Shocking news for UK football fans! Did the Chinese/Japanese invent football already 1400 years ago???
Shocking news for UK football fans! Did the Chinese/Japanese invent football already 1400 years ago???
Real football was invented in the United States!
Just throwing this out there. Was anyone aware of this situation, or read a mainstream media article on the subject? Just asking since some here disregard what's really happening right under their nose!!!
New Hampshire State Agency Seeking to Remove Children from Parents for Using Ivermectin to Treat COVID-19
Recently, New Hampshire State Representative Jim Kofalt wrote a piece for the RAIR Foundation USA, reporting that New Hampshire’s Department of Children, Youth and Families (DCYF) has made a move to separate a teenage boy from his father and mother because the former administered ivermectin to the young man to treat COVID-19.
How far will authorities go now to declare how people living in the United States will care for themselves and their family members? In New Hampshire, the Department of Children, Youth, and Families (DCYF) possesses considerable authority when it comes to matters of child neglect, abuse, and other relevant matters. But what about the case when an off-label treatment is used for a teenager in response to COVID-19?
In this case, a father had no ill intent and arguably there was little risk, depending on whether the ivermectin was prescribed by a licensed professional. Ivermectin is a safe treatment only known for mild side effects if any. Some could argue, as did Representative Kofalt, that many over-the-counter medications pose more danger than ivermectin used for COVID-19 indication. But what if it is used off-label? Obviously, if a licensed physician is involved, this should be a matter between parent and physician. But that has changed since the pandemic.
Protective Order
Representative Kofalt reports that the New Hampshire DCYF issued a protective order, including the deployment of state agents to “be on the lookout” for the children. The state representative writes for the RAIR Foundation USA that the parents moved the children to a “safe location before DCYF could get to them.”
Apparently, legal proceedings commenced but there is much more to this story. In this case, the father writes Kofalt, is a former New Hampshire state legislator and a co-founder of ReOpenNH, a group fighting what it has deemed overly intrusive pandemic-related rules, such as ubiquitous mask requirements, forced business closures, and the like. The father also leads a gun-rights group and homeschools the kids with his wife.
Collusion?
Representative Kofalt asked, are the government authorities and the medical establishment colluding to eliminate any alternative options to care so that the only option remains a vaccination program? Does the fact that the father and mother, in this case, take on conservative, Christian-type views inclusive of homeschooling play a role in the decision?
Call to Action: Check out “Weaponizing the State: Does NH DCYF Have a “Bitter Clingers” Problem?” The RAIR Foundation USA is a conservative-focused nonprofit group. TrialSite has no allegiance with any political or cultural groups—whether to the right or the left—but rather seeks to bring transparency and accessibility to medical research. In this case, fundamental issues of state power, parental rights as well as jurisdiction arise all around the increasingly controversial off-label use of ivermectin
No news, just sailor promises.
A minion asked him:
and the magician answered:
An important promise.
Hello DR Rossi
Can you give a range in months
from the day you receive the
Millionth order until the day a
Customer receives a SKLep.
Regards
Sam
Sam:
I suppose between 1 month and 1 year, depending on the date of the order,
Warm Regards,
A.R.
Orders.
Dear Readers:
Today we reached 500000 ( fivehunderethousand ) units ordered of the Ecat SKLep.
Warm Regards,
A.R.
Ruby:
Yes, the flow of orders continues to be substantial. The success of the video presentation made on December 9th and published on http://www.e-catworld.com has been much higher than we expected.
Warm Regards,
A.R.
Israel: Very concerning development during last week: Number of severely ill vaccinated (green)did increase 4x that of unvaccinated only by 50%!
lighter green is boostered.
#4 (again)
Here is the correct (not concerning) graph of severely ill per 100,000 (baseline rates folded in as must be).
Display MoreJust throwing this out there. Was anyone aware of this situation, or read a mainstream media article on the subject? Just asking since some here disregard what's really happening right under their nose!!!
New Hampshire State Agency Seeking to Remove Children from Parents for Using Ivermectin to Treat COVID-19
https://trialsitenews.com/new-…mectin-to-treat-covid-19/
Recently, New Hampshire State Representative Jim Kofalt wrote a piece for the RAIR Foundation USA, reporting that New Hampshire’s Department of Children, Youth and Families (DCYF) has made a move to separate a teenage boy from his father and mother because the former administered ivermectin to the young man to treat COVID-19.
How far will authorities go now to declare how people living in the United States will care for themselves and their family members? In New Hampshire, the Department of Children, Youth, and Families (DCYF) possesses considerable authority when it comes to matters of child neglect, abuse, and other relevant matters. But what about the case when an off-label treatment is used for a teenager in response to COVID-19?
In this case, a father had no ill intent and arguably there was little risk, depending on whether the ivermectin was prescribed by a licensed professional. Ivermectin is a safe treatment only known for mild side effects if any. Some could argue, as did Representative Kofalt, that many over-the-counter medications pose more danger than ivermectin used for COVID-19 indication. But what if it is used off-label? Obviously, if a licensed physician is involved, this should be a matter between parent and physician. But that has changed since the pandemic.
Protective Order
Representative Kofalt reports that the New Hampshire DCYF issued a protective order, including the deployment of state agents to “be on the lookout” for the children. The state representative writes for the RAIR Foundation USA that the parents moved the children to a “safe location before DCYF could get to them.”
Apparently, legal proceedings commenced but there is much more to this story. In this case, the father writes Kofalt, is a former New Hampshire state legislator and a co-founder of ReOpenNH, a group fighting what it has deemed overly intrusive pandemic-related rules, such as ubiquitous mask requirements, forced business closures, and the like. The father also leads a gun-rights group and homeschools the kids with his wife.
Collusion?
Representative Kofalt asked, are the government authorities and the medical establishment colluding to eliminate any alternative options to care so that the only option remains a vaccination program? Does the fact that the father and mother, in this case, take on conservative, Christian-type views inclusive of homeschooling play a role in the decision?
