At least five Galway girls are suffering a catalogue of life-changing debilitating ailments which they blame on the cervical cancer vaccine.
The Health Products Regulatory Authority has stated that it has received 934 reports of suspected adverse reactions to the human pappilomavirus (HPV) vaccine Gardasil, administered to teenagers to protect against a virus that causes seven out of ten cervical cancers. These included dizziness, headache, fainting, injection site swelling, injection site pain, raised temperature, muscle pain, nausea and vomiting.
Reports of persisting or chronic fatigue or severe pain, in some cases with other non-specific symptoms such as drowsiness, gastrointestinal upset, joint swelling, flu like illness and menstrual disorders have also been received.
These were forwarded to the European Medicines Agency’s EudraVigilance database for inclusion in global signal detection activities.
A review published earlier this month by the European Medicines Agency (EMA) dismissed a connection between the vaccine and two reported syndromes, complex regional pain syndrome (CRPS) and postural orthostatic tachycardia syndrome (POTS), a condition where the heart rate increases abnormally on sitting or standing up, together with symptoms such as dizziness, fainting and weakness, as well as headache, aches and pains, nausea and fatigue.
However 127 cases of severe ongoing side effects in young Irish girls have been catalogued by a support group set up parents to fight for better treatment and to raise awareness about the risks associated with the vaccine.
At least five of them are from Galway, according to Senator Fidelma Healy Eames, who is backing the parents in their campaign.
Regret – Reactions and Effects of Gardasil Resulting in Extreme Trauma – believes a pattern of debilitating illnesses, including extreme fatigue, chronic pain and constant fits, has resulted from the vaccine in their daughters who were healthy and extremely sporty before taking part in the vaccination programme currently rolled out at secondary schools.
They point to the pharmaceutical manufacturer’s own clinical trials where 2.5% (one in 40) of participants reported a serious adverse event after taking the vaccine.
In addition, 3.3% (one in 30) also reported a new auto-immune condition. The parents say the risks outweigh the benefits with the current rate of incidence of cervical cancer in Ireland at 13 per 100,000 (or 0.013%).
The Irish parents are not alone in their campaign against the vaccine. A Spanish support group has criticised the focus of the EMA review, saying the two syndromes were only officially diagnosed in a small minority of cases.
In Denmark a study published by the Danish Medical Journal in February found there was a consistency in the symptoms of 53 patients examined, which included “pronounced autonomic dysfunction including different degrees of orthostatic intolerance, severe non-migraine-like headache, excessive fatigue, cognitive dysfunction, gastrointestinal discomfort and widespread pain of a neuropathic character”.
“Our findings neither confirm nor dismiss a causal link to the Q-HPV vaccine, but they suggest that further research is urgently warranted to clarify the pathophysiology behind the symptoms experienced in these patients and to evaluate the possibility and the nature of any causal link and hopefully establish targeted treatment options.”
In September the Danish health authorities replaced the Gardasil vaccine with its competitor Cervarix. Japan withdrew its recommendation for a HPV vaccine in 2013 due to concerns about long-term pain and numbness. Last August guidelines approved by the Japan Medical Association (JMA) for the evaluation and management of symptoms that begin after HPV vaccine injection were issued to healthcare professionals.
Health Minister Leo Varadkar has stated in the Dáil that the vaccine protects against two high-risk types of HPV that caused 73 per cent of all cervical cancers and could save an estimated 60 lives annually in Ireland.
“While no medicine (including vaccines) is entirely without risk, the safety profile of Gardasil has been continuously monitored since it was first authorised both nationally and at EU level,” he said.
“Healthcare professionals should therefore continue using them in accordance with the current product information.”
The HSE said in a statement that 300 women annually are diagnosed with cervical cancer in Ireland and 100 die from the disease. All cervical cancers are linked to high risk HPV types.
“Gardasil has been found to be over 99% effective in preventing pre-cancerous lesions associated with HPV types 16 and 18 in young women aged 16-26 years. Gardasil has been found to be over 99% effective in preventing HPV 6 or 11 related genital warts.
“The impact of a population wide Gardasil vaccination programme has been demonstrated in Australia where there has been a 50% decline in high grade cervical abnormalities in girls under 18 years and a 93% reduction in the number of diagnoses of genital warts in women up to 21 years of age.
