FDA, CDC Guilty of Clinical Malpractice and Scientific Fraud
Today, unquestionably serious cardiovascular, thrombotic and neurologic adverse events related to the Covid ‘vaccines’ have occurred around the world.
The FDA’s own vaccine adverse event tracking system (the Vaccine Adverse Event Reporting System or VAERS) shows substantial and serious risks from the vaccine, even though the FDA only collects an estimated 10 percent of all adverse events.
Still, federal agencies and manufacturers aren’t officially warning the American public about these risks, despite having been privy to this information for almost a whole year. Why? Because it would counter the narrative that taking endless vaccines and boosters is your patriotic duty.
It’s pretty clear today there are both safety and efficacy problems with vaccines and boosters. Because all of the FDA’s 18,000-plus employees had access to the same drug safety data we have, one must ask:
- Where is the updated Covid-19 labeling reflecting the latest safety and efficacy findings in VAERS?
- Where are the FDA “Dear Doctor” letters giving updated safety guidance?
- Where are the “Dear Pharmacist” letters to pharmacists who are still daily administering thousands of boosters to kids and other young healthy people?
- Why isn’t the FDA recommending follow-up symptom tracking to avoid further inflammatory neurologic/thrombotic/cardiovascular tragedies instead of its proposal to extend the dosing interval and cross fingers that it would mitigate risk (as there is no concrete clinical evidence that it will do anything)?
- Why is the FDA ignoring internal drug safety epidemiologists who have stated during official FDA presentations that it only takes a single, well-documented adverse event to justify a safety signal investigation and warning to the American public of the risk?
- Why isn’t the FDA demanding studies addressing genotoxicity, teratogenicity, oncogenicity, the potential for reduced fertility in men and women, the clinical effects of spike proteins in donated blood, and the bioaccumulation of vaccine in women’s ovaries? Why isn’t the agency convening and dedicating a Data Safety Monitoring Board to surveil all these post-marketing effects and others?
Are Americans expected to believe that the $6.5 billion-per-year taxpayer-funded FDA lacks adequate funding to address all these public health issues?
Not Fully Disclosing Safety Risks to Patients Violates Ethics and States’ Licensing Standards
In order for a physician, pharmacist, and nurse, or anyone else with a clinical professional license to work at the FDA or CDC or any other public health agency, that person must have a “current, active, full, and unrestricted license or registration from any state in the US.”
Not fully warning patients about the potential dangers from any drug before administering useless and potentially dangerous vaccines and boosters places these professionals’ licenses at risk, regardless of what the CDC, FDA, or White House says.
Physicians, pharmacists, and nurses have always been held to a higher standard. They are expected to think for themselves rather than simply take orders.
As the truth is elucidated about vaccine efficacy and safety, these federal employees and mRNA vaccine manufacturers who colluded to withhold information from the public will be held accountable, and the whole “I was just following orders” excuse will not cut it.
Just keeping your head down and cruising through your job, handing out vaccines is not an option when it comes to the lives of your fellow Americans when licensures are held to a higher standard.
Once you see a rash of “early retirements” of federal public health employees (with full federal benefits of course), expect the other shoe will drop and starker evidence of clear malfeasance will come to light. When that happens, the licensed practitioners and scientists responsible for withholding vital health information from the public should be thoroughly investigated by their academic boards and licensing authorities.
Taxpayer-Funded Agency Missions are Being Ignored
Separate from that, not speaking out appears to directly violate the Federal Public Health Vision, Mission and Values regarding its very specific obligations and, specifically, relating to sections labeled “public health” and “accountability” and “communication.”
Their silence also contradicts the FDA motto, which is to assure that: “All food is safe; all medical products are safe and effective; and the public health is advanced and protected.” The CDC motto pledges to “Base all public health decisions on the highest quality scientific data that is derived openly and objectively.”
And you know our federal government has jumped the shark on dishonesty when even the unmistakably liberal New York Times expresses outrage at the CDC’s deliberate omission about mRNA efficacy and safety data.
