Stuart McCutcheon, Vice Chancellor Auckland University,
Jonathan Coleman, New Zealand Health Minister, firstname.lastname@example.org
John Key, New Zealand Prime Minister, email@example.com
Simon O’Connor, Chair of New Zealand Select Health Committee, firstname.lastname@example.org
From: Gayle Dickson, founder of Gardasil Awareness New Zealand (www.ga-nz.com), email@example.com
Dear Vice Chancellor McCutcheon
I presume you are aware of the allegations by Dr Sin Hang Lee made on 14 January 2016 (1. Allegations_of_Scientific_Misconduct_by_GACVS; 2. GACVS_Statement_HPV_12_March_2014_Copy
The evidence appears clear cut that Dr Helen Petousis Harris has been part of an orchestrated litany of misinformation to knowingly mislead a Japanese public hearing on HPV vaccine safety issues, by incorrectly portraying and misapplying her own scientific data, overstating her knowledge and skills, and leaving out other known data on safety issues. I would imagine this should be of considerable concern to you and your colleagues at the University; the New Zealand Government and any person, government or organization following the safety issues to do with this vaccine.
To better assist you and others cc’d to this email I have laid out below the events, the issues, the outcomes from this and the data that shows this to be the case, some of which was contained in information released under FOI in New Zealand, which is attached.
In Dr Lee’s open letter, he quoted as Ref 12 the paper by Herrin et al. which stated in the abstract: “Elevated levels of circulating plasma cytokine/chemokines were observed post first vaccination in Gardasil recipients and proinflammatory cytokines were elevated following 1st and 3rd Cervarix vaccinations.” (Herrin DM, Coates EE, Costner PJ, Kemp TJ, Nason MC, Saharia KK, Pan Y, Sarwar UN, Holman L, Yamshchikov G, Koup RA, Pang YY, Seder RA, Schiller JT, Graham BS, Pinto LA, Ledgerwood JE. Comparison of adaptive and innate immune responses induced by licensed vaccines for Human Papillomavirus. Hum Vaccin Immunother. 2014; 10:3446-54)
But Dr Petousis Harris told the Committee members:
“We have conducted a clinical trial using Gardasil vaccine. We specifically examined the reactogenicity of the vaccine and associations with 27 cytokines inlc TNF and IL1, all the main players. There was no elevation of any cytokine associated with reactogencity. I have it on a list to publish and it had been peer reviewed in a PhD thesis which is available in the University Library and the data is available for scrutiny.”
The clinical trial Dr Petousis Harris is referring to, is in her PhD thesis starting page 157 of the thesis, called “CHAPTER 5. FACTORS ASSOCIATED WITH REACTOGENICITY - THE FAR TRIAL” The thesis (Attachment 6) is attached for your convenience. (6. Petousis-Harris Thesis 2011)
A REASONABLE QUESTION IS: Is it possible that the method used by Dr Petousis Harris neither accurately measured, nor was sensitive enough to answer the rationale of the study? If so, why is this not mentioned? What was the limit of detection for the method actually used?
2. Dr. Lee quoted a paragraph on page 224 from Dr Petousis Harris’s PHD thesis:
“Timing and lack of baseline cytokine measures: Only a single blood sample was taken.
The absence of a baseline measure precludes any within-individual changes. It cannot be determined if there were any changes in cytokine levels as a result of the administration of the vaccine or if these were base-line levels. In addition, blood samples were taken on day two, the day following vaccine administration, as it was thought local reactions would peak on this day. Injection site reactogenicity is not reported in a way that clarifies the peak time of reactions therefore this was an educated guess. Reactions actually peaked on the day of vaccination. It is possible that any elevations in cytokine levels may have waned by day two. Also, as many cytokines have localised activity it is possible that increased activity is not captured systemically. The fact that atopic score was associated with a range of cytokines supported that the assays were conducted successfully.”
According to Dr. Lee, this paragraph indicates that Dr Petousis Harris’s research did not prove there was no increase in cytokines in the serum after vaccination because of the “absence of a baseline measure”. In order to provide an accurate measurement of cytokine rise, blood should have been taken before the vaccine was administered. In this paragraph, Dr Petousis Harris stated “as many cytokines have localised activity it is possible that increased activity is not captured systemically.”
