Adjournment Matters - Medicinal Products

Tuesday, 27 March 2012

Seanad Éireann Debate
Vol. 214 No. 9

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Senator David Norris: Information on David P.B. Norris  Zoom on David P.B. Norris  The fascinating dialogue between the Minister of State, Deputy Dinny McGinley, and Senator Trevor Ó Clochartaigh in which the Leas-Chathaoirleach intervened was one of the most interesting and fluent exchanges I had heard in the Irish language for many a long day. I doubt such has been heard in the Dáil for quite a while either, which is another good reason to keep Seanad Éireann going. Let it be recorded that the Minister of State nodded.

I raise a poignant case involving the death of a young man who was a constituent of mine, albeit not one personally known to me. His mother had, however, written to me on a number of occasions about various matters and I know the family is a fine one. The young man in question did not want presents for his 21st birthday; he wanted everything to be given to the Society of St. Vincent de Paul. He had also helped out with the homeless and was completely against violence, even when it had been visited upon him. Despite this, in August 2009 he killed himself and another young man. The reason, his mother believes, is that he was having [549]emotional difficulties which she described as a broken heart. While I presume it was a romance that did not work, I simply do not know the circumstances. In any case, she took her son to the doctor who prescribed anti-depressants. After 17 days on the drug citalopram he took the dreadful action mentioned. His mother enlisted the support of a leading Irish authority, Professor David Healy, who has given evidence in trials in the United States and is a world renowned authority on the relationship between certain anti-depressant drugs known as selective serotonin reuptake inhibitors, SSRIs, and suicide and homicide. He gave evidence to the Coroner’s Court that in his opinion the drug had caused the young man in question to become suicidal and homicidal. A number of other Irish academics, whose names I will give subsequently, have come to the same conclusion.

That SSRIs have the potential to cause suicide and homicide is acknowledged in the United States where the relevant patient information leaflet lists these side effects. Unfortunately, the patient information leaflet in Ireland does not include such a warning. Whereas the Canadian leaflet includes a five page black box, the Irish leaflet contains absolutely nothing. I ask that a question be raised about a conflict of interest between the Irish Medicines Board and the interests of the patient in question. The IMB which has links with drug companies continually refers to the European Medicines Agency, a body which is under inquiry because of its conduct with regard to various drug companies.

It is important to note that the jury at the inquest into the death of the young man in question returned an open verdict, in other words, it did not return a verdict of suicide. The drug in question only has a particular effect on specific individuals. While I do not deny it has an anti-depressant effect on some people, a minority experience severe trauma as a result of taking it and this can lead to totally uncharacteristic violence.

After the inquest, the manufacturer of the drug stated on an RTE news programme that its drug could not have caused the events and that there was no evidence to support Professor Healy’s claim, despite the fact that it had a kind of “Dear Doctor” letter stating side effects could include self-harm and harm to others, also known as suicide and murder or homicide. The College of Psychiatry of Ireland dismissed the views of Professor Healy as speculative, despite the drug manufacturer accepting the existence of the side effects of self-harm and harm to others.

The drugs in question can cause people to become uncharacteristically suicidal or extremely violent; the facts are known. I, therefore, ask that the issue of a conflict of interest be examined to get at the facts, to establish by investigation what is the impact of the drugs and ensure there are adequate warnings placed before patients in order that they and their doctors will know there is a possibility of side effects. I refer to two learned articles which may be of assistance: Anti-Depressants and Violence: Problems at the Interface of Medicine and Law, by Professor David Healy et al in PLoS Medicine which can be downloaded from the Internet, and Suicidality, Violence and Mania caused by Selective Serotonin Reuptake Inhibitors, SSRIs: A Review and Analysis, by Peter R. Breggin in The International Journal of Risk and Safety in Medicine.

While I am aware that the Minister of State, like me, is not a qualified doctor and that this is not his particular area of responsibility, I would be grateful if he would bring the matter to the attention of his colleague in government, the Minister of State, Deputy Kathleen Lynch, and ask her if she would be willing to receive a deputation, including the bereaved mother of this wonderful young man. From everything I have learned about him, I wish I had had the opportunity to know him because he seems to have been an adornment to this planet.

