The FDA is hazardous to your health.

 

Marty Makary’s recent piece on Substack detailing the data showing the inefficacy of COVID vaccines in children, that have been approved, nevertheless, for use in small children, shows how we have come full circle in at least one government agency originally set up to supposedly protect public health.

The FDA was one of the original Progressive Era agencies set up under the onslaught of campaigning, such as Upton Sinclair’s The Jungle. Outrage over unsanitary food processing (meat packing), as well as the snake oil impression of patent medicines led to the creation of the agency: protecting public health was an urgent priority of Progressive government.

Sinclair’s book was published in 1906, and Congress responded the same year with the Pure Food and Drug Act.  Regarding drugs, the idea was to verify that medications were both safe and effective before they could be unleashed on the public. From humble beginnings, the FDA has become a juggernaut with a choke-hold on the development and marketing of new medications.

So high are the costs that drug developers favor blockbuster drugs that can recoup the costs of development and FDA regulatory requirements are preferred, before patents expire. Next, the game has become patent extension by minor proprietary modification of the original drugs. Both of these cases can be illustrated by Eli Lilly’s development of Mounjaro, a “twincretin” that in premarketing studies appears to be superior to “ordinary” incretins for the treatment of type 2 diabetes and obesity, and may herald a new era of Type 2 diabetes and obesity treatment. The second case is Lilly’s attempt to supplant Humalog use with Lyumjev, a marginally more effective short-acting insulin.

With COVID vaccines, however, we are in an entirely different world. The federal government is now forcing vaccine approvals with data that do not show efficacy, let alone detail safety, strictly for political “policy” reasons that have nothing to do whatsoever with the efficacy of the vaccines nor even the supposed public health problem that is being addressed. Further, the federal government has both removed any liability for the manufacturers of the vaccines while failing to sufficiently assess safety.

Further still, the government has purchased the vaccines, leading to tens of billions of dollars of profits to the manufacturers without need to market the vaccines or do anything else. The government has illegally promulgated mandates for administering these poorly vetted vaccines. As Dr. Makary has detailed, the FDA, CDC, and NIH have all destroyed their credibility by obeying their political masters and ignoring the science. The approval process is now strictly a rubber stamp, automatically applied, at the behest of political masters.

While the pharmaceutical developers of these vaccines are not without fault, it seems to me that they are less culpable. They are allowed minimal vetting, held accountable for nothing, and guaranteed massive profits for lending their expertise as it were, to the federal government. That was an offer the drug companies couldn’t refuse.  Consider the consequences if they hewed to their usual standards of efficacy and safety and withheld ineffective products from the target recipients in defiance of their political masters:  If they did so, would they ever get anything through the FDA again? Likely not, at least not under a Progressive administration (is there really any other kind?).

So the FDA has become a tool of both exploitation and intimidation, as well as enrichment of cooperative private companies, in the service of foisting ineffective or potentially dangerous products on the public. The opposite of the supposed Progressive reasons for establishing the agency in the first place.

Rather than the title above, perhaps the title should be, Progressives are hazardous to your health. Not to mention your wealth. And happiness.

I suggest that the FDA be abolished, that the FDA, along with the NIH and CDC be dismantled and restructured as entities that have no role in public health nor in distributing research funds.

Also, a Constitutional Amendment should be passed that bars public officials, local, state, and federal, from having police powers regarding public health. (That is, that Jacobsen v. Massachusetts be eliminated, overturned, annulled, repealed, killed, to paraphrase the hired hit man in Men in Tights). They can have, perhaps, advisory powers, but even those appear suspicious, so egregious have been the actions of public officials regarding public health. Such officials are a clear and present danger to the health and prosperity of the nation.

No one, of course, will ever take such a proposal as this seriously.

One final thought:  It does appear that the public health measures taken, when there was excellent evidence that an opposite approach was the far better approach,  were intentional, not just based on either ignorance nor incompetence, and done with malice aforethought, with intent to harm the populace.  Will anyone ever be held accountable? Unlikely.

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There are 14 comments.

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  1. MarciN Member
    MarciN
    @MarciN

    How can the FDA grant approval for any drug for any child? It is illegal, immoral, and unethical to conduct medical experiments on children. I imagine that the drug companies get around that by getting the parents’ consent, but I often wonder if they first explain to those parents their guardianship duties for their children.

