REGRET Parents meet with EMA Investigators in London.
Parents representing the Irish Support Group REGRET met with investigators from the European Medicines Agency (EMA) in London last Wednesday, 16th September. The EMA are currently conducting a safety review on the HPV vaccine 'Gardasil' after widespread reports of
serious adverse reactions.
Kiva Murphy and Karen Smyth were representing 80 Irish families who believe their daughters' debilitating illnesses are caused by the
vaccine. Speaking after the meeting, Mrs Smyth told reporters: "I showed them the data we had collected from our members, figures on symptoms and first-hand accounts. They agreed this was exactly the kind of information they needed. The EMA investigators were left in no
doubt about the scale of the problem, and before leaving we requested that they provide a progress report at a later late".
The Health Products Regulatory Authority (HPRA) is the official adverse reporting agency in Ireland, but it's reporting process can be considered to be flawed and of limited use for the kind of review the EMA is undertaking. For example, a seizure that occurred immediately after a shot may be reported by the nurse giving the injection, but no follow up is ever done to see if any more seizures continue after that, or how frequently. Also, the single word checklist employed in the reporting form, such as 'headache', 'fatigue', 'malaise' etc, does not capture the severity of these conditions (which can be completely debilitating). Nor is information captured on whether these symptoms are temporary, or whether they continue for days, months or years afterwards.
Despite these limitations, the Irish adverse reporting system reveals the number of reports for Gardasil to be almost double those of the second most reported vaccine. This is despite the fact that even when parents point out to Consultants and GP the obvious connection between getting the Gardasil injection and the onset of their daughter's illness, these same doctors were typically not sending in adverse reaction reports. At least that was the experience of families from the Support Group REGRET.
In recent meetings with the health authorities who run the HPV immunisation program in Ireland, REGRET representatives tried to communicate the seriousness of the medical conditions being suffered by schoolgirls, which they feel are due to the effects of the vaccine. However the vaccination program will not be suspended in Ireland while the EMA review is taking place. It was this laissez-faire attitide among Irish authorities that prompted the Support Group to request a meeting with the EMA itself so that the dozens of detailed case histories the group had collected could be delivered directly to them.
Recovering from the Gardasil vaccine is a long and complicated process requiring the kind of medical expertise that may not be available in Ireland. This account from a Danish mother describes two years of struggle, including trips to a Swiss clinic, to slowly achieve some kind of recovery from more than 30 symptoms. Although the goal of the EMA meeting in London was to spare more families from the traumatic effects of Gardasil reactions, the primary focus is on getting effective treatment for the seriously ill schoolgirls, something they HSE has not been able to provide.
The HSE recently published the content of the information leaflets that will be distributed to parents as part of the informed consent process for the 2015 schools HPV vaccination program. REGRET.IE has launched it's own information campaign which will refer parents to the vaccine maker's original product information, including results from the vaccine maker's own clinical trials.