Anti-vax? Nope, just Anti-Gardasil!

February 19, 2016

 

 

On 15 February, a post appeared in Stuff.co.nz that called GANZ and our attempts to have Gardasil investigated in New Zealand "anti-vax". (L1, L2).

 

Yesterday, we sent Stuff reporter, Erin Speedy, our response. We are still waiting for them to publish it at the time of penning this blog.

 

The majority of the comments in the Stuff post were by Dr Helen Petousis-Harris, the same person implicated in Dr Lee's allegations - allegations that Helen has not yet responded to.


Upon receipt of Dr Lee's allegations, GANZ fired off a range of questions to the Vice Chancellor at Auckland University. Prof Stuart McCutcheon declined to answer, directing us to refer them to Helen - we have done, with no response nor even acknowledgment of receipt!

 

Does Helen think these questions will just go away? They won't!

Does Helen think her anti-vax comments will scare us off? They won't!

Does Helen think we'll just forget about her and move on to something else? We won't!

 

We believe she has a duty to the New Zealand public to answer the questions that have been put to her already, and to respond accurately and honestly to the questions we have put to her via our response to the Stuff column.

 

FORMAL RESPONSE:

 

18 February 2016

 

It is disappointing that Dr Petousis-Harris, predictably, resorts to any person or group who challenges HPV vaccine efficacy and safety as “antivax”, rather than actually responding to the scientific questions that have been raised by GANZ and others over the last few months. It is particularly noticeable that she continually makes vague and unsupported references to efficacy and safety without reference to peer reviewed science based support; or, when it is offered, it is so poorly constructed or irrelevant to the issue as to be embarrassing.

 

Repeated below are some of Dr Petousis-Harris’ recent statements and our response to these:

 

A)        "There are no scientific reasons to be concerned about the vaccine, it's all just misinformation"


RESPONSE: Goodness, where do we start with this?

  1. Dr Lee raised some serious allegations that Dr Petousis-Harris appears to have conspired with others from WHO and the CDC to mislead a Japanese Government health symposium on the safety and efficacy of HPV vaccines. She represented herself as an expert, presented a poorly constructed study with a sample of 1, used blogs and her employment as a lecturer at Auckland University in support of these actions. At no stage  have these issues (all evidenced by documents sourced under OIA) been addressed by her, even though she has been directly implicated (L5).

  2. The latest Vaccine Adverse Events Reporting System from the USA discloses the following very high level of adverse events associated with HPV vaccines:

     

     

  3. While Dr Petousis-Harris accuses GANZ and anyone else who challenges the safety and efficacy of HPV vaccines of misinformation, the evidence is very clear that this is a flawed product, as evidenced by the above references and numerous other scientific and peer reviewed studies. Dr Petousis-Harris needs to stop posturing, stop spouting the usual antivax line, and start answering the very serious allegations made against her, and the even more serious data that clearly shows that this is a vaccine that fails to do what is supposed to do, and does so causing significant harm.

 

B)        “There was no basis for the information in the letter, she said and no reason to be concerned about the Gardasil vaccination - which had been controversial in the past.”

 

RESPONSE: The letter sent to schools (L6) clearly provided the basis of the peer reviewed and scientific studies we relied on in making the statements we did. On the other hand, Dr Petousis-Harris has provided no evidence whatsoever for refuting these allegations.

 

C)         “The information in the letter claimed an open email was written to the director of the World Health Organisation (WHO) which alleged "misconduct, malfeasance and what could be potentially be criminal behaviour by certain officials to mislead the global public on the safety of Gardasil". Petousis-Harris said the WHO in every country supports the vaccine.

 

RESPONSE: This is not a claim, rather a fact.

 

The open letter was sent by Dr Lee to the Director of WHO, Dr Margaret Chan, on 14 January 2016, and CC’d to the Japanese Minister of Health, the Director of the CDC and the Vice Chancellor of Auckland University, Prof Stuart McCutcheon. It contained links to considerable email exchanges between Dr Petousis-Harris and others that would cause any reasonable person to conclude that Dr Petousis-Harris has some rather serious explaining to do.

