In the video above, Russel Brand discusses the conflicts of curiosity that come up when a regulatory company is funded by the business it’s charged with regulating. Take the U.S. Food and Drug Administration, for instance. In years previous, the FDA was funded totally by U.S. taxpayers.
Today, practically 45% of its annual finances comes from consumer charges paid by the drug corporations that search approval for a given product, Brand says. This transition from public to company funding has had a major affect on how the company operates, and it’s clearly not within the public’s finest curiosity.
Brand cites information exhibiting the FDA has gone from a drug approval fee of 38% in 2005 to 61% in 2018. In conditions the place a drug is geared toward a illness the place few remedy choices exist already, 89% of latest drug purposes are authorized on the primary attempt.
Has drug growth merely gotten that significantly better? Probably not. The truth is that drug corporations view the FDA’s consumer charges as cost for service rendered, and that service consists of approval. They’re not paying for the FDA to show them down.
- Why FDA and Big Pharma Have a Trust Problem
- FDA Advisers Receive Payouts to Approve Drugs
- FDA Has Already Lost Most of Its Credibility
- FDA Approves COVID Boosters for Seniors
- 1 in 1,000 mRNA Shots Results in Heart Inflammation
- COVID Shots May Be Killing Two for Every Life Saved
- What Do the VAERS Data Tell Us?
- Children Are Now the Next Target
Why FDA and Big Pharma Have a Trust Problem
In response to the COVID-19 pandemic, the FDA issued emergency use authorizations for utterly novel varieties of “vaccine” in a matter of weeks. While some applaud this speediness, it’s value remembering that as speedy approvals have elevated with different medication, so have the quantity discovered to be dangerous after the very fact.
Data cited by Brand present that 21% of FDA authorized medicines in the end needed to be faraway from the market or be given a black field warning. Essentially, in case you’re taking a newly authorized drug, the probabilities that this drug can be discovered to be extraordinarily harmful is 1 in 5, which is hardly encouraging!
A 2017 Yale examine1 discovered the scenario is much more dire than that, exhibiting practically 1 in 3 FDA authorized medication finally ends up having new issues of safety detected within the years following approval.
The FDA can be permitting drug makers to revenue on the expense of public well being by permitting them to “claim success in trials based on proxy measurements instead of clinical outcomes like survival rates or cures, which take more time to evaluate,” Caroline Chen notes in a June 2018 ProfessionalPublica article.2
FDA Advisers Receive Payouts to Approve Drugs
In addition to that, “pay-later conflicts of interest” are widespread, in line with an investigation by the journal Science.3 This is when medical doctors who advise the FDA or sit on drug panels which might be accountable for drug approval are paid by drug makers AFTER the approval is a executed deal.
Science examined 107 doctor FDA advisers who voted on drug approvals. Of these, 40 ended up receiving greater than $10,000 in submit hoc earnings from the drug firm whose drug they voted to approve; 26 of them obtained greater than $100,000 and 6 had been paid greater than $1 million. FDA advisers who assist drug makers acquire approval additionally reap rewards in different methods. As famous by Science:4
“The FDA says its guidelines, together with federal legal guidelines, cease staff from improperly cashing in on their authorities service. But Science discovered that staff on the company typically reap later rewards — jobs or consulting work — from the makers of the medication …
A 2016 examine discovered that 15 of the 26 staff who left the company later labored or consulted for the biopharmaceutical business. Of the greater than $24 million in private funds or analysis assist from business to the 16 top-earning advisers, 93% got here from the makers of medicine these advisers beforehand reviewed.”
FDA Has Already Lost Most of Its Credibility
As argued by Brand, the info is relatively unequivocal. It tells us corruption is rampant and the FDA has utterly deserted its constitution to make sure public well being and security. It’s actually simply there to provide the looks that somebody is searching for public well being, whereas really it’s a venue by which drug makers are enabled to revenue from unsafe and unproven medication.
