asked the Minister for Health and Children if will outline the background to the administration of animal vaccine to children under a State-sponsored vaccination programme; when this revelation was brought to his attention; if he will now establish a full public inquiry into the Trivax scandal; and if he will make a statement on the matter.
Private Notice Questions. - Vaccination Programme.
asked the Minister for Health and Children if he will address the revelation that a veterinary vaccine, normally administered to cows, was given to children during the 1970s as part of drugs trials for a company; the implications of this revelation for childhood vaccination programmes; and his views on the necessity for a full public inquiry on the issue.
Deputies refer to a matter first raised in an article in today's Irish Independent. As a result of that report, I have asked my Department to carry out an investigation and preliminary inquiries indicate that the National Drugs Advisory Board, the Eastern Health Board and my Department were not aware of the information contained in it. The suggestion is that one of the lots used in the preparation of the vaccine administered as part of the vaccination programme in 1973 may have contained the animal vaccine, Tribovax T. My Department was not made aware of any such allegation prior to today's newspaper report. The Eastern Regional Health Authority is making inquiries as to whether this issue has been raised previously but senior staff working in its public health department are not aware of it. The company mentioned in today's report has also been asked to furnish me with the result of its investigations into this matter. I have stressed that I would like this information as a matter of urgency and asked the Irish Medicines Board, formerly the National Drugs Advisory Board, to investigate. In view of the implications for standards of good manufacturing practice, should the allegations be proved correct, I have asked that the board liaise with the UK Medicines Control Agency in the conduct of its investigation. I will await the result of these inquiries before considering if further investigation is necessary. I will make the results of these investigations known to the House as soon as possible.
I stress this issue is not related to the current immunisation programme and take the opportunity to reassure parents, health professionals and the general public about the safety of current vaccines. All expert advice available to me in my Department indicates that the vaccines in use in the primary child immunisation programme are very safe and highly effective in preventing infectious diseases in individuals and the community generally. It is important to note that vaccines are subject to rigorous testing before being licensed and ongoing monitoring when in use. Immunisation has proven to be a safe and effective measure in combating infectious disease in children and the community and played a major part in the reduction of childhood death and illness from infectious disease. The primary child immunisation programme will continue to be an essential element of our health service and I urge all parents to have their children immunised. That will ensure individual children and the population generally will have maximum protection from the diseases concerned.
In light of the fact that the suspect lot of Tribovax T was administered as part of the drug trial now being investigated by the Laffoy commission and that the reactions to all the vaccinations in this trial were returned to Wellcome, is it not probable that Wellcome knew this vaccine was destined for animals rather than humans? Can the Minister assure the House that neither the Eastern Health Board nor the Department of Health and Children was informed by the Wellcome Foundation, as it was then known, that the vaccine was destined for animals? Were the parents of the child concerned informed and, if not, is the Department researching and collating the data with a view to contacting the individual involved? Were the batches in question withdrawn?
The human and veterinary vaccines were not recorded separately, they were recorded on one list. Does the Minister agree that the fact they were recorded at the same time, in the same log book and against general manufacturing practice, gives rise to huge concern?
My reply refers to the fact that this vaccine might have been administered as part of the vaccination programme in 1973. The Deputy said it was part of a clinical trial in 1973, the one described in the chief medical officer's report on vaccine trials in institutions, industrial schools and orphanages. It is not immediately clear whether it was either one, or a subsequent vaccine trial. The Irish Independent referred to the possibility of there being additional vaccine trials, aside from those covered, which may have been in a community setting. It is too unclear at this point to narrow down exactly the circumstances and context in which this vaccine was administered.
It looks like it was done in a trial.
We have referred any trial undertaken in an industrial school or orphanage to the Laffoy commission. Let us be clear that was in relation to vaccine trials per se, and the fact that vaccine trials were conducted on children in orphanages where the issue was abuse and assault. The wider issue covered for some time in this House and elsewhere was the general one of Trivax, its potency and the quality of particular batches administered during the 1970s. The use of an animal vaccine in a clinical trial, or other context in Dublin in 1973, is a new element broached in the pages of the Irish Independent this morning. We have initiated preliminary investigations to elicit preliminary answers and on receipt of those answers we will be in a better position to plan ahead or make decisions as to where we go from here. I give an undertaking to return to the House next week regarding updates on the issue.
Does the Minister think it was acceptable to use Irish children as guinea pigs in this experiment in order that multinational pharmaceutical companies, such as Wellcome, could make even greater profits? It is frightening and obscene. It is all the more frightening that such a basic error could have been made and that the children concerned could have been vaccinated with an animal vaccine. Where will the buck stop? Will the Minister ensure people are called to account? Will he ensure Wellcome is called to account? Are we to continue contracts with this company, having discovered it made such an error? Will the Minister assure the House he will do everything he can on this? I will raise this at the Committee on Health and Children asking that we can conduct an inquiry into this using powers of compellability, as it is a scandal. Will the Minister ensure that everyone in his Department, the health authorities and Wellcome is thoroughly investigated in a preliminary investigation he will carry out?