 

GANZ referred this letter to the Vice Chancellor of Auckland University and raised questions as to the manner in which Dr Petousis-Harris used poor science, blogs, her association with Auckland University and more to allegedly conspire to mislead a Japanese Government symposium. Prof McCutcheon has made it clear that he will not respond to the scientific questions and would undertake no investigation unless a formal complaint was made to the University over the conduct of Dr Petousis-Harris. He did suggest that we put these questions directly to Dr Petousis-Harris, which we have now done (and we believe others have, too). At the time of releasing this statement, no response has been received, nor any acknowledgment of the receipt by Dr Petousis-Harris of our questions. We can confirm that GANZ is in the process of attending to the Vice Chancellor’s other recommendation.

 

D)        “It's really important to reflect on the importance the vaccination has had on the disease, she said. Already there had been a significant reduction in cervical cancer and genital warts.”

 

RESPONSE: Can Dr Petousis-Harris provide the facts and figures for this statement? As well as her proof of her statement that: "We are potentially seeing a decrease in a whole lot of other cancers that this little malicious virus can do as well." This is just puffery with absolutely no science based evidence to support it.

 

E)         “Among the controversy more than six years ago, an Upper Hutt teenager's death was blamed on the Gardasil vaccine. However, the recently released coroners findings into the death of Jasmine Nicole Renata found no evidence of an abnormal reaction to the vaccine. Petousis-Harris said it was a "shame" that the teen's parents did not go through with the cardiac testing to rule out an inherited heart disorder as advised, and instead kept blaming her death on the vaccination.”

 

In response to this attempt to rewrite history, we note that in the Coroner's final hearing he stated that it wouldn't have mattered if the parents had the testing done for a cardiac defect, he would have still handed down the same finding, which was that the cause was UNKNOWN.  None of the testing done on Jasmine, or the extensive DNA testing done on Jasmine's DNA in London as a follow up, disclosed any inherited cardiac disorder whatsoever. What was agreed was that IF Jasmine showed any problems re heart, THEN the rest of the family would be tested.

 

What Dr Petousis-Harris is insinuating is that Jasmine died of an inherited heart disorder when that is completely unproven. Nothing was found to warrant support that assumption. Yet again Dr Petousis-Harris distorts the facts and makes claims unsubstantiated by evidence, an all too frequent occurrence.

 

F)         "Every year hundreds of young people get sick and a portion of those are unexplained. When you don't have a reason for that, that's when people go looking."

 

There is a refusal by the medical profession as a whole (both in New Zealand and elsewhere) to admit that illnesses and symptoms being reported to doctors and hospitals have anything to do with Gardasil. They are thus forcing parents to undertake their own investigations. When girls are told their symptoms are “Psychosomatic” or that they have eating disorders, or when parents are told they are being overly protective, when clearly there is an underlying medical issue, then parents have no alternative but to start seeking advice elsewhere. It is common knowledge that some vaccines CAN and DO cause harm – refer to the VAERS database data above (that is widely accepted to be under-reported by a factor of 10 or more). But mention a potential vaccine injury as the likely cause of the various symptoms being suffered in New Zealand, and you’re met with outright derision rather than any serious attempt to investigate further.

 

G)        “The risk of unexplained illnesses was just the same as whether you were vaccinated or not, she said.”

 

This statement from Dr Petousis-Harris is not just wrong in fact, but scientifically wrong! We know from Merck’s own prescribing leaflet for Gardasil 9 (L8), which contains safety data on both Gardasil and Gardasil 9, the following:

 

The Merck-produced leaflet disclosed adverse events at a rate per 100,000 and the numbers are noted below:

  • Serious adverse health events – 2.5%;

  • Systemic Auto immune disorders - 3.3%; and

  • Spontaneous Abortions - 12.7 – 14.6%

It is simply beyond belief that Dr Petousis-Harris can state “The risk of unexplained illnesses was just the same as whether you were vaccinated or not” and apparently not be aware of the staggering level of serious adverse health events, systemic autoimmune disorders and spontaneous abortions that Gardasil manufacturer Merck discloses? How can she explain her stated position, which contrasts to greatly against data published by Merck?

