RFK Jr. on HIV and AIDS, Part One

 

This is my sixteenth entry into reviewing Robert F. Kennedy, Jr.'s book, The Real Anthony Fauci. Fauci became the head of NIAID, the National Institute of Allergies and Infectious Diseases, in 1984, at the time that the AIDS crisis was gaining momentum. Kennedy looks at HIV and AIDS and, of course, takes digs at Fauci, claiming Fauci promoted the deaths of millions. The previous entry is here. The first entry to the series is here.

HIV and AIDS. Chapter 5, The HIV Heresies and Chapter 6, Burning the HIV Heretics. 

I thought of trying to analyze these two chapters step-by-step and page by page, but I found Kennedy's approach too disorganized. For example, he describes deficiencies in PCR testing on page 185, talks about it in more detail on page 191, then gets back to it in the next chapter. On page 181, Kennedy writes: "In July 1981, CDC reported a unique outbreak of immune deficiency-related health problems in a group of highly promiscuous gay men in Los Angeles, New York, and San Francisco." He doesn't return to defend that statement until page 222.  

Instead, for this post, I'll first try going through highlights of the chapter five and then focus on Kennedy's arguments centering around Koch's postulates. 

At the beginning of Chapter 5, Kennedy makes the point that "I take no position on the relationship between HIV and AIDS." (page 178) He then spends 65 pages presenting the arguments that HIV does not cause AIDS. He spends zero effort on analyzing the deficiencies of HIV-AIDS deniers' argument or why they are, at times, batshit crazy.

Further down page 178, Kennedy presents his thesis statement for the next two chapters. "Specifically,  the original hypothesis on AIDS is an illustration of how vested interests (in this case, Dr. Anthony Fauci), using money, power, position and influence, can engineer a consensus on incomplete theories, and then ruthlessly suppress dissent."

On page 179, Kennedy introduces Dr. Peter Duesberg as "the world's accomplished and insightful retrovirologist" going on to say, "Specifically, Dr. Duesberg accuses Dr. Fauci of committing mass murder with AZT, the deadly chemical concoction that according to Duesberg causes and never cures---the constellations of immune suppression that we now call 'AIDS.'" This mass murder amounts to tens of thousands. (page 226)

Dr. Duesberg is the most prominent among those who promote the theory that HIV does not cause AIDS. 

According to the index, Duesberg is cited on 25 pages. That only begins to highlight his presence in the book. RFK's book has subchapters titled "Peter Duesberg," "Do Retroviruses Cause Diseases?", "Punishing Duesberg," "Refusal to Debate [Duesberg]", "Duesberg's Theory," along with several more detailing Duesberg's theories. Furthermore, he is cited on several pages not mentioned in the index. 

Duesberg has personal resonance in my life. I began researching HIV in the late 80s. My first exposure to him and his theories came through an article in the magazine Spin. 

Bob Guccione, Senior, founded Penthouse, a popular and brazen (for its time) pornographic magazine. Bob Guccione, Junior, his eldest son, launched Spin, a music and pop culture magazine, in the late 80s. 

For the Spin issue of September 1993, Bob Guccione, Jr. interviewed Peter Duesberg, PhD in chemistry, providing him a platform for denying that HIV causes AIDS. 

At the time, I was a postdoc working in an HIV laboratory. Along with some cutting edge research, I was performing a lot of routine tests, such as growing HIV in culture and measuring how the drug AZT lowered HIV production in these cultures. These experiments were routine. I would fill wells in an array with white blood cells, add media with HIV virus stock, look at how the HIV killed the cells (in comparison to uninfected controls, the cells would naturally die over time), look at how different concentrations of AZT limited that killing, and then sequence the virus to look for changes in the enzyme AZT targeted.

Duesberg claimed that no one had ever performed the studies on HIV that I was performing, and which, as I said, were routine. I thought to myself at the time, "You have to be pretty smart to be that dumb."

Robert Gallo 

Before getting into discussing Duesberg's theories, Kennedy diverts to talking about Gallo and his "den of thieves." 

I have met Gallo (and Fauci and, briefly, Montagnier). In contrast to Fauci and Montagnier, I would characterize Gallo as being a vampire. Well after the world had pegged Gallo as dishonest in the discovery of HIV, I saw him make a fascinating presentation of the role of a protein called "tat" in the origin of Kaposi's sarcoma. I was impressed. Those conclusions turned out to be an artifact, so even that nod of acclaim that I was giving to Gallo, evaporated. Such egotistical, unethical researchers as Gallo set back research and stain science. 

Kennedy's narrative doesn't do justice to the seedy tale of Gallo's (temporary) stealing of the discovery of HIV, the monetizing of early HIV testing, and the French tragedy in refusing to use the early testing. The French prime minister was charged for crimes in this matter and acquitted. The French health minister was convicted of manslaughter, and the director of France's National Blood Center served four years in prison.

On page 182 Kennedy says, "Before the appearance of AIDS both men [Montagnier and Gallo] had vainly strived to implicate retroviruses as the culprit in leukemia." I take exception to this comment. The retrovirus investigated, HTLV-1, did prove to increase the likelihood of acquiring leukemia. Oncoviruses, viruses that promote cancer, are now understood to be common, with approximately 12 to 20% of cancer cases associated with them. 

Koch's Postulates 

Moving along, perhaps the most significant sign that Kennedy's arguments are desperate can be found in how he cites Koch's postulates as evidence that HIV doesn't cause AIDS. These arguments begin on page 192. 

Koch's postulates were first published in 1890 and represented the primary attempt to provide a guide for determining an infectious agent as the cause of a particular disease. 

To prove that an organism causes a disease, Koch put forward four principles.

1) The microorganism must be found in abundance in all [infected] organisms suffering from the disease but should not be found in healthy organisms.

2) The microorganism must be isolated from a diseased organism and grown in pure culture.

3) The cultured microorganism should cause disease when introduced into a healthy organism.

4) The microorganism must be re-isolated from the inoculated, diseased experimental host and identified as being identical to the original specific causative agent.

Although they represented a landmark in the discourse of the then new field of microbiology, over the course of the last 135 years his postulates have been shown to be incomplete time and time again. Only a charlatan would present them as absolutes. 

The first exception to Koch's postulates presented itself less than 20 years later in a very famous case. Intrepid public health researchers discovered the common link between cases of typhoid: a woman who infected several households without she, herself, presenting dramatic signs of illness. She became known as Typhoid Mary and her existence violated Koch's hypothesis that "the microorganism . . . should not be found in healthy organisms." The belief that Koch's postulates were absolute slowed down the recognition of Typhoid Mary's role in the outbreaks. Nowadays, the concept of asymptomatic carriers and carriers with modest, overlooked symptoms is well understood in many diseases. A relevant example: "CMV [cytomegalovirus] is a common virus that infects 50 to 80 percent of people at some time during their lives but rarely causes obvious illness." [source] "People with a compromised immune system (such as people with HIV/AIDS or those receiving chemotherapy) may experience more serious illness involving fever, pneumonia and other symptoms." In AIDS patients, CMV can cause blindness.

