Joint Committee on Health and Children debate -
Thursday, 3 Dec 2015

Gardasil Human Papillomavirus Vaccine: Discussion

Chairman

Apologies have been received from Senators Jillian van Turnhout and John Crown and Deputies Peter Fitzpatrick and Regina Doherty. I remind members, witnesses and those in the Public Gallery that mobile telephones should be turned off or put on airplane mode for the duration of the meeting as they interfere with the broadcasting equipment which affects the recording of the meeting and also affects staff.

This is our second meeting of the day and the first meeting of the joint committee. Its purpose is to discuss the Gardasil human papillomavirus, HPV, vaccine. We already had a previous meeting on the issue. I welcome those who are watching at home, those who are in the Gallery and committee members and witnesses. It is important that we have a discussion on the matter today. Members of the Oireachtas met the representative group, REGRET, which is the support group for families of children experiencing health issues in relation to the Gardasil HPV vaccine. The committee will also hear medical evidence from the Department of Health and the HSE. Public vaccination plays a key role in the protection of public health. It is important we have a balanced and fair debate and that any claims made are based on scientific evidence rather than on opinion. The role of the committee is to facilitate a discussion.

I welcome Ms Karen Smyth, Ms Anna Cannon, Ms Kiva Murphy and Mr. Tom Reddy from the REGRET support group. They are all very welcome and I thank them for being here. I also welcome Dr. Colette Bonner, deputy chief medical officer of the Department of Health, Dr. Brenda Corcoran of the national immunisation office of the HSE, Dr. Kevin Kelleher, assistant national director of health protection in the HSE, Dr. Joan Gilvarry, director of human products monitoring in the Health Products Regulatory Authority, and Dr. Kevin Connolly, chairman of the national immunisation advisory committee. They are all very welcome to this morning's meeting.

By virtue of section 17(2)(l) of the Defamation Act 2009, witnesses are protected by absolute privilege in respect of the evidence they are to give this committee. If they are directed by the committee to cease giving evidence in relation to a particular matter and they continue to so do, they are entitled thereafter only to a qualified privilege in respect of their evidence. They are directed that only evidence connected with the subject matter of these proceedings is to be given and they are asked to respect the parliamentary practice to the effect that, where possible, they should not criticise nor make charges against any person or persons or entity by name or in such a way as to make him, her or it identifiable. Members of the committee are reminded of the long-standing parliamentary practice and rulings of the Chair to the effect that members should not comment on, criticise or make charges against a person or persons outside the House or an official either by name or in such a way as to make him or her identifiable. I invite Mr. Reddy to make the introductions and then I will call the other witnesses to make their presentations.

Mr. Tom Reddy

I will say a brief few words and introduce members to the two speakers from the support group, namely, Ms Karen Smyth and Ms Anna Cannon. Ms Cannon will be the first to speak on behalf of the group. We represent more than 130 individuals and the number seems to increase every day. We are delighted to be here. We welcome the opportunity to present to the committee and hope it will make a recommendation to the Government on behalf of the group and the families we represent.

Chairman

I invite Ms Cannon to make her opening remarks.

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.

Ms Karen Smyth

Six months ago, we were just a few mums and dads who recognised a pattern of similar illnesses among our daughters. Today, we represent more than 130 teenage girls and receive more reports every week of girls displaying a similar pattern of debilitating side effects.

The Department of Health and the HSE have acknowledged they know some young women will suffer detrimental effects from the vaccine. We represent 130 of these girls. My daughter Laura celebrated her 18th birthday last week and this is her story. When Laura brought home the consent form from school in 2010 I read it thoroughly. I also went on the World Health Organization's website to educate myself about this vaccine as it was new to Ireland and I did not know much about it. After reading the information supplied by the HSE, I felt not only reassured that this was a safe vaccine but also that this was something very important for my little girl and her future health. I naively thought that all details, good and bad, had to be printed to enable parents to make properly informed choices for their children.

After Laura’s vaccination she became severely fatigued on a daily basis and her short-term memory and concentration deteriorated. She also started to experience food intolerances for the first time. Laura suffered visual disturbances and noise sensitivity. Severe daily headaches, burning muscles and joint pain were her constant companions. She was unable to continue with sports, which had played such an integral part of her life before the vaccination. All extra-curricular and social activity had, by now, become impossible for her. Her friends stopped calling as she did not have the strength to go out with them. Slowly, life as Laura knew it was changing.

To put things in perspective, my mother, who was in her 80’s, was going out to day care while Laura was lying in bed or on the couch. We had to use my mother’s wheelchair for Laura when she did not have the energy to walk. It was plain for anyone to see something was very seriously wrong. We started to visit our GP more and more but no one seemed to have any idea what was going on. Tests and more tests were performed and nearly every box on the blood forms was ticked. Every kind of sample one could imagine was requested, yet none of the results showed any clues as to what was wrong with my daughter.

Weeks and months went by, with Laura lying in her bed exhausted but unable to get any kind of rejuvenating sleep, racked with pain and barely able to communicate. The weeks became months, and we saw less of her around the house as she was spending most days in her bed. At her lowest point, I found her younger brother Conor spoon-feeding her as she did not have the strength to feed herself. She moved into a spare bed in his room, as she was lonely and afraid on her own.

Five years post-Gardasil, my daughter was so debilitated that she could not attend her uncle's wedding and struggled to attend her grandparents' funerals. She is no longer able to attend family outings with us and we feel guilty if we leave her at home. Laura knew from an early age what she wanted and had her sights set very high. Since receiving the vaccination all this has changed as Laura has missed almost her entire secondary school education.

This is Laura's story in her own words:

Hi, my name is Laura, I'm 18 years old and live in Louth. I am one of the too many girls who have been affected by the HPV vaccine, Gardasil. It has rendered my life very difficult. I am lying here in bed when I should be in school preparing for my leaving cert. My cognitive function is so bad I can't even manage home schooling at the moment. My symptoms include chronic fatigue, chronic pain, severe headaches, dizziness, short-term memory loss, very poor concentration, food intolerances, cysts, heart and breathing difficulties, light and noise sensitivity and menstrual disruption.

I’d like to think I am an intelligent girl, once aiming to study psychology in Trinity. I was playing basketball and kayaking. I had so many friends and wanted to travel the world. Now all those things have been taken from me. You have no idea how horrible this is. My own mother has devoted every second of her life to helping me and finding me relief in expensive therapies, supplements, and hopefully one day a cure. Not only has this vaccine taken my life, it's stolen my mother's. I'm five years down the line and I just turned 18. I try my best to keep positive but at this point I don't have the energy to keep going the way I am. I just want recognition and help for all these girls. We've been put in a box for far too long.

The Irish Government or the HSE has not put in place a support system to cater for all of these previously healthy Irish girls suffering ongoing, chronic and long-term symptoms post-Gardasil. Their fate is unknown and their debilitating health issues are potentially life-long. Many of these girls will never complete their leaving certificate.

We need to provide holistic long-term treatment plans for these girls. Families are not coping financially with the ongoing need for doctors, specialists, hospital stays and medication. We need to get help for these children to explore alternative options for schooling and education, and allow them exemptions if attempting to sit their leaving certificate. We need to support these girls with basic requirements such as disability allowances and medical cards as their condition is not being recognised.

I thank the Deputies and Senators for their time and interest in the young women throughout the country affected by the State-sponsored HPV vaccination programme. We ask them for the suspension of the HPV vaccine programme pending a full, independent and transparent investigation into the safety of the HPV vaccine, including the many long-term side effects and adverse reactions suffered by the girls in REGRET; recognition and acknowledgement of our daughters' post-Gardasil conditions followed by holistic approach medical treatments by specialists in this area; financial assistance for our families to meet their children’s ongoing medical needs; the urgent establishment of a task force comprising senior officials from the Departments of Health, Education and Skills and Social Protection to fast-track support for our daughters; and full information to be given from the HSE to parents, including the patient information leaflet as drawn up by the drug company, which requests that parents inform their health care provider if their daughter experiences any of the 21 known side effects as part of the informed consent process.

