Denis Naughten (Longford-Roscommon, Fine Gael)

I welcome the opportunity to speak on this legislation. I want to raise a specific element which is not included in the legislation, that is the issue of the vaccine trials carried out on children in residential institutions without their consent, which is being swept under the carpet, facilitated by this Bill.

The vaccine trials were carried out on children during 1960-61 and in the early 1970s, up to at least 1973. The current amending legislation before the House does not refer to the vaccine trials. The Government is brushing aside a vital issue that affected many vulnerable children in State care at that time. The Commission to Inquire into Child Abuse Act became law in 2000. The Government sought to amend the Act in 2001 to allow for investigations into vaccine trials. However, the amendment was challenged in the courts and any investigation into the trials has now been put on hold. Since then, the silence on vaccine trials has been deafening. I, together with a number of other colleagues, up to and including 2001, raised this issue, and related issues, on several occasions. When it was referred to the Laffoy Commission we thought we would eventually get some answers to these issues. Now this appears to have been parked.

This issue first came to light when the trials were the subject of media comment in October 1990, and subsequently in May 1991. The then Minister for Health, the current Ceann Comhairle, Deputy O'Hanlon, answered questions in this House on the issue on 7 May 1991. At least two separate studies were carried out. The first was the 1960-61 study, which was the subject of a subsequent report in the British Medical Journal of 21 April 1962. It described a comparative study comparing three-in-one, diphtheria, tetanus and pertussis and a separate polio immunisation, with a four-in-one. The four vaccines combined were tested on 52 children resident in five orphanages.

In 1973, the Eastern Health Board noted above expected levels of adverse reactions following the administration of the DTP vaccine. It discussed this with the pharmaceutical company, Wellcome, who manufactured the vaccine. I want to focus specifically on the trials conducted during the 1970s and these adverse reactions. I will give the background to the trials in the 1970s, during administration of the three in one DTP vaccine. In the late 1960s and early 1970s, there was a great upsurge in the number of severe adverse reactions in children who received them, so much so that in 1973, the Eastern Health Board's records showed that the official in charge of the administration of the vaccine within that health board's region was inundated with reports of severe reactions among children. On 24 September 1973, the official in question, Dr. Dunleavy, wrote to Wellcome, the manufacturer of the vaccine, enclosing a list of lot numbers of Trivax which had caused severe adverse reactions. She wrote to Glaxo Wellcome to express concern and the company replied that it had no indications as to the reason therefor. However, three years earlier, in 1970, a senior scientist in Wellcome had warned in a memo to senior colleagues that if further reports of severe reactions to the vaccine were received, it might be desirable to cease its manufacture altogether.

The pertussis of whooping cough element of the three-in-one vaccine is widely believed to have been responsible for the adverse reactions and the Eastern Health Board asked Wellcome about the possibility of reducing or altering that element in the vaccine. There were so many adverse reactions to the three-in-one vaccine in the early 1970s that, by 1974, the extent of the adverse reactions was such that more than 50% of parents were opting for the two-in-one vaccine instead and omitting whooping cough or pertussis cover when vaccinating their children. That is the background to the trial that took place in 1973.

In the first six months of 1973 in particular, more than 80 reported adverse reactions were recorded. Lot numbers were documented for these and they are still available. The Eastern Health Board co-operated with the pharmaceutical company in carrying out a 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.

The 1973 trial involved an institution and a comparative control group outside that institution. A total of 116 children were involved, 59 from the community and 57 from two children's homes in the Dublin area. The children participating in the study were due to be immunised with DPT vaccine as part of the national immunisation programme. The children in the community were given the normal commercial vaccine and those in care were given the new trial vaccine that was being studied at the time. The results of the study were inconclusive in that no significant difference between the vaccines emerged.

The trials that took place in 1973 were approved by the then National Drugs Advisory Board. However, prior to 1987, there was no statutory basis for conducting clinical trials in Ireland. In 1987, legislation was enacted which laid down protocols for conducting clinical trials. The National Drugs Advisory Board was not even a statutory body at the time of the 1973 trial.

