Tag: FDA

New Proof of HCQ Covid Effectiveness Despite FDA Bias

Agency portrayed ivermectin as dangerous by conflating human and livestock dosages, but didn’t take pains to warn providers Moderna jabs have “notably more” than authorized for kids.

From Science Matters

By Ron Clutz

Greg Piper reports on untrustworthy behavior by public health officials in his article FDA downplays COVID vax overdosing as hydroxychloroquine shows more promise in European research.  Excerpts in italics with my bolds.

Agency portrayed ivermectin as dangerous by conflating human and livestock dosages, but didn’t take pains to warn providers Moderna jabs have “notably more” than authorized for kids.

The Agency portrayed ivermectin as dangerous by conflating human
and livestock dosages, but didn’t take pains to warn providers
Moderna jabs have “notably more” than authorized for kids.

The FDA repeatedly told the public that an antiviral with a sterling safety record, ivermectin, should not be used to treat COVID-19 because it was also prescribed, at higher dosages, to livestock.

https://twitter.com/US_FDA/status/1429050070243192839?s=20

The agency didn’t appear to show the same concern about correctly dosing the new single-shot mRNA COVID vaccines and is now scrambling to educate healthcare providers not to give children adult-strength jabs even while denying that overdosing is a safety risk.

Its demonization of cheap, widely available antivirals to treat SARS-CoV-2 infections in higher-risk populations looks increasingly shortsighted, with two new peer-reviewed studies on hydroxychloroquine’s effectiveness when combined with azithromycin, a common antibiotic.

The Food and Drug Administration yanked emergency use authorization from HCQ in summer 2020 despite The Lancet retracting a study three weeks earlier that linked the antiviral to a higher risk of death from COVID, saying the authors could not “vouch for the veracity” of their data sources.

The New England Journal of Medicine also expressed concerns about the data integrity of the same international registry used for The Lancet study, known as Surgisphere, in an NEJM study of COVID risk in cardiovascular patients.

The FDA issued a bulletin Wednesday night warning of Moderna vaccine overdoses for children, without specifying how widely they were happening.

The agency simply said it had “become aware” that some providers didn’t know the vials contained “notably more” than the 0.25 milliliter authorized for children through age 11, and “some” may be giving kids the whole vial rather than withdrawing 0.25 mL and discarding the excess.

An agency spokesperson acknowledged but did not answer a Just the News request to explain why it appeared so much more concerned about appropriately dosing ivermectin than COVID vaccines and why it authorized the same vial for age groups with different recommended dosages.

Last week, Elsevier journal New Microbes and New Infections published its second study in a month on HCQ-azithromycin treatment. The first, by Belgian researchers, found the combination had a statistically significant advantage over the “standard of care” in 352 hospitalized patients in spring 2020.

The second study, by French researchers and formerly censored American cardiologist Peter McCullough, looked at a much larger and more diverse group over a longer window.

Among over 30,000 adults treated as inpatients or outpatients from March 2020 through December 2021 at IHU Méditerranée Infection in Marseille, about 23,000 received the combination and had a six-week all-cause mortality rate of 0.82%. The control group of about 7,000 had a rate of 4.89%.

The odds ratio of death following the combination treatment was 0.16, meaning a far lower mortality risk. (An OR above 1 means treatment and death are positively correlated.)

The adjusted OR maxed out at 0.55 after various subsamples considered sex, age, patient management, period, viral variant, vaccination status and comorbidities, they found.

Earlier randomized controlled trials of HCQ likely didn’t show a benefit because many were “published or stopped at an early stage, despite the fact that the calculated sample size of patients had not been achieved,” the paper states.

Yale epidemiologist Harvey Risch, an early proponent of HCQ against COVID and fierce critic of the feds’ demonization of the low-cost antiviral, told Just the News the French study authors “made a big mess of the analysis as published.”

