The FDA and the Greatest Grift

 

Safe and effective are terms that should not be debatable but here we are. Recently the FDA has approved the use of the reformulated MRNA vaccines, which they are calling bivalent vaccines. These new versions have been modified to contain a more omicron-specific antibody. Since they are using the same manufacturing process, the powers at be feel comfortable pushing ahead with this product despite a lack of human trials.

Strangely enough after approval of the new versions, word came down that the older versions could no longer be given legally as a booster; which is quite the pivot. Availability of the new products has been haphazard; we quickly used all the Moderna that we were given and had only Pfizer for a while. Most patients who desire it have no problem mixing and matching after all the products are so similar that Moderna is currently suing Pfizer for patent infringement.

Rushing another product to market while stating there is no time for trials certainly raises a few eyebrows. Clearly you would not need to reformulate it if any of the original claims held up. The vaccine narrative has shifted from the ironclad “you cannot get Covid if you are vaccinated” to the arguable “well, trust me, it would have been worse without it.” The most disturbing part of this entire fiasco is that we have given millions of doses of an experimental product and have no control to compare the results to. Even in the trials, the threat of the virus was deemed so high that it was unethical to even continue the control group. From a research perspective, it is impossible to explain how great this sin was, and it will keep graduate students busy for a long time to come.

If you had spoken with me prior to Covid, you would have found no fan of the FDA. It is a bloated, bureaucratic organization filled with doctors who do not practice and are instead paid obscene amounts of money to promulgate excessive rules and regulations that stand in the way of novel treatments and therapies. For most of my life, the FDA was far too conservative, in my opinion, when it came to approving new products. This did not happen by accident. There are good historical reasons why the FDA would err on the side of caution with loads of regulations stacking up over the years only to be ripped off like a band-aid due to the ongoing national emergency declaration.

The most well-known is thalidomide, the notorious drug given for morning sickness all around the world that would cause widespread and horrific birth defects. In the only bright spot in history for the FDA, thalidomide would not be approved for morning sickness. While the organization has taken credit for this over the years, the truth is that the decision not to approve the drug was due to a single employee Frances Oldham Kelsey and a stroke of luck. She would bravely stand up to the drug company Richardson-Merrill which was infuriated that she would hold up their drug that had already received approval in forty countries.

Kelsey had read about neurological toxicity in adults taking the medication in the British Medical Journal and correctly had legitimate concerns about how this toxicity would present itself in the fetus of a pregnant woman. To defend themselves, the company pointed out that it was certainly safer than barbiturates which were already approved. The antagonistic relationship between Kelsey and the drug company back then stands in stark contrast to our present situation, where the FDA co-owns the patent and is less a regulator and more a business partner.

So, what was the stroke of luck? This was only the second approval her team was assigned, which fortunately left enough time for her to review and deny the application. Kelsey would admit in her memoirs that, as work would pile up, many drugs would be automatically approved simply because they were unable to review them in the allotted two-month period! Ironically, thalidomide would eventually receive FDA approval in 1998 because it is quite safe when you are not pregnant and has other uses.

Dr. Kelsey would be hailed as a hero and given the President’s Award for Distinguished Federal Civil Service in 1962. Legislation would be passed that assured no drug would be sold without first obtaining the agency’s approval. Kelsey would be first put in charge of the Investigational Drug Branch and later would develop the Division of Scientific Investigations, which was tasked with inspecting clinical sites for integrity. She would pass away at the ripe old age of 101 in 2015; thankfully, before she could live long enough to see her life’s work simply disregarded.

The MRNA vaccines, like many other therapies, are great tools that we have unfortunately used with the finesse of a monkey with a hand grenade. Like opiates and benzodiazepines, their overuse has created a set of unique problems and concerns. Hormone blockers like Lupron are interesting drugs that, in saner times, the general public would not even know existed. Instead its use is trending in teenage girls. The story is always the same and the “let no crisis go to waste” mantra applies here because this emergency has allowed for the removal of safety regulations that lobbyists could only dream of.

