Showing posts with label FDA. Show all posts
Showing posts with label FDA. Show all posts

Wednesday, May 6, 2026

William Egan, FDA, Acting Director, Office of Vaccine Research and Review confirms in 2000: Thimerosal — the mercury-based preservative injected into babies for decades — has NEVER been properly safety-tested since Eli Lilly introduced it in 1929.

An FDA official confirms: Thimerosal — the mercury-based preservative injected into babies for decades — has NEVER been properly safety-tested since Eli Lilly introduced it in 1929. The only study?
27 dying meningitis patients in 1929… who all died anyway. No rigorous long-term testing on healthy infants. No data proving it’s safe when injected. Yet it was still put into childhood vaccines for generations.
Big Pharma knew.
Regulators knew.
And they kept doing it anyway. This isn’t “settled science.” This is why trust in the system is gone. Watch the full clip and ask yourself: Why are we still playing Russian roulette with our kids’ brains in 2026?What do you think? Drop your thoughts below and SHARE, we need to get the word out.

ENOUGH is ENOUGH! 

William Egan, FDA, Acting Director, Office of Vaccine Research and Review.

Representative Dan Burton is the Indiana Congressman.

Since creators on X refuse to give details, Grok confirms, 
The congressman asking the questions is Rep. Dan Burton (R-IN), Chairman of the House Committee on Government Reform.
The hearing is titled “Mercury in Medicine—Are We Taking Unnecessary Risks?” and took place on July 18, 2000.
This is an older clip (from a 2000 House hearing) of FDA official Dr. William Egan (then Acting Director, Office of Vaccine Research and Review, Center for Biologics Evaluation and Research) being questioned about thimerosal (a mercury-based preservative) safety testing in vaccines. Rep. Burton, who chaired the committee and led these vaccine safety inquiries, is the one pressing Egan on the lack of modern safety studies since the 1929 Eli Lilly tests.
The video in the X post matches this exact hearing (transcripts and records confirm the exchange about the 1929 meningitis patient tests). Note that thimerosal was largely phased out of most routine U.S. childhood vaccines as a precaution in the early 2000s, though it's still used in some multi-dose flu vials and other contexts.

Saturday, July 19, 2025

SASHA LATYPOVA: mRNA vaxxes don't get recalled, because the FDA does not have any authority to force a recall of a military weapon.

Monday, April 28, 2025

But they still have Thimerosal in them?

Yes.  They still also have multi-dose vials that do contain . . . 

Why don't they go to single-dose vials?  I know that they are considering the feasibility of . . . 

Why don't you tell them to do that?  

We consider these vaccines, which also contain  Thimerosal as a preservative, to be safe and effective.  However, we do consider that is important to have vaccine . . .

Did you hear any of the testimony earlier from those people that were testifying, those scientists and doctors?  

Yes, I did.  Did you see the study from Canada there that showed the damage that's done when a very minute amount of Mercury is given put in proximity to brain cells?

00:37.  I think it's hard to extrapolate that data to what actually happens in the clinical situation . . .

Well, you know, every study that's been done, Doctor, that you guys have put forth as showing that there's no correlation between  Thimerosal and autism doesn't say categorically that Thimerosal doesn't cause autism.  They never say that.  Can you tell me right now categorically, without any doubt whatsoever, that mercury in vaccines does not cause autism? 

1:02.  I think what have to say is what the Institute of Medicine concluded is that the body of evidence neither allows to accept or reject . . .

No, I want you to give me a yes or no.  Can you tell me, can you say right now just flat out can you tell me without any doubt whatsoever that the Mercury in vaccines does not cause neurological problems or autism?

01:19.  We can neither accept nor reject a causal relationship . . . 

So, what you're saying is you cannot tell me that you cannot say categorically.

1:26.  You don't know one way or another.  

1:27.  So why are you keeping something in there if you don't know one way or the other when you know that there is an epidemic of autism if there's an epidemic of something why do you keep it in there when you're not sure because every study I've seen flatly says you're not sure you say you can't say yay or nay.

1:43.  I think you have to consider the benefit that vaccines confer and there's a definite benefit from influenza vaccine and having an adequate Supply of vaccine is very important.

1:51.  Okay well let me follow up on that then.  Single shot vials does that need a Thimerosal?

1:56.  No they don't but . . . 

1:58.  Then why don't we have single dose shots?