I hope the stories of these 130 Irish teenage girls will trigger a positive response from the committee, and that committee members will help us ensure their immediate and long-term needs are met. This is the very least they deserve from us, as their future has been so unfairly impacted upon by medical decisions outside of their control.

Dr. Colette Bonner

In 2009, the national immunisation advisory committee recommended the HPV vaccination for all 12 year old girls, and in September 2010 the programme started for all girls in first year of second level schools.

My colleague, Dr. Kevin Connolly, is chairman of the National Immunisation Advisory Committee. He will give the committee examples of how NIAC makes recommendations for inclusion of new vaccines in the primary childhood immunisation schedule and school immunisation programme.

Gardasil is the vaccine used by the HSE in the school immunisation programme and is provided free of charge. My colleague, Dr. Brenda Corcoran, will give details of the school immunisation programme and discuss the information given to parents.

Why did we introduce the human papillomavirus vaccine? The reason is that it protects against HPV types 16 and 18, which are known to cause over 70% of cervical cancers. In Ireland, approximately 300 cases of cervical cancer are diagnosed each year. Up to 60% of women diagnosed with cervical cancer are under 50 years of age and there are approximately 100 deaths each year. This vaccine could save up to 70% of these women's lives.

What happens when a new vaccine or medicine is introduced to the market? All medicinal products, including vaccines, are required to go through extensive trials before they are reviewed by the European Medicines Agency and licensed by the European Commission. Even after any products are licensed, the EMA, the Health Products Regulatory Agency and all EU competent authorities continue to monitor them to ensure they continue to be safe and effective. My colleague, Dr. Joan Gilvarry, will explain the regulatory regime in greater detail.

I am aware of reports of serious health problems alleged to have occurred following HPV vaccination and I have great sympathy for any family caring for a sick child. However, I emphasise that this does not mean the symptoms have been caused by the HPV vaccine. Over 170,000 girls in Ireland and up to 63 million girls worldwide have received this important cancer-preventing vaccine. The vast majority of reported side-effects have been consistent with the expected pattern of short-term adverse side effects for the vaccine.

Two reported conditions have recently been examined by the European Medicines Agency. These are complex regional pain syndrome, a chronic pain condition affecting the limbs, and postural orthostatic tachycardia syndrome, a condition causing symptoms such as dizziness, fainting, headaches, chest pain and weakness. It should be noted that these two syndromes are recognised to occur in the general population, including adolescents, regardless of whether those affected have had the HPV vaccine. The EMA review confirms that the evidence does not support a causal link between the HPV vaccine and the development of CRPS and POTS. Therefore, there is no reason to change the way the vaccines are used or amend the current product information. My colleagues will give the committee further details of these reviews.

Anyone in Ireland who is experiencing ill-health is eligible to seek medical attention and access appropriate health and social services, irrespective of the cause of the symptoms. I strongly advise any girls and their families in this situation to seek medical advice from their doctors and be guided by that advice, so that they can have an opportunity to return to full health as soon as possible.

Dr. Kevin Connolly

I am here in my capacity as the chairman of the National Immunisation Advisory Committee. I will offer some background or additional helpful information. Up to last year, I was the Irish representative on the expert committee of the European Medicines Agency known as the paediatric committee. One of the functions of the committee is to stipulate in detail the contents and timelines of all trials by any company for any vaccine intended for use in Europe. These plans include a large emphasis on safety monitoring during the trials and after the vaccine is introduced. The companies must comply with these conditions or they will not get a licence.

I have been a member of the advisory committee of the Health Products Regulatory Agency for over 20 years. I worked as a paediatrician for 32 years up to 2010, dealing with children with chronic ongoing debilitating conditions. I am a parent of four children. One of my children had chronic fatigue following infection with glandular fever, a well-recognised cause of chronic fatigue.

I am keen to make clear that I strongly empathise with the children and families represented by the Reactions and Effects of Gardasil Resulting in Extreme Trauma support group. Chronic fatigue syndrome can be a debilitating chronic condition, and no one who has listened to the stories could fail to recognise that. I have met and spoken with representatives of REGRET. Any person in Ireland with a chronic condition should have ready access to services that can, in a timely fashion, appropriately assess, investigate and manage their problems on an individual basis. If that is assured, the main aim of REGRET. will be achieved.

I will address four areas to help inform the committee and to answer some of the questions put by the representatives of REGRET. First, I will set out some information about the immunisation advisory committee. Second, I will outline some facts about the infection and disease caused by HPV. Third, I will outline some information about the vaccine. Fourth, I will try to tease out the differences between adverse events and adverse reactions.

The immunisation advisory committee is an independent committee of the Royal College of Physicians of Ireland. Members include members of the college of physicians, the Royal College of Surgeons in Ireland, the Irish College of General Practitioners and the faculties of paediatrics, occupational medicine and public health medicine in universities. There are also representatives from the national virus reference laboratory as well as the Travel Medicine Society of Ireland and nursing and midwifery experts. The committee also includes representatives of the Health Protection Surveillance Centre, which gives us information about the incidence and pattern of diseases. A representative of the Health Products Regulatory Authority is on the committee because the licensing and legality of particular decisions must be ensured. Finally, there are representatives from the Department of Health and the national immunisation office as well as another observer from the HSE.

I will set out the relevant responsibilities of the immunisation committee. I call it NIAC for short because it is easier to say. First, the function of the committee is to review new licensed vaccines to see whether they are suitable for inclusion in the Irish vaccine schedule. Second, its role is to give advice or make recommendations to the Department of Health with regard to vaccines.

I will set out the main criteria we consider when we are considering new vaccines. First, the availability of a safe and effective vaccine. Second, knowledge of the incidence of the disease or infection in Ireland. Third, whether there is a significant disease burden. In other words, a mild infection such as a cold does not really require a vaccine whereas a significant infection like the cancer-causing HPV would. Fourth, we consider whether the recommended vaccine can be easily added to the current vaccine schedule. This is why the national immunisation office is represented on the committee. We also consider the experience in different countries that may have already introduced the vaccine and an economic analysis to see whether the vaccine is cost-effective. Then we provide advice or recommendations to the Department.

Another function of the committee is just as important as making the decision. This is the ongoing review of all available information regarding the vaccines, including the safety and their effectiveness. I will set out why this is relevant to the infection caused by the human papillomavirus. HPV infection is the commonest sexually-transmitted infection and it is very contagious.

It is estimated that up to 80% of males and females will have contracted the infection by the time they are 50. It is known that it causes cancers of the cervix, vagina, vulva, penis, anus, mouth and throat. It also causes anogenital warts. Without the screening mentioned by REGRET, the lifetime risk of sexually active people developing cancer from this virus is about one in 30, which is very appreciable.

Most HPV infections of the cervix and the anus have no symptoms and more than 90% of infections are cleared naturally within two years. Early infections in both sexes may be accompanied by mild changes at the site of infection and for females these changes can be identified in cervical smears, which is part of the cervical screening programme. The term given is cervical intraepithelial neoplasia, which to me means abnormal cells in the cervix, and this can go on to cause cancer. As the infection persists, the cancer precursors are noticed. This means that if these remain untreated they have a high chance of leading to cancer. It can take ten years or longer for the cancer to show; there is a very long incubation period.

Cervical cancer is the second most common cancer in females and the virus is estimated to result in nearly all of the approximately 250,000 deaths from cervical cancer. In Ireland each year there are more than 300 cases of cancer of the cervix and 100 deaths.

No vaccine is 100% safe or 100% effective, but they are very safe and very effective. The trials of drugs normally involve hundreds or thousands of subjects. In the case of vaccines, the trials involve tens of thousands of subjects, as they are given mainly to people who are well and the bar is set much higher. This safety is monitored both in the trials carried out before licensing and in follow-up reports. The clinical part of the trials on the HPV vaccines in Europe lasted more than four years and not the six months that was stated in the United States. So they happened for appreciably longer.

