Saturday, December 21, 2024

Robert F. Kennedy's book on "The Real Anthony Fauci." Hydroxychloroquine, Part One

  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.


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.


After describing the popularity of hydroxychloroquine in Africa and their use of it as a prophylaxis for malaria, Kennedy says that, "HCQ [hydroxychloroquine] is the #1 most used medication in India . . ." No. Hydroxychloroquine is no longer commonly used for malaria prophylaxis. There is way too much resistance. I was told this back when I was taking medical pharmacology in the 1980s.



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."



A February 2021 study of hydroxychloroquine for COVID found severe cardiac effects (including torsades de pointes arrhythmias and cardiac arrest) occurring in 3 out of 1000 patients, and 5% of patients having to discontinue the drug for cardiac problems.



Another paper summarizes the toxicities of hydroxychloroquine. 



"Cardiomyopathy (0.7%), palpitations (0.6%), cardiac failure (0.4%), tachycardia (0.3%), cardiac failure congestive (0.3%), nausea (5.3%), diarrhoea (3.6%), abdominal discomfort (2.4%), vomiting (2.3%), abdominal pain (1.3%), insomnia (0.7%), depression (0.6%), anxiety (0.4%), completed suicide (0.3%), sleep disorder (0.3%), headache (2.8%), dizziness (2.1%), visual field defect (0.6%), paraesthesia (0.6%), hypaesthesia (0.6%)."


Hydroxychloroquine can cause hypoglycemia, a concern for diabetics, especially those taking insulin. Taken over long periods, it causes retinopathy.


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. 

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.


 


Wednesday, December 18, 2024

Robert F. Kennedy's book on Anthony Fauci: The Most Eye-Opening, Jaw-Dropping Statements

  This is my eleventh entry in 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. So far, I have written over 20,000 words in my critique and have covered six pages of the Acknowledgments & Dedication, ten pages of the Introduction and nineteen pages of Chapter One. This works out to be more words in my critique than in the book (so far). This is because Kennedy tosses out one ridiculous line after another, sometimes not providing any reference in support, sometimes providing a reference that shows his statement to be a lie. One sentence from Kennedy often requires several sentences to set the record straight. 

The next entry.


In my last entry I discussed ivermectin, a drug which Kennedy spent many pages promoting as a treatment for COVID (according to the Index, it is referenced on 32 pages). I had hoped to continue by discussing hydroxychloroquine, a more complex candidate for aiding COVID patients. I will save that analysis until after the holidays. For now, I will summarize some of my findings.


The Most Eye-Opening, Jaw-Dropping, Ridiculous Statements in the Book Thus Far.


I didn't know what I was stepping into by reading this book. I had supposed that Robert F. Kennedy, Jr. would at least try to make a reasoned argument. Instead, it is page after page of poorly-thought-out material from a disoriented mind who knows little to nothing about science. 


There are no page numbers in my copy of the book (although references to page numbers exist in the Index and Table of Contents). The page numbers presented for the quotes given below are from hand-numbering. I numbered the Introduction using Roman numerals (i to xiv) and the pages in the first chapter beginning with the number 1. 


#1. Kennedy cites lunatics.


Kennedy cites various doctors, describing them as bravely responding to the arrival of COVID by immediately putting forward their own recipes for treating the disease. He quotes Dr. David Brownstein of Detroit (page 15, Chapter One, emphasis below in bold, mine). 


"'We've been treating viral diseases here for twenty-five years, COVID can't be any different.' In all that time, our office had never lost a single patient to flu or flu-like illness. We treated people in their cars with oral vitamins A, C, and D, and iodine. We administered IV solution outside all winter with IV hydrogen peroxide and vitamin C. We'd have them put their butts out the car window and shot them up with intramuscular ozone."


Kennedy doesn't recognize that this statement is batshit insane and, rather than support his arguments for physicians being heroic, shows that Kennedy knows nothing about medicine or patient well-being. IV hydrogen peroxide has no special advantage to treat a viral infection and, if it were administered in any antiviral concentration, it would be poisonous to the patient. Ozone becomes a liquid at -112 degrees Celsius. So, if not liquid ozone, were the IM injections by gas? In his Dedication & Acknowledgments, Kennedy cites Dr. Brownstein as part of his "Heroic Healers Honor Roll." 


Kennedy cites several other doctors who performed human experimentation using drugs and compounds to treat COVID which could politely be called unproven treatments. As I note in my entries, the doctors themselves cite evidence that they didn't have the required institutional board approval for ethical research. The were egomaniacs administering sometimes dangerous drugs.


Before treating someone in a study with a drug like hydroxychloroquine, it is necessary to have approved inclusion and exclusion criteria. Exclusion criteria (for excluding prospective patients from the study) for hydroxychloroquine would include patients with arrhythmias and those with G6PD deficiency, among other prerequisites. When the pioneering doctors that Kennedy references published, if they made any reference to receiving approval for their protocols, they made clear they had approval covering retrospective analyses, not for the patient treatments.


#2. Kennedy believes that Fauci is responsible for virtually all things bad that have happened in the health world since the mid-80s. 


From page ix of the Introduction.


"Some 80 autoimmune diseases, including juvenile diabetes and rheumatoid arthritis, Graves' disease and Crohn's disease, which were practically unknown prior to 1984, suddenly became epidemic under his [Fauci's] watch."


First of all, the claim of a great increase in the numbers isn't the case. Kennedy provides one citation in the reference to this claim. It refers to a study conducted in a single Polish hospital regarding juvenile diabetes in a retrospective analysis and which, among other things, doesn't mention Crohn's disease. Second of all, any doctor who has been practicing since the 1980s knows that the listed diseases were not "practically unknown." Kennedy makes wild statements and doesn't care what his citations say.