Postulate #1, argument #1 from Kennedy, page 193. "Koch's first postulate requires that a truly pathogenic virus [comment: Koch's doctrine came out before the discovery of viruses] can be found in large quantities in every patient suffering from the disease. The failure of the HIV/AIDS hypothesis to meet this critical threshold remains one of Dr. Fauci's most exasperating dilemmas. [comment: no it hasn't] For starters, Gallo claimed that he found HIV virus in fewer than half of the ailing AIDS patients from whom he drew blood." 

Now, Kennedy cites Gallo's competency? Gallo tried to culture the virus, at that time, a difficult task. Gallo eventually used Montagnier's culture and even stole Montagnier's photo of the virus for the initial publication. I've tried culturing the virus. You need what is called a high titer because initiating the infection has to overcome cellular defenses. That is why researchers have resorted to other means of detecting the virus in infected persons.

"Furthermore," Kennedy says, "every one of the thirty discrete illnesses we call AIDS occurs in persons uninfected by HIV." A poorly written sentence. There are not thirty discrete illnesses called AIDS. As for whether the opportunistic infections that often characterize AIDS can be found in people without HIV infection, of course, they can. These are infections that have always been around and they are called opportunistic infections because they are infections. This was put forward on day one from the first reports (which Kennedy goes on to cite). Why they were appearing with alarming frequency in a particular cohort was the problem, that was the point of the paper. To cite the first report of what would become known as AIDS: "The occurrence of pneumocystosis in these 5 previously healthy individuals without a clinically apparent underlying immunodeficiency is unusual." Unusual, not exclusive. Pneumocystis pneumonia and other "AIDS-defining" infections were never considered exclusive to AIDS patients. 

Furthermore, Kennedy can't seem to figure it out, even as a possibility, how people can have HIV and not AIDS. 

AIDS is the end-stage illness that comes years after being infected with HIV. HIV destroys the immune system so a variety of common and uncommon infections appear.  Why is that hard to understand? Diseases that take years to appear after infections are a very common thing. (I'll talk more about that below and in my next post.) People with HIV and not AIDS is a simple straightforward thing. Koch, 130 years ago, did not foresee this.

Kennedy claims that the HIV antibody test proves that the person who tests positive could not have HIV. Page 191, "Finally, and most importantly, critics point out that Gallo's HIV antibody tests flipped traditional immunology on its head. Throughout all of medical history, a high antibody level indicated that a person had already successfully battled against diseases, the presence of antibodies signals a welcomed immunity from the disease" and "Dr. Fauci never explained this inexplicable paradox."

No, no, no! This is so basic that I have to ask whether Kennedy knows anything about medical issues. Has Kennedy never heard of neurosyphilis? This is a disease progression that takes place years (decades) after the initial syphilis infection. All the time the person will be positive for syphilis antibodies, which makes sense, his immune system saw the initial infection. It fought the infection and the organism hid out. This gets to another bit of incompleteness in Koch's first postulate. It is possible to have the disease and not have an abundance of organisms found. 

Neurosyphilis is far from the only chronic infectious disease. When I teach viral infections to my medical students, one of my first slides says, some viruses [that infect humans] are fast and mean. Some are slow and mean. Does Kennedy deny all slow viruses? Hepatitis A? Influenzas? Fast viruses. Hepatitis B and C? Slow viruses. You get infected with hepatitis B or C and then 20 to 30 years later you have a deteriorating liver. And, of course, you get antibodies produced early on and forever. (I've had this happen in family.)

Kennedy says that Fauci didn't want answered "why some HIV infected individuals never succumb to AIDS." (page 197) Those who are infected with HIV, and who, even in the absence of antiretroviral therapy, do not progress are termed called long-term non-progressors. Is it a weaker version of the virus (one that replicates just enough to survive but not cause damage)? Is it some aspect of the patient (they have a genetic difference or some other means that prevents the virus from progressing)? Or is it possibly environmental, for example, good health principles of the patient? Searching the National Library of Medicine for HIV non-progressors I received hits for 575 papers. If I tweaked the search terms, there would be many more.

Koch's postulate #2. The microorganism must be isolated from a diseased organism and grown in pure culture.

Kennedy writes (page 197) "Highly respected scientists including Éttienne de Harven argued that HIV has never been isolated or grown in pure culture." I've personally cultured HIV on numerous occasions as part of other research protocols. I've certainly spoken to many scientists who have discussed the difficulties and what sort of cells to use. Even Kennedy describes the intrigue in which Gallo stole Montagnier's culture (after having difficulty to start his own.)

Kennedy goes on to Koch's third postulate. "The cultured microorganism should cause disease when introduced into a healthy organism." Kennedy states on page 198, "No one has tried injecting HIV into a healthy human being [he doesn't mention it, but I assume he is conceding to ethical considerations], but scientists have stuck all kinds of mice and rats and monkeys and chimpanzees, and none of them has gotten anything resembling human AIDS." 

There are several problems with Kennedy's conjecture. First, there have been 58 confirmed (and 150 more possible) incidences of accidentally acquiring HIV through working with HIV directly or working with HIV-infected patients, in the latter case, typically through needle stick accidents. Secondly, there are a whole number of animal models that can be infected with HIV. One problem is that in the natural course, humans take 10 years to come down with a disease effect, and several animals such as mice and rats, mentioned by Kennedy above, do not have that kind of a lifespan. Which gets to a point of possible criticism: these animal models that do get used usually have some modification in their genetics, anatomy, or virus to get the virus to function more quickly. These modifications could include, for example, transplanting human thymus into the animal (the organ which helps blood cells to differentiate).

Furthermore, there are naturally-occurring immune deficiency virus that directly target certain animals: cats, monkeys, and horses, for example (feline immunodeficiency virus, simian immunodeficiency virus, and equine immunodeficiency virus, respectively.) Transmission experiments have be done in these species. Beyond the ethics of animal experimentation, one limit to such experiments comes from the fact that larger, longer-lived species are very expensive to test over the course of years.

Kennedy argues that viral load (the number of virus particles) with HIV are low. From page 198, "Traditional viruses such herpes, influenza, smallpox, etc., only cause disease at very high titer---thousands or millions of infectious units per cubic millimeter of infected tissue." This is a poorly written sentence. Which herpes virus? There are eight of them in humans. Smallpox? No one has investigated viral loads in infected tissue for smallpox since it was eliminated as an infectious disease fifty years ago. Influenza viruses do multiply to high titers: as mentioned above, it is a fast and mean virus. Finally, "infected tissue" does not speak to the way HIV is measured except for perhaps in the rare instances of lymphoid biopsies or post-mortem examinations. HIV viral loads are measured as particles per milliliter (not cubic millimeter) of plasma. 

I've read a lot of HIV viral loads in my life,. Typically during disease, when the immune system has collapsed the numbers run in millions. Below is a typical representation. Ten to the sixth power represents 1 million. (Source cited below graph). 

