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The Washington Free Beacon reports today that the FDA approved COVID boosters for children as young as five without convening the Vaccine Advisory Panel. The FDA circumvented the usual process for vaccine approval. Anyone with minimal sentience can see that these FDA vaccine approvals are purely political, and not based on any sort of “Science.”
Specifically, there is virtually no benefit to vaccinating, let alone boosting, small children. The reason for that has been recognized almost from the onset of COVID: For the virus to enter cells, activated androgen receptors are required, that is, androgen receptors in the cell cytoplasm that are occupied by testosterone. Such receptors exist in very low if any quantities at all in the cells of small prepubertal children. The activated androgen receptors move from the cell cytoplasm into the nucleus where they induce the expression of a protein, a serine peptidase that splits proteins at serine amino acid residues. That peptidase is necessary for allowing the virus to open its envelope to merge with the cell membrane and release viral materials into the cell.
The clinical data of very low incidence of COVID in children, and a very mild course in all but the most vulnerable children, tracks with the basic science understanding of the virus.
And with the variants now present, it is questionable that there would be any significant protection at all from another shot. The data have not been reviewed by the advisory panel, which is mandatory in normal times.
One assumes that Anthony Fauci will be personally receiving royalties from Pfizer and Moderna for this additional indication for administering the vaccine. We, of course, don’t know that but redacted information released regarding royalty payments to NIH employees indicates that may very well be the case.
Milton Friedman once said the following: “The FDA has done enormous harm to the American public by greatly increasing the costs of pharmaceutical research and thereby reducing the supply of new and effective drugs, and delaying the approval of such drugs….”
The FDA has now done an about-face in the case of COVID vaccines and boosters, and willy-nilly approved vaccines without knowing risks, in circumstances in which benefit is likely to be minimal, with the exception of the very few children who may be under treatment for cancer, or have severe immune deficiency disorders. And in these cases, there simply is insufficient data to evaluate risk and benefit.
If there were any science applied to the vetting of vaccines, the vaccines would all still be under Emergency Use Authorization, given their abysmal track record in preventing COVID, and the absence of data on side effects and risks, which have been at best swept under the carpet. The vaccines should not have received full approval. That was done simply to allow vaccine mandates a la Jacobson v. Massachusetts, a Supreme Court decision that has been massively abused during COVID. COVID vaccines are nothing like Small Pox vaccines. They do not prevent the disease. There is some evidence that they may enhance the transmission of the disease.
On the other hand, the FDA just approved Tirzepitide, the first of a new class of diabetes medicine, called “twincretins.” Based on studies done on the drug, it is more effective than a similar class of medications, the GLP-1 analogs (Ozempic, Trulicity, Bydureon, Victoza) in controlling type 2 diabetes and inducing weight loss. This is a new class of drugs because it has the effects of two different hormones, Glucagon-Like Peptide 1 (GLP-1) and GIP (Glucose-dependent insulinotropic polypeptide), both of which are incretins. Incretins are hormones (produced by the intestine) that enhance insulin secretion after a meal and improve insulin action. These are the two main incretins. Their effects are somewhat paradoxical and it took a while to understand that together they have a more potent clinical effect on type 2 diabetes than either hormone alone. That was not predicted by the early studies on the effects of these hormones, which are, to say the least, quite complex.
Research and development of these hormones and drugs have been underway for decades. The manufacturer of the twincretin (Eli Lilly) has been working on the drug for at least a decade (see Milton Friedman quote above). The cost of the medication is likely to be very high. Due to prior “guidelines” by such entities as the American Diabetes Association and the American Association of Clinical Endocrinologists and the Endocrine Society, which have advised stepwise addition of newer medications to older medications; and due to the fact that Medicare and Insurance companies have latched on to such guidelines to block use of the newer agents, the use of this new class of medication is likely to be stymied for years to come. The process of “Prior Approval” will burden physician offices and staff, and hamper patient use. Part D of Medicare is structured to utterly eviscerate the use of such new agents by Medicare beneficiaries. Insurers have many tricks to avoid having to pay for such medications for patients.
It is quite likely that it would be a boon to everyone, patients, insurers, the government, the manufacturer, if, instead of blocking use of such a drug, or pricing it out of the reach of patients, all of the above would promote the use of the drug at a reasonable cost, or at least not obstruct the use of the drug.
The first patient I ever treated with Bydureon when it first came out (a long-acting, much more effective and better-tolerated formulation of Byetta, the original GLP-1 analog), was a middle-aged woman with type 2 diabetes who was taking about 300 Units of insulin a day. She weighed 300 pounds. Despite the high doses of insulin she was taking, her blood sugars averaged around 300 (diabetes out of control) and her HGBA1C was 12% (normal less than 6%, again, diabetes completely out of control). She was intolerant of Byetta, but tolerated the bydureon. Within three months on bydureon, she had lost 30 lbs., come off insulin completely, and her HGBA1c was 6%. She happened to be a Medicaid beneficiary, and this was in Texas. Texas barred the use of Bydureon for Medicaid beneficiaries. We had to provide her with samples for the three months that she was on Bydureon. At that point, however, we were out of samples and simply couldn’t keep her supplied. She had no option but to return to her previous regimen and thus returned to her previous state of weight gain, high-dose insulin, and Diabetes out of control.
A similar scenario is likely with this new agent. Thanks to the regulatory regime and health industry structure under which we live.
ON another note, the FDA appears to be returning with a vengeance to its foremost original mission, which was food safety (the FDA was created in 1906, the Progressive Era, by the Pure Food and Drug Act, inspired by Upton Sinclair’s book, The Jungle, a muck-raking expose’ of the meatpacking industry). It appears that the infant formula shortage is to a great extent the result of the FDA closing an Abbott plant that produced infant formula. Adding that to current supply chain problems and the protective barriers to imported infant formula that were established to benefit the dairy industry in the US, appears to be the cause of the shortages. So the FDA has gone from blocking life-saving or enhancing medications, to forcing poorly vetted vaccines on children, to taking food out of the mouths of babes.
I agree with Milton Friedman: The FDA needs to be abolished. It is wreaking havoc on the lives and health of Americans. When a product is plentifully available in Mexico and almost unobtainable in the US due to one of our most powerful regulatory agencies, one has to ask: Can we afford this sort of governance?Published in