Pre-marketing drug testing involves a couple years of testing in animals. Animals are dosed, and after a time interval, sacrificed, their tissues dissected and examined under a microscope for any pathology. It’s also done in pregnant animals and their offspring are examined for two generations. From what I have been able to find, Pfiz…
Pre-marketing drug testing involves a couple years of testing in animals. Animals are dosed, and after a time interval, sacrificed, their tissues dissected and examined under a microscope for any pathology. It’s also done in pregnant animals and their offspring are examined for two generations. From what I have been able to find, Pfizer did not do these studies before testing in humans and proceeding to market. We are the guinea pigs. And one of the adverse effects is a disruption in menstrual cycles among women. Why? What is going on with hormones, ovaries? Shouldn’t Pfizer be studying this? Gee, weren’t we told how safe the mRNA in a lipid nanoparticle is? Except now we read they tweaked one part of the mRNA molecule so it couldn’t be degraded easily. And now they want to inject this into my granddaughter?
Food additives like Splenda have more animal safety data than this vaccine.
Are you insane? There were more man-hours committed to development and testing of these vaccines than virtually every vaccine in history. You're using the wrong measure. Also, the vaccine literally saved lives. You know who's not around to complain about the vaccine? People who died of COVID before they could get vaccinated.
You cannot do a 2 generation repro study and a 2 yr carcingenicity study with more man hours.
Do we know whether the vaccine causes reproductive toxicity? No we don’t. Yet pregnant women were given the vaccine. And women’s menstrual cycles have been disrupted, suggesting some unexpected effect on hormones or ovaries.
Do we know whether the mRNA or its spike protein is carcinogenic? No, we don’t. It takes 2 yrs to assess that.
I also think that rushing to get the vaccine out in 2020/21 was justified given the actual crisis at hand. Now, we have a different situation. Not only do we understand more about the risks of the vaccine, we also have the data to understand the risks of getting covid across age groups and comorbidities. That data should guide decision making, not blanket mandates.
I don't know NCMaureen but I'll take a wild guess that she, indeed, is not insane.
It would be great if you can share your reference that shows that 'more man hours committed to development and testing of the covid vaccines than virtually every vaccine in history'.
I read that the animal studies were replaced with computer simulations. Any computer simulation is only as good as the data entered. Whereas animal studies produce readily observable results.
Funny you should mention Splenda. I am highly allergic to sucralose (Splenda) and the FDA was well aware of the gastric distress it causes. But did they put a warning label on the product? No they did not.
Wonder why? And now that poisonous garbage is in every food product imaginable. Try to buy a protein supplement that doesn't have it. Including protein bars etc.
Fortunately for me (considering that I have Type 1 diabetes), I have not have bad reactions to any artificial sweeteners. But I know people who do. Labeling needs to be required.
Several of these new sweeteners make me throw up, and unfortunately they are often hidden/not labeled in an informative way. They are included in regular (not diet) soft drinks in Europe to address the WHO’s anti-sugar concerns. 
I got on the anti-sugar bandwagon only to learn it is bankrolled by the artificial sweetener industry. Yes I know sugar is an inflammatory so I moderate my intake. The same thing happened with no-fat years ago and lead to mass consumption of trans fats. Think for yourselves. It is the only way to navigate the various snake pits.
My husband went through a nutrition phase two decades ago. First it was no eggs ever. That lasted 6 or 7 years. Then it was two per week. Now it’s two every morning.
Me? I’m not going to spend my life hoping some easy answer to the mystery of life expectancy is lying in a statistician’s data set. I eat what I want in moderation. The St Augustine Diet I call it
Me too. Otherwise it is like a dog chasing its tail. Additionally I think that individuals are different and one size fits all. That is probably true of this vaccine as well - it may be okay for some and very bad for others
Ugh, all artificial sweeteners are bad! I’m trying unsuccessfully to convince my fiancé to give up Coke Zero. The amount of garbage US citizens consume and call “food” is insane.
