This article has been updated and can be found here. The comments for this article have been closed permanently.
I could have a full-time job just debunking the rumors and myths about the HPV cancer-preventing vaccine, Gardasil. I’d bet one year of my Big Pharma Shill Income™ that the anti-vaccination gangsters make up more junk science about Gardasil than all other vaccines put together. And now, bogus claims that Gardasil causes behavior issues – time for a critical analysis.
This new claim about Gardasil arises from an article, “Behavioral abnormalities in young female mice following administration of aluminum adjuvants and the human papillomavirus (HPV) vaccine Gardasil,” published in the well respected, relatively high impact factor, journal Vaccine. When it was first published, my thoughts were that the editors of Vaccine missed something. Given that it’s been “temporarily removed,” I guess they did.
But let’s look at this claim with our critical thinking skills, which most of the readers here have.
Gardasil causes behavioral issues?
Because the article has been withdrawn, the abstract no longer exists on the Vaccine website or is indexed on PubMed. Some websites do have the original abstract, with no mention of the retraction. Of course.
The authors of the study claim that,
[infobox icon=”quote-left”]It appears that Gardasil via its Al adjuvant and HPV antigens has the ability to trigger neuroinflammation and autoimmune reactions, further leading to behavioral changes.[/infobox]
Predictably, the anti-vaccination crowd jumped on this article (ignoring the fact that it’s been removed), claiming that,
[infobox icon=”quote-left”]…given the large numbers of reports of adverse reactions from people who been vaccinated with Gardasil and the other HPV vaccine, Cervarix, the mice who were injected with the vaccines showed signs and symptoms consistent with vaccine-induced damage.[/infobox]
Of course, this ignores two huge clinical trials, which show that it’s about as safe as a vaccine can get:
- In a large study, that included nearly 200,000 young females who had received the vaccine, the researchers found that the vaccine was only associated with same-day syncope (fainting) and skin infections in the two weeks after vaccination. The authors stated that, “this study did not detect evidence of new safety concerns among females 9 to 26 years of age secondary to vaccination with HPV4.”
- In another huge study, that included nearly 1 million young females, a HPV vaccinated cohort was compared to an unvaccinated cohort. The authors concluded that “this study identified no safety signals with respect to autoimmune, neurological, and venous thromboembolic events after the qHPV vaccine had been administered.”
- Another huge study, including nearly 2 million doses of HPV quadrivalent vaccine, showed no increase risk of multiple sclerosis or other demyelinating neurological disorders in vaccinated vs. unvaccinated groups.
- A review of all of the post-licensure studies of quadrivalent HPV vaccines provide strong evidence that Gardasil is extremely safe.
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Point by point analysis
But there’s more silliness to this study than just ignoring well done research. Let’s look at some of the bogosity of this article:
- Two of the authors of the article, Christopher A. Shaw and Lucija Tomljenovic of the University of British Columbia, are well-known as paid researchers of the anti-vaccine (generally, anti-Gardasil) movement. Shaw and Tomljenovic have been compensated very well to continue to publish nonsense anti-vaccine research, generally in predatory journals. Of course, Vaccine is most certainly not a predatory journal, so it gives their “science” an air of legitimacy.
- Furthermore, the World Health Organization’s (WHO) Global Advisory Committee on Vaccine Safety critically examined two widely touted studies by Shaw and Tomljenovic. Both studies (here and here) asserted that aluminum adjuvants in vaccines are linked to autism. Predictably, WHO’s advisory committee found their research to be “seriously flawed.” Improbably, the research was based on population level numbers (that is, compare autism rates for a large population with vaccination rates) to conclude that there is a causal association. That kind of research methodology would be laughed out of a first year epidemiology course. According to the WHO’s advisory committee, “…ecological studies cannot be used to assert a causal association because they do not link exposure to outcome in individuals, and only make correlations of exposure and outcomes on population averages.”
- Nevertheless, animal studies do not constitute the basis of evidence for human medicine. As I have written before, claims based on very early research rarely, less than 10% of the time, ever amount to anything important.
- In the hierarchy of medical research, animal studies rank near the bottom of the barrel. Why? See above, because primary studies based on an animal model so rarely end up having applicability to science based medicine.
- There is little biological plausibility to their hypothesis that the HPV cancer-preventing vaccine can cause behavioral issues. First, we have little (really no) evidence that the HPV antigen causes neuroinflammation or autoimmune conditions. We would see this with the virus itself (irrespective of the vaccine), yet we don’t. In addition, the fear of aluminum is overstated by too many people, and the limited amount in Gardasil (or any vaccine) would have no biological effect on humans. Unless, we stop breathing, because we get a lot more aluminum from the air.
- As I mentioned above, huge studies, often containing millions of doses, have not uncovered any neurodegenerative disorder of any kind. Unless we count fainting events when the patient sees the needle – that apparently is more common than we thought.
