Liam Twomey (Wexford, Fine Gael)
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I congratulate the Tánaiste on her new position as Minister for Health and Children. She has taken on a very responsible job and I wish her the best in it as the area is a very difficult one. In her role as Minister for Health and Children and in mine as Fine Gael spokesperson on health, patient care is our primary concern.

Ireland has a significant pharmaceutical industry and the issue I now bring up is no reflection on it because most of the businesses involved operate to highly ethical standards. Three weeks ago an anti-arthritic drug was rapidly withdrawn from the market due to the highly adverse side effects picked up in the trials which follow the launch of such drugs. The matter was treated very quickly and professionally, which is how we like to see things done because we all know that adverse reactions can show up at a later date, while not necessarily showing up during extensive clinical trials.

However, allegations made in a recent "Panorama" programme about another drug must be raised in this House because of the serious implications not only for psychiatry but for all medicine and especially the medication and drug industry. I do not know if the Minister is aware of this but if so I would like to know if she has made inquiries about the "Panorama" programme, if she knows what was said on it and if she has had inquiries from Glaxo SmithKline regarding the issues raised.

I am not making specific allegations against the drug company involved. Given that such a wealth of clinical data is made available on every drug, the information can sometimes be overlooked and missed, rather than deliberately being presented in a misleading manner. However, concerns were raised on "Panorama" about some of the data on this anti-depressant drug and since the drug is available in this country and is widely used, we should investigate the matter. I will read some remarks made on the programme by the President of the Royal College of Psychiatrists in the UK:

I personally felt cheated, and heaven only knows what the children, adolescents, their parents and their GPs on the other end of that felt — very much the same. I also felt very confused because I know that there are some of my patients in the past for whom the SSRIs have been important in their recovery as well as all the other things that I might be doing with them, and yet suddenly the balance between risk and benefit was quite clearly tilted in a different way.

He was talking about the clinical trials data which were shown up in the course of the programme, suggesting the company was deliberately misleading the regulatory bodies in the UK as to the effectiveness of the drug. It was stated on the programme that the drug, which would increase the adverse reactions for children, in other words increase the risk of suicide, had no beneficial effects compared to placebos and other treatments for those children. Further clinical trials showed that the drug raised the risk of suicide through all age groups. That may be an effect of all selective serotonin re-uptake inhibitors, SSRIs, but the company involved with this drug seems to have moved to cover up its status. An indication that this was so was given in the following note quoted on the programme:

Confidential — for internal use only, October 1998. It would be commercially unacceptable to include a statement that efficacy has not been demonstrated, as this would undermine the profile of the drug in question.

As legislators and Members of the Oireachtas, we must take seriously such practices that may be occurring with regard to pharmaceutical products, which I am using for my patients and which are being prescribed for other patients in Ireland. Will the Tánaiste inquire into the matter? Many thousands of drugs are prescribed in this country every year and we are lucky to have a very low adverse incidence with mandated drugs. There may be some hype involved regarding the drug in question but the issue is important enough to be dealt with at official level.

Tim O'Malley (Limerick East, Progressive Democrats)
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I thank Deputy Twomey for raising this issue and I welcome the opportunity to reply. I am well aware of this problem, which has been in the public arena since before the screening of the "Panorama" programme. Unfortunately I did not see that programme but I have discussed it with several members of the expert group which I set up about a year ago to examine the mental health area. That group will examine the issue, on which it has very strong views, and will return to me next year.

The Irish Medicines Board is the statutory body responsible for the regulation of medicinal products in Ireland. It is responsible for monitoring the safety of all medicinal products licensed for use in Ireland and for evaluating all new scientific data that emerge. In consultation with its European colleagues, the IMB has continuously monitored the safety of the class of medicines known as selective serotonin re-uptake inhibitors since they were first licensed for the Irish market several years ago.

The board has taken regulatory action on these products when deemed necessary. Most recently the board took part in a European-wide review of medicinal products containing paroxetine, one of the group of SSRIs used to treat mild to moderate depression and which includes Seroxat. This review was undertaken on the basis of safety concerns relating to these products. The board actively participated in the review, which involved a complete benefit-risk reassessment. The review concluded that the benefit-risk profile of products containing paroxetine remains positive. A number of recommendations were made for inclusion in the products licence documents, the purpose of which was to harmonise the information on these products throughout member states. This documentation includes special warnings and precautions for use, particularly on the need for close monitoring of patients using medicinal products containing paroxetine.

I am informed that the majority of these recommendations are reflected in the licence documentation currently approved in Ireland. These include a warning to reflect that paroxetine should not be used in children and adolescents. In the EU paroxetine is not authorised for use in this population. Data from clinical trials raised concerns regarding suicidal behaviour and hostility. In addition, data from clinical trials have not adequately demonstrated efficacy in these age groups. Although paroxetine is not authorised for use in children and adolescents, doctors can prescribe this product for an individual patient if they feel it may be of benefit. However, they are advised to exercise caution. Alternative treatments for childhood depression such as cognitive behavioural therapy may be prescribed by child psychiatrists.

Prescribers are warned to recommend close monitoring of patients at high risk of suicidal behaviour. These include patients with a known history of suicidal behaviour or suicidal thoughts prior to starting treatment and possibly young adults. There is also a recommendation that prescribers and patients should be warned regarding the occurrence of withdrawal reactions on stopping treatment. Generally, these are mild to moderate and self-limiting. However, in some patients they may be severe and-or prolonged.

Following a review of the existing data on paroxetine by medical experts from the member states, these recommendations were issued. Ireland — via the IMB and its national experts — participated in this review and I am advised these recommendations are considered appropriate on the basis of the data assessed. The committee for human medicinal products, a scientific committee of the EMEA, will take further action on paroxetine if new data emerge which indicate that this is necessary. This committee is currently considering a review of all the other SSRIs and related anti-depressants and I understand a review of these issues is also ongoing in America.

The Deputy will appreciate that the full safety profile of a medicine only becomes apparent after long-term and widespread use. As regards medicines used in the treatment of psychiatric disorders, it may be particularly difficult to distinguish between the underlying condition and the possible effects of new treatment. These issues are under continuous review by the Irish Medicines Board and its European counterparts. The Deputy may rest assured that my Department, which is continually monitoring the situation, will take any further regulatory action deemed appropriate.