Call to Action: Check out “Weaponizing the State: Does NH DCYF Have a “Bitter Clingers” Problem?” The RAIR Foundation USA is a conservative-focused nonprofit group. TrialSite has no allegiance with any political or cultural groups—whether to the right or the left—but rather seeks to bring transparency and accessibility to medical research. In this case, fundamental issues of state power, parental rights as well as jurisdiction arise all around the increasingly controversial off-label use of ivermectin
This story is all over the web told by the father who has pending legal action over custody of his children.
As always with custody issues the picture is murky and I see no way we can get the real story: it will be confiential for child's sake. And the father - politicising it - will still have the bexcuse of legal action so he will be able to leak out the things that sound good without context.
I VERY MUCH doubt that ivermectin is the key issue here unless the father was using animal ivermectin - which would constitute child poisoning.
Manuse said medical staff “immediately blamed the ivermectin for the son’s [Acetaminophen] story and called the Division of Children, Youth and Families (DCYF),” then “coordinated with police to have all of JR’s minor children removed from his home.”
The issue hinted at from this (pro-father politicised) account is to do with the Son's story. We would absolutely need this to work out what is going on here.
But... I'm expecting there are those who are quite certain on this no info except the unchecked statements of a father in a legal battle over custody.
I would want not to jump to conclusions. For example, there could be extant every one knows but not quite enough for legal action allegations of child abuse and this allows them to do what is in the child's best interest (and what the child wants - notice we have not heard from them.
Generally with child welfare cases you can write them up - missing things out - to look obviously favourable to one side. Of course occasionally they are like that, but more often not. In this case if NY behaves properly we will not know because these things need to be confidential for everyone's sake (mainly the children).
Social Services (in the UK) have a dreadful job. Everyone hates them. They are under-resourced and not paid much, with case loads too high. If they do nothing and a child gets killed or raped there is a big fuss. If they take children away from parents unnecessarily there is a big fuss. And some abusive parents are very good at covering things up - so it is not easy to be sure. In the UK COVID has made these things a lot worse because schools normally serve as the people who can know when things are wrong - children have been away from school for a long time.
Update from Ontario : Despite the premier promising just 3 weeks ago that we would not go into lockdown, we have again gone into a state of lockdown. (This kind of total reversal has been seen throughout the pandemic. Reminds me of psy-op techniques.) Schools that were supposed to be open January 3 are now closed for at least two weeks, leaving parents and teachers scrambling. Many indoor activities such as gyms, indoor dining, museums, etc are now shut down. Now the vaccinated are getting a taste of how the unvaccinated have been treated.
Here is data from the province of Ontario. The levelling off of rates at the end is likely because of recent restraints on testing. Notice how infection rates of the vaccinated have surpassed those of the unvaccinated.
Our neighbouring province of Quebec has implemented curfew again, from 10pm to 5am. (Their previous curfew that was supposed to be for one month lasted five months.) Also the Quebec premier is contemplating requiring a vaccine passport to enter liquor and cannabis stores. This, despite all the evidence that the vaccinated are at least as likely to be infected as the unvaccinated. Again, it's not about health, it's about compliance and control.
Early COVID-19 tests Contaminated, US Government Documents Reve.
US government documents have shed light on why early COVID-19 testing proved faulty. In early 2020, the Centers for Disease Control and Prevention (CDC) were rushing to design and manufacture test kits that could detect coronavirus. In February 2020, public health facilities reported errors with PCR tests designed by the CDC, leaving the United States blind to the increasing number of COVID-19 cases. Although other countries were producing effective test kits, these were not adopted in the US, as reported by TrialSite. The early failure of the CDC’s test kits was due to contamination and an overburdened laboratory, according to a BuzzFeed investigation. Buzzfeed News has gained access to interview notes and investigative documents from the US Department of Health and Human Services (HHS), the department responsible for investigating the test’s failure, which shed light on what went wrong with the tests. Of course, fast forward to today and yet another testing crisis occurs—there aren’t nearly enough available to respond to the massive Omicron wave. It would appear for a second time now a shortage in SARS-CoV-2 tests materially impacts response in America. What can we learn from recent history?
Why was the CDC making COVID-19 tests?
When news of about a novel coronavirus started circulating globally in December 2019, the responsibility for developing a new test to detect the virus in the US fell to the Respiratory Virus Diagnostic (RVD) Lab of the CDC. The RVD Lab was staffed by 9 people, only three of whom were full-time employees.
In January 2020, the World Health Organization (WHO) published instructions from the German Center for Infection Research for a successful COVID-19 test. Countries across the world started manufacturing the tests and distributing them using these instructions, yet the CDC continued to develop their own test. According to interview notes acquired by Buzzfeed News, scientists from the CDC believed they could produce a better test, as in 2012 the CDC’s MERS test performed better than the WHO test, according to a CDC employee.
A CDC employee told BuzzFeed News that the CDC believed it would be better if there were both US and German tests distributed worldwide, and that simply copying instructions for the WHO test would not have been possible, politically. The employee went on record to say, “Imagine the backlash we would have had if CDC had said, ‘Hey, let’s use a German test’”.
How do the tests work?
The test to detect SARS-CoV-2, the virus responsible for COVID-19, was developed by Xiaoyan Lu, a microbiologist at the RVD Lab, in January 2020. Three key regions of the virus genome were used for the test: N1, N2 and N3. N1 and N2 were new and specific to SARS-CoV-2, whereas N3 was found in all SARS-like coronaviruses.
The RVD lab ordered large batches of chemicals, called reagents, to detect the three viral regions. These reagents were developed off-site in a “core lab” at the CDC. A fourth part of the test, called the positive controls, was also needed. These positive controls are copies of the part of the virus’ genes keyed to each of the three reagents. Every lab that acquires a new test needs to mix the reagents and positive controls to prove that the test is working and can detect the virus.
