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Seanad Éireann debate -
Wednesday, 15 Nov 2000

Vol. 164 No. 10

Clinical Vaccine Trials Report: Statements.

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.

I welcome this debate. What disturbs me is that, welcome though this report is, it seems to have been sat upon in the Department for two years. I am not criticising the Minister too much, as he is relatively new to this portfolio, but we have known that the report was complete since early 1999. We should recognise the distress of those who were children in the orphanages and homes where these trials were carried out. This delay leads to even more distress. When one considers that the first we heard of this matter was in The Sunday Tribune of 28 October 1990, it has taken a long time to reach this stage. I am glad we now have the opportunity to debate the matter in the open, but it is incredible to be reminded of how long ago this came to public knowledge.

I was reading that edition of The Sunday Tribune report when preparing for this debate and one pithy remark in it struck me forcefully when the Minister mentioned children's rights. The article mentioned the fact that trials took place, and Dr. Patrick Meenan is quoted as saying:

In those days there was almost a tradition of doing testing in orphanages. You went to where the material was, to put it crudely.

At least we have now gone beyond that, a fact he also recognised.

As the Minister may know, I have personal knowledge of two of the homes involved. The Cottage Home for Little Children and Mrs. Smylie's Home, or the Bird's Nest, are both in Dún Laoghaire. I acknowledge the pain and distress of those who were children in those homes, some of whom are friends of mine. The Minister will be aware that Councillor Victor Boyhan has been very involved in this matter, having been in the Bird's Nest home.

In relation to Mrs. Smylie's Home, while the chief medical officer indicated he was aware a trial was taking place, he stated that he believed that the children in this home were being given the standard vaccines and were being used for comparison with other children being given the vaccines prepared for the trial elsewhere. In the case of the Cottage Home, the chairman of the committee of management stated that he was satisfied that at no time were trials carried out on children in this home and that only standard vaccines in routine use were administered to these children. He subsequently clarified his statement saying that it was based on information supplied to the home by Dr. Webb and Professor Hillery and was not arrived at by reference to any independent source. The documentation provided by Wellcome shows that the vaccines prepared for the trial were administered to the children in these two homes in the context of a clinical trial. The report says it is unclear whether effective consent was obtained in relation to the participation of children in these two homes in the trial.

It is strange how these matters hit one locally. In my constituency there are particular concerns about the report and what happened to those children in the 1960s and 1970s. As we know, the report deals with three sets of vaccine trials which were carried out at that time. The first trial was of 58 infants in five children's homes and it compared polio vaccination given separately to the three in one – diphtheria, tetanus and whooping cough – and the quadruple vaccine where all four were given together. The second trial involved 69 children in children's homes in Dublin and 23 children living at home who were given the same vaccine for rubella. The third trial was of 53 children in mother and baby and children's homes in Dublin. There were five of those and 65 children were given different sets of vaccines – those children were at home.

As I said, the children's institutions administered the modified three in one vaccine, while the children at home got the usual vaccine available through the Eastern Health Board. I have been told that the board instigated the third trial in 1973 because of objections to the three in one vaccines in use at the time. As we know, the Department of Health at the time, through the agency of the National Drugs Advisory Board, did not object to any of the trials going ahead.

That must raise questions about the role of the Department of Health and Children, a matter raised by Deputy Gay Mitchell. He stated that an expert group was set up in 1977 by the Minister for Health to examine people who, it was claimed, at the time had been permanently damaged by whooping cough vaccination in the 1960s and 1970s. That group found that in 16 of the 93 cases presented to it there was a reasonable probability that the vaccine was responsible. An ex gratia payment was offered to each of the 16 to the sum of £16,000 and 15 of them took the payment. In 1992 the Supreme Court found in favour of the 16th person, Mr. Kenneth Best.

According to the research seen by Deputy Mitchell, the vaccine was administered to at least 243 children in 1968 and 1969. The clinical vaccine trials were obviously taking place in the homes during the same period. The Deputy, not unreasonably, makes the connection between the suspicion about the bad batch of whooping cough vaccination and the reaction to it by so many children throughout the country and the trial tests subsequently carried out on children. He asks questions about the role of the Department of Health and Children and its agencies in this regard. That is one of the many questions which must be answered as a result of this report.

The report is unsatisfactory because, as the Minister said, it raises as many questions as it answers. That is unfortunate. In terms of getting at the truth about what happened, the option preferred by the adults who were the children in question in these homes was to have an independent tribunal of inquiry. Having been persuaded by the Minister they now accept that the report should be sent to the Laffoy Commission on Child Abuse. The people in question wanted a tribunal of inquiry to investigate this matter because it would be able to deal specifically and solely with drug trials. Their main concern was that their case would be appended to the work being carried out by the Laffoy Commission.

