, compared with the local standard of care.
Added value of this study This study presents real-world data on the effectiveness of remdesivir use during a non-surge phase of the pandemic in the UK, specifically looking at patients for whom the ACTT-1 trial suggested would be most likely to benefit from remdesivir.
Implications of all the available evidence We show that during the pandemic, remdesivir was given to a wide demographic of patients in the UK (on average older than those in clinical trials). At 14-days post baseline no reduction in absolute mortality was observed. Propensity score matching achieved balance for measured baseline variables. However as with all observational studies, differences between the groups in unmeasured variables that may influence clinicians but were not recorded in our study, are plausible.
Discussion
In this analysis of data from a large UK-wide study, we found that remdesivir use was not statistically significantly associated with improved 14-day mortality. There was an absolute difference in incidence of 2.6 percentage points in favour of remdesivir, but this was not statistically significant after adjusting for potential confounders. The confidence interval for the adjusted odds-ratio indicated considerable uncertainty regarding potential effect of remdesivir of a 40% reduction, to having no effect. A small reduction in 28-day mortality was detected, though as a secondary outcome, this result should be considered hypothesis generating. Our study does not exclude the possibility that effectiveness might be present in specific patient subgroups.
Our study population was representative of severe COVID-19 patients of all ages, treated in hospitals across the whole UK, predominantly of white ethnic background, and male. Compared with both the ACTT-115 and SOLIDARITY17 trials, our cohort was older, and less ethnically diverse. As age is a key factor in risk of death from COVID-19 absolute survival outcomes presented here should not be compared directly with the rates published in these trials. Patients in our study received many types of treatment during hospitalisation, but the data do not indicate when these treatments were received, nor the dose, nor duration. Use of other antivirals was rare - the control group can be considered a ‘Non anti-viral therapeutics’ group. There is an indication that dexamethasone use (and by implication corticosteroid use) was greater in the remdesivir group, and also use of antibiotics. Complications during hospitalisation indicated some imbalance in the groups. The remdesivir group had higher recorded prevalence of viral pneumonia. This measure is difficult to interpret, and arguably our inclusion criteria define patients that were presenting with viral pneumonia at baseline. It may have little meaning recorded in the complication CRF, or may have been a proxy for greater baseline severity, or a secondary effect to the antiviral, though there is less biological plausibility for the latter. Hyperglycaemia, ARDS, and liver dysfunction were also more observed in the remdesivir group. One in eleven patients in our cohort were recorded as suffering from acute renal injury or failure, but this was similar in the two groups. NIV usage was more likely in the remdesivir group. This could represent a higher level of illness in this group, which was not apparent from the baseline data. Alternatively, it could represent a lower threshold for escalation of care in this group, or a perception that escalation was less likely to be futile in this group. See appendix p17 for further discussion regarding secondary outcomes.
This analysis used data from a prospective observational study, using routine care data collected during a pandemic. There are limitations in that effectiveness estimates are not from randomised patients, and the data collected reflect local practice by the clinical teams at numerous hospital sites. The study was designed pragmatically to be simple enough to be rapidly implemented, using data that were being collected under a generic protocol. The analysis was planned and made open for comment prior to any data being provided for analysis. Data completeness for baseline characteristics and final clinical outcomes were found to be extremely good thanks to the diligence of participating sites throughout the country. Daily follow-up data was less available than expected, and this meant that two outcomes and clinical status at day 15 could not be derived as planned. Inclusion and exclusion criteria were used to define a cohort that represented the type of patient that would have been eligible to have received remdesivir, and with the greatest potential to benefit from it, according to the existing evidence base. This created a clear analysis cohort with similar baseline level of severity of COVID-19. 73% of patients given remdesivir were excluded – chiefly because their treatment did not start within 24 hours of baseline. We justify their exclusion as the data collection tool could not guarantee determination of clinical status at start of treatment at other times. Other remdesivir patients were excluded because they required respiratory support or ECMO at baseline. These excluded patients are of interest, in the overall assessment of effectiveness, but would have to be the subject of a separate study. Propensity matching was used effectively to select a control group that had a similar profile to remdesivir patients and balanced according to the risk-score balance diagnostic. The control group were slightly older, but had similar clinical frailty scores, and numbers of comorbidities. Propensity score matching is a powerful design tool in an observational study – provided all key factors that increased likelihood of treatment are considered when developing a propensity score model. A priori matching factors were principally demographic and baseline clinical characteristics that might be related to chance of being given remdesivir, or chance of death within 14 days, or both. Several baseline continuous measures were not prespecified in the SAP for inclusion in the development of the propensity score model: oxygen saturation, respiratory rate Glasgow coma score, urea and C-reactive protein (CRP). With hindsight these may have been important to consider, though missing CRP and urea data would have led to at least 20% of patients being excluded from the matching algorithm. Nevertheless, these variables all contribute to the 4C mortality score, for which good balance was observed.
