Continuing my series of extracts from the IAS charity complaint. This one focuses on the Gardasil vaccine and the paranoia that has arisen around it. I have included a link to the article but for convenience I have reproduced here the parts that I refer to in the complaint.

Gardasil Horrors
Posted April 6, 2011

First, the very title of this entry is calculated to be sensationalist and to undermine trust in a vaccine that has so far had an exemplary safety  record1.

The post is copied from the proceedings of an FDA advisory committee and is not representative of the full content of the meeting2. The content is the submission of Roberta Boyce founder of the anti-Gardasil website  truthaboutgardasil.org. The submission contains misleading information,  misunderstandings and errors of fact as well as unsupported assertions; all aimed at undermining the vaccine.

The submission starts out by alleging that the Gardasil vaccine causes vitamin deficiencies in the girls who receive it, specifically niacin.

[Quote]
“…I presented information last September against the vaccine at a similar FDA meeting when you were considering extending the vaccine to boys and older women.  At that time I told the advisory panel that many of the Gardasil girls were showing symptoms of severe vitamin deficiencies, specifically niacin.”

This  appears to be based on the submitter’s personal experience as the medical literature does not seem to back-up such a claim3. A charitable  interpretation might assume that the medical literature has not yet caught  up with a reaction that has been observed by parents and medical  professionals. To this end the VAERS database4 was queried by myself in  an attempt to verify whether vitamin deficiency is indeed a reaction seen in “many of the Gardasil girls” as claimed in the submission. The VAERS database did not list niacin as a filtering criterion, in this case then all criteria that where related to vitamin deficiency or decreased vitamin levels were used.

The data for worldwide events was searched, a total of 44 events were found. Given that by now millions of doses of Gardasil have been administered5 44 events (of which 11 were considered “non-serious”) seems minimal. Certainly far from the “many” quoted above. When it is factored in that the VAERS database does not show causal connections but is merely for reporting events that occur in close temporal proximity to the vaccine there is no reason to determine that these events are anything more than normal occurrences within a population.

Part of the submission references the May 2006 FDA VRBPAC report on the clinical results for the development of Gardasil as a prevention of HPV in women6.

[Quote]
“Already the May 2006 FDA VRBPAC reports that if a woman has HPV and receives Gardasil, her chances of getting cervical cancer increase by 44.6 percent after inoculation. “

The submission reference is at best a misreading of the report and at worst cherry-picks facts out of context in order to support a specific conclusion. It is alleged that women already infected with HPV strains targeted by the vaccine experience an increased risk of cancer of 44.6%. This is incorrect on two counts; first, the possible increase is in CIN 2/3. This refers to Cervical Intraepithelial Neoplasia, generally regarded as “pre-cancer”7. This may appear to be hair splitting but in science precise terminology is used for a reason.

Second, the data referred to is made up of small numbers and is a sub-group of the main study population. As such, further in the report it is suggested that the observed increased risk is actually due to slight imbalances between the intervention and placebo groups. This conclusion is reached after additional information about the sub-groups and data using larger sample numbers is provided by the study authors. In conclusion, it is likely that this result is simply noise and the use of it without context amounts to cherry-picking.

The submission continues with further medical misunderstandings and eventually devolves into what appear to be paranoid theories about drug companies targeting girls with a particular genetic make-up for sterilisation using the Gardasil vaccine.

[Quote]
“My daughter recently tested sterile at age 21, although she is still getting a relatively normal period.  Could it be that Merck intentionally developed this vaccine thinking it would affect a small number of individuals with PK deficiencies?  Is this what their intent was when they developed their recently approved fertility drug Aleva, which was just passed for European use?  I wonder if Merck and other big pharmas have intentionally taken advantage of genetic deficiencies.  I believe they have, and I believe this is what has happened many, many times over.  In fact today’s presentation by Dr. Garner clearly stated that DNA extractions were performed in their tests.”

As corroborating evidence the submitter refers to a previous presentation during the committee that referred to DNA extractions, once again ignoring the context in which this was stated – clearly in reference to looking for evidence of HPV DNA in subjects, not screening the genetic profile of the subjects themselves.

Finally the submitter implies that the Gardasil vaccine is a self-manufactured curse from God for Christians because they have not adequately spread God’s word. Beliefs such as this may motivate some people but they do not constitute a valid argument when it comes to health and science. Evidence is required and the evidence provided, such as it is, is not adequate.

The appearance of this submission on the IAS website implies an endorsement of its views and that it is considered information worthy of inclusion about the safety and efficacy of the Gardasil vaccine. As it is based almost entirely on personal experience, assumptions and misunderstandings its inclusion on a website run by an organisation that ostensibly is concerned with providing accurate information to parents is completely inappropriate.

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Footnotes:
1. Gardasil Postlicenture safety Surveilence report:
http://jama.ama-assn.org/content/302/7/750.full.pdf+html

CDC Safety information:
http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/VaccineSafety/ucm179549.htm

2. Full FDA Advisory committee Meeting muinutes:
http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/VaccinesandRelatedBiologicalProductsAdvisoryCommittee/ucm241266.htm

3. Literature search was carried out using the PubMed database found here:
http://www.ncbi.nlm.nih.gov/pubmed

4. Vaccine Adverse Event Reporting System. Data from which may be accessed here:
http://wonder.cdc.gov/vaers.html

5. Gardasil Doses
http://www.bestshot.co.nz/Gardasil%20Q-A.pdf pg11

6. FDA VRBPAC report:
http://www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4222B3.pdf

7. Information on Cervical intraepithelial neoplasia:
http://www.thehpvtest.com/about-hpv/cervical-dysplasia-faqs/

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