Ms Anna Cannon:

I thank the committee for hosting us today. We are representatives of a group of parents who have come together from throughout the country to form REGRET, which stands for Reactions and Effects of Gardasil Resulting in Extreme Trauma.

We are a support group for families with children suffering long-term and life-changing health issues following the administering of the Gardasil HPV vaccination. Our 130 daughters display a series of debilitating, long-term and chronic symptoms corresponding directly with the Gardasil patient information leaflet, or PIL, provided by the manufacturer. The PIL is the folded leaflet everyone gets included in the medication package when they go into the pharmacy to collect medication. We were not given this information when signing the consent form for our daughters to get vaccinated with the Gardasil HPV vaccine in first year of secondary school. Instead, parents are given a marketing leaflet outlining five mild side effects. Nowhere are we told about the risk of long-term, chronic and life-changing side effects. We were not told about the daily severe headaches our girls struggle with for years, the nausea and stomach pains, the debilitating fatigue, the fainting and seizures and onset of autoimmune disorders. We were not told that we might regularly end up in the accident and emergency department watching our teenagers scream in pain while doctors rule out one condition after another. We were not told that our previously healthy, sporty and high-achieving girls might never play sports again never mind socialise with friends to enjoy what should be the most carefree time in their lives. We were not told about the impact of these illnesses on our daughters' ability to continue their education and the resulting psychological impact of having this basic human right taken away.

Parents are not prepared for the emotional strain of watching a child struggle to get out of bed to face another day of pain, fatigue, muscle weakness, dizziness and inability to concentrate. We worry about how we will manage to raise the funds to meet our daughters' many medical needs in years to come. Some of our daughters have contracted potentially life-threatening conditions which are rare or unheard of in children their age. While some doctors admit that they think it is connected with the Gardasil HPV vaccination, most medical professionals in GP clinics, accident and emergency departments and hospitals throughout Ireland will not acknowledge any connection with this vaccine. Maybe if we as parents had been given the PIL, we could have pointed out the list of possible side effects to these doctors. Instead we struggled, sometimes for years, to understand our previously healthy daughters' range of health issues before making the connection.

We believe there is significant under-reporting of HPV vaccine adverse reactions to the Health Products Regulatory Authority, HPRA. Before contacting REGRET, most parents had never heard of the HPRA or the adverse reaction reporting system. It is also their experience that doctors and consultants failed to report suspicions of side effects even when parents had pointed out the connection. We all wanted the very best for our children. We trusted that the HSE would act responsibly and respect our right as parents to be fully and honestly informed before making the decision to sign the consent form. This is a significant decision for parents, considering Ireland is one of the very few countries in the developed world that still does not have a vaccine damage compensation scheme. When the Gardasil vaccination programme was discussed by this committee three years ago, Dr. Colette Bonner from the Department of Health noted the committee's concern that there is no vaccine damage compensation scheme. She said, "There is an expert report which we are considering. I will convey the committee's concerns both to the secretary-general and the Minister on this point."

We now know that Gardasil got CDC fast-track approval and underwent a mere six months' of human trial research. Subjects were only followed for five to 15 days in the safety studies and only 1,200 girls under 16 years of age participated even though this is the target age for the vaccine. During these clinical safety trials paid for by Merck, 95% of the placebo injections contained the same toxic aluminium adjuvant as the vaccine itself which resulted in Merck being able to claim that adverse reactions were not significantly higher than those of the placebo group. We also now know that in a later four-year clinical trial by Merck, one in 40 trial participants reported a serious adverse event after taking the Gardasil HPV vaccine. In addition, one in 30 also reported a new autoimmune condition. Given that the current rate of incidence of cervical cancer in Ireland is only 13 in 100,000, the benefits of this vaccine hardly appear to outweigh the risks. According to politicians and health authorities, the benefit is that 50 to 60 lives a year will be saved by the HPV vaccine in Ireland. However, health technology assessment reports from other countries show that these statistics can only result from the combined effect of screening plus vaccination. In Ireland, however, these figures are being presented as the effect of vaccination alone. The truth is that our girls will still require ongoing and regular pap smear tests because protection from the HPV vaccine has not been shown to last longer than eight years.

Worldwide, concern is mounting about the safety of the Gardasil HPV vaccine. Gardasil has now been dropped from the childhood immunisation schedule in Denmark and replaced with an alternative vaccine. As of 1 September 2015, approximately 1,100 girls were being treated in five Danish regional medical centres for suspected Gardasil related conditions. Japan no longer recommends the HPV vaccine after conducting its own investigation into serious reactions. This month, we have been told that Gardasil's safety has been reaffirmed based on the results of a European Medicines Agency, EMA, review which found no link between Gardasil and two specific medical conditions, CRPS and POTS. However, the research director and consultant, Dr. Jesper Mehlsen, from Denmark has studied many girls with suspected adverse reactions to the HPV vaccine. He has criticised the EMA for not releasing the evidence of records and data when submitting its early release conclusion. Dr. Mehlsen is now heading an independent investigation into the HPV vaccine with results due out in April 2016. Speaking in June this year, he said, "A realistic estimate is that one in 500 girls experience serious side effects."

Spanish doctor and professor of public health, Carlos Alvarez-Dardet, from the University of Alicante has initiated a petition against the HPV vaccine. He is a former President of the European Public Health Association and was also an adviser to the WHO. He is now calling for an immediate stop to the vaccine. Last month, researchers announced the results of a Canadian study to show the effect the HPV vaccine had on 170 teenagers whom they followed for four years. They now question both the safety and benefits of the HPV vaccine, urging Quebec to halt HPV immunisation until its alleged dangers have been independently investigated. In France, Michèle Ravasi MEP has compiled a large petition with hundreds of physicians' signatures calling for a moratorium on the HPV vaccine.

As parents, we feel that the Minister for Health has a duty of care for the 130 teenage girls suffering chronic ill health since receiving the Gardasil HPV vaccination. However, he has consistently declined our requests for a meeting to discuss our daughters' situation. By way of a parliamentary question in October, Deputy Maureen O’Sullivan asked the Minister for Health the reason parents are not provided with a copy of the patient information leaflet prior to signing the consent form for the HPV vaccine. The HSE provided a response in the form of a letter from Dr. Kevin Kelleher, assistant national director of public health, which included this explanation:

All the information provided to parents about vaccination is prepared from the available licensed documentation for each vaccine, the Summary of Products Characteristics (SPC) and Patient Information Leaflet (PIL). The information is presented in clear simple language and approved by the National Adult Literacy Agency so that it can be understood by all adults as the average reading age in Ireland is 12 years of age.

As such, the official reason for the HSE withholding the list of known serious, debilitating and long-term side effects from the HPV vaccine information literature is because "the average adult reading age is 12 years old". That is the basis on which the content of these information leaflets is determined. I hope the absurdity of this logic is not lost on the joint committee. As an aside, I note that it was Merck Sharp & Dohme who sponsored NALA's 2007 Irish health literacy research project. This is the manufacturer of the Gardasil vaccine.

There are some who would rather dismiss us as anti-vaccine parents, but we all gave our other children their vaccinations just as we all signed the consent form for this one. We thought we were doing the best for them. Instead, we signed away our girls' futures and five years later they are still struggling. Our lives will never be the same following the Gardasil HPV vaccination of our daughters. Years have been taken from them, their parents, their siblings and their grandparents. We have been given no answers, no guidance and no hope. We live with the guilt of our decision to sign the Gardasil consent form every day as we watch our previously healthy young girls struggle to get through their day with our bags packed 24-7 in case of yet another emergency visit to the hospital.