I do not wish, in any sense, to take away from Ms Justice Laffoy and the work she is doing. However, people must understand the fears of people who have already experienced delay. In the estimation of these individuals, this matter has been ongoing since 1990.

As Members know, the Laffoy Commission to Inquire into Child Abuse covers physical and sexual abuse without distinction. However, there is a belief that the matter in question is a separate and distinct case. One can understand people's concerns in that regard and I would query the timeframe it is intended to impose in relation to this matter.

Notwithstanding the fact that it is proposed that the report be referred to the Laffoy Commission, the Minister stated that it would also be referred to the Joint Committee on Health and Children for its consideration. I await the proposals he will produce tomorrow on foot of the recommendation of the Attorney General. My colleagues certainly believe that the joint committee should be empowered to investigate this matter, particularly in terms of the role played by the Department of Health and Children in authorising or approving vaccine tests on children in institutions and any other questions which might arise.

The Minister is aware of and sensitive to the need to listen to those people who have been affected. As he stated, we do not believe they were affected physically by what happened in the 1960s and 1970s but there is no doubt that they were psychologically affected. We must learn from the other investigations that took place and listen to the stories told by victims of abuse. It is important that we know what questions they want to have answered before the Laffoy Commission commences its work.

The people to whom I refer want to see the terms of reference which will apply; they want to ask questions about the relationship between the Department of Health, University College Dublin and the Eastern Health Board; they need to know if there is a register of all the children who were involved; and they are intent on discovering whether the Minister has all the information he requires. They also want to be informed about the help and support that has been given to the children affected by these trials in the 1960s and 1970s.

The Minister stated that these people can contact an 1850 number. That number should be advertised in the national press. I accept that the number of those involved is not huge, but there is a need to reach out to all of them. The Minister also referred to counselling services. If we want to give support to the people involved, we should make it as easy as possible for them to access that support. We should not make life more difficult for them. It is at the time when people feel vulnerable and hurt that we must reach out to them. They must not be obliged to make requests for help. The people involved feel they suffered, and we must offer them our support, not wait for them to beseech us for help.

Another crucial issue for the people to whom I refer is the information that will be made available to them. For example, will their personal files or medical files be made available to them? If not, will their medical files be made available to their family doctors? I do not believe that is an unreasonable request. These are the types of questions which must be answered because it is vitally important that we learn lessons from this matter and ensure that the necessary safeguards are put in place.

There must be a speedy response to the demands of everyone involved. Answers must be given to questions the report failed to answer. The Minister alluded to those questions earlier but there is no harm in reiterating them. Why were the children in care exposed to the more experimental vaccine? What was the rationale behind this? Were the trials held for the public good or for the commercial advantage of the manufacturer? The fact that some of the medication was given to children outside the age group at which the vaccines were known to be effective raises serious questions. Why are the records not full and complete?

The Minister identified these questions as those which require answers but he must also listen and ensure that the terms of reference cover all aspects of the fears and concerns of those who see themselves as victims. We must remember that the report states that, theoretically, vaccines did not leave children open to adverse effects and there is no evidence that any occurred. However, the inadequacy of records must come under extra scrutiny because of that statement. There is no doubt, as the report points out, that there are breaches of the Nuremberg code of 1947 and the Declaration of Helsinki of 1964 in relation to consent. There are other questions that need to be asked, specifically in respect of the role of the Department of Health and Children and those of its agencies to which I referred.

The fact that the Department decided who should investigate this matter was challenged by many of those involved. I ask the Minister to confirm that the fact that the Laffoy Commission is investigating this report will not inhibit the Oireachtas Joint Committee on Health and Chil dren in its deliberations. In that context, it must be borne in mind that the Minister is due to come before the Lower House to outline the advice he has received.

When all things are considered, it is important that we vindicate the rights of children. We must ensure that the Laffoy Commission is given appropriate terms of reference. We must also ensure there is a speedy resolution to any investigation so that those affected will be guaranteed that their rights will be vindicated.

I welcome the Minister and compliment him on his excellent contribution which was open, forthright, honest and courageous. If the follow-through is on a par with his speech, we will get to the bottom of this matter in a quick and efficient way. Whether any Minister, doctor or other individual can address everyone's fears or deal with the trauma which has resulted from those fears is another day's work.

