Kennedy's Citations

 

Kennedy's Citations

 I began my critique of Robert F. Kennedy, Jr.'s book on Dr. Fauci with an entry titled "Big Conspiracy." There are those who will wrap their arms over your shoulder and pretend to be your friend, all the while pointing to someone else, saying that "they are the real enemy." As you walk along, they will be robbing you. Usually they will point to an enemy that does have real faults. In Kennedy's case, he targets, at times, Big Pharm. 

These people scratch the itch of paranoia, blur the lines of reality, and make money from selling you their books and making speaking engagements. Sometimes they believe what they sell or at least convince themselves of their con. Robert Preston, as Professor Harold Hill (no relation), said, of believing his phony scheme, "There's always a band."

I cannot count Kennedy among the true believers. His arguments are so dishonest, so insincere and calculating, that I believe he must know he is lying. He will take a reference and claim it says the opposite that it does. He cloaks himself in famous names and quotes marginal sources as authorities.

This is clear in the citations that Kennedy has at the end of chapters. For a book purported to be about science, relatively few citations are from scientific studies. Instead, he quotes conspiracy books and conspiracy news articles. He cites YouTube videos that sell conspiracies. I'm surprised he doesn't cite his own book on Fauci as a source. (He does cite his website as a source of his information.)

For Chapter Six of his book, I decided to tally his citations, 180 in total. 

For his most common source, he cites anti-HIV books 39 times. These books have accusational titles and lengthy subtitles such as Peter Duesberg and the Duesbergians: How a Brave and Brilliant Group of Scientists Challenged the AIDS Establishment and Inadvertently Exposed the Chronic Fatigue Syndrome Epidemic. The book, Virus Mania: How the Medical Industry Continually Invents Epidemics Making Billions at our Expense had 24 citations by itself.

The full list of books cited is at the bottom of this page. 

He cites newspaper articles 36 times. This includes 25 of what I would term mainstream media, and others that are niche publications. On top of this, he cites pop magazines, such as Spin, 6 times, and a mainstream magazine, once. One pair of newspaper articles by Elinor Burkitt is cited 18 times.

Actual articles in scientific journals are cited 29 times, or 16.1% of the time. 

YouTube videos are cited 24 times. Blogs are cited 12 times.

The remaining groups of citations are less than five times each (drug insert, website, etc.)

This is not how a reasoned argument is bolstered. This is a person citing books every bit as incompetent as his own as proof of what he is saying. Kennedy never tries to present the other side of the argument, that HIV does cause AIDS, or look at its possible merits. He never cites a book that says such, or a newspaper article. He does cite Duesberg often, in support of Duesberg.

Full List of Books Cited in Chapter Six:

Peter Duesberg and the Duesbergians: How a Brave and Brilliant Group of Scientists Challenged the AIDS Establishment and Inadvertently Exposed the Chronic Fatigue Syndrome Epidemic

Virus Mania: How the Medical Industry Continually Invents Epidemics Making Billions at our Expense

Impure Science: AIDS, Activism, and the Politics of Knowledge, Rethinking AIDS: the Tragic Cost of Premature Consensus, Inventing the AIDS Virus

The AIDS War: Propaganda, Profiteering, and the Genocide from the Medical-Industrial Complex

Death Rush: Poppers and AIDS

AIDS: The Burden of History

The Chronic Fatigue Syndrome Epidemic Cover-Up: How a Little Newspaper Solved the Scientific and Political Mystery of Our Time

Dancing Naked in the Mind Field (no subtitle!)

Science Sold Out: Does HIV Really Cause AIDS?

A book on conspiracy theories and the damage they cause:

Conspiracies do exist. Probably at a rate of one per thousand conspiracy theories.

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.

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RFK and HIV, Part Two

I am continuing to look at the RFK, Jr.'s presentation about "the doubts that exist" as to whether HIV causes AIDS. In the previous entry, I looked at a number of miscellaneous topics in Chapter Five and focused heavily on RFK's arguments about Koch's postulates from 1890. 

