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FDA’s New Drug Approval Process Too Slow and Complex. Usually.
A friend of mine used to do research for a pharma company. He told me of the day they sent the official application for a new drug patent to the FDA for review. At this point, they’d been working on this new drug for nearly 15 years, doing multiple long-term studies involving tens of thousands of patients in research centers worldwide. The application was enormous — five semi-trucks filled with paper. When the semis pulled out of the parking lot to drive the application to DC, everyone lifted their champagne glasses and cheered. That was 20 years ago. The process is much more complex and time-intensive now. Usually.
A new COVID vaccine was released recently. The Moderna version is supported by a research study that involved 50 patients. The Pfizer version has no human data at all — their study involved 10 mice. Neither has any efficacy data or safety data. The FDA has approved both, the CDC recommends that everyone over six months old should get these new vaccines, and the US government has already paid billions of dollars to Moderna and Pfizer for millions of doses.
While COVID remains common, it has predictably become less deadly over time. We’ve been averaging less than 100 COVID deaths per day all summer. In a country of 350 million people.
Suppose the new vaccine reduces the risk of death by half (which, of course, we don’t know, because there is no data). So we hope to reduce those deaths from 100 to 50. But to do so, we’d have to administer vaccines to nearly 350 million people.
Well, ok. But if any of the 349.999 million people who don’t benefit from the vaccine have an adverse reaction, we could be creating more disease than we are preventing. Even if the vaccines are very effective, which they might be. But we don’t know, because there is no data.
Again, I have no idea if those numbers are even close to correct.
But neither does anybody else. So how did the FDA approve these vaccines so quickly? And why?
The CDC is publicly stating that these new COVID vaccines reduce the risk of hospitalizations, prevent long COVID, and reduce the risk of spreading the disease to others. There is no evidence to support any of these claims. If Moderna or Pfizer had made such claims, the FDA would fine them hundreds of millions of dollars — it is illegal for Pharma companies to make claims that are not supported by data.
It’s ok for the CDC to do that, apparently.
I don’t understand what’s going on here. Why are the FDA and CDC doing this? It makes no sense. They’ve never done anything like this before. Approving untested drugs, which the government then buys in bulk whether anyone wants them or not. What on earth? I’ve been in this business a long time, and I’ve never seen anything like this.
I miss the days when our government tried to hide corruption. That was better.
This is unbelievable.
At least, I wish it was unbelievable. Crap.
Published in General
The US Government is addicted to imperatives. Is there a treatment program we could send them to?
My goodness that’s brilliant. I’m pissed I didn’t recognize that. That would have been a great post.
Awesome observation.
According to the largest publicly traded mortuary company, the American death rate has gone up 15% since the introduction of the VAX. Hey, we don’t have to worry about the economy anymore cuz the mortuary business is booming!
I agree.
People would be shocked at the government’s control over the financial industry.
Can we go back in time for a second? These mRNA vaccines were produced under Operation Warp Speed in record time. It was a global research effort taking millions of workhours globally. The companies involved were Johnson & Johnson, AstraZeneca. GlaxoSmithKline, Moderna, and Pfizer. Pfizer used its own money to fund the research. This concert, John Rutter conducting the Oxford Philharmonic Orchestra, was an emotional tribute and thank-you to the Oxford vaccine teams. The concert does a good job in conveying the heightened emotions of that time.
I agree with Dr. Bastiat in saying that we lack the research to support using these vaccines as widely as we have been. He’s been consistent in making this point since the vaccine was first debuted, and it has stayed with me ever since, paraphrasing, “These are new vaccines. It will take time to evaluate them. Let VAERS do its job. Wait three years.” It was a sensible thing to say at a time when we were swirling in bad or incomplete information and advice. I am a huge fan of the doctors who set up the VAERS project and database. It was a brilliant idea. We should stick with it.
But in making today’s argument against its widespread deployment as a preventive medicine strategy, we are at risk of condemning all future vaccine development that cannot wait for fifty years’ worth of research and FDA approvals. The cynicism among consumers will long outlive the current crisis.