FDA and CDC Still Pushing the Original, Ineffective COVID-19 Vaccine
In fact, FDA and CDC officials are still pushing a potentially unsafe and seemingly ineffective COVID-19 vaccine by purposely hiding facts from the public. The original strain of COVID-19 has been replaced by mutations. Continuing to promote the original vaccine for the mutated strain of COVD-19 is akin to promoting last year’s flu vaccine for this year’s flu strain. The original, Wuhan, China version of COVID -19 doesn’t exist today.
But that hasn’t stopped the FDA or the CDC: Just look at an archived image of today’s screenshot of the FDA website still pushing boosters onto the American public and even showing images of kids and young adults with bandages from their latest vaccination and/or boosters, despite the latest CDC data saying that there is essentially no benefit in those younger groups.
The same nonsense can be seen on an archived image of the CDC’s vaccines.gov website from today:
Future CDC and FDA Accountability
No scientific accountability will ever take place under the existing leadership. It will likely take a combination of courageous whistleblowers, a strong President who actually believe in “following the science,” and an assertive new Congress to call the necessary hearings and issue the necessary subpoenas to uncover the many CDC and FDA civil and executive service malefactors who, along with Anthony Fauci, have taken the American people for fools.
These outrageously political, manipulative, science-ignoring federal officials must be held accountable. Of course, nothing will happen to them while the Biden-Harris administration controls the White House and its pliant allies control Congress.
Even worse: If the republicans somehow gain control again, will anyone other than Sen. Ron Johnson do anything to hold CDC and FDA officials accountable?
Or will they just again “reach across the aisle” and try to “find a middle ground” and play the whole “go along to get along” game and conform to general expectations so as not to disrupt or endanger their elected offices, university club memberships, and general belonging as they have done historically?
It’s hard to stay optimistic about the odds.
See more here: americanthinker.com
About the author: Dr. David Gortler is a pharmacologist, pharmacist, and an FDA and healthcare policy oversight fellow at the Ethics and Public Policy Center in Washington DC. He was a professor of pharmacology and biotechnology at the Yale University School of Medicine, where he also served at Yale’s Bioethics Center, and was an FDA medical officer who was later appointed by the White House as senior advisor to the FDA commissioner for drug safety, FDA science policy, and FDA regulatory affairs. He is a columnist at Forbes, where he writes on drug safety, health care and FDA policy.
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Richard Noakes
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Covid Vaccines are Gene Therapy after giving away millions of Taxpayers Money to expand production of Covid Jabs in the UK
By The Exposé on April 1, 2022
The UK Government has awarded a grant of nearly £16 million of hardworking tax payers money to a Chemical producing giant, under the premise that they will significantly increase production capacity of lipids which are an essential component in Covid-19 vaccines. But in doing so, the Government has been forced to admit that the Covid-19 injections are in fact gene therapy.
A grant of £15.9 million has been awarded to chemical producer Croda International Plc (‘Croda’)” to increase the UK’s manufacturing capacity of speciality lipids, an essential ingredient in mRNA vaccines, the government has announced.
This investment will enable Croda, a global market leader in the field, to significantly increase production capacity at its facility in Leek, Staffordshire.
This will also allow them to increase both the range and volume of lipids it is able to produce in the UK, – particularly the mRNA lipid used in a number of Covid vaccines.
From 2023, the expanded facility will be able to produce a sufficient volume of lipids for around 3 billion vaccine doses – an estimate based on the volume of lipids required to produce existing COVID-19 vaccines – a significant contribution to global lipid supply and future vaccine production.
Health and Social Care Secretary Sajid Javid said: “The mRNA technology produced at this site has the potential to unlock the next generation of cutting-edge treatments for existing and new health threats”.
