Questions posed to the Ombudsman
FOR THE ATTENTION OF JUDGE PETER BOSHIER Dear Judge Boshier, I am writing to you with a matter of some urgency and in the hope that you may be able to assist me with my inquiry. Whilst I fully appreciate that this approach is perhaps unorthodox, or irregular, there appears to be no other avenue for me to approach as I am not receiving any replies to my questions from those who I have respectfully requested answers to reasonable and relevant questions. To date, I have communicated with the Ministry of Health, Jonathan Coleman, the NZ Royal College of General Practitioners, NZ Best Practice Advocacy Centre, IMAC, Pharmac and a number of other high profile medical professionals in New Zealand. To be frank, I have been appalled at the lack of commitment from these individuals to provide information to me, in keeping with the Code of Rights and in the interests of Informed Consent. I have at no point been discourteous or offensive to any of these people. Perhaps they have found my tenacity to be somewhat irksome, but the seriousness of the inquiry is undeniable, as is my sincerity, and with this in mind, I saw no reason to accept this blatant disregard for a reasonable request from those who ought to be fulfilling their obligation to responsibilities regarding due diligence and duty of care.
My inquiry concerns the safety of the HPV vaccine Gardasil.
The open letter, which was sent to the WHO, Director General, Dr Margaret Chan, by pathologist Dr Sin Hang Lee, January 2016, alleged Scientific Misconduct and Malfeasance, pertaining to the HPV vaccine Gardasil.
This letter, named a high profile New Zealand scientist, among other authorities, in the open letter and included the emails of this person, which had been released under the NZ FOIA. No action, as far as I am aware, has been taken to investigate these serious allegations by the Ministry of Health. More recently, an official complaint has been filed by Nordic Cochrane of Cochrane Collaboration. This appears to be a damming indictment of the EMA's (European Medicines Agency), evaluation of November 2015, into two of the new medical conditions, that a significant number of young girls have been experiencing following the HPV vaccine, Gardasil. This is a global occurrence. The complaint highlights the inappropriate use of active placebos in the clinical trials and the implications for the safety of the vaccine as a result of this, the conflicts of interest of those involved in the evaluation, and the substantial omissions of data from the evaluation.
This has been sent to the Minster of Health and others. Once again there have been no responses. This is particularly concerning, given Pharmac's plans to extend the vaccine to boys in New Zealand in the near future, and would seem to demonstrate a disregard for a serious safety concern, raised by a highly respected organisation.
Medsafe have relied upon the EMA, as has the MOH and IMAC. This is concerning, as the EMA approved the Gardasil vaccine in the first place. They have also approved the Gardasil 9 vaccine, which used Gardasil as a comparator in its trials. This is particularly worrying, given that the adjuvant used in the Gardasil vaccine AAHS or aluminium hydroxyphosphate sulphate, at 225mcg, has been increased to 500mcg in Gardasil 9 and was raised as a concern by Nordic Cochrane in their complaint.
In view of these two attachments below and as a member of the New Zealand public, mother, grandmother, tax payer and retired nurse, I respectfully request your response to the concerns detailed in this email. My concerns are shared by many parents and young girls around New Zealand and are being expressed internationally by parents, their children and organisations which have been established to support young girls and boys who have been affected deleteriously, after receiving Gardasil.
I would like to draw to your attention the following points:
1. The placebos used in the trials for the HPV vaccine, Gardasil, did not comply with the WHO Gold Standards for placebos to be used in 'new' vaccine clinical trials. They were not Inert and contained a neurotoxic adjuvant, which was also used in the vaccine itself at the same time, as were other vaccines and a control solution, containing Polysorbate 80, L-Histidine, Sodium Borate and Saline. These are not placebos and have an 'effect'. This skewed the data outcomes and the public has no awareness of this, believing the placebos to have contained just 'saline.' This is verified in the vaccine Product Monograph and other sources.
2. The vaccine has been found to contain HPV DNA fragments. This constitutes a contamination. No recalls have been ordered and no further evaluation for potential carcinogenicity carried out.(Dr Sin Hang Lee)
3. NO ovarian studies were done in trials and male fertility studies were 'limited.'
4. VRBPAC (Vaccine Related Biological Products Advisory Committee, who advise the FDA) and CBER (Center for Biologics Evaluation and Research - Dr Peden September 19 2012) findings on Gardasil in respect to prior exposure and Co -actors, make valid points and contribute a great deal to the questions of safety and efficacy.
5. The non-investigation of the NZ Scientist, named in the allegations of Scientific Misconduct and Malfeasance, whose emails, among others, are in the public domain; emails which were released under the NZ FOIA. This has been in the public domain since January 2016. The Allegations were sent in an open letter to the HO Director General, Dr Margaret Chan, by pathologist, Dr Sin Hang Lee.
