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Monday, August 30, 2021

After The Third Time I've Seen This COVID Vaccine Dysinformation ...

(*Edited - content added)

I have seen two Americans, and one British person, showing memes of Fauci and his wife, Christine Grady, claiming that her being on the bioethics committee for the NIH means she had control over vaccine approval lol.

I didn't say anything to any of them, I'm just saying it here, because such dysinformation especially irritates me as a pharmaceutical transcriptionist.

Because that's not the way any of this works! lol

I'm especially embarrassed for the 2 Americans spreading this dysinformation - the ignorance, refusal to do their homework, or blatant dishonesty is astounding.   

First of all, the NIH and FDA are two separate entities - with the FDA being part of the executive branch of our government, while the NIH and CDC are not - they're part of Health and Human Services.  This means the FDA ultimately has authority over the NIH (and the CDC as well) - not the other way around.

It also means neither the NIH nor the CDC have the authority to approve drugs - in fact, approving drugs, or even recommending drugs, isn't even within the scope of focus or jurisdiction of either the NIH or the CDC.

The purview and purpose of the NIH and the CDC are researching disease states and  publishing new data (NIH) and/or evaluating public health diseases and providing standard-of-care guidelines for public health diseases (CDC) - period. 

Members of the NIH can sit on one of the many expert-reviewer panels for a new drug as disease-state experts - when asked to do so by the FDA - to help assess the results of clinical trials for a particular drug, and give their recommendations - which the FDA weighs and can even choose to ignore, should they choose (like they did with Aduhelm for Alzheimer's.)

There are several review panels, both government and independent review panels.  The review panels do typically contain members of the NIH,  but they are not solely comprised of just NIH members - also CDC experts, key-opinion leaders from academic institutions, members of medical societies/reputable publications for a specific disease state, as well as others considered experts in a disease state - but they are almost always MDs and PharmD's.

As experts in a specific disease state, the committee panels will be asked to give a review of a drug and their recommendations  - but it's several separate review panels who give their recommendations to the FDA via majority democratic vote for each committee -  meaning no one person ever has full control.

In the the end, the various review committees give their recommendations to the FDA (but never "approval") so that the FDA can weigh them and hopefully find a consensus for their decision, and it's rarely just a "yay" or "nay" recommendation vote, and they have to qualify and quantify the vote.   

For example, even if a clinical-review committees/panel gives a positive recommendation, they will usually include specifics, along with any concerns - i.e., recommendations for restricting the drug for specific indications or for a specific population, restrictions to a specific dosing, or they can even suggest to the FDA include a black-box warning for toxicity concerns or contraindications - which the FDA can consider, include in full or part, or even completely ignore (like the did with Aduhelm).

Now - though Fauci's wife, Christine Grady, is the Chief of Bioethics at the NIH - she is a nurse - making it highly unlikely that she has ever sat on any review panel for drug evaluation with the FDA, or even any P&T committee for any-scale government institution, large commercial institution, or insurance company.

Even sitting on the P&T committee for a regional or local hospital or clinic, helping to make decisions about adding drugs to their internal formulary, would be a stretch of her capacity as an RN, unless she also had an MBA (Master of Business) or MPH (Master of Public Health) and was a healthcare-business  administrator, rather than a clinician.

Also, her focus of bioethical research is in HIV - not COVID - and clearly, the people passing around this meme don't even know what  the word "bioethics" means (see below)

More importantly, her husband, Dr. Anthony Fauci is an MD, and is actually a medical director at the NIH -  the Director of NIAID (National Institute for Allergy and Immunology Department).

This means that unlike his wife - who again, is a nurse -  he has, and will continue to, sit on many review-committee panels, when the FDA asks him to, to review clinical trials. 

So if anybody had any pull on  the FDA's decision on vaccine approval, it'd be Fauci himself as an MD and an NIH director, requested by the FDA to sit on a review panel, not his wife - and yet still, he's one of many on a committee and just one vote for recommendation -  not approval!

Lastly, and most importantly, the people sharing these memes clearly don't know what bioethics means, and were too lazy to  look it up and find out lol.

(Or maybe the word "ethics" was like holy water to them, and the depraved souls simply recoiled from the term? lol.)

Bioethics is simply making sure that ethics have been upheld in clinical research and the field of medicine in general.

Bioethics have zero to do with efficacy and safety of a drug, and certainly not approving one - other than they check a box on whether or not the ethical standards were upheld during clinical trials for a drug - period.

The FDA has their own internal bioethics committee, and even they do not have the power to actually approve or not approve drugs - they simply make sure that ethical standards were followed and upheld in the clinical research presented by the pharmaceutical companies.

Therefore, the FDA has no need, nor would they appreciate, some nurse from the NIH coming in and telling them how ethical the clinical trials were, without being asked, because they have their own internal bioethics experts.

And they most definitely would not appreciate -  nor would they ever even ask -  a bioethics nurse educator's opinion on the actual efficacy and safety of a drug, and whether or not to approve it!!! 

So ... what have we learned from these memes?

All we've learned is that women-blamers and misogynists - and their female enablers - will go out of their way, beyond the point of reason, rationality, or even possibility - to try to find a way to blame a woman  - despite the fact that said woman literally has no power, authority, or educational or practical expertise to do so, but her husband does  - and it's hilarious!!!  LOL

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