MercolaWatch: Mis-information about the Gardasil HPV vaccine

Recently, Joe Mercola published another anti-Gardasil vaccine article, the bulk of which is based on a couple of studies (both by the same researchers) purporting to show that not only is Gardasil not safe, it’s not even effective. It appears that he makes some inaccurate claims in the article, and argues well past the actual evidence at hand.

The article jumps right in by discussing scary results from the Vaccine Adverse Event Reporting System (VAERS) related to Gardasil. This should always be seen as a red flag and taken with a grain of salt, because anybody can make a claim to VAERS. Basically if you believe that following the taking of some medication or having a medical procedure, that it caused some reaction that you later had, then you can report to VAERS. It is only after statistical analysis and follow-up that the data is meaningful. And the CDC has in fact done that analysis, and found:

…the vast majority (94%) of adverse events reported to VAERS after receiving this vaccine have not been serious…

The 32 death reports were reviewed and there was no common pattern to the deaths that would suggest they were caused by the vaccine. In cases where there was an autopsy, death certificate, or medical records, the cause of death could be explained by factors other than the vaccine. Some causes of death determined to date include diabetes, viral illness, illicit drug use, and heart failure.

 

Link between Gardasil a Cerebral Vasculitis-like symptoms “proven”?

He cites studies by “researchers from the University of British Columbia” who, in one study, link Gardasil to Vasculitis and in another perform a systematic review of HPV vaccine trials and conclude that the claims about it are over-inflated. I honestly thought to myself “wow, Mercola managed to find a credible study from a university that finds the claims of Gardasil to not be accurate.” However,  if you follow through on the sources a bit, you’ll find:

  1. The link to the article itself is hosted on the website of an anti-vaccine documentary.
  2. The primary author (Tomljenovic) has a history of publishing articles that question vaccines (usually linking them to autism… which has been debunked), and in one case, an article promoting the link to gut bacteria and autism (part of a set of responses to the news that Andrew Wakefield’s retracted and fraudulent study linking gut bacteria and autism was fraudulent).
  3. The lead authors are in the ophthalmology department at UBC… yet all of their papers seem to be about vaccines. Perhaps it is normal for all of someone’s research to be outside of their official department. This oddness was also pointed out by “Skeptical Raptor” (the author has themselves done post-graduate work related to medicine/biology) in their own analysis of the study.
  4. Both authors were speakers (along with other relatively famous people in the anti-vaccine, anti-aspartame movements along with none other than Andrew Wakefield) at the “vaccine safety” conference in 2011. The one thing I will note total agreement is the spirit of the portion of her bio on the speaker page which states that “she values open-minded discussions on controversial topics and the pursuit of truth in research endeavors, wherever they may lead.” Unfortunately, those in the anti-vaccine, etc movements never really stop even after the evidence has led nowhere.

So, suffice it say, this was not an impartial study coming from the University of British Columbia. But, strictly speaking, none of that is relevant to whether or not this specific study is good science, it’s simply reason to be initially wary. The study managed to garner the attention of the CDC (it seems due to some noise from various “vaccine safety” groups). They put together a panel that found the study to be invalid. Their conclusions (emphasis mine):

After thorough review and discussion of the Tomljenovic article, the CDC-CISA working group identified substantial methodological concerns and lack of evidence to support the authors’ conclusions that the two patients had vasculitis, that HPV4 vaccine particles were in the brain tissue, or that HPV vaccine was causally associated with death from cerebral vasculitis.

Effectiveness of Gardasil HPV vaccine in question?

Their other study, “Human Papillomavirus (HPV) Vaccines as an Option for Preventing Cervical Malignancies: (How) Effective and Safe?” is an “Ahead of print” copy from September 2012 for publishing in Current Pharmacological Research, but it’s not clear if and when it will appear in the actual journal, so as of now it is not officially published scientific literature. There are currently no citations or responses to it, and I am not qualified to add in my own analysis of that paper. But given that the simple 2-case study was shown to be invalid, it seems wise to at least be wary of a more complex statistical analysis by the same authors.

