Gardasil vaccine – RFK Jr makes false and unscientific claims – Part 1

Recently, Robert F Kennedy Jr has been making numerous false claims about the Gardasil vaccine, which is the cancer-preventing human papillomavirus vaccine. Of course, he has recently become a loudmouth anti-vaccine acolyte, who has been chastised by his own family for helping “to spread dangerous misinformation over social media and is complicit in sowing distrust of the science behind vaccines.”

Now, he has decided to go on the attack against the HPV vaccine, providing the world with “25 reasons to avoid the Gardasil vaccine.” For some unknown reason, he’d rather pass along “dangerous misinformation” about vaccines than actually focus on the health and lives of children. I don’t understand his motivation, but it sickens me.

As a result, I must take the time to respond to his 25 lies about the Gardasil vaccine. This article will cover the first 12 lies – the remaining 13 will be discussed in a few days.

gardasil vaccine

Lie #1 about the Gardasil vaccine

A placebo is supposed to be an inert substance that looks just like the drug being tested. But in the Gardasil clinical trials, Merck used a neurotoxic aluminum adjuvant called AAHS instead of using an inert saline placebo.

This is the start of many strawman arguments used by RFK Jr. He is claiming that amorphous aluminum hydroxyphosphate sulfate (AAHS), used as an adjuvant in some vaccines to boost the immune response, is “neurotoxic.” Of course, real science published in real science journals studied by real scientists says that aluminum is safe in vaccines.

Furthermore, there are no safety signals regarding “neurotoxicity” discovered in huge epidemiological studies of the HPV vaccine. None

Of course, RFK Jr may be using a retracted study as the basis of his misinformation. 

As for the placebo, since there have been zero safety signals regarding neurotoxicity, his claim is a pure strawman argument – because he has no evidence supporting his misinformation, he tries to make us look at the squirrel of how the placebo was set up. But he has no clue about clinical trials, so he is just pulling his junk science out of thin air.

Furthermore, RFK Jr is obsessed with aluminum toxicity and Alzheimer’s disease – something that has been utterly dismissed by the scientific community. In fact, the Alzheimer’s Society does not mention aluminum once in their discussion of risk factors for dementia

But let’s get back to the clinical study control trope. According to an article by the loquacious Orac, which will be relevant to Lie #2, 

Let’s look at the first trope, which is a common anti-Gardasil trope that it is an inappropriate control to compare an aluminum-containing vaccine like Gardasil to an aluminum adjuvant without the actual antigens from the vaccine. The argument is that the best control should have been normal saline; i.e., an inert control.

This is a profoundly ignorant argument when you have an intervention known to be safe based on many studies in many vaccines over the years (like aluminum adjuvants). When you have such an ingredient, then if you want to determine whether or not a vaccine containing that ingredient works and is safe, an excellent way to do it is to compare it to a control containing everything in the vaccine except the antigens that produce the immune response.

In other words, the adjuvant-only control is a very good control. Channeling antivaccine tropes aplenty, the authors of the review try their best to convince you that the real reason this control was chosen in so many studies of Gardasil and Cervarix was to hide adverse events due to these vaccines.

Of course, the existence of long term studies (like this one) comparing HPV vaccines to saline placebo controls rather undermines this particular antivaccine talking point. Basically, we have evidence from both studies comparing HPV vaccines to adjuvant-only controls and to saline controls showing that HPV is both effective and safe.

Oh yeah. I forgot to mention the fact that the HPV vaccine actually was tested versus saline controls. Thanks, Orac, the heavy metal loving surgeon.

Lie #2

mong girls and women who received the vaccine and among girls and women who received AAHS, an astonishing 2.3% in both groups experienced conditions indicative of “systemic autoimmune disorders,” many shortly after receiving Gardasil.

RFK Jr is referring to this study, published in a low impact factor journal of marginal quality. And it is a pseudo-systematic review, attempting to draw conclusions by bundling all of the numbers together, without examining how the test groups compared to the control groups in each of the underlying studies.

This is a serious error in analysis, since the anti-vaccine authors, who have been criticized by the World Health Organization, looked for numbers that supported their conclusions rather than doing real systematic analyses. This is not a legitimate study of the Gardasil vaccine. 

Of course, our good friend Orac, in the article mentioned above, also slammed this terrible study:

Overall, this is a terrible systematic review. It is clearly designed to make HPV vaccination look as bad as the authors can make it look by playing up known adverse events due to HPV vaccines, such as syncope, claiming that adverse events are vastly underreported, and citing papers by antivaccine cranks as “evidence” that there are all sorts of horrible things caused by Gardasil that “They” don’t want you to know about. Not surprisingly, it’s spreading in the antivaccine crankosphere. Surprisingly, I haven’t seen it on Natural News yet. It’s coming, though. I’m sure of it.

