Gardasil – Ireland’s Political Hot Potato

March 19, 2016

Mná Na hEireann, the women of Ireland, have through the centuries of Irish history displayed a certain kind of strength and courage which is admired the world over. They are the subject of songs, folklore, legends, poetry, and wars. Throughout history we can see examples of the impact of such influencers as St. Brigid, Maude Gonne, Grace O’Malley, Constance Markievicz and Mary Robinson.

In today’s world, Irish women leave an impression of being strong and forceful, the ones that hold the family together with an inclination to be a little feisty with it. I have met and talked with many such mná cróga (brave women) in the last year, and I am humbled to tell you one such story here:

A few short months ago, a nurse from Co. Westmeath, Fiona Kirby, earned my respect and admiration when she stood up for her young daughter Aoife (pronounced EE-fa), who is suffering from an apparent reaction to Gardasil. Aoife suffers from fatigue, nausea, muscle wasting and is in constant pain.

Last November, Ms. Kirby courageously brought a High Court case against the Health Products Regulatory Authority (HPRA or “the Authority”), seeking the withdrawal of Gardasil from the market in Ireland, even temporarily, pending an investigation. The job of the HPRA is to “make sure that health products (they) regulate are as safe as possible.” Counter to this mandate and despite mounting media reports of girls being injured in Ireland and throughout the world after this vaccine, the case was dismissed after four months of testimony.

Fiona Kirby

So how did the HPRA persuade the High Court of Ireland to dismiss Ms. Kirby’s claim on behalf of her daughter, even though the judge acknowledged that the vaccine may indeed have caused her daughter’s injuries? I think the reasons display the kind of “callous disregard” we have seen many times before when the validity of any element of a vaccine program is at stake. We cannot disclose all the reasons given at this time, but we will do so once Ms. Kirby’s case documents are available to the public.

What we can tell you, however,  is that the HPRA’s response was to deny Ms. Kirby’s claim outright and deny that her daughter’s reactions were due to Gardasil. This was despite a letter from her GP supporting Ms. Kirby’s assertion, and despite the fact that the HPRA never asked to have a doctor independently examine Aoife.

The HPRA claimed that the judge had no jurisdiction in the case as Gardasil is licensed by the European Medicines Agency and not the HPRA. The judge ruled in the Authority’s favor and stated that any legal challenge may only be made to the European Court of Justice in Luxembourg.

Is this a legitimate response, however? It’s hard to tell. Every department which deals with vaccines in the Irish government seems to deny any responsibility for any negative side effects and what to do about them. Very often it’s a question of the language used and how each side interprets it. Express definitions for the many terms used – “licensed,” “regulated,” “authorized,” “withdrawn,” and “revoked” – are not given and can be very confusing (probably deliberately so) when it comes to an issue such as harm done by a government-sponsored vaccine like Gardasil.

When the advocacy group REGRET, made up of girls harmed by Gardasil vaccination and their parents, asked the Health Service Executive (HSE) (informally) to halt the school-based vaccination programme, they were told that the schools invite them to administer the vaccines per the schedule. However, when members have asked their local schools about this, they are told that it is the HSE that arranges the administration of each vaccination. It seems that no one in authority will take responsibility for the well-being of these children. Passing the political hot potato is a powerful thing.

According to Ireland’s immunization guidelines for 2015, section six describes the HPRA’s role in vaccine safety as:

Vaccines used in Ireland have been licensed by the European Medicines Agency (EMA) in conjunction with the Health Products Regulatory Agency (HPRA). Following licensing of vaccines or other medicines the HPRA is responsible for post marketing surveillance. Reports of adverse events are available on http://www.hpra.ie. The HPRA has when appropriate withdrawn products from the Irish market where there have been public safety concerns.

That’s true.  The HPRA (via the Health Information and Quality Authority) recently removed the BCG vaccine from the infant schedule. The vaccine will only now be administered to “at risk” babies as it was perceived to be uneconomical due to the mere 400 cases of tuberculosis (TB) a year in Ireland, very few of which arise in children (~12 cases in children under 15). This makes a lot of sense and saves the country a lot of money, not to mention (as the HIQA’s Dr. Ryan describes here) the injuries to otherwise-healthy babies at birth.  Similarly, there are approximately 300 cases of cervical cancer annually in Ireland, fewer than TB. Pre-cancerous cervical changes are diagnosed on average at 32 years of age and generally take about 10 years to progress to cancer. Regular Pap screening can catch 90% of pre-cancerous conditions, which can then be effectively treated. One must question, then, the justification for vaccinating 32,000 girls (and boys will be added in the next school year) at a cost of 10 million Euros annually when the vaccine carries a significant risk (2.5%) of serious injury and has never shown to prevent a single case of cancer. I fail to see how the HPV vaccine differs from the BCG vaccine such that it cannot be handled in the same way, with removal from the schedule while maintaining availability for those who request it. This is exactly how similar issues were handled in Japan, despite apparent CDC collusion to deny recent science highlighting health concerns associated with the administration of Gardasil.

In its defense, the HPRA cited the recent safety review of Gardasil by the European Medicines Agency (EMA), which was requested by Denmark under article 20 of Regulation 726/2004. This report was approved in January, well ahead of the original May 2016 deadline. The defense claimed that this report was sufficient to establish the safety of the vaccine as Irish cases were part of that investigation. However, the only two conditions evaluated by the EMA, postural orthostatic tachycardia syndrome (POTS) and complex regional pain syndrome (CRPS), were not the only illnesses reported by the Irish teenagers. Therefore, it would seem that a new investigation could be entered into under article 20 for Ireland, which is within the HPRA’s mandate.

