The report of the chief medical officer of the Department of Health and Children into certain clinical trials involving residents of children's homes was laid before both Houses last week.
The three clinical trials – all of them involving vaccines – happened in the 1960s and 1970s. Questions of ethical propriety, consent and responsibility have been raised. These children were in the care of the State and it is important to establish if the State fulfilled its obligations to them. The report does not and could not provide answers to all the questions raised and it cannot be the end of our interrogation of this issue.
I will provide Senators with some background information on the three trials. Trial No. 1, published in 1962, examined what would happen if four vaccines, diphtheria, whooping cough, tetanus and polio, were combined in one. At the time, the standard approach was to administer tetanus vaccine and polio vaccine separately at different times and at different injection sites.
Trial No. 2, published in 1971, was to find out if German measles vaccine, administered intranasally, could spread to susceptible contacts. If it did, serious consequences could ensue, particularly for pregnant women.
Trial No. 3 was carried out during 1973, but not published. It compared the propensity of a commercially available DPT vaccine to produce adverse reactions as against the capacity of a modified vaccine to produce the same reactions. The modified vaccine had fewer organisms per dose.
Concern about this matter first surfaced almost a decade ago when raised by former residents of children's homes where the vaccination trials appear to have been conducted. The then Minister for Health first answered questions in the Dáil on this matter in 1991. In 1993, there was correspondence between the then Minister and a former resident in a Dublin children's home.
In 1997, my predecessor as Minister, Deputy Cowen, promised the Dáil that he would have inquiries made into the matter following which he would consider what was the most appropriate action to take. The Minister asked Dr. James Kiely, chief medical officer of the Department, to make the promised inquiries.
From the moment I became Minister for Health and Children, I have been aware of this issue. I have met a representative of past residents of a number of children's homes who believe they might have been involved in these trials.
Even though there does not seem to have been any negative medical outcome for any of these children, the story has made many of them extremely anxious. I arranged with the chief executive officers of the relevant boards, the Eastern Regional Health Authority and the Southern Health Board, that where supporting documentary evidence is available, former residents can be informed immediately whether they were part of any of these three trials. For former residents of the homes in Dublin area, the Eastern Regional Health Authority's customer service telephone number is 1800 520 520 and for former residents of Bessboro in Cork the relevant Southern Health Board's telephone number is 021 486 1260. In addition, I have ensured a counselling service for any former resident of a children's home involved in such trials, which is also available from the relevant health boards.
Before submitting his report to me, Dr. Kiely sent draft copies to anybody named in it who might be affected by its publication. That afforded them the opportunity to comment on the contents. All those comments were considered fully.
On the face of it, the trials appear to have had no medically negative consequences for any of the children involved. In some cases, the vaccine used was somewhat weaker than the alternative, but when this emerged, booster doses were given to many of the children involved. We have no evidence that any child contracted a serious illness as a result of the trials.
In view of the fact that the report makes no suggestion that any child was directly harmed by these trials and that two of them were published in prestigious medical publications, it might be expected that, as Minister for Health and Children, I should now be saying that this is the end of the story, but I want to make it clear that is not what I am saying.
The chief medical officer's report is a good report, but it is incomplete. It raises as many questions as it answers. Some of those questions go to the heart of our attitudes to children and their rights. The report is incomplete because in some areas, the most rigorous interrogation of the system failed to produce documentary records of the trials. While we must remember that the trials were not recent, this lack of documentation is at best puzzling. It is certainly unsatisfactory and it is my hope that perhaps the publication of this report will help us to fill in the missing bits in the jigsaw by stimulating memories or helping to locate lost files.
I have read and reread this report. I have discussed it with the chief medical officer in detail. In spite of the information gaps and the indications that no child was medically harmed, each reading made me more sure that his work must be regarded as the beginning and not the end of the matter. When a child comes into the care of the State, the State must fight fiercely for all of that child's rights, rights such as bodily integrity. The State does not have the right to view children in care as lesser citizens. Their bodily integrity is a basic human right, which can never be watered down or infringed.
