Chevron & Remdesivir
Major Good News that the Mainstream Media is not publicizing
To understand this matter, I’ll use the FDA as an example of a government agency losing its way. How has it gone astray? Start with its own Mission Statement:
“The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human drugs…”
Let’s say that scientists, medical professionals, etc. have solid scientific evidence that the FDA is NOT “ensuring the safety, efficacy, and security of human drugs” on some matter. After being unsuccessful in approaching the FDA directly, they try to fix this by suing the FDA for deviating from their statutory obligations. However, thru June of 2024, they then ran up against courts allowing the FDA to use the Chevron defense.
This basically meant that courts would not get involved in adjudicating the scientific evidence or the merits of technical policies (medical, energy, climate, etc.), as they deferred to the “experts” at various federal agencies (FDA, CDC, DOE, EPA, etc.). As a result, 99% of lawyers would give up before even filing such a case.
The Net effect is that this gave federal agencies free rein to do just about whatever they wanted, as they had little fear of courts over-ruling their policies. Considering the competence level and politicization of most federal agencies, this situation led to some horrifically unscientific results (e.g., here).
This poor legal ruling also led to a death sentence for many Americans during COVID. The FDA declared that COVID was an emergency matter (it was), which meant that the FDA could shortcut its normal testing protocol. What resulted were “Emergency Use Authorizations” (EUAs) for COVID treatments and vaccines.
This in turn led to compromised safety and efficacy. However, due to the Chevron deference, no one would have any success in overturning these EUAs, no matter how unscientific (unsafe & ineffective) they were… REALLY BAD!
Effectively the courts had ruled that federal agencies: 1) were always providing scientific policies, and 2) such policies were always consistent with their statutory obligations and in the best interest of the public. What nonsense!
Let’s look at an example: the use of Remdesivir for treating COVID in hospitalized patients. Here is the initial FDA’s EUA. It said a variety of self-serving things:
“FDA’s emergency authorization of remdesivir, two days after the National Institutes of Health’s clinical trial showed promising results, is a significant step forward in battling COVID-19… From day one, the FDA has been committed to expediting the development and availability of potential COVID-19 treatments. Today’s action is an important step in our efforts to collaborate with innovators and researchers to provide sick patients timely access to new therapies where appropriate, while at the same time supporting research to further evaluate whether they are safe and effective.”
“Based on evaluation of the emergency use authorization criteria and the scientific evidence available, it was determined that it is reasonable to believe that remdesivir may be effective in treating COVID-19, and that, given there are no adequate, approved, or available alternative treatments, the known and potential benefits to treat this serious or life-threatening virus currently outweigh the known and potential risks of the drug’s use.
So what was the scientific basis for this EUA? The FDA’s site showed these studies. To the untrained eye, it looks like there is scientific legitimacy for this EUA. However, once the wheat is separated from the chaff, the takeaway is that the effectiveness of Remdesivir was about 10%. TEN PERCENT!
It gets worse. In an unprecedented move, five short months later the FDA then upgraded their EUA to an Approval (their top level of endorsement). The FDA said:
As a public health agency, FDA uses the best scientific information available to make decisions through a deliberative process. Drugs must undergo a rigorous evaluation of safety, quality, and effectiveness before they can be approved for use in the United States.
There is no publicly available evidence that the FDA subjected remdesivir to “a rigorous evaluation of safety, quality, and effectiveness.”
There are at least two takeaways from this:
1 - Normally the FDA does not Approve a drug (or vaccine) unless it has at least 50% effectiveness. That the FDA gave an EUA to a 10% effective drug — and then an Approval(!) — showed how low their standards had become.
2 - What is important is the NET consequence — i.e., Benefits minus Liabilities. The FDA did not appear to calculate that, as with only 10% Benefit, the Liabilities were likely in excess of that small number. (See the FDA’s remdesivir warnings.) [Note: here is a later Study identifying numerous remdesivir adverse side effects.]
There are predictable results from taking major scientific shortcuts.
A lot of the concerns with remdesivir were known relatively early on. Consider this 2022 Lancet Study. It compared the outcomes of Remdesivir + Standard Care to Standard Care by itself (!). The clear conclusion:
“In this randomized controlled trial, the use of remdesivir for the treatment of hospitalized patients with COVID-19 was not associated with clinical improvement at day 15 or day 29, nor with a reduction in mortality, nor with a reduction in SARS-CoV-2 RNA.” !!!
Was the FDA Approval subsequently withdrawn? No, it still exists today!
And it gets even worse. After the remdesivir EUA, independent scientists started conducting studies to assess the effectiveness of remdesivir. The current score is that after some seventy-two (72) studies of 187,000± subjects, the efficacy is only 1%!
ONE PERCENT!
[To see these studies plus lots more data about COVID treatments, see my webpage. To see a more detailed technical assessment of remdesivir’s effectiveness, read this.]
Bottom Line
The point of all this is not to expose remdesivir as being ineffective, as the cited studies do that. Rather, this debacle is an indictment of the FDA’s unscientific actions that were contrary to its statutory requirements.
A primary source of the blame here is due to Chevron. The evidence indicates that the FDA likely acted irresponsibly because they felt shielded by the Chevron deference.
I’ll end on a positive note.
As of 6-28-24, the US Supreme Court overturned the Chevron precedent! The implications of this are profoundly important.
This should mean that lawyers who were intimidated from suing a federal agency might now find the courage to do so. That in turn will hopefully mean that scientific aspects of technical federal policies will be more likely resolved based on scientific evidence, rather than a blanket deference to authority…
Some may argue that courts should not get involved with adjudicating scientific questions. However, considering how bad the current situation is, it would have to go a long way before it is worse than now.
The other benefit of this new ruling is that scientific arguments will now be publicly made in court. Forcing federal agencies to spell out the claimed science behind their technical policies is unquestionably a good thing.
Here are other materials by this scientist that you might find interesting:
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?
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Thanks for this insightful discussion.
About fifty years ago, an author characterized FDA as "the Frantic Dithering Administration."
"The other benefit of this new ruling is that scientific arguments will now be publicly made in court. Forcing federal agencies to spell out the claimed science behind their technical policies is unquestionably a good thing."
People have asked whether courts would have the expertise to do this. Of course, on their own, they don't. But honest judges would insist upon both adversaries, not just one, presenting expert witnesses.