From page viii-ix of the Introduction. 


"Under Dr. Fauci's leadership, the allergic, autoimmune, and chronic illnesses which Congress specifically charge NIAID to investigate and prevent, have mushroomed to afflict 54 percent of children, up from 12.8 percent when he took over NIAID in 1984."


Do over half of children today have such illnesses? A ridiculous assertion which Kennedy doesn't even try to defend with a citation. From a scientific point of view, measuring the prevalence of all allergic, autoimmune, and chronic illnesses (which fall under NIAID) from a specific year, 1984 to date, is a near impossible task. (Even more so, the 80 diseases cited above). Lots of studies are out there trying to tackle the prevalence of one specific disease.


#3. Kennedy blames Fauci for worldwide disasters and millions of deaths.


From page vi of the Introduction: 


"As Dr. Fauci's policies took hold globally, 300 million fell into poverty . . . [and] In 2020, disruptions to to health and nutrition services killed 228,000 children in South Asia."


In my blog posts, I point out that Kennedy's citations do not support what he says on the above matters. Furthermore, Fauci's policies did not control the worldwide response to COVID beyond Kennedy's imagination that Fauci was all-powerful.


Kennedy cites Dr. Vladimir Zelenko who put forth the assertion that COVID vaccines themselves caused millions of deaths


#3a. Kennedy blames Fauci for such things as the destruction of global democracy and the American middle class and much more.


From page viii of the Introduction. In one incredibly poorly-written run on sentence that repeats item after item such as constitutional rights and Bill of Rights as though they were non-overlapping things, Kennedy says:


"With fears of COVID generously stoked, the dramatic and steady erosion of constitutional rights and fomenting a global coup d'état against democracy, the demolition of our economy, the obliteration of a million small businesses, the collapsing of the middle class, the evisceration of our Bill of Rights, the tidal wave of surveillance capitalism and the rising bio-security state, and stunning shifts in wealth and power going to a burgeoning oligarchy of high-tech Silicon Valley robber barons seemed, to a dazed and uncritical America, like it might be a reasonable price to pay for safety." (And if this repetition weren't bad enough, the previous sentence bemoaned how an "outlaw gang has stolen our democracy, our civil rights, our country, and our way of life . . .)


I guess you have to be a conspiracy theorist to get paid for such mediocre thinking and writing.


#4. Kennedy sometimes cites unqualified or else unsavory people and sources. 


Kennedy cites Alex Gutentag as an authority, not mentioning that Gutentag is a middle-grade school teacher. (He is responsible for the above quote about 228,000 children dying.)


Kennedy makes this particularly snarky claim: "Dr. Fauci dreamily recounted his own grade school measles and mumps vaccines—an unlikely memory since those vaccines weren't available until 1963 and 1967 [respectively], and Dr. Fauci attended grade school in the 1940s." (page 4, Chapter One)


First of all, the mumps vaccine came out in 1948 (1950 for widespread use when Fauci was still in grade school). Second of all, the citation that Kennedy provides saying Fauci "dreamily recounted" such a memory is a Twitter post from a group described (in Wikipedia) as one that promotes neo-Nazi propaganda. 


Kennedy not knowing when the mumps vaccine came out segues into the next problem. 


#5. Kennedy doesn't know science. 


From page 6, Chapter One.


"During the centuries that science has fruitlessly sought remedies against coronavirus (aka the common cold), only zinc has repeatedly proved its efficacy in peer reviewed studies."


Coronaviruses are neither "aka the common cold" nor are they the main cause. From the American Lung Association. "Rhinoviruses are the most common cause of colds in the U.S. Parainfluenza viruses, adenoviruses, enteroviruses, human metapneumovirus and common human coronaviruses also cause colds." Coronaviruses cause about 20% of common colds. 


Kennedy did inadvertently state a truth: lots and lots of compounds don't work as antivirals. 


#6. Kennedy often cites sources that plain disagree with what he is stating or simply disagree with him about issues such as vaccines.


One of the most egregious examples comes with this quote. Page 5 of Chapter One. Kennedy begins by referencing his own obsessions about conspiracies surrounding 9/11.


"Public surveys showed that, just as Fox News audiences were shockingly misinformed following the 9/11 bombings, CNN viewers and New York Times readers were catastrophically misinformed about the facts of COVID-19 during 2020. Successive Gallup polling showed that the average Democrat believed 50% of COVID infections resulted in hospitalization."


Kennedy provides a citation for this Gallup poll. It says nothing like what he claims it does. First, it doesn't mention anything about CNN viewers or New York Times readers. Second, while it does discuss Democrats views on what percentages of COVID infections result in hospitalizations, it divides up that perception of risk into whether the individuals at risk were vaccinated or unvaccinated. In their survey they found 54% of Democrats said that risk was 1% or less for those vaccinated, and only 2% said that the risk was higher than 50%. As for the risk for those unvaccinated, 41% of Democrats said that the risk was 50% or greater. Furthermore, the survey pointed out their own numbers said that being vaccinated led to a 78-fold reduction in hospitalizations. 


Vaccination rate by Political Affiliation, U.S. through September 2021
From the abovementioned Gallup Poll


Kennedy cites Stephen Woolf of the Virginia Commonwealth University regarding the decreased longevity in the U.S. subsequent to COVID. He doesn't cite Woolf decrying COVID conspiracy theorists and the fact that Woolf supports COVID vaccination. 


#7. Kennedy seems to think America followed Fauci's recommendations.


