• Adulteration of Vaccine Safety and Efficacy

    July 15, 2023
    9 Comments

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    The preamble for the FDA for many decades was: “The importance to the American Public of safe and effective vaccines cannot be understated.”

    Over the previous century drug laws for vaccines became more and more stringent, until the US government and DoD was found guilty of violating US law and treating US troops as “guinea pigs.” In 2003 the government suffered injunctions for using their DoD patented anthrax vaccine in an investigational and unapproved manner, illegally, without our troop’s prior consent.

    Beginning in 1906 with the Pure Food and Drugs Act, followed by the establishment of the Federal Food Drug and Cosmetic Act in 1938, the addition of the Kefauver-Harris amendment efficacy requirements in 1962, and finally the transfer of vaccine regulation to the FDA in 1972, every step in the historic regulatory record sought to provide increasing proof of safety and effectiveness for vaccines offered to the American public.

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    The ever-increasing stringency of vaccine regulation changed, was adulterated, in 2005 with the first-ever application of the Emergency Use Authorization (EUA) for the DoD’s anthrax vaccine. The DoD’s workaround to the injunction was to offer the anthrax vaccine on a strictly voluntary basis, which was documented in the Federal Register. Was it acceptable to create a new, lower standard for vaccines? Yes, according to our Congress, but with the express proviso that the government follow the law.

    The Federal Register entry could not be clearer. There would be “no penalty,” and no loss of benefits or entitlements, no job loss, and no punishments for declining administration of an investigational unapproved EUA medical product. This was the precedent application of the very first use of an EUA, because the law does not allow mandates of EUA products.

    The US government created EUA law to provide a new “lower level of evidence,” “may be effective,” and “reasonable to believe” standard for vaccines provided to the American public in times of a public health emergency. But both Title 10 law, section 1107a, and laws for all citizens under Title 21, section 360bbb-3, made clear everyone had the prior consent right and “option to accept or refuse” the administration of these new, lesser known benefit vs. risk EUA products.

    If it was not concerning that the US government diluted the laws pertaining to vaccines, it should be concerning that they then broke that law when announcing COVID vaccine mandates for large employers, federal employees, and contractors considering the only available products were indeed EUAs. The government added to the gargantuan fraud by re-issuing EUAs for COVID vaccine at the same time they “approved” an unavailable vaccine. Ultimately, all mandates were either declared illegal by the Supreme Court, and other Federal courts, or were ultimately rescinded by the President.

    Though the government initially made the argument that mandates and “consequences” were permissible according to a Department of Justice memo, the illiterate attempt to deceive the American people defied the express context of 21 CFR 50.25 and the 2005 Federal Register precedent for anthrax vaccine. Those federal regulations and precedents clearly prove “consequences” are strictly medical in nature and that the administration of investigational unapproved medical products are strictly voluntary.

    It’s vitally important Americans understand that mandates were patently illegal, both for our troops and all citizens. The core law and precedent supported the voluntary nature of EUA COVID countermeasure and vaccine programs. The government willfully ignored and violated the law and encouraged subordinate state, local and private entities to do the same.

    Once our citizens and Congress digest the enormity of the fraud perpetuated, we must strive to return to the preamble of the FDA and insist on proven safe and effective vaccines for our country. Dilution of laws, while permitted, cannot coexist with a simultaneous abrogation of established medical rights upheld by the same laws. Rather than ‘moving beyond’ the COVID vaccine mandates, our government should be correcting the damage inflicted on our people.

    It’s ‘reasonable to believe’ that returning to the original, unadulterated FDA standard of proven safe and effective vaccines would be healthy for our government public health officials. Reflecting on the history of vaccine regulation and resurveying the lowering of standards also ‘may be effective’ in restoring the public’s trust.

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    Johnny Dangereaux

    How about we eliminate the FDA NIH CDC and all those that screwed us all over?
    We don't need "reform" we need an enema!

