Dáil Éireann díospóireacht -
Wednesday, 9 Jul 1997

Vol. 480 No. 2

Adjournment Debate. - Test Trials on Orphans.

Mr. Shatter

I too congratulate the Leas-Cheann Comhairle on his election to that post. I wish him well. I know he will conduct business extremely well in the context of his experience in the House.

While Deputy Cowen and I have been protagonists on occasions, I congratulate him on his appointment as Minister for Health. I welcome the fact that he is present to deal with this issue.

Newspaper reports have now been confirmed by Glaxo Wellcome that the Wellcome pharmaceutical company used children in orphanages in Ireland in 1973 and 1960 for the carrying out of trials on new vaccines. That is extremely disturbing. It appears from what has been reported in our newspapers and from a statement made by the Wellcome Corporation that it accepts that orphans were used as guinea pigs in drug trials. It appears such trials were run in 1973 involving 57 children in two children's homes and in 1960 an unknown number of children were used in the carrying out of drug trials in five children's homes. Even more extraordinary we have been told by Wellcome that the trials in 1973, whatever of the l960 trials, were approved by the National Drugs Advisory Board and then carried out.

Children were put in orphanages or residential homes to be properly cared for and those running the homes exercised a very sacred trust over those children. It is extraordinary that such a cavalier attitude was shown to those children. They were regarded as objects available to the medical profession for the testing of new pharmaceutical products. That is entirely unacceptable. Tests of this nature were conducted on children in Irish residential institutions because multinational corporations would have fallen foul of the law in their home base if they had carried out such testing there. If the Wellcome Corporation carried out such testing in the United States, what would have been the reaction?

This happened when none of us was in politics and no responsibility attaches to the Minister for what occurred. However, there are a series of questions we are entitled to have answered. Will the Minister arrange for a formal inquiry to be conducted into these events to obtain the answers for these questions? The Wellcome Corporation admitted to such tests being organised and funded by them. How many other such tests were carried out on children in Irish residential homes in the sixties and early seventies? Were such tests carried out on children in homes in the fifties? How many children were affected? Were there any long-term implications for any of those children who were used as guinea pigs? Was consideration ever given to obtaining permission from relations of the children?

Those in charge of residential homes had no power to allow children in their homes to be used in that way; we must assume they assented to their being so used. In my view they could not have done so without court orders, the children having been made wards of court. I cannot see any circumstances in which our courts under our then laws would have sanctioned children being used in that way. Are there any records remaining that may be held by the pharmaceutical company, the medical practitioners who carried out those tests or those who were in charge of children's homes of which children were so used? Is there any way to follow up those who were subjected to testing who are now in the middle of their adult years to find out if what they were subjected to has had a detrimental impact on their health?

There are a series of questions to be asked and the ones I am raising this evening are by no means exhaustive. Are there any people currently living or born in this State who were in residential homes now suffering illness they suspect may have derived from something that occurred during their childhood because of such testing?

Too often we hear that events which occurred in orphanages or children's homes in this State decades ago occurred in a different era and that we are now judging these events by the mores of today. We have heard that excuse put forward, if not to justify then at least defend why some children were treated brutally in orphanages that operated in this State in the forties, fifties and sixties. Some of these events took place in the early seventies when we were conscious of children's rights and aware of our obligations to children. In this House in the early seventies, there were debates about issues relating to children and the need to protect their rights. However, what happened showed an extraordinarily cavalier attitude to children's rights and is unacceptable.

I emphasise that the current Minister for Health, Deputy Cowen, holds no responsibility for the events which occurred. The Minister and the Government have a definite responsibility to inquire into what occurred, to get answers to these questions and to ensure that no child in a residential institution either run by a State agency or a voluntary group is ever again used as a guinea pig in the testing of pharmaceutical products for multinational corporations.

Minister for Health (Mr. Cowen)

A Leas-Cheann Comhairle, comhghairdeas on your elevation today. I thank Deputy Shatter for allowing me to raise this matter. Before dealing with the Deputy's specific question, I would like to take this opportunity to clarify and put in context three issues relating to the vaccination of children which have been the subject of extensive recent media comment.

There has been comment about the outcome of the work of the expert group which examined the cases of 93 children between 1977 and 1984 to establish if their condition was linked to the administration of the pertussis or whooping cough component of the 3-in-1 — DTP-vaccine. This is a separate and distinct matter from the vaccination of children in orphanages and I will return to it later in my reply. Recent media reports have also referred to the vaccination of children in orphanages in 1960-61 and in 1973. These reports are not new.

They were the subject of media comment in October 1990 and May 1991 and the then Minister, Deputy Rory O'Hanlon, answered questions in the House on the matter on 7 May 1991. Essentially, we are now addressing the same issues.