Yes. I am shocked that this could happen and on a previous occasion, in relation to a similar related matter, I stated in the House that children should never be used as guinea pigs in any trial, particularly without the consent of guardians or parents. I am as shocked by this morning's revelations as Deputy Gormley and am equally concerned that we get fast answers from those concerned. If we do not get answers we will have to consider the options we then have.
I appreciate the Minister is not in a position to answer all the questions but it is important to get clarity in as far as we can. Since this is such a serious matter, has he yet worked out how he is to properly follow up an investigation into children who were not in industrial schools or other institutions being used for clinical trials? It appears here that trials were carried out on children who attended health board clinics. Does the Minister envisage that being the subject of some form of inquiry in the way that those institutions are now subject to an inquiry?
I also seek clarification as to the role of the health boards. Have they no records of what happened here? When Wellcome was contacted about clinical trials being carried out on children in care, was there no indication from Wellcome of experimental work it had done on children in Ireland other than those in care? Were questions raised by the Department in that regard that were left unanswered? Reference is made to one baby who showed serious signs of the effects of the wrong administration of drugs used for animals. Are we clear that there was only one?
There were a number of adverse reactions as reported in today's newspaper, with one case where the reactions were very serious. The health board concerned, or its successor, has not uncovered anything yet in relation to information relayed to it by Wellcome at the time. Its view is that Wellcome did not make anyone aware at the time of the fact that this vaccine was used in a clinical trial.
Regarding the matter of clinical trials in a community setting, I have not given immediate consideration to that but obviously it must now be addressed as well, as the emphasis to date was on clinical trials within orphanages and industrial schools. Prior to 1987 there was no statutory basis for the conduct of clinical trials in Ireland but legislation was put in place in 1987 which laid down protocols and so forth for the conduct of clinical trials. The National Drugs Advisory Board was not a statutory body then either, though we have contacted the Irish Medicines Board, which is concentrating today on securing information from the company concerned regarding the allegations made in today's newspaper.
How positive is the Minister that the Irish Medicines Board will be any more successful on this occasion than it was in the past in eliciting information from Wellcome, which is now Glaxo Smithkline? When the Minister published his report on batch No. 3741, it stated that lot No. 84019 did not come from batch No. 3741. If that is the case, what batch did it come from? There were a huge number of reactions to lot No. 84109. If it is the case that that lot did not come from batch No. 3741, as stated in the report, does the Minister know what batch it came from? There were a series of other batches involved; does the Minister know where those came from? That is very pertinent in relation to the lot about which we are talking.
Given that there were more than 80 adverse reactions, as reported in today's newspaper, recorded in the first six months of 1973, and that lot numbers are available for those, why do the records of the National Drugs Advisory Board note only two suspected adverse reactions for the whole year, none of which have a lot number?
According to the Minister's documentation on the clinical trials, the injections were given between June 1973 and January 1976, which is well outside the two year period of the licence given to Wellcome. It is also reported that in July 1977, according to a Wellcome memo, Dr. Hillery was still carrying out work in this area related to adverse reactions. Does the Minister agree that these trials were ongoing perhaps up to and including 1977 and maybe later? Can he give us some indication as to whether the consent of parents was obtained in relation to these trials? My information is that it was not. Does the Minister have any information on this?
Regarding lot No. 84019, the report we published in November last year was a compilation of efforts by departmental officials over the years on behalf of families which came forward looking for information.
And parliamentary questions.
And parliamentary questions from Deputies Naughten, Molloy and others. The idea at that time was to produce information to help the families concerned to take legal action against the relevant company. The Department's role over the years was to secure as much information as possible. What we published in November was a compilation of all the information that had been secured to date; it was by no means a definitive or conclusive report on anything. It was a collection of all the various data.
We do not know where lot No. 84019 came from. I have been advised we do not have that information but obviously we will pursue that issue now. Regarding June 1973 and the clinical trial in 1976, that will be investigated by the Laffoy Commission—
No. That will investigate only the trials on children in care.
The trial referred to by Deputy Naughten was in June 1973, which is an issue for the Laffoy Commission. I suspect the community one is from a later date.
The trial referred to the Laffoy Commission had two elements to it, one of which related to children in care and there was another for children in the community to compare—
It was a comparative study but it was the one study.
I presume all that is being referred to the Laffoy Commission is the element relating to children in care and whether consent was obtained, rather than the other elements.
To come back to my original point, we cannot yet definitively say it was that particular trial within which the animal vaccine was administered.