[550]Deputy Dinny McGinley: Information on Dinny McGinley  Zoom on Dinny McGinley  Gabhaim buíochas leis an Seanadóir Norris as ucht an ábhair seo a ardú inniu. Perhaps the Senator might be good enough to convey my condolences and sympathy to the mother and family of the unfortunate young man to whom he referred.

Selective serotonin reuptake inhibitors, SSRIs, are anti-depressants available on prescription only. They are licensed for use in Ireland and across the European Union for the treatment of depressive disorders and some anxiety conditions. It is estimated that at any one time more than 450,000 people in Ireland experience depression. Young people, in particular, can find it hard to cope with depression and one in ten adolescents experience a depressive episode. Untreated depression can have a fatal outcome. Anti-depressants, when used properly, are effective in the treatment of depression and lead to a reduction in suicidal thoughts. According to the College of Psychiatry of Ireland, approximately 3% of Irish adults use anti-depressants. It is important to note that, in addition to the significant health benefits of medicines, all medicines carry some risks. People taking anti-depressant medicines may also experience adverse effects.

The Irish Medicines Board is responsible for the licensing and safety and monitoring of medicines in Ireland. In conjunction with medicines authorities in other member states, it continuously monitors the safety of medicines in a collaborative way and takes actions, as necessary, to ensure medicines continue to have a favourable benefit-risk profile for patients. As part of the system of monitoring medicines’ safety, it has a spontaneous reporting system by which health care professionals and patients can report suspected adverse reactions to medicines. It also reviews, approves and continuously updates the product information and package leaflet of medicines to reflect the current state of knowledge of each medicine and the risks associated with its use. All new and emerging safety data are assessed by it in conjunction with EU medicines authorities.

Unfortunately, depression can be associated with an increased risk of suicidal thoughts, self-harm and suicide in some patients. This risk persists until significant remission of the depression occurs. It has been known for some time that there is a potential risk of suicide related behaviour, particularly in the early stages of treatment with anti-depressants. The approved product information for anti-depressants specifically highlights the need for careful monitoring of patients with suicidal thoughts following initiation of treatment.

In 2008 a comprehensive review of the safety profile of SSRIs was undertaken at European Union level by EU medicines authorities. During this safety review the existing warnings contained in SSRI product information were further strengthened throughout Europe and manufacturers of SSRIs were obliged to update the product information on all SSRIs. The new updated warnings were communicated by the Irish Medicines Board to health care professionals.

While anti-depressants play a central role in the treatment of depression, patient safety must be paramount. The Irish Medicines Board actively monitors the safety of medicines, including SSRIs, on an ongoing basis and does not hesitate to issue safety warnings and update information, if required. At European level, new legislation will be implemented later this year which will include a range of new measures to improve patient safety such as improved systems for monitoring the safety of medicines and patient reporting of adverse reactions. The purpose of the legislation is to ensure the system of monitoring medicines safety in Ireland and throughout the European Union is as responsive as possible to the emergence of new information on medicines safety in order that patients continue to have access to safe and effective medicines.

[551]Senator David Norris: Information on David P.B. Norris  Zoom on David P.B. Norris  I thank the Minister of State for his gracious reply and, in particular, his words of sympathy to the mother of the young man, which I will certainly pass on with a copy of his statement. I wish to comment briefly on the statement, in particular the Minister of State’s remark that the IMB “has a spontaneous reporting system by which health care professionals and patients can report suspected adverse reactions” and that it is continuously monitoring. This simply has not worked. In fact, it has been useless. As I understand it, the IMB has not even replied to this woman.

The assistant State pathologist, Dr. Declan Gilsenan, has expressed very considerable concern in this area and lent his full weight to it. He said he has seen too many suicides among people who had started taking these drugs and, in his considered view, the evidence was more than anecdotal and he was hoping to raise the matter directly with the Minister of State, Deputy Kathleen Lynch. This adds strength to the case, which has the support of Dr. Gilsenan, Professor Healy, Dr. Pat Bracken and Dr. Terry Lynch. I would be grateful if the Minister of State, Deputy McGinley, would draw this to the attention of the Minister of State, Deputy Kathleen Lynch. Perhaps she may be prepared to see a delegation.