Since the launch of the Covid-19 injection programme authorities and mainstream media have frequently stressed that the Covid-19 injections are just like any other traditional vaccines, and have denied that they are gene therapy. But for anyone interested in knowing what they were having injected into their bodies, all they had to do was carry out a quick google search to conclude that the authorities were lying.
But now the UK Government has quietly admitted in their press release on the above that the Covid-19 injections are in fact gene therapy, clarifying that “lipids are an essential component in COVID vaccines as well as other gene therapies”.
Source
The mRNA technology in the Pfizer and Moderna Covid-19 injections had never before been authorised for use in the general population, and even now it is only temporarily authorised for emergency use. And there’s good reason for that.
Gene editing once promised to revolutionise medicine, until it killed a 20 year-old male named Jesse Gelsinger in 1999.
By all accounts Jesse Gelsinger was a sweet, sharp-witted, if not particularly ambitious kid who loved motorcycles and professional wrestling. In 1999 he was living in Tucson, Arizona, with his parents and siblings, attending high school, and working part-time as a supermarket clerk. As he got older, he became more independent and, like many teens, a touch rebellious; in his case that led to life-threatening health problems.
Jesse had a rare metabolic disorder called ornithine transcarbamylase deficiency syndrome, or OTCD, in which ammonia builds up to lethal levels in the blood. Babies born with OTCD usually fall into comas soon after birth and suffer brain damage. Half of them die within a month. Jesse’s milder version of the deficiency was diagnosed when he was two years old, and he managed the condition with a low-protein diet and a regimen of nearly 50 pills a day.
Still, he had occasional health crises. When he was 17, he stopped taking the drugs regularly. One day his father came home to find him curled up on the couch, vomiting uncontrollably. He had to be intubated and kept in an induced coma until his ammonia levels were brought under control.
So when a doctor told Jesse that a clinical trial for a potential OTCD treatment was in the works, he was very interested. Researchers at the University of Pennsylvania in Philadelphia were developing a fix for the OTC gene, which produces an enzyme that prevents ammonia buildup. Patients would be injected with working copies of the gene that had been attached to an adenovirus, a type of cold virus (very similar to the AstraZeneca and Jannsen Covid-19 injections). The virus, altered to be harmless, would infect the patients’ liver cells and integrate the added gene into their chromosomal DNA.
The field of gene therapy had so far helped just a few people with genetic diseases. But the researchers’ experimental treatment had lengthened the lives of lab mice bred to be deficient in OTC enzymes, and the scientists were hopeful the gene-repair method they were testing could eventually be used to treat many liver diseases. The trial Jesse would join was a safety study, aimed at moving toward a treatment for babies with OTCD, and was not intended to improve the participants’ health. But Jesse was eager to help, and he flew to Philadelphia in September 1999 to take part.
Jesse was the 18th person to receive the modified virus. Previous patients in the trial had experienced flu-like symptoms, but he had a much worse reaction. Within a day he became disoriented and showed signs of jaundice. He had an intense inflammatory response and developed a dangerous blood-clotting disorder, followed by kidney, liver, and lung failure. Four days after receiving the shot Jesse was declared brain dead and taken off life support. The team of doctors and nurses caring for him were stunned by his rapid decline and death.
The news that an experimental treatment had killed a basically healthy volunteer rocked the field of gene therapy and the broader world of biological research. News coverage portrayed the trial researchers as overeager and undercautious, taking shortcuts and disregarding rules meant to protect the people in their care.
In a flash the field of gene therapy collapsed, taking its grandiose promises of miracle cures along with it.
Biochemist Jennifer Doudna, who later discovered the CRISPR-Cas9 gene-editing mechanism, remembers feeling the shock waves as a young researcher, even though her work had nothing to do with gene therapy or any kind of medical research.
“We were all very much aware of what happened there and what a tragedy that was,” she said in a recent interview. “That made the whole field of gene therapy go away, mostly, for at least a decade. Even the term gene therapy became kind of a black label. You didn’t want that in your grants. You didn’t want to say, ‘I’m a gene therapist’ or ‘I’m working on gene therapy.’ It sounded terrible.”