Going through Kennedy's arguments is a frustrating task. He commits a sin that is commonly referred to as a Gish gallop. This is a means of arguing by throwing a hundred things out regardless of quality and expect the debater to waste time disputing minutiae. If the debater doesn't do this, he claims victory by saying that there was so much the debater did not address. 

As I've documented time and again, Kennedy often presents bat-shit crazy or wholly contrived arguments. I have undertaken many hours dissecting Kennedy's lies. There are many more I neglect. This should not be my life's work. He should be responsible for his own honesty. In a just world, he would correct himself. 

As noted in my last entry, Kennedy claims to be agnostic as to whether HIV causes AIDS. He does however, spend 65 pages presenting arguments that it doesn't, and dedicates no space to the arguments that it does. This is typical of his fake evenhandedness. 

In this section I'm going to go briefly over Kennedy's criticism of tests to determine whether someone has an HIV infection and then dive into Duesberg's alternative view of what causes AIDS.

On page 190, Kennedy says, "The most significant diagnostic tools doctors use to determine if someone is infected with HIV, and therefore, whether they have AIDS are:

1. HIV antibody test.

2. PCR viral load tests.

3. Helper cell counts. (CD4 cells)"

This is poorly worded. Infected with HIV does not mean the patient has AIDS as I discussed in the previous post. CD4 counts do not diagnose whether someone has HIV. They correspond to immunological status. And his list doesn't include tools that researchers use such as p24 antigen, culturing, full virus sequencing, or in some instances, electron microscopy. 

General Comment on Diagnostic Tests

First, let's consider a general matter about tests. No test is perfect. The television show "House," devoted whole episodes to trying to diagnose through testing and exam. There are four possible outcomes to any disease test. First is a true positive. That means the test shows someone has the disease and, indeed, that person does have the disease. Then there is the true negative. That means the test shows someone does not have the disease, and, indeed, that person does not. Then there are the unwanted outcomes. False positive. In this case the test shows someone does have the disease when that person doesn't. Finally, there is false negative. In this case, the test says the person does not have they disease when they actually do. 

The obvious idea behind a test is to have the true positives and true negatives vastly predominate. For a specific test for tuberculosis, false positives can range from 1-2% to higher, depending on the patient's circumstance and the study. This doesn't mean that Mycobacterium tuberculosis doesn't cause tuberculosis or that the test is useless. With science, uncertainty in any given approach goes with the territory. That's why the lawyers add provisos with the tests: this is not a definitive diagnosis. They don't want the test manufacturers to get sued.

There have been lawsuits from people falsely diagnosed as having HIV. To avoid these, the diagnostic exam companies add a disclaimer. This disclaimer results in something good (we do have tests) and something bad (the companies have less incentive to better their tests). As I said, no test is perfect.

Kennedy cites such lawyerly provisos to dismiss HIV tests as being useless and meaningless. Page 192, "Do not use this kit as the sole basis for detecting HIV infection." 

HIV Antibody Tests

Kennedy's first complaint is about the HIV antibody test. He throws out head-scratching arguments. "HIV antibody tests were not actually designed to specially to detect HIV." (page 191) Of course not. They detect antibodies. I have already commented on Kennedy's bizarro comment "High antibody level indicated that a person had already successfully battled against infection and was now protected from the disease." Such an argument says that every battle against diseases is successful. 

Kennedy includes this statement on how antibody tests are made which should make researchers laugh. (Page 190) ". . . the inventor must isolate the target virus and expose it to human cells in a petri dish, which then generate the specific antibodies responsive to that virus."