But because “they made their individual subject data public” for Risch to review, “I have analyzed those data myself to come to the numerical conclusions that I will use, again showing significant mortality reduction when used in outpatients,” he wrote in an email. (The Belgian study did not include outpatients, the focus of Risch’s interest.)

Risch shared a raft of papers showing HCQ benefits against COVID,
some in combination with azithromycin and other low-cost treatments,
mostly in peer-reviewed journals. 

Risch provided his own meta-analysis charts of the various studies on hospitalization and mortality risk and calculations on the Italian study.

Harvey Risch hospitalization meta-analysis.pdf

Harvey Risch mortality meta-analysis.pdf

Harvey Risch Italian study calculations.pdf

It’s a 1775 moment says Vivak Ramaswamy — but the deep state “is a machine we are up against”

Vivek Ramaswamy has a plan. It’s quite something to listen to. He has an extraordinary combination of skills.

From JoNova

By Jo Nova

Vivek Ramaswamy has a plan. It’s quite something to listen to. He has an extraordinary combination of skills.

This is a man who is only 38, and has studied molecular biology*, made millions in biotech, understands Big Pharma, but he’s also done a law degree at Yale. He is that rarest of combinations — the CEO who understand biology and science, and the lawyer who reads the constitution, and the investor who has played and won on Wall Street. He is all of these things.

I’ve never heard a Presidential candidate speak like this — with an eight year plan grounded in the legal foundations of the nation. He knows employment laws make individuals unsackable, but whole departments can be razed. Nothing can stop the President from dismantling the FBI if he wants to. Ramaswamy is already assembling a team, picking the players. He can list what he will get done by 2033 when he leaves office and his youngest starts high school.

Last week I played a small extract of this interview with Shawn Ryan — where Ramaswamy described how the FDA is captured by Big Pharmaceutical firms. ( “Big Pharma is the worlds biggest lobbying organisation”)  But the whole interview is compelling and I’ve listened to interviews before about his books, about Woke Inc, about Strive (the Capital Fund he set up that runs counter to BlackRock and ESG) but this is  about Ramaswamy himself, and his plan for the US, the Deep State and this strange moment in history.  As the child of Indian immigrants he can explain what makes America Great better than many Americans can.

His role in this campaign will surely change it — his competitors must be listening to interviews like this, taking notes.

“It’s a machine that we are up against”

Ramaswamy describes the Deep State as a machine which needs puppets to represent them  — the people we elect to run the government are not the ones who run the government. It’s no accident we have a gerontocracy, he says. It’s designed to be that way. The real laws of this country are not made in Congress, they’re made in the halls of bureaucracy.

The machine in the Monster that we have created. There are many good individuals doing what they think is a good job inside the machine. The waterfall of power flows from the President to the administrative state, to executives in social media, to managers in third party firms to AI. The decisions are not even being made by humans. The AI has learnt to spot US Flags in social media as a risk factor.

We the People cannot be Trusted to run the country

In the old world, Ramaswamy says, people got together in smoky rooms in the back of Palace Halls to decide how to run countries. Now it’s the enlightened elite making these decisions. We the People cannot be Trusted to run the country and decide about issues like climate change or racial injustice. The real divide now is not Republican or Democrat, it is between the managerial class and the citizen.

We fought a revolution to say Hell No to that theory and that We The People in this constitutional republic must be the ones who decide.

Now that old monster is rearing its head again, he says, except this time the power is diffused. We might think the power is at the back of a three-letter-government building in Washington DC, but there’s no smoking hall there. Maybe the power lies at the corner office of BlackRock, but it’s not quite there either. Instead the power is woven into a machine of the managerial class. It’s very hard to identify. It’s very pervasive…

Vivek Ramaswamy – EXPOSES Deep State, BlackRock, Big Pharma, Central Bank Digital Currency | SRS #71

It’s a two hour interview. You can convert it to Mp3 and listen as you jog, drive or cook. It was compelling starting from 3 mins in.

