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August 31, 2021 10:34 AM EDTUpdated 11:11 AM PeopleFDA+
BREAKING: In a major blow to vaccine efforts, senior FDA leaders stepping down

THE TWO LEAD FDA VACCINE REVIEWERS ARE QUITTING
Gee, I wonder why?

Alex Berenson

Don’t worry, though. You can be confident this has nothing to do with political pressure to push boosters or vaccines for kids or the full “approval” that came last week.

Nothing to see here, folks!

Recognizing the Obvious: Hard Data from Israel Reveals Vaccine Failure
By Vasko Kohlmayer

September 4, 2021 ...

It is truly regrettable that most people today fail to see the obvious truth that stares us right in the face.

Since we are all being forced to take the vaccine, we urge everyone to consider the reality before our eyes.

The evidence coming from Israel glaringly exposes the dire fact: the Pfizer vaccine does not work. It does not shield its recipients from Covid-19.

Pfizer, however, is not the only failing vaccine. Quite to the contrary, it appears to be one of the most “effective” available, which is one of the reasons why it was the first one to receive full approval from the Food and Drug Administration (FDA).

Please carefully ponder the full implications of this.

FDA Leaders, Other Scientists Say Most People Don’t Need Vaccine Boosters
BY JACK PHILLIPS September 13, 2021

An international group of vaccine experts, including officials from the Food and Drug Administration (FDA) and World Health Organization (WHO), said that there is no evidence to suggest that the general population needs COVID-19 vaccine booster shots.

The authors warned that if booster shots are introduced too soon, they may cause more side effects in the general population, including myocarditis or Guillain-Barre syndrome. Should that occur, the researchers said, it would create even more problems with vaccine acceptance in the general population.

The paper was published Monday in The Lancet medical journal and was co-authored by Marion Gruber and Phil Krause, two top FDA officials in charge of regulating and approving vaccines. Both Gruber and Krause are slated to depart the FDA in the coming weeks, the agency confirmed about two weeks ago.

former heads of FDA vaccines division say there is no compelling evidence for booster shots
now able to speak freely, they caution that the data is poor, the conclusions premature, the process politicized. we should listen.

el gato malo
Sep 13

two weeks ago, marion grueber and philip krause (director and deputy director respectively of the office of vaccines research and review) quit the FDA in disgust over the politicization of their agency around vaccines and the relentless drive to push boosters without sufficient evidence.

i spoke to this and their unusually blunt comments as they left HERE.

these 2 were the backbone of the science team at FDA for vaccines. ...

this level of statement from them is exceptional and starts to evidence the rage and disgust i’ve been hearing so much of out of all but the biggest in pharma and biotech. no one can believe what has happened to the FDA in the last 2ish years since gottlieb (who had, frankly, been doing a great job, one of the best in decades, possibly ever) abruptly resigned mid-term to “spend more time with his family.” he’s was 46, hardly “gold watch and hearty thanks” territory.

he was replaced by acting head woodcock. she has, after 2 years, still not been confirmed. this means she’s 100% politically vulnerable and can be yanked any time. so when political bosses say “jump",” she must say “how high?” or hit the bricks. ...

the FDA is and US health agencies are going to need a nose to tail rework when this is all over.

they are run by politicians, grifters, and fief builders. liars like fauci who push gain of function research (perhaps because his wife is the head of bioethics that should have reigned this in?) and then lie about it are just a symptom. this is a fully metastasized institutional cancer and it’s only going to get worse until we address it.

if you think this public health response got out of control, wait until you see what it looks like with all the good, principled scientists gone.

better still, let’s not wait. let’s make this a priority and let’s get this fixed. absolutely no one should need to see how much worse this can get.

💊 CNN ran a story this week about allegedly safe and effective FDA-approved drugs headlined, “Long-term use of certain reflux medications is associated with a higher risk of dementia, study suggests.”

Researchers found that commonly-prescribed, safe and effective drugs like Prilosec, Nexium, and Prevacid were linked to a +33% increased risk of developing dementia, according to a study published Wednesday in the journal Neurology. CNN explained:

Dr. Gregory Day, an associate professor in the Department of Neurology at the Mayo Clinic in Jacksonville, Florida, and a fellow of the American Academy of Neurology, agreed that there may be a link between PPIs and the effects on amyloid in the brain.