Before giving all the information now available to me in relation to the 1960-61 and 1973 studies I want to clarify a number of very important points which are critical to a proper appreciation of the issues we are considering. The administration of the vaccines to the children in the children's homes was not in any way experimental. The children were due to be vaccinated in accordance with scheduled vaccination programmes at the time and the vaccines used were all approved under the regulatory framework which prevailed at the time.

The purpose of the studies was to determine which of the approved vaccines was most appropriate for use in the national vaccination programmes. The 1973 study, as I will make clear, was the larger study and was not confined to children's homes. The medical officers attending the homes gave their permission for the administration of the vaccines and were perceived to be acting in loco parentis in so doing. All the information available to me indicates that not only were the studies carried out in accordance with the then prevailing ethical guidelines but that additional measures were taken on a voluntary basis to ensure the highest standards of safety and efficacy. I would now like to provide the information available to me on both these studies.

The 1960-61 study was the subject of a subsequent report in the British Medical Journal of 21 April 1962. It described a comparative study comparing 3-in-1 — diphtheria, tetanus, pertussis — and separate polio immunisation with a 4-in-1 — all vaccines combined — carried out on 52 children resident in five orphanages. The vaccines were administered to the children as part of the child immunisation programme. The study was carried out in accordance with the then prevailing ethical guidelines and no adverse reactions occurred which were ascribed to the immunisations.

Mr. Broughan

Do they have different ethics in England?

Mr. Cowen

I am giving the House all the information that is available to me. If the Deputy has any further questions he can table them and I will answer them in full.

The immunisations were conducted with the consent of the medical officers attending the children's homes and this is acknowledged in the British Medical Journal article. It is a fact that information on this study has been in the public domain for 35 years. In addition to the facts set out in the BMJ article I have been informed, as a result of recent intensive inquiries by my Department, that a number of children who were adopted subsequent to the vaccination study were followed up to be given booster vaccinations for polio, as required, as it had emerged that the separate polio vaccination was more effective than the four vaccines combined. I think this shows an impressive level of care and commitment, given the inevitable difficulties in following up on adopted children.

I would now like to set out the information available to me in relation to the 1973 study. In 1973, the Eastern Health Board noted above expected levels of transitory adverse reactions following the administration of DPT vaccine and discussed this with the pharmaceutical company. The health board co-operated with the company in carrying out a comparative study comparing four types of DPT vaccines, two of which were already in use and two of which were composed of the same basic components and which were approved.

Prior to the study being undertaken, Wellcome, the company supplying the vaccine, submitted a detailed Protocol to the National Drugs Advisory Board, to which the board raised no objection. This was done on a voluntary basis as there was no statutory requirement to do so. The study proceeded on this basis. A total of 116 children were involved, 59 children being in the community and 57 children from two children's homes in the Dublin area. The children participating in this study were due to be immunised with DPT vaccine as part of the national immunisation programme. The results of the study were inconclusive, in that no significant difference between the vaccines emerged.

I am not aware of any other similar studies or trials involving children in orphanages, but I have asked all health boards to report to the Department on the situation as a matter of urgency. When this information is received I will review the situation and decide what further action, if any, should be taken.

It is inaccurate and extremely unhelpful to refer to the children vaccinated during these studies as guinea pigs and I hope the information I have given will help to reassure all those involved that nothing irregular was undertaken.

I would like to take this opportunity to urge parents to continue to have their children immunised against whooping cough. The benefits greatly outweigh any risk. Whooping cough is a serious and distressing disease which can have severe complications such as convulsions, pneumonia, brain damage and, in some cases, death. It is also essential that we increase our uptake level of DPT vaccine to eliminate the disease. I would like to reassure parents that DPT is a safe and effective vaccine. There are very few contraindications and these are advised in the recently published guidelines on immunisation which have been made available to all doctors involved in primary childhood immunisation.

Finally, I wish to refer briefly to the work of the expert group. The Expert Medical Group on Whooping Cough Vaccination was established in 1977 by the Minister for Health "to examine persons who, it was claimed, had been permanently damaged by whooping cough vaccination, to review the medical information available in relation to them and to indicate whether, in its opinion, the damage was attributable to the vaccination".

Some 93 cases — and I am well aware that this means 93 children, indeed 93 families — presented themselves to that group. The group found there was a reasonable probability that the vaccine was responsible for damage in 16 of these cases. Where there was a reasonable doubt in any case, the group gave the benefit of that doubt to that person.

Between 1982 and 1984 an offer of an ex gratia payment of £10,000 was made in each of the 16 cases, from the group of 93, where the expert medical group found in favour of the children. Thirteen families accepted the offer of the ex gratia payment. One other case was processed through the courts. The Supreme Court held in that case that the pharmaceutical company was liable for that person's brain damage.

Since then, where requested, the Department of Health has made available to the families concerned the expert medical group's file.