Look at what happened with Ivermectin. That may be our future with all vaccines if we are not careful.
I am dead set against all vaccine mandates, even for kindergartners. Vaccines should be prescribed by doctors, not the government.
But I am not willing to condemn these particular vaccines or mRNA vaccines in general yet. And I think their development was an achievement the researchers can be proud of. We may need to do this again. I don’t want to wait fifty years for FDA approval.
I’m a data guy. So I share your concerns about this new flavor. But the old ones…. If you are over 50 or have some at risk health issue…it’s very clear. And I know it’s not the point of your OP, but any time I see “useless vaccines” in a comment I’m going to challenge that assertion because it just ain’t so.
Some questions I have for those who are new to the process of waking up regarding the FDA and CDC and its fast track for vaccines:
How many here realize that one of the riskiest vaccines, the Hep B vaccine, was approved after only four days of study?
How many here realize that polyethylene glycol or PEG, is one of the usual toxins found in almost every vaccine that is injected into our bodies?
Here is a recent webpage with disturbing info about just one study re: this component:
https://www.lawsuit-information-center.com/miralax-problems.html
Please note: one bit of mis-info on the above webpage is that it refers to people being allergic to Miralax, a remedy used as a laxative. That misinformation is the sentence stating that people are “allergic” to Miralax.
People are not allergic to Miralax. No one is set off by an allergy to Miralax – they are set off by their bodies normal reaction to PEG, which is an extremely dangerous item and should not be allowed to be digested or injected into our bodies.
Don’t forget: Polyethylene Glycol is made by polymerising ethylene glycol, the main ingredient in antifreeze solutions, and has a strong presence in the medical industry.
One of the problems with PEG is that the first time around, we can have it injected into our bodies and be okay with it during this initial phase of experiencing it.
https://www.news-medical.net/life-sciences/What-is-Polyethylene-Glycol-(PEG).aspx
But since it is used in personal care products such as hair color enhancers, mousse, the laxative Miralax, and of course vaccines other than the first round of COV shots, our initial exposure can involve us becoming sensitive to it.
PEG was put inside the COV vaccines. This means that there are going to be huge numbers of people developing many ailments, some of which might be cleared up if they studiously avoid all PEG containing products in the future.(Not sure this is even possible.)
But since USA’s med doctors are clueless about this type of thing, due to med educations being heavily directed by Big Pharma, most people won’t get the medical advice they need to screen products for this component before bathing in it or consuming it. (During a civil action that took place in Massachusetts regarding another toxin, a study showed we absorb more of a toxin by showering or bathing in H2O containing it than we would if drinking small amounts of it. The tense court room drama “The Civil Action” details some of this.)
Another question that should be asked about COV vaccines is this one: it came out that during one of the Moderna firm’s COVID vaccine clinical trials down in South America that a young man died. Then it was announced that this individual was inside the control group. So he had not received the the COV vaccine, but a meningitis vax as the placebo. Say what?
Scott, you are not alone in avoiding the COV vaxxes.
After all, how many people here went along with round one of the vax program, but decided after experiencing ill effects from it, that their health demanded that they avoid round 2 or 3, or on into infinity?
Excellent points all, but had to snip some for space to reply.
In mid June 2020, Gavin Newsom received his one billion dollars worth of flimsy masks via his contract with China which used state of Calif taxpayers’ monies.
So on Thursday June 25th,of that month, a mask mandate went into effect regarding banks and credit unions and other businesses.
I was physically assaulted that day. Grabbed by my shoulders & shoved into a plastic chair – not inside the building but outside it – after the assistant mgr was annoyed that I politely asked if she couldn’t take my deposit ticket w/ my check check into the credit union and bring them back to me. (State law itself demanded anyone with a handicap who was not able to wear a mask could ask for such a non-intrusive activity to occur. This angered the woman past the point of no return in a mere 45 seconds.)
I have submitted a semi-legal complaint to a local credit union regarding how people were treated for not wearing masks.