Jacob Hyatt Pharm D.
Father of three, Husband, Pharmacist, Realtor, Landlord, Independent Health, and Medicine Reporter
https://substack.com/discover/pharmacoconuts

hyattjn@gmail.com

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www.jeffersongroverva.com

Further Reading and References

https://www.govinfo.gov/content/pkg/CHRG-106hhrg73042/html/CHRG-106hhrg73042.htm

https://www.bbc.com/news/health-62691102

https://www.npr.org/sections/health-shots/2022/08/18/1117778748/whats-behind-the-fdas-controversial-strategy-for-evaluating-new-covid-boosters

https://www.uchicagomedicine.org/forefront/biological-sciences-articles/courageous-physician-scientist-saved-the-us-from-a-birth-defects-catastrophe

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  1. OmegaPaladin Moderator
    OmegaPaladin
    @OmegaPaladin

    One thing you might want to write about is the FDA’s reaction to a particular COX-2 inhibitor that was safe when taken according to the FDA guidelines.  Incidents occurred where physicians prescribed it off-label or for other dosing schedules, which got the FDA bureaucrats really steamed.  They trusted doctors a lot less after that.

    The problem for a lot of regulatory agencies is that they have only one incentive normally – prevent blowback from a regulatory failure.  This is why basically no new reactor designs have been approved by the NRC, even the proved CANDU used in Canada for decades with an excellent record. 
    With  the vaccine, they are now being pressured to keep a supply of a better vaccine in the pipeline.

    • #1
  2. Annefy Member
    Annefy
    @Annefy

    OmegaPaladin (View Comment):

    One thing you might want to write about is the FDA’s reaction to a particular COX-2 inhibitor that was safe when taken according to the FDA guidelines. Incidents occurred where physicians prescribed it off-label or for other dosing schedules, which got the FDA bureaucrats really steamed. They trusted doctors a lot less after that.

    The problem for a lot of regulatory agencies is that they have only one incentive normally – prevent blowback from a regulatory failure. This is why basically no new reactor designs have been approved by the NRC, even the proved CANDU used in Canada for decades with an excellent record.
    With the vaccine, they are now being pressured to keep a supply of a better vaccine in the pipeline.

    Pressured by whom ?

    • #2
  3. TempTime Member
    TempTime
    @TempTime

    Annefy (View Comment):

    OmegaPaladin (View Comment):

    One thing you might want to write about is the FDA’s reaction to a particular COX-2 inhibitor that was safe when taken according to the FDA guidelines. Incidents occurred where physicians prescribed it off-label or for other dosing schedules, which got the FDA bureaucrats really steamed. They trusted doctors a lot less after that.

    The problem for a lot of regulatory agencies is that they have only one incentive normally – prevent blowback from a regulatory failure. This is why basically no new reactor designs have been approved by the NRC, even the proved CANDU used in Canada for decades with an excellent record.
    With the vaccine, they are now being pressured to keep a supply of a better vaccine in the pipeline.

    Pressured by whom ?

    Pfizer.

    • #3
  4. Mad Gerald Coolidge
    Mad Gerald
    @Jose

    It’s amazing that the mRNA vaccine was so bad that the CDC changed it’s definition of “vaccine”.

    As CNSNews.com reported on May 4, 2021, the CDC at that time defined vaccination as “The act of introducing a vaccine into the body to produce immunity to a specific disease.”

    But that definition has changed over time. The CDC website now defines vaccination as “the act of introducing a vaccine into the body to produce protection from a specific disease.”

    • #4
  5. Fritz Coolidge
    Fritz
    @Fritz

    I have had some 20 years of annual flu shots, starting when a family member was undergoing chemotherapy.

    But now the whole covid madness has so distorted the FDA and the CDC that I wonder how to trust even a flu vaccine again. Will new ones secretly be stealth mRNA formulations? If so, I would decline the shot, but how to know whether a claim the vaccine is not based on mRNA is true or not? I cannot trust either bureaucracy to be on the level. (And did not take the covid shots either). May take my chances instead. What are others thinking about this issue?

    • #5
  6. Mad Gerald Coolidge
    Mad Gerald
    @Jose

    Fritz (View Comment):

    I have had some 20 years of annual flu shots, starting when a family member was undergoing chemotherapy.

    But now the whole covid madness has so distorted the FDA and the CDC that I wonder how to trust even a flu vaccine again. Will new ones secretly be stealth mRNA formulations? If so, I would decline the shot, but how to know whether a claim the vaccine is not based on mRNA is true or not? I cannot trust either bureaucracy to be on the level. (And did not take the covid shots either). May take my chances instead. What are others thinking about this issue?

    I don’t trust the health system bureaucracy either. Flu shots were mandatory in the military, and then when I worked in health care, but I have no plans to get them in the future.