To prove the test does not deliver false positives, the reagents should also be mixed with distilled water to cause a negative result. To prevent contamination resulting in false positives, manufacturers do not add positive controls until the final step before shipping. In most situations, positive controls are mostly manufactured at a separate site to ensure there is no contamination.
Due to time pressures, the RVD lab requested that the core lab that was responsible for the reagents also make the positive controls. “We couldn’t get it anywhere else,” said Lu.
By January 18, 2020, the RVD lab had a diagnostic test ready for manufacturing. The RVD lab required assistance to produce the tests, and the CDC responded by “activating” the Emergency Operations Center, establishing a task force of senior officials to oversee the manufacturing of the tests.
What went wrong?
Despite preparedness for pandemics and health outbreaks by the US government, the CDC kept coronavirus research contained to the small RVD lab, which was underfunded.
The RVD lab required the FDA‘s emergency use authorization (EUA) to distribute the new tests to public health facilities. Receiving the EUA was a challenge that required the core lab to send over reagents for 600 test kits, while the RVD team had to check that each test was working. The RVD lab also took over making the positive controls using templates from the core lab, according to the interview notes.
The initial goal for the CDC test was to detect outbreaks, not to diagnose sick people. However, in the early days of the pandemic in 2020, the CDC test was the only legal test to be used in the US once FDA EUA was granted on February 4, 2020.
Due to the small number of tests available, testing was limited to symptomatic travelers returning from China. These criteria were determined before there were any cases in the US and it was still believed that only symptomatic people were contagious. This meant that the new emergency authorized CDC test was aimed at a group too small to spot an outbreak.
Once EUA was received, the RVD lab released 400 kits for distribution. Each of these kits contained enough tests for 800 people and were sent to 48 public health labs across the US. Before tests could be used, the labs had to verify that the tests worked by testing reagents against positive controls and distilled water.
By the end of the first week, the RVD lab received the results of the test verifications. The water test produced false positives 75% of the time, specifically for N3, however, the N1 reagents also failed in some labs in New York. The only COVID-19 test available in the US for spotting a coronavirus outbreak didn’t work.
The hypothesis for the failed tests was that the core lab was contaminated when manufacturing the reagents and the positive controls. Although the core lab was thoroughly cleaned and decontaminated, an FDA microbiologist, Timothy Stenzel, was sent to the CDC’s headquarters in February 2020 to determine why tests were failing. Stenzel discovered that the core lab and distribution lab was clean, however, the respiratory virus lab appeared “messy”.
Stenzel realized that the RVD lab had handled both virus samples and positive controls in its main room, possibly resulting in contamination of the N1 and N3 reagents in the rooms nearby, as scientists were allowed to move freely between the rooms. Stenzel urged CDC leaders to move manufacturing of the test kits out of their labs and to a private manufacturer, a move that happened a week after his visit.
Aftermath of the test failures
As case numbers in the US rose and the situation evolved to a global pandemic, the CDC’s unreliable and faulty tests were scrapped. By the end of February 2020, the CDC permitted public health labs to get rid of the N3 component from tests they had received. The CDC started sending out kits with only the N1 and N2 reagents.
By this time, medical centers and academic labs across the US had started developing their own tests using the N1 and N2 components. The FDA permitted these tests to be used on February 29, 2020.
The CDC is yet to announce its own explanation of what went wrong with the initial test kits. The fact that the responsibility to manufacture tests was placed solely on the CDC is a problem that needs to be addressed prior to future pandemics. The issues encountered point to the lack of a national strategy for dealing with the pandemic. Not only were there not enough tests at the start of the pandemic, but there was also a lack of ventilators, masks, personal protective equipment, and swabs.
Looking forward
The current Biden administration has a plan to create a central pandemic office, and a proposal for a $65 billion (although it has been scaled down to $10 billion) “mission control” office to deal with any future pandemics. Whether or not this will be based at the CDC is still unclear. TrialSite will continue to report on the situation, and any further explanation from the CDC about the 2020 tests. Hopefully similar mistakes aren’t again underway
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Display MoreUpdate from Ontario : Despite the premier promising just 3 weeks ago that we would not go into lockdown, we have again gone into a state of lockdown. (This kind of total reversal has been seen throughout the pandemic. Reminds me of psy-op techniques.) Schools that were supposed to be open January 3 are now closed for at least two weeks, leaving parents and teachers scrambling. Many indoor activities such as gyms, indoor dining, museums, etc are now shut down. Now the vaccinated are getting a taste of how the unvaccinated have been treated.
Here is data from the province of Ontario. The levelling off of rates at the end is likely because of recent restraints on testing. Notice how infection rates of the vaccinated have surpassed those of the unvaccinated.
Our neighbouring province of Quebec has implemented curfew again, from 10pm to 5am. (Their previous curfew that was supposed to be for one month lasted five months.) Also the Quebec premier is contemplating requiring a vaccine passport to enter liquor and cannabis stores. This, despite all the evidence that the vaccinated are at least as likely to be infected as the unvaccinated. Again, it's not about health, it's about compliance and control.
Canada defines fully vaccinated as 2 doses, even if 6 months previously.
So, without boosters:
(a) omicron peak will be high and fast
(b) hospitalisation rate will be higehr than they can stand (I guess).
It is not about controlling people, it is about taking public health action needed to keep hospitals working.
But I think the UK - give everyone boosters quickly juts before the omicron peak way is better.
Those who think these lockdowns are some sort of weird political dance should think back to the tv pictures of hospitals overflowing and doctors saying they don't have enough ICU beds etc etc.
It is not certain - the problem is that if you wait till it is certain you need these measures you have baked in 2 weeks of patients not able to get treatment.
We are definitely better off than Canada and the UK is just on the edge of what will be OK (not sure which side - we will find out).
One of the issues is that hospital staff get COVID - so you have a lot of staff absences over the peak demand.
THH
Well argued - and good that we have people who are prepared to rethink things.
I thought molnupiravir did not look great initially. It now looks worse.
...