I am not disputing that.
It appears from reading the newspaper that it was a different trial within which the animal vaccine was administered, though that remains to be clarified; we cannot state that definitively yet. The 1973 trial involved an institution and a comparative control group outside that institution and 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.
I know that.
It is a new element that will have to be treated separately.
One element of the question I put to the Minister that was not answered was our contractual relationship with Wellcome. Will the Minister elaborate on that? Does he believe we can cease any contracts that exist after what has happened? I accept that Wellcome is a different company now but the same people are involved. As far as the Minister understands, were people paid to take part in trials for Wellcome in Ireland? This is disputed.
My only knowledge of trials are from the 1970s relating to the Chief Medical Officer's report on vaccine trials within institutions. Those responsible for the conduct of those trials were adamant that there was no payment involved. I am not in a position to state whether payments were made in relation to any other trials in the community or in health board clinics.
Does the Minister think that we should cease such contracts?
No. Companies have changed and new protocols have emerged. There is a new era in terms of regulatory controls etc. I am conscious that vaccine supplies were usually sourced from two companies to ensure that there was a contingency supply in the event of one company going out of business. It would be foolish to give any commitment in that regard, or to say on the hoof that we will cease our relationship with a company without taking cognisance of the impact that might have on our immunisation programme. I do not want to collapse that programme.
The Minister could start with another company.
It is not that easy. It takes a long time to work up contracts with companies to have a sufficient supply of vaccines.
As regards protecting the integrity of the vaccination programme and of clinical trials which are an important part of medical development, will the Minister consider dealing with the Wellcome Foundation to assert the importance of getting the full facts on what happened? It is disturbing when such information leaks out through the media. People naturally become concerned. It is difficult when we are dealing with a company that is not in Ireland. Will the Minister take a pro-active role in getting the message across to the Wellcome Foundation, or whatever the company is now called, that it is essential for us to ensure that we have a decent vaccination programme and that this matter is fully investigated? I presume the Minister will require a public inquiry into the community vaccination trials as opposed to those of children in care. He should take a certain initiative on this matter. He should not just say that we will not take particular vaccines any longer, but assert that we must have all records and information to protect the integrity of the good work being done here in terms of protecting children.
There is a serious issue in terms of the integrity of the entire vaccination programme. Issues like this can undermine public confidence in the vaccination and immunisation programme. I will the Deputy's view on board and will take up the matter with Wellcome.
Will the Minister confirm that Wellcome is no longer producing that vaccine? That is important for public confidence. The Minister stated in relation to the trials on 9 November last, that the records of some of them were woefully inadequate. He described the lack of documentation relating to the trials as puzzling and unsatisfactory. With that in mind, what have the Minister and the Department done in the meantime to obtain information from Wellcome?
Does it not look strange that an eminent scientist such as Dr. Irene Hillery would keep inadequate records? What has happened to Dr. Hillery's notes? They seem to have disappeared. Does the Minister not agree that following today's revelation, with the Department now trying to trace 296 children who received batch No. 3741, and with the Laffoy Commission investigating the initial trial in 1973 of children in homes and in the community, there is a need for a full public inquiry to get to the bottom of this scandal which has gone on for far too long? Parents want to know the truth about what has happened to their children.
The Minister spent the last part of his speech trying to allay parents' fears. Does he accept that there are parents that have well-founded, well-informed concerns about vaccination, that these concerns should be respected and that these parents do not wish to have their child vaccinated? Will the Minister assure the House that he will not put forward proposals to discriminate against those parents or children who are not vaccinated? There are proposals emerging in some quarters that children who are not vaccinated should be given less preference in terms of schooling, etc. Will the Minister assure the House that this will not happen?
The latter point is outrageous. I could not condone any such behaviour. It would be reprehensible for anyone to even contemplate that. I fully respect the right of parents to make a choice. I am a parent, and these choices have to be made by parents in consultation with their general practitioners. As Minister for Health and Children, I am an advocate of immunisation. I know that Deputy Gormley has a different position. I assure him that in any given community when a particular outbreak happens, the rush to get vaccinated is incredible. For instance, when a meningitis case occurs in a class of 20 or 30 children, parents call on the health board to ensure that all those children are vaccinated.
I accept that there cannot be black and white positions on this matter. I have met many interests on this issue including parents' organisations and researchers who have put forward alternative viewpoints. In terms of MMR, those researchers acknowledge that nothing has been proven yet. Nothing conclusive can be drawn from their deliberations. Therefore, the World Health Organisation and many international bodies, including our national authorities, have strongly advocated vaccination and immunisation as a major contributor to public health status, and have urged and advised me to pro-actively promote that issue. I respect the Deputy's views and those of others who have a different perspective.
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.
Written answers follow Adjournment Debate.