Chairman

I ask Dr. Connolly to conclude because he has exceeded his allocated time.

Dr. Kevin Connolly

I am very sorry. I did not know.

Chairman

We normally give six minutes to each person.

Dr. Kevin Connolly

I am sorry. I was not informed about that.

An adverse event is different from an adverse reaction. An adverse event happens in association with the vaccine but is not necessarily caused by the vaccine, whereas an adverse reaction is. In order to determine whether the chronic fatigue symptom is caused or coincidental, it is necessary to know the incidence of the syndrome in those who were never vaccinated, for instance before the vaccine was introduced, and the incidence subsequent to the vaccine. We know that the numbers expected for chronic fatigue syndrome in Ireland before the vaccine was introduced are conservatively 340, and up to 680. Some 170,000 children have been vaccinated, so the reports that have been received - I believe 120 or 130 was mentioned - are less than would be expected. As is known, it is under-reported, but based on that there is no evidence to suggest that the vaccine caused chronic fatigue syndrome in these children.

Dr. Brenda Corcoran

I am representing the HSE national immunisation office, which is responsible for the co-ordination of all publicly funded immunisation programmes. We are responsible for training and communication materials for health professionals and the general public.

The HPV vaccine is one of three different vaccines given to first year students in second level schools. The HPV vaccination programme commenced in 2010, using the Gardasil vaccine manufactured by Sanofi Pasteur, which was awarded the contract after a competitive tender. All vaccines used by the HSE are on the recommendation of NIAC and are licensed by the Health Products Regulatory Authority and the European Medicines Agency.

The programme is delivered in schools because there is international and national evidence that better uptakes are achieved. We have regular engagement with the Department of Education and Skills and school management bodies to ensure the smooth running of the programmes. The World Health Organization promotes school vaccination programmes and other countries with successful HPV vaccination programmes such as the UK and Australia do so through school-based programmes.

Our programme started initially for girls in first year in 21 second-level schools in May 2010. This allowed us to ask parents if they were happy with the content of the information materials they received and over 95% were. The vaccination programme was fully rolled out in September 2010 for all girls in first and second year. The following year a catch-up programme started for all girls in sixth year. Since that concluded at the end of 2013-14, the routine programme has continued for all first year girls.

Initially, girls required three doses of HPV vaccine at zero, two and six months to be fully vaccinated. This changed to a two-dose schedule in 2014 as new scientific evidence showed that two doses at zero and six months gives the same protection.

The target uptake is 80% for a completed course of vaccine in first year girls. The programme has achieved the target uptake every year since it started with the most recent figure of 84%. Over 95% of girls who start the vaccine course complete the required number of doses, which is a great credit to the dedication of the HSE school vaccination teams.

The HSE is committed to providing accurate information for parents about all the diseases, the vaccines to prevent them and side effects from those vaccines to allow them to choose whether to give consent to vaccination. All the information provided to parents about vaccination is prepared from the available licensed documentation for each vaccine - the summary of product characteristics and patient information leaflet. The information is presented in clear simple language and approved by the National Adult Literacy Agency so that it can be understood by all. The language is in line with the HIQA guidance entitled Communicating in Plain English, published in July of this year.

Prior to all school immunisations, parents receive an information pack in a sealed package with an information leaflet, consent form and cover letter. All the information booklets, including that for the HPV vaccine, include information on the most common, quite common, rare and very rare adverse events that can occur after vaccination. The information booklet does not include conditions that are not known side effects of the vaccine.

Each information leaflet also refers parents to the national immunisation website, where additional information including the licensed documentation can be found. Information leaflets for the very successful UK and Australian HPV vaccination programmes contain less information than ours on side effects and also refer parents to websites for further information. Our website has been accredited by the World Health Organization as providing good credible information. The website allows members of the public to contact us to ask questions if they require further information.

Parents are also given contact details for their local immunisation office and advised to speak to a member of the school team if they have any further questions. The information materials for all school vaccines are reviewed annually and the website content is constantly updated.

The HSE acknowledges concerns from parents about the level of information they receive about HPV vaccine and will take these on board to ensure parents receive as much accurate, credible information as possible to allow them to choose this life-saving vaccine for their daughters.

Chairman

We did not have a copy of Dr. Corcoran's presentation for members but hopefully we will get copies to them afterwards.

Deputy Billy Kelleher

I welcome the witnesses and attendees today and thank them for their testimonies. I can only speak for myself. I have no medical, scientific or clinical expertise but I think it is important that we provide a forum where the witnesses can present their case and outline their concerns about the Gardasil vaccine. Equally, we have an obligation as a committee to question and hold to account State agencies that work on behalf of the people in terms of oversight, and to ensure that there is strong oversight of vaccines and observation of any potential adverse effects. The testimonies presented today were very powerful and moving, and create huge anxiety and concern. At the same time, we have an obligation to ensure that we have vaccination programmes in place that protect the health of our people. We have agencies in place to oversee the vaccination programme but also to monitor any potential adverse effects.

In the context of the experiences of the parents and Ms Smyth, they felt the information provided in the patient information leaflet was not sufficient. That is a small part of the bigger issue they are facing now. In their interaction with the health services, from general practitioners to the HSE to the Department of Health, was there any understanding of their concerns due to their belief that Gardasil was the reason for the adverse effects on their daughters? Having met with individuals and, collectively, with REGRET, I have detected that there was no clear understanding of their concerns. That may not be the case for every person who has interacted with the general practitioner services and the HSE in general. When the parents explained their concerns, was any effort made to interact with them beyond what would take place in the context of an ordinary illness?

Japan and Denmark would certainly be first world countries and they have suspended the vaccination programme. I would point this out to the various officials who are here today and ask if they have considered why those countries have done so. On the broader issue of the vaccine itself, I know the European Medicines Agency carried out a review of it recently. Can the officials tell me if that was just a standard review, or if it came out of concerns about the vaccine and potential adverse effects?

We now have 130 people who feel their children suffered adverse effects because of the Gardasil vaccine. Is there any centralised monitoring system in place whereby there is an obligation to report to some agency in the State in order to collate information and data? We would be all failing in our duties if we did not have at least some system in place to monitor that nationally. There should be some centralised way of collating all that information so that we could at least be able to observe trends on a national basis. That might lead us to revisit the whole issue of the Gardasil vaccination programme.

As I do not have any scientific evidence, I cannot say it is the wrong way to go, but equally I believe it is critically important that the witnesses' voices are listened to. We must ensure that information is provided to parents in a way that is legible and understanding and that informs them of the full potentials of the risks around the vaccination programme. In the broader context, perhaps we could have a view as to what the Departments of Health and Social Protection and the HSE are doing to assist families who are finding themselves with these conditions, whether or not we can establish that Gardasil is the cause. I do not have the expertise in that area but there is surely an obligation on the State to ensure every effort is made to assist families that are going through this.

Deputy Caoimhghín Ó Caoláin

I welcome the representatives from REGRET and the other health professionals who make up the panel. I would like to ask a number of questions about the patient information leaflet that comes with Gardasil when accessed across the counter. Is it still the practice that the same detail is not provided to parents in advance of their signing the consent form for their daughters to be vaccinated at school? If that is the case, could the officials explain why the information provided through the school vaccination programme falls short of that offered by the patient information leaflet?

Ms Cannon stated that there has been significant under-reporting of adverse reactions to the HPV vaccine. For the information of Ms Cannon and her colleagues, in a parliamentary reply I received on 5 November on this matter, which I have been pursuing for some time, it is advised that the Health Products Regulatory Authority, HPRA, had at that point received 919 reports of adverse reactions and events associated with the use of Gardasil in Ireland. That may, in the minds of some, be few in terms of the number of those who would have participated in the vaccine programme, but 919 reports of adverse reactions and events over what is a relatively short period is not insignificant, in my opinion. I am only offering that as additional information.

Would Dr. Bonner like to confirm to the committee that she did indeed convey the committee's view regarding a vaccine damage compensation scheme to her colleagues as undertaken at that time? Would she or anyone else like to comment on the potential for such a scheme to occur in the near future?