“ There has also been an 82% reduction in genital warts diagnosed in heterosexual men up to 21 years of age which is attributed to herd immunity.”
The executive also insisted there was no evidence of long term “sequelae” to Gardasil.
The HSE pointed out that by March 2015, over 187 million doses of Gardasil had been distributed to 72 million people worldwide either as part of national immunisation programmes or by private doctors.
Life was changed forever by vaccine for cervical cancer
Mary O’Malley* from Galway City, said her twelve-year-old daughter had been a sports fanatic before receiving the HPV vaccine in 2010.
After the first shot she had sore glands, headaches and tiredness, all normal symptoms which subsided after a few days.
Following the second shot, she had profuse bleeding from the injection site and then developed severe headaches. Her mom put it down to her being run down from doing too much sport.
Within eleven months the teenager was barely able to get out of bed. She was surviving on rice cakes and water yet piled on three stone in two months.
Every inch of her body ached. Numerous trips to the GP and tests conducted at the hospital failed to get a diagnosis other than teenage hormones or emotional problems.
She eventually had to give up school and studied at home for the final two years, managing to pass her leaving cert despite her illnesses. In 2013 a paediatrician diagnosed her with chronic fatigue syndrome. It was only when Mary discovered a parent in America complaining about the exact same symptoms in her daughter on a health website that a link with the HPV vaccine emerged.
“From day one my daughter said she didn’t feel right after the vaccine and I didn’t listen to her,” she sighs, tears in her eyes.
“The initial symptoms – she’s learned to cope with them – but now there’s new chronic pains, her left leg has started to turn in, 18 months ago she lost her eye sight, it came back but the peripheral sight in her left eye never came back. She’s under a neurologist for ice pick headaches,” explains Mary.
“She has no social life, she can’t go into town, she’s never been to a disco, she couldn’t go to her debs. She’s lost most of her friends since dropping out of school – yet nobody cares.”
A dad from South Galway said his 15-year-old daughter was a county camogie player before her life changed dramatically five months ago. She collapsed on a GAA pitch and was out cold for thirteen minutes.
After that, the fits kept occurring, even when she was sitting on a chair. She sleeps up to 20 hours a day and can no longer go to school. A single dad, he cannot leave her alone for long in case she passes out.
Medical tests have revealed low blood pressure but so far no definite reason has been uncovered for her dramatic change in health.
When he read accounts of the girls published on the Regret website, he recognised all of the symptoms, none of which were present before she got the vaccine when she was twelve.
“My girl’s personality has changed completely. She used to be so outgoing. She used to do sean nós dancing. She can’t do anything now. The other mothers don’t want her over because they’re afraid she’ll collapse.”
After meeting with eight such parents from across the region, Oranmore Senator Fidelma Healy Eames has raised the plight of the girls in the Seanad. She is calling on the Minister for Health Leo Varadkar to set up a multidisciplinary team to investigate the cases and to properly treat the teenagers.
She is also urging the HSE to accurately outline the possible side effects in their leaflets so that parents can make an informed choice.
“These girls all have very similar symptoms in common which they only developed after the vaccine and they can’t find out why they have them. They were all gifted at sports. We have a duty of care to them and to the next round of girls who get the vaccine – we could be robbing their teenage years from them,” he exclaimed.
“We’re not trying to scaremonger – I’ve been subjected to a lot of abuse on social media since I raised this. But these girls are very sick, they’re totally debilitated, their personalities have changed. The doctors’ hands are tied because this is public health policy.”
Mary would dearly like a holistic assessment of her daughter’s condition so that an overall plan of action could be drawn up together by medics across the specialities.
“Denmark and Japan have clinics up and running and protocols there to treat these girls. We want to be able to go to a GP without being dismissed, without being told it’s in their heads. Say that to a girl who is a bungling mess, who can’t put on her clothes because of the horrific pain, who can’t brush her teeth or even stand up.”
*Names changed or not used to protect the privacy of the girls
New Galway centre for sexually-abused children
A new Galway centre for sexually abused children is based on an overseas model where the numbers of investigations doubled and prosecutions tripled once all services were brought under one roof.
