I could not believe the lack of compassion from Minister Varadkar in blanking the question I put asking him to meet with representatives of over 106 girls who have become chronically ill with the common denominator being the HPV Vaccine. It was heart-breaking to listen to these mothers describe how their bright, articulate daughters who were in education or training are now so ill with dramatically altered lives. If the Minister does not believe the HPV vaccine is responsible, why is he avoiding an independent investigation into the vaccine and into the same debilitating symptoms all 106 girls are experiencing?
The information pack that went to schools provided information on the most common adverse reactions to the vaccine and parents were then directed to a website for additional information. Surely all of the information should be included in one information pack. I was also alarmed to read medical reports questioning the fact that this vaccine has any effect on cervical cancer. One report said the vaccine would have no effect in 87% of HPV viruses that might cause cancer and that the causal link between HPV and the later development of cervical cancer is far from definitive and that regular smear tests, with no side effects, can catch cervical cancer in time.
Deputy Maureen O’Sullivan: I and others attended a meeting with parents of girls who received the HPV Gardasil vaccine and whose lives have been dramatically altered as a result. These parents brought a number of concerns to our attention, such as breathing difficulties, hives, joint and muscle pain, muscle weakness, swollen glands, chronic fatigue, headaches, neural damage, noise sensitivity, chills, sleep disturbance, menstrual disruption, food intolerance, difficulty concentrating, panic attacks and depression. The research carried out by these mothers shows that this is not confined to one area in Ireland; therefore these effects are not caused by a rogue batch of vaccine. These effects have also occurred in other countries on the Continent.
In a response to a parliamentary question I put to the Minister, he told me there is an expected pattern of adverse effects in line with product information. However, the information mentions minimal adverse effects, not the full range I have mentioned. Also, there is no mention of these adverse effects lasting indefinitely, which is what is happening for over 106 girls here in Ireland. If the Minister does not believe the HPV vaccine is responsible, will he conduct an investigation into why these 106 girls are chronically ill, all with the same debilitating symptoms? It was heart-breaking to listen to these mothers describe how their bright, articulate daughters who were in education or training are now so ill with dramatically altered lives. The information pack that went to schools provided information on the most common adverse reactions to the vaccine and parents were then directed to a website for additional information. Surely all of the information should be included in one information pack.
I was also alarmed to read medical reports questioning the fact that this vaccine has any effect on cervical cancer. One report said the vaccine would have no effect in 87% of HPV viruses that might cause cancer and that the causal link between HPV and the later development of cervical cancer is far from definitive and that regular smear tests, with no side effects, can catch cervical cancer in time.
Deputy Michael Moynihan: I welcome the opportunity to raise this issue along with Deputy O’Sullivan. I also met with parents of young girls affected by this issue, a number of whom are in my constituency. A meeting on the issue was also held in Killarney a couple of weeks ago, attended also by Deputies Brendan Griffin and Tom Fleming. There, parents outlined the side effects affecting these young women and the only common denominator is the HPV vaccine. They are extremely concerned about it and I have raised the matter in a number of parliamentary questions.
There are several issues. Information is provided with the vaccine, but when parents are asked to consent to the vaccine when these young girls enter second level, a very short information document is provided by the HSE. This document only mentions some of the side effects, compared with the number included on the document supplied with the vaccine by the manufacturers. I believe the issue for these parents and young women is genuine and serious and would not raise it here otherwise. I have heard their stories and have heard of the debilitating effects on these young women and of the emotional damage to these families.
I urge the Minister to consider an independent assessment of this matter as there seems to be only one common denominator. Also, the information being given to parents of young women about to get the vaccine should be fully informative. They should not be given a shortened account of the effects. The concern of these parents is that every one of these girls has a pattern of ailments, as outlined by Deputy O’Sullivan, and all seem to suffer from chronic fatigue.
They have gone around the world at this stage for advice from general practitioners and consultants.
In some countries, this vaccine is not given. Why have other countries not fully bought into this vaccine? They have some concerns about it. Surely then we should take the cautious approach; we should stop it and see if it is absolutely safe. To my mind – although I am far from knowledgeable on medical issues – there is a fundamental issue here. I believe the vaccine is having a deadly effect on young women, on their lives and the lives of their families.
Deputy Leo Varadkar: I thank Deputies Moynihan and O’Sullivan for giving me an opportunity to address the House on this issue. I want to acknowledge the concerns of families who believe their daughters have experienced adverse reactions and health issues after receiving the HPV vaccine.
As the House will know, the vaccine protects against two high-risk types of HPV that cause 73% of all cervical cancers. The link between HPV and cervical cancer is as well established as the link between HIV and AIDS, even though some very odd people still seem to dispute that. It is estimated that the HPV vaccine will save 60 lives annually in this country. It also protects against genital warts and other cancers, including head and neck cancers, which are truly awful.
The vaccine used in the school immunisation programme is Gardasil, a fully-tested vaccine which was licensed by the European Medicines Agency in 2006. Following this, the National Immunisation Advisory Committee recommended that the vaccine should be offered to all girls aged 12 years on an annual basis. The Health Products Regulatory Authority is the statutory authority for medicines in Ireland. While no medicines, including vaccines, are entirely without risk, the safety profile of Gardasil has been continuously monitored since it was first authorised nationally and at EU level. Decisions on the supply of vaccines are undertaken by specific expert agencies rather than being the responsibility of the Minister of the day. This is as it should be as it ensures that decisions are made solely on scientific information and expert advice, rather than being influenced by political pressure or lobbying.