So those are the risks, as I see them. With the benefit shown in the interim analysis from the MOVe-OUT trial (whose enrollment was stopped for efficacy, remember), molnupiravir looked like a good bet. But what if that benefit isn't as high as it looked like? That's what made the advisory committee vote close (13-10), and it very much complicates the FDA's decision about whether to approve the drug (and under what conditions). Herper's article quotes a committee member saying “I think we need to stop and acknowledge that the whole reason we’re having this discussion is because the efficacy of this product is not overwhelmingly good". The initial results were a 50% relative decrease in hospitalizations in the study's unvaccinated high-risk patients (on an absolute basis, a decrease from 14% hospitalized down to 7%). But the final data showed only a 30% relative decrease, and because the numbers also changed in the control group, the absolute change was only 3% in the end. The advisory committee kept trying to work out how this happened, and it appears that Merck's team really didn't have a good answer, either. But it really makes you think that the interim read was about the rosiest view available, and that the real-world effects are going to be less impressive. I mean, the way those numbers were going, who's to say that this is the floor? And remember, these were patients at higher risk of developing severe disease - what would the benefit look like if you opened the drug up to use by the general population as soon as anyone tested positive?
who said they don't use ivermectin in Japan?
ICU Study at Osaka University Hospital Shows Ivermectin Positively Impacts GI Complications & Ventilator-Free Days
Recently, a team of medical researchers from Osaka University with expertise spanning critical care, medical statistics, and laboratory studies led by corresponding author Kentaro Shimizu, MD, Department of Traumatology and Acute Critical Medicine conducted a study centering on mechanically ventilated patients in the ICU at the Intensive Care Unit, Osaka University Hospital from December 2020, to May 2021. Concerned with reported SARS-CoV-2 related digestive symptoms, known to have poor outcomes, the study team administered ivermectin to the patients to investigate if the common, economical antiparasitic drug has any positive effect on gastrointestinal complications as well as ventilator-free days in the study subjects.
Problem Statement
During the pandemic, dexamethasone has emerged as a regimen used in severe COVID-19 hospitalized cases with mechanical ventilation; however, the powerful steroid weakens host immunity. Meanwhile, remdesivir is also widely used in hospitalization cases and has been shown in, at least some studies, to decrease time to clinical improvement. Of course, the World Health Organization (WHO) Solidarity study resulted in no clinical benefit. Some emerging safety concerns are also associated with this antiviral drug produced by Gilead.
With overall limited data on patients mechanically ventilated, the study team considered ivermectin, a drug of course, well known for not only parasitic infections (e.g., onchocerciasis and lymphatic filariasis) but also over 70 studies investigating benefits for COVID-19 patients.
The Japanese team reminds the reader in the pre-proof (accepted for publication but not published yet) that 3.7 billion doses of ivermectin have been administered around the world mostly in Africa, and Central and South America to control parasitic disease. They also point out that the generic drug, on the World Health Organization Essential Medicine List, evidenced in vitro activity against several viruses. Pointing to the path-breaking research of Drs. Jean-Jacques Rajter and Juliana Cepelowicz-Rajter (ICON Study), the Japanese team points out that in the case series in Broward County, Florida the ivermectin-based regimen lowered mortality in 280 COVID-19 patients in the propensity-score matching study. But the Japanese team also points out the Lopez-Medina study, which didn’t demonstrate efficacy—of course, TrialSite contributors have raised conflict of interest and data integrity questions about that study.
Regardless, Dr. Shimizu and the team acknowledge the controversy swirling around in their paper. They point out “there are a few clinical data on intubated COVID-19 patients in the intensive care unit (ICU).” The authors share a body of research indicating the relation between the novel coronavirus and gastrointestinal (GI) symptoms, noting “there is little research on established treatment for these GI symptoms.”
In attempting to address refractory diarrhea and regurgitation symptoms, they selected ivermectin for intestinal prophylaxis.
Research Question
Does ivermectin improve GI complications and respiratory conditions in mechanically ventilated patients with COVID-19?
The Study
Eighty-eight mechanically ventilated patients in the ICU were put into two study groups, including 1) administered ivermectin within three days post-admission and 2) a control group. 39 of the patients were assigned to the ivermectin group and 49 to the control group. Those participants in the ivermectin group received 200 μg g/kg via a nasal tube. Did this regimen help alleviate the incidence of gastrointestinal complications and ventilator-free days within four weeks from admission? The clinical investigators in this case series-like study used a propensity score with the inverse probability weighting method.
Results
The Japanese research team recently had their findings published in the pre-proof of the Journal of Infection and Chemotherapy. They report that the hazard ratio for gastrointestinal complications in the ivermectin group, when compared to the control group, equaled 0.221 (95% confidence interval [CI], 0.057 to 0.855; p=0.029) in a Cox proportional-hazard regression model.
Furthermore, the team wrote that the odds ratio for ventilator-free days compared to the control group equaled 1.920 (95% CI, 1.076 to 3.425; p=0.027) in a proportional odds logistic regression model.
Based on the results, the team concluded that ivermectin not only improved gastrointestinal complications but also the number of ventilator-free days in severe COVID-19, mechanically ventilated patients in the ICU.
Limitations
The authors report limitations, as with all studies. These include A) imbalance in the patients’ ages between the treatment groups even after weighting; B) mutant variants differences which were not understood for this study.
Lead Research/Investigator
Kentaro Shimizu, MD, Department of Traumatology and Acute Critical Medicine, Osaka University
The other authors can be reviewed at the source.
Call to Action: The team suggests that “the intestinal effect of ivermectin might influence COVID-19 infection, and thus, evaluation of intestinal viral load could be the next target to confirm this supposition.” Given a large body of research that shows some positive antiviral activity, more studies should be seriously pursued. This body of research follows that the gut just might be a sort of “motor” of multiple organ failure, a “causative factor” in the progression of various diseases, possibly even SARS-CoV-2. What if COVID-19-triggered intestinal harm triggers corresponding inflammation and actual alternation of the gut microbiota leading to respiratory disease progression? The team points out that when analyzing the microbiota of those patients infected with SARS-CoV-2, they have observed a marked decrease in gut microbiota bacterial diversity along with an increase in “opportunistic bacteria
Does COVID-19 Vaccination Cause Stillbirths as Canadian Doctor Claims?