I have of course no expectations that I would be compensated for the reality that the assistant mgr assaulted me, outside the credit union building for not wearing mask. After all, this occurred on the very first day of the state-wide mandate, and it would be her word against mine. (She also assaulted another older woman like myself either a short time before or after my being shoved around.)
End of Part One
Part Two The credit union mgr phoned yesterday to state that by submitting my written statements, I created tension and fear now felt by the woman who had assaulted me. Plus I had no right to do this at this time, since what happened occurred 3 yrs ago.
I pointed out to said mgr that anyone carefully reading the two sentences I wrote would see my complaint involved matters going on in the future just as much as matters in the past.
She insisted i tell her why I made the complaint now rather than in the past.I stated that at the time of late June 2020, the COVID-will kill-us-all hysteria was in full swing, and that all public opinion seemed to be on the side of “Mr Science.”
I further stated that the tide of public opinion was turning, as so many people have lost loved ones after the vaccines were injected. (Ed Dowd has the stats on this.) And so many people experienced everything from massive amounts of acne, plus staph infections involving their nasal passages and their lungs, so it is not just the vaccine policy that is oppoed right now, but masking itself.
The manager on the phone then said “Well the jury on all of these matters will be out for a long long time.”
So I think the word is already out that we are about to experience Pandemic Number Two. Those involved inside Big Business such as banking and credit unions are already being fed the “fact” that both sides of the issue regarding COV restrictions are equally non-provable, so the public going forward must realize that to be safe, it is best to once again completely comply!
Apparently that can happen when gain of function research is used in a sketchy lab. Ask Fauci.
Now those are stories I would love to hear!
DeFronzo has been involved in the study and release and education of us grunts in the use of most of the cornucopia of new medications for type 2 diabetes that have been developed in the last 25+ years that we now have at our disposal (except that most of my patients can’t get their meds, as either their insurance refuses to cover them—one week I had 29 denials out of 30 patients—or their pharmacy has them on back order).
So we appreciate his efforts, and they have been sufficiently rewarding for him that he is able to afford those very nice Italian suits, shoes, etc that he wears.
Harrumph!
Wasn’t mRNA development already underway for years, partly to deal with vaccinations for military purposes that might need to be produced quickly? The mRNA technology has been described as an “operating system” that can be relatively easily “re-programmed” for specific situations, and much more quickly than independent treatments could be developed.
But just because it’s maybe good for THOSE situations, doesn’t mean it should be relied on more universally. And indeed, while certain risks may be acceptable in the situations that it was intended for, those risks may be unacceptable elsewhere.
Your first paragraph matches my understanding.
You’re probably right about the second.
I don’t know. The doctors on Ricochet are divided on this, if I include Kozak. And my friends are as well.
I give up.
:)
You want them to risk the life and limb of actual humans before they start using it?
Yes why in the world would our society need a system whereby diabetics can easily receive the needed meds?
We have been told for the past 3 years that our government loves us so much that each of us can receive 443 COV vaccines & boosters – without paying a dime.
But diabetes meds? The diabetic patient or the family member has to read all 185 pages of that person’s current health insurance guidebook to discover what brand to order.
After all, how can that industry keep employing people unless someone in some cubicle somewhere is not deciding that Brand X – which was covered last year – is now to be forgotten. But after it is figured out, at a cost of 8 hours of one’s life, the insured individual now realizes that Brand X can easily be replaced by Brand YZ. (Even though the tests strips and meters are basically all the same.)
Why? I guess variety is the spice of life.
During the clinical trials for the mRNA vaxxes for corona viruses, the animals did great after being injected with the product. But then due to antibody dependent enhancement, when the animals were exposed and came down with the actual corona infection, they all died.
So all that research, development and testing would have gone down the drain. Until someone somewhere came up with the realization that if a virus was released from a lab and then declared to be a pandemic creating a national emergency, the formula could be dusted off and used on everyone – or else no job, no sports events or eating out!