An accurate statement would be that the FAR study ONLY looked at reactions in terms of serum cytokine level the following day and cannot be extrapolated to any other systemic, or auto-immune response from the vaccine.
Given that the first part of Dr Petousis Harris’s thesis analysed the MenZB trials which did use a prevaccine blood test as a scientific baseline to compare with post-vaccine antibody levels at different time point, so an important scientific question is, Why did the study protocols of the Far Study not require a baseline blood test before the vaccine was administered, to compare with serial blood test taken afterwards? I understand that is a standard scientific practice in order to compare “before” and “after”? Indeed, most other studies including Herrin, did just that.
Even if Dr Petousis Harris thinks she did not find increased cytokines in the serum (though how that is possible without a prevaccine blood test, is a mystery), it is still possible to have “localised” cytokine activity increase in the tissues where the activated macrophages may have traveled to, such as in the lymph nodes, the spleen, the heart, the joints and the brain.
The peripheral blood mononuclear cells (PBMCs) of HPV-vaccinated women are known to be able to produce a variety of cytokines/chemokines under certain stimulation (Attachments 7, 8), and these activated PBMCs may result in local macrophages in various organs. Therefore, the absence of cytokine increase in the serum, does not mean the absence of cytokine increase in the whole blood or in any tissues of the women vaccinated with HPV vaccines. Something Dr Petousis Harris alludes to when she said, “increased activity is not captured systemically. (7. Shebl FM, Pinto LA, García-Piñeres A, Lempicki R, Williams M, Harro C, Hildesheim A. Comparison of mRNA and protein measures of cytokines following vaccination with human papillomavirus-16 L1 virus-like particles. Cancer Epidemiol Biomarkers Prev. 2010;19:978-981 ... 8. Gonçalves AK, Giraldo PC, Machado PR, Farias KJ, Costa AP, Freitas JC, Eleutério J Jr, Witkin SS. Human Papillomavirus Vaccine-Induced Cytokine Messenger RNA Expression in Vaccinated Women. Viral Immunol. 2015;28:339-342)
This is important because Dr Petousis Harris’ presentation in the Japanese public hearing was made with the intent to persuade the Japanese authorities to ignore research by both Dr Lee and Dr Shaw on autopsy samples from Jasmine Renata. This is a false application of her thesis, since she had neither baseline blood tests to compare with a blood test a day after, and she never attempted to see if there was subsequent systemic immune activation. To use her thesis as the basis for expert standing to comment on systemic reactogenicity, has no basis in science.
3. The problems Jasmine Renata had, along with my daughter and many vaccine recipients, do not arise from local reactions. They arise from a cascade of long-term, sequential systemic immune reactogenicity.
This is why Dr. Lee said it is inappropriate to use “no increase in serum” as evidence for “No elevation of any cytokine associated with reactogenicity
QUESTION: Does Dr Petousis Harris think he is wrong?
4. Dr Petousis Harris was quoted as saying:
“given the extremely small quantities of residual HPV DNA in the vaccine, and no evidence of inflammation on autopsy, ascribing a diagnosis of cerebral vasculitis and suggesting it may have caused death is unfounded.”
In the statement above, while phrase relating to residual HPV DNA addresses Dr Lee’s work, the statement about the diagnosis of cerebral vasculitis related to Dr Shaw’s laboratory evidence at the inquest. Dr Shaw found widespread inflammation and immune activation in the brain, and all that evidence was clearly presented at the inquest. The response of the pathologist, Dr John Rutherford, was that he didn’t have the methods of testing used by Dr Shaw’s laboratory available to him.
Therefore, Dr Petousis Harris’s statements are an illogical extrapolation of residual HPV DNA to an autopsy which failed to find brain inflammation using outdated technology.
