Senator Rand Paul has released Anthony Fauci's pandemic diary, and Dr. Fauci has volunteered himself to provide the example my last paper was missing.
The paper is called Approval Is Not Exposure. Its argument is simple. FDA approval and accumulated human exposure are both evidence, but they are not evidence of the same thing.
Approval tells us that a particular product completed a particular regulatory process for a particular use. Exposure tells us how many opportunities a substance has had to surprise us after entering actual human bodies.
Those categories overlap. They do not become identical merely because people are accustomed to saying "FDA-approved" when they mean "safe."
The mistake is everywhere. It is useful to drug companies, regulators, hospital systems, insurers, lawyers, reporters, and anyone else who needs a complicated medical decision compressed into two words. It is also a problem for informed consent. A person cannot weigh what is known and unknown when the institutional category used to describe the treatment hides the difference.
The examples in my paper explain the mistake. Fauci's diary shows it happening.
What Fauci knew on March 18
On March 18, 2020, the White House was considering making hydroxychloroquine and remdesivir broadly available. Fauci objected to treating the two drugs alike.
He followed the meeting with an email. Hydroxychloroquine, he wrote, was an approved drug with adverse effects but "tons of experience with it." Remdesivir was different. It was unapproved and investigational. Fauci wrote that he had "more concern about the potential toxicities" of remdesivir and noted that it had shown no clear benefit in the Ebola experience. His proposed course was equally plain: "We should consider leading with HC in a flexible distribution protocol" while accelerating the remdesivir trial.
That is Approval Is Not Exposure in Fauci's own handwriting.
He understood that the two candidates occupied different evidentiary positions. Hydroxychloroquine had extensive prior human exposure. Remdesivir had less. Neither had convincing randomized evidence for COVID-19 at that moment, but uncertainty about efficacy did not erase the difference in accumulated safety knowledge.
The next day's entry is where the problem appears.
The administration, Fauci wrote, was going to make the drugs broadly available through compassionate use. "I convinced them not to." Three days later, an online system intended to track the drugs and make them available through physicians was, in his words, a "Bad idea," acceptable to him only if it did not interfere with randomized trials.
This does not prove that hydroxychloroquine worked. It does not need to.
The question is why an emergency response facing a new lethal disease would contract the number of interventions available for monitored use instead of expanding the number available for rapid, disciplined comparison.
The indication nobody could already possess
At the beginning of COVID-19, no established medicine could already be FDA-approved for COVID-19. The disease had not previously existed.
"Not approved for COVID-19" was therefore the necessary starting condition of every known medicine. It was not evidence that all of those medicines had failed comparative evaluation. It was not evidence that their ordinary toxicities were unknown. It did not distinguish a failed candidate from an unstudied one, or an unsafe substance from a familiar substance without a sponsor willing to finance a new indication.
Yet that unavoidable absence became a public warning label.
Old medicines were discussed through the approval package they did not have. Novel proprietary products were discussed through the approval package their sponsors could produce. The regulatory outcome then appeared to describe the biology.
It did not.
It also described who owned the product, who could finance trials, who could prepare an application, who could recover the expense, and which candidate the government had organized itself to move through the channel.
Then the category error changed sides
The mRNA vaccines arrived with COVID-specific trial evidence and almost no accumulated human exposure. Their intended mechanism was to deliver messenger RNA instructing human cells to manufacture a modified SARS-CoV-2 spike antigen.
Spike protein has demonstrated cardiotoxic and neurotoxic biological potential. After mass deployment, surveillance established a causal association between mRNA vaccination and myocarditis, particularly in younger males. Research continues into the roles of vaccine-derived
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