Mandatory stay-at-home orders for COVID for much of the country lasted six weeks or less. Many states never had mandatory orders. Five states never passed even voluntary lock downs (Arkansas, Connecticut, Nebraska, North Dakota, and Wyoming). Superspreader gatherings were regular occurrences. There was massive resistance to masking. America had a poor vaccination rate compared to many countries which had much better survival rates. 

 

#8. Kennedy often presents lies when it would be easy to tell the truth. 


I find this to be one of Kennedy's most annoying habits. From the Introduction, page iii. 


"Dr. Anthony Fauci spent half a century as America's reigning health commissar . . ." (Kennedy repeats this claim of Fauci having 50-year "regime.") 


As of the publication date of Kennedy's book, Fauci had been the head of the NIAID for 37 years. The NIAID has a small percentage of the budget of the National Institutes of Health and even a smaller percentage of budget for U.S. health research. Kennedy lied about Fauci's career and influence to make his wild claims. 


Continued with a look at hydroxychloroquine.


Martin Hill Ortiz is the author of several novels including most recently the thriller, Floor 24. 

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.


 

Monday, December 9, 2024

Continuing with reviewing Robert F. Kennedy's book on Dr. Anthony Fauci. Entry Ten

   This is my tenth entry in 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. Why so many entries, why so many words? It is easy to hurl out lies. Truth-telling takes more time. The next installment is here.


I had hoped to get as far as the entries on ivermectin and hydroxychloroquine in my last installment. Instead, I'll start broaching those topics here. 


Ivermectin


Principle #4. Bad science does get published. Sometimes in respectable journals.


Principle #4a. Over time, good science tends to win out. Why the delay? Because good science is slow.


Bad science gets published, quite often in marginal journals. Some science journals exist solely to make money and have no regard for science integrity. "Scandals" pop up from time to time when scientists, seeking to expose such journals, send in joke articles that would be clearly rejected if anyone competent at the journals bothered only to read it. 


An extreme example of this was a scientist who sent off and had published an article that claimed, among other things, that the state New Mexico was part of the Galapagos Islands. Co-authors of the paper were claimed to be the Breaking Bad characters, Walter White and Jessie Pinkman. 


Being published is not the hallmark of being proven good. This makes it difficult for the non-scientist consumer (and for scientists as well) to evaluate the worth of a published scientific claim. 


While sometimes the claims that a bad treatment works only appears in sketchy journals. Sometimes good journals get things wrong. I have already discussed ivermectin in vitro. Here, I will go into clinical trials in humans.


One review in favor of the efficacy of ivermectin for the treatment of COVID-19 was published in the American Journal of Therapeutics, the first author being Pierre Kory, a strong advocate for ivermectin treatment. This paper was in a form of review called a meta-analysis. This sort of analysis combines the data from previous papers to see how they support or conflict with one another and what conclusion can be derived from those studies.


The review in American Journal of Therapeutics and its conclusions were brought into question nearly immediately. The review included unpublished studies (or "preprints," that are made available to read, but not yet approved for publication), eight in all. It included studies where the subjects did not provide prior consent. 


Using preprint articles is risky. Sometimes such papers never get published because they have fundamental flaws. The largest study, in terms of numbers of participants (Elgazzar, et al.), used in Kory's paper was unpublished and later retracted. Among its many problems, "The authors claimed they conducted the study between the 8th of June and 20th of September 2020, however most of the patients who died were admitted into hospital and died before the 8th of June according to the raw data." And "The main error is that at least 79 of the patient records are obvious clones of other records." Another study by Niaee, et al., was called into question for unrealistic data. A third study by Khan was called into question


The flaws in these studies are often uncovered by "science police." These are a network of scientists who review studies to ensure that they were properly done. Sometimes they find outright fraud. Eleven ivermectin studies are among the 461 (at the time of writing this) COVID papers that have been retracted. One study was withdrawn after its author admitted that, instead of COVID results, he had accidentally analyzed data from a file used to teach students statistical analyses. A science watch group, Retraction Watch has listed two of Kory's meta-analyses under their category of "Expressions of Concern" due to relying on specious studies, including the American Journal of Therapeutics meta-analysis.


Dr. Kory went on to write a book "The War on Ivermectin: The Medicine That Saved Millions and Could Have Ended the COVID Pandemic."


His book cover has that same design aesthetic as does Kennedy's. 



Cochrane reviews are sort of the "gold standard." They maintain high standards as to what studies are included in their reviews/analyses. While the Kory meta-analysis came out in May, 2021 and included 24 studies, Cochrane first came out in July, 2021 and found 14 studies that met their criteria. Drawing results from these were difficult because they (quite rightly) examined different questions. Was ivermectin good for prophylaxis? Was it useful for inpatient care? Was it useful for outpatient care? The paper came to the conclusion: "Based on the current very low‐ to low‐certainty evidence, we are uncertain about the efficacy and safety of ivermectin used to treat or prevent COVID‐19. The completed studies are small and few are considered high quality."


Cochrane made a follow-up review in June, 2022. Unfortunately, more time resulted in fewer studies being included. "We excluded seven of the 14 trials included in the previous review version; six were not prospectively registered and one was non‐randomized. This updated review includes 11 trials with 3409 participants investigating ivermectin plus standard of care compared to standard of care plus/minus placebo."


This time their conclusions were more brutal. "For outpatients, there is currently low‐ to high‐certainty evidence that ivermectin has no beneficial effect for people with COVID‐19. Based on the very low‐certainty evidence for inpatients, we are still uncertain whether ivermectin prevents death or clinical worsening or increases serious adverse events, while there is low‐certainty evidence that it has no beneficial effect regarding clinical improvement, viral clearance and adverse events. No evidence is available on ivermectin to prevent SARS‐CoV‐2 infection."


Note: Cochrane Reviews is notoriously rigorous in their analyses. It is hard to impress them. 