6. It has been conveyed to a parent of a young girl in NZ, who has been severely affected in relation to the Gardasil vaccine, that her case number, adverse report/CARM), has been removed from the CARM public data base; her case was deemed 'high profile'... she took part in a New Zealand television documentary about Gardasil. This child has not recovered from her injuries to this day. Apart from this child, the other girls who took part in the documentary have also had their names removed from the CARM (Centre For Adverse Reports Monitoring) public data base, as have 20 others, who have experienced adverse events following Gardasil. I can provide details of the mothers concerned, if you wish to contact them.
One young Christchurch girl filed a CARM report and an ACC claim, supported by a General Practitioner. She also took part in the documentary. This was declined by ACC, based on the advice of Dr Tatley (Pharmocovigilence/CARM) .Dr Tatley, requested that his name NOT be disclosed to the Health and Disability Commission as having given advice to ACC and also that his name not be published in any Health and Disability Commission report. This was indicated by a tick box option of Yes or No at the foot of her report.
This seems to indicate a lack of transparency. Dr Tatley was also involved in the case of the child, whose name is referred to earlier, as having been removed from the CARM public data base. Is this a usual practise, Judge Boshier, and how does this permit the public or medical professionals to access accurate statistics of adverse events with the Gardasil vaccine? Is this a deliberate concealment of public information? If so, I suggest that this is very misleading and tantamount to a downplaying of relevant safety signals.
7. There has been a concerted effort to convey to parents that it is important to vaccinate young girls in NZ with Gardasil, prior to sexual debut. This would seem at odds with established fact that prior exposure can occur in utero, birthing and via surface transmission, and that HPVs have been found on the tonsils and in the mouths of Greek, Japanese and American infants and children. Prior exposure, if then vaccinated with Gardasil, carries a considerable increased risk of cervical dysplasia, by 44.6%(ref. (VRBPAC)
8. This vaccine was fast-tracked onto the market and has never been proven to have prevented one case of cervical cancer. It could not, as it has not been in use for a sufficient amount of time, to determine or prove this outcome. Endpoints in the clinical trials were 'surrogates.' What is clear, is that some girls are developing cervical cancers, after receiving Gardasil. There has been some serious word-polishing regarding its efficacy, as even the Australian clinician who created it did not state it 'would' prevent cervical cancer, or 'had' prevented cervical cancer. This was supported by one of the Gardasil vaccine researchers, Dr Diane Harper.
9. There has been no acknowledgement for the potential for HPV strains that are eradicated to not have that void filled with more virulent strains for HPV, which may be even harder to treat.
10. There has been no recognition, of the fact that many CINs spontaneously regress; even some of the high risk strains, or the many ways in which these can be monitored and ways to promote cervical health and assist the host immune system to deal with these epithelial changes.
11. Given the 'undone' science, the Nordic Cochrane Complaint May 2016 and the Serious Allegations by Dr Sin Hang Lee, January 2016, none of which have been addressed by the New Zealand MOH, as yet, it is in the public interest or safety to continue with the administration of the Gardasil vaccine, or to extend its use?
Until these matters have been robustly debated and evaluated, The MOH ought to enforce a Moratorium on Gardasil.
They have an absolute obligation to address the Precautionary Principle and allow doctors and nurses to practice, in keeping with their oath, To First Do No Harm.
12. Informed Consent. The New Zealand Bill of Rights and the Nuremberg Code. These laws state that no person can be forced to receive treatment through the use of coercion, or can be forced to take part in an experiment without their consent.
Under the NZ Bill of Rights any medical procedure, of which vaccination is a medical procedure, a person must be offered disclosure of risks and benefits, in order to make an informed decision.
At present, with so much 'unknown' about the safety of the HPV vaccine Gardasil, it is clear that the process of Informed Consent is being usurped and, in doing so, potentially putting citizens in harm's way. In fact, one could say that they are being asked to take part in an experiment, given the lack of science, eg. active placebos used in trials, no long term safety data, absence of evidence for synergistic toxicity.
The new medical conditions which follow are difficult to diagnose and treat. Recognition of this has not been given consideration; so many girls may be falling by the wayside and are therefore statistically invisible. Routine testing appears to be inadequate. Perhaps the time has come to look and see what other countries are doing in respect to this. Some countries have established rehabilitation facilities to assist these girls. Some practitioners are using orthomolecualr/cellular testing and with success.
Parents in New Zealand are being left to work this out for themselves. Some girls in the North Island, are falling through the cracks and turning to prostitution in order to pay for pain killers. The chronic nature of the pain is debililtating for these girls and depressing. For some, it can be a very isolating life. Not everyone can afford the treatments or supplements that other parents are turning to to alleviate these symptoms. One aspect of Gardasil injury, which seems to be not well understood, is the extreme types of pain (Allodynia, Complex regional pain, gynaecological pain, chest pain and headaches), and inflammation that is experienced. It is unconscionable to think that this is taking place in our country.
