Continuing my critique of Robert F. Kennedy, Jr.'s book, The Real Anthony Fauci: Bill Gates, Big Pharma, and the Global War on Democracy and Public Health. My first entry is here and you can follow the links from there.
After jumping ahead in the book to talk about ivermectin in a previous post, I'm coming back to a portion of the book about hydroxychloroquine.
Immediately prior to the section on hydroxychloroquine, Kennedy set up his arguments by presenting an extensive list of drugs, supplements, and compounds as COVID treatments and prophylaxis. He quotes one doctor as saying he used such treatments on 2,000 patients and that "Using repurposed drugs, we could have ended the pandemic by May 2020 . . ."
Kennedy goes on to place special focus on two drugs: ivermectin and hydroxychloroquine.
Title of Subchapter: Killing Hydroxychloroquine
RFK, Jr. begins his presentation on hydroxychloroquine by saying "Most of my fellow Democrats understand that Dr. Fauci led an effort to deliberately derail America's access to lifesaving drugs and medicines that might have saved hundreds of thousands of lives and dramatically shortened the pandemic."
He provides no source for that remarkable statement. I did find these polls:
"79% of Democrats said Fauci has done a good or excellent job handling the pandemic, compared with 56% of independents and 54% of Republicans." October 14, 2020
This next poll is from January, 2022, three months after Kennedy's book and includes numbers going back to April, 2021.
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| 88% of Democrats very or somewhat confident in Fauci. |
RFK puts forward that Fauci and Bill Gates had to put the kibosh on hydroxychloroquine and other agents because they could not pursue vaccine research under emergency use authorization if alternative candidates were available.
Kennedy: "Under federal law, new vaccines and medicines cannot quality [sic] for Emergency Use Authorization (EUA) if any existing FDA-approved drug proves effective against the same malady."
Kennedy goes on to quote part of the law regarding emergency use authorization.
"For FDA to issue an EUA, there must be no adequate, approved, and available alternative to the candidate product for diagnosing, preventing, or treating the disease or condition."
He leaves out the sections of the law that goes on to describe exceptions. He doesn't mention the fact that EUA does not prevent research into the vaccine. (There was no vaccine to authorize to use.) He leaves out the fact that alternative and imperfect treatments were available and approved for preventing and treating COVID (dexamethasone, vitamin D3, remdesivir, and Regeneron's antibodies) before vaccines became available, some with emergency use authorization. (And certainly diagnosing was available.)
Before talking about the effectiveness of hydroxychloroquine for COVID, RFK talks about its relatively safety. He out and out lies.
The Toxicity of Hydroxychloroquine.
Kennedy says, "It [hydroxychloroquine] is a generally benign prescription medicine, far safer -- according to the manufacturer's package inserts -- than many popular over-the-counter drugs."
All right, let me say even before visiting the link Kennedy provides, that his claim doesn't pass the sniff test. Being a pharmacologist, I've read many drug package inserts and none of them make claims like their drug is "far safer than many popular over-the-counter drugs." These inserts are put together to cover the drug manufacturers' asses. Rather than making Pollyannish claims about safety, they are filled with dry warnings about potential complications. Visiting the page (and you can, too, last updated in 2017, so it is what Kennedy had available), no general claims that hydroxychloroquine is safe are made.
The insert does present a page of warnings, a page-and-a-half of precautions and drug interactions, and a page of adverse reactions.
From the CDC advisory (2017): "There are only a few places left in the world where hydroxychloroquine is still effective [against malaria] including parts of Central America and the Caribbean."
So, Does Hydroxychloroquine Work to Treat or Prevent COVID-19? In Vitro Studies.
It is not necessary to be directly antiviral to provide a benefit to treating COVID. Hydroxychloroquine is a powerful antiinflammatory and inflammation can contribute to COVID's pathology. Early on, dexamethasone, a powerful antiinflammatory drug, was shown to be life-saving for those COVID patients on respirators.
With hydroxychloroquine, we run into two problems: it is relatively toxic (as mentioned above), and those promoting its use for COVID claim that, unlike dexamethasone, it is also directly antiviral and can be used for prophylaxis. Using drugs for prophylaxis carries special concerns because the users may be taking the drug for a continuing length of time.
So, first of all, does hydroxychloroquine work in vitro, and if so, at what concentration? In other words, is it directly an antiviral?
The below graphs present the effectiveness of hydroxychloroquine (and chloroquine) in the inhibition of COVID virus in cell culture. CC50 is also presented. It is the important experiment that looks at how much drug it takes to kill the cells. (A lot, for hydroxychloroquine, 50% death at 250 μM.) The various MOI are related to the dose of the virus. It addresses the concept of more exposure to virus perhaps needs more drug. These graphs show that the 50% inhibitory concentration of hydroxychloroquine is 2.7 μM at the lowest MOI and 13 μM at the highest tested MOI. Translated to ng/mL (to compare to the dosing numbers below) these numbers are 907 and 4367, respectively. (Interestingly, chloroquine performed slightly better than hydroxychloroquine in this study.) The SI numbers reported reflect a ratio, the selective toxicity to the virions versus the cells.
What is the standard plasma concentration of hydroxychloroquine at doses that are given to patients? From a study of 527 patients taking hydroxychloroquine for lupus, the mid-range of plasma mean concentrations was approximately 1000 ng/mL. This is above the IC50 for the lowest MOI tested.
A different study showed a lower dose of hydroxychloroquine needed for treating an in vitro infection (720 nM for 48 hours), but a higher than ordinary dose for prophylaxis (approximately 6000 nM). The prophylactic dose would be 2000 ng/mL, at the high end of commonly-used concentrations.
So, unlike ivermectin, a standard therapeutic dose of hydroxychloroquine is within the range of acting as antiviral therapy (although not prophylaxis). This paper does a good job of taking into consideration the factors that compare in vitro efficacy of COVID-19 to the potential effectiveness in the patient.
There is a lot of technical talk above, but what I am saying is that hydroxychloroquine is not being eliminated as a potential therapeutic based on in vitro studies. So, does it work in patients?
To be continued.
Martin Hill Ortiz is the author of several novels including most recently the thriller, Floor 24.
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| Floor 24 Oliver-Heber Books |
"From the mob underworld to the tops of new skyscrapers, Floor 24 is a heart-thumping New York 1920's historical mystery!" - Holly Newman, bestselling author of A Chance Inquiry mystery series.
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