Kennedy's book has tables for three outcomes: prophylaxis, early treatment, and mortality. They list a total of 38 studies. All but one shows marked improvement using ivermectin. He almost entirely excluded studies that showed no effect or ambiguous results.


Kennedy's book goes on to interview Andrew Hill who had his own study about ivermectin retracted


A 2024 meta-analysis in International Journal of Antimicrobial Agents that looked at ivermectin in 7035 non-hospitalized patients came to the conclusion "In non-hospitalized COVID-19 patients, ivermectin did not have effect on clinical, non-clinical or safety outcomes versus controls. Ivermectin should not be recommended as treatment in non-hospitalized COVID-19 patients."


So, how to sort things out? The principle applies: good science is slow. That's because good science is rigorous. Bad science is slapdash. Maintain a high degree of skepticism until confirmatory work is done. But how will we know if the confirmatory work is true? This is difficult. Learning to sort the good from the bad can be done, but it often requires a lot of expertise that takes years to hone. As I have mentioned, there are watchdog groups in science who look for bad science. They are usually driven by a desire for integrity in science. Unfortunately, even experts make mistakes. Drugs get approved that shouldn't have been. 


To some extent this is related to a general problem we are faced with the dilemma of modern day life. Things out there are so complex that we have to rely on experts. How to sort out which experts to trust is a topic that is too long to cover here. People who claim to be experts are often self-described experts. (I used to go around proclaiming the cynical quote: "The bad news: the experts are always wrong. The really bad news: we're the experts.")


Continued with a summary of the most jaw-dropping quotes.  

Martin Hill Ortiz is the author of several novels including most recently the thriller, Floor 24. 

Floor 24
Oliver-Heber Books



Ivermectin is a great drug for treating certain worm infections. Its discovery was rewarded with a Nobel Prize. At the concentrations used to treat worm infections, it has low toxicity. (Nothing is completely non-toxic.) Let's look at it for treating COVID-19.




Principle #3. Finding compounds that work against viruses is hard. Attacking viruses through pharmacology is difficult.




The whole concept of antiviral therapy is to be toxic to the virus while being much less toxic to the host (e.g., human). This concept is called selective toxicity. Ozone kills viruses. It also kills human cells. Before there were good treatments for AIDS, there were a lot of treatments that had no selective toxicity, for example, taking the blood out of the body and heating it up to the point it killed the virus. That same method also killed the white blood cells which the virus was targeting anyhow. The method was useless.




Viruses are closer to being vectors than living creatures. They are guerilla warriors. They attach to specific human cells, enter them, possess a few mechanisms (through proteins called enzymes) to make more copies of their genetic information while plundering the cell's resources (like guerilla raiders), package those copies, and break out of the cell to go on to invade more cells. That provides precious few targets to attack. Most antiviral compounds target the few enzymes the virus uses to make more viruses, or they bind to the virus in the blood (antibodies/vaccines which produce antibodies), or they block entrance into the cell. There are damned few truly good antiviral drugs, those which are effective and which do not have significant toxicities. Ivermectin has been argued to have direct antiviral actions.




To be fair, I should note, that you can contribute to the health of a COVID patient without directly attacking the virus. Vitamin D, by supporting the immune system, does this. Dexamethasone, by lowering inflammation---which can become acute and even fatal during COVID's disease course---is helpful, even though dexamethasone lowers the immune system. 




Principle #3a. When it comes to judging a novel therapy, something that has been shown to work in the laboratory seldom works in real life.




Broadly speaking, to prove the effectiveness and safety of a drug, there are three stages: in vitro, preclinical trials (animal), and clinical trials (human). Let's start by looking at ivermectin in the laboratory. In the case of examining drugs that have already been approved, safety studies have mostly been done. In rare situations, using a known drug for a new indication may run into new toxicities. It should also be stressed that, just because safety studies have been done, that doesn't make an approved compound safe. Every drug has potential toxicities.




In vitro, colloquially means showing a drug has an effect in a test tube. More commonly, these experiments take place in well plates. A well plate is an array of tiny depressions. Each well provides an environment to examine a set of conditions. In this setting, testing an antiviral drug requires three ingredients: human cells (which the virus infects), the virus (often at different amounts representing different degrees of exposure), and different concentrations of the treatment being examined. If the treatment works in vitro, the drug rescues the cells from viral damage or death, or else limits or prevents viral growth. At the same time, some wells have the drug (at various concentrations) without the virus to examine whether the drug is toxic to the cells. (You can kill the virus by killing the cells.) 




For drugs that work, its effects follow a dose-response relationship: more dose, more response, and  hopefully with little to no toxicity at the effective levels. With too little drug there is no effect. With increasing amounts of drug that works you achieve a maximal effect (for example, completely stopping the virus). The response follows a curved line between no effect and maximal effect and from that you can determine the concentration which is 50% effective in inhibiting the virus. 





Each "well" is like a tiny test tube.




Ivermectin has an anti-COVID effect in vitro. This can be seen in the graph below. 





Ivermectin, in vitro inhibition of COVID-19 (from above cited article).




From the above graph, several things stand out. One is that the concentration of the drug that inhibits 50% of viral growth (IC50) is 2.8 µM. Secondly, strangely, even 2.0 µM seems to have little effect before a very steep drop. 




So, what does 2.8 µM mean? One small problem is that these concentrations tend to get reported in two ways in literature, either as µM (or nM) or else by µg/mL (or ng/mL). The number 2.8 µM is equivalent to 2450 ng/mL. 