1:58.   There are a lot of manufacturing issues associated with switching over.  You need much more filling capacity for the lines.  You need a lot more other kinds of things that need to be introduced.  Although it can be done and both Evans vent is pasture have started to introduce that, it is not something that at present they have the capacity to do.

2:18.  Do these pharmaceutical companies have produces vaccines in the past the ability to produce and have they produce single shot vials? 

2:27.  

Sunday, January 26, 2025

DR. TOBY ROGERS: but as they are taking Mercury out, they're adding more aluminum back in. And I believe they did that to keep autism rates rising so that they wouldn't be blamed for rising autism cases.

00:50.  Aluminum agents were in more than half of the vaccines given to children today.  Backstory, parents in the 1990s were seeing autism in their children, they were seeing skyrocketing autism rates.  They discovered that mercury was in vaccines.  They protested against that.  So the FDA and the CDC removed Mercury from lots of vaccines not from all.  They're still in the 10-dose flu vial and some of the others, but as they are taking Mercury out they're adding more aluminum back in.  And I actually believe they did that to keep autism rates rising so that they wouldn't be blamed for rising autism cases.  This was in the early 2000s.   

Wednesday, October 9, 2024

SASHA LATYPOVA: And, in summary, I can say none of it is regulated. The FDA kind of pretend regulates [the vaccines], and that's been the case since forever...

"None of it [vaccines] is regulated. The FDA kind of pretend regulates these things, and that's been the case since forever...up until 1973 there were no regulations and no standards for manufacturing...[then] in '86 there was [The National Childhood Vaccine Injury Act]." Retired pharma R&D executive Sasha Latypova (@sasha_latypova) describes for Dr. Drew () how "vaccines" are not actually regulated in the U.S. by the FDA but rather only "pretend regulated." The pharma insider notes that the injections were entirely unregulated prior to 1973, and then, by 1986, protected by The National Childhood Vaccine Injury Act—meaning there's no liability and thus, in effect, still no regulations. "My colleague, Katherine [Watt], traced the relevant US law all the way back to late 1700s. And so, we now have a better understanding of the regulatory frameworks in the US as it applies to all vaccines in general, and then, a much greater understanding about the COVID shots, which are EUA countermeasures and how that's regulated," Latypova says. "And...in summary, I can say none of it is regulated. The FDA kind of pretend regulates these things, and that's been the case since forever..." "In the US, the vaccines have not been under FDA mandate until 1973," Latypova adds. "Many people don't realize that. They were not regulated at all as pharmaceuticals. They were manufactured essentially by public health service, which is predecessor of CDC, the US government, public health service." "After 1973, they technically came under FDA purview. And as you know, in '86, there was [The National Childhood Vaccine Injury Act and] that shielded all the manufacturers from liability; that was under Reagan." "Since then, the manufacturers of vaccines [have] had no liability. And if you have no liability for injuries or deaths that you cause, then it's as if regulations don't exist for you because you have no consequences," Latypova notes. Partial transcription of clip: "So the manufacturing, those remain great concerns. In fact, I've I've gotten additional information that it's even worse, than I thought, and the problem actually goes a long time back. Even my colleague, Katherine [Watt], traced the relevant US law all the way back to late 1700s. And so, we now have a better understanding of the regulatory frameworks in the US, as it applies to vaccines, all vaccines in general, and then, a much greater understanding, about the COVID shots, which are EUA countermeasures and how that's regulated. And...in summary, I can say none of it is regulated. The FDA kind of pretend regulates these things, and that's been the case since forever... "So the law research is ongoing, and, Katherine and one of the colleagues are writing a big report on relevant law tracing back to, as I said, late 1700s when, you know, vaccination as we kind of know it in a modern world has, started being used more or less in mass subjects. Now, in the US, the vaccines have not been under FDA mandate until 1973. Many people don't realize that. They were not regulated at all as pharmaceuticals. They were manufactured essentially by public health service, which is predecessor of CDC, the US government, public health service. And, they were sort of, you know, you could order order the samples or whatever you needed, the box. You could even, like, order it in the mail from the US government, and they would send it to you. "And so up until 1973, there were no regulation and no standards for manufacturing, for purity testing, for contaminants, for, characterizing what you have made in the pharmaceutical process, which is standard for anybody who works in pharma making drugs. That didn't exist, really. It wasn't anything codified. After 1973, they technically came under FDA purview. And as you know, in '86, there was a national vaccine, I forget the correct name of the law, but basically, the act that came in that, shielded all the manufacturers from liability that was under Reagan. "And since then, the manufacturers of vaccines had no liability. And if you have no liability, for injuries or deaths that you cause, then it's as if regulations don't exist for you because you have no consequences."