    • #1
  2. RushBabe49 Thatcher
    RushBabe49
    @RushBabe49

    From my email this week:

    Doctors posit that new variants of neurodegenerative conditions may be a result of the Covid vaccines.

    May I reprint your post over at RushBabe49.com?

    • #2
  3. Mark Camp Member
    Mark Camp
    @MarkCamp

    Good article! You described well the Federal Governments misdeeds and bad intentions in the COVID offensive against the people.

    As for the solution, I would support it. It might well indirectly give significant temporary relief.

    However, I believe that eliminating those current agencies will do nothing to prevent the Legislative, Executive, and Judicial branches of the Federal Government from giving the same malignant moral responsibilities and powers—and more—to themselves through bureaucracies with different names, if we the people simply continue to re-affirm their duty and authority to do so in every election.

    • #3
  4. Unsk Member
    Unsk
    @Unsk

    I suggest that the FDA be abolished, that the FDA, along with the NIH and CDC be dismantled and restructured as entities that have no role in public health. Nor in distributing research funds. 

    And that a Constitutional Amendment be passed that bars public officials, local, state, and federal,  from having police powers regarding public health.

    Yes! Absolutely!

    • #4
  5. CarolJoy, Not So Easy To Kill Coolidge
    CarolJoy, Not So Easy To Kill
    @CarolJoy

    deleted for being duplicate

    • #5
  6. CarolJoy, Not So Easy To Kill Coolidge
    CarolJoy, Not So Easy To Kill
    @CarolJoy

    So it was amazing even to lil ol’ cynical me, that to go full tilt through the whole regulatory process back in the late 1930’s would have cost the individual some 20,000 bucks. Now an individual would need Millions – and even then you most likely won’t have your remedy offered FDA approval if it threatens any Big Pharma product currently  on the market or in development.

    Plus the fact that the FDA, CDC, NIH agencies are all revolving door institutions between themselves and industry means that real science is no longer alive and well.

    We all just witnessed that over the past two years, while being told by our “regulatory agencies” that the actual remedies for COVID that have been in use for over three and four decades without any serious health problems could not be used, basically because Fauci said so. Then the corrupt “science study” was published in “The Lancet” explaining how HCQ causes heart attacks. (Which it actually did cause, because the trial participants were given the drug at two to three times a higher dose than any doctor in their right mind would ever employ! Aggravated murder charges should have been enforced against whichever Wise Guy(s) was running the protection racket for their bosses at the agency or Big Pharma!)  However when  HCQ plus zinc or ivermectin are used on foreign soil they work incredibly well against COVID.

    Meanwhile the “plaque in the brain” is what causes Alzheimer’s theory has been accepted as fact – even though there are remedies that might have been studied which ignore that theory and deal with Alzheimer’s in a different manner. Might they have worked better than what is being promoted now? Like Janet Reno used to say about other important stuff: “We’ll never ever know.”

    And I guess we don’t need to know – because it is no longer about us but about them. If the group of industry loyalists now fully entrenched and ruling at the FDA, Seedy Cee and NIH had been around at the FDA’s creation, they’d have seen to it the contaminated tins of beef that were killing off American soldiers actually should simply have had  their labels removed, with a new brand and label design imprinted on each can.

    • #6
  7. CarolJoy, Not So Easy To Kill Coolidge
    CarolJoy, Not So Easy To Kill
    @CarolJoy

    I will always remember how it was implied that all us unvaccinated folks were expected to get sick and die while all the vaccinated were supposed to not get sick.

    • #7
  8. Nanocelt TheContrarian Member
    Nanocelt TheContrarian
    @NanoceltTheContrarian

    Mark Camp (View Comment):

    Good article! You described well the Federal Governments misdeeds and bad intentions in the COVID offensive against the people.

    As for the solution, I would support it. It might well indirectly give significant temporary relief.

    However, I believe that eliminating those current agencies will do nothing to prevent the Legislative, Executive, and Judicial branches of the Federal Government from giving the same malignant moral responsibilities and powers—and more—to themselves through bureaucracies with different names, if we the people simply continue to re-affirm their duty and authority to do so in every election.