In the weeks after Jesse’s death James Wilson, the director of the University of Pennsylvania’s Institute for Human Gene Therapy, and the other doctors involved in the trial tried to understand what happened. They focused on the possibility that the adenovirus had triggered a fatal immune response for reasons that were not yet clear.
He and his team concluded that the teenager had probably experienced a rare phenomenon called antibody-dependent enhancement.
Meanwhile, journalists and federal health officials discovered several troubling lapses in the conduct of the study. For example, the researchers had earlier told the FDA they would tighten up the trial’s eligibility criteria, but they never followed through. When two patients suffered serious side effects, the scientists did not immediately inform the agency or put the study on hold as required. It turned out Jesse’s pretrial test results showed he had poor liver function, indicating he arguably shouldn’t have received the OTC gene injection.
But perhaps most damning were failures in the informed-consent process. Researchers hadn’t told Jesse about the earlier patients’ side effects or about two lab monkeys killed by high doses of adenoviruses. If he had been properly briefed about these previous issues, he might have dropped out of the study and still be alive today. Wilson was also accused of a conflict of interest: he had a stake in the company that owned the gene-transfer technology and stood to benefit if the trial succeeded.
Wilson denied that financial considerations affected the study and said it was impossible to predict that Jesse would suffer such a bad reaction. Nevertheless, the Gelsinger family sued, and the university quickly settled for an undisclosed sum, while declining to take responsibility for Jesse’s death. In January 2000 the FDA suspended human research at Penn’s Institute for Human Gene Therapy, and the university eventually shut the program down.
The investigations drew attention to wider problems in oversight of gene-therapy experiments and human research generally. For example, the FDA and NIH revealed that 691 volunteers in gene-therapy experiments had either died or fallen ill in the seven years before Jesse’s death; only 39 of these incidents had been reported promptly as required.
The adverse reactions and subsequent death suffered by Jesse Gelsinger, sound an awful lot like the reactions that have been suffered by countless people throughout the world to the Covid-19 injections, don’t they?
The Expose
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Richard Noakes
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So the “vaccines” are Gene Therapy: Dr Ugur Sahin, the COVID-19 vaccine he designed for Pfizer was designed in just few hours in a single day (on a computer) on January 25, 2020. No other vaccine in history has been created and manufactured so quickly. Previously, the fastest vaccine ever developed took more than four years. co-founder of BioNTech Not only that, Pfizer Chairman (((Albert Bourla))) hasn’t gotten around to having his shot, or Dr Ugur Sahin, last I knew. And it went from laboratory straight into human arms without any animal testing first – mRNA never used in humans ever before – doesn’t that strike you as odd?
Obviously, no virus was present, when this vaccine was made on a computer and a Covid infection, was not the basis of the vaccine creation, either.
Documents by Pfizer Show BioNTech Paid FDA $2,875,842.00 “Drug User Fee” for COVID-19 Vaccine Approval
Vaccine Impact
“Vaccine efficacy is generally reported as a relative risk reduction (RRR). It uses the relative risk (RR)—ie, the ratio of attack rates with and without a vaccine—which is expressed as 1–RR. Ranking by reported efficacy gives relative risk reductions of 95% for the Pfizer–BioNTech, 94% for the Moderna–NIH, 91% for the Gamaleya, 67% for the J&J, and 67% for the AstraZeneca–Oxford vaccines.
“However, RRR should be seen against the background risk of being infected and becoming ill with COVID-19, which varies between populations and over time. Although the RRR considers only participants who could benefit from the vaccine, the absolute risk reduction (ARR), which is the difference between attack rates with and without a vaccine, considers the whole population. ARRs tend to be ignored because they give a much less impressive effect size than RRRs: 1·3% for the AstraZeneca–Oxford, 1·2% for the Moderna–NIH, 1·2% for the J&J, 0·93% for the Gamaleya, and 0·84% for the Pfizer–BioNTech vaccines.”