That’s what you get from pseudoscience – invent a trope that Gardasil is evil, then do everything you can to publish a terrible “study” to confirm your beliefs. 

And, one more thing. Huge epidemiological studies have shown no link to any auto-immune conditions. In other words, real science.

gardasil vaccine
Protect these teens from HPV. Photo by Melissa Askew on Unsplash

Lie #3

Multiple scientific studies associate aluminum not just with autoimmune diseases but with autism, Alzheimer’s disease, dementia and Parkinson’s disease as well as behavioral abnormalities in animals.

There are no robust, repeated epidemiological studies, published in high impact factor peer-reviewed journals that support these claims. I’m sure that RFK Jr is relying on the recently retracted sheep study that tried to show that aluminum adjuvants are linked to autism. Or other “studies” (not actual studies, just opinion pieces) from discredited pseudoscientists. 

In fact, actual peer-reviewed scientific studies completely dismiss these claims.

Lie #4

Merck lied to study participants, falsely saying that the clinical trials were not safety studies, that the vaccine had already been found to be safe and that the “placebo” was an inert saline solution. [Source: The HPV Vaccine on Trial  (photo evidence, pp. 6 and 12).]

Professor Dorit Rubinstein Reiss, who happens to understand vaccine science better than RFK Jr., critically reviewed the book referenced. It is not evidence of anything. As Professor Reiss wrote about the “book”:

…uses unsupported, often suspect anecdotes, poisoning the well, and ill-founded claims to try to build a case against this vaccine protecting millions from cervical cancer. Their efforts do not effectively counter data from large studies and the views of expert organizations all around the world that HPV vaccines are safe and effective.

However, to actually refute Lie #4, there were numerous HPV vaccine clinical trials that did actually use a placebo. Like this one, which I reviewed many years ago.  

Lie #5

When Merck conducted clinical trials for its next HPV vaccine formulation, Gardasil 9, it used Gardasil as the “placebo” in the control groups, again relying on the lack of an inert placebo to mask safety signals.

This is one of the most ridiculous and unethical tropes of the anti-vaccine religion. The anti-vaxxers scream that all vaccines must be tested against a placebo group. 

In fact, many vaccines are tested in double-blind, placebo-controlled clinical studies before licensing. And that includes the original HPV vaccine as we mentioned above.

However, it is unethical to compare a vaccine to a saline placebo if the antecedent vaccine is available. Gardasil 9 replaced the original Gardasil (which was quadrivalent), so Gardasil must be evaluated for safety and effectiveness vs. the original Gardasil.

RFK Jr and most anti-vaxxers do not understand this basic point. It is unethical and immoral to put anyone at risk of disease if there is a preventative vaccine already available. No clinician would participate in such a study. 

No Institutional Review Board (IRB), who are tasked at hospitals or academic institutions to review and approve any study that involves the institution, would approve such a study on humans. And the FDA demands that IRB approvals are part of the FDA applications for new drugs. RFK Jr does not understand this point – he claims that is interested in the well-being of children, but he wants to create a whole clinical trial that is disgustingly immoral.

gardasil vaccine
Let’s protect them from cancer. Photo by Eliott Reyna on Unsplash

Lie #6

The 500 micrograms of aluminum adjuvant (AAHS) in Gardasil 9 are more than double the amount of aluminum in Gardasil; this raises the question of whether Gardasil 9’s heavy reliance on the Gardasil trials for comparison is justifiable.

First, not to repeat myself, but this is another strawman argument because numerous large epidemiological studies have shown us no significant adverse effects of the Gardasil vaccine, irrespective of aluminum. 

Second, let’s refer to the most basic point of toxicology – the dose makes the poison. How does 500 µg of aluminum compare to real-world situations especially since aluminum is such a common element in the environment?

Breastfed infants ingest about 7 mg (or 7000 µg for those unfamiliar with the metric system) of aluminum during their first six months. Formula fed infants ingest about 38 mg (38000 µg). Soy formula-fed infants ingest almost 117 mg (117000 µg) of aluminum. In other words, infants get nearly 14-234X more aluminum from food than from vaccines.

The air itself has lots of aluminum. In a city, the air contains 0.4 – 8.0 µg of aluminum per cubic meter of air. A baby inhales about 7.2 cubic meters of air every day, which means that they’re inhaling from 2.9 to 57.6 µg of aluminum every day. Thus, a baby may get from 1100 to 10500 µg aluminum just from breathing during their first six months of life, right around what you would expect from vaccines during that period of time.

Of course, anti-vaxxers try to claim that getting aluminum from vaccines is somehow physiologically different than ingesting or breathing in aluminum. There is no biological plausibility for such a claim. And there is no robust, peer-reviewed evidence that supports such a trope.

Lie #7

The World Health Organization states that using a vaccine (rather than an inert substance) as a placebo creates a “methodological disadvantage” and also notes that it may be “difficult or impossible” to assess vaccine safety properly without a true placebo.