The unhappy actuality is that whereas FDA approval used to imply one thing, at the moment it has mainly misplaced all that means. Just as a result of a drug is FDA-approved doesn’t imply it’s been confirmed secure and efficient.
Again and once more, medication are discovered to have critical issues of safety within the years after their approval. As a end result, drug corporations are allowed to profit whereas public well being is sacrificed, which is exactly the scenario that the FDA was created to forestall.
FDA Approves COVID Boosters for Seniors
September 17, 2021, the FDA authorized the Pfizer-BioNTech COVID shot Comirnaty as a third-dose booster for individuals over the age of 65 and different high-risk people. As reported by The Vaccine Reaction September 19, 2021:5
“Despite not convening the Vaccines and Related Biologic Products Advisory Committee (VRBPAC) final month to vote on effectiveness and security of the Pfizer-BioNTech COVID-19 vaccine (licensed underneath the identify COMIRNATY), the U.S. Food and Drug Administration (FDA) convened the advisory committee on Friday, Sept. 17, 2021 to vote on booster doses of the vaccine.
The FDA requested the VRBPAC to vote ‘yes’ or ‘no’ on the next query: Do the protection and effectiveness information from scientific trial C4591001 assist approval of a COMIRNATY booster dose administered at the least six months after completion of the first collection for use in particular person 16 years of age and older?
The C4591001 booster dose examine didn’t embody any topics underneath 18 years of age and solely 12 topics 65-85 years of age in Phase 1 of the trial and none in Phase 2/3.”
At the tip of the day, 16 of the 18 VRBPAC members voted “no” on approving a Comirnaty booster dose for individuals over the age of 16. A second vote was then swiftly thrown collectively, after members indicated they’d be comfy recommending a booster for seniors and “people at high risk of severe COVID-19,” which the FDA is defining as well being care employees and people at elevated danger of publicity because of their occupation.
This unscheduled second vote handed unanimously. However, as reported by The Vaccine Reaction:6
“It’s necessary to notice the info VRBPAC was requested to think about for Vote #2 is totally different than for Vote #1. For Vote #2 they had been instructed to think about the ‘totality of scientific evidence available’ — not simply Pfizer’s booster dose scientific trial.
Had the VRBPAC been required to solely think about the proof supplied by Pfizer, it could have needed to base its choice on information from solely 12 topics 65 years and older in Phase 1 of the trial as a result of they weren’t included in Phase 2/3. The specific proof foundation for VRBPAC’s approval of a booster dose for this group was not specified.”
What’s extra, the FDA out of the blue shifted from “individuals at high risk of severe COVID-19” an infection, to having it apply to “health care workers or others at high risk of occupational exposure.”
“This effectively shifted the focus from those who were at high risk of become severely ill from COVID-19 to those who are simply at high risk of being exposed, which will greatly expand the scope of those recommended to have a booster dose,” The Vaccine Reaction states.7
In a September 19, 2021, look on CBS News,8 director of the National Institutes of Health Dr. Francis Collins acknowledged he absolutely expects the FDA to increase boosters past seniors aged 65 and older, well being care employees and others at excessive danger of occupational publicity.
1 in 1,000 mRNA Shots Results in Heart Inflammation
So, the FDA claims the Pfizer shot is secure and efficient sufficient to warrant a 3rd booster for sure teams. But is it? According to a retrospective examine9,10 by the University of Ottawa Heart Institute, 1 in 1,000 mRNA injections (Pfizer and Moderna) have resulted in myopericarditis, i.e., irritation of the center or coronary heart sack, inside one month of the shot, though symptom onset sometimes occurred inside days.