Natural Progression of HIV The viral load is shown in red, and the CD + 4 cell counts in blue. (Figure adapted from Giorgi, 2011)

This is not "infected tissue." This is plasma, which is cell free, and represents only the freely circulating virus, a fraction of the actively virulent virus. 

Kennedy (page 199) states "the onset of AIDS symptoms almost always arrive decades later (an average of twenty years following exposure) when viral loads are at their lowest." I've never seen anyone say "decades," and viral loads at the time of AIDS are their highest as shown in the above graph.

Kennedy goes on to quote John Lauritsen, a journalist and author of The AIDS War, to say "The virus infects very, very few cells---as few as one in 100,000." I don't know where Lauritsen got his numbers, but I have spoken to others who cited the one in 100,000 number. They used the fact that it typically took 100,000 virions to successfully start an infection of cells in culture, an entirely different thing from the fraction of cells infected. It really depends on the moment in the disease course, but typically, the number of infected circulating cells are 1 to 15%. 

On page 200, Kennedy says "But even the most faithful acolytes no longer believe that HIV kills T-cells in any way." There is a huge body of literature on HIV killing T-cells. I am certain some are written by "faithful acolytes." 

Before Koch.

Not satisfied to to say that HIV violates Koch's postulates, Kennedy goes further back in time to say that HIV infection doesn't have the predictable spread of infection as shown in William Farr's investigation of typhus cases (1849). No, it didn't. There is more than one graph that describes disease spread and the final voice on that didn't come in 1849.

Kennedy says, page 202, that "In Western countries, AIDS has never broken away from its original core pool of homosexual men and drug addicts." AIDS is not a gay disease. In the year 2000, for the US, 41% of those living with AIDS were infected by male-to-male transmission. This number is slightly exaggerated. Bisexual men with AIDS are often pigeonholed as to getting HIV through gay contact. 

Kennedy says, page 202, that "Dr. Fauci's acolytes claim this [HIV] is supposed to be "the most infectious virus that has ever existed." I doubt that anyone sane has claimed that. 

As I tell my students, the reason that sexually transmitted diseases are (primarily) sexually transmitted is because they are wimps. They go from one moist warm place to another for incubation, and do not survive on toilet seats, or in aerosols, or in the guts of mosquitos.  

To be continued

A Note Regarding Kennedy's Use of Citations. 

Kennedy's book makes a lot of citations. Relatively few of them are directed to foundational work. Instead, he tends to cite news articles, YouTube videos, and sometimes tweets from irrelevant sources as though they represent scientific authority. He quite often quotes people who demonstrate no expertise on a subject. He also quotes people who are experts but leaves out the parts where they disagree with him. 

At the end of Chapter 6, he includes 180 citations. For citation number 151, he points to Elinor Burkett, "HIV, Not Guilty?" Tropic Miami Herald (December 23, 1990). For citation 152, he points to Elinor Burkett, "Is HIV Guilty?" Miami Herald (December 23, 1990). Are these even two different articles.

I call out these two because this "pair" of references are repeated as citations numbering, 156, 157, 158, 159, 160, 161, 163, 164, 165, 166, 167, 168, 169, 170, 176, 177. That's how you get 180 citations for a chapter.  

At the end of the same chapter he cites "HIV & AIDS, Fauci's First Fraud," a YouTube video, 20 times. A YouTube video is not a legitimate citation. He might as well say "the internet." The content in the YouTube had to come from somewhere, and if that source is legitimate, that would be a legitimate citation. He cited the same video 8 times in the previous chapter.

Martin Hill Ortiz is a professor of pharmacology and author of several novels. 

My new novel, The Missing Floor, is now available from Oliver-Heber books. The first in the series, Floor 24, is newly available in audio book format. The audiobook has quite a complimentary review here.

The Missing Floor

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Why RFK Jr is Dangerous

 

I have chosen to not go through the book line-by-line. I did much of that in my first fifteen posts. In the instances in which I did examine RFK Jr.'s claims at a microscopic level, it was easy to demonstrate that they were false. He doesn't even try hard to put together an honest argument. He either doesn't read the sources he cites, or else he willfully lies about his claims. His dishonesty isn't subtle. 

Why do I believe he is dangerous? This is an example, page 82 or 83 (according to the index or hand-numbering). RFK Jr. speaks of the experience with COVID in Vermont. He writes:

"Vermont is America's most vaccinated state. On October 10, 2021, with 86% of its citizens fully vaccinated (according to the COVID Dashboard), Vermont officials nevertheless reported the largest rate of infections ever--and revealed that more than three-quarters of Vermont's September COVID-19 deaths occurred in the "fully vaccinated."" 

Note: Beyond COVID Dashboard, RFK does not provide a citation for the above statistics. Vermont's largest rate of infections ever? Yes, they maintained a fairly low number of cases, approximately 5400 in September versus 3600 in August. (September's figure being 0.8% of Vermont's population. The U.S. as a whole had 1.4% of its population with new cases.) As for 86% being fully vaccinated in Vermont, that is higher than the figures I can find, but Kennedy does like to make up numbers (January 2022 numbers are presented below). Perhaps 86% had a single dose by then. 

Now, I followed the COVID numbers state-by-state on a rather exquisite basis. And when I saw RFK picking on Vermont's numbers, I thought, "What the hell?" Among states (and DC) in the United States, Vermont performed quite nearly the best. 

I have cited worldometer's data site here a number of times. (RFK sometimes cites it.) It is not the definitive source, but it is easy to navigate and is in agreement with the official sites. With one click, a user can rank the COVID statistics for each state. In terms of mortality, Vermont outperformed 48 of 50 states and the District of Columbia. 

Let's compare Vermont to the United States as a whole. 

Vermont's death rate is less than half of the U.S. If the United States had Vermont's death rate, it would have had over 600,000 fewer deaths. If there is a future pandemic, following RFK Jr.'s advice would double the deaths over following Vermont's wisdom.

RFK states that three-quarters of Vermont's September 2021 deaths from COVID took place among the fully vaccinated. While other states were witnessing appalling numbers of deaths from COVID, Vermont had 37 total between August 31 and October 2, 2021. He claims 86% of the state was vaccinated, so three-quarters of the deaths among the vaccinated indicates a protective effect. Another way to put that is that one-quarter of the deaths took place among the 14% not fully vaccinated. (It is more complicated than that. The age demographics and vaccination rates even more strongly favor vaccination.) 

I teach vaccines to medical students in Puerto Rico. I have presented them with the slide shown below. It cites numbers from January 2022. At that time Puerto Rico had the highest rate of being fully vaccinated for COVID (this is after combining the age groups) compared to individual states. And Puerto Rico did not have the 86% fully vaccinated that Kennedy claims in October 2021. (update: I ran the numbers for January 2022 using age demographics for Vermont and found that 84% of those 12 and older were fully vaccinated by that time.)