You make an excellent point! I have been in pharma R&D for my entire career - 37 yrs, and for the last 25, in Regulatory Affairs. I used to defend FDA and their high standards. Covid has changed that (as well as FDA's approval of Aduhelm, the "Alzheimer's drug" (in quotes because its a poor excuse of drug and isn't even marketed at this point). So then the question is, how can CDC list this as a recommended vaccine WHEN IT HAS NOT GONE THROUGH THE NORMAL, PAIN-STAKING, AND DEEP preclinical and clinical testing, as well as the years of CMC development? I've lost all faith, so I guess it's good I am less than a year from retiring. Makes me sad and disgusted.
The FDA and drug companies seem to have gotten way too cozy. When I was dealing with the FDA, it almost felt adversarial, and the easiest thing they could do was say, No. Now it looks like they are pressured to say, Yes with way too little data and time to digest it all. The appearance of adverse effects could halt a product, but with these vaccines, adverse effects don’t even cause a pause. They just broaden to include babies.
Abramson’s recent book “sickening” and earlier ones recount in great detail the infiltration of Pharma money into every element and phase of the medical system, including FDA, the medical journals etc since the late 1980s. What happened with Covid seems to be classic playbook.
100% agree. Every single (approved) drug has a benefit, and risks. All of the risks for these vaxes seem to have evaporated into thin air. I've worked for large, med and small companies and I have seen a LOT. And although I do think there are good scientists at FDA, frequently they are asleep at the wheel and only wake up when something is politically hot, or there's a serious side effect that's erupted. If you want your head to spin, do some research on FDA's approval of Aduhelm. The approval was so unjustified, there was a neurology group in the DC area that placed an orange sign on their door that said "if you're here to sell us Aduhelm, do not come in". How much more do you need to know?
Unfortunately, those who love big government think that the bureaucracy problem is solvable, not an inherent aspect of bureaucracy. And they TRUST bureaucracies made up of people who share their political views.
I’ve been on a few medications that worked very well for me but were pulled because some subset of patients had some side effect that wasn’t detected during approval testing. Celebrex was one.
Celebrex returned to the market after a larger subset who turned to OTC NSAIDs had higher rates of gastric bleeding.
These are complex issues requiring years to resolve.
The COVID shot fetish is going to have extensive impacts we’ve not yet even imagined.
The worst part is that the whole thing is a man made catastrophe.
My father-in-law nearly bled to death on Celebrex. I mean within minutes of graveyard dead. He was a German Lutheran living in Wisconsin - a very strong believer in authority, and under no circumstances would he buck or even question his quack physician - who was the worst I have ever seen, and I've seen a lot - who tried to put him back on it after he recovered from the radical stomach surgery that saved his life.
Dr. Scott Gottlieb went directly from heading the FDA to the board of Pfizer. He then tried to silence reporter Alex Berenson in the summer of 2021 when Berenson discovered that the Covid vaccine didn’t actually prevent transmission. He urged Twitter to ban Berenson from the platform, and generally tried to have him silenced.
Impose personal liability. Every person who suffers a negative outcome should be able to sue Gottlieb personally. Ruin him. Ruin every government official and corporate flack who was behind this.
But, but, but lawyers!!!! They are ranked down there with used car salesmen! Seriously the character assassination of lawyers through tort reform and othe Democrat policies may be where liability started to unravel.
Absent specific knowledge of the Berenson situation I’ll stipulate to your assertions. However Gottlieb had a more nuanced take which he lays out in detail in his book”Uncontrolled Spread”. Worth a read even where there is much to disagree with.
Agree! It's sad that his intelligence and knowledge has been sucked into the $$$$ vortex of board seats and DC grab-assing. The man is smart, but it's being used in the wrong way. He's a political animal out to make millions. As I've told my kids, whenever there is bad behavior or someone's moral compass is gone, guaranteed it's sex, or money....or both!
Pre-marketing drug testing involves a couple years of testing in animals. Animals are dosed, and after a time interval, sacrificed, their tissues dissected and examined under a microscope for any pathology. It’s also done in pregnant animals and their offspring are examined for two generations. From what I have been able to find, Pfizer did not do these studies before testing in humans and proceeding to market. We are the guinea pigs. And one of the adverse effects is a disruption in menstrual cycles among women. Why? What is going on with hormones, ovaries? Shouldn’t Pfizer be studying this? Gee, weren’t we told how safe the mRNA in a lipid nanoparticle is? Except now we read they tweaked one part of the mRNA molecule so it couldn’t be degraded easily. And now they want to inject this into my granddaughter?