I wish to highlight a number of points which struck me during the Minister's contribution. The trials in question were conducted in an era when the culture of authoritarianism was rampant throughout Ireland. Anyone who lived during that period will know that our society has changed completely. There is a danger of using the standards of today to judge the standards of yesterday.

Another point which emerged from the Minister's contribution – he did not refer to it directly, but it is contained in the sub-text – is the danger of too close a relationship between the medical profession and drug companies. That is one of the dangers of too close a relationship between the medical profession and drug companies. The medical profession's agenda is supposed to be the disinterested pursuit of its patients' health and well-being, while drug companies, no matter how ethical, have a different agenda, that is, to make money.

To put the matter in context, it is important to remember that these trials were carried out at a time when we had come through the worst polio epidemic ever seen. The Minister's home county suffered more than other county from this epidemic. Dublin escaped relatively lightly, but Cork was in an emergency situation for many months.

This matter raises three major issues, the first of which is the ethics of using humans in clinical trials no matter how well meaning the testers and people pursuing the trials are. Second is the issue of informed consent. While adults may be able to give informed consent, children definitely cannot do so as they do not have the necessary power or understanding of the issues in terms of their health. I may be accused of being authoritarian, but no person under 18 years should be allowed to partake in these trials. I have grave doubts about using humans in such trials, but there are strong arguments for using people who have been properly informed about the risks.

Third, there must be statutory control over trials. At the time these trials were carried out there was either none or very little statutory control over their conduct. The people involved were mainly children in care and obviously blanket consent was given by people who were not their parents. If I was asked to allow one of my children to take part in a clinical trial which had a million to one chance of endangering their health my answer would be "no". I do not think any Member of the Seanad would agree to such a request today.

As late as 1973 a senior medical figure in the House of Lords, in response to a proposal to legislate for the introduction of ethics committees to supervise research in the national health service, stated:

The provision of these ethical committees is not a suitable subject for legislation. We should leave things as they are and trust in the good sense and responsibility of the doctors.

Like Senator Henry, I have been involved in the medical profession for a long time and doctors, like everyone else, are prone to making mistakes or misjudgments. The person who made that statement would not get away with making it now in this or any other House.

At that time ethical considerations were not of primary importance. My ethics lectures in college dealt with sex, human relationships, procreation, etc., but to the best of my knowledge – I may be wrong – no reference was made to the ethics of conducting trials into medication. During the 1960s and 1970s, ethics was not a very serious subject in medical school. Researchers generally did not query ethical standards or have them to the forefront when considering trials.

There was little statutory control over these trials and, unlike the Flood and Moriarty tribunals, there does not appear to be a paper trial. Very few notes seem to have been taken and there is minimal documentation on these trials in terms of the people involved, their names, ages and addresses. We know the medications used, one of which was of a weaker strength than that used by the Department of Health and health boards or, as they were known then, the county medical boards. I am talking about DPT, which is used every day. I do not know why one of the medications used in the trial should have been of a weaker consistency.

This brings me back to the rights of children and their right to know what was done and why it was done. These trials were small. They would not be considered adequate by today's standards as the numbers were too small to give proper results. In fact, Burroughs Wellcome did not use the results. The results were published in the British Medical Journal, probably the most reputable medical journal in the English language. It published the article but did not carry out an in-depth inquiry into the ethics of using these medications or vaccines on these children who were in care.

It is correct that the Minister referred the matter to the Laffoy Commission, which has the proper background, experience and staff. It also has the necessary trained bureaucracy in place – I do not use this as a pejorative term. It has done an excellent job in the hepatitis C investigation and if that standard is maintained in this investigation then we will get answers quickly and efficiently.

I wish to share my time with Senator Norris.

Is that agreed? Agreed.

I thank the Minister for his statement. I also listened to his statement in the Dáil last week. I know both the first and second authors of the trials and the chief medical officer. I am glad the Minister recognised in the Dáil that these people's professional reputations are also of importance.

It is of the utmost importance that those involved in the trials, especially those who lived in homes, should get their medical records. It is ridiculous that it has taken nearly ten years to get to this position. There seems to be a paucity of records and in this context I was very much taken by one letter to Dr. Kiley which stated: "Lack of records could be due to the fact that the files you are seeking are quite likely in the category of no longer existing." This is a nice way of saying the files had been destroyed. The fact that these records no longer exist has nothing to do with malice. One person who wrote in said that prior to the Archives Act, 1987, records were not so carefully kept. It is important to make this point.