*Molecular biology is my favourite science — it’s not possible to understand the human condition, life, viruses, medicine and biotechnology without it.

“Big Pharma is the worlds biggest lobbying organisation”

Vivek Ramaswamy worked in the pharmaceutical industry. Now that he’s free to speak, he distills the utter corruption of the FDA in under four minutes, it is beyond redemption, rotten to the core.  “That’s’s why I favor a dramatic drastic gutting of the FDA…” — he says. Exactly…

By Jo Nova

Vivek Ramaswamy worked in the pharmaceutical industry. Now that he’s free to speak, he distills the utter corruption of the FDA in under four minutes, it is beyond redemption, rotten to the core.  “That’s’s why I favor a dramatic drastic gutting of the FDA…” — he says. Exactly…

From his Twitter feed:  “The corrupt FDA says you don’t have the right to even *try* medicines that haven’t been through 10+ years of testing, yet the government *mandated* Covid vaccines that sailed through FDA approval in less than 1 year.  You can’t believe both things at once. Countless FDA regulations and actions are hypocritical, harmful & unconstitutional. I will rescind them accordingly, using the Supreme Court’s holding in West Virginia vs. EPA as my legal basis for doing so. For years I was coached by industry veterans not to speak out against FDA. It’s well known that if you anger FDA, they will punish you by blackballing review of your drug review applications. “FDA never forgets” is a quietly-whispered, well-known pharma industry adage. Well, they could only shut me up for so long. Now I speak freely as a citizen.” — @VivekGRamaswamy

Meanwhile — circulating somewhere on the web, sent in by Charles:

 Scott Gottlieb (Pfizer)  | James Smith | Stephen Hahn |  Anthony  Fauci

Secret CDC Reports confirm .6 Million American Children & Young Adults have died since the FDA approved the COVID-19 Vaccine

A shocking report secretly released by the U.S. Centers for Disease Control (CDC) has revealed that COVID-19 vaccines, touted as the solution to the alleged SARS-CoV-2 virus, may actually be killing tens to hundreds of thousands of children and young adults in the United States.

BY THE EXPOSÉ 

A shocking report secretly released by the U.S. Centers for Disease Control (CDC) has revealed that COVID-19 vaccines, touted as the solution to the alleged SARS-CoV-2 virus, may actually be killing tens to hundreds of thousands of children and young adults in the United States.

According to the Centers for Disease Control (CDC), a staggering 608,590 children and young adults have died since the FDA gave emergency use authorization for the COVID vaccines to be administered to the American public.

This represents a huge increase in excess deaths among the age group compared to 2020 at the height of the COVID-19 pandemic when 43,938 excess deaths were recorded

But the U.S. is not the only country facing this issue.

Source

According to an official report published by the UK Government’s Office for National Statistics, Covid-19 vaccinated children are a staggering 4423% or 45 times more likely to die of any cause than unvaccinated children, and 13,633% or 137 times more likely to die of COVID-19 than unvaccinated children.

Source

These findings are nothing short of alarming and have raised serious concerns about the safety and effectiveness of COVID-19 vaccinations.

Despite these shocking statistics, both the U.S. and UK government have continued to push for more vaccinations, going as far as to extend the emergency use authorisation of the COVID-19 vaccine to children as young as 5 years old in the UK, and as young as 6 months old in the USA.

While the vaccines were allegedly designed to protect everyone from the alleged COVID-19 disease, the data suggests that the vaccines themselves may be responsible for the alarming increase in excess deaths.

In the wake of the recent report by the UK Government’s Office for National Statistics on the alarming increase in deaths among vaccinated children, many are left wondering what could be causing this phenomenon.

Neither reports delve into specific causes of death, but there are several possible explanations that have been put forward by medical experts.

One of the most concerning potential causes is the adverse effect that the COVID-19 vaccine may have on the heart. Recent studies have shown that the Covid-19 vaccines can cause inflammation of the heart, a condition known as myocarditis, particularly in young people.

