Denis Naughten (Roscommon-Galway, Independent) | Oireachtas source

First, I acknowledge the role my former colleague, Katherine Zappone, played in supporting the commission throughout her term of office, which was not easy at times. Most important was her engagement, in a respectful manner, with the survivors and their families. History will show that the Independent Ministers in the previous Government fought against the systemic bias towards sweeping issues under the carpet and just hoping they would go away. This is, at least in part, the reason we ended up with the institutions such as mother and baby homes and many more institutional scandals, which at the very least were known to official Ireland and were at best just ignored and swept under that very same carpet.

The commission's report has provided new information and in the case of the vaccine trials, provided some answers to the children involved. It has also raised many other questions. For those who criticised the work of the commission, I want to put on record that it has provided information and hopefully secured documentation that the State had conveniently brushed under that carpet by turning a blind eye to the failure to comply with the most rudimentary standards for vaccine trials. The State willingly returned personal medical documentation in the past without considering the implications for the people, then innocent children, involved. The Ryan commission records of the vaccine trials were returned by the State to the congregations involved nearly a decade ago, without giving access to the individuals who had been impacted by them.

While the commission has reviewed the medical records available to it and concluded that there was no evidence of injury to the children involved in the vaccine trials, such a conclusion is simplistic. These children were treated as little more than human pincushions by the companies and clinicians involved, due to the large number of injections they received and the blood samples that were taken. How can we be sure that there were no delayed immunological impacts from these particular formulations if no guardian was in a position to tell the clinician treating that child after the end of the trial that he or she had previously received an experimental formulation? The child as an adult would also not be in a position to inform his or her treating doctor that he or she was involved in an experimental trial. Each of these children must be contacted and provided with medical records and these, combined with their medical history, must be independently reviewed and a full and transparent report published on the conclusions. This should happen immediately and the full cost must be born by GlaxoSmithKline.

The commission did, however, flag the issue of consent and the failure to secure it. Why is the issue of consent so important? It is primarily because we all have a basic human right to our own bodily integrity. There is a need for informed consent in advance of any medical study. This was not sought despite it being the legal and regulatory requirement at the time. Without engaging with the parents or guardians of the children, a clinician could not deem them to be suitable for inclusion in any trial. For example, paragraph 34.121 of the report, on the 1968-1969 measles vaccine trial, states that the trial should have excluded children "with a personal history of convulsions, or allergy, asthma and eczema, or strong family history of same".

Without consent, how could this have been ascertained in respect of these children? At least in some of the homes, consent was a standard procedure for vaccinations outside of clinical trials at that point in time. Paragraph 34.71 states:

The Dunboyne institutional records contain completed written consent forms relating to instances where infants resident there were presented for immunisation at the public health clinic. These consent forms were signed by either the mother or the matron.

However, there were no consent forms available for the clinical trials.

It is also clear from the report that the Department of Health had serious problems with the use of children in these homes for clinical trials, similar to concerns raised in the UK. However, paragraph 34.92 states:

A Department of Health document dated 13 December 1963 dealing with this application noted that, in April 1962, Professor Meenan had asked to field-trial an Oral Polio Vaccine in Pelletstown. In that instance, it was noted that the Department of Health had no objection to the trial itself but raised concerns regarding the selection of Pelletstown: 'While the procedure proposed appeared to be a safe one, the selection of the group to participate was open to objection and approval was not given on that occasion.'

The Department did not want clinical trials being carried out on children in homes. However, it did not seem to make any difference to the clinicians involved whether the Department gave consented or not. Indeed, paragraph 34.163 notes that permission was sought to field trial an oral polio vaccine on children in Pelletstown and was refused. The report goes on to state: "The Commission takes the view there is a high probability" that Pelletstown was in fact used in the trial, despite the refusal to grant approval by the Department.

GlaxoSmithKline has many questions to answer. Why did the scientific publications on UK and Nigerian trials specifically make reference to consent, yet these references were conveniently left out of the very same publications on trials based on Irish children? Why was Ireland seen as a soft option for trials involving children in institutions? Clearly, such trials could not take place in the UK. That would that have been the case in Ireland, based on the regulatory and legal system that was in place at the time. However, because of a lack of enforcement in Ireland, they were happy to proceed. Paragraph 34.122 states:

On 5 September 1968, Dr Coffey told Dr Burland [from Glaxo Laboratories] that she had come up against 'the usual complications' while trying to arrange to field-trial Glaxo’s measles vaccine in Dublin.

The response from Glaxo was very interesting. According to the report:

Dr Burland advised Dr Coffey to liaise with Dr Hillery as ‘she may be able to suggest a way in which you could overcome the problems you have encountered’.

In other words, there could be a way to get around the law of the land and the refusal of the Department of Health to sanction this trial. GlaxoSmithKline needs to clarify why these formulations were not placed on the market on a commercial basis. Was it because they were not effective in actually preventing the diseases that they were supposed to? If that was the case, it would have impacted on the subsequent immunity of the children involved in these studies. Were children outside of homes, either in Ireland or the UK, subjected to the battery of needles that the children in these homes were? There was multiple administration of vaccine doses, and multiple blood sampling procedures took place. As a matter of urgency, there must now be an engagement with GlaxoSmithKline on behalf of the children who were involved in these trials. As a very first step, it must provide a clear and unequivocal apology and forthright answers. It must also put in place financial support package in place for those exploited by ignoring their basic fundamental right of bodily integrity. GlaxoSmithKline benefited financially from this research. It was happy enough to ensure that those who conducted the trials also benefited from it. It needs now to live up to its responsibilities to the victims.

There was a clear benefit to the clinicians involved in these trials. Direct payments are referenced. At the very least, funding was provided for research facilities, which would assist those researchers in securing scientific publications. Many of the researchers were also involved in scientific publications which helped them secure promotions and status within the scientific community and would also have been of benefit to the universities involved. We must now see an apology from the two universities involved, namely, UCD and Trinity College, Dublin.

It is also important to point out that these scientific publications were peer-reviewed in advance of publication. In the British Medical Journal and The Lancet, interestingly, publication of the British trials include an outline of the consent and confirmation that consent was obtained in line with the law and ethical standards, but not when it came to the publication of the Irish studies. Why was this not set as a precondition of publication? It should have been. If it had been and the academics were told that they must provide that, maybe then, those particular children would not have been exploited and those institutions would not have been used again and again. There must be an explanation as to why this did not happen and an apology from both the British Medical Journaland The Lancet.

As I said at the start, there was a cover up right to the top. The attitude was one of brush it under the carpet and it will go away. Paragraph 34.153 of the report states that the Department of Health had flagged it in 1968 that Professor Meenan had conducted vaccine trials without the authorisation of the Minister for Health. There are many questions here. The victims must be supported to get answers and apologies right across the board.

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