It is possible that further benefit could be gained if remdesivir, or a similar orally available direct acting antiviral, could be given earlier in the disease process, when pharyngeal shedding and by inference viral replication in the lower respiratory tract is at its highest.12 SARS-CoV-2-infected rhesus macaques were successfully treated when remdesivir dosing was initiated 12 hours after virus inoculum. The authors noted that the efficacy of such direct acting antivirals against acute viral respiratory infections usually drops with time after infection and stressed the importance of dosing humans as quickly as possible. The ACTT-1 trial15 confirmed that benefits associated with remdesivir were larger earlier in the disease course (<=10 days vs >10 days). Our study contains too few hospital-acquired patients to explore this hypothesis.
We note that liver dysfunction was increased in the remdesivir group. This is not unexpected, since raised transaminases are an expected adverse event in nucleoside analogues, and indeed alanine aminotransferase (ALT) was elevated in 7% of remdesivir clinical trial participants.26 The current data does not allow us to distinguish the level of severity of this liver dysfunction or whether it was reversible.
Overall, our study does not provide evidence that remdesivir is of benefit in patients hospitalised with severe COVID-19.
This critique is interesting and shows the reason why scientists are cautious
Stefan You should know the difference between a study and a opinion piece. What you linked is paid FUD!
that people have the right to decide whether to accept vaccines or not, especially since these are experimental vaccines," Dr. Malone said, pointing to the fact the vaccines are not formally approved but instead being administered under Emergency Use Authorization
This is why people like Malone at the end get fired. With truth you never make tons money. Ask THH.
But I would not recommend that one removes the P-values as
Of course not. The p value for Ivermectin being useful is 99.9999999999%. So its relatively high.
A Coronavirus Epidemic Hit Humanity 20,000 Years Ago, DNA Study Reveals
https://www.sciencealert.com/s…onaviruses-in-our-dna/amp
A coronavirus may have swept across East Asia more than 20,000 years ago, leaving traces in the DNA of people in modern China, Japan and Vietnam. Our research, published in Current Biology, found evidence of genetic adaptation to the coronavirus family of viruses in 42 genes in modern populations in these regions
The COVID-19 pandemic, caused by the coronavirus SARS-CoV-2, is so far responsible for more than 3.8 million deaths and billions of dollars in economic losses worldwide. The coronavirus family also includes the related MERS and SARS viruses, both of which have caused significant deadly outbreaks in the past 20 years.
Our results show how the hunt for genetic traces of historical viral outbreaks may help us treat the outbreaks of the future.
Pandemics may be as old as human history
We have had pandemics before. In the 20th century alone, three variants of the influenza virus each resulted in wide-ranging outbreaks that killed millions: the "Spanish Flu" of 1918-20, the "Asian Flu" of 1957-58, and the "Hong Kong Flu" of 1968-69.
Historical records of outbreaks caused by viruses and other pathogens stretch back thousands of years. It seems plausible that these interactions go back even further, to the earliest periods of human prehistory.
The ancient migrations that saw our ancestors spread out from Africa across the world would have introduced them to new pathogens. Like many other environmental challenges, these ancient viral encounters may have triggered adaptions that helped our ancestors survive. These adaptations may have included physiological or immunological changes that improved resistance to infection or reduced the health impacts of the disease.
Adaptation to disease can leave genetic traces
Over the past few decades, geneticists have devised powerful statistical tools to uncover genetic traces of historical adaptation events that remain present within the genomes of people living today. These tools have allowed scientists to discover genes that mark adaptations for high-altitude living and the adult consumption of milk, among other things.
Our team was curious to see whether historical encounters with ancient coronaviruses have left any such trace in today's human populations. Besides revealing historical coronavirus outbreaks, this information may hold new insights in the genetic basis of coronavirus infection and how these viruses cause disease in modern humans.
Viruses are simple creatures with one objective: to make more copies of themselves. But their simple biological structure means they cannot reproduce independently.
Instead, they must invade the cells of other organisms and hijack their molecular machinery. Viral invasions involve attaching and interacting with specific proteins produced by the host cell, which we call viral interacting proteins (VIPs).
The marks of ancient coronavirus
We applied cutting-edge computational analyses to the genomes of more than 2,500 people from 26 populations around the world. We found signatures of adaptation in 42 different human genes that encode VIPs.