Dr. Irene Hillery and Professor Patrick Meenan are two of the most important people to have ever been involved in virology and microbiology. It is important to remember that Professor Meenan was a barrister as well as a doctor. It is extraordinarily difficult to think that they would do anything which was outside what they considered to be proper and legal at the time. I cannot comment on how the Department of Health should have defended the rights of the children in care. However, given that Professor Meenan was the holder of a licence under the Therapeutic Substances Act, 1932, he would have been extremely careful about the importation of vaccines. I do not think anyone has queried this point.

The Department must have examined whatever work they were doing because a trial was turned down in 1962. The reasons were not given in the report. The Department must have known trials were taking place and it could hardly have thought they were being carried out at UCD. The Minister stated in the Dáil that the Department did not know whether it was legal for people to carry out trials outside UCD. It would be impossible for people to carry out such trials in UCD. The Department must have had a certain involvement in this. It is important to stress that no one involved on the medical side of these trials gained monetarily.

The third person I know who was mentioned in the report is Dr. Pearl Dunleavy, who was the assistant chief medical officer of the Eastern Health Board at the time. Her sole concern in getting the third trial under way was to try to avoid local reactions in small children so that their arms would not be sore. She was concerned that mothers refrained from bringing their children for second and third uptakes of the vaccination because of sore arms.

This is a look back exercise and it is important for us to recall Ireland 50 years ago. Communicable diseases accounted for 25% of deaths at that time. These disease included diphtheria, influenza, polio, measles and whooping cough. Improved socio-economic conditions and the development of new drugs were important but the immunisation programmes were also extremely important. Immunisation against diphtheria, whooping cough and tetanus was introduced in 1952/53 and against polio in 1957 following a terrible epidemic. The number of cases of these diseases rapidly declined to a fraction of pre-immunisation levels.

We had become complacent about the seriousness of these conditions until there was a measles epidemic this year. It is important to recall the two deaths from measles in 2000. I do not know if there were deaths in any other European country. Hundreds of thousands of children die throughout the world from measles. These are serious conditions and the trials were not conducted in regard to something trivial.

The focus nowadays has rightly shifted to vaccine safety but these trials were designed to ascertain a good antibody result with a minimum of adverse affects. Two of the vaccine trials were entirely benevolent. They sought to try to find out if one could reduce the number of injections given to children. The triple vaccine was normally injected in one arm of the child and the polio vaccine in the other. The report refers to other trials carried out in Canada at the same time and I am aware that the Medical Research Council was carrying out similar trials in Cardiff and Bristol which are not mentioned in the report.

An English company did not descend on Ireland to try to experiment on children. Similar trials were taking place in England to try to establish whether the antibody result would be as good if a quadruple vaccine, one injection only, was given to the child in one arm rather than two injections, which meant two sore arms instead of one. That trial discovered that the antibody result from both types of injection was not satisfactory and booster doses had to be given subsequently. The trial was of value to the children and to society in general.

The trial on the other vaccine for DPT was conducted at the instigation of Dr. Pearl Dunleavy because of sore arms. She wanted to establish if the weaker variant could produce as good an antibody result without sore arms which children had developed. This could be described as an experimental vaccine but it certainly was ben evolent. The children in the homes were given the weaker vaccine because they could be better observed. That was not done as a diminution of the rights of the children.

The trial on German measles or rubella was of extraordinary importance. This vaccination was introduced in Ireland in 1971. German measles causes a 50% increase in the rate of spontaneous abortion in women who contract the disease in the first three months of pregnancy. If the pregnancies continue, 70% of babies will suffer from congenital rubella syndrome and will be born with permanent disabilities such as blindness, deafness, brain damage and/or heart defects. Before rubella vaccinations one in 1,000 children in Ireland was born with congenital rubella syndrome.

This trial was conducted to establish whether the vaccine could be given intranasally to avoid having to inject the children. It was successful, but internationally it was found easier for doctors and nurses to vaccinate children with an injection than to give it intranasally. That method of administration never caught on but it could hardly be described as doing down the children.

I totally understand the frustration of those who were in homes and the difficulties they have in obtaining their medical histories and other information to which they are entitled, but I hope they will not want our already weak vaccination programme worsened by anything that might come out of this investigation.

Sometimes attempts are made to link conditions of unknown etiology with vaccination but no one has made suggestions that this has happened in this case. Why did the Minister refer to these adults as "survivors" in his contribution in the Dáil? It was an odd word to use and he did not use it in his contribution today.

All the people who survived from institutions adopted the term "survivor". They prefer that term.

It sums up the way they feel.

I am glad the Minister clarified that because it appeared as if they were survivors of the trial.

That was never the intention. It is the broader term used for children who were in State orphanages and institutions.