Furthermore, as a result of the work done on Jasmine Renata, the tests have been repeated in laboratories outside of Canada in animals showing that Gardasil not only causes brain inflammation, but also causes an autoimmune molecular mimicry where the HPV 16 L1 Protein antibodies cross react with cranial blood vessels, which could indeed cause cerebral vasculitis, (and explain Jasmine’s behavioral changes) and would also provide an immunological rationale to the other different, but related symptoms suffered by many Gardasil recipients. (Inbar R, Weiss R, Tomljenovic L, Arango MT, Deri Y, Shaw CA, Chapman J, Blank M, Shoenfeld Y. Behavioral abnormalities in young female mice following administration of aluminum adjuvants and the human papillomavirus (HPV) vaccine Gardasil. Vaccine. 2016 Jan 8. pii: S0264-410X(16)00016-5).
A LOGICAL QUESTION FOLLOWS from the above quote:
a) Dr Lee’s test appeared to be a qualitative test, showing the presence of HPV (viral) DNA in the vaccine. Dr Petousis Harris raised a quantitative issue. Does Dr Petousis Harris know if anyone has quantified the residual HPV DNA in the Gardasil vaccine?
b) What were Dr Petousis Harris laboratory and research qualifications that allowed her to dismiss Dr Lee’s qualifications, background and published data?
c) Why did Dr Petousis Harris choose to raise these questions in a blogpost, but not in a peer-reviewed science publication?
d) Does Dr Petousis Harris agree that there is HPV DNA in the vaccine Gardasil?
e) If so, how much residual HPV DNA is contained in one dose of Gardasil?
f) How much of the residual HPV DNA in the Gardasil belongs to the HPV-16, HPV-18, HPV-6 and HPV-11?
g) Does Dr Petousis Harris agree that the different genotypes of HPV, or their DNA may have different pathologic potentials, or different biologic characteristics? Or does Dr Petousis Harris have any references to rule out such possibility?
h) How does Dr Petousis Harris define “extremely small quantities of HPV DNA”?
i) Do these extremely small quantities of residual HPV DNA that apparently Dr Petousis Harris knew about, exist as free molecules in solution in the vaccine Gardasil? Or were they bound to the aluminum adjuvant as Dr Lee’s work discusses? Since Dr. Pless (Chair Global Advisory Committee on Vaccines Safety (GACVS) asked Dr Petousis Harris to address the issue of “the alleged role of aluminum binding to DNA fragments and subsequent effects”, and Dr Petousis Harris accepted the task, she must know the percentage of the HPV DNA molecules free in solution and the percentage of the HPV DNA molecules bound to aluminum adjuvant, and their physiopathologic effects, if any, when injected into animals or humans.
j) if Dr Petousis Harris does not have the first-hand data to answer the above questions, can she direct as to where to find them?
5. Has Dr Petousis Harris seen the papers (Attachments 10, 11) authored by Dr Lee with regards to the adoption of a non-B conformation by the residual HPV DNA in the vaccine Gardasil? If so, on what basis did Dr Petousis Harris assume that non-B viral DNA bound to aluminum transfected into macrophages is harmless to the human body, which directly led the GACVS to believe Dr Petousis Harris’s assumptions on HPV safety statements as correct? (10. Lee SH. Topological conformational changes of human papillomavirus (HPV) DNA bound to an insoluble aluminum salt – a study by low temperature PCR. Advances in Biological Chemistry 2013; 3: 76-85. .... 11. Lee SH. Melting profiles may affect detection of residual HPV L1 gene DNA fragments in Gardasil®. Curr Med Chem. 2014; 21:932-940. (Galley proof))
6. In an email dated February 18, 2014 addressed to Dr. Robert Pless, Dr Petousis Harris recommended Prof David Gorski as the other expert, in addition to herself, on the subject being discussed.
Some questions on this follow:
a) What are Professor David Gorski’s qualifications which enable him to comment on Dr Lee’s work?
b) Did Prof David Gorski participate in the conference calls and provide his opinions to the group?
c) Did Prof David Gorski help Dr. Pless or Dr Petousis Harris to create the definition or standard of “extremely small quantities of HPV DNA” which was quoted in the March 12, 2014 GACVS Statement?”