There is an army of pharmacy benefit managers out there getting rich intermediating between Big Pharmacy and Big Insurance to make sure whatever beneficial medications the FDA does approve do not get in to the hands of patients who need them.
Hmm. How does Big Pharmacy benefit from people NOT getting their products?
I wish I could agree. But some moms these days have been convinced that birthing and raising a baby is a dangerous business fraught by hazards. Important decisions are best left to the “experts” …
The women folk in my family come from a long line of proud breeders, and even they have to fight the circle of hell of constant blood tests and “it could be …”
It’s no wonder that a lot of women bag two and decide to never go through THAT again.
Moderna tested their updated vaccine with a clinical trial of a small set of human patients. Pfizer tested their updated vaccine with a preclinical study that used mice instead of people. …
Updated versions of vaccines do not need to go through as much testing before they’re distributed to the public because they’re so similar to past versions of their vaccines that have already gone through those intense testing phases. …
“The flu vaccine is reformulated each year, based only on animal studies for the same reason … unfortunately, we can’t wait on human data because we might not get that until November or December, well after many of us have been infected.”
https://www.khou.com/article/news/verify/vaccines-verify/florida-surgeon-general-covid-mrna-vaccine-xbb-booster-pfizer-moderna-clinical-trials-humans/536-45eef58f-1278-4118-92ca-d14a175ecc9c
In France, where massive advertising campaigns on media outlets by pharma companies are simply not allowed, the risk vs benefit situation is much more widely understood by the public.
Also the public is much better trained as far as logic, so the ridiculous statement that: “Updated versions of vaccines do not need to go through as much testing before they’re distributed to the public because they’re so similar to past versions of their vaccines that have already gone through those intense testing phases. …” would be called into question. Why? Because due to the American-court ordered details of internal Pfizer emails and documents, those of us willing to look into those revelations both here and abroad have learned how Pfizer’s initial clinical trials were frauds!
In the USA, people often lack almost in total the knowledge that each year, as a person ages, if they have left the program of annual flu jabs behind, the individual’s own anti bodies allow the person to avoid flu strains similar to a flu strain the individual has experienced before.
But those who get the annual flu jabs are forever caught up inside the damn antibody dependent enhancement cycle. This can be explained like this:
A person gets a flu jab. The vax material entrains the immune system to look for that particular flu strain,& only that one strain.
If the individual encounters a slightly different strain, the immune system lets it on through to infect the individual.
Had the person not gotten the jab, they might have gotten the flu. But usually it is not as heavy duty an infection as what the jabbed up person experiences.
On top of that, in early & mid 1980’s before vax companies were given immunity from liability for vaxxess, researchers looked into what happens to people who get the flu. Their findings revealed that people who have had a bad flu with a temp of 102 to 103 %s flush out cancer cells in their bodies. Researchers found it hard to discover any unvaxxed people who had had a bad flu who then went on to have cancer within 5 yrs of that flu.
In my neighborhood, few of us were enthused about the COV vax programs. As the fatalities after being jabbed have piled up, we remain “vax hesitant.”
Had 5 Pfizers, no ill effects and never had COVID. That’s just me, not generalizable. It has given me brand loyalty though.
I’d like the vaccine available but not mandatory, (including fed-local two step maneuvers like “CDC recommends and state agency requires following CDC.”)
Masks seldom work and don’t give return on investment except in hospitals where there’s a department to screen you, train you, and gig you if you screw up.
Anyone have an actual study on social distancing? I’m betting advocates are saying real controlled studies have never been done. My response is: if it’s that hard to control your variables, maybe reality is too messy for your intervention to be practical.
When the government lies about vaccines or Covid, it isn’t trusted. If it isn’t trusted, the vaccines might as well be useless because people won’t take them.
Dr. Bastiat . . . ahead of the pack again :) :) :)
I’m over 50, by 20 years. I’ve had covid and weathered it just fine. I see no reason to get boosters and will refuse one. I must get inside the 14 day window before my next cruise so a government mandate won’t be imposed on me. I’m cursing the Biden Administration for giving me this added worry.