The children involved are wondering about their inclusion in these trials. There were no ethics committees in those days, although there should have been. There was no legislation covering clinical trials until 1987. The Medical Council's guidelines and the Helsinki Declaration on human rights were followed by Irish doctors. Two of the trials, as the Minister said, were published in prestigious journals and that would not have happened if anything unethical was done.

Deputy McGennis stated in the Dáil that the rights of single mothers and their children were ill-considered by society in the 1960s. As the president of Cherish, the organisation established for single mothers by single mothers in the 1960s, I recall how little account was taken of its views. I am also sorry Cherish was not thanked in the report because it would have been nice if its co-operation had been acknowledged.

The doctor who vaccinated these children had to have had received consent from someone to go into those homes. She was not attached to the homes. I do not know if the medical practitioners whom she says gave consent for her to do so were entitled to give such consent but someone had to say she could enter the homes. She did not break down the door. She was not a local general practitioner or public health doctor who could have been involved in routine vaccinations. Her presence must have been known to people.

I have read the Department's guidelines on childhood immunisation carefully and it is essential that the uptake of vaccinations is improved. I am sure all Ministers would support the Minister's policy on this.

Mr. Madden of the Southern Health Board in his 1997 report on the trial which took place in Bessboro stated:

The trial was a modification of an existing schedule. No new drugs were on trial, therefore, it was not experimental. Infants would have received vaccination as part of the routine immunisation schedule. All vaccines were approved. No serious reactions were recorded. The study was carried out in accordance with the then ethical guidelines. Consent of the medical officers, and in Bessboro's case according to the home authorities, with the knowledge of the mothers was given.

Professor Hillery has said in a public statement that she will go anywhere to answer any questions. While sympathising with the people involved in the trial who have been frustrated for so long in getting information, I hope people will take account of the Minister's words that the professional reputation of those involved is also important.

I thank my colleague, Senator Henry, for giving me this time for which we fought on the Order of Business. We managed to get it extended because we realised how important a debate it is. I am glad Senator Henry has dealt with the medical issues in the professional way to which we have been accustomed when hearing her speak in the House.

There are things which concern me as a layman. I remember the polio vaccinations which were quite nasty because there were strong adverse reactions to some of them. I know because I was one of those people who had a very strong reaction to the polio vaccine.

There are a number of issues. I agree it is a mistake to be ahistorical and to look back 40 years and introduce criteria which may not have been current at the time. It is true that Professor Hillery did not receive remuneration apart from travelling expenses and so forth and that the British Medical Journal published these experiments apparently with no qualms. However, I have concerns specifically in the ethical area and some signals were raised earlier than these trials. It is important to put the context for the debate to take place in.

Whoever produced the larger of the two reports given to us clearly did not anticipate that the House would take them seriously. They are appalling. Much of the correspondence is completely illegible. On some occasions it has been photocopied in such a way that half the material has gone off the page. We are not being taken seriously when we get this type of material as briefing documents. It was produced with a digest which made things a little more accessible.

From this defective document, I would like to put on record what I see as the context. We are dealing with vulnerable people. There may have been methodological reasons groups in orphanages were chosen, such as it being easier to monitor them, but we should be clear that these were also among the most vulnerable citizens in the State. I think back to my good friend, Dr. Noel Browne, who had a brother who was deformed. To the end of his days Noel was agonised by the fact that he had survived because he was an attractive, nice young kid who was taken up by the Chance family, whereas his brother was subjected to clinical trials of various kinds and eventually died. Noel felt very hard about this.

It is important that the Nuremberg Code is put on record. It emerged from the fact that the Nazis had been conducting medical experiments. I do not draw any parallel but this was the ethical context created after the Second World War. The first protocol is very important:

The voluntary consent of the human subject is absolutely essential. This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, overreaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him to make an understanding and enlightened decision.

I will not read the rest of it, partly because this is one of the pages where I have had to imagine the words at the ends of the sentences.

A distinction is also drawn between different types of experiments or trials – those which have as their goal the ultimate good of society and those which have as their goal the individual's good and medical treatment. Significant points were made in this regard.

It is important to note that, in some of the reports dealing with those resident in homes, namely, orphans of a very tender age who obviously could not give consent, no real indication of consent is given in the report and it appears that consent was not established. Senator Henry said they did not kick in the doors or barge in, but that does not imply consent. I cannot say definitively that consent was given and I compare this with material in the same report which says that the mothers in the controlled sample out in the wider community were asked for and gave their consent. Some of the other mothers were given the opportunity either to give or withhold their consent. It is this issue of consent which is paramount.