Day, who was not involved in the study, said proton pump inhibitors can “alter enzymes in the brain” that clear buildup of a protein in the brain called amyloid, a key component in Alzheimer’s disease.

I’m just a lawyer, and I don’t qualify for any pharma grants, but it seems to me that this study describes unanticipated, serious long-term side effects from these FDA-approved drugs. Which is so weird because I’ve been assured that the FDA’s rigorous testing standards that are totally not captured by pharma absolutely one hundred percent prevent this kind of thing from slipping through.

The FDA first approved Nexium in February, 2001. So it’s been over 20 years now. I’m starting to think the best policy might be not to take any medicine approved after the year 2000 or so. Some good newer ones might slip through the cracks but on the other hand, well, you know. Better safe than sorry.

The story made me wonder, what will we find out about the mRNA injections in twenty years? At the rate we’re going it can’t possibly be good. Now, I’m just asking, don’t cancel me.

I honestly think it would be insane for a healthy person<65 who had covid and/or multiple doses of vax to get another dose. Not just unnecessary, but probably detrimental. Sadly FDA works for Pfizer and will not ask for randomized data.

💉 Get ready, here they come! In spite of historic levels of excess deaths that mysteriously ramped up right after the modRNA shots were initially authorized, the FDA has, once again, rubber-stamped Moderna’s newest experimental modRNA shot for the Fall covid season. The Hill boosted the story in a grotesque article headlined, “Moderna’s updated COVID-19 shot shows ‘significant boost’ in antibodies against ‘Eris’ strain.”

I bet you never even heard of the Eris strain.

The FDA approved the shots based on what Moderna called “preliminary clinical trial data.” Preliminary. The ‘preliminary data’ allegedly showed a “significant boost in neutralizing antibodies against EG.5 and FL.1.5.1 variants.” Uh huh.

And so what? Antibody production has never been proven to protect anyone. It obviously doesn’t stop people from catching the disease or spreading it. It’s all based on a guess. And it says nothing, zero, zilch, nada, about safety.

But … who cares! Jabs! Whee!

Here’s the Moderna statement the FDA based its witless approval on: “These results suggest that Moderna’s updated COVID-19 vaccine may effectively target the expected circulating variants of COVID-19 during the upcoming vaccination season.”

‘May’ effectively target. May. And the jab “may” target the “expected” variant. “Expected” meaning they’re guessing. Brilliant.

I say good luck to them. It’s a pass for me. Hard pass.

Now let’s return to our regularly scheduled SADS catchup programming. Just a few more and we’re all caught up. For today.

did the pfizer vaccine even really have a drug trial?

if the process is the product (and it is) then pfizer's product looks like it went to market untested

the key sleight of hand is this:

the pfizer BNT162b2 trial was performed using a compound produced using a very different manufacturing process from the one used to create the drug that was actually shipped and sold.

it was a small batch, high cost process that could not scale to make millions much less hundreds of millions of doses. and that is a VERY big deal because in this sort of biologic, the industry axiom has been constant for 100 years: “the process is the product.” make it a different way, and you have no idea if it’s the same thing. and the FDA knows this full well; it’s been a cornerstone of their approval process since the beginning.

In my 28 minute interview with Joshua Guetzkow, senior lecturer at Hebrew University, he discusses how Pfizer/BioNTech’s biological product injected into the arms of billions, was not the same one used in Pfizer’s mRNA vaccine clinical trial. There’s been a “bait-and-switch”….

In the interview, Guetzkow also refers to the fact how the regulators were aware of the drop in the RNA integrity of the commercial batches of the Pfizer/BioNTech vaccine, compared to the clinical ones but simply lowered the standard just before emergency use authorisation was granted. ...

https://researchrebel.substack.com/p/comirnaty-or-comirnaughty

FDA shuts down enquiries about DNA contamination in covid vaccines

After months of enquiries, the FDA says it will not provide further comment on DNA contamination

The recent findings of DNA fragments in the Pfizer and Moderna COVID-19 vaccines has led many to question why the FDA, which is responsible for monitoring the quality and safety of the vaccines, has failed to sound the alarm. ...

Put simply, the FDA acknowledges the possibility that fragments of DNA left over by the manufacturing process can be incorporated into a patient’s own DNA, to potentially cause cancer.