Regarding worldwide concerns, Deputy Kelleher has also made reference to Japan and Denmark. Who takes that into account? Is it the HPRA? We know the HPRA has indicated that it does not have the authority to withdraw the licence for the vaccine but can only make recommendations. Are we taking into account international concerns and evidence? I use the word evidence quite positively. What is the situation in Denmark? They have replaced it with an alternative vaccine. Have we such a choice? Is there any evidence to suggest the alternative vaccine is safer than Gardasil or that there are not the same concerns attributable to it? Is it an alternative, safer vaccine? Perhaps Dr. Bonner or Dr. Gilvarry could comment on that.

The decision of Japan to no longer recommend is not an insignificant decision on its part.

It is totally understandable that families are not coping financially. Ms Smyth made this point in her contribution. I advise the representatives from REGRET and any other interested party present that I raised this matter by parliamentary question this morning on the floor of the Dáil with the Minister, Deputy Varadkar in the area of disability allowance, medical card entitlement, etc. While the Minister's response was anything but encouraging - he kept referring to the criteria for qualification for medical cards - I reminded him that not so long ago medical cards were issued on the basis of medical need. The breach has happened and it is an important one. I asked the Minister to look at this particular cohort favourably, sympathetically and humanely. I would reference it to the representatives of REGRET. If they are not able to access the exchange, I would be happy to forward it to them afterwards.

Dr. Bonner, in her contribution, stated the signalled expectation was that the vaccine, Gardasil, could save the lives of up to 70% of women.

Chairman

If I may interrupt the Deputy, there is a vote in the Seanad.

Deputy Caoimhghín Ó Caoláin

I ask Dr. Bonner or any of the rest of the professional panel how many years before evidence presents in Ireland as to its effectiveness. As for the 70% signalled expectation of prevention, when the vaccine is applied to those aged 12 it will take some period of time before the evidence presents. I wonder are we still at too early a point in time in order for that.

I presume the European Medicines Agency, EMA, is the HPRA equivalent on the European stage. It confirms that the evidence does not support a causal link, but can it assert that there is not any link?

I am disappointed with Dr. Bonner's closing remarks and I say so to her directly here. I can only imagine how insensitive her closing sentence must have been to the parents of these children here today when she stated, "I strongly advise any such girls and their families to seek medical advice from their doctors and be guided by that advice". I would have every confidence that these parents have done that to exhaustion.

Deputies

Hear, hear.

Chairman

I ask that we have silence in the Visitors Gallery. One is not allowed to interfere in the proceedings of the committee.

Deputy Seamus Healy

I welcome the witnesses, both from REGRET and officials, and thank them for their various submissions, particularly the powerful submissions from Ms. Smyth and Ms Cannon on this subject. It is something that is deeply traumatic for their daughters, families and extended families.

This is an optional vaccine that requires permission from parents. On that basis, parents should surely be made aware as fully as possible of all the various positives and negatives.

Chairman

Sorry, is Senator Healy Eames aware there is a vote in the Seanad?

Senator Fidelma Healy Eames

Yes.

Deputy Seamus Healy

Parents should be made aware in as full a way as possible of both the positives and the negatives that we are aware of in its regard. On that basis, I would be concerned that the patient information leaflet is not available to parents. I hear what has been said about the reason for that but I do not see it as being acceptable. If the leaflet is available it should be made available to parents. Even at this late stage, it should be made available to parents who have daughters coming into this scheme. I would like some further explanation from the medical officials on that area.

I would like clarification on the current position on the monitoring of incidents. I take it there is not a legal requirement. What requirement, if any, is there that doctors should inform the Department on what they believe are adverse effects of this vaccine and to what extent is there ongoing monitoring of the position at departmental level? In this regard, what link have we with other countries internationally? Denmark and Japan have been mentioned. Is there any communication between ourselves and these countries on this matter and is there any understanding as to why Denmark should advise an alternative and Japan should recommend against this? It would appear a bit incongruous that First World countries would have this view about the vaccine. Is there ongoing communication and linkage internationally in this regard?

The other question that arises is the area of communication between REGRET and the Department and the HSE. At what stage are those communications or are there any communications, or are there any proposals for communications in the future? Are there any proposals for any schemes to support the families and the individual girls who are affected? Are there any discussions in relation to a compensation scheme? Are there any treatment plans for the girls affected? What is the general level of communication between REGRET and the families who are affected by this and the Department and the HSE?

Chairman

Three members of the committee are indicating. I have Deputies Catherine Byrne and Mitchell O'Connor and Senator Colm Burke on the list, and then I have Senators Mooney and Healy Eames. To be fair, I will go to the panel first and then come back. Following Ms Cannon, I will go to the HSE and Dr. Bonner. I ask that they keep their answers precise and to the point.

Ms Anna Cannon

I thank Senator Kelleher for his input. We have a lot of families in Cork. One family has two daughters affected by the after-effects of the Gardasil vaccine. I want to address the point of fatigue, as it sounds like it is the key issue for the girls. It is one of many side-effects the girls are experiencing.

As regards the question on interacting with the NIO and the HSE, I will give some clear examples. I have a list of my daughter's side-effects - or what I believe are side-effects - from Gardasil: severe headaches, which are worst morning and evening; hot flushes of the face; nausea; lack of appetite; balance issues; dizzy spells; clotted nose bleeds, mainly in the night-time; lockjaw; extreme fatigue; low blood pressure; and marks on upper chest and thighs, very similar to other girls in the group. She also contracted pancreatitis, which is a life-threatening condition. The doctor had never seen that in a girl of her age group in over 50 years of practice. This is possibly chronic. Therefore, we are not only talking about fatigue here, we are also talking about many other issues. Most of our girls have been tested for glandular fever. It would be one of the first blood tests that are assessed for antibodies.

When my doctor wrote to the NIO and voiced my concerns to it, she said she had a 17-year-old girl with multiple symptoms, including severe headaches, myalgia, pancreatitis and loss of energy, etc. The reply from the NIO included a statement to the effect that:

The HPV vaccine has been licensed since 2006 and, to date, no causal link has been established between Gardasil, the HPV vaccine used, and chronic headaches, myalgia, loss of energy, low mood and pancreatitis. Therefore I would refer this girl, as you would normally refer any other patient who presents with the symptoms you describe.

That was the response. There were no questions and no contact with me as a parent. This would reflect the 130 girls in the Regret group, so we are not experiencing a great response, either from the HSE or our doctors. We are lucky in that we have finally found a few GPs who are supporting us and who are linking this with the Gardasil vaccine. In my statement, I said there was a four-year trial by Merck. One in 40 of those who took part experienced a serious adverse event and one in 30 experienced a new autoimmune condition.

I thank Deputy Ó Caoláin for his support. Of course, the statement was insulting. We have exhausted every medical avenue for these girls. We have been to GP clinics, hospitals and neurologists but they are not recognising this long list of side-effects that are mirrored between 130 girls in our group alone and also internationally. They are, in fact, stated on the patient information leaflets, PIL, so I do not see why a doctor cannot connect with or acknowledge a long list of symptoms that are unrelated to each other, but directly connected to the PIL.

As regards the protection of the HPV vaccine, we know it only covers two strands, but we also know that it is not proven to last more than eight years. These girls received the vaccine at 12 years of age. Many of them are so sick that they will not have a boyfriend for the foreseeable future, so by the time they reach an age at which they are sexually active, the benefits of this vaccine will be gone.

We need to look at how the benefits are misrepresented, as well as the risks, in terms of the information that parents are receiving before signing consent forms.

On the HSE's own website, www.medicines.ie, a clause from the Guide to Professional Conduct and Ethics for Registered Medical Practitioners, 7th edition, 2009, section 35.2, states:

As part of the informed consent process, patients must receive sufficient information, in a way that they can understand, to enable them to exercise their right to make informed decisions about their care. This refers to the disclosure of all significant risks or substantial risks of grave adverse consequences.