    R.Baker

    May I first say that I find it very refreshing to find a publication in Colorado once again that doesn't write every word from somewhere waaaaaay away out in left field? I had honestly given up on being able to read about CO- based issues without a liberal bias, and just last week cancelled my Tribe subscription. Ever since the Denver Post took the helm, it has been trying to export the crazy Denver mindset to Greeley and environs, and lost ever more subscribers as a result.
    As to your assertion that returning to the old policies by the FDA might restore faith in th e institution once more, I have to tell you that I believe that you're being unrealistically optimistic. Many of us,including and perhaps e specially those of us with backgrounds in medical care professions were growing suspicious of the FDA and their recommendations long before the planet tipped off of its axis and became unrecognizable. Too many of our real-world experiences were just not corresponding with the official expectations / projected outcomes, for one. Any questions or attempts to re-examine the methodologies or results were met with resistance. That's not the scientific way. Then, with the succession of lies they told us regarding the pandemic, the eagerness with which they embraced their enhanced abilities to assert control and the hesitancy to release it again; The insistence that no voice of dissent or argument be allowed, nor meaningful discussion of alternative therapies or treatments; Acting as if every human in the country was not as smart as they, and could not make devisions for themselves any longer but must be treated like willful children; Treating our medical professionsls and researchers as if all of their education and experiences were so much garbage and threatening their licensure and livelihoods when/if they dared to do what their logic advised them to in order to save their people; The unapologetic attitudes after so many lies and so much destruction; And of course, the recent admissions by upper management types that the pharmaceutical companies have never done any of the safety studies required by law prior to requesting certifications for vaccines now permanently mandated into our childrens' bodies for the foreseeable future; And failure to meet many to most of their responsibilities required under the vaccine immunity agreement they've been using as cover for decades... I don't think anyone who's been paying attention will ever find them trustworthy again. I personally don't even know anyone who'd be willing to give them a chance. And as they're a part of the upcoming WHO-UN attempt to seize worldwide control over all governments through an unspecified future "catastrophic event", defined by themselves of course and without any oversight or recourse if (or should I say," when") they abuse the ability, I don't believe that the FDA even deserves to continue receiving federal funding any longer. I'll mention here that I get most of my information regarding this issue from scientific white papers. There are an infinite number being published all of the time,as researchers are always publishing their data and conclusions, or peer-reviewing some other colleague's work There's so very much information if you just look,. Perhaps the best solution would be to simply de-charter the whole FDA agency and create it anew, but with much stricter checks and restraints upon the 'new' agency,in order that such cavalier treatment of human lives & medical sovereignty cannot ever be attempted again.

    Jim Zietlow

    The point of this article is to discuss the key laws broken used to implement mandating these illegal injections. Only if the actions and key organizations are identified and challenged is there a chance for change. Otherwise history is likely to reoccur.

    Mr_Yesterday

    The more pertinent question; What gave these people constitutional authority to have control over our bodies in the first place?

    The answer; They never had the authority to begin with.

    You know, when the FDA was initially being formed more than a century ago to combat literal snake oil salesmen, many practitioners warned of it's eventual demise. Clearly understanding as I have detailed in my longer post above, how all government systems are far more susceptible to corruption than standard free market forces. Something went wrong because the only things FDA does approve these days is snake oil. Honest free market competition which benefits the public is just railroaded right out of the building these days. The very last place we turn to for any advisement is the government.

    Jim Zietlow

    Mr. Yesterday. What happened to the doctor patient relationship? Most of us know Life, Liberty and the Pursuit of Happiness involves making our own health care decisions. Millions of Americans took the injections and have injuries, died or worry whether they will have significant side effects like cancer, neurological or heart problems. With 17% booster uptake, the public has decided whether to (NOT) trust the FDA "science". Jim

    Mr_Yesterday

    Shoot, that particular aspect of medical care has been absent at the major hospitals for decades. Insurers and financially focused administration bodies run the show now. They prescribe how many patients everyone sees, how frequently, what is or what is not on the menu for various health dispositions. Basically, if there is no code in the system to enter, that is not an acceptable disposition choice for the doctor. Patients are dollar signs on a conveyor belt which runs at a certain speed and shall never slow down. See patient. Identify something able to be diagnosed. Prescribe medications. Like clockwork, that's how it goes down. Myself, being generally apprehensive about medical offices, am constantly 'diagnosed' with OCD, on account of being generally nervous and stand off ish with medical staff. They're always asking me to tattle on myself and honestly disclose how many beers and cigarettes or what not I'm personally consuming on a daily basis. 'You know, been cutting back lately...' Then whatever number they throw out, sure sounds about right. The point being, because they have limited time and really don't care about anything other than their own performance stats to diagnose then prescribe, I never really get anywhere in terms of documenting major physiological issues. Picture the time at a drive through window for fast food, understanding there is a constant quota to deliver the food in under so many minutes time. Absolutely no different at hospitals. The Dr Patient relationship was severed, when patients started paying insurers and bloated administrative staff, rather than handing money to the doctor and/or one of his direct employees. I mean, even the staff, the doctors no longer are in charge of who is hired and who is not. Not in the big box hospitals at least. Again, insurers run the show now and the patient experience is no different than a scene from fight club, a cost benefit vs loss and liability analysis. Highest medical care costs in the world, and an ever falling decreasing outcome. That's 'not for profit' health care for you. A family member had a stroke, and the official total cost of care bill was $400k or there abouts. Thankfully we have 100% covered insurance but that's inconsequential. If we had less insurance, the number would have been lower. The shell game of care costs being routed through admin and their puppet partner insurer agents. One can positively identify the corruption at any medical service provider, by simply asking up front questions on exact costs ahead of time. It would take a miracle to get an honest answer, prior to furnishing your insurance data. Because the answer for costs, is always relative to your insurance. If you want a reasonable doctor patient relationship, first one needs to establish the insured insurer relationship ahead of time. People be arguing about socialized health care. Newsflash; We're already there.