Tuesday, August 13, 2024

REP. THOMAS MASSIE: Why does the FDA and the Dept of Education need weapons of war, like AR-15s?

6:06, MASSIE.  When you enter these agencies, you have to go through a metal detector.  These agencies have a civilian mission; they do not have a military mission.  And I think Dan Bishop said it well, "How can you say that these are weapons of war and then argue that they need to go to agencies that are not engaged in war and should never be engaged in war?"

7:33, GAETZ.  The entire reason we have the Bill of Rights is because there are certain rights that have to be reserved to the people, not government.  And Mr. Massey's amendment shows how this legislation has turned the Constitution, the Bill of Rights on its head.  It takes powers reserved to the people and it deprives the people of those powers and rights and then it reserves explicitly the very same rights for government, not for the military but for like the Deputy Commissar of Pencil Erasers at the Department of Education.  They want you weak and the government strong.  They want you disarmed and the government armed to the teeth.  I'm reminded of a quote from Austin Powers, where Austin Powers introduces one of his colleagues as a representative from the militant wing of the Salvation Army.  I didn't know we had a militant wing of the Department of Education or the USDA.  But I am certainly aware that our fellow Americans are concerned about a very troubling trend where these bureaucracies are getting their own militias and arsenals.  It would probably surprise most Americans that just this year the IRS has purchased $700,000 worth of ammunition.  So when you peel back all the layers of the onion, the party of big government isn't actually against guns and ammo; they're just against you having them because they want a citizenry that is repressed and dominated and ultimately subjected.  And by the way, our founders were so brilliant they knew this would happen and they knew that the Second Amendment wasn't going to be about hunting or self-defense, but about curating an appropriate balance that is necessary for a free society where we don't have to live in fear, that one day some Deputy Administrator from the Department of Education is going to knock our door down and that as a result of us not having the appropriate protractor that we are somehow going to be in a disadvantageous position regarding our safety, and far more important, regarding our Liberty.  I yield back to the gentleman from Ohio.

Sunday, June 30, 2024

BROOK JACKSON: What does overturning Chevron mean? Let's consider an actual case involving FDA - Bruesewitz v. Wyeth.

Chevron Deference Aspect: The court acknowledged FDA's expertise & regulatory authority in approving & monitoring vaccines. The court implicitly deferred to the FDA's judgment that vaccines are safe & effective when they meet regulatory standards, thus preempting state law claims based on design defects. What are the implications of overruling Chevron Deference:

Courts would independently interpret the NCVIA & other relevant laws without automatically deferring to the FDA's expertise. WIN!! Brook Jackson

🚨What does overturning Chevron mean? Let's consider an actual case involving FDA - Bruesewitz v. Wyeth. Background: The case involved Hannah Bruesewitz, who suffered seizures & developmental problems after receiving a DTP vaccine manufactured by Wyeth, now a part of Pfizer. The family sued Wyeth, claiming the vaccine was defectively designed. Legal Context: The National Childhood Vaccine Injury Act (NCVIA) of 1986 established a no-fault compensation program for vaccine injury claims & removed the liability of vaccine manufacturers. The FDA's role in approving vaccines & its interpretation of safety standards were central to the case. Court's Decision: In 2011, SCOTUS ruled in favor of Wyeth, holding that the NCVIA preempts all design-defect claims against vaccine manufacturers brought by plaintiffs seeking compensation for injury or death caused by vaccine side effects. Chevron Deference Aspect: The court acknowledged FDA's expertise & regulatory authority in approving & monitoring vaccines. The court implicitly deferred to the FDA's judgment that vaccines are safe & effective when they meet regulatory standards, thus preempting state law claims based on design defects. What are the implications of overruling Chevron Deference: Courts would independently interpret the NCVIA & other relevant laws without automatically deferring to the FDA's expertise. WIN!! Plaintiffs might be more likely to challenge FDA approved vaccines in court, arguing that the FDA's safety standards or approval processes are insufficient or flawed. WIN!!
Courts would scrutinize FDA decisions more closely, likely leading to different outcomes in cases involving vaccine injuries or side effects. WIN!!