I would however like to quickly discuss a note that Mercola adds about how the documents submitted to the FDA by Merck (manufacturer of Gardasil) that there may actually be increased risk of cervical cancer from taking the vaccine if you have been exposed previously. In this case, he does in fact link to the FDA, but I believe he is speaking past the actual evidence, in that it really is specific to women who have uncleared infections (more reason for early vaccination), and even then the particular group in the study was unbalanced, skewing the numbers. The FDA’s analysis on that was (emphasis mine):

while the subgroup from study 013 remains a concern of the clinical review team, there is some evidence that this represented an unbalanced subgroup where Gardasil™ recipients at baseline had more risk factors for development of CIN 2/3 or worse. Furthermore, when the subgroups from three studies are combined, these groups appear to be more similar. Finally, there is compelling evidence that the vaccine lacks therapeutic efficacy among women who have had prior exposure to HPV and have not cleared previous infection (PCR positive and seropositive), which represented approximately 6% of the overall study populations.

If you read the rest of the document, you can see just how truly effective the vaccine is (discussed below as well).

Condoms are more effective than vaccination?

Mercola continues…

First, in more than 90 percent of cases, your immune system can clear HPV infection within two years on its own. Keeping your immune system strong is important.

This strikes me as a rather dangerous statement to make, despite it technically being true. It makes HPV sound like it is not a big deal. According to the CDC (emphasis mine), “each year, about 12,000 women get cervical cancer in the U.S. Almost all of these cancers are HPV-associated.” So, yes, of the millions of cases of HPV (6 million new cases a year), most go away on their own. But sub-clinical ones, or ones that your body isn’t able to fight for some reason or another, can lead to cervical cancer.

Mercola again:

In addition, HPV infection is spread through sexual contact and research has demonstrated that using condoms can reduce your risk of HPV infection by 70 percent, which is far more effective than the HPV vaccine!

Mercola does not cite where he got the information that 70% prevention is “far more effective” than the HPV vaccine, considering that the vaccine has a 94-100% (also here and here) success rate at preventing the cancer-causing versions of HPV (the focus of the vaccine). It’s possible he’s referring to an 18-40% number that is applicable across all strains of HPV (which are not targeted specifically by the vaccine), but he does not in any acknowledge the larger numbers that are more relevant (Merck and the FDA know that the vaccine is not effective against every single strain of HPV).

Not surprisingly, the doctors at Science-Based Medicine have explored the safety and efficacy of the Gardasil HPV vaccine (efficacy links come from them). And of course, the CDC is a great “official” source for information about dangers of HPV and reason for vaccination, while the FDA contains information about the safety of the qHPV vaccine.

Conclusions

The rest of the article on mercola.com discusses “informed consent” and getting involved with legislatures and submitting personal anecdotes to the media and Internet. That’s not within the scope of this short entry so I won’t comment further on those issues.

The FDA and CDC continue to affirm the safety and efficacy of the Gardasil HPV vaccine. The information presented by Mercola does not add anything to the case against the vaccine. One study is apparently invalid, the other is actually unpublished (so not part of the scientific record yet). I have two daughters myself, so this topic is not purely academic to me. My hope is that articles like the one I discussed do not dissuade parents from avoiding ensuring their adolescent children are properly vaccinated to protect against future cervical cancer. And by the time my own daughters are old enough, we should have enough years of the qHPV (possibly even improved) to see lowered cervical cancer rates (it’s actually too early to really tell as it can take 15-20 years for the cancer to come about following HPV).