The serious adverse events being reported globally indicate an urgent need to address these unanswered questions, which have been asked of the NZ MOH and others for some months now. The standard letter that is returned, says that Gardasil is a safe vaccine, which has been extensively researched and will continue to be used in the schedule, until Medsafe says otherwise. This review is long overdue. The Nordic Cochrane Complaint must be recognised.
Health professionals who have knowledge deficits regarding these matters are in no position to consent for vaccination with Gardasil. Patients and parents cannot make an informed decision if their health professional is unaware of the trial data and outcomes, or the recent questions that have been raised by pathologist, Dr Sin Hang Lee (whose findings have been reproduced by Professor Laurent Belec) and the damming indictment against the EMA by Nordic Cochrane.
Is it appropriate for Pharmac to seek opinion from the public through mainstream media, on whether they feel extending Gardasil use is desirable? This appears to be happening.
The public have so little objective information on which to base their opinions or knowledge.
Parents of girls and boys who are enduring the daily burden of the fallout post Gardasil would make a vital contribution to any discussion, if given the opportunity. They are currently being denied a voice. If a commission of inquiry was to be established, they would be an invaluable asset to inform those who have no idea what is taking place.
Opinions are not science. We must be clear on this. Evidence Based Science and Best Practice are required to evaluate this matter, so that we can arrive at safe and sound conclusions.
Science is never settled. Dissent is essential, for that is how we learn and make progress surely?
That said, anecdotal evidence must not be dismissed, so that we can avoid the errors of the past. The anecdotal evidence is overwhelming. Parents must have a voice and be afforded the opportunity to contribute to this grave situation they find themselves in, caring for their unwell daughters and in some cases, sons. At the moment, they are denigrated and dismissed by those who have no experience of this and very little knowledge of how to cope with this damage. These people have a wealth of knowledge and are seeking answers and help. They trusted the medical profession and have been let down.
Given the undone science and erosion of best practice, I think it is best that those who have not done due diligence must look to themselves, before asking the public to guide them on whether or not Gardasil should be administered to boys. The public, after all, have placed their trust, until now, in the medical profession, Pharmac, Medsafe and in IMAC. How are they to know what is best? Ask the parents of these vaccine injured girls. Please meet with them ... no one else will.
Regrettably, vital information is not being conveyed to the medical profession, regarding signals and alerts pertaining to the HPV vaccine Gardasil. With time constraints at clinics, it is an unfair expectation placed upon them to expect them to obtain a legal consent for this vaccine. It is also not fair to place nurses in the position of administering Gardasil, when the matter of adverse events are downplayed about Gardasil and they are running clinics and teaching about Gardasil in our schools, without an awareness of actual risk and benefit.
It is perhaps most surprising, to see that Gardasil is included in the Level 2 Biology Assessment for NCEA; ironic, given the aim of the assessment is to determine a student's ability to analyse bias and non-bias, accurate and inaccurate information on Gardasil and whether it is good for their family.
As we reflect on the concerns currently being raised by esteemed organisations, such as Nordic Cochrane/Cochrane Collaboration and specialist clinicians, immunologists, biochemists, cardiologist, neurologists and even paediatricians around the World, on the safety and efficacy of Gardasil, this would seem to be an 'inappropriate' topic to be used in the NZ Educational system.
It may also be placing School Boards in an invidious position and having to consider their legal position in the future, in light of the Nordic Cochrane Complaint and other matters.
Interestingly enough, I am aware of some girls, who have done independent reading outside the set resources for NCEA level 2 Biology on Gardasil, who have come to the conclusion that there are serious questions that have been left unanswered about the safety of this vaccine. However, because they do not wish to fail their assessments, they feel compelled to write what 'they believe is expected of them,' in order to pass.
One thing I trust that we can all agree upon, is the established evidence, that Pap smear screening and educational measures, which minimise the risk for cervical cancer are not disputed. Pap smears have been the one single most efficacious intervention thus far. As CBER have concluded, Co-factors have been deemed to be necessary 'with' HPV, to induce cervical cancer, not HPV alone. This is perhaps one of the most important scientific findings to keep in mind, when assisting the public with their knowledge about HPV infections.
Please Judge Boshier, help these families and ensure that no other children have to be put in harm's way, until there has been a full investigation and by those with no links to the matters raised in this email, or conflicts of interest.
A review of the Informed process of Consent and the observation of The Precautionary Principle, are non negotiable.
This vaccine ought never to have been deemed safe, in the absence of robust scientific evaluation.
If you initiate an investigation into this matter, I believe that you will come to the same conclusion.
(NAME SUPPLIED BUT WITHHELD FOR PRIVACY REASONS)