The Barnahus Onehouse Galway service will be the first of its kind in Ireland and will be used to roll out other centres across the country.
The location has yet to be finalised but is expected to be operating within months – treating children and adolescents in the Galway/Roscommon catchment areas.
Forensic, child protection, medical, therapeutic and policing services for children who have been subjected to sexual abuse or are suspected victims will be delivered together in a child-friendly setting to avoid re-traumatising them.
At the launch at NUI Galway, the centre was described as a game-changer by Dr Geoffrey Shannon, former Special Rapporteur on Child Protection, and leading expert in child and family law on whose recommendation the centre was set up.
The Galway-born solicitor’s audit of 5,400 cases of emergency removal of children from their families by Gardaí over eight years uncovered poor and limited interagency communication and cooperation, which he declared was the key road block in child protection.
The audit was carried out following the removal of a blonde child from a Romanian family after complaints from the public that the child may have been abducted – claims that were later found to be unfounded.
The Galway centre involves three departments – Children and Youth Affairs; Health; Justice and Equality – and three agencies – Tusla; the HSE; An Garda Síochána – working together.
By co-locating the services together, essential agencies can share vital information about children and their families, he pointed out.
“Emergency powers need to be followed up by continuity of care informed by communication, cooperation that goes beyond a paper exercise,” he told the lecture hall.
“Meaningful cooperation would ensure interventions are proportionate, developmentally appropriate and culturally sensitive
“In the absence of such cooperation, there is the very real potential that services designed to ensure protection will cause further trauma.”
And after examining centres in Iceland, New York, Antrim and Oxford, it was clear the model had very tangible results.
In Iceland, twice as many investigations of child sexual abuse cases were carried out while the number of cases that were prosecuted tripled.
“It is a safe place to disclose abuse, it is child friendly, it provides a supportive environment, safe from those suspected of perpetrating abuse,” he told the press conference.
Dr Shanahan said it was reassuring to have both the Minister for Children and Youth Affairs Katherine Zappone as well as the Minister for Justice and Equality Charlie Flanagan at the launch, which spoke volumes about the Government’s commitment to child protection.
Noting that there was still much work to do to help victims of sexual abuse, he said legislation was needed to allow the child victim to give evidence and be cross-examined within a short time of the event occurring using video technology.
This could then be used during the court case, allowing the child to get on with life and recover from the incident, rather than re-live it when the case eventually comes to court.
Minister Zappone said it was Dr Shannon’s 2017 audit that was a catalyst for her to set up a steering group to establish the centre which was a priority project during her tenure.
“When children cross the threshold, they feel safe, supported, loads of beautiful colours, with a section where they can play if they want to.
“It’s not just being in the place. It’s developing the processes and ways of communicating and the trust that makes the difference. And even then, it’s hard to do what it is you need to do to work with a child or young person that has so brutally been abused.
“…This is such important work.”
She said one of the most appealing aspects of the Barnahus model was the child centred of the approach which reduced the need for children to repeatedly recount their traumatic experiences as they engaged with multiple agencies. It also allowed families to be supported in caring for their child throughout a difficult process.
Minister Flanagan said all the bodies involved would “overlap, work together and become entwined”.
Officers specially trained in interviewing sexual abuse victims will be available in Divisional Protective Services Units located in all Garda divisions by the end of the year.
These officers would support the delivery of a consistent and professional approach to the investigation of sexual crime, for adults and children alike.
“This is a very positive step towards reducing the trauma and supporting victims through the criminal investigative process.”
Eilish Hardiman, who was speaking on behalf of the Minister for Health Simon Harris, noted the increased number of referrals to the Galway centre before it even opens.
“So there is an unmet need here,” she told the conference.
She said Minister Harris had promised ring-fenced funding for permanent posts to staff the centre.
Before and after the conference, a seminar also took place attended by 100 healthcare professionals with international and local speakers giving an overview of how the service would operate.
Authorities detain stricken ship close to Kinvara
Irish authorities are still detaining a ship close to Kinvara, after its hull sprang a leak while loading cargo for the Bahamas.
The 30m Evora was detained last week at Tarrea Pier near Kinvara by the Marine Survey Office (MSO) under port-state control regulations which prevent the vessel from going to sea.
