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Home » Debunking RFK Jr and Hooker’s book “Vax-Unvax” – Part 5, HPV vax

Debunking RFK Jr and Hooker’s book “Vax-Unvax” – Part 5, HPV vax

This article, part 5, on the HPV vaccine, of a series of 7 debunkings of a new book, “Vax-Unvax: Let the Science Speak” is written by Frank Han, M.D., an academic board-certified pediatrician/ pediatric cardiologist. He splits his time between cardiac imaging (Nuclear, CT, MRI, and echocardiography), inpatient cardiology, and outpatient cardiology. He primarily cares for cardiology patients of all ages with congenital heart disease and is dedicated to educating pediatric residents and medical students.

Dr. Han first became aware of and interested in the incursion of pseudoscience into his chosen profession while completing his pediatric residency at Connecticut Children’s Medical Center and saw it explode during the COVID pandemic. He has since focused his efforts on spreading the joy of science literacy and teaching patients how to take charge of their health while navigating the tricky online world of medical information. Dr. Han has no conflicts of interest to disclose and no ties to the pharmaceutical industry. He can be found on Twitter as @Han_francis. The comments expressed by Dr. Han are his own and do not necessarily represent the views or opinions of OSF Medical Center, or the University of Illinois College of Medicine.

As I did in Part 1Part 2Part 3, and Part 4 of this series, I will emphasize one chapter of the book “Vax-Unvax: Let the Science Speak,” by Robert F Kennedy Jr and Brian Hooker. In this chapter, the authors attempt to describe the science behind the HPV vaccine (Gardasil from Merck). Of no surprise to people who read this blog – the book authors have a profoundly impaired understanding of the concepts they are trying to communicate.

This article will review each of Kennedy and Hooker’s allegations about the HPV vaccine one by one.

Vax-Unvax HPV vaccine
Robert F. Kennedy Jr. arrives in the lobby of Trump Tower in New York, Tuesday, Jan. 10, 2017, for a meeting with President-elect Donald Trump. (AP Photo/Evan Vucci)

Allegation 1 – Vax-Unvax and the HPV vaccine

Vax-Unvax says don’t worry about the HPV vaccine because you can use Pap smears.

There are several logical errors in this statement. The simplest of the logical errors is – it is far preferable for a patient to prevent cancer than to get diagnosed with cancer (the HPV vaccine is one of a very short list of vaccines that can prevent several kinds of cancer associated with HPV). The next logical error is – that the authors are entirely unaware of the procedural pain that is involved in completing a Pap smear (there was no evidence in the book chapter, that they spoke with any women who underwent it).

Next up, although the smear is quite good, it is not a foolproof test, meaning some patients with cancer still slip through the cracks. The problems with the smear were at one point so severe there was a scandal in Ireland. In conclusion, the smear is a good screening test, but getting the HPV vaccine in the first place is so much more effective to prevent cancer from occurring in the first place. Antivaxxers care about none of these issues.

Allegation 2 – Vax-Unvax and the HPV vaccine

If you get cervical cancer, you can get a loop electrosurgical excision procedure anyway.

This particular procedure, known as a loop electrosurgical excision procedure or LEEP, is a cauterizing procedure meant to physically cut out regions of the cervix that contain cervical cancer. While it is one of the most straightforward procedures in the obstetrician/ gynecologist’s toolkit, this procedure is not without side effects.

Some of those risks include negative impacts on the ability to carry a pregnancy, and the ability to safely start a pregnancy. As the book authors have none of the clinical expertise of actual obstetricians, they can’t relate to the significance of cervical incompetence on the ability of the pregnancy to go to term.

Allegation 3

Vax-Unvax says that the HPV vaccine was rushed through its approval in 2006.

This is a willful misinterpretation of the Prescription Drug User Fee Act. The point of this law, which was passed in 1992, was to enable the FDA to gather enough financial resources to approve drugs at a quicker pace and collect fees from drug companies to make that a reality. Complaining that the FDA fast-tracked one specific version of Gardasil ignores all the preclinical work and clinical trials that went into the second-generation vaccination, and the modern data that show very effective prevention against oral, genital, and anal cancers caused by the most oncogenic strains of HPV.

Allegation 4

Vax-Unvax says it was objectionable that the HPV vaccine was not tested versus saline placebo.

Again, the book authors exhibit their profoundly impaired basic English reading comprehension. It takes very little effort to pull up the FDA package insert, which by the way, antivaxxers implore that we read – to find the following quote:

In 7 clinical trials (5 Amorphous Aluminum Hydroxyphosphate Sulfate [AAHS]-controlled, 1 saline placebo-controlled, and 1 uncontrolled), 18,083 individuals were administered GARDASIL or AAHS control or saline placebo on the day of enrollment.

Allegation 5

RFK Jr and Brian Hooker claim that the placebo group was offered the HPV vaccine 6 months into the trial, so there is no long-term follow-up of the safety and effectiveness of the vaccine.

There are quite a few studies with quite a few different follow-up lengths – it takes just a few clicks to find studies as long as 126 months.

Allegation 6

Merck stacked the deck because they compared their HPV vaccine to a placebo containing adjuvant.