    B Seidem

    Vaccines do not work. A virus has never been seen. Read "Virus Mania", 2020 and get the unvarnished truth. Will never trust gov, health agencies, or doctors again. $$$$$$$ are their god. All that is left is the guillotine.

    Sargent Pepper

    The pharma phuckers experimented on us with bio weapons with the assistance of gov. Just like they did to their own soldiers 2003. And it’s been going on longer than that. I would say get another Nuremburg trial, but apparently the first one never stuck and some of the worst perpetrators never stood accused.
    Complaint.pdf

    Mr_Yesterday

    Here is another take on these matters; How about we just admit the government is probably the most incompetent slowest to react most dangerous steward of anything, especially health care. FDA has long since been corrupted. A pay to play system. The very last place we turn to for any product food or medicinal safety advisement is 'the government'.

    Here is how the problem happens; Because taxpayers fund something, another entity whom is well versed on taking advantage of taxpayer funded systems sneaks in. The original intention of the government program and effort, no matter how noble or pure, is inevitably corrupted and pieced out to special interests. The rise of the non profits. The free market would be a far better manager at just about anything, compared to the government bureaucrats. Central planning never works.

    Additionally; There is no such thing as a 'safe vaccine'. Take a look at this simple time graph, comparing normal rates of all cause mortality (normal volumes of human deaths), and overlaying this with the covid shots. It does not take a rocket scientist to interpret this graph. Excess deaths happened after the NIH protocols for treatment were installed, and implementation of the covid vaccine programs. Additionally, if a company or person proved themselves so incompetent as to allow something that dangerous come to market, and be subsidized by taxpayers, and be mandated via coercive uses of force on the public, and be sanctioned by the government institutions, and provide grand payouts for billions of dollars worth of product orders, and the product turned out to be wholly defective and the strategy of distribution incredibly corrupted. Why in the heck would anyone turn back to that same company or person and trust them again with the next task? Half of the covid shots were saline, we have learned later via the phizer disclosures mandated by court order. Isn't that embezzlement and product fraud and product fraud to charge taxpayers $300 per shot, only to deliver half of them as water?

    Repeat after me; You're fired! That is what you should be telling these people. From food safety to medicine to the extreme risks posed by genetic modification, fast track pay to play approvals, the revolving door with lobbyists and bureaucrats within government, insider trading, pump and dump schemes, the list of offensive immoral activities conducted on a regular basis within governmental systems is indeed lengthy. Think about the futility of demanding some labeling or descriptive correction, as if that will solve anything. If we truly desire peace and prosperity, free markets with less government interference is the only way forward. Be wary of those promoting various socialistic programs as new or exciting solutions, as those have been tried time and again through many different societies and have always failed.

    While so many people beholden to the establishment struggled to break free of their mass formation psychosis, so easily programmed into a state of panic and fear, we simply opted out on principal. Because; Good ideas do not require force. The moment anyone had to use the force of government to redistribute wealth, subsidize the product, or compel people to subscribe, is how you know the governments own presence, alongside their special interest affiliates, will inevitably do more harm than good. Besides, in the truly free market outside of their totalitarian censorship and control schemes, there was clear as day reliable information how dangerous these products were. Truthful reliable information has been out there this entire time. Yet those within the system still struggle to reconstruct and reconcile the lies they were told, alongside the slow walk of truths which inevitably come forth. We live in a sea of propaganda and are lied to constantly. Get your mind around that.

    We'd all have been better off if the government and society did absolutely nothing about covid, and then simple low cost effective treatments would have come forth, no vaccines were necessary, lock downs needed never occur, and that many people did not have to perish. In a free market people support a product because the product makes sense. In a socialistic governance, you are required by force and color of law to purchase a product and follow some government guidance, even if the product maims kills millions and millions of people. Keep on existing within the confines of some illusionary situation where you are no longer free men, but rather slaves to the state if that is what you choose to believe. There is a better way.

    Colorado is sliding into tyranny so fast lately, the people should pause and reflect on the lies they have been told so often, for so long, and consider if they are even still willing to give any credit to the people telling those lies, or simply reject them and their ideology of central planning all together. We're better off on our own if you ask me.

    The evils in government exist only in it's abuses. Andrew Jackson.

    death per vax time 1.jpg

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