💉 Yesterday, Fierce Pharma ran a shocking story headlined, “Cell therapy bigwigs endorse CAR-T in Nature Medicine article amid FDA safety probe.” Wait, what? Safety probe? It’s true; a whole category of cancer-fighting, “individualized” genetic treatments that the FDA previously found safe and effective are now suspected of causing cancer. Can you believe that? ...

The point is: unexpected long-term injuries from any new drugs exist, and that is probably even more true with new, high-tech genetic therapies.

Anyway, it’s a good thing the genetically-based mRNA covid shots don’t have any of these kinds of problems. Whew!

Dr Ghalili sympathizes with Bobby because of his own brush with death after being prescribed the antibiotic as a young man.

'At my worst point, I had called local cemeteries and gave my family my final wishes,' he told ABC.

Six fluoroquinolones are currently approved for use in US: ciprofloxacin, ofloxacin, gemifloxacin, levofloxacin, moxifloxacin and delafloxacin.

Some 14.8 million people were prescribed them in 2022, according to figures provided by the CDC.

Its recommended uses include: anthrax, gonorrhea, typhoid fever, complicated bacterial infections and UTIs if other treatments have failed.

The FDA has received reports of hundreds of thousands of serious adverse events associated with fluoroquinolones from more than 60,000 patients since the 1980s.

The most frequent adverse effects include tendon rupture and neurological and psychiatric symptoms.

The drug is meant to be used as a last resort, but has been overprescribed by doctors, the American Pharmacists Association said.

DEBI EVANS: Hello. Welcome everyone to UKColumn. My name's Debi Evans and I'm the Nursing Correspondent. And today I have got the most fascinating interview lined up for you. But before I tell you who it is, I want to just show you this box of tablets.

[Evans holds up a box of ibuprofen 400 mg tablets].

And I want to ask, how does this box of tablets get into my cupboard? What journey does it have to make before it's here in my cupboard?

So I am absolutely delighted to welcome Hedley Rees. Now Hedley is Managing Consultant of PharmaFlow, Ltd. He's also an amazing author and he's got an incredible Substack, so please go and look at Inside Pharma Substack. And he's been the author of many books, including Taming the Big Pharma Monster.[1]

Hedley has been in biotech and industrial engineering, logistics and supply chain industry for over 35 years. He's worked with Bayer and British Biotech to name but a few. His experience is absolutely phenomenal as is his knowledge. And so Hedley knows [again Evans holds up the box of Ibuprofen 400 mg tablets] exactly what the journey is from molecule, because that's how drugs start, from molecules, to man. How do they get to us?

So without further ado, I'd really love to welcome Hedley and ask you first off, Hedley, what actually were the red alarm bells that were, were ringing in your head that alerted you to things weren't, weren't going correctly within the distribution and the manufacturing part of what we are calling the vaccines, but we know is a gene technology.

So welcome, Hedley, and thank you so much for agreeing to join us today on UKColumn.

2:30
HEDLEY REES: Hi Debi, yes, you're very welcome and thank you for that absolutely embarrassing introduction. I would sort of say at the start, everything I say here is on my Substack. I share, most days I, I, I share different posts, so I'm glad that Debi argumented that as well.

So, so talking about paracetamol.[2] Now paracetamol is what they call a small molecule product, which means it's made using chemical synthesis. The vaccines or injections, call them what you will, are actually called biologics, which means they're made from living things. And they're very much more difficult to manufacture and, and keep safe than the small molecule products.

And to look at the journey, we have to go back to the person who first invented paracetamol, because obviously, it would have to be proven safe and effective first. And if you're going to take any compound element into your body you have to know that it's safe. You know, effective is obviously what you're aiming for, but first of all it has to be safe. And you start off with what's called a, a, a new chemical entity, well, in fact a new molecular entity it's called now because it covers both small molecules and biologics. Biologics' are very large molecules, they live in things, and, you know, they're very difficult to, to, to control.

So you have to start off with that new molecular entity, and you have to prove through preclinical testing that it's safe to be administered to humans. So the preclinical testing is in animals. It could be done in test tubes as well, and there's there's a possibility of doing it using computer simulation. It's mainly in animals. And typically the way it goes is, you make enough of the paracetamol to be able to test in animals, and thus typically about 10 to 15 kilos. It's not a huge quantity. And then you send that off to a contract testing organization, and they'll give the compound to animals, and they'll come back with a report which explains exactly how safe the drug could be in animals, and they advise as to whether you could go into trials in humans.