These VIP signals were present in only five populations, all of them from East Asia – the likely ancestral homeland of the coronavirus family. This suggests the ancestors of modern East Asians were initially exposed to coronaviruses around 25,000 years ago.
Further testing revealed that the 42 VIPs are primarily expressed in the lungs, which is the tissue most affected by COVID-19 symptoms. We also confirmed these VIPs interact directly with the SARS-CoV-2 virus responsible for the current pandemic.
Other independent studies have also shown that mutations in VIP genes may mediate SARS-CoV-2 susceptibility and the severity of COVID-19 symptoms. In addition, several VIP genes are either currently being used as drug targets for COVID-19 treatments or are part of clinical trials for this purpose.
Several of the adaptive VIPs identified in our study are also drug targets for other types of viruses, such as Zika virus and hepatitis C. Several of these drugs have been successfully repurposed, and suggests that others could potentially be repurposed for COVID-19 treatment.
By uncovering the genes impacted by historical viral outbreaks, our study points to the promise of evolutionary genetic analyses as a new tool for fighting future outbreaks.
Reducing Data on Breakthrough COVID Infections Not in Public Interest
https://trialsitenews.com/redu…s-not-in-public-interest/
Joel S. Hirschhorn
Here is the critical question. How well does the artificial immunity provided by experimental COVID vaccines really work to protect people from getting infected? The answer is revealed by how many “breakthrough” infections develop two weeks or more after full vaccination. But can we trust the federal government to collect comprehensive data on them? Now, the answer is NO.
In early June, the CDC revealed that they stopped tracking all cases where experimental COVID vaccines failed to prevent infections. Rather than get systematic data on all breakthrough infections as it was doing originally, it announced that it would only attempt to get data on people who got very sick and were hospitalized or died.
The inadequacy of that is that the overwhelming number of American who have been infected have not gotten very sick or died. This means, therefore, that experimental COVID vaccines that are now seen only as having to be effective in preventing people from getting very sick or dying are not really necessary at all for all people. This is even more true for roughly half the population that has achieved natural immunity because they were previously infected and, again, were not likely to get very sick or die.
What seems a logical conclusion of the CDC action to greatly limit getting data on breakthrough infections is that the government does not really want to determine and reveal how effective the experimental COVID vaccines are.
Before the CDC decision there was a lot of data showing large numbers of vaccinated people coming down with COVID infection. Though they may be a small fraction of all vaccinated people, they are often of catastrophic consequences for those who are impacted.
How do you alleviate the suffering of a family that has lost a loved one to COVID even after being fully vaccinated?
Here are some relevant data. Some 10,262 of the 101 million people who were fully vaccinated as of April 30 caught the virus, according to a recent CDC report. This was from just 46 states and territories. At least 2,298 fully vaccinated people have been hospitalized, and at least 439 people have died from COVID-19, according to the CDC.
Under the new CDC system here are some recent data. As of May 10, 1,359 breakthrough cases that resulted in hospitalization or death have been reported to CDC. At that time, about 115 million people in the United States had been fully vaccinated.
As of June 8, the CDC reported around 3,300 hospitalizations amongst the 140 million people fully vaccinated, a rate of one hospitalization for every 42,000 people. They also report a rate of one death for every 230,000 people. That is about 1,000 more hospitalizations in about five weeks. This could be a significant undercount.
Several experts, including Dr. Harvey Risch of Yale, have said that 60 percent of new COVID cases are for fully vaccinated people.
Breakthrough infections and deaths are an issue in Europe. In a nursing home in Belgium, 55 residents tested positive and 12 died despite being fully vaccinated.
Data from the UK found that 0.00636 percent of fully vaccinated Brits known to have contracted the virus died, which was six times higher than the 0.000957 percent of unvaccinated people who died after testing positive for the virus. Additionally, hospitalizations for those carrying the Indian variant are higher among the vaccinated, with 2 percent of 4,087 COVID positive and fully vaccinated individuals being admitted to a hospital. This compares with 1.48 percent of 35,521 COVID-positive individuals who were unvaccinated being admitted to hospital.
Here is what one critic of the new CDC policy said: “Just looking at hospitalizations or cases from people who die is really keeping, I believe, blindfolds on your eyes and not fully understanding what’s happening with this virus,” said Rick Bright, a former federal health official who’s now with the Rockefeller Foundation. “It puts us at a disadvantage of better understanding this virus and how to end the pandemic. These variants are spreading, and if you’re just looking at the small percentage, then you’re really missing the big picture,” Bright said. “You’re missing the big story of where the virus is and how it’s changing.”
Here is another view. At the very least, the CDC should be regularly sequencing the genetic code of a random sample of virus from all types of breakthrough infections, according to Saad Omer, a vaccine researcher at Yale University.