Vermont is included on the above list as among the most vaccinated. Here is the ranking for mortalities among states, including Puerto Rico, also from my presentation. The rankings go up to 52: the 50 states, DC and Puerto Rico.

Vaccines save lives. 

Continued here.

Martin Hill Ortiz is a professor of pharmacology and author of several novels. 

My new novel, The Missing Floor, is now available from Oliver-Heber books. The first in the series, Floor 24, is newly available in audio book format. The audiobook has quite a complimentary review here.

The Missing Floor

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The Real Anthony Fauci: Problems with the Book Itself.

  Over the course of 14 posts, I have made it so far through the introductory material and on to page 61 of Robert F. Kennedy's book: The Real Anthony Fauci, etc. I have written approximately 100 pages commenting on the book to this point. It is only 100 pages because I greatly limited what I could comment on. There is so much bad faith material and outright lies crammed into the book, I could have written much more. The book is approximately 480 pages.

One dilemma I've considered is how to go forward. Do I really want to write twenty pages of commentary on every dishonest table he presents? I'm going to be more selective.

For this entry, I thought I'd sum up how poorly this book is presented in its published form. I read about fifty books a year. Not a huge amount, not a small amount. In all my years of reading, covering thousands of books, I have never encountered a book so lacking in proofreading and so poorly assembled as this one (and I've read a few self-published books). In regards to the assembly, I am not talking about the binding or inking. 

I've mentioned some of the book's glaring faults at proofreading while others I've not brought up. I thought I would include photos. Some of the flaws are so egregious, I wonder whether people would believe me if I didn't include pictures. 

The following includes a couple of items that I've already mentioned. 

#1. The pages have no numbers. I can't ever recall running into that phenomenon. However, the Table of Contents and Index refer to page numbers. Perhaps with so many outrageous lies, he didn't want people to be able to pinpoint their location to avoid citations. When I've given page numbers to present specific problems, it is from self-numbering.

#2. It gets even worse than that. The books starts out with odd number pages on the left hand side. For example, in the Table of Contents, Chapter One is listed as page 1 and begins on the left hand side. According to the Table of Contents, Chapter Two begins on page 128 and is also on the left hand side. Page 127 doesn't exist. (I presume the misnumbering starts there, of course there are no numbers immediately before it.)

Page numbering switching. Hand-numbering is mine.

#3. Sometimes references are numbered, sometimes they are not. Unlike every research paper and every other book with references that I've seen, what the reference is referring to is NEVER connected to the material in the text. Matching up a reference with material in the text through sheer determination can often be performed, for example if it is a quote and the quote can be found at the citation. Lots and lots of wild assertions have no reference to match them. Without numbering, how do I know this? In trying to link up claims to citations I found sometimes there are very few citations over several pages to support assertions. Some pages are crammed with citations. 

Sometimes references are numbered.

Sometimes not. The references are given <?>.

#4. Beginning on page 151 (hand-numbered), the text on the right hand pages cuts off in the middle of the page. This is not due to a break in paragraphs or else due to a figure or large table taking up the beginning of the next page. It is sometimes takes place midsentence. This phenomenon recurs regularly through the final chapter.

The right hand page breaks off mid-sentence "The CDC shelved the Haverkos study and began parroting Dr. Fauci's hostility toward the . . .". This happens at least a hundred times.

#5. The Index, to the best that I have so far determined, does refer to items I could connect to on my hand-numbered pages. This means that whoever assembled the Index must have seen the weird page breaks and there must have been some realization the pages had no numbers.

#6. There are a lot of errors a simple proofreading would have found. A single numbered citation lists the same information twice, for example. 

#7. There may be more gross errors. I only discovered items 2 and 4 today.

Robert F. Kennedy has thrown together a book that doesn't even measure up to the most amateur of self-publishers. He seems to have paid equal inattention to his research, citations, and his garbled screeds. How are we are expected to trust the contents of the book, when the author is so sloppy? RFK Jr. is giving the same level of attention to making health decisions that affect the well-being of the country.

Continued with: Why RFK Jr. is Dangerous.

Martin Hill Ortiz is a professor of pharmacology and author of several novels. 

My new novel, The Missing Floor, is now available from Oliver-Heber books. The first in the series, Floor 24, is newly available in audio book format. The audiobook has quite a complimentary review here.

The Missing Floor

Continue reading →

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

  In this series of critiques of Robert F. Kennedy, Jr.'s book "The Real Anthony Fauci: Bill Gates, Big Pharma, and the Global War on Democracy and Public Health," I left off discussing Kennedy's table of studies that show hydroxychloroquine is effective. 

Continuing with the table on page 22. I had intended just to sample a couple of the cited studies. But then the first study was retracted. The second study didn't even look at hydroxychloroquine. The third study was never published. 

So I continued to review the studies, one by one. In doing so, I intend to demonstrate that Kennedy is, in practically every detail, a liar who puts up phony evidence. When I'm done with the list of studies, I'll try to give an overall picture. How many were never published, how many that don't agree with what Kennedy presents, and how many the authors concluded that hydroxychloroquine doesn't work.

Here, below, is Kennedy's chart from page 22 of Chapter One of his book.

RFK Jr.'s list of "All thirty-two" studies with early intervention with hydroxychloroquine.

(Continuing from my last entry.)

Nineteenth study. Guisado-Vasco. Kennedy correctly references 2 deaths in 65 patients (3.1%) who had taken hydroxychloroquine before admission and 139 out of 542 who did not (25.8%). However, remarkably, an additional 493 patients out of 607 total took hydroxychloroquine after admission to the hospital and 125 of them died (25.4%). If you add early hydroxychloroquine to later hydroxychloroquine, 127 of 558 died (22.8%). Of the 607 patients in the study, additional drugs taken include lopinavir/ritonavir (487), cyclosporine A (an immunosuppressant, 253), glucocorticoids (antiinflammatory and immunosuppressant, 159), and tocilizumab (an immunosuppressant and antiinflammatory, 132), the magnitude of the numbers saying that two or more drugs were taken. Tocilizumab and cyclosporine A were also deemed to have promoted survival to a statistically significant degree. 

Twentieth study. Szente Fonseca. The Szente Fonseca study has a total of 717 patients with 334 receiving hydroxychloroquine (175 hydroxychloroquine alone and 159 hydroxychloroquine plus prednisone, a glucocorticoid), with 139 receiving prednisone alone, and 244 given neither prednisone nor hydroxychloroquine. Approximately half of all patients received azithromycin (53.3%) and/or ivermectin (47.4%) and/or oseltamavir (12.7%). To further confuse things, 65.7% of those in the category "hydroxychloroquine alone" received ivermectin and 42.9% were given azithromycin. A total of 122 patients were said to receive no medication, which would have made a good control, but they didn't report those results. All these categories and overlapping treatments (and lack of specificity as to how they overlap) really complicate making conclusions about what worked. 

