A CORK-FORMED group is taking legal action against the HSE to prevent the roll out of a cervical cancer vaccine in secondary schools before a European investigation into the vaccine’s safety profile is complete.
The National Citizens Movement is seeking an injunction against the HSE, claiming that the health authority must provide more information to parents before they can give their informed consent on Gardasil HPV vaccine. The full list of reported side effects — 20 of which are published on vaccine producer Merck’s manufacturer leaflet — are not currently being circulated to schools, or parents, before consent forms for the vaccines are sent home with pupils.
And a letter sent from the HSE to secondary school principals specifically stipulated that no additional information should be circulated to students on the vaccine.
This move has angered some Cork parents, who feel that they are not being given the time to make a fully informed decision.
Una Heelan, right, whose daughter Roisín Heelan, left, has been ill since receiving her third shot of the Gardasil vaccine in May 2011, although no link has been established between the onset of Roisín’s debilitating symptoms and the vaccine.
Elizabeth Hourihane, who founded the National Citizens Movement in Cork last year, said that concerns about the scope of the information being provided by the HSE has caused a Dublin member of the National Citizens Movement, Steve Sinclair, to take the legal action.
“We want to ensure that the HSE is giving parents fully informed consent,” Ms Hourihane said.
An application could go before the High Court in the coming days.
The National Citizens Movement was a group originally set up in Cork in 2014 to take on Irish Water in the courts. It also says it is concerned with tackling political reform with accountability.
Gardasil, produced by Sanofi Pasteur and Merck, aims to vaccinate against certain strains of HPV, a sexually transmitted virus which can cause cervical cancer in some women; the vaccine is currently offered to girls in first year of secondary school.
The vaccine’s safety is being reviewed by the European Medicines Agency (EMA), after the Danish Government noted that significant numbers of previously healthy girls developed similar chronic conditions after being vaccinated. So far, the EMA has not advised countries to change their national vaccination policies ahead of the release of its final recommendations, and the HSE has not yet altered its vaccination policy.
A HSE letter sent to secondary school principals asks that only HSE information be included with the vaccine consent forms sent to parents.
Some campaigners want the manufacturer’s full list of 20 recorded potential side effects to be circulated to parents as well.
However, the HSE made the decision to circulate the pared-down information due to a recommendation by the National Adult Literacy Agency (NALA), which warned that as about one in four Irish adults have literacy problems, some parents would have difficulty understanding technical details.
Some parents also expressed concern to the Evening Echo that not enough information or time is being given before parents are expected to return signed consent forms.
Cork woman Una Heelan’s daughter Roisín has been ill since receiving her third shot of the vaccine in May 2011, although no link has been established between the onset of Roisín’s debilitating symptoms and the vaccine.
Among her symptoms have been chronic headaches, joint pain and fatigue.
Mrs Heelan, from Boherbue, is now a member of REGRET.ie, an Irish support group for people who feel that they or their children may have been injured by the Gardasil vaccine.
She believes that the HSE should circulate the full list to parents of serious side effects that have been reported post-vaccine.
“I feel that the HSE should be advising parents on the full list of side effects that may be experienced with this vaccine, and at the very least, parents should be encouraged to do their own research into the vaccine, and be given the option and the time to do so before consent forms are expected back,” she said.
“I have parents contacting me frequently, either looking for more information on the vaccine, or from parents who believe that their daughters may have been injured by the vaccine.”
“The REGRET group started with just seven members in June, and it is now at 77,” Mrs Heelan added, who believes that the fast increasing numbers contacting the group may indicate that the vaccine can cause serious side effects for some girls.
Mrs Heelan said she knows of cases where children have been handed the consent forms on their first day of school to be signed and returned the next day.
“Giving parents only one night to research and decide whether or not to vaccinate their children as part of the school programme is clearly very limited,” she said.
“This week I’ve had concerned parents whose children are attending Millstreet and Mallow schools, looking for more information on the vaccine. I’ve also had one parent contact me this week who believes that her daughter has been damaged by the vaccine,” she added.
“What I believe may be side-effects linked to this vaccine have become an ongoing part of everyday life for me, and I believe that schools need to give parents more information, and more time before they expect signed consent forms to be returned for the vaccine.”
Catherine Weitbrecht, a founding member of REGRET.ie, is also concerned that parents do not have ready access to the information necessary to make a fully informed choice.
“Additionally, the Danish Government has requested an urgent investigation into their reports of similar symptoms that significant numbers of previously healthy girls in Denmark developed post-vaccine,” she said.
The HSE say that Gardasil is considered safe and well tolerated.
“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,” a HSE statement reported.
The HSE also told the Evening Echo that Ireland is implementing its HPV vaccination programme in the best interest of its citizens, to maximise health, prevent disease and prolong life. Cervical cancer is the fourth most common cancer in women worldwide.
Each year in Ireland around 300 women are diagnosed with cervical cancer and 100 die from the disease.
However, fatalities have fallen in countries where female populations are routinely screened for pre-cancerous cell changes in the cervix. As cervical cancer develops slowly, regular screening has a high success rate.