Deputy Dinny McGinley: Information on Dinny McGinley  Zoom on Dinny McGinley  I appreciate the Senator’s deep knowledge of this drug. His comments will certainly be brought to the attention of the Minister of State, Deputy Kathleen Lynch.

Senator David Norris: Information on David P.B. Norris  Zoom on David P.B. Norris  I am very grateful.

Senator Thomas Byrne: Information on Thomas Byrne  Zoom on Thomas Byrne  Tá mé an-bhuíoch don Leas-Chathaoirleach as ucht na díospóireachta seo a roghnú ar an Athló, díospóireacht a bhfuil an-tábhachtach, i mo thuairimse.

I raise the specific issue of narcolepsy which has been diagnosed recently in at least 32 children in Ireland who received the Pandemrix vaccine at the time of the swine flu epidemic. Narcolepsy is a malfunction of the sleep-wake regulating system in the brain. There are thought to be 2,500 sufferers in Ireland but there are at least 32 persons in Ireland who have developed it since the swine flu epidemic and the administration of the Pandemrix vaccine at that time. The symptoms include excessive sleepiness during the day time — so-called sleep paralysis — micro-sleep, where the person continues to function even though asleep, and night-time wakefulness. There is a further condition called cataplexy, which is the sudden loss of muscle control and is very dangerous for people who might want to engage in activities such as driving or normal day-to-day business. There is also a syndrome known as sleeping beauty syndrome, which is very frightening. One can imagine from its name what is entailed.

At the time of the administration of the vaccine, studies were carried out in the Scandinavian countries plus Finland which identified some causal links between the vaccine and narcolepsy, which is having a terrible effect in particular on young people in Ireland. I know at least one of the families involved in this issue and know it is literally a living nightmare for them.

There are many medium-term and long-term issues to be addressed. While I will not deal with them all today, I put the Minister for Health on notice that I intend to raise this matter on an ongoing basis. I wish to focus on two issues that arise for the families concerned. First, a study is being carried out by the Department of Health — it is referred to as an inquiry, although I am not sure of its exact status — with regard to the causal links between Pandemrix and narcolepsy. We understand this study is about to be completed. What the parents want as soon as possible is for the report to be released at least to them in order that, if there is valuable information in that document or reference to research of which the Department has become [552]aware in recent months, it would be made available to the families in the hope that a better situation for their children may result.

Second, the families want to know what efforts are continuing at a pan-European level in terms of examining further the causal links and the treatments available. Only two treatments are available, namely, ritalin and Provigil. These are both essentially stimulants to keep children awake and are not cures for the disorder. They temporarily deal with some of the symptoms that arise, as I understand it. The families want to know from research at pan-European level in regard to rare diseases, which we debated in the House some weeks ago, what efforts are under way. This problem has arisen throughout Europe and we will not solve it on our own.

The families involved want one point person to deal with in Departments. The families were offered medical cards, for example, and most have availed of this. Initially, however, the staff in the medical card section did not seem to know about this offer and people were refused medical cards even though they had been promised. While I understand this has been addressed, other issues arise, in particular in regard to the Department of Education and Skills and how these children are dealt with at school. As the Minister of State can understand, if children have the symptoms I have described, it is very difficult for them to continue their ordinary day-to-day activities, which mainly involve school at their current ages. They want one point person, preferably in the Department of Health but one who can also speak to the Department of Education and Skills, to whom they can bring all the issues, which would be helpful. These people are going through something that has not been gone through before and deserve further help.

Many other issues arise. The families have set up an organisation called SOUND and they have been making a lot of sound about this. They are willing to work with the Government but they are anxious to have some contact from the Department in regard to the studies that are ongoing.

I quoted from an Irish Examiner article of 25 February. While I do not have the name of the journalist, I hope I can give it as I quoted directly from her article, although I must return to my office to get her name. The article certainly explains the situation very clearly and in depth.

That is what I have to say at this stage. I put the Minister on notice that the parents involved are banding together in a representative body, as they should do. They intend to make noise about this and to do the best for their children. We would not expect anything less.