Dr Petousis Harris also needs to answer the following questions which go towards the establishment of her self-expressed expertise in the field of HPV vaccines; residual HPV DNA in vaccines and its conformation; biological activity and safety. Particularly since the GACVS depended so heavily on her limited understanding of HPV DNA fragments in Gardasil to formulate its advisory policy on behalf of the WHO. Given that in testifying in Japan, Dr Petousis Harris used her PHD thesis study on local reactogenicity, as the basis upon which to extrapolate on long-term systemic reactivity, and to shape her current blogs giving her opinion/understanding, it follows that her PHD thesis and the FAR study protocols, methods and changes to both, ought to be re-examined in the public interest. Some obvious questions need to be asked.
a) How many years laboratory experience analyzing DNA does Dr Petousis Harris have?
b) Has Dr Petousis Harris published any papers on DNA and/or DNA conformation in peer-reviewed journals? If so, how many, and could she please list the PMID numbers.
c) Does Dr Petousis Harris have information regarding any scientific peer-reviewed studies proving the safety of HPV L1 specific DNA fragments attached to aluminium when injected? If so, can she please provide the PMID numbers, or the actual articles for review?
Given that Dr Petousis Harris thesis stated: “…. vaccine safety is of paramount consideration”, I believe the above questions are relevant and highly pertinent!
I look forward to your detailed answers to these, not just for the sake of my daughter, but for the sake of all other parents whose concerns are dismissed because Dr Petousis Harris’s blog thoughts are considered the only proven science. If Dr Petousis Harris is found to have misled the Japanese enquiry, and has been part of a orchestrated campaign to continue to mislead, by overstating her skills and expertise, and misapplying the inexact results of the flawed FAR trial from her thesis to situations outside of her knowledge or expertise, what actions will the University of Auckland take to ensure that Dr Petousis Harris stays within her actual skills, and how will Auckland University properly inform the public record and correct the information Dr Petousis Harris provided to the Japanese Government, GACVS and on her recent series of blogs, relating to the safety of HPV vaccines?
Founder, Gardasil Awareness New Zealand
PO Box 55-199, Eastridge, Auckland, 1146, New Zealand
T: +64 21 281 7699
Herrin DM, Coates EE, Costner PJ, Kemp TJ, Nason MC, Saharia KK, Pan Y, Sarwar UN, Holman L, Yamshchikov G, Koup RA, Pang YY, Seder RA, Schiller JT, Graham BS, Pinto LA, Ledgerwood JE. Comparison of adaptive and innate immune responses induced by licensed vaccines for Human Papillomavirus. Hum Vaccin Immunother. 2014; 10:3446-54.
Petousis-Harris Thesis 2011
Shebl FM, Pinto LA, García-Piñeres A, Lempicki R, Williams M, Harro C, Hildesheim A. Comparison of mRNA and protein measures of cytokines following vaccination with human papillomavirus-16 L1 virus-like particles. Cancer Epidemiol Biomarkers Prev. 2010;19:978-981.
Gonçalves AK, Giraldo PC, Machado PR, Farias KJ, Costa AP, Freitas JC, Eleutério J Jr, Witkin SS. Human Papillomavirus Vaccine-Induced Cytokine Messenger RNA Expression in Vaccinated Women. Viral Immunol. 2015;28:339-342.
Inbar R, Weiss R, Tomljenovic L, Arango MT, Deri Y, Shaw CA, Chapman J, Blank M, Shoenfeld Y. Behavioral abnormalities in young female mice following administration of aluminum adjuvants and the human papillomavirus (HPV) vaccine Gardasil. Vaccine. 2016 Jan 8. pii: S0264-410X(16)00016-5
Lee SH. Topological conformational changes of human papillomavirus (HPV) DNA bound to an insoluble aluminum salt – a study by low temperature PCR. Advances in Biological Chemistry 2013; 3: 76-85.
Lee SH. Melting profiles may affect detection of residual HPV L1 gene DNA fragments in Gardasil®. Curr Med Chem. 2014; 21:932-940. (Galley proof)