You can tell when someone needs to invent a list when they repeat themselves over and over and over. We’ve dealt with this placebo issues in Lie #1. And who are we to trust? The World Health Organization, staffed by dedicated scientists and public health officials, or RFK Jr, who disgusts his own family? I’m going with WHO. 

gardasil vaccine

Lie #8

In the only Gardasil trial in the target age group (11- and 12-year-old girls) with a control group design, fewer than 1200 children received the vaccine and fewer than 600 served as controls. This single trial involving fewer than 1800 children set the stage for the vaccine’s subsequent marketing to millions of healthy preteens all over the world.

Not only does RFK Jr not understand vaccine science, but apparently he never took a statistics course. Clinical trials are routinely in the low 1000s because the results can be shown to be statistically valid at that point.

He is a politician (though not even in the same class as most of his family) – public opinion polls do not require millions of respondents to be accurate. In fact, many highly accurate polls only require a few hundred individuals to represent a whole country. 

We don’t need to have a million individuals in a clinical trial to get statistically valid results. And, once again, we have huge, +1 million subject epidemiological studies that are powered to find tiny events that may signal an issue with the HPV vaccine. And, once again, we’ve found nothing.

Lie #9

The Gardasil clinical trials had numerous exclusion criteria. Not allowed to participate in the trials were people with: severe allergies; prior abnormal Pap test results; over four lifetime sex partners; a history of immunological disorders and other chronic illnesses; reactions to vaccine ingredients, including aluminum, yeast, and benzonase; or a history of drug or alcohol abuse—yet Merck now recommends Gardasil for all of these groups.

This betrays RFK Jr’s either intentional or unintentional ignorance of the construction of clinical trials. The study design must control for as many factors as possible, otherwise, we’d get nonsense results. 

For example, someone with severe allergies may be contraindicated for a vaccine. Someone with abnormal Pap test results may already have HPV (seriously, how could he not understand this basic point). Someone who has over four lifetime sex partners is at risk of an HPV infection already. 

A proper clinical trial needs to be set up in a way that allows the researchers to answer two simple questions – does it work, and is it safe? If they don’t have exclusion criteria, all we would have is a giant jumble of data that makes no sense.

RFK Jr ought to quit playing a scientist on the internet because he’s really bad at it.

gardasil vaccine

Lie # 10

Some of the study participants—but not all—were given “report cards” to record short-term reactions such as redness and itching. The report cards monitored reactions for a mere 14 days, however, and Merck did not follow up with participants who experienced serious adverse events such as systemic autoimmune or menstrual problems.

Apparently, RFK Jr, along with not understanding anything about clinical research, also has no clue about anecdotes – they are not data. His claims about “serious adverse events” is based on a roundly criticized Slate article

As Vaxopedia concluded about this article:

Downplaying the risks of vaccine-preventable diseases, while trying to scare folks about vaccines – that’s what gets you labeled as anti-vaccine.

Furthermore, causality cannot be determined beyond a few days. After that, the accuracy of such data becomes increasingly useless. And, since RFK Jr is only utilizing anecdotes, not real science, there is nothing here.

Lie #11

Injured participants complained that Merck rebuffed their attempts to report adverse side effects. In numerous instances, Merck maintained that these “weren’t related to the vaccine.”

Once again, RFK Jr. is referring to the Slate article (because he’s trying to make the list to number 25, he’s repeating himself). My guess is that Merck “rebuffed” their efforts because they knew they were in the control group.

Nevertheless, let me repeat this once again – huge, unbiased epidemiological studies have found nothing. And the FDA found no malfeasance either.

Lie #12

Half (49.6%) of the clinical trial subjects who received Gardasil reported serious medical conditions within seven months. To avoid classifying these injuries as adverse events, Merck dismissed them as “new medical conditions.”

Once again, this shows his complete lack of understanding of clinical trials. Many of the “serious medical conditions” were simply not related to the vaccine. There is just no reasonable scientific logic that would tie the vaccine to these conditions.

Moreover, because so many other confounding factors would arise over such a time, such as other health issues arising because health issues arise all the time with individuals, it’s nearly impossible to determine causality. That’s why post-marketing studies are employed – they continue to monitor for short- and long-term results.

And, I’m sure I’ve mentioned this – huge epidemiological studies, which have no time limit, have shown nothing with regards to the Gardasil vaccine.

Well, this enough for this article, or it would be 15,000 words. We will get to the last 13 lies in a few days. I need to rest and recover from this nonsense.

Citations



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The Original Skeptical Raptor
Chief Executive Officer at SkepticalRaptor
Lifetime lover of science, especially biomedical research. Spent years in academics, business development, research, and traveling the world shilling for Big Pharma. I love sports, mostly college basketball and football, hockey, and baseball. I enjoy great food and intelligent conversation. And a delicious morning coffee!