The examine was posted on the preprint server medRxiv September 16, 2021, the day earlier than the FDA voted “yes” on boosters for the aged and sure high-risk teams. As defined by the authors:11
“This examine is a potential assortment and assessment of all instances with a myocarditis/pericarditis analysis over a 2-month interval at an instructional medical middle … Patients had been recognized by admission and discharge diagnoses which included myocarditis or pericarditis. Inclusion standards: in receipt of mRNA vaccine inside one month previous to presentation …
Diagnosis was primarily based on scientific presentation, ECG/echo findings and serial troponins and was confirmed in every case by CMR. Incidence was estimated from complete doses of mRNA vaccine administered within the Ottawa area for the matching time-period. This information was obtained from the Public Health Agency of Ottawa …
Results: 32 sufferers had been recognized over the interval of curiosity. Eighteen sufferers had been recognized with myocarditis; 12 with myopericarditis; and a pair of with pericarditis alone. The median age was 33 years (18-65 years). The intercourse ratio was 2 females to 29 males.
In 5 instances, signs developed after solely a single dose of mRNA vaccine. In 27 sufferers, signs developed after their second dose of. Median time between vaccine dose and signs was 1.5 days …
Chest ache was the most typical symptom, however many others had been reported. Non-syncopal non-sustained ventricular tachycardia was seen in solely a single case. Median LV ejection fraction (EF) was 57% (44-66%). Nine sufferers had an LVEF beneath the traditional threshold of 55%.
Incidence of myopericarditis general was roughly 10 instances for each 10,000 inoculations. This is the biggest collection within the literature to obviously relate the temporal relationship between mRNA COVID vaccination, signs and CMR findings.”
COVID Shots May Be Killing Two for Every Life Saved
According to skilled testimony given throughout the September 17, 2021, FDA Vaccine Advisory Committee assembly (see video above),12 the pictures could in reality be killing way more individuals than they’re saving.
According to Dr. Joseph Fraiman, an emergency medication doctor in New Orleans, there’s no scientific proof to show the COVID pictures are saving extra individuals than they hurt. He instructed the committee they must:
“Demand the booster trials are large enough to find a reduction in hospitalizations. Without this data we, the medical establishment, cannot confidently call out anti-COVID-vaccine activists who publicly claim the vaccines harm more than they save, especially in the young and healthy. The fact we do not have the clinical evidence to say these activists are wrong should terrify us all.”
Steve Kirsch, government director of the COVID-19 Early Treatment Fund, then went on to point out what Fraiman feared essentially the most, particularly that the Pfizer shot kills two individuals for each individual it saves.
“We had been led to imagine that the vaccines had been completely secure, however that is merely not true. For instance, there are 4 occasions as many coronary heart assaults within the remedy group within the Pfizer 6-month trial report. That wasn’t simply unhealthy luck.
VAERS exhibits coronary heart assaults occur 71 occasions extra typically following these vaccines in comparison with another vaccine,” Kirsch stated, including: “If the net all-cause mortality from the vaccines is negative, then vaccines, boosters and mandates are all nonsensical.”
Here’s a screenshot from Kirsch’s slide present, exhibiting the variety of individuals killed by the COVID pictures, in comparison with the variety of lives saved by them.
Kirsch went on to state that whereas the VAERS information is the one information which might be statistically vital, the opposite two information sources are nonetheless “troubling”:
“Even if the vaccines have 100% safety, it nonetheless means we kill two individuals to avoid wasting one life … Four specialists did analyses utilizing utterly totally different non-U.S. information sources and all of them got here up with roughly the identical variety of extra vaccine-related deaths — about 411 deaths per million doses.
That interprets into 115,000 individuals who have died (as a result of Covid-19 vaccines) … The actual numbers verify that we kill greater than we save. And I might love everybody to take a look at the Israel ministry of well being information on the 90+ 12 months olds the place we went from a 94.4% vaccinated group to 82.9% vaccinated within the final 4 months.
In essentially the most optimistic state of affairs it implies that 50% of the vaccinated individuals died and 0% of unvaccinated individuals died. Unless you possibly can clarify that to the American public you can not approve the boosters.”