Vaccine manufacturers will face more uncertainty regarding liability & regulatory standards impacting vaccine development & availability. WIN!! 

Thursday, June 27, 2024

AARON SIRI: [Peter Marks] sat, as I would expect, as a partner with Pfizer, defending them from their misconduct. He should have been outraged. He should have said, "Why didn't you report this?" irrespective of why you thought this was related. You had an obligation to tell us of all injuries"

Though Dr. Peter Marks concedes that the COVID-19 vaccine causes a 5-fold increase of myocarditis in children, he still pushes the vaccines.

Wednesday, December 6, 2023

LATYPOVA: ‘We can now have a non-investigational substance and use it in [a] non-medical and non-investigational way… That makes it [an] illicit drug.”

“[W]hen you switch the status [of a regulatory pathway for a drug with the FDA]… to the non-investigational one [the EUA countermeasure pathway], the clinical trial becomes not a clinical trial—it’s just a collection of people trying drugs. Just like a recreational party…”

LATYPOVA:
The “first time the emergency use authorized thing came in was November 2003 through the National Defense Authorization Act, not through a bill that had to do with the FDA, or NIH, or public health, or anything like that.”

The FDA lawyers said, in effect, “We want to violate the law, and we can’t, unless we design this new, extrajudicial pathway for ourselves.”

Friday, October 20, 2023

Brook Jackson is SUING @Pfizer + @VRG_FortWorth on behalf of the American people for multiple violations under the False Claims Act

I have followed the COVID-19 condition, the mask mandates, and the made-up 6-foot distancing, it's all been one big con.  Don't get me wrong, I've had fun with it.  Anyone who insisted I wear a mask, I either outright refused or gave them a mindful of their $.69 cents' worth of authority.  But even after 3, nearly 4 years of this war on everything that human beings value, I am still appalled and disgusted with what some of these companies got away with.  

Brooke Jackson says the first thing she noticed was a lack of informed consent.  They weren't consenting patients properly; they weren't consenting patients at all.  So that was really the first thing that she saw.  There was unblinding.  There was no reporting of the adverse events properly.  They were mixing up lab samples.  The better question is what was Ventavia doing correctly?  Which was nothing.  She got a text message that was basically to lie to Pfizer that she never unblinded her patients.  She was removing documents from patients' charts and shredding them so that they wouldn't find out that we'd actually unblinding all these patients.  Just reading through some of the emails that she was getting she recognized there was an obvious rush to get the vaccine study to meet the enrollment goals.  There was just something that was not right, a gut feeling.  So on the 25th of September, she took [her findings] to the FDA, and she got fired about 6 hours after she contacted the FDA.  She feels like it's an effort between big Pharma and big government and she feels betrayed in a lot of ways, especially knowing that this product is dangerous and that it's hurting people.

Tuesday, August 29, 2023

FDA's Curtis Wright: Sold out a nation of youth for $400,000 a year job from Purdue Pharma, manufacturers of Oxycontin

When we talk about a bureaucracy we are describing the structure of a system, the top-down structure.  Bureaucracies don't change that much.  They might increase or decrease in size, but the direction of power and control is usually the same.  So in that regard, they don't really change that much.  Systems don't change either, so even if you have these whistleblowers coming out and they out someone, know that the system doesn't change.  Curtis Wright, IV, won the lottery.  

Monday, August 14, 2023

"The FDA is not your doctor. Their job is to approve drugs to the market and that's it. They should not be prohibiting drugs. They shouldn't be endorsing drugs. That's not their role, and that's the point of our lawsuit"

purpose of our lawsuit, to remind everybody that the FDA is not your doctor.  Their job is to approve drugs to the market and that's it.  They should be neutral.  They should not be prohibiting drugs.  They shouldn't be endorsing drugs. That's not their role, and that's the point of our lawsuit.  --Dr. Mary Talley Bowden.

Three doctors who were fired for prescribing or promoting the cheap therapeutic drug, Ivermectin, for the treatment of Covid-19, asked the 5th Circuit Court of Appeals to revive a case that a federal judge dismissed back in December 2022.  

[The judge in this case is The Honorable Priscilla Richmond she's the chief judge for the United States Court of Appeals for the Fifth Circuit.  The date of the hearing was August 8th 2023.]