Yet another critic said this. “To say that a breakthrough infection has no clinical consequence, it feels too early to say that,” said Kavita Patel, a primary care physician at the Brookings Institution. “I just feel like we’re just way too early in this pandemic to kind of write off the value of information at this point.”
Here is another critical view of the new system. “We are driving blind, and we will miss a lot of signals,” Ali Mokdad, an epidemiologist at the University of Washington and a former senior scientist at CDC, said.
And here is a wise view of the situation. “Asymptomatic, mild symptoms, hospitalized, passed away—all that information is important,” said Ryan McNamara, a virologist at the University of North Carolina at Chapel Hill, where he and his colleagues are sequencing samples from breakthrough cases across the spectrum of severity. “If you’re asking what variant is driving worse clinical outcomes, you need both ends of the data,” he said.
Are states following the new CDC procedure? Not uniformly. Many have been tracking breakthroughs of all kinds for months, and are not sure they want to follow the CDC, according to an article in The Atlantic. “Previously, labs were sequencing all the breakthrough cases we could get our hands on,” Kelly Wroblewski, the director of infectious disease at the Association of Public Health Laboratories (APHL), said. ”Some states, such as Illinois and Tennessee, quickly followed the CDC’s lead. Others are hesitant.” For now, “we’re not changing what we’ll be sequencing,” Myra Kunas, the director of Minnesota’s state public-health laboratory, said. They want to keep getting data on COVID variants in infected people.
Experts aside, probably most Americans would probably vote to gather all possible data on breakthrough infections. But getting the most possible data would hurt the government’s efforts to compel all people to get vaccinated. Vaccine hesitancy and rejection would surely be reinforced by data in local media showing that experimental COVID vaccines are not fully protective. This is the inevitable result if more people get better informed about natural immunity and a number of cheap, proven, and safe treatments that work as prophylactics to prevent infection, mainly hydroxychloroquine and ivermectin.
And if they get better informed about a number of ugly side effects of the experimental vaccines. Smart people can weigh the risks of getting and not getting an experimental vaccine. They can and should follow the science.
A new commentary by two distinguished physicians have proclaimed important views about the experimental COVID vaccines that the public should take very seriously, especially in light of the cut in breakthrough data:
“Some scientists have raised concerns that the safety risks of Covid-19 vaccines have been underestimated. But the politics of vaccination has relegated their concerns to the outskirts of scientific thinking—for now. …the large clustering of certain adverse events immediately after vaccination is concerning, and the silence around these potential signals of harm reflects the politics surrounding Covid-19 vaccines. Stigmatizing such concerns is bad for scientific integrity and could harm patients. …The implication is that the risks of a Covid-19 vaccine may outweigh the benefits for certain low-risk populations, such as children, young adults and people who have recovered from Covid-19. …And while you would never know it from listening to public-health officials, not a single published study has demonstrated that patients with a prior infection benefit from Covid-19 vaccination. That this isn’t readily acknowledged by the CDC or Anthony Fauci is an indication of how deeply entangled pandemic politics is in science.”
Clearly, the CDC wanted to keep public data about breakthrough infections as low as possible. It does not want Americans to believe they have options besides experimental vaccines. But they do.
Dr. Joel S. Hirschhorn, author of Pandemic Blunder, worked on health issues for decades. As a full professor at the University of Wisconsin, Madison, he directed a medical research program between the colleges of engineering and medicine. As a senior official at the Congressional Office of Technology Assessment and the National Governors Association, he directed major studies on health-related subjects; he testified at over 50 US Senate and House hearings and authored hundreds of articles and op-ed articles in major newspapers. He has served as an executive volunteer at a major hospital for more than 10 years. He is a member of the Association of American Physicians and Surgeons, and America’s Frontline Doctors.
U.S. Federal Government Doesn’t Possess the Data to Calculate Transmissibility & Thus No Vaccination Target Can Foretell ‘Herd Immunity’
https://trialsitenews.com/u-s-…n-foretell-herd-immunity/
Achieving so-called “herd immunity” underpins the major mass vaccination drive, the premier goal of the Joe Biden presidency thus far. Represented by the targeted goal of at least 70% of Americans with at least one jab, is the underlying rationale sound here? But what is herd immunity and, importantly, what is needed for achieving this status? COVID-19 vaccines don’t actually prevent SARS-CoV-2-based infection and moreover don’t stop viral shedding once infected. A 90%+ effective rare for the vaccines means actually that once an individual develops COVID-19, they have more protection, reducing the risks of complications from disease progression such as hyperinflammatory syndrome. While predicting disease necessitates viral infection, that’s not enough as many get infected yet don’t develop the disease. All of this matters for the goal of herd immunity, again the very point of why POTUS seeks a target of 70% of the American population treated to at least one dose of the COVID-19 vaccines (e.g. Moderna, Pfizer-BioNTech, or Johnson and Johnson).