No, when you test your vaccine versus your adjuvant you can separate the side effects due to the active ingredient versus the side effects due to the adjuvant. Multiple kinds of aluminum adjuvant have been tested separately for their safety and immunogenicity.

Allegation 7

Merck’s claim that HPV vaccination protects against tumors that aren’t cervical, is untested
Failure of basic fact-checking once again. Several investigators have looked at this issue.

Allegation 8 – Vax-Unvax and the HPV vaccine

RFK Jr and Hooker make the following claim: “Researchers never independently tested a component of the Cervarix adjuvant, monophosphoryl lipid A. The rate of new autoimmune conditions within the Cervarix trial was 0.8% in both the experimental and control groups.”

First off, the book authors can’t get their simplest historical data correct – Cervarix has been taken off the market as of 2016 due to low demand, so readers don’t even have to worry about Cervarix anymore in the United States. It didn’t require a professional historian to find that out. A quick Pubmed search will reveal over a thousand articles on monophosphoryl lipid A, many of which involve human testing.

Allegation 9 – Vax-Unvax and the HPV vaccine

RFK Jr and Hooker make the following claim: “The 2012 Vaccine Adverse Event Reporting System (VAERS) data showed that more serious adverse reactions were attributed to Gardasil than all other vaccines, with Gardasil accounting for more than 60% of the total. The Gardasil vaccine also accounted for 63.8% of all deaths, 61.2% of all life-threatening reactions, and 81.8% of all cases of permanent disability recorded in the CDC VAERS data.”

First, the authors who made these claims, Christopher Shaw and Lucija Tomljenovic, have several article retractions under their belt for shoddy research methodology.

Next, VAERS must never be used on its own to come to conclusions of causation. A modern vaccine that everyone recognizes is the COVID vaccine, which is known to cause myocarditis mostly in a very small subset of teen boys and young men.

This relationship was arrived at through extensive work from multiple investigators and national health agencies – not through the evidence-free declarations of a few antivaxxers or isolated analysis of VAERS. One may not assert that VAERS is evidence for causation any more than one may assert that aliens are real “because I said so”.

Allegation 10

“Based on our analysis using data from the Nagoya City surveillance survey, a possible association between HPV vaccination and distinct symptoms such as cognitive impairment or movement disorders exists.

This article is typically cited along with the claim that “Japan banned Gardasil”; that would again be a failure to comprehend really simple English. Here’s what really happened.

For the specific study cited by RFK Jr and Hooker, there are at least several mistakes. One problem is that the significant findings were arrived at by adjusting the study periods of monitoring (the amount of time the subjects were observed). If you look for longer periods, you can gather more symptoms, but you run the risk of catching symptoms related to other conditions.

The next problem is that the authors of the study did not disclose their conflicts of interest they worked for organizations in Japan that are anti-HPV vaccination.

Lastly, the main data analysis group did not perform age adjustment – which artificially inflated their odds ratios. The book itself makes use of a classic antivax trick – they show the calculated odds ratio without showing the confidence interval, with which they hope to dupe readers who are not well-versed in the fundamentals of statistics.

Lastly, the fact that only this group of investigators found this relationship, means that the generalizability of the findings is limited.

Allegation 11 – Vax/Unvax and the HPV vaccine

Female mice receiving three human weight-equivalent doses of quadrivalent Gardasil vaccine produced anti-brain protein and anti-brain phospholipid antibody titers at 8.5 and 10 times that of unvaccinated control mice. These antibody differences between Gardasil and control mice were statistically significant, with p-values less than 0.002.

The multiple problems with this article have been addressed here.

Allegation 12

In this study, a cohort of women from Sweden and Denmark showed a significantly higher risk of celiac disease after receiving the human papillomavirus vaccine than unvaccinated control women (95% CI of 1.29 to 1.89).

If the authors of the book had thoughtfully read the conclusions of the actual study, they would have realized that the authors of the study have a likely explanation for these findings. Citizens of Denmark, in general, have chronically underdiagnosed celiac disease, which when actively screened for, can be identified in a study such as this. Also, this finding was mainly found in the Danish cohort of the study rather than the Swedish cohort. Moreover, the book authors forget that there is no way for the HPV vaccine to place the main celiac genetic risk factor into patients, HLA-DQ2. Your genes are your genes.

Allegation 12

The study’s lead author, David A. Geier, is affiliated with the Institute of Chronic Illnesses in Silver Spring, Maryland. Using data from the National Health and Nutrition Examination Survey, the study authors determined that HPV vaccine recipients have an 8.01 times greater incidence of asthma compared to persons not receiving the HPV vaccine (95% CI of 1.98 to 32.41).

The lead author is the same person who misrepresented his credentials, failed to obtain informed consent before engaging in human subjects research, misdiagnosed precocious puberty, and erroneously prescribed medicines based upon that misdiagnosis. His medical license has been suspended for these and multiple other offenses.

In the study itself – the authors make no effort to reconcile their findings with a related German study that found no association between vaccines and asthma. In addition, the study writers do not attempt to reconcile their analysis with the multiple known genetic and environmental risk factors for asthma, which could have represented confounding variables in their dataset. For a deep dive into some of the known molecular biology of this process, see here (note that this article focuses specifically on anaphylaxis).

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