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Home » Christoper Exley whines about placebos and the HPV vaccine

Christoper Exley whines about placebos and the HPV vaccine


Recently, Christopher “Aluminum” Exley, an anti-vaccine quack who thinks aluminum adjuvants are dangerous without any evidence supporting that claim, has been whining lately about the “lack of placebos” in the clinical trials for the HPV vaccine. Although his claim has been debunked several times, it’s time to smack down this trope again.

Exley relies on bad research to justify his claims that the HPV vaccine is not safe because of a lack of placebos (based on his definition of what a placebo is). But he ignores the vast body of large case-control and cohort studies that show the HPV vaccine is safe.

Since I rely on evidence for any claim, I’m going to contradict Exley’s beliefs (they are not facts) with this real scientific evidence that was published in highly respected biomedical journals, something that never happens with these anti-vaccine claims.

open grey metal soda can
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The HPV vaccine and placebos paper

Exley uses a bad opinion piece, not a clinical or epidemiological study with actual data that can be reviewed, published in a low-impact factor predatory journal (generally, pay-to-publish with little or no peer review) based on a case study, one of the lowest of the hierarchy of biomedical research.

But it gets worse — Lucija Tomljenovic and Leemon B McHenry authored the paper. McHenry is in the Department of Philosophy at California State University, Northridge. I’m not sure why a philosophy academic is publishing about vaccines, but a review of their papers shows that Leemon seems to love publishing in this predatory journal. They are not a vaccine scientist or even a real scientist in any field of study. I’m sure they’ve carved out a niche as some sort of anti-vaccine activist by publishing bad papers to show some sort of legitimacy in vaccine science.

However, we should focus on the author, Lucija Tomljenovic. I have a long history of writing about Tomljenovic, who often teamed with Christopher Shaw, another anti-vaxxer. The key point is that several of their articles have been retracted for being bad or deceptive. Furthermore, Tomljenovic seems to currently work for Children’s Health Defense, an anti-vaccine organization fronted by Robert F Kennedy Jr, who has a long history of writing nonsense about the HPV vaccine.

I could dismiss this paper outright for being borderline garbage, but let’s address the key point directly, which is the lack of placebos with the clinical trials for the HPV vaccine.

These authors are trying to make a point that aluminum adjuvants were included with the placebos, so Merck, the company that manufactures the Gardasil HPV vaccine, was not using actual placebos in the clinical trials.

Let’s start first with the aluminum adjuvants. Adjuvants are added to vaccines to boost the immunological effects of vaccines. They are safe, despite the claims of the anti-vaccine authors, who present their claims about the adjuvants without any repeatable, reliable, and credible evidence.

The thing about adjuvants is that they can cause localized effects because they are boosting the immune effect. So what Merck did was compare the adverse effects between three study groups — vaccine only, placebo containing the adjuvant, and saline placebo.

Why do it this way? The localized events of the HPV vaccine would “unblind” the trials because the doctor and patient would both know if they received the vaccine or a saline placebo. This would make the data from the clinical trial not very useful, especially when looking at adverse events. You can’t compare the incidence of adverse events (or effectiveness) if the vaccine group knew that they were receiving the real vaccine and the saline placebo group knew it was receiving the placebo.

Thus, the researchers created three groups — vaccine, saline placebo with adjuvant, and saline placebo without adjuvant. The group that received the saline placebo without adjuvant showed the lowest localized reactions which was predicted. However, it was no longer a placebo group because the researchers and study subjects generally knew they were receiving the placebo. Because of the power of the placebo effect, it would provide no useful information on the safety and effectiveness of the vaccine.

Dr. Helen Petousis Harris wrote an extensive review of the HPV vaccine clinical trials and why adjuvant-containing placebos and saline placebos were used in the studies. One can conclude from her review that nothing nefarious was going on, Merck was just trying to design the best clinical trial that provided scientists with objective data that was not biased by potential unblinding concerns.

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The HPV vaccine is safe

This whole HPV vaccine and adjuvants claim really is just a strawman argument that has no logical validity. They are trying to point to their biased analysis of clinical trials while intentionally ignoring all of the powerful evidence that the HPV vaccine is safe (and effective).

Let’s take a look at a few of these studies:

  • A review of 109 studies, including 15 population-based studies in over 2.5 million vaccinated individuals across six countries showed no safety issues.
  • A cohort study of nearly 4 million women in Denmark and Sweden showed no risk of multiple sclerosis or other demyelinating disease from the HPV vaccine.
  • A case-control study of women across France showed that there was no increased risk of autoimmune diseases in those who received the HPV vaccine.
  • This study of nearly 200,000 women showed no increased risk of primary ovarian insufficiency in the HPV vaccine group.
  • This study, which included over 838,000 doses of the HPV vaccine in the Vaccine Safety Datalink, showed no safety signals.
  • This study reviewed 7244 reports about the HPV vaccine in the VAERS database and found no safety concerns. This should be compared to the 28 million doses of HPV vaccine given during that period.
  • This study reviewed medical records of nearly 1.4 million Danish-born female participants aged 10 to 44 years during 2007-16 and found no links between the HPV vaccine and selected syndromes with autonomic dysfunction.

I could go on and on but I don’t want to bore the reader. Every single safety study of the HPV vaccine, many of them that contain millions of participants, has shown no serious safety issues with the disease.

Summary

Christopher Aluminum Exley and Lucija Tomljenovic have a long history of trying to show something, anything, about the HPV vaccine, but they lack one thing — clinical trials or epidemiological studies. They have nothing to back their specious claims.

They try to get you to look at their “no placebos” claims about the vaccine which isn’t exactly true. There is a reason why the clinical studies had to use a complex methodology, mainly because it was hard to develop a true placebo that would not unblind the study and make its results incomprehensible and useless.

They try to make you look that way because it ignores the vast wealth of clinical and epidemiological evidence that shows that the HPV vaccine is one of the safest pharmaceutical interventions out there.

Citations

Michael Simpson

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