Kennedy says that "Gallo's antibody test also reacts to people with fever, pregnant women, and people who have overcome a tuberculosis infection." (page 190) Why Kennedy is still talking about Gallo's 1980s antibody test is one problem, but the notion of what percent of tests have false reactions is dealt with pretty well in this explanatory article. It depends on how prevalent the true local infection in HIV is. If you almost never have a true HIV infection locally, then many positive reactions are likely to be false. If it is common, then the likelihood of a false positive is diminished. That's the nature of disease testing. The source gives a 94.5% true positive rating for men who have sex with men in the United Kingdom. 

My ongoing frustration with Kennedy is that a mature and interesting discussion of these matters is both possible and informative.

PCR Testing 

On page 185, Kennedy starts a rant on PCR, a general method used to detect all sorts of illnesses and causative agents. He continues this in several spots, including page 190 and 191, with a subchapter titled "PCR Testing Deficiencies." His mind does jump around. 

So, what does PCR do? Every organism has genetic material that is specific to its species. In straightforward PCR (and there are many variants), you use a pair of segments of DNA (called primers) to amplify copies of a region of the genetic material of a specific organism. That genetic region represents a "DNA fingerprint" of the organism. PCR is also used in forensics to provide a sequence of genetic information that is unique to a particular human and which is considered definitive in criminal cases.

On page 191, Kennedy says, "The Polymerase Chain Reaction (sic) PCR technique does not measure the actual, live virus in the body . . ."  No, PCR doesn't measures "live" viruses. No one says viruses are "alive" by the standard definition of life, anyway. Perhaps he means to say "viable virus," or "infectious virus," but I shouldn't have to write his book for him.

Done right, PCR proves the presence of a specific organism's genetic material. 

As I said, PCR can be thought of as genetic fingerprinting much in the same way the genetic fingerprint of a criminal can prove the source of biological material. Blood on a glove. Semen in a rape kit. In the case of HIV, it is the genetic signature of the virus. Can something go wrong? I know of a case where the police mislabeled the blood samples and arrested a man because his voluntary DNA sample matched another tube of blood with his voluntary DNA sample. PCR can't overcome that. Contamination in the lab can screw up results. Otherwise, done right, PCR tests are a standard means for identifying the presence of a wide variety of infectious organisms, and can be used to detect mutations that exist in genetic diseases. PCR is one of the great inventions of the last half-century.

On pages 190-1, Kennedy cites Kary Mullis, the inventor of PCR to say, "Quantitative PCR is an oxymoron. PCR is intended to identify substances qualitatively, but by its very nature is unsuited for estimating numbers." Sorry, Dr. Mullis, yes (duh) PCR can be quantitative. There is an entire field called real-time PCR. It can be used for many diseases and is a standard means of measuring gene expression. Searching the Library of Medicine online, the phrase "real-time PCR" brings in over 100,000 papers. ("Quantitative PCR" as a search term brings in 48,000 results, although many of those are bound to overlap with the previous search.) Quantitative PCR has a very straightforward means of testing amounts in comparison to standardized controls of known quantities. 

There are different varieties of PCR which cover many different diseases including those that quantify gene products, disease organisms, and HIV.

Kennedy repeatedly says that PCR can only amplify viral fragments. While this is usually all that is necessary, this is a review of papers that look at full genome length amplification. 

CD4 Tests

Kennedy devotes only one short paragraph to discussing CD4 tests (page 192). He argues that CD4 counts are merely a surrogate marker and "The problem is the use of a surrogate endpoint, which is notoriously im- precise (sic)." I mostly agree. Surrogates are imprecise. That doesn't make them useless. My own experience with those with very low CD4 counts from patients is that they were at the end stage disease process. This was before 1995 and the arrival of powerful HIV therapy. Much fewer HIV patients have collapsed immune systems these days. 

Duesberg's Theory About What Causes AIDS and Kennedy's Homophobia.

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."

The above is an example of RFK, Jr.'s book includes a number of anti-gay snide remarks. Homosexuals are highly promiscuous! As he says, cited further below, they are all drug users. 