Myocarditis causes inflammation of the heart muscle, which can then cause the heart to become weakened and unable to function properly. Symptoms of myocarditis can include chest pain, shortness of breath, fatigue, and rapid or irregular heartbeat.

Source

In severe cases, myocarditis can lead to heart failure, cardiac arrest, or even death.

While the exact cause of myocarditis after vaccination is not yet fully understood, some experts believe it may be due to an immune response triggered by the vaccine that mistakenly attacks the heart tissue.

Another possible explanation for the increase in deaths among vaccinated children is the emergence of a strange and rare type of blood clotting disorder known as thrombosis with thrombocytopenia syndrome (TTS).

This disorder has been observed in many people who have received the AstraZeneca and Johnson & Johnson COVID-19 vaccines, and it is thought to be caused by an immune response to the vaccine.

But data published by both the U.S. CDC and the UK’s MHRA confirm both Pfizer and Moderna’s mRNA gene therapy injections are causing the same conditions.

Some medical experts have also raised concerns about the potential long-term effects of the COVID-19 vaccines, particularly on the developing bodies and immune systems of children. It is possible that the vaccines could have unforeseen consequences on children’s health that have not yet been fully understood or studied.

Despite these potential risks and concerns, many Governments and pharmaceutical companies continue to push for widespread vaccination, arguing that the benefits outweigh the risks.

However, the recent findings from the UK Office for National Statistics and the CDC in the United States suggest that this simply isn’t the case, particularly for children.

In light of these findings, many experts are now calling for a re-evaluation of the risks and benefits of COVID-19 vaccination for children. The risks of serious adverse events must be weighed carefully against the potential benefits of vaccination, of which years of data now suggests there are none, particularly in light of the low risk that COVID-19 poses to children.

Source

Despite the mounting evidence against the safety of COVID-19 vaccination, pharmaceutical companies and governments continue to push for more vaccinations, claiming that they are safe and effective.

Only time will tell what the future holds for the millions of children and young adults who have received these vaccinations, but for now, the shocking truth has been revealed.

Covid-19 vaccination is killing children and doing far more harm than good.

Pfizer, FDA, Dr. Walensky Knew Fetuses, Babies Died

Babies in this section of the Pfizer documents sustained respiratory distress, including from air sacs leaking between lungs and chest walls. Babies and fetuses were dying.

From Outspoken with Dr Naomi Wolf

By Dr. Naomi Wolf

The darkest of all of the WarRoom/DailyClout Pfizer Documents Analysis Reports so far has appeared — this one by COO and WarRoom/DailyClout Pfizer Documents Analysis Project Director Amy Kelly. Pfizer’s latest-released tranche of internal documents — which the FDA sought a court to keep hidden for 75 years — confirms that Pfizer knew that women who had been “exposed” to the vaccine — including prior to pregnancy – were sustaining spontaneous abortions and miscarriages. [https://dailyclout.io/bombshell-pfizer-and-the-fda-knew-in-early-2021-that-the-pfizer-mrna-covid-vaccine-caused-dire-fetal-and-infant-risks-they-began-an-aggressive-campaign-to-vaccinate-pregnant-women-anyway/]

Pfizer knew that “exposure” as they defined it, included sexual intercourse with vaccinated men, as well as skin contact and inhalation. They knew that 19 per cent of the babies identified, in the first three months of the study, sustained adverse events, many of them serious; one baby was rushed to the hospital.

Babies in this section of the Pfizer documents sustained respiratory distress, including from air sacs leaking between lungs and chest walls. Babies and fetuses were dying. My interview with Northern California longtime midwife Ellen Jasmer revealed that she is seeing a great deal of this — babies who seem fine at birth, go home, but who are rushed to hospital within a day with respiratory distress — and Pfizer knew in April 2021 — two full years ago — that this would indeed happen.