During the hearing, a justice department attorney named Ashley Cheung Honold tried to defend the FDA's strong campaign against Ivermectin including this tweet where they tell people to just stop it to suggest that the only form of ivermectin comes as horse paste listen

They did not purport to require anyone to do anything or to prohibit anyone from doing what about when it said no stop it why isn't that a command that seems to me that if you were in an English class they would say that is a command stop it that is different than we are providing helpful information.

Your honor, the language that was used in these tweets were merely quips, and I don't think these quips change the substance of the FDA's statement as plaintiffs concede.

Is that a command, "Stop it"?

The tweets about the horse Ivermectin were intended to advise consumers that they should not use Ivermectin intended for animals and that this could be unsafe.

Here is the manipulative ad in question.

I'm sorry, can you answer the question, please?  Is that a command, "Stop it"?

Senator Ron Johnson took to Twitter about the about-face of the federal government when confronted with the actual law.  Senator Johnson pointed out that the government admitted in court that the doctors indeed have the authority to prescribe Ivermectin off-label.

Here the FDA was not regulating the off-label use of drugs.  These statements are not regulations.  They have no legal consequences.  They don't prohibit doctors from prescribing Ivermectin to treat Covid or for any other purpose.  Quite to the contrary, there are three incidences that I'd like to point the court to in the record that show that FDA explicitly recognizes that doctors do have the authority to prescribe Ivermectin to treat covid.

So then why are your patients still facing backlashes like this at the drug counter?  "Hi.  I had the same prescription filled at the other store."

Joining us now to discuss these huge developments in the case are two of the plaintiffs Dr. Paul Merrick and Dr. Mary Bowden.  Welcome to you both.  It's good to see you.  This was really big . . . the line of questioning and the struggle to answer from the government lawyer was just amazing.  I'll start with you, Dr. Bowden.  The main argument here is that the FDA admitted to regulating big Pharma.  It doesn't have the authority, though, right, to tell doctors what they can and cannot do, which they acknowledge in court, but if you talk to a doctor, which I did, some of them pretend as if their hands are tied, that they couldn't prescribe Ivermectin.

4:15. There's a misconception that the FDA has more power than they do I think.  The Judge pointed that out quite nicely.  She said, you know, "People believe that the FDA has this power, this right," and that's sort of the purpose of our lawsuit, to remind everybody that the FDA is not your doctor.  Their job is to approve drugs to the market and that's it.  They should be neutral.  They should not be prohibiting drugs.  They shouldn't be endorsing drugs. That's not their role, and that's the point of our lawsuit.

I was quite struck and I played this for my audience on Friday about the argument of sovereign immunity Dr. Merrick.  Essentially the FDA says that we can put out information that's not exactly correct, or that could even harm American citizens and that they have sovereign immunity.  How did you feel about that statement do you believe that's true?

5:19. Yeah, clearly that's absurd.  It means that they are allowed to do anything illegal under the pretense of sovereign immunity.  So let's be clear that the FDA has been on a campaign, a vigorous campaign to deface and dehumanize the use of Ivermectin, which is a safe effective medication, and as a result of this, as you saw in that clip, patients are being denied access to Ivermectin.  Physicians are losing their licenses because they prescribed Ivermectin.  So the misinformation that is being perpetuated by the FDA continues, and as Mary said that is beyond their jurisdiction.  They should not be interfering with the patient-physician relationship.  Their role is to approve drugs they are not in the business of practicing medicine and from the clips that you saw it seems that they're doing a rapid 360 about turns because clearly they made a mistake.

6:30. Yeah, clearly and it seemed like based on what I heard from the hearing, Dr. Bowden, that the judges will likely rule in your favor.  Where do you see this going?  Is the case going to be reinstated?

6:45. Well, unfortunately, the purpose of the lawsuit is basically to have them take down their tweets and take down the misinformation that they put on their website.  Our attorneys don't anticipate that we will get any sort of retraction, although I feel like that is warranted.  We are not seeking damages. Where this goes from here is at the appeal was over sovereign immunity so what may go back to the district court where then we have to prove standing so it's a little up in the air.

7:20. But the damage is already done.  Look if the information is out there. I tried to get Ivermectin for a different purpose than it's used for off-label and the doctor who was willing to prescribe it told me, "Look, don't take this to a local pharmacy.  You got to tell me what pharmacy you're going to take it to because I don't want to hurt my relationship with a pharmacy that I prescribe other medicines, you know, to my local patients."  And that's just absurd.  The damage is done.  If they don't issue a retraction or put out a statement, do you see this war on Ivermectin, Dr. Marick, ever ending, especially as we're we are being warned this other wave of Covid coming? 