When we consider vaccination trials, the issue of consent is involved immediately. I am not satisfied that the chief medical officer has been able to find solid, informed consent on the record, given by the people who were entitled to give it. Let me put this in context, the history of drug trials includes some ghastly case studies where the rights of individuals were grievously ignored.
The vaccine trials covered in this report are in a different league, a different country and a different time. In addressing them, we must be careful of the reputations of the highly regarded professionals involved. We must remember that, in many cases, we are looking at marginal degrees of difference in the vaccines administered, not at experimental, unproven or dangerous medications. We must take into account that the protocols of 30 years ago are not necessarily the protocols applied today.
The key issue, that of consent, cannot be fudged because it is fundamental. Children in care have the same rights as other children. The vindication of those rights is the constant responsibility of the State. We need to find out if we cared for the children the way we, as a nation, should have cared for them. If we did not, we need to find out why the failure happened and we need to apply what we learn to the future. That is our responsibility, as legislators, to the general good.
As Minister for Health and Children, my responsibility goes further. It goes to the individual children involved and it means I must ask questions this report cannot answer. For instance, if one group of children was given the more experimental vaccine, why did the children in care get that one? What rationale led to the decision that children not in the State's care got the regular vaccine while children in care got the variant? Was the end result from each trial for the public good or for the commercial advantage of a manufacturer? Why were some medications given to children who were outside the age group and which of these medications were known to be effective? Above all, why are the records of some of the trial so woefully inadequate at almost every point?
All those questions must be asked irrespective of the overall intent of the trials and the indications that no child suffered medically as a result. Not only must they be asked but they must be asked in a context which offers the competence to carry out investigative and therapeutic trawls. For that reason this report has been sent to Justice Laffoy so that the Commission to Inquire into Child Abuse may consider it as part of its wide-ranging investigation. This decision is based on the rights of those involved, who are entitled to a thorough, wide-ranging and public investigation of the ethical issues involved. The Laffoy Commission offers a comprehensive vehicle for dealing expeditiously and rigorously with the totality of the issues. Contrary to what some people have alleged, this would include an examination of the role of my Department in the matter.
The commission's terms of reference are broad and it has the full gamut of powers and personnel needed, an experienced secretariat, a strong panel of experts with the requisite qualifications and an investigative and legal infrastructure. That combination offers an unrivalled capacity for ruthless thoroughness and appropriate speed. Much of what the Laffoy Commission has been investigating runs parallel to this, so the search methods for documents going back to the 1950s is already in place. There is a clear synergy between investigating this matter and the other matters being addressed by the Laffoy Commission. The full gamut of powers at its disposal means that we do not have to reinvent the wheel, the instrument for comprehensive investigation exists.
In that context, arising from exchanges in the Dáil yesterday on the Order of Business we sought further clarification in terms of the legal situation from the Attorney General and we will be tabling a motion sometime next week regarding referral of the report to the Joint Committee on Health and Children for its consideration. We have a motion on the Dáil Order Paper referring the report to that committee for its consideration but we will have full clarity on that tomorrow morning.
Not only does that instrument for investigation exist but there is provision for compellability and it has the capacity to provide for confidentiality for witnesses. This route is the ultimate guarantee against a cover-up or whitewash. Justice Laffoy has indicated her willingness and competence to take this on. I am grateful to her and my Department will of course co-operate fully with her.
We believe that entering this process makes a clear and unambiguous statement to those involved in the trials: "We do not know whether your rights were protected all those years ago, we just do not know, but we believe it is important for you and for the wider society to move heaven and earth to find out and we want to do it in a forum which has the power to investigate, to compel witnesses and to publish its findings without fear or favour to ensure compensation is made if that is required." I recognise the keen interest of Members in the report and that is why it is going before the Joint Committee on Health and Children for its consideration.
A desperately simple question comes out of this report. Reading it one finds oneself wondering out loud, who was minding the rights of the child? We do not know the full answer to that but we can answer the second question as to who is now endeavouring to mind the rights of those who were participants in the trials. Through the information and counselling services arranged with the health boards, publication of this report and its proper referral to the Laffoy Commission, it is clear that we are determined to vindicate the rights of the adults who participated in these trials as children.