The July 3, 1981 MMWR publication (actually the second report of the phenomenon which would become known as AIDS) nowhere describes the cohort as "highly promiscuous." They are referred to as homosexual and the degree of their sexual behavior is not mentioned. The actual July 1981 report. 

On page 222, RFK gets around to commenting on the actual first report of what came to be known as AIDS from June of 1981. Kennedy states "The first AIDS cases were five gay men—all unknown to one another—diagnosed with a rare (PCP) pneumonia and Kaposi's sarcoma, a form of cancer that previously only afflicted elderly men." The actual June 1981 report. 

I clench my teeth here. Why can't Kennedy get anything right? None of the first five cases had Kaposi's sarcoma. 

Further down the paragraph on page 222, he references Dr. Michael Gottlieb (co-author of the first report, and, in part, a discoverer of AIDS) and goes on to say, "The men were all promiscuous party enthusiasts in the "fast lane" gay lifestyle" and "They daily had multiple anonymous sexual partners—upward of a thousand per year—and contracted most of the sexually transmitted diseases like syphilis, gonorrhea, and hepatitis B." 

What does the Gottlieb's MMWR paper say? "The five did not have comparable histories of sexually transmitted diseases" and "Two of the five reported having frequent homosexual contacts with various partners."

While Gottlieb did not say what Kennedy claimed, he did, however, in an interview, trash Duesberg and spoke of his own early work on AZT. (Warning: the link has auto-starting videos of the interview, so you might want to mute your computer if you merely want to read.)

GOTTLIEB: Disinformation and a false narrative did not originate recently. Peter Duesberg and his colleagues were ahead of the time in disseminating misinformation and a false narrative, for unclear motives. Duesburg and the AIDS deniers did a huge amount of damage and undoubtedly cost peoples' lives. [snip] Peter Duesberg is flat wrong. One has only to look at the success of ART in changing HIV from a death sentence to a manageable condition with projected longevity for young people that approximates what their lifespan would have been without HIV. The only thing different is the fact that they are treated with medication that addresses HIV specifically and not any other virus or factor in their lives. [emphasis mine]

GOTTLIEB: My message to them is to stop it.

The full paragraph and context of Kennedy's statement about Gottlieb and the promiscuous gays reads (Page 222). I include a commentary below this.

The first AIDS cases were five gay men--all unknown to one another--diagnosed with a rare (PCP) pneumonia and Kaposi's sarcoma, a form of cancer that had previously afflicted only elderly men. Dr. Michael Gottlieb, a researcher searching California hospitals for new diseases with unusual symptomology, is credited with the initial discovery and its epidemiological context. (the following sentence, with its repeat portion, is presented as it is in the book.) in  Los Angeles in 1981 by Dr. Michael Gottlieb, a researcher searching California hospitals for new diseases with unusual symptomology. The men were all promiscuous party enthusiasts in the "fast lane" gay lifestyle. They were taking many different recreational drugs simultaneously and combining drugs in excess of patterns among straight drug users. They frequented bars, clubs, and bathhouses. They had multiple daily anonymous sexual partners--upward of a thousand per year--and contracted most of the common sexually transmitted diseases like syphilis, gonorrhea, and hepatitis B. They were, therefore functionally addicted to a pharmacopoeia of antibiotic prescription medications; "all of that created a situation where a handful of gay men," say Mark Gabrish Conlan "were burning the candle at both ends and putting a blowtorch to the middle. It's no wonder that after a while, their immune systems started to collapse and they started getting sick in these unusual ways that previously only been seen in older people whose immune systems had deteriorated with age." 

There is a lot to unpack there. Old people do not get immunodeficiency diseases in any way similar to those with AIDS. Kaposi's sarcoma was not just known in "elderly men." Outside of AIDS, it has a very specific genetic and regional occurrence. Dr. Gottlieb was not "searching California hospitals for new diseases." You would think from the above paragraph that Gottlieb, a respected AIDS researcher, was the one claiming these men were "in the fast lane." The transition to Conlan's words are not clear. Conlan is a journalist. Where Conlan's quote came from is unclear, it is not among Kennedy's citations. 