There is also the question of the mentally and physically handicapped children included in these trials. The impression is given that one must include these people because they are part of the general situation and that they cannot be excluded. There is no evidence that anything of specific value to people who are mentally or physically handicapped was produced by these. It was not an experiment which was calculated to deal with the specific problems of these people. They were just dosed and excuses were found afterwards. That is what concerns me.

On a point of information, they would have had the same physical propensities to get these conditions as children who did not have any problems.

That is fine but it is certainly not made clear.

The language often concerns me. If I look through the files dealing with Glaxo Wellcome, there is an interesting use of language relating to when documentation was being sought. In light of the inquiries we have had, the lack of clear documentation is concerning. One encounters this type of dubious statement: "What I am basically saying is that the files you are seeking are at this stage quite likely to be in the category of no longer existing." Apparently Senator Henry has also found this. There are numerous examples.

It is interesting that both Senators placed opposite constructions on it.

I find it extraordinary. The language is a type of obfuscation. My main concern is the selection of the group for the convenience of the scientific inquiry. Less than complete sensitivity was shown towards these children. I do not say this in a wish to tar any of the scientists involved. I know some of them and I worked with Dr. Irene Hillery on the board of the AIDS fund.

We must learn lessons from this, one of which is that scientific intellect can become detached from a feeling of absolute sympathy with the subject of the trial, and this seems to have happened in this instance. It may well be part of an histori cal period but it is still something from which we need to learn.

I have a number of questions arising from the main document. In trial two:

...sixty nine children resident in a childrens' home in Dublin had blood taken of whom twelve were subsequently administered intranasal rubella vaccine. In the same trial, twenty three children living at home were administered this vaccine.

It does not say whether they were administered it intranasally. These types of gaps mean I am not in a position after reading this document to know whether the children were disadvantaged because they came from the orphanage group. Apparently not, but it is not in this document.

In trial three:

In this trial in which fifty three children in Mother and Baby homes and childrens' homes in Dublin and sixty five children living at home in Dublin were administered vaccine to compare the reactogenicity of the commercially available batches of Trivax vaccine and Trivax AD vaccine, with a vaccine of equivalent efficacy but of lesser potency.

It does not say which group got which. Both got them, but again it is not clear which was involved.

Issues for consideration are listed in this document, as are legal issues, such as the 1932 Act and the fact that it apparently did not extend to cover some of these trials. Issues which need to be clarified are also listed. First is the statutory controls relating to the importation and use of vaccines; second is the statutory controls relating to the conduct of clinical trials; third is the ethical standards which governed such trials; and fourth is whether the participants were exposed to any or any additional risk by the administration of these vaccines. In my opinion, that is quite the wrong order. Question No. 3 regarding the ethical standards should be first. Question No. 2 should be whether there was any risk. Only after that should we come back to the legalistic questions. We are dealing with the most vulnerable element in the community and we should really have their interests at heart.

With regard to the three in one vaccine, the reports states:

. an examination of the Department's records in this regard reveals that none of the children on whose behalf claims were made received their vaccinations in any of these trials.

However, it does not show that none of those vaccinated was affected. It only says they have checked out a group who have made claims. In other words, there is a grey area about which we still know nothing.

I welcome the opportunity to say a few words on this very serious matter and I thank the Minister for his remarks pertaining to what he intends to do about it. My colleague, Senator Fitzpatrick, correctly said that at that time ethics were not a high priority. I know, however, that the Senator, as a medical doctor, will agree with me that in the interim period it was a very serious matter for those involved in the clinical trials. If it took place almost 30 years ago, in 1961, there would be a period of 20 years or more during which the people who received those vaccines were concerned. I applaud the Minister for the proactive manner in which he has dealt with this matter.

In his statement, the Minister said he found no evidence that the State had given the necessary imprimatur. Having worked in a hospital for many years, including times when things were not as good as they are now, I know that in the old days when nurses were administering prescriptions there was no such thing as a medical chart. Nowadays, one has to sign for every item one administers, and rightly so. It is in the interests of good record keeping and, thus, medical and nursing staff will know exactly what a patient has received.

I find it somewhat difficult to understand the suggestion that no adequate records were kept of a vaccine, whether it was administered subcutaneously, intramuscularly or intravenously. I find that inexplicable, even given the conditions obtaining in those times. I am not trying to apply modern standards retrospectively over 30 years, but I am concerned for the people who have worried about these matters for some 20 or 25 years. They have been assured that no real harm will come to them, but it is a bit like cutting off someone's head and handing them an elastoplast. We must be concerned about the victims of these circumstances.

