Considering the mess that Progressives have left America in, it could be difficult to know where to start fixing things. My view is that (other than adequately addressing the immigration disaster), our departure from real Science is arguably the most impactful matter that needs to be properly resolved.
Science is a process. The point of the Science process is to give the public the best understanding of the technical truths of our existence. But that is not happening!
Just a few real-world examples of this should convey the enormous adverse consequences of this almost totally ignored issue:
Example #1: Our energy choices should be made based on what real Science indicates that our best options are. None of that is happening!
Example #2: Our concern about Climate Change should be resolved by applying real Science. Almost none of that is happening!
Example #3: Our healthcare system (FDA, CDC, etc.) should be 100% focused on conveying to the public what real Science indicates is in their best interest. As the COVID-19 fiasco exposed, almost none of that is happening!
Example #4: Our K-12 education system should be teaching our children what real Science is — which includes training them to be Critical Thinkers. Due to the widespread adoption (49 states!) of the NGSS, none of that is happening!
Etc., etc.
To our profound detriment, what has replaced real Science is political Science. What that means is that technical matters are dealt with based on political correctness, on virtue signaling, on who profits, etc. None of these have anything to do with real Science, or what is in the best interest of the public and our country.
With Trump as our next President, we have an unprecedented opportunity to make major inroads against the Left’s concerted efforts against real Science. Here I’m sharing what I will be suggesting RFKjr to do regarding the healthcare debacle. I’ve focused on the FDA as they are at the top of the heap.
To narrow this down even further, I’m advocating for major changes on how the FDA grants Emergency Use Authorizations (EUAs). That may sound academic, but the current incompetent EUA process is the main reason that unscientific COVID-19 injections and medications (e.g., Remdesivir) were allowed. It is also the primary reason that scientifically proven treatments (e.g., Ivermectin) were not approved.
Properly fixing the FDA’s EUA issue would set a precedent that would carry over into ALL aspects of all healthcare agencies. As such it would arguably be the most significant (and beneficial) US healthcare change made in the last fifty years…
For more background on the rationale behind my technical recommendations to RFKjr, carefully read the sample lawsuit that I drafted awhile back. It is filled with citations.
My recommendations (esp. for serious matters like COVID-19) are:
1 - The FDA be required to include a representative sample of chronic illness subjects in both testing and placebo groups of all clinical trials for products seeking EUAs.
Where an EUA has already been granted, or when the above is (or was) not practical:
2 - The FDA be required to include in their EUA Fact Sheets for Healthcare Providers:
“This EUA was granted after a very limited scientific assessment of this product for this medical condition. As a result, the FDA has a low confidence level regarding the safety or efficacy of this product for this condition.”
3 - Since the safety and efficacy for the majority of Americans from such EUA products are not scientifically established, the FDA should be directed to prohibit any EUA product manufacturer from claiming that their product is Safe or Effective.
4 - The FDA should be obligated to require that all EUA clinical trials (and subsequently the FDA) publicize Absolute Risk — preferably, exclusively.
Note 1: This is consistent with an important FDA advisory publication. A key conclusion (see page 60) is that the public is: “unduly influenced when risk information is presented using a relative risk approach; this can result in suboptimal decisions. Thus, an absolute risk format should be used.”
Note 2: The CONSORT 2010 Statement — Updated Guidelines for Reporting Parallel Group Randomized Trials states: “… presentation of both absolute and relative effect sizes is recommended…”
5 -The FDA should be obligated to promptly develop and publicize regulations for Informed Consent regarding the public’s taking of EUAs. (These should be comparable to the FDA’s informed consent conditions for clinical trial subjects [which includes many pages of conditions and caveats: see here].) EUA product recipients should effectively be considered to be clinical trial subjects.
6 - The FDA must be prohibited from granting an EUA based on a subset of any RCT results (e.g., like here).
7 - The FDA be required to give detailed acknowledgement in their EUA Fact Sheets for Healthcare Providers, of the critical omission of inadequately testing persons with chronic diseases. Since (due to this omission) the majority of American adults are put at additional risk by taking this EUA product, the FDA must give them notice (necessary for informed consent) that their underlying chronic disease condition may worsen (including death) when taking this EUA product.
Takeaway —
The bottom line is that the FDA, et al have been taken over by Big Pharma and other parties who have political and/or economic objectives inconsistent with what is in the best interest of public health (children and adults).
This needs to be aggressively and properly addressed. My recommendation is to recognize the indisputable departure they have made from real Science, and to focus on a real world example (e.g., FDA EUAs) as a representative matter to properly fix.
This is 100% consistent with what RFKjr said that Trump assigned him to do: 1. Clean up the corruption in our government health agencies. 2. Return those agencies to their rich tradition of gold-standard, evidence-based science. 3. Make America Healthy Again by ending the chronic disease epidemic.
Success in correcting this one important issue would have profoundly beneficial impacts on the health of US citizens (male and female, adults and children) — and would resonate throughout the US healthcare system.
—————
PS — I realize that RFKjr has a special interest in the healthcare of children, and the EUA matter directly affects essentially all children.
PPS — RFKjr’s efforts regarding healthcare should be in parallel with the efforts of other pro-Science parties to fix education, energy, and climate change policies…
Here are other materials by this scientist that you might find interesting:
I am now offering incentives for you to sign up new subscribers!
I also consider reader submissions on Critical Thinking on my topics of interest.
Check out the Archives of this Critical Thinking substack.
WiseEnergy.org: discusses the Science (or lack thereof) behind our energy options.
C19Science.info: covers the lack of genuine Science behind our COVID-19 policies.
Election-Integrity.info: multiple major reports on the election integrity issue.
Media Balance Newsletter: a free, twice-a-month newsletter that covers what the mainstream media does not do, on issues from COVID to climate, elections to education, renewables to religion, etc. Here are the Newsletter’s 2024 Archives. Please send me an email to get your free copy. When emailing me, please make sure to include your full name and the state where you live. (Of course, you can cancel the Media Balance Newsletter at any time - but why would you?
Thanks for reading Critically Thinking About Select Societal Issues! Please pass a link to this article on to other associates who might benefit. They can subscribe for FREE to receive new posts (typically about once a week).
Can't disagree with the thrust to fix FDA EUA processes. But, I'd suggest little of what you propose will happen until the FDA's parent Secretariat (HHS) and sister organizations such as CDC are purged and overhauled.
At the least - the revolving door between Pharma and these agencies has to stop. The literal 'funding' of all of these agencies by Pharma, Big Ag etc has to stop. Allowing government employees to receive payments on patents and essentially kickbacks, has to stop. The grants and endowments from taxpayers to corrupted research and academics has to stop.
Perhaps outside the scope of your article here but...the FDA (HHS) should have no power of mandate and no power whatsoever over State/local health authorities.
Just as RFKjr can have a great effect on health issues, so Elon Musk will be in a position to cut funding currently wasted on all forms of emission reduction efforts.