As shared by TrialSite advisory committee member Dr. Robert Malone, the milestone called herd immunity actually precludes the viral infection prerequisite as “Reaching herd immunity requires no viral infections—no viral spreading—in the group (herd). No viral shedding. But the vaccines do not prevent either infection or shedding.” As Dr. Malone recently emphasized, this is a #Sciencefact not a PolitiFact.
The Challenge
Again, the premise in the 70% POTUS directive: that American society is driving to “Herd Immunity” collectively with each jab. But how can this be the case when the actual effectiveness of the vaccines in preventing transmission of the virus (transmissibility) isn’t actually known? That’s right; at present, it’s not known just how effective the vaccines are at preventing transmission. If in fact transmissibility was known, that is to say that based on extensive study scientists could measure the COVID-19 vaccines’ were 50%, or 70% or 20% effective, then biostatistical calculations can be programmed into algorithms which will predict the segment of the populace that would need to have been inoculated to reach that milestone called herd immunity.
However, to actually achieve this goal necessitates granular data heretofore not known nor currently available. That is, what is the reduction in viral transmissibility rates for each vaccine? Scientists must be able to measure, quantitatively as well as aggregate mean calculations concerning just how effective each vaccine actually is in preventing person-to-person transmission. But presently, these data aren’t known.
Moreover, these vital underlying data (transmissibility rates), a fundamental prerequisite to perform the calculations that could lead to the herd immunity target assessment, were not required by the U.S. Food and Drug Administration (FDA) for neither clinical studies nor licensure. Rather, the FDA was concerned with disease prevention as an urgent endpoint, with an emphasis on hospitalization and death.
Media & Pundits
So let’s do a review of what media, pundits, and other so-called experts correlate the POTUS goal with herd immunity. According to the Baltimore Sun editorial board, if we don’t reach 70% goal by July 4th then we have only ourselves to blame. These enlightened characters declare, “Of course if the July 4 deadline passes and the magic number is not yet met, that doesn’t mean the vaccine effort has failed or will stop. The effort must be kept up until we reach herd immunity…or we risk another outbreak…” Now these pundits and purported experts could be confusing the use of an anti-SARS-CoV-2 virus drug effectiveness with a vaccine as these necessitate different algorithms.
Are the Blind Leading the Blind?
Now with this important information in mind, it’s important to revisit the federal government’s goal of the 70% target by July 4th, 2012. Or there is Johns Hopkins epidemiologist Gypsyamber D’Souza with Johns Hopkins University quoted in the Washington Post explaining how the jabs help achieve herd immunity. Or a real expert in these matters, a business writer Robert Hart on Forbes staff, who pens “It’s possible immunizing 70% of Americans would reach the herd immunity threshold needed to stop the viral spreading” and then goes on a discourse of facts and figures with no bearing on the actual reality. And it goes on and on to POTUS himself who has used the term without really understanding what it means and what one actually needs to calculate its arrival.
Words of Wisdom
The TrialSite Community should look into this matter, studying the underlying assumptions, and consider multiple sources to ensure verification of any new knowledge. And the next time either a public health official or some media talking head declares that the inoculation of a certain percentage of the populace is required for the bid to reach “herd immunity”, then step back and remember that based on the lack of sufficient data today—again for the reasons mentioned above—you can conclude that they are clueless. Remember the data required to support such calculations do not exist.
Ivermectin Authorized in Indonesia as Pharma Issued License for Production to Battle COVID-19
https://trialsitenews.com/iver…ction-to-battle-covid-19/
Indonesia’s now in the middle of its most severe wave of the COVID-19 pandemic. Now thanks in part to a wealthy entrepreneur presently serving as the Minister for State Owned Enterprises (SOE), the country’s national drug regulator authorized the use of ivermectin on an off-label basis targeting COVID-19. In 2020, the Indonesian government brought in a wealthy, dynamic, and aggressive businessman to shake up and turn around state-owned enterprises known as “SOE.” Now they’ve turned Erick Thohir loose on COVID-19, and there’s nothing but business. A pragmatic yet big thinker, the new SOE Minister of the Food and Drug Supervisory Agency, known for the acronym BPOM, issued a distribution permit for ivermectin, meaning the regulatory body for this Southeast Asian nation of 270 million, the worlds’ fourth most populous nation, has authorized the use of the generic, low-cost drug as a therapeutic for COVID-19. Based on the results of a study, this BPOM action led to a distribution license to PT Indofarma Tbk; and production now has commenced with plans for distribution of over 4 million units per month. This fascinating and unfolding situation is the result of the dynamic SOE minister driving state enterprises to solve the COVID-19 crisis as the BPOM still takes the position that the treatment is accepted but on an off-label basis. But BPOM has declared formally that ivermectin is now authorized as a therapy for COVID-19.