The results were given in terms of number treated who were hospitalized out of total number hospitalized. Hydroxychloroquine alone, 25 out of 114. Prednisone alone, 14 out of 114. Hydroxychloroquine plus prednisone, 16 out 114. Numbers were not presented for the other treatments, however, not having hydroxychloroquine or prednisone would have 59 cases out of 114. This study is a bit maddening on not identifying basic information that could help determine effectiveness, especially the question, what was the rate of hospitalization for the 122 patients with no treatment? 

What does Kennedy conclude? 25/175 in the treatment were hospitalized versus 89 out of 542 in the control group. How did they get those figures? They seem to have considered hydroxychloroquine plus prednisone and every other treatment as part of the controls. 

This study is a mess.

Twenty-first study. Cadegiani.  Cadegiani, et al., looked at hydroxychloroquine, nitazoxanide (an antiprotozoal drug), and ivermectin, together with azithromycin. This is getting exhausting. If you want to prove something with certainty, stick to one thing, or two at the most. "Of the 585 subjects, all patients used azithromycin. A total of 357 patients used NIT [nitazoxanide], 159 used HCQ [hydroxychloroquine] and 110 patients used IVE [ivermectin], alone with azithromycin or in combination with other drugs." Several other drugs were mentioned as optional. Mercifully, Cadegiani describes the drugs taken in addition to hydroxychloroquine. All 159 patients on hydroxychloroquine took azithromycin, 21 also took ivermectin, 113 also took nitazoxanide, 86 also took spironolactone (an antidiuretic), and 7 also took dutasteride, an antiandrogen. I say mercifully because it is good for the sake of clarity, but it is impossible to pin down the role of hydroxychloroquine alone.

Kennedy presents the conclusion that 0/159 died in the hydroxychloroquine group and 2/137 in the control group. Cadegiani says that there was zero deaths in the treated population, all 585. He does not break out the numbers for the hydroxychloroquine treated patients, although zero is zero, which means that every treatment group and combination had zero deaths. Since the study had everyone treated, the control group of 137 were outside cases matched and added in.

Twenty-second study. Simova. Thirty-eight health care workers were found to be COVID positive. Half were asymptomatic. Thirty-three agreed to take azithromycin, hydroxychloroquine, and zinc. Five declined. Of the 33 who took the medication, none required hospitalization. Of the five who declined, two ended up being hospitalized. As an observational study, other than the small number of controls, this is not bad. It is a bias to allow the control group to define itself. Five of those taking hydroxychloroquine experienced prolonged heartbeat intervals (QTc intervals) which is a toxicity of the drug. They were discontinued from the treatment.

Twenty-third study. Omrani. There were three arms in this study, each with 152 participants. Azithromycin plus hydroxychloroquine, hydroxychloroquine alone, and no treatment. That would make for a good study design. Omrani presents the figure copied below as part of the results.

Placebo outperformed the drug treatments, although not to a statistically significant degree.
p = 0.072

Omrani set viral recovery on day 6, virus below detection, and day 14 as the primary and secondary endpoints of their study. Kennedy reported hospitalization. Omrani looked at that outcome. "The HC+AZ [hydroxychloroquine plus azithromycin] and placebo groups each had four participants hospitalized (for each group, 2.6% of 152). The HC group had three participants hospitalized (2.0% of 152). There was no association between group and proportion of hospitalized cases (p = 1.000 by Fisher's exact test)." (emphasis mine) Researchers seldom get a p = 1.0, absolutely no support for their hypothesis (or technically, for rejecting the null hypothesis). Omrani, in his discussion, is very critical of the use of hydroxychloroquine and provides a survey of studies that it reject its usefulness.

Twenty-fourth study. Agusti. This study looked at 142 patients. Eighty-seven agreed to treatment with hydroxychloroquine. The controls consisted of those who declined treatment (43) and those who had contraindications to hydroxychloroquine (12). Kennedy says that 2 of 87 of those treated and 4 of 55 of those not treated made the endpoint of the study which he described as "progression." I'm not sure how he came up with his numbers. The study measured whether someone continued to be positive for the virus at days 7, 10, 15, 22, and 28 after diagnosis. Agusti found, "In conclusion, our study failed to show a substantial benefit of HCQ [hydroxychloroquine] in viral dynamics and in resolution of clinical symptoms. Treatment with HCQ was associated with a numerically higher percentage of negative PCR-tests at some points during follow-up in comparison with the non-treatment group, and a shorter duration of some symptoms was also seen with HCQ, but differences were only marginally significant and not clinically relevant." 

Twenty-fifth study. Su. Although Su, et. al., does perform statistical analyses on their data, they do not provide the numbers of patients who were given particular treatments or how many improved compared those to controls. They don't even define controls. The conclusion from their statistical analyses are that "The early use of hydroxychloroquine decreased the improvement time and the duration of COVID-19 detection in throat and stool swabs." 

Twenty-sixth study. Amaravadi This is another case of a paper that failed to be published. The preprint version is available. Early in the text there is this strange statement: "Out of 5511 SARS-CoV-2 positive patients, 1072 met initial eligibility criteria for telephone-based recruitment, but only 34 subjects were able to be randomized." and "Six randomized patients failed to complete the study leaving 28 patients for analysis of the primary outcome." and ". . . this study was terminated early due to lack of feasibility." That is just painful to read. 

Twenty-seventh study. Roy. One problem with tracking down what Kennedy claims in his table is that he provides little information. For example, Roy. Which study is that? We have clues. It looked at recovery time (or did it? sometimes he gets that wrong), there were 14 in the treatment end and 15 in the control end. There is no published paper with Roy as the first author that includes the terms hydroxychloroquine and COVID. Okay, some of the studies Kennedy references were never peer reviewed and formally published. I finally found it.

Roy's paper is another one that does not exist outside of preprint. A total of 56 patients were divided into four groups. "1) having HCQ [hydroxychloroquine] 200 mg twice daily [14 patients] . . . 2) IVR [ivermectin] + DOX [doxycycline] . . . 3) AZR [azithromycin] and, the last group as per NIH guidelines who refused any treatment other than supportive treatment with antipyretics and oral rehydration solution. [15 patients]"  

Roy's conclusion? "Mild COVID-19 infection in patients having low-risk to progress can be managed symptomatically without any specific drug intervention." 

Twenty-eighth study. Mokhtari. My first impression: nearly 30,000 in a study. There are some quibbles with those numbers: 1898 were COVID test negative and another 4087 were not tested. Did they have COVID? 

A major problem with the study is that "HCQ [hydroxychloroquine] was added to the supportive care for patients with mild COVID-19 illness who did not require referral to the hospital." This presents a huge bias: those who did not receive hydroxychloroquine were healthier. Kennedy reports 27 deaths out of 7295 in the hydroxychloroquine group and 287 deaths out of 21464 in the control group, consistent with Mokhtari's presentation.

Twenty-ninth study. Million. Looked at 10,429 ambulatory patients. Of these, 8315 were prescribed hydroxychloroquine and azithromycin. Zinc was later included as the study went along. 

