I thank the Chairman and the committee for the opportunity to present our case today and, together with Ms Ava Battles, Brainwave's director of services, I look forward to answering any questions members may have on this issue. Dr. Norman Delanty, Ireland's leading epileptologist, was to have attended today but a major problem has arisen for him at Beaumont Hospital and he cannot join us. He has, however, assured us of his full support for our presentation today.
Epilepsy is described as the tendency to have recurring seizures and seizures are caused by abnormal neuronal activity or electricity in the brain. There are approximately 40,000 people with epilepsy, PWE, in Ireland and fewer than half of them have their seizures controlled, even though up to 70% of people with epilepsy can have their seizures fully controlled through the use of the correct anti-epileptic drug or drugs, AEDs. To achieve this seizure freedom, a person with epilepsy needs to have access to an epilepsy specialist with follow-up annual visits after control has been achieved. There are only four neurologists dealing with adults, out of a national total of 17, who have a specialised background in epilepsy.
These 17 neurologists represent one for every 249,000 people in Ireland, which is an improvement of one for every 7,000 since we made our submission to the joint committee last summer, an extra neurologist having been appointed. Most European countries have a neurologist for every 30,000 or fewer people. Many people with epilepsy in Ireland never get to see any neurologist, much less an epileptologist, and their diagnosis, treatment and care falls to their family doctor. Misdiagnosis is, therefore, very prevalent and Dr. Delanty and his colleagues must deal with the consequences of this every day.
Most European countries, even poorer eastern ones, have had epilepsy centres for more than 100 years. Many of these establishments started out as residential units but many have evolved to become centres of medical excellence in the treatment of epilepsy. Ireland has no such centre. Many of those countries also have national guidelines on epilepsy, setting out appropriate treatments and services for people with epilepsy. Again, Ireland has no such guidelines.
Irish people with epilepsy have had quite enough difficulties to deal with before this potential problem of inappropriate switching of branded anti-epileptic drugs, AEDs to generic AEDs was recently brought into play — a problem which hangs over their lives like the sword of Damocles. A change in the law protecting AEDs from inappropriate switching will lift this threat and that is what we are seeking the committee's help with today.
Since our submission to the committee last June, a major new study has been published on the subject of generic AED switching. One of most significant things about this work is the standing of its four authors. All four are world renowned epileptologists led by Dr. Pam Crawford from York, with Dr. Morgan Feely, an Irish clinical pharmacologist based in Leeds, Dr. Alan Guberman, a leading Canadian neurologist and Dr. Guenther Kramer, a world-renowned German opinion leader. All of the concerns expressed by Brainwave in its submission are warned against in their conclusions. They say: "As other AEDs lose patent protection, it is important to ensure that patients, pharmacists, prescribers and decision-makers are all aware of the issues to consider". The authors mention the medico-legal implications of switching and conclude: "Furthermore, the legal situation should be clarified, with responsibilities assigned for ensuring patients and physicians are informed".
Brainwave is the national body for people with epilepsy, their families and carers. It was established more than 50 years ago as a part of the Rehab Institute and has existed as a stand-alone member-driven charity since 1966. It has established offices in all parts of the country with a part-time staff member in each regional office. From these offices we provide a range of services to people with epilepsy and my colleague Ms Ava Battles can provide full details of each of these services by county and region, if necessary. For many people with epilepsy and their families and carers, Brainwave's services providing support, advice, information, literature, support groups, seminars, advocacy, training, epilepsy specialist nurse services etc., represent the only available services they can access.
When people go to a shop to buy a packet of Kellogg's Corn Flakes they do not expect to receive a brand X, Tesco or SuperValu packet of corn flakes and be told it is the very same thing. The Kelloggs corporation states it only makes its own brand of corn flakes and that the only way to get Kellogg's Corn Flakes is to buy that brand. It is much more important to ensure that every time one goes to the pharmacy, one receives the same brand of anti-epileptic drug, AED. A generic packet of corn flakes is unlikely to do any harm to one's health but an inappropriate generic AED could cause serious damage to every aspect of one's life.
Magda, not her real name, is a young German woman aged 32 who has frontal lobe epilepsy with nocturnal seizures. She works full time and needs a driving licence because travelling by car is the only way she can carry out her job. Her nocturnal seizures have been well controlled on tegretol, the generic name of which is carbamazepine, but one week after being switched to a generic version of carbamazepine she had her first generalised tonic clonic, GTC, seizure during the daytime. Magda's whole life unravelled as a result and the loss of her driving licence has dramatically impacted on her social life, quite apart from the effect on her job. In theory, Magda could sue all those responsible for what happened to her but she would probably need a very good, expensive lawyer who would could prove that her first GTC seizure, which was also her first ever daytime seizure, might not have happened anyway. Magda's case is one of many which are happening around the world at present. Even with all her problems, Magda is the patient of Dr. Guenther Kramer, one of the world's top epileptologists and her access to public transport in Germany gives her hope.