This, by the way, is the kind of abnormal, flattened, damaged placenta that Nurse-Midwife Ellen Jasmer is seeing now in her practice. She says she sees almost no normal placentas any more:

https://gettr.com/post/p2ejop3facf

Ms Jasmer describes the horrors of the delivery room these days, and the calcified, damaged placentas and babies in respiratory distress that are now common in her practice: https://dailyclout.io/calcified-placentas-a-nurse-midwifes-disturbing-testimony/

Pfizer knew perfectly well that it was harming multiple aspects of the reproductive process in women. In its secret documents the company calmly described what it called “fetal poles” with no heartbeats, and amniotic sacs without any fetuses, along with other horrors. The documents make use too of the bizarre phrase “missed abortions”.

Why would you use such a phrase in internal documents unless you are trying to elicit spontaneous abortions or miscarriages?

In addition to damage to the fetuses and babies via the moms’ injections, the new tranche of documents also reveal that the PEG in vaccinated moms’ breast milk causes horrendous damage to tiny newborns trying to nurse. We broke this story about contaminated breast milk many months ago, but this tranche of new documents adds confirmation to the fact that Pfizer knew it was poisoning vaccinated women’s breast milk.

The babies in the documents who nursed from vaccinated moms had peeling skin, blurred vision, agitation, convulsions, rashes, fevers, myalgia, vomiting, inflammation of tissues, tissue edema, and many other horrendous conditions.

The data about all of this damage to fetuses and babies were compiled by Pfizer by April 20 2021. The report went to the FDA, and from there to the CDC. Astonishingly, three days later, knowing about this shocking report tallying dead fetuses, dead babies, and babies in distress, Dr Rochelle Walensky called a major White House press conference, at which she declared that the vaccines were “safe and effective” and launched an aggressive PR campaign to urge, bully and “recommend” that pregnant “persons” receive mRNA vaccines ‘for the safety of their babies.’

Dr Walensky was guilty of these shocking lies, in her April 23 2021 press conference:

“Moving on, I want to share a new study that was published this week by CDC scientists.  On Wednesday, the New England Journal of Medicine published the preliminary findings of post-COVID-19 vaccine surveillance in pregnant persons.  Clinical trials of COVID-19 vaccines did not include pregnant people, leaving us with limited data on the safety of vaccination in pregnant people and babies to date. 

Through county — country-wide surveillance, using the CDC v-safe app and the v-safe Pregnancy Registry, as well as the Vaccine Adverse Event sys- — Reporting System, we were able to follow over 35,000 pregnant people who were vaccinated.

Pregnant people experienced the same side effects as others following vaccination.  We were also able to follow, in detail, more than 3,900 pregnant women, and over 800 of whom have completed their pregnancies. 

Importantly, no safety concerns were observed for people vaccinated in the third trimester or safety concerns for their babies. [Italics mine]

As such, CDC recommends that pregnant people receive the COVID-19 vaccine.  We know that this is a deeply personal decision, and I encourage people to talk to their doctors or primary care providers to determine what is best for them and for their baby.” [https://www.whitehouse.gov/briefing-room/press-briefings/2021/04/23/press-briefing-by-white-house-covid-19-response-team-and-public-health-officials-31/;

I have in my book The Bodies of Others already taken apart “V-Safe” — the non-science pathetic excuse for a surveillance system for pregnant “people” – which is not in fact a double blind study in any way but is rather a phone app, staffed not by physicians or scientists, but by a call center, to which strangers you are supposed to self-report your miscarriage or spontaneous abortion — a totally normal thing to want to do when you have lost your baby.

This pathetic substitute for science, this phone app, is also designed to stop tracking women and babies right when newborn babies are going to reveal problems, if problems exist.

Dr. Walensky hid from American and the world’s women, the fact that Pfizer in its in- depth internal documents had calmly concluded that the company was murdering and injuring babies and fetuses; and she called attention, rather, to the awesome outcomes revealed, or engineered, by a thoroughly gamed phone app.