"The primary objective was to evaluate the age-specific 6-week IFR [infection fatality rate] of unselected adult outpatients infected with SARS-CoV-2 who were managed early in a dedicated COVID-19 day hospital offering standardized treatment based on HCQ+AZ. The secondary objective was to test whether the use of HCQ+AZ was associated with improved IFR and lower ICU [intensive care unit admission] and HC [hospitalization in a conventional ward] rates in this cohort."

So, Kennedy reported absolute death rates, 5 out of 8315 for those treated with hydroxychloroquine and azithromycin (plus or minus zinc), and 11 out of 2114 for those that weren't. If the ages of the two groups were equal, that would be in line with the study's goal. The study reported that no deaths took place in any patients who were under 60. It worked out to be that 18.0% of the treatment group were over 60 and 24.6% of the control group. Furthermore, this age difference became even more pronounced with older age with 5.9% of those in the treatment group being over 70 and 11.2% in the control group.

Adjusting for age, there was still a higher rate of mortality in the control group, but not nearly so dramatic as presented in Kennedy's numbers. As for the other two endpoints, hydroxychloroquine plus azithromycin did not reduce ICU or conventional ward hospital admissions to a statistically significant degree. 

 

Thirtieth study. Sobngwi. A total of 95 patients receiving hydroxychloroquine were evaluated in comparison to 92 who received doxycycline, an antibiotic. All patients received vitamin C and zinc. "The primary endpoint was the rate of clinical recovery determined by the percentage of participants who became or remained asymptomatic. Key secondary endpoints included the percentage of participants requiring hospitalization due to worsening symptoms, as well as the proportion of participants displaying a negative SARS-CoV-2 PCR test."

Kennedy reported one of their findings, recovery at day 10: 4 had not recovered in the doxycycline group and 2 had not recovered in the hydroxychloroquine group, a result deemed insignificant (p = 0.44). From the paper: "In conclusion, we did not observe any significant difference in terms of safety and efficacy between doxycycline and hydroxychloroquine-azithromycin for the management of mild COVID-19."

Thirty-first study. Rodrigues. This study is interesting in that it is the only one among the 32 that Kennedy admits shows negative results, that is, not favoring the use of hydroxychloroquine. This is kind of harsh. Just like Kennedy's decisions to say that hydroxychloroquine worked where there was insufficient evidence, there is insufficient evidence here to say that it didn't work.

The patients were randomly assigned either hydroxychloroquine plus azithromycin or placebo. 

"The primary outcome was the time to viral clearance within a 9-day evaluation period following enrolment after the onset of symptoms and the study enrolment dates. . . . Secondary outcomes of interest included: viral load reduction, improvement of symptoms, hospitalisation rates, and adverse effects to the trial medications."

Kennedy only reported hospitalization rates, saying 1 out of 42 in the hydroxychloroquine plus azithromycin group and 0 out of 42 in the placebo group. From the researchers' discussion: "In this randomised, double-blinded, placebo-controlled clinical trial evaluating outpatients with early and mild COVID-19 treated with HCQ/AZT or placebo, there was no benefit in the treatment arm on primary and secondary outcomes."

Thirty-second study. Sawanpanyalert. For the final study, there is a major problem. These researchers used chloroquine or hydroxychloroquine interchangeably and without distinction. These are not the same drugs. Hydroxyamphetamine is not the same amphetamine. Diacetylmorphine is illegal in the U.S. while morphine is not.

Their mix of drugs was complicated. "Among 533 symptomatic patients, 45 (8.4%) received CQ/HCQ alone [chloroquine or hydroxychloroquine], 10 (1.9%) received bPI alone [lopinavir/ritonavir], 197 (37.0%) received CQ/HCQ with bPI and 140 (26.3%) received FPV [favipiravir] with CQ/HCQ and/or bPI.  Of 132 patients who received azithromycin, 121 (91.7%) also received CQ/HCQ."

The lack of identifying when hydroxychloroquine was used prevents evaluating it for this commentary.

So, there are thirty two studies. The problems with these. 

Retracted: one.

Never published: four

Didn't include hydroxychloroquine at all: two.

Didn't identify what the results were for hydroxychloroquine: two. This number is being generous. Several more studies did not make clear what drugs were included in the hydroxychloroquine group versus control.

The authors state clearly that hydroxychloroquine was not shown to be effective: ten.

Studies with confidence intervals that negate a clear result: nineteen. 

Studies that mix hydroxychloroquine with a second drug or third drug (or more) as part of the protocol: fourteen. 

Many of the studies had hydroxychloroquine plus a second, third, or fourth treatment. These are problematic. Did hydroxychloroquine add anything to the therapy? Is it possible that the azithromycin, for example, did all the work? There was only one study that looked at hydroxychloroquine alone, hydroxychloroquine and azithromycin, azithromycin alone, and placebo. Several of the studies did not specify how many patients were receiving hydroxychloroquine alone versus hydroxychloroquine plus other treatments.

Earlier Kennedy had made the point that the lethality of COVID had been exaggerated. On page 5 of the first chapter, he said that even for the people hospitalized: "The real number [hospitalizations due to COVID] was less than one percent."

So what numbers does he show in his studies where hydroxychloroquine is cited as an early intervention (and not an intervention among those already hospitalized or critical)? There were twelve studies cited in the above table that had death as an outcome and which provided the numbers studied. (Excluding Bernabeu-Wittel (no totals to calculate percentage) and the study with the obtuse outcome of hospitalization/death). The control groups had the following as percent lethality: 

40.0%, 2.9%, 3.4%, 9.1%, 26.4%, 4.5%, 53.3%, 1.5%, 25.6%, 1.5%, 1.3%, 0.5%. 

Four studies had a death rate of over 25% among controls including one with over 50%. What the hell was going on in those studies?

Continued with a look at the book itself. 

Martin Hill Ortiz is a professor of pharmacology and author of several novels. 

My new novel, The Missing Floor, is now available from Oliver-Heber books. 

The Missing Floor, now available

Continue reading →

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

 

 There has been a long interval between my last post and this one. I apologize. I have been very busy.

In this series of critiques of Robert F. Kennedy, Jr.'s book "The Real Anthony Fauci: Bill Gates, Big Pharma, and the Global War on Democracy and Public Health," I left off discussing hydroxychloroquine.

Hydroxychloroquine in Perspective

RFK, Jr. puts forward a dizzying number of treatments for COVID. I counted 28 in his book, but it was a bit difficult to sort out the exact number. He sometimes presents the same treatment by different names as though each were different treatments. Although Kennedy included anti-stomach-acid agents, tea, IV hydrogen peroxide, intramuscular ozone, various vitamins, an antigout agent, an antidepressant, etc., he focused on two particular drugs: ivermectin and hydroxychloroquine. Having discussed ivermectin, a relatively safe compound that is not effective against COVID, I went on to discuss the safety issues and in vitro efficacy of hydroxychloroquine, concluding that hydroxychloroquine is a relatively unsafe drug that does have an in vitro effect against COVID viral replication in concentrations similar to those when it is given for other diseases. 