So typically all that takes around 3 years, the, the, the preclinical testing because you obviously have to manufacture small batch, starting from scratch, starting from raw materials, then making immediate chemicals, make the active ingredient, then make it into a drug product, into a tablet or an injection, and then, you know, and then doing the testing. So it's official US Government Accountability Office[3] data that says that preclinical testing takes 3 years on average.

Then once you've proved that it is safe to trial in humans, you apply for a license to run clinical trials. You have to explain exactly what you're going to do, what the supply chain is like, and, and you are given the license if the regulatory authority's happy with it you're given the license to progress into trials in humans.

And the first trial is Phase 1 studies. And Phase 1 really is all about healthy volunteers. You collect, you know, 50, 100 volunteers, in some sort of building where they have, you know, they're looked after, they have Game Boy and the whole thing, and they get paid for being on the study. And at the end of it you've collected all the medical data and everything else that you need to prove the drug is safe.

At this point there's not much evidence of efficacy because you're still early days. You may get some indication, but in the main, the end point for a Phase 1 study is to prove safety. If you do that you could then move in to Phase 2 studies, in people who've actually got the disease, or indication, it's typically called indication.

Now it's normally split up into Phase 2A and Phase 2B. Phase 2A is where you sort of get the dose right. You use different doses and you select the most effective dose. And the 2B study's then to study that dose in the patients. And the end point, each one of these studies has got an endpoint which has to prove what you're saying the drug does it actually does.

7:25
So if you reach the endpoint in Phase 2, you can then move into Phase 3 clinical trials. And as you move into these human trials, you have to make more drug and you have to prove again it's safe. You might make 50 to 100 kilos for the safety studies and the Phase 2 studies, but you have to go through animal testing again on that to make sure that the new manufacture is also safe, because once you scale up, you are likely, you are liable, you potentially could create what you call a polymorph. This is where the chemical structure actually changes because of the scale up. Because when you make something bigger there could be changes that you weren't predicting, so you have to test that, that new scale in animals again.

And I've had clients who have lost a drug in Phase 2 because scale up created a polymorph and they have to end, end the program. Very important because— and in the Orange Guide, the, the European Medicines rules and guidances on manufacture and distribution [4], they warn against that, and, and they say potentially the drug could either be, not work at all or it could be toxic. So. So it's always been hugely important that each time you scale up, you do more trials on, on, on safety.

And then when you go into Phase 3 to study a large number of people who've actually got the indication, you make more again, you may make 2 or 3 times the scale and then that will be used for clinical trials in Phase 3 and potentially for some launch quantities that you use for, when, when you launch. So this all takes around 11 years.

The last stage is once the, once the, the company has completed all these trials, the safety trials, it, it, its clinical data, and importantly, data on the supply chain, they have to submit what's called a common technical document to the regulators which submits all the data about the safety results, the studies, the protocols, about the clinical studies, and about the supply chain. So every single company in that supply chain has to be registered. And if the drug's approved, only that company can be used to manufacture that drug. You can't go to someone else. So when you launch a launch a drug you have to be very careful that you don't get locked in to one supplier and find yourself in, in, in difficulties.

10:24
So you then submit that common technical document to European Medicines Agency, MHRA, or FDA[5] and they typically take a year, a year and a half to go through all that documentation you submitted. And this is huge. You know, it used to be when we had files of paper, it used to be pallet loads of files that went to the regulators. It's all electronic now, but the amount of data is absolutely immense.

And typically the regulator would come back with questions. Each, each, each reviewer of the various elements, the safety, clinical, or what's called chemistry manufacturing control, which is the supply chain, they will come back with questions and say, look, you did this, explain how you think that works, and , you know, you have to explain everything. And there's this exchange of information. And eventually, you either get a refusal or you get an approval. And as I say, that takes one year to a year and a half, and this is documented by the US Government Accountability Office Report that was written in 2006. So typically you're looking about, you know, 10, 11 years.

11:39
With a biologic it could be even longer because it's a process that is so difficult. And with a novel therapy such as an mRNA vaccine, well, who knows? But 9 months or 12 months, you know, is, is a joke. It is a joke.

https://transcriberb.dreamwidth.org/150689.html

11:39
With a biologic it could be even longer because it's a process that is so difficult. And with a novel therapy such as an mRNA vaccine, well, who knows? But 9 months or 12 months, you know, is, is a joke. It is a joke.