As part of its monitoring of the safety of medicines the Health Products Regulatory Authority operates an adverse reaction reporting system, where healthcare professionals and patients are encouraged to report adverse reactions they consider may be associated with their treatment. All reports received are evaluated and considered in the context of the safety profile of the product concerned, with reports followed up as necessary for further information that may assist in the assessment of the case.
I have been informed by the HPRA that up to 9 October it had received 921 reports of suspected adverse reactions or events notified in association with the use of HPV vaccines. The vast majority have been consistent with the expected pattern of adverse effects for the vaccines as described in the product information, such as gastrointestinal symptoms, malaise, headache, dizziness and soreness or a rash at the injection site. These are short-lived. As for all licensed medicines, the safety of these vaccines is monitored by the Pharmacovigilance and Risk Assessment Committee, an EU-level drug safety committee, where the HPRA is represented and actively contributes.
I am aware that the European Medicines Agency has commenced a review of the HPV vaccines to further clarify aspects of their safety profile, although the agency points out that this review does not question that the benefits of HPV vaccines outweigh their risks. The HPRA is participating in the review, which aims to clarify aspects of their safety profile and is specifically focusing on rare reports of two conditions, complex regional pain syndrome and postural orthostatic tachycardia syndrome.
I have been informed of a project in Denmark which aims to identify possible causes or potential risk factors for adverse reactions to the HPV vaccine. It would not be appropriate for me to comment any further until the results become available. This study, however, follows a major Danish-Swedish register-based study of a million girls from 2013, 300,000 of whom received the HPV vaccine. That study showed no evidence supporting associations between exposure to the HPV vaccine and serious diseases. It has been confirmed by the Danish authorities that they continue to offer the HPV vaccine as a result, as part of their childhood immunisation programme.
In the meantime, the European Medicines Agency has advised healthcare professionals that available data does not warrant any change to the use of HPV vaccines. Healthcare professionals should therefore continue using them in accordance with the current product information. Any changes to this advice will be made following the outcome of the review by the European Medicines Agency.
Deputy Maureen O’Sullivan: What has happened in Ireland has happened in Spain, the UK, France, Denmark, Sweden and Italy. There is now a Europe-wide group for those affected. I think it is significant that the Danish Government is spending €940,000 for an independent investigation into the vaccine and the side effects. The experts involved have no ties to the pharmaceutical industry. I must admit to being very wary of the pharmaceutical industry. Whatever good it does, it is really a profit-making machine.
I do not want to deprive anybody of a vaccine that is beneficial and I do support any preventative measures, but the reality is that there are at least 106 girls in this country with very debilitating symptoms and the common denominator is the vaccine they have taken. These girls’ lives are totally changed. They are not able to live normal lives like their peers. That has to be investigated. It warrants a meeting with the Minister or a very high-ranking official in the Department of Health or the HSE.
In 2009 there was a vaccine damage steering group report at which the previous Minister for Health, Deputy Reilly spoke. He said the most important thing is to remedy the damage that has been done and provide the support the person needs to live as normal a life as possible. I ask the Minister to outline the position regarding the recommendations made by the group.
Deputy Michael Moynihan: I know that the parents who have come together – they are a great group – have sought a meeting with the Minister. I ask him to meet with a representative body of these parents so they can outline the concerns they have.
I have scanned through the official response. The word “risk” is there. If there is any risk, no matter how minute it might be in terms of the proof and examination of it by the authorities concerned, if there is a risk that even one young woman could have an adverse effect such as those the parents have been outlining to us, if there is any minute risk at all, should not the State err on the side of caution and withdraw the vaccine until there is a full assessment of what is at stake? The debilitating condition that these young women have is frightening. It merits a full investigation from the State, the Department and the HSE. They should park the vaccine until they can prove that there is no side-effect. That would be in the best interests of everybody. I am aware a request has been made to the Minister for him to meet with a representative of the parents towards the end of November.
Deputy Leo Varadkar: I am very concerned about this whole debate, where it is going and the comments made by some of the Deputies opposite. I am alarmed to hear we are getting into this space again. Deputy O’Sullivan is almost implying that there is some sort of plot from the pharmaceutical industry against people, that it is all about those in the industry making money and that this is not based on evidence or scientific advice.
I am also very concerned to hear a Fianna Fáil Deputy calling for a vaccine or drug to be withdrawn without scientific evidence to back it up. That bothers me because we have been here before. We had a similar scare around the MMR causing autism, which some people still believe. Children developed autism and parents connected the vaccine to autism because it was given around the time that those symptoms appeared. Some people still believe in that connection, even though the doctor who came up with it has retracted and been struck off and even though there is no scientific evidence to support it. The result of that scaremongering and irresponsible behaviour by people who should know better was that some people got measles, mumps and rubella because their parents did not vaccinate them. There is a similar issue on which the jury is still out in respect of narcolepsy, whether it was caused by a vaccine or was coincidental and caused by something else such as a virus.
What do we know about this vaccine? We know that it does prevent cervical cancer, which is an awful cancer that kills many women every year. We know it prevents genital warts, head and neck cancers, and also penile and anal cancers in men. We have scientific evidence that this is the case. We do not know if these long-term psychological and physical effects that some people are reporting are any more common among girls who have had the vaccine than among those who have not. The Swedish-Danish study done so far, which went back over a million girls, 300,000 of whom had the vaccine, did not see any higher incidence of any diagnosis or disease in the 300,000 who had the vaccine compared to the 700,000 who did not.
I appeal to the Members opposite, to Deputies in general and to Senators to be responsible in their comments on this matter because scares in respect of people using medicines and vaccines cost lives. Any decisions that are taken must be based on the scientific facts and the epidemiological evidence, and nothing else. No meeting with me will change that. These decisions are made based on scientific and expert advice and I appeal to Deputies to be responsible in their comments and actions around this issue.
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