 

The above Merck data begs the question: how is this an acceptable adverse safety rate, given the perceived (but one may suggest illusory) benefits that Gardasil offers? The answer is resounding – it is not acceptable, particularly when you compare apples with apples! Cervical cancer rates are always quoted as a number per 100,000. On the above basis, for every 100,000 vaccinated with Gardasil in NEW ZEALAND, there would be 2,500 serious adverse events. Compare this with the cervical cancer diagnosis rate in New Zealand of circa 160 women a year (L9) in a population of around 1,78 million women aged 15+ (L10). That’s diagnoses, not deaths.

 

GANZ notes with considerable concern that the most recent prescribing leaflets for Gardasil available in New Zealand, issued by CSL and dated 27 August 2014 (L11, L12), do not disclose this data and are therefore totally defective, misleading and again reinforce the lack of informed consent in relation to this vaccine.

 

We recently requested information from Selwyn Medical Centre in Kohimarama, Auckland to ensure that the documentation provided had not been updated.  A scanned copy is attached marked “Gardasil Info-Selwyn”. For ease of reference, we have also included in this document a current version of the Consent Form that is sent home to New Zealand parents. Neither of these discloses the adverse events data that Merck has provided.

 

Further, how does Dr Petousis-Harris explain the number of adverse events reported to CARM that relate to Gardasil? Minister for Health Dr Jonathan Coleman has stated in an email that, of the 200,000 girls vaccinated in New Zealand, over 500 adverse events have been reported.

 

As previously pointed out by GANZ, the adverse event reporting system is a passive one and thus the numbers of actual adverse events are likely to be far higher. Most parents we speak with who have girls injured by Gardasil aren’t even aware that CARM exists, with the vast majority having no idea that they could file an adverse event for something as insignificant as a rash or sore arm, let alone the ongoing headaches, digestive issues, mental issues, joint and muscle complaints, seizures, auto immune type symptoms and more!

 

We were also staggered by Dr Jessamine’s directive to Principals and Boards of Trustees (L3) following the GANZ email.

 

Below are some of Dr Jessamine’s statements from that directive, together with our response:

 

a)      “We are writing to you to confirm the safety and effectiveness of the Gardasil vaccine. There is a significant body of safety data on the vaccine, which has been approved for use in over 125 countries and administered to more than 80 million girls or women. The vaccine offers lasting protection against human papillomavirus (HPV).”

 

RESPONSE: Where is the evidence for 'lasting protection'? The fact is there is none. Indeed one of the lead researchers on the initial Gardasil trials, Dr Diane Harper, is on record as stating:

 

"If we vaccinate 11 year olds and the protection doesn't last... we've put them at harm from side effects, small but real, for no benefit."

 

MedCheck, April 2015 (L13), not only questions the safety and effectiveness of Gardasil, but calls for a withdrawal of the vaccine from the market!

  • “While there is no evidence yet that HPV vaccine decreases mortality from cervical cancer, if we assume that the vaccine could cut the cervical cancer mortality by half, the expected maximum benefit would be 2.0 less deaths per 100,000 person-years. Hence, the harm experienced is overwhelmingly greater than the expected maximum benefit.” 

  • “As the harms of HPV vaccine became well known, many serious adverse reaction cases were reported long after injection including unprecedented “severe reactions”, which were completely new even to specialists in neurology and collagen disease of childhood. Because the risk of autoimmune disease is estimated to be several hundred-times higher and even the excess fatalities higher than the maximum expected preventable cervical cancer death risk by several orders of ten; so, the harms are definitely unacceptable. The MHLW and the manufacturers should admit the causality of the HPV vaccine in serious adverse reactions as soon as possible. HPV vaccine should be withdrawn from the market and all women inoculated with HPV vaccine should be followed up.” 

 

b)      “Unfortunately, the Ministry of Health is aware that misleading information regarding HPV immunisation has recently been circulated to schools by email. Schools host school based immunisation programmes, but decisions about the safety and administration of the vaccines given in those programmes are made by Medsafe, PHARMAC and the Ministry of Health.”