For months, India’s national authorities have authorized ivermectin as a regimen to be included targeting COVID-19 yet this authorization was then removed due in part to both internal and external political pressure. Now the world’s fourth most populous nation’s regulatory authority has authorized ivermectin’s use in a major breakthrough for the drug’s role in the COVID-19 pandemic.
To date, only 12.6 million people have been fully vaccinated in Indonesia, representing about 4.7% of the population. In the meantime, the country now enters its worst phase of the pandemic, a third spike where on June 23 a record number of daily cases, 15,308, were recorded.
COVID-19 Market
Presently, 60 studies have produced overwhelmingly positive data indicating ivermectin-based efficacy and safety signals in the context of COVID-19. A generic drug industry won’t make a huge return with this drug hence despite mounting evidence and large trials now in both America and England, a confluence of factors and forces have served to inhibit ivermectin’s potential in the richest economies. TrialSite’s shared that the market for early-onset, mild-to-moderate COVID-19 could easily total $3-$5 billion per annum for the pharmaceutical company that can come up with the first compelling product. Presently, the top contenders are Roche, Merck, and Pfizer but each one of these firms’ investigational products show potential limitations.
TrialSite’s been the only life science-dedicated media and social network platform tracking the results of ivermectin studies since the Spring of 2020.
BPOM’s Declaration
While authorizing the use of ivermectin off-label for COVID-19, BPOM declared a number of points. The regulator declared that due to the pandemicm the state must find either new drugs or use repurposed drugs to treat the viral infection. While BPOM acknowledges ivermectin’s antiviral qualities, they declared that there’s still a need for compelling scientific safety and efficacy data through additional clinical trials. Undoubtedly, this statement ensured that BPOM could align with Western regulatory agencies, such as the U.S. FDA and Europe’s EMA.
BPOM declared that ivermectin 12 mg tablet is now registered in the nation for the indication of helminthiasis (Strongyloidiasis and Onchocerciasis). The product label calls for a dose of 150-200 mcg/kg body weight with the use of once per annum. It’s only available in Indonesia via a licensed physician’s prescription.
Moreover, although they’ll allow physician-driven off-label usagem this falls under the condition of a clinical trials program led by the Health Research and Development Agency, Ministry of Health of the Republic of Indonesia, involving a number of major hospitals.
Side Effects with Uncontrolled, Long-Term Use
The drug regulatory agency cautioned that ivermectin’s long-term, uncontrolled use could lead to side effects including muscle/joint pain, skin rash, fever, dizziness, constipation, diarrhea, drowsiness, and Stevens-Johnson Syndrome.
Oversight
BPOM’s responsible for the ongoing oversight of the off-label use of the drug targeting COVID-19. The regulatory agency committed to ongoing communication with the World Health Organization (WHO) and regulatory authorities around the world.
No Over-the-Counter or Online without Prescription
BPOM was also clear, via a request to the public, not to buy ivermectin over-the-counter without a physician’s prescription. This includes the use of online platforms and caution that business ventures set up to sell the drug online without a licensed physician’s prescription would violate the law, leading to regulatory-imposed sanctions.
Contacts
BPOM makes itself available to the public via a number of channels, including a primary contact, lapor.go.id, HALOBPOM Contact Center (call center) 1-500-533 (local credit), SMS 0812-1-9999-533, WhatsApp 0811-9181-533, email [email protected], Instagram @BPOM_RI, Facebook Fanpage @bpom.official, Twitter @BPOM_RI, or Consumer Complaints Service Unit (ULPK) at Balai Besar/Balai/Loka POM throughout Indonesia.
Spreading via Social Media
Now Indonesia and soon the world is buzzing with this news. An Indonesia-based YouTube channel clarified the news with SOE’s Special Staff of the Minister Arya Sinulingga.
TrialSite’s Indonesia POV
TrialSite published a special on Indonesia, highlighting that this diversified, dynamic, and growing economy with big middle-class aspirations demands attention. TrialSite’s founder Daniel O’Connor shared that “the Indonesian SOE minister has serious business pedigree, brings a unique combination of vision, statecraft and pragmatic ability to the effort of fighting COVID-19.” O’Connor continued, “BPOM stepped up in a big way, paving the way for other regulatory agencies to both progress the research imperative while also in parallel, imminently serving the human health interest in response to this devastating global pandemic and associated public health crisis.”