How is it that I, as a parent, cannot understand the following paragraph in the patient information leaflet?

As with other vaccines, side effects that have been reported during general use include: swollen glands (neck, armpit, or groin); muscle weakness, abnormal sensations, tingling in the arms, legs and upper body, or confusion (Guillain-Barré Syndrome, Acute disseminated encephalomyelitis) [I do not understand that part]; dizziness, vomiting, joint pain, aching muscles, unusual tiredness or weakness, chills, generally feeling unwell, bleeding or bruising more easily than normal [etc.] ...

It is clear and simple what are the side-effects. I do not see why we, as parents, do not have the basic human right to understand the full risks of this vaccine before signing the consent form for 12 year old kids.

Mr. Tom Reddy

One of the difficulties is that there is no themed response to the problems our daughters have experienced. We all acted individually until we became aware that this group existed. Every parent has the same story when they get in contact with the group and join it. They thought they had been operating alone. They went from doctor to specialists and were working in a twilight zone by themselves, thinking that nobody else was affected by it. Since we have been able to go public, we have found that more and more parents are identifying with members of the group. They find that it is almost a template reaction, in a sense, as to what they have had to go through concerning their daughters' symptoms. The other difficulty in people identifying with the group is that sometimes the symptoms take a long time or there could be different symptoms before they actually present. It could be a matter of weeks, months or years.

Chairman

Does Mr. Reddy have a phone next to him that is on?

Mr. Tom Reddy

No.

Chairman

Okay.

Mr. Tom Reddy

I just wanted to say that this is a further complication.

Ms Anna Cannon

Dr. Corcoran referred to accurate information. We know the overall issues that we never see. We never get the patient information leaflet, PIL. We get this little marketing brochure with five very mild, on-the-day, side-effects because apparently we are too illiterate to understand the full consequences of this vaccine.

Chairman

That was not said by Dr. Corcoran, to be fair to her.

Ms Anna Cannon

Okay.

Chairman

Ms Cannon should be careful what she says. I want to protect her.

Ms Anna Cannon

Okay. I apologise. What is written in the information leaflet is that one in four in Ireland are illiterate and, on that basis, that decision is taken but it is an incorrect figure. That has been acknowledged by Dr. Corcoran. It is one in six that are illiterate. That type of information is quite important.

Dr. Colette Bonner

I think Dr. Gilvarry needs to give her opening statement because she did not get the opportunity to do so.

Chairman

I am sorry. I apologise.

Dr. Colette Bonner

Dr. Kelleher will follow up on some of the questions.

Chairman

I did not realise that. I am sorry.

Dr. Joan Gilvarry

It may also help to answer some of the questions that were posed. I will be as brief as possible.

As has already been stated, the product was licensed by the European Commission and placed on the market across the European Union in 2006. It has also been approved in 130 countries worldwide and it is estimated that 63 million subjects have been vaccinated. No regulatory authority in the world has taken any action to suspend this product. After any medicine or vaccine is licensed, as new information appears and emerges during the marketing experience, the benefit-risk evaluations continue to be carried out by the regulatory authorities which consider if any steps need to be taken where there is a change in the risk-benefit. As part of the system for monitoring the safety of medicines and vaccines, the HPRA has a spontaneous reporting system by which patients and consumers, and all health care professionals, can report any suspected adverse reactions to us. These reports are then reviewed and transmitted into the European agency database, which is called EudraVigilance, for inclusion in global activity so that we can see trends as they emerge.

Specifically with regard to Gardasil, post-marketing monitoring included: review of all the cumulative data in this database; the published literature; epidemiological studies; and any additional clinical trials that were conducted. It also includes assessment of periodic safety update reports, which the company must submit, and which are reviewed by the regulatory authorities at regular intervals. Indeed, the last evaluation was conducted in December 2004 and the EMA determined that the risk-benefit remains positive.

I wish to talk a little bit about the current European-wide review. In July of this year, what is officially called a referral was initiated by the European Commission based on concerns raised by the Danish competent authority - our sister agency in Denmark.

The European Medicines Agency co-ordinated this review and, in accordance with the applicable legal framework, it was conducted by the agency's pharmacovigilance risk assessment committee, PRAC. The PRAC is a committee of the agency that is responsible for assessing and monitoring the safety of human medicines. It is composed of experts, including doctors, pharmacists and scientists from every EU member state, and representatives of patient organisations and health care professionals. The review focused on the two main conditions reported, POTS and CRPS. Reports of these conditions in young women who received the HPV vaccine had been previously reviewed by the PRAC as part of routine safety follow-up procedures, and a causal link was not established. In the context of this review, the PRAC reviewed all the available data in the EudraVigilance database and from clinical trials. It took account of scientific literature, including everything submitted by Denmark in addition to information from Japan. It also reviewed detailed information submitted voluntarily by the public and patient groups, including patient groups in Ireland. The PRAC also sought the scientific advice of the expert vaccine committee at the European Medicines Agency and supplemented it with expertise in neurology, cardiology and pharmacoepidemiology. Following this in-depth scientific review and robust assessment of all the available data, the PRAC members concluded unanimously that the evidence did not support a causal link between HPV and the aforementioned syndromes in children. The review found no evidence that the overall rates of these syndromes in vaccinated subjects differed from expected rates in the age group, even taking account of possible under-reporting. The PRAC also considered specifically the overall overlapping syndromes of POTS with chronic fatigue syndrome. The results of a large, detailed published study showed no link, and that was highly relevant to the review in respect of chronic fatigue syndrome.

The PRAC review concluded on 5 November of this year that there was no reason to recommend changes to the way the vaccine was reviewed or to amend the current product information. As is standard practice with all these reviews at European level, the recommendation went to the European Medicines Agency's committee for medicinal products for human use, CHMP, which is essentially the licensing committee at the agency. Again, it comprises experts from all member states. Extra representation from patient groups was also considered at the time. The CHMP concurred unanimously with the PRAC recommendation that the available evidence did not support a causal link with the syndromes. The CHMP also concurred that there was no need for any changes to the HPV vaccines and the way they were used, or to the product information. That report was published on 20 November. In accordance with standard practice, the opinion from the European Medicines Agency has been submitted to the European Commission for a legally binding decision that will be applicable in all member states. We expect that in the spring of 2016.

Let me say a few words on our national reporting experience, as it has been referred to. At the start of the HSE school immunisation programme in 2010, the Health Products Regulatory Authority, HPRA, wrote to public health doctors and health authorities, as would be normal practice, and asked them to help us with its monitoring by reporting any suspected adverse reactions to us. Up to the end of October 2015, we received 927 reports. Each of those was entered in the European database and has been viewed as part of the European review. The vast majority of the reports reflect the expected pattern of adverse reactions to vaccines, which include syncope - that is, fainting - malaise, headache, myalgia, gastrointestinal symptoms, dizziness and allergic reactions. There have been some reports of chronic and persistent fatigue, chronic muscle pain and, in some cases, multiple other symptoms of headaches and malaise, as we have heard today. Again, all of these reports have been entered in the European database and were considered as part of the review.

Taking into account the totality of the available information, the Europe-wide review, which involved experts from all member states, has concluded the evidence does not support the view that the HPV vaccines Gardasil and Cervarix cause these syndromes, and that the benefits of both of these vaccines continue to outweigh the risks. We will continue to do our job and monitor them, along with the European Medicines Agency and PRAC, in all member states, including Ireland.

Deputy Catherine Byrne

I thank everyone for their statements and presentations. I was glad to hear Dr. Connolly say no vaccine is 100% safe or 100% effective. When my children were young and being vaccinated, whether it was the BCG vaccine, the MMR vaccine or the Hib vaccine, there was always a question in the back of my mind as to whether I was doing the right thing. I trust the general practitioner I have attended for the past four years. I trust his advice in addition to that of the experts. I am not an expert on this. Any parent vaccinating a child will always ask whether he or she is doing the right thing. I have two girls who have had the vaccination the delegates spoke about. They were older than the usual vaccination age and were no longer in school but they received it because I felt as a parent that it was important for them. They believed it was important also. Since young people are now mixing in all sorts of ways in which I probably did not mix, I believe it is important that we safeguard their health.