While we take cognisance of the words of the 1916 Proclamation "cherishing all the children of the nation equally", it is obvious that the children in institutions at that time, 40 years ago, were not cherished equally, and that has been proven. I am not trying to denigrate or castigate any member of the medical profession, but I am making these points because I am concerned for the recipients of those vaccines.

The Minister is on the right track in having referred this report to the Laffoy Commission. In his statement, the Minister said:

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.

The Minister has taken a very proactive role in this matter and I commend him for it. He has also ensured that a counselling service will be provided by the relevant health boards to those who were resident in the said children's homes and who received vaccines pertaining to those trials. That is very important.

The Minister also said:

In view of the fact that the report makes no suggestion that any child was directly harmed by these trials [they did not know that for quite a number of years, but at least something is being done about it now] 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.

Quite clearly, the Minister is saying that it is not the end of the story and that is very comforting for the victims.

The Minister also stated that the State does not have the right to view children in care as lesser citizens. To the observer, however, regrettably and unfortunately, that would appear to be the case that obtained at the time. While it is not fact, it was and remains a perception.

The Minister also said that the history of drug trials includes some ghastly case studies where the rights of individuals were grievously ignored. We are not saying that anybody involved deliberately set out to fudge the issue, but it must have been a living hell for the people who received those vaccines and who had to wait for many years to be assured there was nothing injurious in them and to learn that they would receive counselling, where necessary. The Minister was born around the time these trials took place, so no blame can be apportioned to him. I congratulate him on the proactive measures he has taken in this regard.

The Minister also states that the key issue, that of consent, cannot be fudged because it is fundamental. Of course it is fundamental. The issue of whether or not consent was given is the cornerstone of the whole story. While I have no knowledge of those children's social or legal status, if they were orphans it was the responsibility of the State to give consent. Was consent received? Even going back to the dim and distant past in medical and nursing practice, where vaccines were being administered it was always the practice to prescribe them in written form. Otherwise, in four or five years time, who could say that the same procedures would not be carried out again? I am a little sceptical of that one.

The Minister has posed a number of questions which are already written into the record, so I will not repeat them. However, I will comment on the first one which is centrally important. The Minister asked:

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?

Questions remain to be answered and I know that the Minister is seeking those answers. He has said that 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. That is another very correct step on the Minister's part.

Much of what I wished to say was said earlier in the debate, especially by Senators Henry and Fitzpatrick. The Minister commented:

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?

Who was minding the rights of the children? That is the question.

I know the Minister has made this a crusade. Hopefully it will not be discovered that anyone did wrong to those children, but if someone has done wrong to those children and injured their rights there can be no hiding place for them.

I welcome the Minister to the House. I thank him for this report and I support the action he proposes to take.

I am a member of the Research Ethical Committee in the Belfast Medical School. Today this research would not get past first base but today is not 1972. There is a real danger of projecting back the standards and expectations of today to 1972. I do not know any of the people concerned in this case except by reputation. I know the reputation of Dr. Hillery as a researcher and a medical person of great probity who has brought great advantage to the health of the population of this country, particularly children. I was very taken by Senator Henry's sensitive reference to that.

We can blow this out of proportion by talking about crusades and victims. This was not Dr. Mengele. This was highly egalitarian research according to the temper of the times. All of us who were about at that time know the scourge of child and infant mortality in this society, particularly the scourge of polio, measles and whooping cough. These vaccines were intended to counteract these diseases. We know about the pressure that society placed on researchers and everyone else to find answers. They were told to find a way of giving this to children which they could accept and which was more palatable than what was being done and did not cause them to refuse it. It was not an exotic form of research. It was an attempt to find out whether you could give four in one or two in one injections and whether the adverse effects could be held back.

There are two forms of accountability and ethical responsibility and we should distinguish between them. Consent is important. It seems to me that the researchers believed they had consent. By today's standards they would not have it.

I also take the point that it is significant that the controls were in the community but the experiments were being carried out on children who were in care. This element needs to be con centrated on. Did the people responsible for those children in care feel they had the right to do this? Did they make any efforts to check things out?

To put this in the context of the time, in terms of the things that were done in children's homes, of which we are all ashamed and deeply concerned about, this would rank very low on the scale of impropriety and ill treatment. People need to know that this could not happen now. It would be helpful if we could be told in any report that might come of this how ethical committees work today. How effective are they? Who appoints them? Do they report in any particular way?