Food additives like Splenda have more animal safety data than this vaccine.
Are you insane? There were more man-hours committed to development and testing of these vaccines than virtually every vaccine in history. You're using the wrong measure. Also, the vaccine literally saved lives. You know who's not around to complain about the vaccine? People who died of COVID before they could get vaccinated.
You cannot do a 2 generation repro study and a 2 yr carcingenicity study with more man hours.
Do we know whether the vaccine causes reproductive toxicity? No we don’t. Yet pregnant women were given the vaccine. And women’s menstrual cycles have been disrupted, suggesting some unexpected effect on hormones or ovaries.
Do we know whether the mRNA or its spike protein is carcinogenic? No, we don’t. It takes 2 yrs to assess that.
And you want babies to be given this?
I also think that rushing to get the vaccine out in 2020/21 was justified given the actual crisis at hand. Now, we have a different situation. Not only do we understand more about the risks of the vaccine, we also have the data to understand the risks of getting covid across age groups and comorbidities. That data should guide decision making, not blanket mandates.
I don't know NCMaureen but I'll take a wild guess that she, indeed, is not insane.
It would be great if you can share your reference that shows that 'more man hours committed to development and testing of the covid vaccines than virtually every vaccine in history'.
I read that the animal studies were replaced with computer simulations. Any computer simulation is only as good as the data entered. Whereas animal studies produce readily observable results.
Edited to correct the d$*n autocorrect.
I have been in pharma R&D for 37 yrs (still am) and we still do animals studies in animals...no simulations.
And I’m here to tell you code is easily manipulated.
Oh I know about upcoding. I think there was a lot during covid.
Funny you should mention Splenda. I am highly allergic to sucralose (Splenda) and the FDA was well aware of the gastric distress it causes. But did they put a warning label on the product? No they did not.
Wonder why? And now that poisonous garbage is in every food product imaginable. Try to buy a protein supplement that doesn't have it. Including protein bars etc.
Fortunately for me (considering that I have Type 1 diabetes), I have not have bad reactions to any artificial sweeteners. But I know people who do. Labeling needs to be required.
Several of these new sweeteners make me throw up, and unfortunately they are often hidden/not labeled in an informative way. They are included in regular (not diet) soft drinks in Europe to address the WHO’s anti-sugar concerns. 
I got on the anti-sugar bandwagon only to learn it is bankrolled by the artificial sweetener industry. Yes I know sugar is an inflammatory so I moderate my intake. The same thing happened with no-fat years ago and lead to mass consumption of trans fats. Think for yourselves. It is the only way to navigate the various snake pits.
Wow I had not realized that, good to know.
My husband went through a nutrition phase two decades ago. First it was no eggs ever. That lasted 6 or 7 years. Then it was two per week. Now it’s two every morning.
Me? I’m not going to spend my life hoping some easy answer to the mystery of life expectancy is lying in a statistician’s data set. I eat what I want in moderation. The St Augustine Diet I call it
Me too. Otherwise it is like a dog chasing its tail. Additionally I think that individuals are different and one size fits all. That is probably true of this vaccine as well - it may be okay for some and very bad for others
.
I tell my husband each of us will die eventually. No I don’t want to die today (yet, just started PT so give it time!) but one day.
Life is too short to spend it denying oneself life’s small pleasures in hopes the denial *might* give one an extra 48 hours on the planet.
Ugh, all artificial sweeteners are bad! I’m trying unsuccessfully to convince my fiancé to give up Coke Zero. The amount of garbage US citizens consume and call “food” is insane.
My holistic doc just told me that Stevia - the natural, plant-derived sweetener - is bad too. Apparently it harms gut bacteria.
I’ve heard recently too that Stevia is no good. Bottom line for me is real sugar but only a little of it.
You make an excellent point! I have been in pharma R&D for my entire career - 37 yrs, and for the last 25, in Regulatory Affairs. I used to defend FDA and their high standards. Covid has changed that (as well as FDA's approval of Aduhelm, the "Alzheimer's drug" (in quotes because its a poor excuse of drug and isn't even marketed at this point). So then the question is, how can CDC list this as a recommended vaccine WHEN IT HAS NOT GONE THROUGH THE NORMAL, PAIN-STAKING, AND DEEP preclinical and clinical testing, as well as the years of CMC development? I've lost all faith, so I guess it's good I am less than a year from retiring. Makes me sad and disgusted.