The Lancet Study Doctors for COVID Ethics On The accompanying chart:
Pfizer/BioNtech RRR 95.03% ARR 0.84% From Jab
Moderna (NIH) RRR 94.08% ARR 1.24% From Jab
Janssen RRR 66.62% ARR 1.19% From Jab
Astrazeneca/ Oxford RRR 66.84% ARR 1.28% From Jab
The Lancet
Pfizer ARR 0.84% x3 = 2.52% Covid x3 = 297.48% x4 = 3.36% Covid x 4 = 396.64%
Moderna ARR 1.24% x3 = 3.72% Covid x3 = 296.28% x4 = 4.96% Covid x 4 = 395.04%
Astrazeneca ARR 1.28% x3 = 3.84%Covid x3 = 296.16% x4 = 5.12% Covid x 4 = 394.88%
So 2 shots plus booster = 3 =1,010,880 Trillion, Trillion, Trillion mRNA and Graphene Oxide/Hydroxide particles in your body?
So 2 shots plus 2 boosters = 4 = 2021760 Trillion, Trillion, Trillion Trillion, Trillion, Trillion mRNA and Graphene Oxide/Hydroxide particles in your body?
Jim Woodgett, former Director of Research at Mount Sinai Hospital (2005-2021)
Answered May 5, 2021
The SARS-CoV-2 Spike protein encodes a 1273 amino acid protein. Multiple by 3 to get the number of nucleotides and add some untranslated regions for directing translational start and aiding in stability it rounds to approximately 5,000 nucleotides. 1 nucleotide of RNA has a mass of (averaged) of 320 Daltons. So an RNA comprised of 5,000 nucleotides has a mass of 1600 kiloDaltons.
There are 30 micrograms of RNA in a Pfizer/BioNTech single dose (in 0.3 ml). That means there are about 11.3 x 10 to the power of 12 molecules of RNA per shot.
(First shot?)11,300,000,000,000 molecules of RNA (11,300 Trillion) approximately.
The Moderna shot typically uses more RNA.
Erwin Claassen, Wetenschappelijk Huurling at Waar Niet
Answered May 5, 2021
(2nd Shot) a shitload… dose is 100µg of mRNA (not all vaccines is mRNA), that is around 505.440.000.000.000.000.000.000 copies… more or less (505,440 Trillion Trillion)
So if you have a 3rd booster that might translate to a further 1,010,880 Trillion, Trillion, Trillion mRNA particles in your body?
How COVID Vaccines Deregulate Your Vascular Function
Dr.Bhakdi explains the science behind the blood disorders seen post-vaccination with gene-based COVID-19 “vaccines,” and why, in the long term, these injections may be causing dangerously overactive immune function in hundreds of millions if not billions of people.
He believes the mRNA or DNA in the vaccines are being taken up by the endothelial cells that line your blood vessels. These cells then start producing the SARS-CoV-2 spike protein in the blood vessel wall.
“This is a disastrous situation,” Bhakdi says, “because the spike protein itself is now sitting on the surface of the cells, facing the bloodstream. It is known that these spike proteins, the moment they touch platelets, they active them [the platelets], and that sets the whole clotting system going.
The second thing that should happen, according to theory, is that the waste products of this protein that are produced in the cell, are put in front of the ‘door’ of the cell … and is presented to the immune system.
The immune system, especially the lymphocytes, recognize these and will attack the cells, because they don’t want them to make viruses or viral parts. And the viral parts are now being made in locations where viral parts would never, ever reach [naturally], like the vessel wall in your brain …
If that ‘tapestry’ of the wall [i.e., the lining of the blood vessel] is then destroyed, then that is the signal for the clotting system to [activate], and create a blood clot. And this happens with all of these vaccines because the gene [the instruction to make spike protein] is being introduced to the vessel wall.”