A Canadian doctor claims that the rate of stillbirths in Canada has increased dramatically in women who have received COVID-19 vaccines. Dr. Daniel Nagase is a Canadian doctor who was publicly attacked for administering Ivermectin to some of his patients. The physician claimed that there is a correlation between the vaccines and the uptick of stillbirths. The Canadian physical declared doctors and health practitioners should disclose and print statistics regarding this matter since health authorities will refuse to do it. On the other hand, is there any hard evidence for the claim? While some, albeit minimal research emerges that SARS-CoV-2, the virus behind COVID-19 could be a contributing factor to fetal demise. At this point, no claims are medically proven, regardless of the position.
Dr. Daniel Nagase was interviewed outside a rally outside North Vancouver RCMP office in British Columbia on November 11, 2021, where he exposed information regarding the alleged increase of stillbirths in both North Vancouver and Ontario. The doctor noted his source was Dr. Mel Bruchet, a retired family doctor, whose contacts range all over Vancouver. The stillbirths in North Vancouver were reported by an alleged, unnamed doula and said to be at an all-time high. In a 24-hour period, thirteen stillbirths allegedly took place.
Dr. Nagase emphasized the rising stillbirths in North Vancouver also was observed in Waterloo, Ontario. There were allegedly 86 stillbirths between January and July – shocking, as the usual number of stillbirths in this area is only one every two months. What makes Dr. Nagase’s interview controversial is that according to him, the reports regarding the increase in stillbirths were only among vaccinated mothers, implying that the stillbirths may have been an effect of the vaccines.
Who are Dr. Daniel Nagase and Dr. Mel Bruchet?
Daniel Nagase is a currently practicing family doctor who graduated as a medical doctor from Dalhousie University in 2004. He has earned certifications in the College of Family Physicians of Canada and Competence in Emergency Medicine. Dr. Nagase has been an emergency room doctor for nearly ten years and has been a locum tenens physician since 2015 in the rural Alberta hospital.
He first received attention from the media after he was relieved of his duty after prescribing ivermectin to three of his patients. Daniel Nagase was working as a locum doctor when he administered ivermectin to three patients at a rural Alberta hospital, two of which had sought a quick recovery. In light of this, he was known for stating that provincial health officials are “withholding a life-saving medication from an entire province.”
Dr. Mel Bruchet is a Canadian notable specialist who is now retired. According to the College of Physicians and Surgeons of British Columbia website, he has officially withdrawn his medical license. He also met heavy criticism after his statement saying that COVID is a hoax.
Fact-checking the claims about the North Vancouver stillbirths
According to Global News, a Canadian mainstream media owned by Corus Entertainment, https://en.wikipedia.org/wiki/Corus_Entertainment the data coming from Vancouver Coastal Health (VCH) do not match the claims made by Bruchet and Dr. Nagase. It shows that from April up to August 2021, only four stillbirths were reported all across seven hospitals, and approximately 1,325 live births. The previous year, there were 3,299 live births and eleven stillbirths.
Because of this, Global News reports that the claims regarding the high number of stillbirths are false, as they were unable to find information to verify these rumors. VCH recently broke its silence, as it tweeted statements that dismiss the claims. According to the health authority, “there is no truth to this claim and the individuals spreading this false information have no affiliation to either LGH or VCH. There has been no notable change to the incidence of stillbirths in the VCH region throughout the COVID-19 pandemic.”
Fact-checking the claims about the Waterloo, Ontario stillbirths
The Waterloo, Ontario stillbirths reported by the family doctor were also inconsistent with the available data, according to the Global News fact check. The data from the Better Outcomes Registry & network (BORN), which is Ontario’s perinatal, newborn, and child registry, show that there were only between 12 – 15 stillbirths in Waterloo between the months of January to June 2021. This is another discrepancy found based on claims given by Bruchet and Dr. Nagase. The statistics also showed that in the entire province of Ontario during the first six months of the year, there were 300 stillbirths and 67,199 live births, equating to a 0.44% chance of stillbirth among pregnant women. This is down on the 2020 rate of 0.47%.
TrialSite was unable to access data regarding the stillbirths in Vancouver during this period. We can, however, confirm that the report from Global News is consistent with the data from the Better Outcomes Registry & Network website.
COVID-19 Implications on Pregnancies
The initial safety trials for the COVID vaccines did not include pregnant women, meaning there is little assurance of its efficacy and safety in terms of pregnancies. However, recent data show that vaccinated pregnant women were able to develop antibodies against the virus and had not reported any serious side effects.
According to the updated data of the Royal College of Obstetricians and Gynecologists (RCOG) in the UK, around 250,000 pregnant women have been inoculated by the COVID vaccine and no safety concerns were raised. Six studies showed that of 40,000 pregnant women given the COVID-19 vaccine, there was no increase in the risk of miscarriage, preterm birth, stillbirth, having a “small for gestational age” baby, or congenital abnormalities. The study also stated that the vaccines do not contain ingredients harmful for pregnant women and developing babies.
Data from Public Health Scotland in October 2021 reported that more than 14,000 pregnant women in Scotland had been vaccinated, and no reports of serious adverse effects were recorded. A new safety data by the UK Health Security Agency (UKHSA), reported that in August 2021, about 22% of the women that gave birth were vaccinated, providing “further reassuring evidence” that the vaccines are safe in pregnancy.
COVID-19 Implications on Stillbirths
While the available data does not support the claims made about the link between COVID-19 vaccinations and stillbirths, data does indicate that the COVID-19 virus itself may impact the rate of stillbirths.