Concerns about the four crew employed for the voyage also prompted a visit to the vessel by the International Transport Federation’s (ITF) Irish branch.
ITF representative Michael Whelan said he had met the crew – three Cubans and a Colombian – to check on their situation in relation to pay, conditions, and accommodation for the crew while the vessel is damaged.
The cargo ship had been due to steam to the Bahamas with a large quantity of cement when the ship’s hull was damaged during loading at Tarrea Pier.
Local residents feared that fuel from the ship might leak, causing pollution which would have a serious impact on south Galway’s shellfish industry, including its oyster beds.
The owner said there had been no fuel leak from the vessel and no pollution risk.
The pier is outside the remit of the Galway harbourmaster, and is the responsibility of Galway County Council.
It is understood residents found it difficult to get a response from the local authority, and Galway harbourmaster Captain Brian Sheridan intervened to assist.
The Department of Transport, under which the Marine Survey Office operates, said it could not comment on the details of the detention.
It said that any queries should be directed to the ship’s flag state – as in Saint Vincent and the Grenadines. However, the ship’s port of registry is recorded as Panama on the vessel.
The vessel, built in France 50 years ago, was formerly owned in Rossaveal, but was sold to a new owner within the past twelve months.
The owner confirmed that the vessel had been held as the engine room was flooded, and said “no harmful substances were released into the bay”.
The ITF representative Michael Whelan said he was in regular contact with the crew, and understood they now wished to be repatriated.
He confirmed that the crew had been paid, but did not wish to stay indefinitely, as the vessel had not been inspected by flag state inspectors.
More than 2,000 submissions on waste facility licence
Thousands of objections have been lodged with Galway County Council against a proposed licence for a waste facility in Ballinasloe.
A meeting of Ballinasloe Municipal Council heard that 2,075 hard copy submissions had been lodged with the County Council by the deadline earlier this month.
Last year local residents won a High Court challenge against the granting of a licence for a waste facility at Poolboy in the town.
The court ruled that Galway County Council had erred by granting the licence for a waste facility to Barna Waste, contrary to requirements for protecting natural habitats.
At a meeting of Ballinasloe Municipal Council, Fianna Fail Councillor Michael Connolly described the town as being ‘dogged’ down through the years with dumps and said the transit of waste through Ballinasloe town again would be ‘detrimental’.
Independent Councillor Aisling Dolan said she is happy that five out of the six local area councillors are supporting the ‘Ballinasloe Says No’ campaign.
She told the meeting that one in every three people living in the urban area of Ballinasloe has lodged a formal submission to the Environment department of the county council against the proposal for a waste licence.
The opposition to the waste facility centres on concerns regarding potential health implications and road safety.
Local residents claim that waste trucks will have to navigate through the town, passing Portiuncula Hospital, schools, children’s playgrounds and homes and could increase the risk of serious accidents or fatalities.
Residents also feel that there could be health implications as a result of a potential decrease in air quality.
Among the concerns of local residents is the potential impact on tourism in the East Galway town which is part of the Hidden Heartlands initiative.
They claim that a waste facility at Poolboy would deter investment for Ballinasloe and people would be less likely to want to live and work in the area.
There was some confusion at the Ballinasloe meeting regarding how many tonnes of waste per year would be permitted at the facility, if the licence is granted.
Independent Councillor Declan Geraghty said there is a perception that hundreds of waste lorries will pass through Ballinasloe each week if the facility is granted a licence.
However he added that his calculations suggest no more than three articulated loads of waste would traverse the town if the facility is to only cater for 23,000 tonnes of waste per year.
Independent Councillor Tim Broderick said the licence would allow 23,000 tonnes of waste at the Poolboy facility at any given time.
Councillor Geraghty says he is not against the waste facility but is also supportive of the local residents and would like clarity on the figures as it would be ‘unfair to hauliers and people who are trying to create jobs’.
The location of the proposed site at Poolboy has been described as ‘wrong’ by Sinn Fein Councillor Dermot Connolly, who is arguing that an alternative site, away from the populated area, should be explored and then maybe supported. Galway County Council is due to make a decision regarding the proposal for a waste licence in Poolboy by the end of November.