Are the spike proteins injected, which are designed to be mass-produced in the bodies of the vaccinated, cause of the clotting?
So, an example:
Pfizer ARR 0.84% x3 = 2.52% Covid x3 = 297.48% x4 = 3.36% Covid x 4 = 396.64%
Using the numbers above, after 3 vaccine shots, you have a 2.52% chance of the vaccines stopping Covid and Covid has a 297.48% chance of infecting you.
So 2 shots plus booster (3) =1,010,880 Trillion, Trillion, Trillion mRNA and Graphene Oxide/Hydroxide particles in your body
After 4 vaccine shots you have a 3.36% chance of the vaccines stopping Covid and Covid has a 396.64% chance of infecting you.
2 shots plus 2 boosters (4) = 2021760 Trillion, Trillion, Trillion Trillion, Trillion, Trillion mRNA and Graphene Oxide/Hydroxide particles in your body
Now call me a skeptic, but it seems to me the Covid vaccines are not about the Covid infection at all, or stopping it, they are about putting in the mRNA, Lipids, so the particles go through the Brain, Blood Barrier and Graphene Oxide/Hydroxide particles in your body – the purpose for that has not been explained, or even mentioned.
In the US, the Supreme Court has ruled that vaccinated people world wide are products, patented goods, according to US law, no longer human. Through a modified DNA or RNA vaccination, the mRNA vaccination, the person ceases to be human and becomes the OWNER of the holder of the modified GEN vaccination patent, because they have their own genome and are no longer “human” (without natural people), but “trans-human”, so a category that does not exist in Human Rights. The quality of a natural person and all related rights are lost. This applies worldwide and patents are subject to US law.
Since 2013, all people vaccinated with GM-modified mRNAs are legally trans-human and legally identified as trans-human and do not enjoy any human or other rights of a state, and this applies worldwide, because GEN-POINT technology patents are under US jurisdiction and law, where they were registered.”
See link here: https://ambassadorlove.wordpress.com/2021/12/08/covid-19-patent-horrors/
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Mark Tapley
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Hello Noakes:
There is no virus nor gene therapy vaccine but just another blood toxin injection using graphene oxide and nano particle contaminants. The mRNA spike protein technology has never been shown to work according to microbiologist Stephan Lanka who still has posted a 1.5 Euro reward for anyone who can show the existence of any virus to the German Supreme Court. If the spike protein technology worked there would be a multitude of studies verifying it. There are none. The Insilco (imaginary) gene sequences as well as the patents are just another subterfuge to hide the fact that there is no virus, no variants, no mRNA spike protein, no gain of function, no AED, and no lab made. Just a bunch of fake stories to hide the Zionist syndicate’s latest and greatest effort in the long term program of controlling, weakening and ultimately culling the plantation herd. The following video by Dr. Tom Cowan explains the fake science:
https://www.bitchute.com/video/yu0VtSHWzdou/
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Alan
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It’s too late now to be identifying problems with the covid therapies when millions of people have been convinced to be treated. The time to identify problems was in well-structured trials before approval was given. The graphs which are often shown of reports in the VAERS system showing the number of complaints related to all vaccines showing a low level for years and then a peak with the covid treatment say it all. The reason there is a low number of adverse events in the past is that vaccines went through rigorous trials before approval.
We are witnessing a failure of the manufacturers, health authorities and politicians to protect us from harmful treatments. The jails are not big enough to hold all these criminals.
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Tom
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This is really becoming a joke. The FDA and CDC have been committing fraud in the name of big pharma profits for the last 40 years. Congress is afraid to tackle the problems since they are owned by big pharma lobbyists. Since nothing has been done to date, nothing will be done… period. Rescind the 1986 no-fault-vaccine law and maybe some progress can be made. Otherwise, If you expect anything to change at the CDC or FDA, you are going to be greatly disappointed. Protecting big pharma profits is goal number one. That means more useless and deadly drugs, vaccines and mRNA injections up the wazoo.
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