8:00. So to speak, the horses are out of the barn already.  They have caused enormous damage.  As Mary said, the purpose of our suit is to prevent them from doing this going forward.  We can't have the FDA interfering with the practice of medicine and that's really the basis of our suit.  But you are correct: the damage that's been done is overwhelming and irreversible.  As you say there is this profound misconception that Ivermectin is horse paste, that it's made for horses, and that it's an unsafe medication.  And those two premises are completely false.  It is one of the safest medications on this planet.  And over 3 billion doses have been given to humans safely, so this is a highly effective medication.  It's exceedingly safe and the notion that it's a toxic horse dewormer is really complete Lee false and misinformation and so the FDA themselves are perpetuating false information and they're interfering with the patient physician relationship.

9:10. Dr Bowden before we end what can people do to help you all fight? 

9:15. Well we're in an information War so keeping the dialogue alive continuing to talk about it continuing to put the heat on the FDA to correct this continue to put the heat on our legislators.  If we lose this case it really emboldens the FDA so it's important and we need to keep talking about it. 

Thursday, June 8, 2023

I feel sick.  

I feel sick because I was wrong about two FDA officials who purportedly resigned from the FDA in protest against the approval of the vaccines.  I was wrong.  I'll say it again, I was wrong.  And it only took me one full year to learn of my mistake and to correct it here. 

I made a post with the headline in bold lettering as a kind of breakthrough from institutional corruption, "MARION GRUBER & PHIL KRAUSE: ACTUAL HEROS AT THE FDA."  At that time, June 22, 2022, I was so eager to look for some good news coming out of government institutions that I posted that without critical research to assess and review it like a principled writer.  

The Federal government is made up of a bunch of Madeline Albrights, John McCains, and Lindsey Grahams.  

Okay, dates help to sort things out.  Pfizer applied for EUA on November 20, 2020.  FDA scientist, Marion Gruber, knew the lipid nanoparticles and their payloads were inflammatory in multiple organs, knew they were toxic, and STILL AUTHORIZED THIS FOR EMERGENCY USE ON DECEMBER 11, 2020.

The inflammatory lipid nanoparticles and their payloads collect in the ovaries and other key organs, are not rapidly cleared from the human body and are toxic.

Pfizer scientists knew this before seeking EUA approval from the FDA through the 11/20/2020 EUA application.

FDA scientists led by Marion Gruber knew this when authorizing the product for emergency use on 12/11/2020.

Pfizer, FDA and Gruber withheld this information from the public and knowingly lied each time they described the products as “safe and effective.”

 

Tuesday, December 20, 2022

Every drug that has been recalled by the FDA was first proven to be "safe and effective" by the FDA

Thursday, October 6, 2022

Did you know that Janssen, a J & J division, was from Belgium? Had you known that, would you have taken that, er their, vaccine or any other from a foreign government?

Thank you to Dr. Meryl Nass, dated February 27, 2021.

Yesterday, Feb 26, the FDA’s vaccine advisory committee (VRBPAC), an FDA committee called Vaccines and Related Biological Products Advisory Committeemet to give its assent to the third Covid vaccine candidate applying for an Emergency Use Authorization (EUA). And I spent another day listening in. FDA is expected to authorize use of the vaccine today.

This one requires only one dose.  For now.  The company is doing a clinical trial of two doses and they could be recommended in future. The VRBPAC committee comments were lackluster.  The members had little to go on.  There is no adenovirus vaccine in civilian use in the US, just as there were no mRNA vaccines.  The committee members simply don’t know what they have to watch out for.  One admitted it, and asked if FDA would assist and suggest what types of issues the newly licensed Ebola adenovirus vaccine or the military adenovirus vaccine had faced.  FDA responded with stony silence. Clearly this “advisory” meeting was only needed for its rubber stamp.

Most of the sponsor’s (Johnson and Johnson) presenters were from the Janssen division, based in Belgium. Many of the FDA’s presenters were non-native English speakers. The combination of an audio transmission that kept dropping out, and inability to catch many of the words made it a challenge to fully grasp the presentations. Was this intended? 

This here, is it by will or an omission?  Yeah, that's what I thought . . . .  

FDA has refused to inspect the Covid vaccine manufacturing plants before they are “authorized” under EUA.  I suspect FDA administrators were directed not to slow the warp speed down. 