The Clinical Trials Act, 1987 is an important Act but there are vaguenesses in it. The Minister could look at it. There is no point in doing that until after Ms Justice Laffoy reports to him. It may be sensible to see whether it needs to be amplified or strengthened in any way. In particular it could be brought up to date to cope with today's pattern of multi-centre trials which are taking place all over the world at the same time. Irish doctors participate in these trials and they must do so in order to keep up. It is important that we know there are controls and that these ethical issues are taken account of.

Consent is the crucial ethical issue in all of this, even consent from children. Most children know whether you are going to stick something in them or not and will tell you whether they want it or not. If they are totally incapable, then the consent of the nearest relative should be sought.

I commend the Minister on the action that he is taking. I hope that this inquiry can go on and that debate can proceed as a search for the truth rather than a witch hunt. I hope then that the Minister will bring forward proposals which will assure society, not only the people who have been involved in tests, that their ethical, human and medical rights are all being protected.

I thank Senators for an interesting debate that was free of rancour. This debate endeavoured to throw some light and give different perspectives on the issue, which is about balance. It is about balancing what happened with the standards of the time, the context in which this happened and the issues that I raised in my speech.

In terms of Senator Keogh's point, it was important over the past months that the people who were mentioned in the report were given full opportunity to see the report before publication, make corrections or make their views known to the author or the chief medical officer. That happened but it took time. Before we brought it to the House it was again necessary to send a copy to the principal people so that they could comment and that their views would be considered in the totality of documentation that was laid before the House.

I accept the Senator's point about the need to be more proactive about the broadcasting of the number of people concerned. I undertake to do that in terms of the number of people who want counselling and who contact the health boards.

I do not wish to prohibit the Oireachtas committee but it is pointless to conduct two investigations simultaneously. Once it is referred to the Oireachtas committee for its consideration it is not the tradition of the House to be over dictatorial in terms of how it deliberates.

Senator Fitzpatrick had some very telling questions. He asked if parents would be willing to allow their children go forward for a vaccine trial. That is a simple but very telling question. I think we all know what our answer would be. I know what my answer would be.

Senator Henry raised other very important issues. Nowadays we, as a society, are very complacent about vaccination. To a large extent people have forgotten the ravages of polio. I was born in the 1960s towards the end of the problem and I heard stories about it occurring in Cork city as folklore. I saw all the infrastructure which had to be put in place to help those who contracted polio. The same applied to measles and diphtheria.

To a large extent, there is a new debate. The Oireachtas committee is holding a public hearing on vaccination, particularly the MMR. It is a huge issue which will not go away. It is affecting uptake levels. We cannot put our heads in the sand, it is a reality of modern life. It is important, therefore, that we debate the issue fully and provide the reassurance required. I have initiated a number of vaccination programmes. We continue to promote the MMR, a source of particular concern in Dublin because of the low uptake rate and where two children died last year from measles. This can be related to significant under-participation in the vaccination programme. There is also the issue of autism in respect of which many parental groups are arguing. It is welcome that the Oireachtas committee will hear such groups.

As a Department, we need to do more in terms of holding significant conferences at which international experts can present the findings of their research reaffirming the value of vaccination. The medical community needs to do likewise. There is a debate developing. To take Senator Henry's point, some are questioning the value of vaccination. All sorts of questions are being asked about the meningitis vaccination programme. As a parent, when I heard about a new vaccine for meningitis, in one sense I could not wait for it to come on the market because for any parent the modern terror is the fear that one's child might develop meningitis. It is important, therefore, that we do not try to bury the issue by saying that vaccination is great, we need to argue the issues fully, openly and transparently. The Oireachtas committee is beginning this process. It is important to state that the vaccination programme has had a huge impact in eliminating disease, saving many lives and improving quality of life.

I apologise if some of the reports are defective, an issue raised by Senator Norris. I was not aware of this. It may account for some of the contribution if he could not read some of the paragraphs. He raised similar issues.

Senator Maurice Hayes made a very important point, that the referral of this issue to the Laffoy Commission is a search for the truth and nothing else. That is what an inquiry is about. It cannot prejudge, its purpose is to establish the truth. The Laffoy Commission is an independent institution established by both Houses of the Oireachtas. Therein lies its value. It has the necessary apparatus in terms of a therapeutic forum where people can be heard in confidence and counselling is available. Many of those who spent time in the institutions concerned require counselling before they give evidence.

I am not convinced that the Oireachtas committee is the ideal forum for an inquiry of this kind. That is the reason the Laffoy Commission offers the best vehicle and the best option for finding the answers to some of the questions raised in both Houses.

Sitting suspended at 5.55 p.m. and resumed at 6 p.m.