 

RESPONSE:

  • How does stating scientific facts, challenging statements that are dissembling or misleading or without substance, and bringing to the attention of Government and others using third party peer reviewed science that challenges safety and efficacy, become somehow misleading? All we ask is that Ministry of Health and others explain the scientific data that challenges all of the empty statements they make, and show their science that supports safety and efficacy – the reality is they can’t, because it doesn’t exist.

  • Does this make the Ministry of Health completely responsible for a failure to examine current science and the adverse health events that impact too many young New Zealand girls and women post HPV vaccination?

  • Has the NZ MOH made a unilateral decision to ignore entirely the well-known maxim of informed consent prior to any medical procedure, including vaccination?

 

c)      “The email's central claims are made by individuals involved in campaigns against immunisation in multiple countries. They do not represent reputable or mainstream medical advice.”

 

RESPONSE:

  • Not reputable or mainstream? Who is the judge/jury for this statement? All of the statements made regarding HPV immunisation are science based. They refer to peer reviewed studies published in respected journals. They are clearly both reputable and mainstream.

  • Where has Gardasil Awareness New Zealand been shown to take a stand on vaccines other than Gardasil? GANZ is not against immunisation programs or vaccines per se, and we are not antivax. Rather GANZ is against HPV vaccines being administered without adequate information being supplied to the recipients, and we are against a vaccine whose approval and distribution is based on flawed efficacy and safety data.

  • While GANZ liaises with Gardasil injured parents and girls on both a domestic and an international level, and disseminates global information, our main concern remains raising awareness and halting any further injury in New Zealand, as our name suggests.

 

d)      “The email contains a number of false claims about the likelihood and seriousness of adverse reactions to the vaccine, and misrepresents official statements from the Minister of Health and Medicines Adverse Reactions Committee.”

 

RESPONSE:

  • Exactly what false claims? We ask the Ministry of Health to name each and every one of them. GANZ provided scientific references for every single statement as to reported safety and efficacy issues – not one false claim has ever been made by us. Rather, the issue of false claims and statements lies squarely at the feet of the Ministry of Health, Dr Jessamine and Dr Helen Petousis-Harris.

  • Dr Jessamine should stop issuing bland admonishments and, for the first time, provide detail as to which statements he deems false and which statements he believes have misrepresented official statements by Dr Jonathan Coleman and MARC.

 

e)      “The HPV immunisation programme was introduced to reduce the incidence of cervical cancer and other diseases caused by HPV. The number of abnormal smear tests and cases of genital warts has decreased significantly in young women since HPV vaccination started.”

 

RESPONSE:

According to a reference in the study discussed later in this letter, "In women vaccinated with one or more doses the proportion of histologically confirmed high grade lesions decreased by 19% (95% confidence interval 7.7% to 28.9%) and all categories of cervical smear abnormalities decreased by 11.3% (6.5% to 15.9%)."20

 

f)       “We expect this will lead to a reduction in cervical cancer as vaccinated women reach the age in which cervical cancer develops.”

 

RESPONSE:  It is pretty sad that the only success Dr Jessamine can quote is in the case of genital warts, without even a promise of cervical cancer reduction; merely an expectation. When did the main purpose of HPV vaccines become the lessening of genital warts?

 

g)      “The Ministry of Health has published an accurate summary of the most recent international research into the safety of the vaccine at www.health.govt.nz/newsmedia/news-items/hpv-vaccination-safety.”

 

RESPONSE: It is interesting to note that the single reference provided above leads to an article about the study in Australia that is used to tout the "proven efficacy" of Gardasil (L4).

 

Here are the facts in relation to that study. Cervical abnormalities in cytology are poorly defined self-reversible categories in young women. Even the vaccine manufacturers did not have the guts to use percentages of the grades of cervical cytological abnormalities as the endpoint to claim efficacy of HPV vaccination in preventing cervical cancer.

 

Even if there were a statistical difference in cytological changes between vaccinated and unvaccinated young women with data manipulations, the paper at no stage supports the primary purpose of mass HPV vaccination in school.