I was interested to hear Dr. Brenda Corcoran saying 95% of young people in the vaccination age bracket have had two doses of the vaccine. What about those who have had only one? What is the outcome for them? Will the vaccine be less helpful to them than those who have had two doses? Why have people not had all their vaccinations? Do the delegates have any concerns about this?

I thank Dr. Bonner and Dr. Gilvarry for their presentations, which I found very interesting.

Are there any records within the HSE on both the short-term and long-term side effects? When people ring in asking for advice, are all the details registered? How is this dealt with? Are there any figures on this?

I believe my last question to be a very important one. When parents sign a consent form for the vaccination to be carried out, particularly in school, is there space on the form in which to state whether their child has had a previous medical condition? If this is taken into account, are parents advised at that stage whether the vaccination is suitable for their children? I thank all the delegates.

Deputy Mary Mitchell O'Connor

I have two or three very short questions, the first of which is on the opening statement by Ms Anna Cannon. I would like the doctors to comment on it. Ms Cannon's submission states, "The truth is that our girls [most girls, I believe] will still require ongoing and regular pap smear tests, as protection from the HPV vaccine has not been shown to last longer than 8 years." As a non-medical person, I am asking why we are giving this vaccine to girls when they will have to have the smear test down the line. It would be picked up later if there was cancer, for example.

Chairman

May I just pause the Deputy because there is a vote in the Dáil? Senator Healy Eames may contribute after Deputy Mitchell O'Connor and then we will suspend.

Deputy Mary Mitchell O'Connor

I will be quick. I have a second question and I will skip to the case. I got a text message from a doctor some minutes ago. She said she would not give her daughters the vaccine. I want to ask the doctors before the committee a question. Perhaps it is a little out of order, but this is about what we do with our own children. Would the doctors present give their daughters the vaccine?

Chairman

Senator Healy Eames, I will take you before the vote. You have three minutes.

Senator Fidelma Healy Eames

Thank you for organising this exchange of views today. We have important decisions to make today. The parents in the gallery are welcome. I have met a number of parents of sick children, sick young girls. I acknowledge the presence of Dr. Colette Bonner, Dr. Kevin Kelleher and others. I have worked previously with Dr. Bonner and Dr. Kelleher.

I am at this meeting and I have deliberately missed a vote because I am very concerned about the health of young girls. I have a 14-year-old daughter who has had the vaccine. Thank God, there have not been any adverse effects. What we do not need is a collision course between the Department of Health, the HSE and parents.

We have two realities, as I see it. First, a patient information leaflet was not disseminated properly. Parents were not properly informed. That leads me to believe that there was in some sense a cover-up. Why was the correct patient information leaflet not disseminated? The second reality is that we have sick young girls who are unable to go to school or a debutante ball or socialise at all. Some are isolated, sleep up to 20 hours per day and are in terrible pain. I know of one child who has had seven operations for severe abdominal pain. I accept what Dr. Bonner said and that we are not proving cause and effect. However, some of the facts hold the key. All of this has come on since these girls received the HPV vaccine.

I have several questions for the Department of Health. What is the hunch of the department officials? I am deliberately using the word "hunch," because the Department has not investigated these girls. What is the hunch of the Department officials about what is going on with these young girls? My second question-----

Chairman

Senator, you cannot use the phrase "hunch".

Senator Fidelma Healy Eames

I can. We are talking about researchers.

Chairman

Hold on a second. I am chairing the meeting. I have been doing it for the past four and a half years. You have to base your questions not on hunches but on opinion or fact.

Senator Fidelma Healy Eames

I am giving numerous facts. Does the Department of Health have a duty of care to these young girls?

Chairman

There is a vote in the Dáil. Members are free to go to the vote.

Deputy Mary Mitchell O'Connor

When can we get our answers?

Chairman

It will be when we come back after the vote.

Deputy Mary Mitchell O'Connor

Are you going to stop the meeting?

Chairman

Yes.

Senator Fidelma Healy Eames

I am going to finish my questions. I will be very quick. Does the Department have a duty of care to these young girls, as they are, whether their symptoms are linked to the vaccine or otherwise? The answer to this question is vital. What is the Department going to do now? I would like if we had decisions coming out of this committee.

Chairman

I have no wish to be adversarial, but the committee makes no decisions. That is not our remit.

Senator Fidelma Healy Eames

The doctors may propose-----

Chairman

Our remit today is not to make a decision. That is not our jurisdiction, as you know. Members of both Houses know that it is not our remit. You cannot put words on the committee or ask for it. We do not have the remit to make a decision. We must be fair to the mothers and girls and the officials from the HSE and the Department of Health. That is not our jurisdiction or role today. Please conclude now.

Senator Fidelma Healy Eames

Thank you, Chairman. I hear what you are saying. I will rephrase the question. Does the Department of Health have a duty of care to these young girls? What is the HSE going to do now? Can we set up something? My recommendation is that we set up a multidisciplinary team to provide a holistic treatment plan for these young girls. First, we need to investigate it.

Chairman

I have to ask you to stop. I will allow you to continue when we come back, if that is okay with you. I want to suspend the meeting for the Dáil vote.

Senator Fidelma Healy Eames

I have one final question, and I will leave it at that.

Chairman

I am not going to miss the vote. I have to vote because I do not have a pair, unfortunately. I am going to suspend the meeting until after the vote. My apologies to everyone. This is parliamentary democracy. We have to vote.

Senator Fidelma Healy Eames

Unfortunately, I cannot come back, but I am grateful for the exchange.

Chairman

We will suspend the meeting until after the vote. My apologies. These are the joys of democracy.

Sitting suspended at 12.55 p.m. and resumed at 1.05 p.m.

Chairman

I apologise to our witnesses and those in the Gallery. I also apologise to Senator Healy Eames for having to stop her.

Senator Fidelma Healy Eames

I will look at the transcript for the answers to the questions.

Senator Colm Burke

It was said that 300 people are identified each year as having cervical cancer and 60% of these are under 50 years of age. Do we have figures on people aged under 30? Is there a difference in how people of different ages recover? Do we have figures on this other than those with which we have been furnished?

Ms Anna Cannon

Dr. Diane Harper worked most of her professional life investigating the Gardasil and Cervarix HPV vaccines. She was a researcher and an original promoter of the vaccine, but she came out of the project expressing serious concern that the vaccine might not work, stating, in effect, that it could have no effect on cervical cancer rates, particularly in the short term. On numerous occasions she has characterised the vaccine as an experiment while pointing out the profit motive of the vaccine manufacturer. She has stated that the vaccine has no public health benefit and presents a very real risk of harming the public. This is a scientist who was directly involved in the development of the vaccine.

Senator Healy Eames underlined that we need to focus on help for these girls. We know, and it has been admitted, that people react to the vaccine and it has side effects. We now have 131 girls in REGRET who present with these, as stated in the patient information leaflet. What will we do to help these girls get better?

Ms Karen Smyth

We have all seen a great number of doctors and consultants, and I have travelled abroad to seek help. The help is not here and this is what we are looking for.

Chairman

When you say the help is not here, will you-----

Ms Karen Smyth

Possibly some of it is with regard to the knowledge of what happens when one goes to a doctor presenting with these problems. Our doctor is extremely supportive and very helpful, but he has sent us to one consultant after another. While they all acknowledge Gardasil could be the cause, they do not know how to treat my daughter.

I have contacted specialists in New York and Denmark who are well renowned in this area. They have come forward in recent years through their experiences. However, I cannot get help here.

Chairman

Does the experience of those specialists relate specifically to the side effects of the Gardasil vaccine or to immunisation in general?

Ms Karen Smyth

It relates to the Gardasil vaccine. We have exhausted every avenue. I travel around the country every week and might have two appointments on the same day in, say, Limerick and Donegal.