This study found peak concentrations of ivermectin in plasma to treat worm in infections in humans to be 60 ng/mL. Other studies are summarized here, which compares the worm-treating dose to the COVID-treating dose: "even with the highest reported dose of approximately 1700 µg/kg (i.e., 8.5 times the FDA-approved dose of 200 µg/kg), the maximum plasma concentration was only 0.28µM" (one tenth the dose needed for 50% inhibition). 




Or, it could be worse than that. There are aspects of pharmacological effect that are not covered in vitro. Ivermectin has a plasma protein binding of 93.2% (seen in plasma, not in well plates). Therefore, only 6.8% of it is available in its active concentration inside the circulatory system. Even more critical is the intracellular concentration, since the antiviral effect takes place in the cell. 




The antiviral effect in humans takes place at a concentration that is forty to several hundred times above its human worm medicine dose. This is consistent with a general truth: in vitro effects rarely carry over to therapeutic effects in humans. 




Principle #4. Bad science does get published. Sometimes in respectable journals.




Principle #4a. Over time, good science tends to win out. Why delayed? Because good science is slow.




Bad science gets published, quite often in marginal journals. Some science journals exist solely to make money and have no regard for science integrity. "Scandals" pop up from time to time when scientists, seeking to expose such journals, send in joke articles that would be clearly rejected if anyone competent at the journals bothered only to read it. 




An extreme example of this was a scientist who sent off and had published an article that claimed, among other things, that the state New Mexico was part of the Galapagos Islands. Co-authors of the paper were claimed to be the Breaking Bad characters, Walter White and Jessie Pinkman. 




Being published is not the hallmark of being proven good. This makes it difficult for the non-scientist consumer (and for scientists as well) to evaluate the worth of a published scientific claim. 




While sometimes the claims that a treatment works only appears in sketchy journals. Sometimes good journals get things wrong. 




One review in favor of the efficacy of ivermectin for the treatment of COVID-19 was published in the American Journal of Therapeutics, the first author being Pierre Kory, a strong advocate for ivermectin treatment. This paper was a form of review called a metanalysis. It combined the data from previous papers to see how they supported (or conflicted) with one another. 




This review and its conclusions were brought into question nearly immediately. The review included unpublished studies ("prepublished," that is made available but not approved for publication), eight in all. It included studies without prior consent. 




The largest study, in terms of numbers of participants, used in Kory's paper was unpublished and later retracted. A second study 




 Several of the studies were called into question due to signs that the results had been faked. One unpublished study in particular, the one with the most participants, was retracted. Among its many problems, "The authors claimed they conducted the study between the 8th of June and 20th of September 2020, however most of the patients who died were admitted into hospital and died before the 8th of June according to the raw data." 




Eleven ivermectin are among the 461 COVID papers that have been retracted. A science watch group has listed two of Kory's metanalyses under "Expressions of Concern" due to relying on specious studies.




Dr. Kory went on to write a book "The War on Ivermectin: The Medicine That Saved Millions and Could Have Ended the COVID Pandemic."





His book cover has that same design aesthetic as does Kennedy's. 




Cochrane reviews are sort of the "gold standard." I say this because they maintain high standards as to what studies are included in their reviews/analyses. While the Kory review that came out in May, 2021 and included, Cochrane came out in 




So, how to sort things out? The first principle applies: good science is slow. That's because good science is rigorous. Bad science is slapdash. Keep a high degree of skepticism until confirmatory work is done. But how will we know if the confirmatory work is true? This is difficult. Learning to sort the good from the bad can be done, but it often requires a lot of expertise that takes years to hone. There are watchdog groups in science who look for bad science. They are usually driven by a desire for integrity in science. Unfortunately, even experts make mistakes. Drugs get approved that shouldn't have been. 




To some extent this is related to a general problem we are faced with the dilemma of modern day life. Things out there are so complex that we have to rely on experts. This leads to a topic that is too long to cover here. People who claim to be experts are often self-described experts. (I used to go around proclaiming the cynical quote: "Bad news, the experts are always wrong. Really bad news, we're the experts.")



To be continued. 


Martin Hill Ortiz is the author of several novels including most recently the thriller, Floor 24. 



Floor 24

Oliver-Heber Books


Saturday, December 7, 2024

Robert F. Kennedy, Jr.'s Book on Fauci. A look at alternative drugs.

  This is my ninth entry in 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. Why so many entries, why so many words? It is easy to hurl out lies. Truth-telling takes more time.


A Multitude of Drugs


Two basic problems with this book, as I've already mentioned, are the lack of page numbers and the lack of attaching specific citations at the end of the chapters to specific statements in the book. It seems as though the book was self-published and unedited. 


One reason I skip over commenting on some individual claims by Kennedy, is that he makes many remarkable assertions and provides no sources: nothing that matches up to the citation list at the end of the chapters. These include quoting people, statistics, and studies he refers to.


A good example of this begins on page 10 of Chapter One. (I self-numbered the pages out of frustration.) A statement is made regarding the percentage of deaths that occurred in nursing homes. Referring to the citations at the end of the chapter, this corresponds to two references, numbers 45 and 46. Good. Skip over two pages and the next reference that can be attached to the claims about drugs/treatments is on page 13. It refers to the use of hyperbaric chambers in the treatment of COVID. Very specific and matches up to reference numbers, 48 and 49. This leaves at least two pages without any reference beyond number 47 which references the FLCC Alliance, mentioned on page 11. 