    A start could be made by reversing Chevron and Auer deference (lookin’ at you, SC) but then a wholesale dismantling of the administrative state needs to be undertaken (bad pun intended). Further such things as Social security and Medicare need to be privatized (just not in the Fannie Mae Freddy Mac method). Whole Cabinet departments need to be eliminated-education, energy, commerce, hhs,  CMS, SS, Transportation, Interior, BLM, BIA, DHS, EPA, Labor,and etc. domestic surveillance, er, I mean Intelligence,services (FBI, NSA, CIA—yes that’s not supposed to be domestic, but it is, particularly in spying on Congress). Then the few remaking cabinet departments such as Treasury, Justice, Defense need to be extensively reworked. And such entities as the Fed need to be eliminated or extensively revised.

    James Buckley’s short book on dismantling the administrative state gives good starting suggestions, in my view.

    Of course the most onerous federal agency that needs to be eliminated is the IRS. This would require that the 16th Amendment be rescinded via a new Constitutional Amendment, direct taxes abolished as per the original Constitution, and federal government income obtained via taxes on the states apportioned by population. The IRS is of course the agency that has most unbalanced the original federalist system set up by the Founders, and so vastly empowered the Central government as to make States almost non-entities. Of course the popular election of Senators contributed to that end as well, so that, for example, here in Georgia we have two far left extremists as Senators from a supposedly red state (Georgia is anything but a red state, and is so discombobulated politically that what might happen at any given time is anybody’s guess).

    Over 100 years of Progressive rot needs to be extirpated from the federal government.

    None of this will happen. Even Newt would oppose it.

    • #8
  9. Nanocelt TheContrarian Member
    Nanocelt TheContrarian
    @NanoceltTheContrarian

    RushBabe49 (View Comment):

    From my email this week:

    Doctors posit that new variants of neurodegenerative conditions may be a result of the Covid vaccines.

    May I reprint your post over at RushBabe49.com?

    Absolutely, of course, please do, be my guest, thank you!!

    • #9
  10. Brian Clendinen Member
    Brian Clendinen
    @BrianClendinen

    This is why I was always against the legalization of weed. It was always limited and not based on principles like the FDA should not even have the power in the first place to regulate it. . I would have voted for a law that put a middle finger to the FDA for any drug that might be helpful. To me, the legalized weed fight was never based on principles or reducing suffering but about having fun. I would have voted for something that included weed if it had been based on foundational principles.

    The FDA has murder way more people than any suffering they ever reduced. And it gave bad drugs legal cover and have a much higher bar for malpractice stuites.

    • #10
  11. I Walton Member
    I Walton
    @IWalton

    Can anyone name a Federal agency that is accountable to the citizens, all citizens, not  just folks  who have special interests related to the agencies’ excuses for spending.   We used to be able to name the US Department of Defense.   It wasted a lot of money, but clearly existed to defend the US.  Now what’s its role?  As some above have said, we would be much  better off if all agencies were abolished but that won’t happened under either party’s Washington establishment. 

    • #11
  12. RichardKoenig Inactive
    RichardKoenig
    @RichardKoenig

    People who have the time and interest, of whom there are very few, can look through the FDA memos to its advisory committee and discover there has been no clinical finding by Pfizer that its mRNA vaccine prevents serious illness in children. For the most part, all that Pfizer had to show was a bump-up in antibodies, even though the FDA itself has said there is no antibody correlate of protection. Do you ever wonder whether the two top vaccine reviewers at the FDA ran for the exits some time ago because they didn’t want to be parties to this nonsense? 

    • #12
  13. MarciN Member
    MarciN
    @MarciN

    RichardKoenig (View Comment):
    For the most part, all that Pfizer had to show was a bump-up in antibodies, even though the FDA itself has said there is no antibody correlate of protection.

    This has always been my understanding of the efficacy of the vaccines all along.

     

    • #13
  14. Cassandro Coolidge
    Cassandro
    @Flicker

    I Walton (View Comment):

    Can anyone name a Federal agency that is accountable to the citizens, all citizens, not just folks who have special interests related to the agencies’ excuses for spending. We used to be able to name the US Department of Defense. It wasted a lot of money, but clearly existed to defend the US. Now what’s its role? As some above have said, we would be much better off if all agencies were abolished but that won’t happened under either party’s Washington establishment.

    Here’s my predicament.  We need the CIA and the FBI.  But we need ones with members and agents who see their mission as not to purge and prosecute citizens, but protect them.

    This takes not just good character in the leadership but in the individual agents as well.  I’m not sure we have the cultural pool to reliably draw such agents any longer.

    • #14
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