Deputy Dinny McGinley: Information on Dinny McGinley  Zoom on Dinny McGinley  Gabhaim buíochas leis an Seanadóir as ucht na ceiste an-tábhachtach seo a árdú agus an seans a thabhairt domsa é a thógáil ar an Athló.

As Senators are aware, the H1N1 influenza pandemic alert was issued by the World Health Organization in 2009. As part of the response, two pandemic vaccines were provided in Ireland, Pandemrix and Celvapan. Subsequently, the Irish Medicines Board, IMB, reported two confirmed cases of narcolepsy in people who had been vaccinated, and it was agreed the Health Protection Surveillance Centre, HPSC, would work with the IMB and clinical experts in narcolepsy to examine the Irish data. The HPSC conducted a retrospective population-based study and submitted a report to the Department of Health in February 2012.

The parents of those affected have formed a group, Suffers Of Unique Narcolepsy Disorder, SOUND. The Minister has already met SOUND and is available to do so again. SOUND has raised the issue of obtaining international expert advice on this matter and the HSE has agreed [553]to facilitate this request. SOUND is obviously concerned about the possible effects which a diagnosis of narcolepsy may have on their children’s education. Officials from the Department of Health, the HSE and the Department of Education and Skills have been meeting SOUND to address the parents’ concerns. There will be ongoing contact between the Department of Health and SOUND and I understand a further meeting will take place in approximately six weeks. Two members of SOUND sit on the HSE serious incident alert group which is managing the issue.

I draw to the House’s attention the additional supports being put in place, as follows: senior officials from the Department of Health met with their counterparts in the Department of Education and Skills to brief them on the report and to discuss the possible educational supports which may be required for the children affected; the HSE will assign a named individual as a single point of contact where families’ service issues can be addressed; a case definition has been agreed by clinical experts; the HSE will begin a multidisciplinary needs assessment of the children affected by requesting primary care physicians or specialists to refer to a nominated lead in each of the four regions — the regional leads have been appointed and the assessments will begin shortly; the multidisciplinary assessments will allow appropriate health and educational supports to be put in place for affected children and adolescents — those about to undertake State examinations will be prioritised; and the multidisciplinary assessments will be repeated every two years to assess the changing needs of those affected.

The Department of Health will consider all other possible supports which may need to be put in place for those affected. The possibility of having narcolepsy-cataplexy classified as a disability has been raised with the Department of Health and the issues involved will be examined prior to any proposals being formulated.

The Minister for Health is preparing a memorandum for the Government which will set out the full response to this issue and will detail the supports for the affected children, adolescents and their families. It is intended to submit it as soon as practicable.

I assure the House that the Minister is treating this issue as a matter of priority as he is aware of the difficulties which both the children affected and their parents are experiencing.

Senator Thomas Byrne: Information on Thomas Byrne  Zoom on Thomas Byrne  I want to raise a number of issues. As I stated, I intend to raise this matter repeatedly because this is a developing situation.

In the experience of my constituent no contact has been made between the Department of Education and Skills and the school involved. I am sure there will be direct contact in that regard with the Department of Education and Skills in that the schools received no advice in that regard.

The single point of contact in the HSE in terms of medical services is important, but it is also necessary between the Department of Health and the Department of Education and Skills from a policy point of view in terms of the information that is sought from across Europe. I do not know whether there are any Ministers of State serving the two Departments anymore. The HSE has agreed to facilitate the request on that pan-European issue, but I want to see more happening on it because there are procedures in place, as I understand it, from a debate here on rare diseases.

I do not think there has been mention of a document to issue shortly, apart from the memorandum to the Government. What is of immediate practical concern, apart from the medical treatment, is that any information the Government has that could be of help to the individuals be provided. We can understand legal advice and such information is not an issue, but if there [554]is information within the Department that can be of assistance, then the parents want to know about it at the earliest opportunity.

An Leas-Chathaoirleach: Information on Dennis O'Donovan  Zoom on Dennis O'Donovan  In fairness, it is up to the Minister of State. He has given a response. The Senator wanted to hightlight that issue, maybe for a future debate. I thank the Minister of State for coming to the House.

The Seanad adjourned at 5.55 p.m. until 10.30 a.m. on Wednesday, 28 March 2012.


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