In addition to the distributor, a number of other pharmaceutical companies operate in the country including Kalbe, Dexa Medical Group, Bio Farma, and Kimia Pharma as examples of local producers. Foreign ventures including GSK, Roche, Astellas, Apotex, Sirtex, Dong-A-ST Co., and Sanaria Inc.
The Distributor
Now PT Indofarma Tbk will be producing at least 4 million batches per month. This local producer got its start back in 1918 as a medical supplies producer. By 1950, it became a state-owned enterprise and by the year 2000 became ISO certified. Since then ,the company’s achieved a number of accomplishments from additional quality certifications and accreditation for the production of pharmaceuticals, pharmaceutical, and medical instruments, bioavailability/bioequivalence (BA/BE) test laboratories, and other specialized services.
The Reformer
SOE Minister Erick Thohir has had a fascinating journey to get to this point. The 51-year old businessman founded and chairs the Mahaka Group, a holding company that focuses on media and entertainment. With a resume that includes ownership of professional soccer (Inter Milan and D.C. United), he’s also the President of the Indonesian Olympic Committee. Again by October 2019, he became the Minister of State Owned Enterprises in a bid to reform, rationalize, and turbo-charge Indonesian business. He owns an Indonesian soccer club with Kaesang Pangarep, a young Indonesian entrepreneur and YouTuber who also happens to be the youngest son of Joko Widodo, a former Indonesian president.
Call to Action: Other regulators should consider what BPOM has done, maintaining a stance that ongoing research is necessary while, at least during the public health emergency, allowing for controlled off-label use of ivermectin for the COVID-19 indication.
it's beginning !
Malaysian Activist Group Files Criminal Report Against Minister of Health for Keeping Ivermectin from the People
https://trialsitenews.com/mala…ermectin-from-the-people/
A consumer rights group in the Southeastern Asian nation of Malaysia filed a police report targeting the Health Ministry for failing to use ivermectin to prevent COVID-19. In an unprecedented action, the Malaysia Muslim Consumers Association (PPIM) issued a statement at a police headquarters in the Dang Wangi district in the nation’s largest city of Kuala Lumpur. Led by Datuk Nadzim Johan, an activist, the group’s had enough of government agencies keeping what they believe are safe and effective medicines from the people during the pandemic. In this nation of 33 million people, about 711,000 cases of SARS-CoV-2 have been recorded along with approximately 4,600 deaths.
While TrialSite reported recently that the health ministry and the Institute for Clinical Research commenced a 500 patient clinical trial investigating ivermectin for high-risk COVID-19 patients at 12 public hospitals, the Malaysian consumer and health activists argue that “Numerous clinical trials have proven that Ivermectin is able to reduce the risk of infection at 88 percent and reduce the fatality rate at 83 percent, many prophylaxes have also confirmed it can reduce Covid-19 transmissions.”
Mr. Nadzim called out the government, declaring, “The Health Ministry’s refusal to consider the effectiveness of Ivermectin is a criminal offense as that has caused more than 2,300 COVID-19 patients to die.”
While the government wants to take its time, conduct a study, and await results before making any moves, the activists’ pleas have gone unheard. Hence the action at the police station. More a symbolic move than anything else, the action evidenced a growing frustration and anger exhibited by common, everyday people against their governments during this crisis.
"A Norwegian study conducted of 100 nursing home residents who died after receiving Pfizer's Corona shots. They found that at least ten of those deaths were likely caused by the vaccine. 10%," said Carlson.
So how many people here think this means the vaccine kills 10% of people?
It is presented in an unhelpful way, with no indication as to how large a set of people were vaccinated from which 90 dies coincidentally and 10 "likely" died from vaccine.
That matters, because we need to compare risks of taking vaccine with risks of not taking it which we know in nursing homes, where with old people COVID is deadly, are high.
But, he noted there is no substantive risk-benefit analysis being applied to the vaccines.
That may be true in the US? But not elsewhere. Actually, I think it is a matter of subjective judgement, you can always argue that such an analysis should be more comprehensive, or should include more data.
Perhaps this testimony of a Japanese dental worker looks more credible to some people here.
I have seen it first hand, tested it with my own hands and thus I don’t need any more proof, but those who plainly deny it perhaps need to pay more attention.
Not very, more symbolic, but the masses are rising and finally being heard
Display More"A Norwegian study conducted of 100 nursing home residents who died after receiving Pfizer's Corona shots. They found that at least ten of those deaths were likely caused by the vaccine. 10%," said Carlson.