A Dutch study recently confirmed that women who caught COVID-19 have increased risk of stillbirths. Pregnant women infected with COVID-19 may experience severe complications in the second half of the pregnancy, which may result in stillbirths. The study, conducted by researchers from Erasmus MC in Rotterdam, identified thirteen stillbirths that were recorded due to the virus damaging the placenta. It was also reported that among the thirteen pregnancies, none of them were inoculated by a COVID-19 vaccine. Examination of the placentas of pregnant women infected by the virus revealed that five out of 36 placentas showed an unprecedented combination of abnormalities that can lead to a stillbirth.
The Netherlands also reported that 36 out of 9,570 coronavirus-infected pregnancies have led to stillbirths. As mentioned previously the Ganor Paz study
The association between SARS‐CoV‐2 infection and late pregnancy loss – Ganor Paz – – International Journal of Gynecology & Obstetrics – Wiley Online Library also indicates a potential issue with COVID-19 and stillbirths.
As of January 2022, the U.S. Centers for Disease Control and Prevention, Canadian Society of Obstetricians and Gynaecologists of Canada, and British RCOG still recommend pregnant women to be vaccinated against COVID-19. According to these health authorities, vaccination is still the best way to prevent infecting COVID in pregnancy for both women and their babies.
Health authorities’ assertive pressure for vaccination rests on the assumption that this regimen protects pregnant women from the more severe symptoms of COVID-19, vaccination is said to provide benefits as immunity from the vaccines does transfer to the fetus through the placenta, providing the offspring immunity from the virus. TrialSite has reported on various data points around the world that vaccine adverse events, while rare, aren’t necessarily uncommon. After all hundreds of millions are now vaccinated in North America alone—this undoubtedly will lead to far more adverse events than is politically correct to discuss on mainstream media today.
Remdesivir: A World Divided & Serious Questions
Remdesivir, the first COVID-19 drug to be approved by the U.S. Food and Drug Administration (FDA), was once hailed as the life-saving drug for hospitalized patients with severe COVID-19 infection. Despite emerging studies indicating it is not effective for inpatient treatment, and a declaration by the World Health Organization (WHO) that remdesivir does not reduce mortality or duration of hospitalization, it is still being used in several countries to treat COVID-19. Remdesivir appears to have been rushed through the emergency use authorization (EUA) process by its sponsor, the National Institute of Allergy and Infectious Diseases (NIAID) – a branch of the National Institutes of Health (NIH) – and trial study endpoints on the impacts of remdesivir were modified to make remdesivir appear more successful in fighting the virus. Dr. Fauci, Director of the NIAID, declared remdesivir the “new standard of care.” By May 2020, a EUA ensured that Gilead – the manufacturers of remdesivir – could monetize the drug. Several months later, the FDA approved formally. As the pandemic continues, and safety issues and concerns of an automatic use in certain conditions merit, TrialSite takes another look at what is actually, a troubling situation.
Research resulting in the development of remdesivir began as early as 2009, and antiviral profiling in 2013 and 2014 showed potential in using remdesivir against virus outbreaks. The University of Alabama at Birmingham (UAB) was instrumental in developing remdesivir for antiviral use through research conducted by their Antiviral Drug Discovery and Development Center.
UAB was awarded a $37.5 million grant from the NIAID to study and develop a treatment for emerging viruses. The grant was a multi-institutional collaboration, and a public-private partnership between several academic institutions and Gilead Sciences, Inc. (Gilead). The grant led to the development of remdesivir, which was originally developed to treat the coronavirus causing Middle East respiratory syndrome (MERS).
The taxpayer has been a partner to the remdesivir enterprise, thanks to public funds continuously allocated between 2000 and 2019. The NIH provided $6.5 billion for research of various antiviral treatments with approximately $161.5 million directed to remdesivir preclinical studies and clinical trials from 2013.
The continued development and manufacture of remdesivir was done by Gilead, one of the world’s largest biotech corporations based in the San Francisco Bay Area in collaboration with the U.S. Centers for Disease Control and Prevention (CDC), and the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIDD), part of the Department of Defense (DOD). In its quest to prepare for pandemics, the U.S. government pursued investigational treatments for RNA-based viruses, such as EBOV (Ebola virus), MERS, and severe acute respiratory syndrome (SARS). Despite widespread public development and funding of remdesivir, the patent is owned by Gilead.
Remdesivir as a Dangerous Ebola Treatment
When the Ebola outbreak occurred in 2013 – 2016, scientists discovered that remdesivir reduced replication of EBOV in nonhuman primates. It was also discovered that remdesivir had antiviral capabilities against other viruses, including the coronavirus MERS. Following these discoveries, more researchers tested the antiviral activity of remdesivir, and it was confirmed against SARS, MERS, zoonotic coronaviruses, and human coronaviruses.
Based on the nonhuman primate studies of remdesivir on Ebola, Gilead pursued FDA evaluation of remdesivir use in humans under the FDA’s Animal Rule which permits the reliance on efficacy findings from animal studies for drugs that are not ethical to conduct human trials.
Driven by the ongoing Ebola outbreak, remdesivir was included in a randomized, controlled trial of Ebola virus therapeutics in patients from the Democratic Republic of Congo. Mid-study primary analyses found that remdesivir was inferior to other antibody-based therapeutics (including ZMapp, Mab114, and REGN-EB3), concerning mortality. On day 28 after infection, the EBOV mortality rate for remdesivir was 53.1%, and the remdesivir use was halted as a treatment for humans with Ebola. Adverse events were also reported, including hypotension and elevated creatinine levels, as well as impaired kidney and liver function.
In April 2020 Dr. Anthony Fauci claimed that remdesivir was safe, based on COVID-19 investigation. Yet, previous research during the EBOLA investigations raised questions.
Remdesivir used against COVID-19
As remdesivir was known to inhibit replication of coronaviruses before the current COVID-19 pandemic, Wang et al. (2020) published that remdesivir, when used with other antivirals, could inhibit SARS-CoV-2 (the virus that causes COVID-19) replication. The authors of the study are all affiliated with the Wuhan Institute of Virology, which has in the past received funding from the NIH for virology research. Gilead facilitated emergency access to remdesivir through a compassionate use program for COVID-19 patients with severe disease and no access to a clinical trial.