As I've noted before, Kennedy's book does not have page numbers, so the following citations come from my own hand-numbering. 

In Chapter One, on page 6, Kennedy said something honest, seemingly by accident. He says, "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." 

Getting beyond the strange notion that Kennedy thinks the coronavirus equals the common cold, he does point out that finding effective antivirals is really, really difficult. 

Contrast the above to the statement to this one, page 21. "Some 200 peer-reviewed studies by government and independent researchers deem HCQ [hydroxychloroquine] safe and effective against Coronavirus [sic], especially when taken prophylactically or when taken in the initial stages of illness along with zinc and Zithromax." Wait a moment, there are lots of peer-reviewed studies that point to a drug works against coronavirus?

He made the above claim at the time of his book being published in October 2001. On page 22, he presents a chart that he says demonstrates that out of 32 studies of hydroxychloroquine, 31 showed benefit. 

As with many presentations in Kennedy's book, there is the problem of having so many things wrong that it is hard to pick and choose what to focus on. Either I'm going to sound like I'm picking on everything, or else that I am implicitly saying, "other than this," it is fine. I've written a lot in my critiques of Kennedy's book so far. I probably could write ten times as much. However, since this table is so full of garbage, I will address it detail.

Chart presented on page 22 of RFK's book

So, he says 31 out of 32 studies showed benefits. That is not what his chart shows. Outcomes are presented with uncertainties (confidence intervals or [CI] as presented in the table). The range of uncertainty is presented as a horizontal line. When a particular line cross the odds ratio mark of one, that means that particular study could not say that the drug worked better than placebo or compared treatment. That degree of uncertainty takes place in 18 of the studies. An extreme is the study by Guérin which has a confidence interval of 0.02 to 9.06 which at the high extreme says treatment could be nine times worse than non-treatment. Only eight of the studies are noted to be randomized controls. Of these, only one has a confidence interval range below one, making the case that hydroxychloroquine doesn't work.

There are a lot more problems with the interpretation of the data. 

1. These are not all the studies of early treatment with hydroxychloroquine. They are not all peer-reviewed.
2. He mixed outcomes. Some refer to hydroxychloroquine in preventing death, some hospitalization, some progression, some viral positive, etc. These are unique and interesting questions that deserve their own analyses. Drugs can work in prophylaxis but not in treatment. You cannot just mash the results together. Often these studies looked at more than one thing. Kennedy only reports one in the table. 
3. In two of the studies there are a total of five controls. You can't get serious results from such a thing. Five more studies have less than 20. 
4. Six of the studies list the hydroxychloroquine dose as n/a, "not available." What kind of study leaves out dosing information from their publications?
5. A huge problem is that many of these studies are combination therapies. Analyzing combination therapies is a very thorny issue. Among other problems: did the hydroxychloroquine plus azithromycin show effectiveness because of the hydroxychloroquine, the azithromycin, or did you need both? Is it possible that the second drug made the combination worse than one drug alone? He says that zinc works against coronavirus. Is the zinc component doing all the work?

Since Kennedy regularly presents conclusions that are contrary to what is presented in the studies he cites, I decided to look at these studies in detail. I hadn't intended to look at them all, but then, once I started and founded study after study to be problematic, I kept on going. Some of the critiques are moderate. Some are jaw-dropping. For example, one study didn't look at hydroxychloroquine. Others weren't ever published in journals. 

Here's Looking at the Studies, Part One.

First one. Gautret. Retracted. 

Second one. Huang. Randomized clinical trial! However, this study doesn't examine hydroxychloroquine. It does have 22 patients divided into chloroquine and a second drug group, lopinavir/ritonavir. It provides several outcomes, including becoming virus results turning negative which interestingly, at 12 days had chloroquine tied with the second drug group with an ~80% success rate. Strangely, the lopinavir/ritonavir group had only a 50% discharge rate in spite of 80% being viral negative.

From Huang, et al. Only the hospital discharge data was dramatically different.

Third one. Esper. Never published, so how it is referred to as "peer-reviewed" is questionable. Maybe the peers did review it and rejected it. The study does not look terrible, but it did make the major mistake of defining those in the control group as those who refused the hydroxychloroquine plus azithromycin treatment. Allowing a control group to self-select is open to bias.

Fourth one. Ashraf. The RFK table says that 10 out 77 treated with hydroxychloroquine died while 2 out of 5 not treated with hydroxychloroquine died. I don't know how they got those figures out of the study. The study had a total of 100 patients with 94 receiving hydroxychloroquine. Further complicating interpretation is that 100% received oseltamivir (an anti-flu antiviral), and 60% received lopinavir/ritonavir (typically used for HIV). There were numerous other drugs. The authors note that azithromycin did not improve outcome. Worrisomely, three patients died during the 14 day follow-up to the study. "Of the 70 discharged patients, 40% had symptom aggravation, 8.6% were readmitted to the hospital, and three patients (4.3%) died." No information on their therapy.

Fifth one. Huang. I could find only one COVID hydroxychloroquine study published in the years 2020-21 with Huang as the first author. It showed a 44% increase in the death rate for those taking hydroxychloroquine-azithromycin to treat COVID (15.0% in the treatment group, 10.4% in the control group.)  Update: While I had searched for Huang studying hydroxychloroquine, Kennedy had referenced a study a Huang study of COVID and chloroquine. Chloroquine is not the same drug. 

Sixth one. Guérin. This study looked at control versus azithromycin versus azithromycin plus hydroxychloroquine. The control group had one death, an eighty-two year old man. Only 58% of the study participants were confirmed to have COVID. Hydroxychloroquine plus azithromycin did not perform better than azithromycin alone (p = 0.26).

Seventh one. Chen. As Kennedy's table says, Chen's study examined 30 patients. RFK identifies viral time as the outcome. The results were not favorable for hydroxychloroquine. "On day 7, COVID-19 nucleic acid of throat swabs was negative in 13 (86.7%) cases in the HCQ group and 14 (93.3%) cases in the control group (P>0.05)." The hydroxychloroquine group had more adverse effects, but the overall study size was small. (Being a common name, there is a study by another Chen of hydroxychloroquine and COVID in 2020, but that involved 61 patients, so it is not the one Kennedy is citing.)

Eighth one. Derwand. A total of 141 patients with confirmed COVID were treated with zinc, low-dose hydroxychloroquine, and azithromycin. Their outcomes were compared to 377 matched controls from the community. One death occurred in the treatment group and thirteen in the control group. All of this sounds impressive and I would have given this study the first thumbs up among the ones I've reviewed so far, except that the senior author is Zelenko, who well before this study made outrageous claims for his triple therapy. The fact that this is a retrospective study and has much fewer numbers than his previous reports (500 patients treated with 100% success rate) which involved treating people without ethical review board permission suggests that he is selecting his data.

