Tuesday, 24 April 2012
I thank the Ceann Comhairle for allowing me to raise the issue of the investigation into the increase in narcolepsy in children and adolescents in 2009 and 2010. I commend Dr. Darina O'Flanagan, director of the Health Protection Surveillance Centre, and the expert group on the work they did looking into this problem. The study found an increased risk of developing narcolepsy in those aged between 15 and 19 who received the Pandemrix swine flu vaccine compared to those who had not received it. These results are very similar to those seen in Sweden and Finland with a clear increased risk evident from the available data. However, it is very unlikely the vaccine alone would be sufficient to explain what has been seen and observed by the expert group. International experts agree a number of factors are likely to have contributed to the increased risk and a number of ongoing international studies will provide additional information. The report shows the rate of narcolepsy among children in Ireland rose 13-fold since the vaccine was administered. The overall findings tally with those gathered in Finland on the sharp increase in narcolepsy among those who received the Pandemrix vaccine. Like Ireland, Finland had a large scale flu vaccination campaign in 2009 and 2010.
As of 16 December last year 28 cases of narcolepsy with a symptom onset since April 2009 had been identified in children and adolescents in Ireland. Of these, 22 had received the Pandemrix vaccine before the symptoms onset. Based on the primary study period between 1 April 2009 and 31 December 2010 and the first health care contact because of narcolepsy symptoms, the group found a significant 13-fold increase in narcolepsy in children and adolescents vaccinated with Pandemrix compared with unvaccinated children and adolescents. The absolute number of narcolepsy cases attributable to Pandemrix vaccination was five per 100,000 vaccinated children.
Narcolepsy is a nervous system disorder and its exact cause is not known. In some patients narcolepsy is linked to a reduced amount of the protein hypocretin, which is made in the brain, but what causes the brain to produce less of this protein is unclear. There is a possibility that narcolepsy is an auto-immune disorder, which is where the body's immune system mistakenly attacks healthy tissue. Narcolepsy tends to run in families and certain genes are linked to it. Narcolepsy symptoms usually occur between the ages of 15 and 30. The symptoms are periods of extreme drowsiness during the day and a strong urge to sleep often followed by a sharp nap or sleep attack often lasting 15 minutes although they can be longer. They may happen after eating, while driving, while speaking to somebody or other situations. Most often the person awakes feeling refreshed. Dreamlike hallucinations between sleep and wakefulness can occur which involve seeing or hearing things and possibly other symptoms. Sleep paralysis is where a person with narcolepsy cannot move as they begin to fall asleep or wake up. It may last for 15 minutes. The person suffers a sudden loss of muscle tone while awake which makes him or her unable to move. Strong emotions such as laughter or anger can trigger cataplexy whereby one's head will suddenly fall forward, one's jaw will become slack and one's knees will buckle. Most attacks of cataplexy last for 30 seconds but in severe cases a person may fall and stay paralysed for several minutes.
There is no known cure for narcolepsy. The approach is to control the symptoms. Lifestyle changes and emotional counselling can help a person to work and take part in social activities. These involve eating lighter vegetarian meals during the day and other issues to do with sleep. It is a lifelong condition. It is not deadly but may be dangerous if episodes occur while driving, operating machinery or similar activities. The complications include difficulty functioning at work and taking part in social activities, injuries or accidents and suffering side-effects of medicines used to treat the disorder. However, it can be controlled with treatment.
I thank Deputy Neville for raising this issue as it provides me with an opportunity to outline to the House its importance.
In response to the 2009 H1N1 influenza pandemic, the HSE procured two vaccines, Pandemrix from GlazoSmithKline and Celvapan from Baxter. The HSE, with the approval of the Departments of Health and Finance, indemnified the suppliers from and against loss and damage in respect of any claim. This was the arrangement for all European countries.
Following reports of an increased incidence of narcolepsy in young people who were vaccinated with the Pandemrix vaccine, the Department commissioned a retrospective population-based study to investigate a possible association. Last week the Minister, Deputy Reilly, published the findings of this study. The study concluded that the increased incidence of narcolepsy in young people may be associated with Pandemrix vaccine. The findings are similar to those found in Finland.
My Department is working closely with the Health Service Executive and the Department of Education and Skills to address the needs of those affected by this condition. A memorandum for Government setting out the full response to this issue is being prepared for submission in the coming weeks. I assure the House this matter is a priority for the Department and all possible options are being explored to meet the needs of those who developed narcolepsy following receipt of the pandemic vaccine. I thank the Deputy for raising the matter.
I thank the Minister of State for her reply. I echo the words of Dr. Tony Holohan, the chief medical officer, that vaccination is very safe and it is important the current vaccination programme continues to protect children and adults against the serious consequences of preventable diseases. This is a very rare thing and people should continue to have a high level of confidence in our vaccination programmes.
I recognise the work of the campaign group, Sufferers of Unique Narcolepsy Disorder, SOUND, which represents 40 children it believes have been affected to ensure their needs are taken seriously.
There is concern in regard to this indemnification by the State in terms of the difficulties that have arisen and the cost to the taxpayer in respect of the services now required. Perhaps the Minister of State will outline the decision making process in terms of the Minister's indemnification of the suppliers from damages in respect of any claims, which is now an issue. While the number of people affected is not high, those affected will suffer severely for the remainder of their lives. Perhaps the Minister of State will comment on the reason for the State's indemnification of the suppliers and the implications of this as set out in the report.
A decision was taken by Government to indemnify the suppliers because that was the only basis on which the vaccine would be available in the country. As I stated earlier, similar arrangements were put in place in other European countries. There was an urgency in regard to making the vaccine available and the only basis on which it could be made available was if the State indemnified it. That is the basis on which the decision was taken.
As stated by Deputy Neville, the parents of those affected have formed a group called SOUND, which is actively engaged with the HSE and has two representatives on the HSE serious incident alert group, which is managing this issue. The group is involved in identifying the needs of the children affected and how those needs can best be met from a health and educational point of view. That work is well under way.