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