Why did the article get “temporarily removed”? According to the folks at Retraction Watch, “the article in question has been temporarily removed as requested by Vaccine’s Editor-in-Chief Gregory Poland. In addition, Dr Poland has recommended the article be further reviewed.”
My guess is that there were a lot of proverbial raised eyebrows at the quality of research in this paper. Shaw and Tomljenovic are in the Department of Ophthalmology at the University of British Columbia, and do not have the credentials that most researchers have in publishing in Vaccine. It is also possible that the research is highly flawed–there are things in there that remind me of Séralini’s laughably designed and analyzed “GMO corn causes cancer” study.
I’m sure the next assertion made by the anti-vaccination crowd will be that the Editor-in-Chief, Dr. Poland, was pressured by Merck, Dr. Paul Offit, and the CDC to retract the article. Oh you think I’m kidding?
For those of you who don’t know Dr. Gregory Poland, he’s had it with the crowd that believe that the MMR vaccine is linked to autism. He has editorialized about this ongoing manufactroversy:
[infobox icon=”quote-left”]To continue pouring money into futile attempts to prove a connection to the MMR vaccine when multiple high-quality scientific studies across multiple countries and across many years have failed to show any hint of a connection, and in the face of biologic nonplausibility, is dangerous and reckless of lives, public funding, and ultimately public health.
At some point, a point I believe we have well passed, the small group of people who claim such connections, who have no new or credible data, and for which their assumptions and hypotheses have been discredited must simply be ignored by scientists and the public and, most importantly, by the media, no matter how passionate their beliefs to the contrary. Such individuals are denialists at best, and dangerous at worst.[/infobox]
Christopher A. Shaw and Lucija Tomljenovic have once again tried to push their nonsense, paid for by powerful anti-vaccine groups, onto the public. I’m not sure how it happened, but it got into a high impact factor, highly regarded journal – but now that article is undergoing further review.
It might eventually get published, who knows. But I stand by my points – it’s bad research that has little impact on what we know about the real science behind the HPV cancer-preventing vaccine.
Gardasil causes behavioral issues? No evidence whatsoever. But it does prevent many dangerous cancers.
Update from Dr. Orac
When the article was first published, I had received an embargoed version, which are given to writers in advance of the publication date. I didn’t see anything important there, and I deleted the email. My bad (and yes, my email program scrubs deleted emails after 24 hours).
But Dr. Orac, who some anti-vaccination trolls think is me, got access to the original article, and skewered it. After reading his critical review of the paper, I stand by my previous point that it smelled just like the awful GMO paper from Séralini that I mentioned before.
Go read Orac’s full review, but let me highlight the key points:
- The author’s hypothesis that “claims that vaccine adjuvants and vaccines can cause autoimmune disease” are generally only pushed by those who are anti-vaccine in general.
- The researchers used a mouse model to use as a proxy for “behavior,” by putting them through some standardized tests for mice. The problem is that the authors have provided a hypothesis, which totally lacks biological plausibility, to harm mice (because they are killed at the end of the experiment).
- The researchers were not “blinded” when they observed the mice go through these tests. Well, at least they didn’t mention if they were blinded.
- Like Séralini, the authors must have flunked basic statistics. The used a type of statistical test, called Student’s t-test, that was meant to determine the statistical significance of two independent groups of data. The authors used it to identify differences between FOUR groups of data. It doesn’t work in those cases.
It’s bad science. No, it’s terrible science – someone might not get vaccinated against HPV which is linked to a bunch of serious cancers.
Update from Vaccine
[infobox icon=”quote-left”]This article has been withdrawn at the request of the Editor-in-Chief due to serious concerns regarding the scientific soundness of the article. Review by the Editor-in-Chief and evaluation by outside experts, confirmed that the methodology is seriously flawed, and the claims that the article makes are unjustified. As an international peer-reviewed journal we believe it is our duty to withdraw the article from further circulation, and to notify the community of this issue.[/infobox]
In other words, this article no longer exists. Except in the minds of those who believe, despite the evidence, that Gardasil is dangerous.
- Inbar R, Weiss R, Tomljenovic L, Arango MT, Deri Y, Shaw CA, Chapman J, Blank M, Shoenfeld Y. WITHDRAWN: Behavioral abnormalities in young female mice following administration of aluminum adjuvants and the human papillomavirus (HPV) vaccine Gardasil. Vaccine. 2016 Jan 9. pii: S0264-410X(16)00016-5. doi: 10.1016/j.vaccine.2015.12.067. [Epub ahead of print] PubMed PMID: 26778424.
- Tomljenovic L, Shaw CA. Aluminum vaccine adjuvants: are they safe? Curr Med Chem. 2011;18(17):2630-7. PubMed PMID: 21568886.
- Tomljenovic L, Shaw CA. Do aluminum vaccine adjuvants contribute to the rising prevalence of autism? J Inorg Biochem. 2011 Nov;105(11):1489-99. doi: 10.1016/j.jinorgbio.2011.08.008. Epub 2011 Aug 23. PubMed PMID: 22099159.