Why Not All of the Above?
Failure of Leadership: Did 21 U.S. Code § 360bbb–3 - Section (c)(3) Kill Hundreds of Thousands of Americans?
At the heart of all of the issues spawned by the arrival of the Sars-CoV-2 pandemic is the simple question of whether the medical authorities adopt, and advise governments to adopt, an all-of-the-above approach to managing the pandemic, or something else. It is apparent that while some very few treatments have been approved for use, like monoclonal antibodies and certain anti-inflammatories like steroids, the medical and political leadership have not only chosen a less-than-all-of-the-above approach, but have actively interfered with doctors and medical practices seeking to adopt an all-of-the-above approach.
Recently in one of Joe Biden's addresses to the Nation on COVID, he said "We are doing everything we can" to combat the pandemic. But that is simply not the case.
This is not a partisan attack. Donald Trump failed in this regard just as Joe Biden has.
A curious thing took place during this pandemic that is hard to explain. For years, the medical regulatory establishment, comprised of the FDA, with the CDC and NIH in the background, allowed doctors to use their best judgment in the use of FDA-approved drugs in cases or for diseases outside the scope of their approval. This is what is referred to as "off-label" use. For some FDA discussion of this idea see the following links https://www.fda.gov/patients/learn-about-expanded-access-and-other-treatment-options/understanding-unapproved-use-approved-drugs-label
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/label-and-investigational-use-marketed-drugs-biologics-and-medical-devices
You have almost certainly heard that there are doctors in the US and around the world using things like Ivermectin and Hydroxychloroquine along with antibiotics and vitamins and minerals to treat people who contract COVID. As a result there are various outpatient protocols like MATH+ and several others. The doctors who created these protocols claim great success. Now I do not know whether they have been successful in a purely scientific sense or not. For them to be so, Science would require that the methods used be well-defined and that the success could be replicated by others following the same protocols.
In the midst of a pandemic, with hundreds of thousands of Americans dying, you might think that the medical authorities would take an interest in such claims. Any leader properly pursuing an all-of-the-above approach would. But for some reason our medical establishment has not only NOT pursued investigation of these methods, they have actively sought to PREVENT them. Not only does the FDA simply not endorse using Ivermectin, for example, they seek to PREVENT its use despite field reports of its efficacy. The official position of the FDA is NOT to use Ivermectin. https://www.fda.gov/consumers/consumer-updates/why-you-should-not-use-ivermectin-treat-or-prevent-covid-19
This has had the effect of preventing doctors nationally from using it. When the regulatory body for health says DO NOT USE, then State medical boards, and the medical practices under their direction will see to it that it is not used. Doctors risk losing their jobs if they prescribe something their practice forbids, because their state medical board forbids it, because the FDA has said DO NOT USE.
What does the FDA recommend for people who have contracted COVID? "In general, most people have mild illness and can recover at home. If you think you have been exposed to COVID-19, notify your doctor, monitor your symptoms, and get emergency medical care immediately for emergency warning signs, such as trouble breathing." https://www.fda.gov/consumers/consumer-updates/know-your-treatment-options-covid-19
Go home. That is the Medical Authorities guidance for people who come down with COVID. They do not even bother to recommend you might boost your immune system with some Zinc or Vitamin D or Vitamin C. Just go home. And if you get really bad and are worried you might die, seek medical attention. Go to the hospital.
That is a failure of leadership. That is not an all-of-the-above approach.
Of course the real push has been to get everyone to take an mRNA shot. What they refer to as a vaccine. And these shots HAVE proven to reduce the severity of the medical outcome. If you take the shot, your likelihood of dying from COVID are greatly reduced. This gets us to the idea of risk versus benefit. The benefit of the mRNA technology looks good for the individual. It has been conclusively proven now, however that they do NOT prevent the "vaccinated" from getting or spreading the virus. Private benefit, not public benefit.
What about the risks? Well those are as yet unknown. The web is chock full of anecdotes of harm. The almost useless public databases recording side effects show a marked uptick for the mRNA shots. The CDC is tight lipped. Like the Sergeant in Hogan's Heroes they "see nothing". The Medical authorities say they are completely safe. Despite only the most cursory trials, which reportedly had several flaws in them. The truth is that they are using the whole of humanity as an experiment for these technologically very exciting vaccines, but whose full risk profile is not yet known. Aside from the ethical problem that poses methodologically, and the legal issues with using large numbers of people for medical experiments, many without their consent, there is another issue.
