…and astonishingly misinterprets the legal concept of the EUA countermeasure
Dec 4, 2023
Calm down everyone, justice is almost happening. We are getting there, but baby steps, ok?
AG Paxton’s complaint is 54 pages long, and I am no legal scholar, so I leave it to others to discuss in full. However, I will address the pages where the complaint talks about the EUA law. The rather strange logic of that part boils down to the following:
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- Injecting a prototype chemical (or drinking bleach, pick your poison) in an emergency generated by scary news on TV/HHS proclamations is ok, because “poorly tested drug is better than no drug” (m-kay…) but the bleach/chemical manufacturer cannot pull numbers out of their rear end and claim its 95% effective. That is a deceptive marketing practice under the laws of Texas.
I don’t want to be a total downer, so I am going to thank AG Paxton for doing something. In fairness, the complaint has strong points, cites lots of good data, goes after some valid aspects of consumer safety (deceptive marketing claims) and, importantly, goes after collusion with media. So not everything is bad.
This maybe better than the rest of state AGs twiddling their thumbs while human slaughter from illicit poisons trafficked across state borders by the feds is ongoing.
However, the part I am going to criticize nags me as a big problem. I also find it astonishing that AG Paxton’s team missed this aspect while writing up a large section of the complaint about the illegal-law (EUA), on which most of the mass murder hinges. Methinks the competent people that they are, they didn’t miss it, they omitted it on purpose.
Let’s review what the complaint says about EUA:
Para 11 states, correctly, that EUA is “alternative and radically different” way of drug authorization and cites USC 360bbb. So far so good, and I like the words “radically different” and also “authorization” instead of approval. We are soooo close!
However in Para 12, we are not so close – “requires a much lower quantum of scientific evidence”. That’s incorrect! It’s not “much lower” – no scientific evidence is required at all. It also precludes the possibility of conducting a legally defined clinical investigation, which means no clinical science can be assembled for this authorization.
Definition of clinical investigation:
- Clinical investigation means any experiment in which a drug is administered or dispensed to, or used involving, one or more human subjects. For the purposes of this part, an experiment is any use of a drug except for the use of a marketed drug in the course of medical practice.
Continuing to the next page:
Para 13-14 compare the “ordinary” FDA approval pathway with the EUA and more or less correctly point out that for the “ordinary” approval demonstrating safety is a must and a biologic must be “potent”, but in sharp contrast – none of this is needed for an EUA, and the only approval criterion is an opinion that the substance “may be affective” and that “known and potential benefits outweigh known and potential risks”. Having any real clinical data to make these determinations is not necessary, and as I pointed above – a legal impossibility.
What strikes me in this discussion – why are they using a colloquial word “ordinary” instead of a more legally precise term “investigational”? This term is used throughout the relevant law that Paxton’s team has clearly read and is discussing in this part of the complaint. Why omit this important term?
Continuing to para 15:
Para 15-16 simply describes what must happen for a formal FDA approval on the “ordinary” regulatory pathway. This is not interesting because none of it applies to the EUA. In Para 17 I begin to wonder which team AG Paxton is really on? This paragraph and the statement in para 12 – it’s like he is offering excuses why EUA pathway is a legit way to “shortcut” something that can’t be shortcut – safety testing… because it can exceed eight years… and because “bad drug is better than no drug”!
In Para 18 AG Paxton correctly notices that clinical trial data for EUA is entirely optional!
In Para 19, however, it does not strike him as illogical that while the Congress fully expects EUA chemicals to be inferior in safety and efficacy since no clinical trials are necessary, there is still an obligation to inform both healthcare providers and public about significant known benefits and risks. How is it possible to know what risks and benefits exist and inform about them if none have to be tested for?
My astute readers are of course aware that this is part of the premeditation of this crime – removing requirements for clinical investigation by obliterating the investigational status of a chemical entity makes the concept of informed consent completely meaningless. See detailed write up on un-informed consent from Katherine
The most important part of this section of AG Paxton’s complaint is what it very carefully omits to say – EUA is a “non-investigational” pathway, designed specifically to break the Food, Drugs and Cosmetics Act.
The statement about “this reduced scrutiny is justifiable … because poorly tested drug is better then no drug” in Para 12 irks me to no end! Have you heard about “do no harm” AG Paxton? Let’s “accelerate” the very long and very expensive design and safety testing of new passenger aircraft, heck, it’s an emergency! We will skip the safety testing, make it optional, push it on the market to all airlines and make the flights mandatory, why not? It’s an emergency, because FAA says so!
Here I am going to speculate why the very curious omission of the “non-investigational” status of EUA and an incredibly stupid idea of what is justified to be injected and mandated in case of federal agency declaring an arbitrary state of emergency. The answer is quite simple. We are in an election year, folks. AG Paxton is a politician. Who wants to place bets whether the wording and framing of this case was run by the Trump campaign?
I am very curious to see what Pfizer’s motion to dismiss will look like…
Calm down everyone, justice is almost happening! Unity and stuff… Acknowledge loss. And healing. Y’all were heroes on the battlefield and deserve purple hearts for fighting the virus. Which of course nobody will give you, but it’s the thought that counts! Because, you see, it is justified to inject everyone with poorly tested (not at all approved) chemicals on the off chance of saving the granny…
Because poorly tested poison is better [to kill you] than no poison at all!
Art for today: Portrait study, oil on panel, 12×16 in.
Due Diligence and Art is a reader-supported publication. To receive new posts and support my work, consider becoming a free or paid subscriber.”