No references are provided for a multitude of assertions in those two pages, including the effectiveness of many, many compounds that are said to treat COVID. Several of the compounds he has already brought up: hydroxychloroquine, ivermectin, zinc, and vitamin D. Others he lists in a dizzying rap. "Monoclonal antibodies work great" [no they didn't], azithromycin, doxycycline, Celebrex (brand name for celecoxib), bromhexine, NAC (n-acetylcysteine---he also lists "glutathione precursor" which is NAC), IV vitamin C (for God's sake, why stick a needle in someone's arm to give them vitamin C?), quercetin, colchicine (which he strangely capitalizes, he capitalizes several generic drug names), aspirin, fluvoxamine (a pretty serious drug with lots of interactions), and famotidine (he also lists Pepcid separately, a brand of famotidine). These are just the compounds listed before he gets around to providing his next reference, which refers to mouthwashes. 


He promotes a whole variety of mouthwashes/nasal irrigants, including povidone iodine, hydrogen peroxide, hypochlorite, Listerine, and cetylpyridinium chloride. He provides a single footnote reference for this which links to an article that asks the question: Did viral rinsing help ASEAN control pandemic or swift action? (an article in the newspaper: India Today) The nasal rinsing study it cites took place in 2019, before COVID.


Some drugs he goes on to name make a limited amount of sense. Dexamethasone had been approved for treating COVID and it is virtually interchangeable in action with the ones he mentions, prednisone, budesonide, and hydrocortisone. (They are also rather toxic and should be reserved for severe cases. One of their toxicities is to lower the immune system. Dexamethasone is chosen because it is longer acting.)


IV Peroxide and Ozone and Other Interventions


This next part comes at the top of a page. As I read it, I thought, I must have skipped ahead as I turned pages. This sounded like satire or else that it must have been introduced with the phrase, "They accuse of us doing ridiculous things like . . ."


Dr. David Brownstein of Detroit. "'We've been treating viral diseases here for twenty-five years, COVID can't be any different.' In all that time, our office had never lost a single patient to flu or flu-like illness. We treated people in their cars with oral vitamins A, C, and D, and iodine. We administered IV solution outside all winter with IV hydrogen peroxide and vitamin C. We'd have them put their butts out the car window and shot them up with intramuscular ozone." (All winter is a strange statement. He published his article in July 2020 and COVID wasn't around for the winter before that.)


IV hydrogen peroxide and intramuscular ozone echo the claim that then President Donald Trump recommended injecting bleach to treat COVID. To be fair, Trump phrased it as a question.


Dr. Brownstein, along with his medical degree, is a graduate of the Desert Institute of Classical Homeopathy. He went on to describe his persecution for his work. "I've been in litigation with the Medical Board for about a year." This is followed by: "In July 2020, Brownstein and his seven colleagues published a peer-reviewed article describing his stellar success with early treatment. FTC sent him a letter warning him to take it down." Brownstein's article is not referenced in Kennedy's citations, but it is not too difficult to find. It was published in Science, Public Health Policy, and The Law, a journal that is directed to health policy rather than clinical studies. 


Brownstein described how he obtained his study participants. "For the calendar year of 2020, charts were retrospectively reviewed for the presence of COVID-19 diagnosis occurring from February 2020 through May 2020." February? The first case of COVID-19 in Michigan came on March 10, 2020. Furthermore, he said he retrospectively reviewed charts for his study but also said he had informed consent which, ethically, should have taken place before treatment.


Brownstein alluded to his jabbing the rear ends of his patients through their car windows in his manuscript. "Since we were only treating COVID-19 patients outside the office in the parking lot, intramuscular injections of ozone were deemed the easiest and safest modality."


Dr. Brownstein has published several books. Among the uses of ozone therapy he includes cancer, fatigue, infections, autoimmune diseases, and arthritis.


Kennedy goes on to cite a few more drugs and categories of drugs, mostly without references to support them. This seems to be a general strategy of Kennedy's. He seems to think that dozens of unsupported arguments are more impressive that a small number of supported arguments. 


On page 14, Kennedy says, "By that time [fall 2020], more than 200 studies supported treatment with hydroxychloroquine and 60 studies supported ivermectin." He provides no citation to support these numbers. Reviews and meta-analyses of the time don't cite so many studies. This is a good segue to examining ivermectin and hydroxychloroquine.


Let's Look at Ivermectin.


Ivermectin is a great drug for treating certain worm infections. Its discovery was rewarded with a Nobel Prize. At the concentrations used to treat worm infections, it has low toxicity. (Nothing is completely non-toxic.) Let's look at it for treating COVID-19.


Principle #3. Finding compounds that work against viruses is hard. Attacking viruses through pharmacology is difficult.


The whole concept of antiviral therapy is to be toxic to the virus while being much less toxic to the host (e.g., human). This concept is called selective toxicity. Ozone kills viruses. It also kills human cells. Before there were good treatments for AIDS, there were a lot of treatments that had no selective toxicity. One infamous example, taking the blood out of the body and heating it up to the point it killed the virus. That same method also killed the white blood cells which the virus was targeting anyhow. The method was useless.


Viruses are closer to being vectors than living creatures. They are guerilla warriors. They attach to specific human cells, enter them, possess a few mechanisms (through proteins called enzymes) to make more copies of their genetic information and viral shells while plundering the cell's resources (like guerilla raiders), package those copies, and break out of the cell to go on to invade more cells. That provides precious few targets to attack. Most antiviral compounds target the few enzymes the virus uses to make more viruses, or they bind to the virus in the blood (antibodies or vaccines which produce antibodies), or they block entrance into the cell. There are damned few truly good antiviral drugs, that is, those which are effective and which do not have significant toxicities. Ivermectin has been argued to have direct antiviral actions.


To be fair, I should note, that you can contribute to the health of a COVID patient without directly attacking the virus. Vitamin D, by supporting the immune system, does this. Dexamethasone, by lowering inflammation---which can become acute and even fatal during COVID's disease course---is helpful, even though dexamethasone lowers the immune system. 