So how many people here think this means the vaccine kills 10% of people?
It is presented in an unhelpful way, with no indication as to how large a set of people were vaccinated from which 90 dies coincidentally and 10 "likely" died from vaccine.
That matters, because we need to compare risks of taking vaccine with risks of not taking it which we know in nursing homes, where with old people COVID is deadly, are high.
But, he noted there is no substantive risk-benefit analysis being applied to the vaccines.
That may be true in the US? But not elsewhere. Actually, I think it is a matter of subjective judgement, you can always argue that such an analysis should be more comprehensive, or should include more data.
The WHO advises against vaccinating that age group. SO just who is following the science? And who should the public trust? Confusion continues to rule!
Additionally, hospitalizations for those carrying the Indian variant are higher among the vaccinated, with 2 percent of 4,087 COVID positive and fully vaccinated individuals being admitted to a hospital. This compares with 1.48 percent of 35,521 COVID-positive individuals who were unvaccinated being admitted to hospital.
Great vaccine news. Sounds like the same effect we know from animal trials. Negative cross stimulation.
“Reaching herd immunity requires no viral infections—no viral spreading—in the group (herd). No viral shedding. But the vaccines do not prevent either infection or shedding.” As Dr. Malone recently emphasized, this is a #Sciencefact not a PolitiFact.
We can only reduce hospital load and social impact. Everything is fairy tales.
So how many people here think this means the vaccine kills 10% of people?
We here think that at least 80 out of the 100 old have been killed by the vaccine. This is still very conservative.
You can make simple comparisons. Look at how many old did die (within 5 days) after the flu vaccine and then compare with the CoV-19 vaccine. May be the true figure is more close to 90/100.
QuoteWaning antibodies is normal once the antigen isn't in your system anymore. Look up memory B cells - they store the info needed for rapid reproduction of antibodies when the threat re-emerges. Boosters are only given (and usually several years after the initial does) if data suggests people are becoming notably reinfected after an amount of time, at which point you pre-empt the drop in immunity. The CDC's just said it - no evidence for boosters any time soon as of yet.
Except it takes ten or more years for tetanus or rabies (whole life immunity) - but for coronavirus or flu infections it just takes few months. The conclusion and message for greedy Big Pharma people is clear: the vaccines and immunization concept is just a waste of public money and unnecessary load of organism for fast mutating viral diseases, where the antiviral prophylaxis like Hydroxychloroquine and Ivermectin should take place instead.
Unfortunately in our overcrowded civilization, once there is just a minute pretence and/or possibility how to get public money, everyone gets immediately furiously after it, because it's the simplest and most reliable way, how to achieve profit. This applies both to subsidizing of collider research, cosmic flights, GMOs research in fight against weeds and mosquitoes, both "renewables", geoengineering and electromobility in fight against global warming and so on.
Nobody cares, if these "solutions" are necessary and/or they actually work - what matters here is the volume of money transferred from larger group of people to smaller group of people, which collect money by "shielding" of real or perceived threats in a way, which is quite equivalent to shielding gravity mechanism in dense aether model (and also the way, in which mafias are paid for "protection"). The way, in which already rich people attract another money and resources in human society therefore teach us a lot about how gravity in universe works - and vice-versa.
FLCCC weekly update
Great vaccine news. Sounds like the same effect we know from animal trials. Negative cross stimulation.
We can only reduce hospital load and social impact. Everything is fairy tales.
We here think that at least 80 out of the 100 old have been killed by the vaccine. This is still very conservative.
You can make simple comparisons. Look at how many old did die (within 5 days) after the flu vaccine and then compare with the CoV-19 vaccine. May be the true figure is more close to 90/100.
Q1: You think the vaccine reduces hospital load? I've looked at the epidemiological studies and I'm not sure - seasonality and all 
Q2: 80 out of 100? You mean 80% of the very vulnerable??
FLCCC weekly update
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THH,
I have not watched this video. I have watched a couple before that were presented by FLCCC, but I have not kept close track of them nor have a close affinity. The couple of videos I watched before seemed fairly solid though and the people do have various qualifications.
So I am not watching this video yet. I would like to ask you to watch it first and then report back what specific issues you have with it....if any. I will then watch the video, having noted your questions / concerns. I would like to do this to see if my opinion is guided. Since I know these people are certainly "pro-ivermectin" and the title contains "irrefutable", if I watched it now, I probably would find it quite positive.
Having your critical review (critical is not a bad thing) before hand, it might allow me to see your thoughts more clearly. Would you do this?
Thank you.
-Bob