REFERENCES

  1. http://www.cdc.gov/vaccinesafety/Activities/cisa/technical_report.html
  2. http://www.cdc.gov/vaccinesafety/Vaccines/HPV/jama.html
  3. http://www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4222B3.pdf
  4. http://www.cdc.gov/std/HPV/STDFact-HPV.htm
  5. Albietz, Joseph. “The HPV Vaccine (Gardasil) Safety Revisited”. http://www.sciencebasedmedicine.org/index.php/gardasil-safety-revisited/
  6. Charo, R. A., J. M. Agosti, L. R. Baden, G. F. Sawaya, and E-mail When Letters Appear. “Quadrivalent Vaccine against Human Papillomavirus to Prevent High-Grade Cervical Lesions.” http://www.ncbi.nlm.nih.gov/pubmed/17494925
  7. Villa, Luisa Lina. “Overview of the clinical development and results of a quadrivalent HPV (types 6, 11, 16, 18) vaccine.” International Journal of Infectious Diseases 11, no. 2 (2007): 17. http://www.ncbi.nlm.nih.gov/pubmed/18162241
  8. Ault, Kevin A. “Effect of prophylactic human papillomavirus L1 virus-like-particle vaccine on risk of cervical intraepithelial neoplasia grade 2, grade 3, and adenocarcinoma in situ: a combined analysis of four randomised clinical trials.” The Lancet 369, no. 9576 (2007): 1861-1868. http://www.ncbi.nlm.nih.gov/pubmed/17544766
  9. http://www.cdc.gov/vaccines/vpd-vac/hpv/vac-faqs.htm
  10. http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/VaccineSafety/ucm179549.htm

About Josh DeWald

I am a software engineer, husband and parent of two. I have been involved in the Skeptical movement for a few years now, especially since having children and so needing to fight pseudoscience related to parenting (vaccines, homeopathy, etc). I've been fortunate to attend TAM twice with my wife (who is also of a Skeptical bent). I also have a blog known as "What Does the Science Say?" (whatdoesthesciencesay.wordpress.com), where I have an odd habit of writing a lot about aspartame.
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5 Responses to MercolaWatch: Mis-information about the Gardasil HPV vaccine

  1. Chris M. says:

    Mercola is quoted above as saying HPV infection is cleared in >90% of cases and that “Keeping your immune system strong is important”, and yet it goes on to advocate condom use to prevent HPV infection. How are those two assertions even compatible? It is so typical of these pseudoscience sites to throw up individual fatuous arguments without any thought as to the whole picture. Not to mention that even in the people who clear the virus in 2 years, there is still that huge window of virus shedding and the possibility infecting others.

  2. Scott says:

    Excellent retort on Mercola’s postings. I will respond to the BC study. You make mention that the reseachers are Ophthamologists. I’m not aware of regulations that limit studies effectiveness due to the authors specific area of expertise. In addition, their affiliation to vaccine safety groups may seem like a conflict of interest, and it may well be, however, show me pharmaceutical papers published by authors who have zero political or financial association with the manufacturers. This happens all the time. You know it, as well as I. Dig deep enough into any clinical trial history, and one will find studies that are scrapped that dont shed positive light on a product that may put shareholders at financial risk. Other than that, I do like your opinions. Keep up the good work.

    • Josh DeWald says:

      Scott –
      Fair point about the area of expertise and past history of publication not actually being relevant to the source… I actually agree with you in the article below the bullets :)

      But for a lay person like myself who might have had someone cite the article to them as proof that the “mainstream” is wrong, I think it is relevant in terms of an initial evaluation. But that’s because I have an existing bias against the points I spelled out. Someone else may see those all as advantages (“fighting against the party line”).

      Thanks!

  3. R. Atkins says:

    Just wanted to say that an “Ahead of Print” article has been accepted for publication, which means that It will appear in the journal after the article is copyedited and the author receives and approves the proofs. This process will not change the results of the study being reported. The articles are posted ahead of print like this because some journals have a backlog of articles, and it may take months for an article to appear. This posting allows the articles to be cited during that potentially long process, usually by DOI number (http://www.doi.org). In addition, most journals now consider their web versions to be the version of record.

    Long story short, if it appears on the journals site, it’s not “if and when,” it’s “when.”

    Source of knowledge: I have worked as a copyeditor in science publishing for nearly 20 years.

  4. valtersgrivins says:

    Mr. DeWald! Not even understanding in what journal the article You criticizes is published is very serious red flag to all Your skepticism in general. “Human Papillomavirus (HPV) Vaccines as an Option for Preventing Cervical Malignancies: (How) Effective and Safe?” is published in “Current Pharmaceutical Design” (http://www.eurekaselect.com/106059/article), not in some Current Pharmacological Research, You point to.

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