Chairman

Does Ms Smyth meet with other girls and their parents or with doctors?

Chairman

I take my daughter to see doctors. I am five years down the road and my child, a very bright and intelligent girl, is lying at home and receiving very little medical treatment. We are here today to seek that medical attention.

Dr. Kevin Kelleher

Like everybody else, we clearly understand this to be a major problem. It is important to emphasise that we are dealing with two linked but separate problems. First is the question of whether the vaccine programme is appropriate and safe and, second and just as important, is the question of how we, as a system, look after these girls who have experienced a series of problems. To reiterate, these are linked but separate issues. On the whole, we have presented a lot of evidence regarding the way we have to make these types of decisions. How we have made the decisions and how we continue to have to make them is based on the evidence or science that exists around the world and is produced for us in a very systematic and structured way by the bodies, both here in Ireland and in Europe, to which we are party. I personally have no doubt that we have shown today that we put a lot of effort into making sure the programme we are putting out there for girls is a safe programme. We have really tried to be party to that. We have made great efforts to get the information out there and to be party to that debate at a European level, where there is a whole host of information and a whole host of experts involved in those discussions.

Clearly, when one has a vaccine that says it will prevent a cancer, one will never see the direct impact of that in the short term, because cancer has a ten-year or 20-year period in which it comes on. That is a long time period. We do know the HP virus is involved in the development of cervical cancer. We know some of the natural history in that regard and we can see the changes that happen. As well as causing cervical cancer, the HP virus causes two other conditions, as we have heard, namely, anal-genital warts and the direct precursor to cervical cancer, which is called cervical intraepithelial neoplasia, CIN. What we are now beginning to see around the world, particularly in those countries where a lot of the vaccine has been given and which have a longer history than us of administering it, is the impact of the vaccine on those two earlier parts of that process. We are starting to see in both the United Kingdom, particularly in Scotland, and in Australia a significant reduction in the number of anal-genital warts in the relevant age group, which is 15 to 25 year olds. We are also seeing a reduction in CIN. A woman does not get cervical cancer unless she has CIN. She will not necessarily get cancer if she has CIN but only women with CIN will go on to get cancer. We are starting to see evidence of a reduction in the incidence of the precursors, as I said, but we will not see actual evidence of a reduction in the number of cervical cancer cases for another ten years or so.

We work closely with our colleagues in the screening programmes both here in Ireland and across Europe in analysing the impact of HPV vaccination programmes on countries' screening programmes. That debate is ongoing but already people are beginning to see a capacity to reduce the involvement of women in the cervical screening programme into the future. However, we will not do that until we have clear evidence it is the appropriate thing to do. The screening programme will continue but, as I said, health authorities in other countries are very hopeful of seeing an impact on their cervical screening programmes.

We are very much aware of the need to react better to children who have the types of syndromes we have heard about today. I am not saying we are the best at doing that. In fact, we need to improve how we are doing it. I am involved in a number of ways with some of the senior clinicians in paediatric services to see how we can do that. It is not easy and I am not saying we will come up with a quick and easy solution to this but we are trying to see how we can do something about it. We are looking at how we can put in stages and support to help people to get through the systems better. Given the nature of some of the symptoms people are reporting, however, it does not leave it open easily for that to happen. We are looking at how we can try to do something about that and we hope to make some changes in the coming months and years.

Chairman

I thank Dr. Kelleher for his candour.

Dr. Kevin Connolly

There is some overlap between the different questioners. I will try to cover all the points raised. It was noted that chronic fatigue syndrome is little known. It is estimated that perhaps 80% of cases are not reported and not diagnosed. There should be much more information out there because there is evidence that the earlier the diagnosis, the less severe the condition and the shorter its duration. Speakers referred to decisions made in Japan and Denmark. In June 2013 - ironically, a day after the World Health Organization declared the vaccine to be safe - the Japanese Ministry for Health issued a notice that while the HPV vaccine could still be given for free to girls aged 12 to 16, it should neither be proactively recommended nor promoted. That decision was not made by either the regulators or the equivalent of the National Immunisation Advisory Committee. With regard to the authorities in Denmark changing the vaccine that is administered there, my understanding is that this was a commercial, cost-based decision. Instead of giving the four-component vaccine we are using, they are now giving the two-component vaccine and, unfortunately, that means they will see an increase in the incidence of anal-genital warts.

Regarding the provision of information, the website of the Department of Social Protection contains an extremely good article on the definition and diagnosis of chronic fatigue syndrome and the services available through the Department for people suffering from it.

Chairman

Has there been any attempt to reach out to the REGRET group rather than simply suggesting its members go through a website?

Dr. Kevin Connolly

Not to my knowledge.

Chairman

To be fair, I realise this might not be under Dr. Connolly's remit.

Dr. Kevin Connolly

I stated very clearly that there should be ready and easy access for the children and their families.

Deputy Ó Caoláin said that the figure of more than 900 adverse events is concerning. It should be noted that adverse events occur in 30% or 40% of people who get a vaccine. Working on that basis, one would expect perhaps 50,000 reports. What is more important than the number of events is the severity of those events. We know there is significant under-reporting of adverse events and there is no legal compunction to report them.

Dr. Kelleher responded briefly to the question about when we will know for certain the effectiveness of the vaccine. There is very good evidence that in Australia, which introduced the vaccine in 2007, the incidence of high-grade changes has reduced to 25% of what its was before the vaccination programme was implemented. In addition, the incidence of anal-genital warts in young girls has gone down from 18% down to 1%. There is good evidence, therefore, that the vaccination is effective. Moreover, the immune response is shown to last up to ten years and there is also very good evidence of what is called a memory response whereby even if the immune blood test is low, if one is exposed to the virus, the memory cells in the immune system are ready to go out and work. The mathematical modelling suggests that effect lasts for at least 20 years.

Even if it does not, what we do with other vaccines as their immunity wanes is to give a booster, and that should solve that problem.

With regard to the question about multiple doses, one dose is significantly less effective than two doses. The two doses are more effective if they are given six months apart. If somebody has had only one dose, she should get a second dose.

On the registration of long-term adverse events, a number of countries have instituted long-term surveys regarding the effectiveness, the immunogenicity and, equally important, the safety of vaccines. Interestingly, the Nordic countries are one of the groups doing that.

The efficacy of the vaccine and screening was raised. Some 30% of cancers are not prevented by the vaccine, so screening is very important. Also, the incidence of cervical cancer under the age of 30 is low because the incubation period is long.

Chairman

I thank Dr. Connolly. Does anybody else care to comment briefly?

Deputy Mary Mitchell O'Connor

I asked a question about the regular Pap smear test. It states in one of the reports that the HPV vaccine has not been shown to last longer than eight years. Can Dr. Connolly comment on that? I also asked - it is personal, but still - whether he would give it to his daughter.

Dr. Kevin Connolly

I would strongly recommend that she get it. I would also recommend that boys get it, because they are equally likely to transmit the virus. They do not get cervical cancer but they get other cancers. I would very strongly recommend it. That is the first point.

The figure of eight years with regard to the effectiveness of the vaccine is based on measurements of its effectiveness in other countries where it is used. It is now known that it is effective for at least ten years, which is the length of time it has been in use. The effectiveness of the vaccine has been shown in Australia in particular, but also, as Dr. Kelleher mentioned, in Scotland and Denmark. This applies to both the reduction in the incidence of warts and the reduction in high-risk cell changes, as well as so-called correlates of immunity. Does that answer the Deputy's question?

Deputy Mary Mitchell O'Connor

I may be wrong, but I thought cervical cancer presented more in older women.

Dr. Kevin Connolly

Yes.

Deputy Mary Mitchell O'Connor

How can one prove it? If one is going to give it to girls - the witnesses spoke of the experience in Australia in 2008, which is seven years ago - whereas cervical cancer presents in women in their 40s, 50s and 60s, how can Dr. Connolly be so sure? He is talking about genital warts and so on. How can he be so sure that it will have an impact on women in their 50s and 60s?