In February 2020, a placebo-controlled clinical trial (ACTT) was launched by the NIH and conducted in 60 locations and 10 countries to evaluate the effectiveness of remdesivir in preventing death in hospitalized adults diagnosed with COVID-19.
On April 28, 2020, Fauci announced that the trial showed a significant improvement of 31% in time to recovery for the remdesivir group, describing this as “clear cut evidence that the drug works.” He predicted that remdesivir would become the new standard of care for COVID.
Based on results from the NIH funded ACTT-1 trial (NEJM JW Infect Dis Dec 2020 and N Engl J Med 2020; 383:1813), remdesivir became the first antiviral drug approved by the FDA as a treatment for SARS-CoV-2 infection and is recommended for treatment of hospitalized patients who require supplemental oxygen but not mechanical ventilation (NIH COVID-19 Treatment Guidelines. opens in new tab). But this was no slam dunk. As discussed below, some large clinical trials failed to produce a remdesivir benefit (N Engl J Med. 2021;384:497. opens in new tab).
NIAID Trial: Moving the Goalposts
TrialSite reported in “Not a Knockout Drug but Knocking it out of the Ball Park: Gilead Windfall as Remdesivir COVID-19 Sales to Hit $1 to $3 Billion in 2020” that the success of remdesivir was made possible by NIAID-funded adaptive clinical trial where the sponsor allowed a questionable change in the trial endpoint, part of what helped the FDA comes to the EUA determination.
After the NIAID director declared “a new standard of care,” he stressed that it most certainly wasn’t a “knock-out drug.”
In his pronouncements, Fauci failed to explain that late in the study the NIAID changed the primary outcome for measuring the success of remdesivir as a treatment for coronavirus.
Initially, the primary outcome of the study had been listed as “Percentage of subjects reporting each severity rating” on Day 15. This was originally based on a 7-point scale, which was then changed to an 8-point scale on March 20, 2020. In both scales, death was included as the most severe outcome; however, the scale was changed to split the category of “hospitalized, not requiring supplemental oxygen” into two: one still requiring medical care, and one not.
On April 16, 2020, the primary outcome of the study was changed to “time to recovery,” which was a new outcome based on the three least severe outcomes from the point scale used previously, including the newly created category for hospitalized patients that did not require medical treatment.
While changing outcomes in clinical trials is not necessarily a problem and can occur—the ACTT-1 trial was adaptive after all, the decision must be declared and justified when results are announced to avoid false positives and misleading external evaluators and readers. The paper resulting from the trial, published in October 2020, states that the change in the primary outcome was made “in response to evolving information, external to the trial, indicating that COVID-19 may have a more protracted course than previously anticipated.” Given the urgency early in the pandemic, significant risk-benefit tradeoffs are understandable. Yet several economical, repurposed drugs were identified as significant potential candidates targeting COVID-19. But the NIH had little interest in these pursuits. Remdesivir seemed like the “chosen one.”
EUA to Approval
Remdesivir’s initial EUA based on ACTT-1 allowed for the drug’s immediate use to treat severe COVID-19 infections on May 1, 2020. The EUA was expanded in August 2020 to include treatment of all hospitalized COVID-19 patients, regardless of the severity of infection.
By October 2020, the FDA approved remdesivir for treatment of hospitalized patients who are 12 years of age or older, weighing more than 40 kilograms (88 lbs.). The approval of remdesivir was supported by the FDA’s analysis of data from randomized, controlled clinical trials of hospitalized COVID-19 patients, including the NIAID trial, the Gilead-funded trial which didn’t have a control group, and a second Gilead-funded trial whose authors questioned the importance of their own findings. “We are pleased that the FDA approved Remdesivir for COVID-19 treatment and that our organization added value to this global fight through its early support of this critical drug’s development,” said Douglas Bryce of the U.S. Department of Defence (DOD).
The drug was formally approved in October 2020. As the only FDA-approved COVID drug between May 2020 and November 2021, it is estimated that remdesivir has been prescribed to 50% of COVID patients in U.S. hospitals – making Dr. Fauci’s prediction of the reach of this drug come true. The company generated several hundred millions of dollars in revenue during the worst parts of the pandemic before it was even formally approved.
How Did Gilead Benefit from Remdesivir?
A big part of successful drug development includes the capitalization of the research expenditures of the public. The decades of public funding culminating in the COVID-19 pandemic ultimately led to Remdesivir’s rise, a windfall for Gilead. Based on research conducted by the United States Government Accountability Office (GOA), federal funding for remdesivir between 2013 and December 2020 totaled at least 161.5 million divided as follows:
$0.7 million for CDC’s preclinical research
$39.7 million for DOD’s preclinical research
$11.9 million for research conducted by NIH and NIH-funded universities
$109.2 million for NIH-funded clinical trials
The federal funding did not result in governmental patent rights of remdesivir, as it did not lead to the development of new inventions.
According to Gilead, the company did not rely on federal contributions to conduct research into the invention of remdesivir, and instead invested $786 million into remdesivir research in development from 2000 to 2020. But clearly, taxpayer funds supported this drug through the early stages of the pandemic and extensively before.
According to an article published in October 2020, Gilead earned nearly $900 million from sales between July and September 2020—only the vaccines from Pfizer and Moderna surpass such a rapid windfall later on. It also comes as no surprise, based on the financial gains of Gilead, that eight experts on the NIH COVID-19 Panel have financial ties to Gilead, according to the NIH’s COVID-19 Treatment Guidelines Panel Financial Disclosure for Companies Related to COVID-19 Treatment Diagnostics document. TrialSite however has no proof of any explicit conflict of interest—we only raise the data points for those interested in possibly learning from the past. Despite remdesivir treatment costing $9.32 to produce, the treatment is said to cost more than $3,100 in hospitals in the U.S.
