Liam Twomey (Wexford, Fine Gael)

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 Three weeks ago an anti-arthritic drug was rapidly withdrawn from the market due to the highly adverse side effects picked up in the trials which follow the launch of such drugs.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.

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