If Magda was Mary Murphy from Blacksod Bay or Kilteegan or Enniscorthy or Scotstown or any other part of Ireland her outlook would be very bleak. Her access to health care, work, education and social life would be radically reduced overnight. It is very unlikely that Mary would be in touch with Brainwave as most people, once their condition is controlled, tend to want to put their epilepsy in a little box letting as few people as possible know about it. This is totally understandable given the stigma still associated with the condition and the myths and misinformation still prevalent in Irish society. Unfortunately, epilepsy tends to raise its head again in many people's lives, even after years free from seizures. It is very difficult for Brainwave to reach these people to let them know about the possible threat to them of AED switching so that they can put in place some preventative measures. Almost certainly, somebody will successfully sue those responsible for inappropriate switching of their AEDs and things will then start to change. In the meantime, Brainwave has been strongly urging all its members and everybody with epilepsy to take preventative measures to ensure that their AEDs are never switched and that every time they go to their pharmacy they receive the same medication each time.
There have been six major, government sponsored, reports on epilepsy in the UK since the Second World War but only since the last one was published in 2002 has there been some follow-up action. This most recent report was called Epilepsy — Death in the Shadows and it concluded that 42% of the 1,000 epilepsy deaths each year in the UK, could be prevented. They found that the key to prevention is seizure control and half of the deaths were due to sudden unexpected death in epilepsy, SUDEP. Ireland's official epilepsy death toll has ranged from 53 to 72 per year over the past number of years according to the figures from the Central Statistics Office, CSO. It would be amazing if these figures were not understated because so many people in Ireland hide the knowledge of their condition.
There was also a landmark Epilepsy Fatal Accident and Sudden Deaths Inquiry in Scotland in 2002 into the death of Colette Findlay which was very critical of the lack of proper medical care she received especially on seizure control. As a result, many general practitioners throughout the UK updated their knowledge of epilepsy for fear of being similarly criticised. A recent survey of GPs in the Cork and Kerry area did not indicate that Irish family doctors have any awareness of such concerns.
Sudden unexpected death in epilepsy, SUDEP is a very real concern for many people. Kathy Sinnott MEP recently wrote about the tragedy of her own sister's death by SUDEP and I know of several people in the Oireachtas who have experienced epilepsy death in their close families. There have been no national reports into epilepsy in Ireland and the condition, in common with other neurological diseases, has a Cinderella status here. It seems to have been viewed at official level as something which, if ignored, can be avoided as a problem.
The expiry of the patents in newer, more expensive, epilepsy drugs and the appearance on the Irish market of generic versions of these drugs has happened in the last two years. This has coincided with the publication of the Brennan report which strongly advocated the extensive use of generics in the long-term illness scheme, LTIS, and general medical service scheme, GMS. The combination of these two elements has led to the major concerns for people with epilepsy, PWE, over AEDs.
The recent deal between the Department of Health and Children with the Irish Pharmaceutical and Healthcare Association, IPHA, would appear to indicate that the widespread substitution of branded drugs by generics is unlikely to happen in the near future. However, in some ways this just makes the situation worse and means that the threat is deferred rather than dealt with now. Lamotrigine, or Lamictal as is its branded name, was the first of the expensive epilepsy drugs to come off patent. Six pharmaceutical companies have now received licences for generic versions of lamotrigine from the Irish Medicines Board. Why have they bothered if there is no market here for them?
Manufacturers must make their branded products to within 5%, plus or minus, of a certain standard set at the time they receive their licences for each batch of the product they produce — that is to say from 95% to 105% accuracy, with a maximum 10% variance. A generic version of the same product may be made to within 20% minus or 25% plus — that is from 80% to 125%, a maximum variance of 45%.
AEDs have a very narrow therapeutic range and cannot be expected to accommodate overnight swings brought on by the replacement of an AED product by another AED which could be up to 45% different in its core ingredient. There are some grounds for hoping that the newer AEDs may not have quite as narrow a therapeutic range as the older drugs such as carbamazepine, sodium valproate and phenytoin. This is not based on scientific evidence but on the premise that the newer drugs are designed to reach specific parts of the brain to prevent seizure activity.
The Food and Drug Administration agency, FDA, has recently moved to protect the three older AEDs mentioned above from switching in the USA, more than 20 years after the FDA introduced its 80% to 125% bioequivalence rule for generics for all drugs. It made this decision some 20 years ago based on what it called "expert opinion" not scientific evidence. It is to be sincerely hoped that we will not be seeing them move, in 20 years time, to protect lamotrigine, gabapentin and the other, by then, no longer new drugs.
It must be obvious then that the switching of brand name AEDs for generics represents a very real legal and medico-legal threat to doctors, pharmacists, healthcare managers, legislators and others responsible for healthcare. Brainwave's real concern, though, is the potential to cause mayhem in the lives of Irish people with epilepsy. I urge the committee, therefore, to assist us in changing the law to protect these vulnerable people with epilepsy and thereby also protect everybody else.