These vaccines have been approved for emergency use under a US law providing for Emergency Use Authorization. One side effect of THAT is that the vaccines makers have no liability for harm. Read that again. No one has any liability if the use of the mRNA shots harms you. Cominarty, by the German company BioNTech has been given full approval. But no shot administered in the US today is Cominarty. Every shot administered today is under EUA. No liability. Those jurisdictions mandating shots for kids, along with everyone else, are doing so with an emergency drug. An experimental drug.
So we have the medical and political leadership urging and where they can, mandating an experimental drug, while at the same time preventing doctors from seeking effective outpatient treatments. Why?
$300 Billion is why. Pfizer and Moderna stand to make hundreds of billions of dollars, mostly US Taxpayer dollars, from the mRNA vaccines. But they cannot make that money if there are effective treatments.
A part of the FDA Act enshrined as 21 U.S. Code § 360bbb–3 - Authorization for medical products for use in emergencies Section (c)(3) states as a requirement for Emergency Use Authorization "that there is no adequate, approved, and available alternative to the product for diagnosing, preventing, or treating such disease or condition;"
So if doctors discovered that Ivermectin (an FDA approved drug) or something else was an adequate alternative for preventing or treating COVID, then the FDA could NOT issue an EUA for the $300 Billion mRNA vaccines. By law. In the face of this law, Fauci and the FDA and CDC and NIH have worked to actively prevent doctors from discovering and using alternatives. Success threatens one of the biggest money grabs in human history.
Of course real leaders, genuinely concerned with fighting the human toll in death and misery caused by the virus and by the government responses to the virus, and pursuing an all-of-the-above approach, would immediately petition the US Congress to pass a law outlining an exemption from existing EUA law in the current emergency. But they have not done that. Instead they have have monomaniacally pursued vaccination with the mRNA shots to the exclusion of all else. Now I do not know if the various outpatient treatment protocols defined by actual doctors treating actual patients in the field would actually have lessened the death toll. But what if they might have? If so, then this one law caused the deaths of everyone who might have been saved. Some doctors say that is half or more of the 800,000 plus deaths that have occurred to date.
Here is the absolutely key point. The Health Authorities and the Medical Establishment have, for the duration of the pandemic, embargoed 2 drugs that might have worked to lessen the impact of the pandemic. If these drugs were dangerous maybe that might make sense. But these drugs, Ivermectin and Hydroxychloroquine, have been prescribed BILLIONS of times EACH. Their safety profile is known and they are exceptionally safe when prescribed properly. Essentially no downside. Only potential upside. Yet not only were they not recommended, which would be bad if you were adopting an all-of-the-above strategy, they were actively PREVENTED by the FDA and CDC and NIH. No one concerned with health and welfare could possibly have pursued such actions without having some ulterior motive.
A more colossal failure of leadership has likely not occurred in a very long time. If indeed these actions and lack of actions cost hundreds of thousands of Americans their lives, it is a worse failure of leadership than the disastrous and ludicrous abdication of leadership in the pullout from Afghanistan. Thank God that the FDA finally approved the protease inhibitor Paxlovid. This drug has the potential to end the pandemic for good. Of course as it is an alternative treatment one wonders whether Fauci and the FDA will do something to sabotage its use and distribution as it will make the mRNA vaccines redundant. We can only hope that is not the case.
Lots of different measuring sticks for the same thing tend to create chaos:
The patient wants best treatment, pref. affordable.
The doctor wants to use best treatment, but his employer also wants profit.
So we have two pairs of metric, one of which is in harmony and one pair in conflict.
Add to this politicians, media, and governement agencies in which each individual making decisions have both their own personal priorites and metric, as well as their groups and their leaders. Try drawing it as a diagram, where you go from your state's highest placed decisionmaker re: best medical practice all the way down to yourself.
If I were to guess, any decision has at least 10 waystations it must pass before being communicated to you. If every waystation enables only two different pairs as in my initial example... well.
We should really be in a state of perpetual wonder that there's not /more/ chaos.
Simple example from my country: the governement pays a premium of ca 150 000:- ($16 500) to anyone buying a new electric car. You get to keep this premium even if you resell the car immediately. So buy new car for 850 000:-, cash premium, resell unused car for 800 000:-, pocket the difference, do it again.
This is however not seen as a bug or failure. How? Because of different metrics:
The agency in charge of the premium measures the success of the programme against how much of allocated tax funds they pay out.
The political parties behind it measure success in people switching from petrol to electricity.
And the dealerships measures success in number of cars sold.
No conspiracy needed, just very human fallability.
Great read, thank you for logically writing what has been swirling inside my head. I too am curious of how the FDA will handle the EAU on the "vaccine". If it's not the only tool in the toolbox, how can they justify cover it's use under the EAU umbrella? Time will tell I guess. I don't see anyone in Washington willing to speak up and turn the train around.