FDA will have to inspect the factories by law before Covid vaccines are fully licensed, but it seems that the game plan is to get the country vaccinated before adequate data become available and licensure can take place. 

Wait, is she saying that the lack of data is precisely the thing that allows the vax manufacturers to have an emergency permission?

Okay, here is the motherload 

While Johnson and Johnson’s Janssen division designed and tested this new adenovirus vectored spike protein vaccine, the vaccine is actually being produced in a factory newly taken out of mothballs, with hundreds of new employees, that has never before produced a vaccine for mass use.  It is owned by Emergent BioSolutions, a company notorious for poisoning soldiers with its anthrax vaccine, which has failed multiple anthrax vaccine inspections.  On Emergent BioSolutions’ board is Kathryn Zoon, a former head of FDA’s Center for Biologics, which regulates vaccines. 

Here is a vague report.  This was interesting.  Turns out that the vaccine that a company will run in a trial may not be the same vaccine that gets made and distributed to the public.  Wow, we all are making way too many assumptions when it comes to how vaccines are made, their testing, distribution, and so forth.  We're all focused on their efficacy only to find ourselves in a 

This factory’s vaccine may not be exactly the same vaccine that about 20,000 subjects in the clinical trial have received. Usually vaccines for clinical trials are made in a pilot plant under stringent conditions. 

So many questions about the vaccines, where it was made, is the company reputable, do they have major lawsuits against previously deadly vaccines, etc.?  So none of these questions are asked let alone addressed.

Does the vaccine work?  The vaccine is said to be 66% effective against moderate to severe disease in the trials, and 100% protective against death. 

Okay, well, according to Fauci, where most of America got its reports on the vaccines, the vaccines started out at 95% effective and went downhill from there.  

In the clinical trials, having a headache and a cough was enough to put subjects in the “moderate to severe” category.  Like the two mRNA vaccines, the vaccine sponsors apparently did not see fit to test whether their vaccines block infection and transmission in humans. This is the fault of the FDA, which sets the standard for the data needed to obtain an EUA.  

You can find the below video here along with a few remarks by Deborah Birx, who admitted that the vaccines were not going to work.  Imagine that.  While Birx is telling the truth in a rare moment, Dr. Fauci doubled down on his "effective" narrative.  Even recently on the Stephen Colbert Show he praised the vaccines again, while giving a thumbs down to Hydroxychloroquine and warning people that Ivermectin was dangerous.  Ha!  

Apparently in the J&J trials, only a subset of participants were evaluated for side effects, "Only a subset of the subjects in the trials were evaluated for side effects.  Why was that?"  See what Dr. Meryl Nass said about the vaccines in general, 

I can’t tell if this vaccine is safe and I doubt anyone else can, either. Nor do I want to be injected with something manufactured by the anthrax vaccine manufacturer, famed for injuring thousands of soldiers twenty years ago, while making 300% profit margins

Read Dr. Meryl Nass's background here.  She's amazing.

Meryl Nass, M.D., ABIM, is an internist with special interests in vaccine-induced illnesses, chronic fatigue syndrome, Gulf War illness, fibromyalgia and toxicology. As a biological warfare epidemiologist, she investigated world's largest anthrax epizootic in Zimbabwe, and developed a model for analyzing epidemics to assess whether they are natural or man-made.  Continue reading . . .

Friday, July 22, 2022

"Drug companies can sue the FDA without a problem, but citizens often cannot. And we're trying to fix that."

Wednesday, June 22, 2022

MARION GRUBER & PHIL KRAUSE: ACTUAL HEROS AT THE FDA

Among the reasons Fauci is so popular with journalists is his delight in spreading fear, the bread and butter of America’s corporate media.

The two FDA officials that he mentions at the 1:25 mark are Marion Gruber, Director of the FDA's Office of Vaccines Research & Review and 32-year veteran of the agency, and her Deputy, Phil Krause, who both resigned due to undue political pressure from the Biden Administration and, you guessed it, Dr. Anthony Fauci. 

Starkmanapproved calls them "Unsung heroes,"

I mention this not to cast judgment on the CDC insiders, but rather to provide context in understanding the bravery and character of Marion Gruber, director of the FDA’s Office of Vaccines Research & Review and a 32-year veteran of the agency, and her deputy, Phil Krause. Gruber and Krause resigned three weeks ago reportedly because of undue political pressure from the Biden Administration and Dr. Fauci to approve Pfizer vaccine boosters for all Americans 16 and over. 