Ninth one. Mitjà. His study looked at hydroxychloroquine in patients with mild COVID. As he concluded: "In patients with mild COVID-19, no benefit was observed with HCQ beyond the usual care."

Tenth one. Skipper. He had similar conclusions as did Mitjà: "Conclusion: Hydroxychloroquine did not substantially reduce symptom severity in outpatients with early, mild COVID-19." I don't know how Kennedy got the numbers he reported. They're different from those in the paper.

Eleventh one. Hong. You may have already noticed that in the columns treatment and control, sometimes Kennedy includes both total numbers and how many of those fit the outcomes (for example, for Skipper, 5/231 (treatment) and 8/234 (control)). In six instances, Kennedy just gives single numbers not providing what they mean. For Hong he lists viral positive as the outcome and 42 (treatment) and 48 (control). So what did the study do? They recruited 100 patients: 92 were treated with lopinavir/ritonavir, 90 were treated with hydroxychloroquine, and 22 were treated with dexamethasone. This means the large majority received both lopinavir/ritonavir AND hydroxychloroquine. How do you get 48 controls from that? And what does it mean to be a control? Viral shedding after 30 days was the endpoint of this study. The study did come to the conclusion that hydroxychloroquine was the only variable associated with protection, however Kennedy's presentation of the numbers is questionable.

Twelfth one. Bernabeu-Wittel.  This study looked at a wide range of interventions. "Ten key processes and interventions were established (provision of informatics infrastructure, medical equipment, and human resources, universal testing, separation of "clean" and "contaminated" areas, epidemiological surveys, and unified protocols stratifying for active or palliative care approach, among others)." As you may note in the above hydroxychloroquine treatment was not a main focus. In Kennedy's table it lists deaths as the end point with 189 deaths in the treatment section and 83 in the control. I cannot figure out how they got those figures or related them to those who took hydroxychloroquine in the study. The authors don't even reference hydroxychloroquine in the discussion or conclusions of their study.

Thirteenth one. Yu. According to Kennedy 1/73 died in the hydroxychloroquine treatment group versus 238/2604 in the control group. According to the Yu paper, "We found that fatalities are 18.8% (9/48) in HCQ group, which is significantly lower than 47.4% (238/502) in the NHCQ group (P<0.001)." The discrepancy between the 2604 and 502 can be relegated to the fact that they reported hydroxychloroquine treatment in only those in critical condition and all deaths came among those in critical condition. The reason for the difference between 1/73 and 9/48 is unclear.

Fourteenth one. Ly.  Ly, et al., looked at deaths in a nursing home among those testing positive for COVID with 116 receiving hydroxychloroquine/azithromycin and 110 in the control group. The patients were fairly old: with 43% of those in the treatment group being over 85 along with 56% of those in the control group. There was a dramatic difference in survival rate between women (14.0% death rate) and men (30.7% death rate). Those assigned to the drug treatment group were 60% women, this leaves unresolved whether age and gender were responsible for the better outcome for those treated. From the paper: "Through multivariate analysis, the death rate was positively associated with being male (30.7% vs. 14.0%, OR = 3.95 [1.65–9.44]; P = 0.002), aged > 85 years (26.1% vs. 15.6%, OR = 2.43 [1.04–5.69]; P = 0.041)."

Fifteenth one. Ip.  Ip, et. al., looked at patient charts to find 97 who had been treated with hydroxychloroquine and matched those with 970 who had not and then looked at outcomes. While the matching appeared studious, the hydroxychloroquine-treated patients had more significantly more comorbidities (suggesting any positive results would speak favorably for hydroxychloroquine). While a significant effect on death was not found (p = 0.578), when age was taken into account, they concluded that hydroxychloroquine lowered hospitalization rates (p = 0.045). 

Sixteenth one. Heras.  Heras looked at outcomes in 100 patients in nursing homes (average age, 85). 

Treatment was varied. "As for the treatment, five categories were defined: patients who received hydroxychloroquine and azithromycin, hydroxychloroquine only, hydroxychloroquine plus another antibiotic, beta-lactam, or quinolone antibiotics, and no treatment." Although most of the numbers are unclear in the presentation, 70% of the patients received hydroxychloroquine plus azithromycin and 17% received no treatment (which the paper confusingly says includes beta-lactam or quinolone antibiotics), leaving 13% (13 patients) divided into the other categories. 

Of the whole group, 24 patients died. The paper leaves unclear exactly how many did not receive hydroxychloroquine. It does provide enough information to determine that 8 of 70 who received hydroxychloroquine plus azithromycin died. It also says that 3 of 9 of those receiving hydroxychloroquine died (presumably meaning hydroxychloroquine alone). Their table goes on to say that there were 21 untreated with 13 deaths. (The results are presented like one of those puzzles that say the man with the red hat stood behind the lady with the blue pants.) None of the results in their paper align with Kennedy's numbers in his table. 

Seventeenth study. Kirenga. He looked at 56 patients with COVID, 29 of whom received hydroxychloroquine. Nearly all who received hydroxychloroquine also received an antibiotic. Interestingly, they averaged 34.2 years old, much younger than other studies. I admire the completeness of his study, he looked into or described many cofactors. The study was conducted at two hospitals. One hospital did not prescribe hydroxychloroquine, the other prescribed it to 94% of its patients. The median hospital stay was significantly shorter for the hospital that did not prescribe hydroxychloroquine (p = 0.012). His conclusion? "Outcomes did not differ by HCQ treatment status in line with other concluded studies on the benefit of using HCQ in the treatment of COVID-19." 

It is strange that Kennedy cites Kirenga in favor of hydroxychloroquine. Kirenga conducted a second study "a randomized open label Phase II clinical trial" looking at hydroxychloroquine. His conclusions: "Our results show that HCQ 400 mg twice a day for the first day followed by 200 mg twice daily for the next 4 days was safe but not associated with reduction in viral clearance or symptom resolution among adults with COVID-19 in Uganda."

Eighteenth study. Sulaiman has not published a peer-review article on the efficacy of hydroxychloroquine. He does have this non-peer reviewed article which is referenced by Kennedy. The study compared those who received only supportive care to those who received supportive care plus hydroxychloroquine, zinc, cetirizine (an antihistamine), and acetaminophen. "The primary outcome of interest was hospital admission within 28-days of presentation. The secondary outcome of the study was a composite of ICU admission and/or mortality during the 28-day follow up period." The numbers that Kennedy references in terms of mortality are consistent with those in the document.

Sulaiman does have a peer-reviewed article on the safety of hydroxychloroquine in 2733 patients (data from the above study). Those treated were prescribed hydroxychloroquine plus zinc, acetaminophen and an antihistamine. 6.7% of treated patients experienced drug-related toxicities and 4.1% withdrew from the study due to those toxicities. 

Continued with Entry 14. 

Martin Hill Ortiz is a professor of pharmacology and author of several novels. 

His new novel, The Missing Floor, will be coming out on April 8 from Oliver-Heber books. 

The Missing Floor, available April 8

Continue reading →