Kirsch additionally confirmed information suggesting 1 in 317 boys aged 16 to 17 will get myocarditis from the pictures, and after a 3rd booster, that quantity could attain as excessive as 1 in 25. He additionally factors out that Pfizer’s Phase 3 trials should clearly be “gamed,” as “it is statistically impossible for protocol violations to be five times higher in the treatment group.” “Why has this not been investigated?” he requested.
What Do the VAERS Data Tell Us?
In a September 18, 2021, interview with The Covexit podcast, Jessica Rose, Ph.D., who holds levels in utilized arithmetic, immunology, computational biology, molecular biology and biochemistry, mentioned what the U.S. Vaccine Adverse Events Reporting System (VAERS) information inform us in regards to the security of the COVID pictures.
Rose covers points such because the magnitude of the uncomfortable side effects in comparison with different vaccination applications, the issue of under-reporting, and the way causality might be assessed utilizing the Bradford Hill Criteria. You can discover a PDF of the slide show that Rose presents here.13 Here’s a abstract of a few of the key factors made on this interview:
Between 2011 and 2020, the variety of VAERS reviews ranged between 25,408 and 49,412 for all vaccines. In 2021, with the rollout of the COVID pictures, the variety of VAERS reviews have shot as much as 521,667, as of September 3, 2021, for the COVID pictures alone.
Between 2011 and 2020, the overall variety of deaths reported to VAERS ranged between 120 and 183. In 2021, as of September 3, the reported demise toll had shot as much as 7,662.
Cardiovascular, neurological and immunological hostile occasions are all being reported at charges by no means earlier than seen.
The estimated under-reporting issue (URF) is 31. Using this URF, the demise toll from COVID pictures is calculated to be 205,809 as of August 27, 2021; Bell’s palsy 81,747; herpes zoster an infection 149,017; paresthesia 305,660; breakthrough COVID 365,955; myalgia 528,457; life threatening occasions 230,113; everlasting disabilities 212,691; delivery defects 7,998.
If there’s no causal relationship between the pictures and hostile occasions, we’d anticipate uncomfortable side effects to happen at any given level between the vaccination date and symptom onset. This isn’t what we’re seeing. Death, for instance, dramatically spikes inside the first few days post-injection, and quickly falls off after day 10.
The Bradford Hill Criteria for causation are all glad. This consists of however isn’t restricted to power of impact measurement, reproducibility, specificity, temporality, dose-response relationship, plausibility, coherence and reversibility.
Children Are Now the Next Target
While the FDA voted in opposition to recommending a 3rd booster to younger adults aged 16 and over, there’s little doubt that the advice will quickly be expanded to individuals underneath the age of 65, and finally even younger youngsters.14 I say that as a result of there appears to be no ceiling above which the demise and incapacity toll is deemed too nice. Why? We haven’t been given a straight reply, leaving us to take a position in regards to the FDA’s intentions.
Why aren’t they involved about security when greater than half one million facet impact reviews have been filed? How come practically 15,000 reported deaths15 haven’t set off emergency alarms and in-depth investigations? As famous by Rose, 50 deaths have traditionally been the cutoff level at which a vaccine is pulled. We’re up to now past that now, it appears there’s no threshold anymore.
At current, one wonders whether or not the FDA’s reluctance to approve a booster for youthful people is mere present. Perhaps they’re attempting to reclaim some measure of scientific authority, which was undermined by the U.S. authorities and Pfizer asserting the discharge of boosters earlier than the FDA had even made its willpower.
Whatever the case could also be, I urge you to assessment as a lot information as you possibly can earlier than you bounce on the booster bandwagon. Based on every thing I’ve seen, I imagine the chance of uncomfortable side effects is probably going going to exponentially enhance with every dose.
If you want a refresher on the potential mechanisms of hurt, obtain and browse Stephanie Seneff’s wonderful paper,16 “Worse Than The Disease: Reviewing Some Possible Unintended Consequences of mRNA Vaccines Against COVID-19,” printed within the International Journal of Vaccine Theory, Practice and Research in collaboration with Dr. Greg Nigh.