    • #6
  7. Flicker Coolidge
    Flicker
    @Flicker

    Fritz (View Comment):

    I have had some 20 years of annual flu shots, starting when a family member was undergoing chemotherapy.

    But now the whole covid madness has so distorted the FDA and the CDC that I wonder how to trust even a flu vaccine again. Will new ones secretly be stealth mRNA formulations? If so, I would decline the shot, but how to know whether a claim the vaccine is not based on mRNA is true or not? I cannot trust either bureaucracy to be on the level. (And did not take the covid shots either). May take my chances instead. What are others thinking about this issue?

    I agree now too.

    • #7
  8. Scott Wilmot Member
    Scott Wilmot
    @ScottWilmot

    Fritz (View Comment):

    What are others thinking about this issue?

    I have not ever had a flu shot and will never take one. Same with the coof. The drug companies do not care about your health – they only want your money.

    • #8
  9. Roderic Coolidge
    Roderic
    @rhfabian

    Ivermectin and hydroxychloroquin would never pass muster with the standards you guys want to apply to the COVID vaccines.  Neither would any of the vaccines that have been used to prevent disease in history.

    There are well done, credible clinical trials that show no efficacy in the treatment of COVID for both hydroxychloroquin and ivermectin, but you either don’t know about these or ignore them.  

    We know that the vaccines for polio work because they essentially wiped that disease out in the US, but then everyone got their vaccines without conspiracy theories stopping them back in the 1950s.

    By the same token we know the vaccines for COVID work for those who took them.  The data, correctly analyzed, is quite clear about that.

    • #9
  10. Fritz Coolidge
    Fritz
    @Fritz

    Roderic (View Comment):

    Ivermectin and hydroxychloroquin would never pass muster with the standards you guys want to apply to the COVID vaccines. Neither would any of the vaccines that have been used to prevent disease in history.

    There are well done, credible clinical trials that show no efficacy in the treatment of COVID for both hydroxychloroquin and ivermectin, but you either don’t know about these or ignore them.

    We know that the vaccines for polio work because they essentially wiped that disease out in the US, but then everyone got their vaccines without conspiracy theories stopping them back in the 1950s.

    By the same token we know the vaccines for COVID work for those who took them. The data, correctly analyzed, is quite clear about that.

    Maybe, but (1) the covid shots are all still only under an Emergency Use  Authorization, (2) the first human clinical trials (other than the population walking around having been vaxxed) will not be complete until sometime in 2023, and (3) the majority of people currently getting infected seems to fall well within the groups most vaccinated, like the Pfizer CEO, quadruple-vaxxed and just reported infected yet again. Oh, and (4) the pharmaceutical companies cannot be held accountable because the only immunity around is legal — theirs.

    So skepticism is not a conspiracy theory, it is a normal response. 

    • #10
  11. Scott Wilmot Member
    Scott Wilmot
    @ScottWilmot

    Roderic (View Comment):

    Ivermectin and hydroxychloroquin would never pass muster with the standards you guys want to apply to the COVID vaccines. Neither would any of the vaccines that have been used to prevent disease in history.

    There are well done, credible clinical trials that show no efficacy in the treatment of COVID for both hydroxychloroquin and ivermectin, but you either don’t know about these or ignore them.

    We know that the vaccines for polio work because they essentially wiped that disease out in the US, but then everyone got their vaccines without conspiracy theories stopping them back in the 1950s.

    By the same token we know the vaccines for COVID work for those who took them. The data, correctly analyzed, is quite clear about that.

    If the coof shots worked why are we on jab/booster #5 or 6? And why do we always see the blue-checks say I’ve been jabbed fully but have the coof? And why am I still paying with my tax dollars for this garbage “vaccine”?

    • #11
  12. Annefy Member
    Annefy
    @Annefy

    Roderic (View Comment):

    Ivermectin and hydroxychloroquin would never pass muster with the standards you guys want to apply to the COVID vaccines. Neither would any of the vaccines that have been used to prevent disease in history.

    There are well done, credible clinical trials that show no efficacy in the treatment of COVID for both hydroxychloroquin and ivermectin, but you either don’t know about these or ignore them.

    We know that the vaccines for polio work because they essentially wiped that disease out in the US, but then everyone got their vaccines without conspiracy theories stopping them back in the 1950s.

    By the same token we know the vaccines for COVID work for those who took them. The data, correctly analyzed, is quite clear about that.

    I would like to see that data, and then I would like an explanation of the conclusion explained.