 

Please refer to the document Lee v Schiffman 2010.PDF (L7) in which Dr Lee raised additional questions, and Dr Mark Schiffman and his colleague of the U.S. National Cancer Institute responded: “HPV vaccination is to prevent cancer not to prevent acute inflections that almost always resolve without disease." Cytological abnormalities and cervical intraepithelial neoplasia 2 induced by acute HPV infections are mostly self-reversible pathologies.

 

How can the New Zealand Government subject young children to 2-3% serious adverse reactions of HPV vaccination and an extraordinary level of spontaneous abortions to prevent some health-irrelevant cervical abnormalities that almost always go away over time?

It is appalling that Dr Petousis-Harris continually fails to respond to the actual references, science and allegations provided by GANZ. It is disappointing that she purposefully lowers the tone of her rebuttals to paint any criticism as antivax in the hopes that the science will be forgotten in the antivax hysteria that follows. We believe that her actions are a ruse to incite the public into taking aim at the antivax statements, rather than actually investigating the very serious issues at hand for themselves.

 

We are pleased to note that we have already received responses to our letter to the schools requesting further information. It appears that some are, indeed, concerned enough about the issues we have raised to begin their own investigations. This was our aim, and it appears be working.

 

We would welcome an independent and public inquiry into the basis of approval, the safety and efficacy of HPV vaccines. We stand ready to use science, and science alone, to prove that Gardasil, and HPV vaccines generally, are flawed products that fail to deliver what they promise, and that the safety issues far outweigh any proven efficacy now or in the future.

 

Spokesperson for GANZ, Gayle Dickson says: “It appears to have escaped the notice of Dr Petousis Harris, and the Ministry of Health, that parents who have vaccine-injured children, are PRO-vaccine. Many parents become concerned about issues after they have been directly affected, whether due the effects of Gardasil, or some other issue. The reason my daughter was vaccinated is because we are a pro-vaccine family.

 

“I am a mother campaigning about an issue that has directly affected my family, and I  have since discovered that Gardasil has also affected many hundreds of other pro-vaccine families, sometimes with devastating effects.

 

“Gardasil Awareness New Zealand seeks to use education and empowerment to foster healthy respect for informed decision making regarding the Gardasil vaccine, and to encourage all parents and all young women to look at, and understand, the evidence and controversy for themselves.

 

“It’s interesting to note that a mother who campaigned against violence after her daughter was murdered has been recognised as one of New Zealand's most influential women. After her daughter Sophie was killed, Lesley Elliott started the Sophie Elliott Foundation. The foundation seeks to use education and empowerment to foster healthy relationships and to prevent violence against women.”

REFERENCES:

 

(L1)     http://www.stuff.co.nz/national/76919364/antivaccine-group-sends-misinformed-letter-to-schools

(L2)     http://www.immune.org.nz/anti-gardasil-letter-sent-schools

(L3)     http://www.immune.org.nz/sites/default/files/MoH/MoH%2C%20Letter%20re%20HPV%20to%20schools%2020160215.pdf

(L4)     http://www.bmj.com/content/348/bmj.g1458?ijkey=5c2e5346236dfe1f24ca03cad57830d5b402813c&keytype2=tf_ipsecsha

(L5)     http://media.wix.com/ugd/573dd1_ae34257b9705492b9d6b18f96986f51f.pdf

(L6)      http://bit.ly/1KlQrWN

(L7)      http://bit.ly/1SPVG41

(L8)      https://www.merck.com/product/usa/pi_circulars/g/gardasil_9/gardasil_9_pi.pdf

(L9)      http://www.health.govt.nz/your-health/conditions-and-treatments/diseases-and-illnesses/cervical-cancer

(L10)    http://www.indexmundi.com/new_zealand/demographics_profile.html

(L11)    http://www.medsafe.govt.nz/consumers/cmi/g/gardasil.pdf

(L12)    http://www.medsafe.govt.nz/profs/datasheet/g/gardasilinj.pdf

(L13)    http://www.npojip.org/english/MedCheck/Med%20Check-TIP%2001-4-25.pdf

 

Attachment: Gardasil Info-Selwyn

 

 

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