This shocks me.  First time I am hearing of it.  The FDA actually voted in favor of not authorizing the booster.  Wow. 

FDA’s vaccine advisory panel, comprised of the leading vaccine experts in the U.S., on Friday validated the positions of Gruber and Krause, voting overwhelmingly 16-2 not to authorize the boosters, except for people who are 65 and older or at risk of severe disease. 

Unfortunately, the kicker is that the FDA isn't bound by the independent panel's decision. 

The decisive vote gave me hope that doctors and scientists still have some measure of control and influence over America’s pandemic response, although the FDA isn’t bound by the independent panel’s decision. The agency is temporarily overseen by Janet Woodcock, under whose watch an Alzheimer’s drug was approved despite the recommendation of an independent advisory panel. Woodcock is a Biden Administration appointee.

had no idea that Zients was an Obama aide and that Woodcock was a Biden Administration appointee.  The democrats really are running the asylum.

It’s alarming that politics would figure into decisions impacting the health of Americans and others around the world, as the FDA’s decisions carry considerable weight with regulatory agencies of other countries. Biden’s closest advisor and vaccine czar is Jeffrey Zients, a former Obama aide whose only education credential is an undergraduate degree in political science. Zients made millions serving as a healthcare consultant, an industry rife with conflicts and ethically challenged behaviors. A company Zients oversaw owned a controversial anesthesia outsourcing firm that was involved in so-called surprise billing and other questionable practices. Zients isn’t remotely qualified to make scientific determinations. More on Zients can be found here

This is absolutely fascinating. 

Even more alarming is that by Dr. Fauci’s own admission, there’s little science backing up his aggressive advocacy for boosters. As recently as last week, Fauci admitted at a conference that U.S. data so far revealed only an “inkling” that Pfizer’s vaccine lost substantial efficacy after six months. Fauci was relying on Israeli data, which leading experts warn might not be representative of the U.S. experience.

Fauci admittedly is a physician-scientist and immunologist, but interpreting scientific data is a highly specialized function and requires an expertise that the National Institutes of Health, whose infectious disease unit Fauci oversees, doesn’t have.

“It’s no secret that FDA doesn’t have the disease experts in the way that the NIH does,” Diana Zuckerman, a former senior advisor to Hillary Clinton and president of the nonprofit National Center for Health Research in Washington, D.C., told Kaiser Health News. “And it’s no secret that the NIH doesn’t have the experts in analyzing industry data.”   

It has seemed pretty clear to me that Fauci, even when he gets technical on any specifics with the vaccines that, he is mostly about talking points designed to keep people in fear and coralled.  

KHN on Thursday posted a feature that revealed Fauci was scheming as early as January to promote boosters, even before Covid vaccines were widely available. In February, scientists working under Fauci organized an international group of epidemiologists, virologists and biostatisticians to track and sequence covid variants. In March, Fauci’s scientists were experimenting with monkeys and reviewing early data from humans showing that booster shots provided a rapid increase in protective antibodies — even against dangerous variants.

Fauci’s initial thesis was that boosters would be required and he was determined to stick with it regardless of whether real world data supported it. 

Does this say it all about who Anthony Fauci is?  It's not just money, folks, though that too.  It's about power as much as it is about the money.  Why do you think he hasn't retired or even been asked by anyone in authority to retire?  The guy loves power and will do anything, I mean anything, to seize it.  

Among the reasons Fauci is so popular with journalists is his delight in spreading fear, the bread and butter of America’s corporate media. It’s a skill Fauci honed from his AIDS crisis days. In May 1983, after a scientist published a paper in the medical journal JAMA that an infant had contracted AIDS, Fauci created panic with his speculation that the disease could be contracted through household contact, a theory the New York Times and others reported on.

The infant contracted AIDS through pregnancy, but Fauci’s reckless speculation resulted in gays being ostracized because of fears one could contract AIDS from routine contact. Phillip Magness, of the American Institute for Economic Research, has more insights on this. (Be forewarned: the corporate media dismisses the AIER as an irresponsible right-wing think tank. Magness provides links that confirm his allegations.) 

Please read the entire article.  It is a must-read.  

Here is the article he refers to at the 6:30 mark, titled, "BNT162b2 Protection Against the Omicron Variant in Children and Adolescents, . . ."