    Because there seems to be no rhyme or reason whether it “works” or not. And the fact that I put “works” in scare quotes, and everyone knows why, is an indication that something is not quite right.

    I know an unvaxxed gentleman in his 90s, with a myriad of underlying conditions; he recovered from Covid with no problem. On the other hand, a four-times-jabbed peer (early 60s in good health) just spent two weeks in bed with Covid.

    I would appreciate it if you could explain how and why the “vaccines for Covid” work.

    Edited to add: And I wonder where the data is coming from? Most of the people I know now who are testing positive are testing themselves, and treating themselves sans any prescriptions, without any interaction with a doctor. So how does anyone even know who is testing positive, who is testing positive multiple times, and whether these people are not jabbed, twice jabbed, thrice jabbed, or four times jabbed?

    Is it just the people who require hospitalization who are being tracked?

    • #12
  13. Mad Gerald Coolidge
    Mad Gerald
    @Jose

    Biologists Bret Weinstein and Heather Hying discuss the widely publicized Together Study which is widely held to have shown that Ivermectin was ineffective.  However there were inconsistencies with how the study was conducted.  Apparently the placebo group was tracked for a different length of time, and while that may be insignificant, it is poor research.

    https://odysee.com/@DarkHorsePodcastClips:b/confusing,-delayed,-and-unclear-together:9

    Also discussed by Weinstein,  is that the Ivecmectin group was given low doses that would certainly negate any effectiveness.  I’m not going to listen to all his podcasts again to find it, but it may be here (if not still worth listening to):

    https://odysee.com/@DarkHorsePodcastClips:b/dosing-and-weight-limit-anomaly-on:3

    Also, political pressure:

    https://odysee.com/@DarkHorsePodcastClips:b/together-trial-principal-investigator:a

     

     

    • #13
  14. Annefy Member
    Annefy
    @Annefy

    Mad Gerald (View Comment):

    Biologists Bret Weinstein and Heather Hying discuss the widely publicized Together Study which is widely held to have shown that Ivermectin was ineffective. However there were inconsistencies with how the study was conducted. Apparently the placebo group was tracked for a different length of time, and while that may be insignificant, it is poor research.

    https://odysee.com/@ DarkHorsePodcastClips:b/confusing,-delayed,-and-unclear-together:9

    Also discussed by Weinstein, is that the Ivecmectin group was given low doses that would certainly negate any effectiveness. I’m not going to listen to all his podcasts again to find it, but it may be here (if not still worth listening to):

    https://odysee.com/@ DarkHorsePodcastClips:b/dosing-and-weight-limit-anomaly-on:3

    Also, political pressure:

    https://odysee.com/@ DarkHorsePodcastClips:b/together-trial-principal-investigator:a

     

     

    I am 100% incapable of analyzing data and studies and have therefore had to rely on people I trust. Bret and Heather have been honest commentators throughout this entire debacle.

    Regardless, I can’t think of one honest reason why there was such a full-court press against Ivermectin and Hydroxy. I really don’t care if they work or not, or sometimes work, since there is little risk to taking either drug. I’d happily take both or either were I suffering. And it’s not like the CDC or anyone else was offering an alternative.

    When Joe  Rogan announced his successful treatments for Covid, Ivermectin was one of a long list of treatments. But everyone lost their minds over Ivermectin, including the CDC with their ridiculous tweet “You are not a horse. You are not a cow. Seriously, y’all. Stop it.”   

    Why?

    I can think of a lot of reasons, but none of them are honest.

    I’ll never believe the CDC or the medical establishment again. And my family is now re-thinking vaccine schedules for their children. Wisely, I’d say.

    • #14
  15. JacobHyatt Coolidge
    JacobHyatt
    @JacobHyatt

    OmegaPaladin (View Comment):

    One thing you might want to write about is the FDA’s reaction to a particular COX-2 inhibitor that was safe when taken according to the FDA guidelines. Incidents occurred where physicians prescribed it off-label or for other dosing schedules, which got the FDA bureaucrats really steamed. They trusted doctors a lot less after that.

    The problem for a lot of regulatory agencies is that they have only one incentive normally – prevent blowback from a regulatory failure. This is why basically no new reactor designs have been approved by the NRC, even the proved CANDU used in Canada for decades with an excellent record.
    With the vaccine, they are now being pressured to keep a supply of a better vaccine in the pipeline.

    My grandmother took that particular product when it was still available and she did pass away from a heart attack so that one stings in particular

    • #15
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