Why does this matter? Kennedy puts forward the crackpot theory that it was through wild drug use that gay people destroyed their immune systems thus causing AIDS. This drug use was specifically tied to "poppers," which typically refers to amyl nitrite.

Kennedy (page 223) says that poppers "are very powerful oxidizing agents." They are moderately powerful oxidizing agents. They are used clinically for angina. He goes on to say they are "powerfully mutagenic and carcinogenic." They are not. And, "poppers are radically immunosuppressant in rodents." A study in humans show limited effects, reversible within a week. 

If poppers cause AIDS, I wonder what the act of telling whoppers causes? Kennedy offers this one. Page 223, "Prior to 1987, every AIDS patient acknowledged heavy consumption of poppers." 

Through 1987 there were 50,280 US cases of AIDS. That is remarkable that they all confessed to heavy consumption of poppers. Did they interview 5,000? Doubtful. And 100% confessed to using poppers? Including those who got AIDS from transfusions? Hemophiliacs? (My first work studied AIDS in children.) Of course, Kennedy's statement is completely made up. 

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. 

More recently, among those newly diagnosed with HIV (2022), 67% were male homosexual or bisexual, 22% were heterosexual, and 7% were IV drug users. That is for the US and AIDS is a worldwide phenomenon. 

Refusal to Debate.

On page 218, Kennedy begins a subchapter on the refusal to debate HIV deniers and Duesberg called Refusal to Debate. I personally have been attacked as someone who has promoted the deaths of hundreds of thousands because of my views which align with those of Fauci. Kennedy himself presents subchapters titled AZT As Culprit and Is AZT Mass Murder? I personally believe that when Duesberg influenced South Africa to deny HIV treatment due to personally pressing his case that HIV does not cause AIDS, he helped cause hundreds of thousands of deaths, a figure presented in this article in the Journal of Acquired Immunodeficiency Syndrome. I cannot debate such a person. I have no respect for the things that come out of his mouth.

I go on to look at Kennedy's sections on Kaposi's sarcoma and AZT in my next installment. 

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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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. This entry continues 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 most 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 voice 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 promotion 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 demonstrating a particular 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 in spite of the fact that she, herself, did not present 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 isn'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 typically resort 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 and they take the opportunity of a lowered immune system to appear. 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 simple and straightforward. 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 also 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.) Page 181, "Dr. Gallo stalled the publication to give him time to cultivate and steal Dr. Montagnier's virus." 

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 tissue 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 doesn'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.  

Continued in Part Two.

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, alternating between "HIV, Not Guilty?" and "Is HIV Guilty?" 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.

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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.

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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. As for saying the complete opposite, 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.)

The Toxicity of Hydroxychloroquine.

Before talking about the effectiveness of hydroxychloroquine for COVID, RFK talks about its relatively safety. He out and out lies and doesn't even try to do a good job of lying. 

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 Pollyannaish claims about safety, they are filled with dry warnings about potential complications. Visiting the page that presents the hydroxychloroquine insert (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 torsade 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, quoted below. 

"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 for those taking insulin. (It is prescribed in India for diabetes.) 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% cell 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 (IC50) 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 for other illnesses? 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. (It is also not doing fantastically well at typical concentrations.) So, does it work in patients?

Continued (sorry for the delay)

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

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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

Ivermectin is a great drug for treating certain worm infections. Two of the discoverers were rewarded with Nobel Prizes. 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.

Nobel Prize winners for the discovery of ivermectin

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. 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 whether 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 50% effective in inhibiting the virus. 

Each "well" is like a tiny test tube.

From viral inhibition studies, ivermectin can be determined to have an anti-COVID effect in vitro. This can be seen in the graph below. 

Ivermectin, in vitro inhibition of COVID-19 (from Caly, et. al, Antiviral Res 2020 Jun:178:104787)

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 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
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