Given the sheer number of investigations into adverse effects of Gardasil all over the world, it seems likely that there is more safety-related data to be found and that the governments in question could find it if they wanted to. Which makes me want to know why nothing of the kind has come to light. Is Merck enjoying some sort of international protection from inquiry or disclosure? When you scratch beneath the surface a little and begin to ask some big-picture questions, you find some interesting “coincidences.”

In the U.S., Merck is protected from any and all lawsuits when it comes to harm caused by vaccines (unless it can be shown that they knew, and willfully withheld such knowledge, that a vaccine is causing more harm than they admit to, an extremely difficult task). Ireland, however, does not offer the same legal protection and should, therefore, be seeking any and all information during the discovery process which might otherwise never be seen by the public and ultimately prove detrimental to Merck. Merck, by the way, is currently defending a criminal investigation in the U.S. with regard to its mumps vaccine.

Thankfully, the FDA keeps good records, and we can see that, right about the time REGRET first began making a lot of noise, the FDA and the HPRA signed a confidentiality agreement – specifically in June 2015, a few months before Ms. Kirby’s case – which allowed the FDA to share sensitive information, including “confidential commercial information,” with the HPRA, but bound HPRA not to disclose it publicly. One has to wonder how – and why – such an agreement is initiated.

Why might this imply some kind of protection for Merck, and how are they even involved? The short answer is the FDA is a Department of Health and Human Services (DHHS) agency and the NIH (another part of DHHS) holds part of the patent on Gardasil, which entitles it to royalties. We do not know exactly how much the government earns from Gardasil royalties because for some reason that fact is “protected from disclosure under the Freedom of Information Act,” but we can thank Dr. Eric Suba for trying to find out.

Delving a little further still, we see these “confidentiality agreements” popping up all over the world where Merck is doing Gardasil business: Denmark, France, Spain, Japan, Australia, New Zealand, and Italy (including the WHO and EMA) to name a few. All of these countries are experiencing huge legal challenges concerning Gardasil, and one can’t help but draw a few dotted lines, especially since the dates of the agreements seem to match closely to Gardasil media crises in those countries, such as the one produced by REGRET in Ireland or by another group of parents in Japan.

I am not a lawyer and so I cannot adequately comment on this case or how all this fits together. I can only speculate as to what “confidential commercial information” is not being disclosed to the public and why we are not allowed to know it. However, I can say that the one agency in Ireland which is responsible for monitoring vaccine safety has failed, and is continuing to fail, 280 girls and counting. We are witnessing a potential catastrophe of our time that may in years to come be compared to the Thalidomide scandal of the 1960s.

Irish Gardasil survivors have reported suffering multifactorial conditions that include but are not limited to: POTS, Epstein Barr Virus, HPV, CRPS, paralysis/GBS, chronic fatigue/ME, early menopause, heavy menstruation, deep stretch marks, thyroiditis and infertility (POF). This is in addition to all the side effects which Merck admits to being potential side effects: injection site: pain, swelling, redness, itching, bruising, bleeding, and a lump, also headache, fever, nausea, dizziness, diarrhea, abdominal pain, sore throat, difficulty breathing, wheezing (bronchospasm), hives, rash, swollen glands (neck, armpit, or groin), joint pain, unusual tiredness, weakness or confusion, chills, generally feeling unwell, leg pain, shortness of breath, chest pain, aching muscles, muscle weakness, seizures, bad stomach ache, bleeding or bruising, skin infection and fainting (syncope).

The advocacy group REGRET, whilst not a party to this case, has stood by Ms. Kirby and came out to support her at a recent court appearance, which was reported widely in the national media. However, they have mainly focused on the political avenue of recourse for help and justice for the 280 members of their grassroots organization. They are attempting to seek more medical help, including medical cards. They want every parent to get the manufacturer-recommended patient information leaflet (PIL), which would allow parents proper informed consent. Currently, schools are instructed by the HSE not to give any material other than the HSE-approved marketing brochure. The brochure does not include all pertinent risk information, something REGRET has been lobbying for from the beginning. It’s hard to find a more blatant breach of the informed consent laws protecting a fundamental human right.

Right now there are few doctors in Ireland who are able to understand, let alone treat, the REGRET girls’ injuries. Many of the girls are recovering with the help of alternative therapies, including supplements and diet changes. However, each child is an individual, and it is of the utmost urgency that the worldwide medical community come together to help these girls, not just in Ireland, but all over the world. I feel like it’s a race against time to stop the narrative from turning into; “Teenage autoimmune illness? Yes, it’s always been around (at least since 2006). Nothing we can do; it’s mostly in their heads . . . .”

So where does all this leave Ms. Kirby? Well she continues to care for her disabled daughter who requires round-the-clock vigilance. She continues to advocate for more informed consent awareness with regard to Gardasil.  She continues to seek justice for her daughter. But, truth be told, this case has taken its toll on Ms. Kirby: She needs a break; she needs help with Aoife; and she needs support and someone to tell her it’s going to be okay. That’s the human side to this tragedy, and it’s playing out in families all over the world as healthy young girls are being struck down and their injuries dismissed as psychosomatic and nothing to do with the vaccine they just received – one huge, big ol’ coincidence.

The HPRA has stated its case. The High Court has refused to invoke the European Precautionary Principle by granting even a temporary moratorium. And Ms. Kirby is passing the baton to the next brave mother in line. There are 279 more and counting. The HPRA can’t hide behind the EMA forever.

Bean cróga na hÉireann, támuid bródúil as tú!
(Brave women of Ireland, we salute you!)

~ ShamROCK

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