Principle #3a. When it comes to judging a novel therapy, something that has been shown to work in the laboratory seldom works in real life.


Broadly speaking, to prove the effectiveness and safety of a drug, there are three stages: in vitro, preclinical trials (animal), and clinical trials (human). Let's start by looking at ivermectin in the laboratory. In the case of examining drugs that have already been approved, safety studies have mostly been done. In rare situations, using a known drug for a new indication may run into new toxicities. It should also be stressed that, just because safety studies have been done, that doesn't make an approved compound completely safe. Every drug has potential toxicities, some of them have a lot of toxicities.


In vitro, colloquially means showing a drug has an effect in a test tube. More commonly, these experiments take place in well plates. A well plate is an array of tiny depressions. Each well provides an environment to examine a set of conditions. In this setting, testing an antiviral drug requires three ingredients: human cells (which the virus infects), the virus (often at different amounts representing different degrees of exposure), and different concentrations of the treatment being examined. If the treatment works in vitro, the drug rescues the cells from viral damage or death, or else limits or prevents viral growth. At the same time, some wells have the drug (at various concentrations) without the virus to examine to what degree the drug is toxic to the cells. (You can always kill the virus by killing the cells.) 


For drugs that work, its effects follow a dose-response relationship: more dose, more response, and  hopefully with little to no toxicity at the effective levels. With too little drug there is no effect. With increasing amounts of drug that works you achieve a maximal effect (for example, completely stopping the virus). The response follows a curved line between no effect and maximal effect and from that you can determine the concentration which is effective in inhibiting 50% of the virus. 


Each "well" is like a tiny test tube.



Ivermectin has an anti-COVID effect in vitro. This can be seen in the graph below. 


Ivermectin, in vitro inhibition of COVID-19 (from above cited article).



From the above graph, several things stand out. One is that the concentration of the drug that inhibits 50% of viral growth (IC50) is 2.8 µM. Secondly, strangely, even 2.0 µM seems to have little effect before a very steep drop. 


So, what does 2.8 µM mean? One small problem in interpretation is that these concentrations tend to get reported in two ways in literature, either as µM (or nM) or else by µg/mL (or ng/mL). For ivermectin, the number 2.8 µM is equivalent to 2450 ng/mL. 


This study found peak concentrations of ivermectin in plasma to treat worm in infections in humans to be 60 ng/mL. Other studies are summarized here, which compares the worm-treating dose to the COVID-treating dose: "even with the highest reported dose of approximately 1700 µg/kg (i.e., 8.5 times the FDA-approved dose of 200 µg/kg), the maximum plasma concentration was only 0.28µM" (one tenth the dose needed for 50% inhibition). 


Or, it could be worse than that. There are aspects of pharmacological effect that are not examined in vitro. Ivermectin has a plasma protein binding of 93.2% (seen in plasma, not in well plates). Therefore, only 6.8% of it is available in its active concentration inside the circulatory system. Even more critical is the intracellular concentration, since the antiviral effect takes place in the cell. 


The antiviral effect in humans takes place at a concentration that is forty to several hundred times above its human worm medicine dose. This is consistent with a general truth: in vitro effects rarely carry over to therapeutic effects in humans. Contrary to Kennedy's galloping list of compounds, a good drug is hard to find.


Continued with clinical studies of ivermectin.

Martin Hill Ortiz is the author of several novels including most recently the thriller, Floor 24. 

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

Tuesday, December 3, 2024

Reviewing RFK, Jr.'s book on Anthony Fauci. Early Treatment and Independent Doctors into the Breach.

 This is my eighth entry in 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. Why so many entries, why so many words? It is easy to hurl out lies. Truth-telling takes more time. The next installment is here.


 The first quote in Robert F. Kennedy Jr.'s book is from Luc Montagnier, Nobel Prize discoverer of HIV.* He said, "Dr. Joseph Goebbels wrote that 'A lie told once remains a lie, but a lie told a thousand times becomes the truth.'" 


As I have detailed in this series of critiques of Kennedy's book, he is lying again and again. He even cites a neo-Nazi website to support one of his lies. He is Joseph Goebbels.


(*Ironically, in contrast to Dr. Montagnier, according to the Index in Kennedy's book, Peter Duesberg, prominent for denying that HIV causes AIDS, is cited on 25 different pages of Kennedy's book.)


General Notes on How to Separate Good Science from Crap


Principle #1. Bad science moves quickly. Good science is slow.


I have worked in the field of HIV for over thirty years. Especially in the early years before effective treatments were available, many useless and dangerous therapies were put forward such as black widow venom and heating the blood. They had one thing in common: hype. 


Such therapies are politely labeled by science as "unproven." They are worse than that. By such standards you could call "crawling on your belly" as an unproven method of winning a sprint race. In science, having some sort of proof is necessary to rise above outright lies. Candidate drugs that have some chance at being safe and effective, must be shown that they are safe and effective.


Bad science moves quickly: good science is slow. And bad science is often not even science, just the passionate idea of a master of hype.


This principle extends beyond proving new therapies. There is a very legitimate question of how COVID got into the general population. One claim is through the exotic animal food market in Hunan. Another is an accidental laboratory leak in Hunan. Finally, some believe in intentional release.


I am not about to discuss the arguments here or weigh their value: to do so would be premature. While there is some evidence for each of the competing theories, sorting through evidence from conjecture would take the length of a book. I bring up the topic to convey that a firm conclusion takes years to nail down: with HIV it was about a decade after from the discovery of the virus before a consensus* understanding was agreed upon as to where it came from. I hope that, in several years, an answer will be found regarding the origin of COVID. Such a definitive determination will have to overcome the opaqueness and obstruction of the Chinese government.