There is too much money to be made.
The FDA and drug companies seem to have gotten way too cozy. When I was dealing with the FDA, it almost felt adversarial, and the easiest thing they could do was say, No. Now it looks like they are pressured to say, Yes with way too little data and time to digest it all. The appearance of adverse effects could halt a product, but with these vaccines, adverse effects don’t even cause a pause. They just broaden to include babies.
Abramson’s recent book “sickening” and earlier ones recount in great detail the infiltration of Pharma money into every element and phase of the medical system, including FDA, the medical journals etc since the late 1980s. What happened with Covid seems to be classic playbook.
100% agree. Every single (approved) drug has a benefit, and risks. All of the risks for these vaxes seem to have evaporated into thin air. I've worked for large, med and small companies and I have seen a LOT. And although I do think there are good scientists at FDA, frequently they are asleep at the wheel and only wake up when something is politically hot, or there's a serious side effect that's erupted. If you want your head to spin, do some research on FDA's approval of Aduhelm. The approval was so unjustified, there was a neurology group in the DC area that placed an orange sign on their door that said "if you're here to sell us Aduhelm, do not come in". How much more do you need to know?
Don't most sentient beings understand that large, unwieldy bureaucracies are not effective?
Unfortunately, those who love big government think that the bureaucracy problem is solvable, not an inherent aspect of bureaucracy. And they TRUST bureaucracies made up of people who share their political views.
The same people want the entire US medical system run by a bureaucracy.
Unfortunately common sense is rare.
I’ve been on a few medications that worked very well for me but were pulled because some subset of patients had some side effect that wasn’t detected during approval testing. Celebrex was one.
Celebrex returned to the market after a larger subset who turned to OTC NSAIDs had higher rates of gastric bleeding.
These are complex issues requiring years to resolve.
The COVID shot fetish is going to have extensive impacts we’ve not yet even imagined.
The worst part is that the whole thing is a man made catastrophe.
My father-in-law nearly bled to death on Celebrex. I mean within minutes of graveyard dead. He was a German Lutheran living in Wisconsin - a very strong believer in authority, and under no circumstances would he buck or even question his quack physician - who was the worst I have ever seen, and I've seen a lot - who tried to put him back on it after he recovered from the radical stomach surgery that saved his life.
Yeah I learned a long time ago to be my own medical advocate!
For reasons unknown, probably genetic, some people react very badly to Celebrex. Others like me rely upon it.
Ultimately any pharmaceutical can have unexpected results in individuals.
The question is how many, how bad and all the other components of cost/benefit analysis.
Glad your FIL came out okay on the bad end of a drug reaction!
Dr. Scott Gottlieb went directly from heading the FDA to the board of Pfizer. He then tried to silence reporter Alex Berenson in the summer of 2021 when Berenson discovered that the Covid vaccine didn’t actually prevent transmission. He urged Twitter to ban Berenson from the platform, and generally tried to have him silenced.
Impose personal liability. Every person who suffers a negative outcome should be able to sue Gottlieb personally. Ruin him. Ruin every government official and corporate flack who was behind this.
But, but, but lawyers!!!! They are ranked down there with used car salesmen! Seriously the character assassination of lawyers through tort reform and othe Democrat policies may be where liability started to unravel.
I’m reminded of an old lament among design professionals -
“engineers get sued for their mistakes, doctors bury theirs”
Absent specific knowledge of the Berenson situation I’ll stipulate to your assertions. However Gottlieb had a more nuanced take which he lays out in detail in his book”Uncontrolled Spread”. Worth a read even where there is much to disagree with.
Agree! It's sad that his intelligence and knowledge has been sucked into the $$$$ vortex of board seats and DC grab-assing. The man is smart, but it's being used in the wrong way. He's a political animal out to make millions. As I've told my kids, whenever there is bad behavior or someone's moral compass is gone, guaranteed it's sex, or money....or both!
Sociopaths come in all shapes and forms. Not all are murderers. I used to work for one.