The FDA Can Say (and Do) Anything It Wants

For example, they can't be sued for providing false or dishonest information

Aug 10, 2023

On September 1st, the court ruled in the three physicians’ favor, saying that they have legitimate legal objections about how the FDA treated Ivermectin (and medical professionals who prescribed it for COVID-19), so the court that denied their original complaint, did so in error. Their case will now be reheard. Kudos to them! [The following is my prior commentary on this important case, and it is unchanged…]

This is an extraordinarily important commentary!

The gist of a current court case that you’ve likely never heard of, is that three heroic doctors are suing the FDA about the loss of their jobs, about their careers being derailed, about the loss of their reputation — all because their professional, scientific opinion as to what was in the best interest of their patients, was different than the political agenda of the FDA. (Here is a bit of background.)

What is at stake here could not be more significant, and it applies across the board to EVERY federal agency. The question is: do federal agencies have the unsupervised right to replace Science with political science? Put another way: can they act dishonestly, incompetently, etc. with essentially no meaningful consequences?

Here is the doctors’ Complaint. Although it was filed a year ago, it is now being appealed this week — and some fascinating audio clips have emerged. There are three judges on a panel, asking the attorney representing the FDA some probing questions.

Five of these short audio clips (3-5 minutes each) are posted here. (The recording of the full proceeding is here.)

IMO some of the key takeaway revelations (so far) are:

1 - The FDA seems to claim that their published warnings are little more than offhand observations. For example, their slamming of Ivermectin was evidently just casual commentary (what the FDA calls “informational”).

Note the title here, on this FDA page which is STILL up! It says “Why You Should Not Use Ivermectin to Treat or Prevent COVID-19”.
Note 1: This is a deceptive headline because that article is mostly saying: a) citizens should not self-medicate, and b) using any veterinary medications can be dangerous. Both of these are legitimate concerns. So, if the FDA was honestly trying to benefit the public their heading should be: “Why You Should Not Self-Medicate Using Veterinary-Grade Ivermectin to Treat or Prevent COVID-19”. BIG DIFFERENCE!
Note 2: This FDA page has changed quite a bit over time. Here is the 2021 version.
Note 3: The current page makes outright false statements like: “Ivermectin has not been shown to be safe or effective for these indications.” I’m one of the few people who has taken the time to put together a spreadsheet of ALL the studies on ALL the major COVID early treatment therapies: see it here.
There have now been 99 Ivermectin scientific studies, and the overall early treatment effectiveness is 62%. IVM’s extensive safety record is extraordinary, with adverse effects (e.g., see here) in the ballpark of only one in a million usages!
Now, also on my spreadsheet, compare what the FDA has approved for early treatment of COVID-19 therapy: Paxlovid = 32% effective with these adverse safety issues, and Molnupiravir = 16% effective with these problematic safety issues!
Despite these LARGE benefits of Ivermectin in effectiveness and safety, the FDA continues to say that “Ivermectin has not been shown to be safe or effective” for early treatment of COVID-19. This is stunningly inaccurate.
Note 4: Even though the FDA now has access to 99 Ivermectin studies, their statement against Ivermectin is stronger now than when the page originally appeared in 2021! IMO this is what happens when a federal agency feels that there is no meaningful oversight, so effectively they can say anything they want.

2 - The FDA says that Courts have no business in reviewing anything they say or do!

Considering the above facts in #1, it’s obvious why this would be their self-serving position. Listen carefully to the second short audio clip, where the FDA’s attorney appears to say that the FDA’s communication to the public can be knowingly false, dishonest, etc. with no oversight or consequences — even when deaths result!
Regretfully, to date, the courts have played along with this game of charades. For example, the Chevron case is frequently cited by non-aggressive attorneys to say that courts will stay out of determining whether FDA processes, documents, and claims are legal, accurate, honest, warranted, etc.
However, that is an oversimplified opinion. Even the Chevron case states that the FDA’s actions must be “reasonable” — but that is rarely argued. BTW, the case we are discussing here would never have been filed if the doctors’ attorneys bought into the bogus idea that federal agencies have unlimited deference. Kudos to them that they did not accept that absurd argument!
Maybe I’m overly optimistic, but based on the judges’ questions and comments in these clips, it seems to me that this case might eventually upend Chevron. That would be EXTRAORDINARILY beneficial for US citizens, as it would apply to all national policies: from immigration to education, energy to climate change, etc.

3 - The FDA asserts that the only recourse that US citizens have about even egregious errors and deceptions by the FDA is through the “political process.” Astounding!

4 - The FDA indicated that the “political process” means that citizens need to elect a competent and attentive President, whose responsibility it is to see that the FDA acts responsibly — or else. The flip side is that when we do not have such a President, all federal agencies have a four-year time period to wreak whatever political havoc that suits them — again, across the board, and without real consequences to the guilty parties.

5 - The FDA’s attorney implied that there would be no compensation given for inaccurate or knowingly false FDA statements — including those that lead to Americans unnecessarily dying — other than an FDA person may lose their job.

6 - Based on these select audio clips, the fact that hundreds of thousands of Americans likely died needlessly due to the FDA’s COVID actions and inactions (see here), was not fully addressed. Hopefully, this will be brought up in this trial.

7 - In clip #3, the FDA attorney makes the startling claim that the FDA has the authority to give citizens medical advice! How is that possible when they know nothing of the medical history of any American citizen? Further, once they assert that right, how is a conflict resolved between what the FDA says and what a citizen’s medical provider says? That is one of the major issues in this important case.

8 - In clip #4, the FDA attorney acknowledges that doctors have lost their jobs, etc. due to their scientific conclusions on such matters as Ivermectin, and their science-based actions that they believed were in the best interest of their patients. However, the FDA attorney then stated that no losses, etc. were due to anything the FDA did. (!)

……….

Note that a lot of the bad behavior with the FDA (and CDC) would be reduced if the Medical Establishment refused to play politics and instead supported real Science for the public. Regretfully, that has not happened and the COVID-19 fiasco exposed this ugly underbelly. See my Report on the COVID failings of the Medical Establishment.

In another Report, I compared the FDA’s approval process for Remdesivir to Ivermectin. This appears to show stunning incompetence at the FDA.

I have made this point before, but it’s worth repeating. The war we are engaged in is that powerful Left-wing forces (exterior and from within) are trying to take America down. One of their primary strategies to do this is to replace Science with political science. That is what this case is about, as the FDA is specifically arguing that they have the right to scrap Science and substitute political science — with impunity!

Draw your own conclusions, but to me, this case is like a Molotov cocktail thrown into the Federal Government bureaucracy. Astoundingly, all three branches of our government are complicit with this nonsense.

Some obvious questions that need to be answered and fixed are: 1) How did Congress give pharmaceutical companies such broad protections against self-serving unscientific actions? 2) How did the Executive branch allow agencies like the FDA to be run by parties that they are supposed to regulate? 3) How did our Judicial system allow bad actor agencies to arrange to have no real legal oversight?

Considering that these failings are applicable to multiple federal agencies, is there any question why such things as COVID policies (and energy, and climate, and education, and immigration, and elections, etc., etc.) are a disaster?

Hopefully, this lawsuit will crack open the door to fixing this horrific mess…

……….

PS — What needs to be done now :

1) Competent attorneys should file friend of the court briefs to support this nationally important case. Overturning the Chevron precedent would have extraordinarily positive benefits for almost ALL US citizens.
2) Competent federal legislators should introduce a “Save America” bill (aka Agency Oversight Act). This legislation will reign in ALL federal agencies, by providing timely and meaningful oversight (plus real penalties) to them all.

Critically Thinking About Select Societal Issues

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