Maybe he needs to say more about boys. I refer to the comment Dr. Connolly made earlier that he would also recommend the vaccine to boys.

Dr. Kevin Connolly

It is accepted that a marker of the likelihood of developing cervical cancer way down the road in ten, 20, 30 or 40 years are these pre-malignant changes that show up in the smear test. There are low-grade, middle-grade and high-grade changes, and the high-grade changes are related to cancer incidence. It has been shown that there has been a significant reduction in high-grade lesions, and it is very reasonable to conclude that it is highly likely there will be a reduction in the development of cancer, but the Deputy is correct in that we will not know for 30 or 40 years. However, there has been a reduction in these markers for the development of cancer and, as far as I am concerned, that is unequivocal evidence now. It was also shown in the trials. Hopefully, that has clarified it.

Deputy Mary Mitchell O'Connor

Would Dr. Connolly talk about boys again?

Dr. Kevin Connolly

Boys are instrumental in passing on the human papillomavirus, and the same proportion of boys become infected with the virus as girls. Boys can pass on the virus to susceptible girls and vice versa. For equity's sake, and if it is found to be available at a cost-effective price, boys should also be offered the vaccine at age 12 to 13.

Dr. Kevin Kelleher

It would prevent anogenital warts in both boys and girls and also reduce the likelihood of the other related cancers of which we know. We always speak about cervical cancer, but it is now quite clearly known that other cancers, as mentioned by Dr. Connolly earlier, including cancers of the anus, the mouth and under the pharynx, are also linked to this virus because they are, basically, a sexually transmitted disease. Therefore, boys need it not only to help with the prevention of the cervical cancer but also for their own personal protection. The National Immunisation Advisory Committee, NIAC, has made that recommendation. As Dr. Connolly stated, it depends on whether it turns out to be cost-effective for us as a state to do that.

To answer the Deputy's question - I am sorry I did not do so - my daughter has had the vaccine. I actually paid for the vaccine because she had it before the programme was introduced in this country. It is a national programme. My daughter would have received it under the national programme that I lead, but I paid for her to receive it.

Chairman

Senator Burke indicated, and I ask him to be brief.

Senator Colm Burke

I asked about cervical cancer among those under 30. I was recently speaking to someone who had a patient who was only 21 and who had been treated by her GP for eight months before being referred on, and it turned out she had cervical cancer. I wonder do we have any figures. We were talking about 60% under the age of 50.

Dr. Kevin Kelleher

We can get the figures giving the ages of women with cervical cancer from the cancer registry for the Senator.

Chairman

I ask Deputy Byrne to be brief, because I want to finish by 1.30 p.m.

Deputy Catherine Byrne

I want to go back to what Dr. Connolly said. I asked Dr. Corcoran the question about the 5% of children who did not go back for the second dose. I am anxious about that cohort. The reason I ask is that I want to know whether, if they get the first dose at 12 years, there is a period within which they should have the second dose. If they do not get the second dose, does that mean they can start again and have two doses?

Dr. Kevin Connolly

That is a good question, and I will ask Dr. Corcoran to answer it.

Dr. Brenda Corcoran

To answer Deputy Catherine Byrne's question, as I mentioned, over 95% of the girls who start the dose finish the course at either the second or the third dose. There are some girls who move away. The teams really try. They invite the parents or the girls to come to clinics. They go back into the schools. They do all they possibly can. Ideally, the second dose should be given within a year, but it is not too late for a girl to complete the course when the teams go back into the school. The teams really make a huge effort. No other country has the retention rate that we have, whereby over 95% of those who start complete the course.

Ms Anna Cannon

Obviously, there is no one here who argues the benefits of a safe, well proven lifelong cancer vaccine. I just want to say that.

In regard to the two- and three-dose schedule, we have many girls who reacted particularly badly after the third dose of the vaccine. They got three vaccine doses within the space of six months. Now they have changed the vaccine schedule to two doses six months apart. I question that. I have a child who reacted particularly badly after the third dose. I ask the witnesses for their justification of the change to the dosing schedule.

Senator Healy Eames asked a direct question of Dr. Kelleher. She asked why parents are not given the patient information leaflet, PIL, when they sign the consent form and what the cover-up was. The HSE brochure that parents are given before they sign the consent form states:

There may be some mild side effects, including:

- pain, redness or swelling in the arm where the vaccine was given

- headache

- dizziness

- nausea

and/or

- a mild fever.

These can be treated with paracetamol or ibuprofen.

I would like an answer to that question. Why are those providing the vaccine withholding the PIL for parents when they are signing such an important medical decision for their daughters, and how are we supposed to connect all our daughters' symptoms to the PIL when we are not given it in the first place? That was the question the Senator asked earlier.

Deputy Seamus Healy

That is the question I wanted to ask. Is the HSE proposing to put that leaflet into the pack and, if not, will it consider putting it into the pack?

Dr. Kevin Kelleher

We spent a significant amount of time discussing what information would be provided. It was based on what we had been doing historically in all our vaccine programmes but also, more particularly, because of the nature of this programme, on the extensive consultation that we carried out in 2010.

We have engaged in further extensive consultation since. We have repeatedly spoken to people in this and other countries about what would be an appropriate way to go about it. That is why we are where we are. We have repeatedly thought about whether the patient information leaflet, PIL, should be given out. The reason we do not give it out is the complexity of the document compared to what people require. We have made every effort in our documentation to cover what is included in the document but in much simpler language. We heard somebody try to describe what was in the PIL and how complex it was. We have put great effort into trying to ensure the document covers exactly what is in the PIL but in a much simpler way to ensure people understand the problems and it gets out. We will continue to do so. While we will reconsider what happens as a consequence of today’s discussion, we must take account of all aspects of it to ensure it is understandable. A very important issue is that the language used in most PILs on most drugs is not easily understandable. Every one of them is very difficult to read, even for medical practitioners, let alone the public.

Deputy Seamus Healy

The company considers it necessary to provide the leaflet.

Dr. Kevin Connolly

By law, the contents of the PIL and the summary of product characteristics, SmPC, must be provided. On the issue of the number of doses, the vaccines are given for priming and boosting. The first vaccination signals to one’s immune system that it needs antibodies, while the second gives an extra boost. It was found, initially, that if three vaccinations were given - at zero, one or two months and six months - there was stepwise boosting. The companies were also asked to conduct trials involving two vaccinations - at zero and six months - and it was found that the response to the two doses was as good as the response to three. Therefore, fewer doses result in the same immune response.

Ms Anna Cannon

In e-mail correspondence with the NIO I was told that one of the reasons it had withdrawn the third dose was that it would result in fewer adverse events.

Dr. Kevin Connolly

I am not aware that there is a difference in the number of adverse events following different numbers of doses. I do not know whether that is correct, but I see Dr. Corcoran assenting.

Deputy Mary Mitchell O'Connor

We are hearing different views. I ask the Department of Health to take on board the points the parents have made and the request that the leaflet be improved in order that parents will have more information.

Chairman

I thank everyone for attending. The committee will reflect on the testimony given. It is important that we work collaboratively in order to ensure the concerns of the parents who represent a significant body of people are listened to and that the scientific and medical evidence is taken on board. It is beyond the committee's remit to make any decision on recommendations on what can and cannot be done in the vaccination and immunisation programme.

I hope everybody feels he or she had a fair and balanced hearing. It has been a very informative meeting on both sides of the debate. All of us in the room are concerned about public health. The parents are concerned about their daughters’ lives, health and well-being. As legislators, we are concerned about public health and the committee will make a recommendation on how it will proceed. If Dr. Gilvarry, Dr. Connolly and Dr. Kelleher have opening statements, will they give them to us in order that we can circulate them to members?

On Wednesday the committee will meet representatives of the HSE to discuss the issue of medical cards. On Tuesday the select committee will meet to discuss the Supplementary Estimate for the Department of Health.

The joint committee adjourned at 1.35 p.m. until 2.30 p.m. on Wednesday, 9 December 2015.