The trial begged a number of questions and they need to be answered. Sadly, we will not get the answers through the Laffoy commission. In the first six months of 1973, more than 80 adverse reactions were recorded, yet the records of the National Drugs Advisory Board which gave approval for the trial to take place noted only two suspected adverse reactions in the whole year. No lot number is recorded for these.

Prior to 1987, there was no statutory basis for conducting clinical trials. Under what authority did the National Drugs Advisory Board approve these trials? It obviously did not have much control over them given that it had no record of the 80 adverse reactions. These 80 adverse reactions pertain only to a certain region and do not represent the total national count.

According to documentation released by the Department of Health and Children on the clinical trials, the injections were given between June 1973 and January 1976, which is well outside the two-year period for which the licence was given to Wellcome. It is also reported that in July 1977, according to a Wellcome memo, Dr. Irene Hillery was still carrying out work in the area related to adverse reactions.

On 28 June 2001, during Private Notice Questions, I asked the then Minister for Health and Children, Deputy Martin, when these trials ceased. In his response, he stated: "Regarding June 1973 and the clinical trial in 1976, that will be investigated by the Laffoy commission." This is no longer the case. On 9 November 2000, the then Minister then stated the records pertaining to some of the clinical trials were woefully inadequate. He described the lack of documentation relating to the trials as puzzling and unsatisfactory.

Does it not seem strange that an eminent scientist such as Dr. Irene Hillery would keep inadequate records? What has happened to her notes? I have no doubt that she kept detailed notes on the trials. However, they seem to have disappeared. I asked the then Minister about this on 28 June 2001. He stated:

As regards Deputy Naughten's question, his quotation from my speech refers to the vaccine trials that have now been sent to the Laffoy commission for investigation. The Oireachtas forwarded that to the Laffoy commission due to the inadequacy of records and information. The Laffoy commission has the powers to compel and secure documents. Therefore, it is now a matter for the commission to pursue those issues.

This is no longer the case as there is to be no investigation into this matter by the Laffoy commission.

The 1973 trial involved institutions and a comparative control group outside the institutions. The children in the community were given the normal commercial vaccine whereas the children in the institutions were given a new trial vaccine. Why were the children in care used as guinea pigs? On 28 June 2001, the former Minister, Deputy Martin, said:

. . . obviously the entirety of that trial comes under the Laffoy commission, as there are the issues relating to why the control group was not given the changed or trial vaccine. They were given the normal commercial vaccine and the children in care were given the new type of trial vaccine. That is an issue that needs to be teased out. The Laffoy Commission will have the competence to do that. The broader issue does not fall within its remit.

It will not have the competence to do so because it will not carry out this task.

Some might believe the control group got off scot free in respect of the trials. This is not the case because one must bear in mind the Tribovax T vaccine. In this regard, let us reconsider Dr. Dunleavy's letter to Wellcome in September 1973. Enclosed was a list of lot numbers of Trivax which had caused severe adverse reactions. Included in this report were two lot numbers which corresponded to Tribovax T. At the time, Tribovax T was used by the agriculture industry because it was an animal vaccine. We still do not have answers regarding this matter. It is alleged that three different doctors in Dublin transcribed the lot numbers that corresponded to Tribovax T, the animal vaccine, and not Trivax, the human vaccine that was in use at the time. It is understood that at least one such lot of animal vaccine was administered as part of the drug trial which was supposed to be investigated by the Laffoy commission. The administering of animal vaccine to children as part of a trial in 1973 is a scandal in itself. The National Drugs Advisory Board obviously did not note that adequately.

Consider the shoddy controls that were put in place by Wellcome in the era in question. One of the other batches that was administered in the late 1960s and early 1970s was batch No. 3741 which was administered to a child called Kenneth Best. In 1991, this case came before the High Court during which Wellcome admitted openly that its quality control procedures at the time in question were virtually non-existent. When cross-examined by Mr. Dermot Gleeson as to whether other batches of similar or greater potency were released, Mr. Peter Knight, manager of the immunological product support group of the Wellcome Foundation stated:

There may have been a half dozen, a dozen or 100 more . . . Goodness knows what I would have found if I had looked wider.