*By consensus understanding, I mean the large majority of scientists. There are still those who believe in conspiracies and other wild theories of HIV's origin.


Corollary to Principle #1: the promoters of bad science have instant certainty and usually a lot of it. They usually cut corners in their determinations or just skip straight to promoting fraud. 


Principle #2. It is easy to find bad science and bad scientists.


Kennedy begins a lengthy section highlighting physicians who opposed COVID vaccinations and who promoted alternative therapies and prophylactic treatments. His main argument, quoting Dr. Peter McCullough, is that "We could have dramatically reduced COVID fatalities and hospitalizations using early treatment protocols and repurposed drugs including ivermectin and hydroxychloroquine and many, many, others." Central to Kennedy's arguments is that these repurposed drugs were being ignored because they were cheap and big Pharma wanted to make big money. (I don't understand the statement many, many. I've only seen claims about several others. Added note: the book goes on to describe many in passing.)


First of all, it is not difficult to find doctors and scientists who have atypical perspectives and you can argue most any fringe idea by citing them. Kennedy highlights several, including some with impressive backgrounds. As for those with mainstream arguments, Kennedy seems to believe that all those who disagree with his viewpoint are shills for big Pharm, uninformed, or deluded (or all three). I'm not sure which category he'd put me in.


Kennedy's doctors certainly share a minority opinion. As of May 2021, several months after the vaccines came out, 96% of U.S. physicians were vaccinated for COVID, with about half of the remainder saying they were going to.


According to another survey conducted in May 2021, 88.8% of U.S. primary care physicians strongly agreed or somewhat agreed that vaccines are safe while 6.7% strongly disagreed or somewhat disagreed. This survey also found 89.9% of primary care physicians strongly agreed or somewhat agreed that vaccines are effective while 7.2% strongly disagreed or somewhat disagreed.


Still, Kennedy likes to focus on that 2-7%. These include Dr. McCullough, who according to the Index, is referenced on 19 different pages of Chapter One. Extending the above cited argument, McCullough said, "Using repurposed drugs, we could have ended the pandemic in May 2020 and saved 500,000 American lives." Dr. Pierre Kory is quoted in agreement, "The efficacy of some of these drugs is almost miraculous."


Dr. Peter McCullough (photo from his Cardiology practice website)


Kennedy goes on to champion Dr. Didier Raoult. "On March 17, 2020, Dr. Raoult provided a preliminary report on 36 patients [20 treated plus controls] successfully treated with hydroxychloroquine and sometimes azithromycin at his institution in Marseille." 


I mentioned in an earlier post that Dr. Raoult retired in 2021 after a scandal regarding "30 years of unregulated experiments on humans." In this context, this makes sense. He had a preliminary report on March 17, 2020? It was successful in spite of examining two different drugs, hydroxychloroquine and "sometimes" azithromycin? Anyone with experience in clinical trials knows that would be impossible to have meaningful results from a multi-drug trial in so brief a time and with so few people. 



Dr. Didier Raoult


Kennedy continues with "In April, Dr. Vladimir (Zev) Zelenko, M.D., an upstate New York physician and early HCQ [hydroxychloroquine] adopter, reproduced Dr. Didier Raoult's 'startling successes' by dramatically reducing expected mortalities among 800 patients Zelenko treated with the HCQ cocktail." 


Zelenko first posted his results of a triple-compound therapy, azithromycin, hydroxychloroquine, and zinc on YouTube and Facebook on March 21st, 2020, in which he claimed to have treated 500 patients, all with positive results. For perspective, all of New York state had 528 COVID cases through March 14. Zelenko followed his media posts by sending a letter directly to Trump on March 23rd passed along by Trump's lawyer Rudy Giuliani.


Dr. Vladimir Zelenko


Zelenko, Vladimir.   A Report on Successful Treatment of Coronavirus. Global Research.  23 March 2020.

Tweet, March 21, 2020


Good science is slow. Putting together a legitimate clinical trial takes time. You need to write up a protocol, have it approved as ethical by a supervisory board (in the US these are called Institutional Review Boards or IRBs), acquire informed consent, specify and recruit a meaningful number of patients, run the protocol for a period of time, and document and analyze the results. That can't be done in a couple of weeks much less in a couple of months. Period. Twenty patients with two drug protocols is meaningless. The only way to recruit and treat those patients in such a timeline is to do what Raoult was accused of: starting without approval from an ethics board, or, unlawful human experimentation. 


Similarly, Zelenko's claim to have treated 500 patients with a five day protocol and a 100% success rate had to take place through immoral experimentation. There's no other way to get those numbers so fast. Zelenko essentially agrees: when he did publish a paper with his results in October 2020, it says that the cases reflected a time period from March 18 to May 14 and that IRB approval was given on June 16. While this IRB approval was for a retrospective study, he would have had to have IRB approval to dose humans with an experimental protocol. Hydroxychloroquine for COVID-19 was an off-label use in the US at the time of his initial experiments.


This article examines Zelenko's claims and the ethics of his experimentation. 


Zelenko went on to claim COVID vaccines caused millions of deaths


Finally, multidrug therapy studies proceed more slowly than single entities. The questions are: does each drug contribute? Does the combination of drugs add to toxicities? Both hydroxychloroquine and azithromycin separately can cause fatal arrhythmias. Azithromycin is listed among the list of drug interactions for hydroxychloroquine. 


Continued with 

Principle #3. When it comes to judging a novel therapy, something that has been shown to work in the laboratory seldom works in real life.

and

Principle #3a. Finding compounds that work against viruses is hard. Attacking viruses through pharmacology is difficult.

and

a look at a multitude of treatments.


Martin Hill Ortiz is the author of several novels including most recently the thriller, Floor 24. 

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