Senator David Norris.
Yesterday an Adjournment Debate was held in the Seanad, initiated by Senator Norris. I had contacted him a while back asking if he could raise the issue of the suicidal homicidal adverse effects of antidepressants. While he was extremely friendly and sympathetic, I wasn’t expecting anything, as I understand it is a delicate issue to raise. The only other politician who raised my concerns was Jan O’Sullivan in a Dail debate, here.
I cannot thank Senator Norris enough and hope the usual Psychiatry brigade do not give him a hard time. The devastating side-effects of antidepressants have now been raised in the Dáil (Parliament) and the Seanad (Senate) and our meeting with the Minister for Meltal Health (Kathleen Lynch) will be held on May 3rd. People deserve to be warned and the Irish warnings are pathetic and verge on criminal. Senator Norris addressed the issue perfectly. I have so much respect for this man because he had the guts to tackle this problem head on and is no doubt prepared for the usual onslaught.
Sitting Time 17:30
Sitting Date 27/03/2012
^ Medicinal Products ^
Senator David 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 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 myself, 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.
Deputy Dinny McGinley: Gabhaim buíochas leis an Seanadóir Norris as ucht an t-ábhar 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.
Senator David Norris: I thank the Minister for his gracious reply and, in particular, for 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.
I want to further put on the record that 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: 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: I am very grateful.
End of Take