It is reported that Gilead spent $2.45 million lobbying the U.S. Congress in the first quarter of 2020, more than ever before, with a 32% increase from 2019. This coincided with the drafting and passing of the Coronavirus Aid, Relief, and Economic Security Act, which includes funding for the development of treatments for COVID-19.
In the world of business, of course, Gilead did exactly what it was supposed to do. Corporations exist to drive revenue, profit, and importantly, growth and subsequent economic value return for shareholder value. In such an urgent, emergency setting as the COVID-19 pandemic, any reform or temporary pause in expected self-interested behavior, for example, requires dialogue and alignment of interests with large institutional equity holders—a topic far beyond this media.
Questions Arise: The WHO Solidarity Study
The WHO conducted the world’s largest randomized controlled trial on COVID-19 therapeutics called the Solidarity Therapeutics Trial. The trial is ongoing and includes 14,200 hospitalized patients from 600 hospitals in 52 countries. The trial primarily looks at “the effects…on overall mortality, initiation of ventilation, and duration of hospital stay in hospitalized patients.”
On October 15, 2020, WHO released interim results from the trial in a press release, stating that “remdesivir, hydroxychloroquine, lopinavir/ritonavir, and interferon regimes appeared to have little or no effect on 28-day mortality or the in-hospital course of COVID-19 among hospitalized patients.”
Despite these interim results and ensuing announcements by many nations to suspend use of the drug for COVID-19 patients, many countries continue to use remdesivir as inpatient treatment. By November 2020, after the WHO press release, Gilead reported that remdesivir continued to be “the first and only approved antiviral treatment for patients with coronavirus in approximately 50 countries.” Although a conclusive list of countries using remdesivir is not available, it appears that it is still being used by major economic powers, and has been approved or received EUA to treat COVID in India, Singapore, Japan, the European Union, the United States, Canada, Czech Republic, and Australia, although since the WHO findings many countries in Europe and elsewhere suspending use.
Safety Concerns with the Use of Remdesivir
As remdesivir continues to be used in several countries to treat COVID-19, data continues to emerge regarding its usefulness and safety. Most initial data regarding the safety of remdesivir came from clinical trials conducted to support the EUA.
A paper by Singh and Kamath (2021) published in Expert Opinion on Drug Safety assessed the adverse events associated with remdesivir use using real-world data. The authors looked at the FDA Adverse Event Reporting System (FAERS) and analyzed adverse events more frequently reported with remdesivir compared to other COVID-19 drugs. The study found that elevated liver enzymes, acute kidney injury, raised blood creatinine levels, bradycardia, cardiac arrest, and death had a disproportionately higher reporting with remdesivir than compared to other drugs.
Researchers from the University of Cincinnati also conducted a study into the effectiveness of remdesivir and found that remdesivir stops activity associated with CES-2, an enzyme required for the breakdown of several medications in the intestines, liver, and kidneys. This cautions against the use of remdesivir along with other drugs, as “this finding provides a mechanistic explanation to the observed high rate of serious adverse events and mortality with the use of remdesivir.”
This result comes as no surprise when considering the adverse events, including kidney and liver damage, hypotension, and elevated creatinine levels reported when the drug was used against Ebola. Indeed, with the widespread use of remdesivir in U.S. hospitals, there is speculation that the adverse effects of this drug could possibly be contributing to the deaths chalked up to COVID-19. Discussions with several critical care physicians, who wish to remain anonymous, raised concerns about use of the drug so uniformly on COIVD-19 patients in hospital settings.
Looking Forward
Regardless of negative findings and problematic data points, influential medical societies in the U.S. such as the Infectious Disease Society of America (IDSA) point to strong support and an absolute acceptance in an overall benefit promoting widespread use during the pandemic.
With new variants of SARS-CoV-2 emerging and evidence of remdesivir resistant strains mutating, questions of remdesivir efficacy and safety for COVID-19 patients persist. Despite the WHO Solidarity findings and subsequent recommendations, not to mention mounting safety issues, several countries continue to depend heavily on remdesivir as a treatment against COVID-19.
In the pursuit of objective, unbiased medical research, transparency, accessibility, and stakeholder engagement, TrialSite will continue to monitor the global use of remdesivir, as well as emerging safer and more effective alternatives for COVID-19
Here is the correct (not concerning) graph of severely ill per 100,000
More pipi. Did you notice you checked age 60?
About 14 percent of Israelis over the age of 20 have not been vaccinated. They account for 68 percent of all serious cases, and 54 percent of new serious cases recorded over the past week.
and 54 percent of new serious cases recorded over the past week.
The actual problem is the steep raise over the week in cases among vaccinated. Cases among non vaccinated did not much change over the last 5 weeks.
Also Canada reports more cases (For children I do not say seriously ill patients) among vaccinated as UK does since 3 months.
But as Omicron is very mild - at least 100x less severe than delta - I see no problem in both cases except for investors that now sell off vaccine shares...
Real football was invented in the United States!
me and my country cousins used to play football with a freshly killed pig's bladder..
..dates back to to Tang Dynasty.... more squishy than the 300BC shuttlecock
"taking large doses of ivermectin is dangerous"
True,,
LD50 50mg/kg
If I were to ingest 20 packets of Equimec contents below all at once... I might be dead.
However the squeezed daily amount just makes me say "Neigh"
Natural products derived from plants as a source of drugs
Nature, the master of craftsman of molecules created almost an inexhaustible array of molecular entities. It stands as an infinite resource for drug development, novel chemotypes and pharmacophores, and scaffolds for amplification into efficacious drugs for a multitude of disease indications and other valuable bioactive agents. Since time immemorial, natural products have been the backbone of traditional system of healing throughout the globe, and have also been an integral part of history and culture. Although the use of bioactive natural products as herbal drug preparations dates back hundreds, even thousands, of years ago, their application as isolated and characterized compounds to modern drug discovery and development started only in the 19th century. It has been well documented that natural products played critical roles in modern drug development, especially for antibacterial and antitumor agents