At the conclusion of the Best case in the High Court, Mr. Justice Liam Hamilton described Wellcome as negligent and criticised the company's quality control procedures. It appears that, as part of a trial involving children in care, animal rather than human vaccine was administered. The commission will not investigate this because it has been written out of this Bill. The investigations and trial were prompted by severe adverse reactions to Trivax DTP vaccine manufactured by Wellcome and administered in the late 1960s and early 1970s.

The Irish Medicines Board received notice of 224 suspected adverse drug reactions to the DTP vaccine since 1972, 87 of which were classified as serious, in accordance with agreed international criteria. The State Claims Agency, established in 2002, manages personal injury claims against the State. Information the agency provided indicates that four claims have been received from parents regarding alleged vaccine damage from the State supported MMR vaccine programme. There are also cases involving the South Eastern Health Board and the Western Health Board, relating to the BCG vaccine.

Wellcome used shoddy procedures and kept poor records in the late 1960s and early 1970s. Consequently, there were many adverse reactions to the vaccine, which led to the trial. Following those complaints at least 93 parents claimed their children had been severely damaged by the DTP vaccine.

This came to a head in 1977 when the then Minister for Health established an expert medical group on the whooping cough vaccination to examine claims that persons had been permanently damaged by that vaccination; to view the medical information available on these claims; and to indicate whether in its opinion the damage was attributable to the vaccination. The group found that in 16 of the 93 cases presented to it there was a reasonable probability the vaccine was responsible for damage.

In private correspondence to parents of brain-damaged children in 1982, Deputy Woods, then Minister for Health, admitted that the side effects such as mental retardation, paralysis, collapse and convulsions were generally recognised as occurring occasionally following whooping cough vaccination. However, when the expert medical group concluded its evaluation of these children the then Fianna Fáil Government pursued a policy of trying to buy off the parents by offering them a once-off ex gratia payment of £10,000, despite strong advice from senior officials in the Department of Health.

At an early stage, following the expert group's initial findings, the officials said it would be inconsistent and inconclusive not to concede proper compensation. Thirteen families accepted the offer of the ex gratia payment. The Best family declined the offer and received more than £2.9 million in the High Court during the early 1990s.

It has taken 20 years since that Government offer for the Department of Health and Children to progress the issue of adequate compensation. Following a meeting with the Minister for Health and Children in spring 2002, the Department undertook a preliminary review of the vaccine damage compensation schemes in place in other countries. The report was submitted to the Minister last year and is now on the Tánaiste's desk. The Tánaiste has included it in her Department's work programme for 2005 which means it will not be considered before 2006.

Two critical elements need to be put in place immediately. At least 16 of those children deserve fair and reasonable compensation. Others who have been damaged, or have submitted claims, need to have those claims assessed in regard to vaccine damage and to receive compensation where appropriate. We need a full inquiry into the vaccine issue. This cannot be allowed to be covered up.

Several investigative avenues are open to the Government on this issue. If one is closed, alternatives are available through which the Government can fully investigate this matter. I have raised enough questions this morning to ensure that such an investigation takes place.

The debacle of these vaccine trials has tarnished the reputation of Dr. Irene Hillery, an eminent scientist. She should be given the opportunity, through some mechanism, to clear her name in a non-adversarial way. I urge the Minister of State, and her colleagues in Government to consider this issue, which falls under the remit of the Departments of Education and Science, and Health and Children. They should ensure this is thoroughly investigated, and the truth is uncovered.

Deputy English and I know some of the parents involved. They want answers about what happened to their children, many of whom are now in their mid-30s and early 40s. The parents must try to care and provide for them. They do not mind whether there is a "no-fault" compensation scheme, such as Deputy Twomey mentioned but they deserve compensation and their children deserve the State's care.

The State was negligent in their respect whether the children were in care or not and the parents want answers before they die. Sadly many of those parents are quite elderly and are badly hurt by the way the State and various Governments have treated them. This is not a party political issue but it is more serious than the scandal of the nursing home charges will ever be. The parents seek only the truth.

I know one family whose child spoke her first word, "Dada", on the morning of the vaccination. That was also the child's last word. On the way home from the vaccination the child had convulsions and has never spoken since, and cannot walk without assistance. Until that day she had reached all her developmental milestones. Those parents and many others deserve answers. Will the Minister of State take an interest in this issue and speak to her colleagues about establishing the truth?

See this speech in context