Written Answers - Drug Trials.
Liz McManus
Question:
63
Ms McManus
asked the
Minister for Health
if he will immediately provide a full and comprehensive report on the drug trials in the development of the three-in-one vaccines on Irish children in orphanages in view of the serious public disquiet; the number of those children with physical or mental handicap; the extent of adverse reaction to these trials; and if he will make a statement on the matter.
[14186/97]
Michael Noonan
Question:
66
Mr. Noonan
asked the
Minister for Health
if children in orphanages were used in drug trials during the early 1960s and 1970s; and if he will make a statement on the matter.
[14189/97]
I propose to take Questions Nos. 63 and 66 together.
As I explained last night to the House, recent media reports referring to the vaccination of children in orphanages in 1960-61 and in 1973 are not new. They were the subject of media comment in October 1990 and May 1991 and the then Minister, Deputy O'Hanlon, answered questions in the House on the matter on 7 May 1991. Essentially, we are now addressing the same issues.
The administration of the vaccines to the children in the children's homes was not in any way experimental. The children were due to be vaccinated in accordance with scheduled vaccination programmes at the time and the vaccines used were all approved under the regulatory framework which prevailed at the time.
The purpose of the studies was to determine which of the approved vaccines was most appropriate for use in the national vaccination programmes. The 1973 study was the larger study and was not confined to children's homes. The medical officers attending the homes gave their permission for the administration of the vaccines and were perceived to be actingin loco parentis in so doing. All the information available to me indicates that not only were the studies carried out in accordance with the then prevailing ethical guidelines but that additional measures were taken on a voluntary basis to ensure the highest standards of safety and efficacy.
The 1960-61 study was the subject of a subsequent report in the British Medical Journal of 21 April 1962. It described a comparative study comparing 3-in-1-diphtheria, tetanus, pertussis and separate polio immunisation with a 4-in-1, all vaccines combined, carried out on 52 children resident in five orphanages. The vaccines were administered to the children as part of the child immunisation programme.
The study was carried out in accordance with the then prevailing ethical guidelines and no adverse reactions occurred which were ascribed to the immunisations. The immunisations were conducted with the consent of the medical officers attending the children's homes and this is acknowledged in the BMJ article. It is a fact that information on this study has been in the public domain for 35 years.
In 1973, the Eastern Health Board noted above expected levels of transitory adverse reactions following the administration of DPT vaccine and discussed this with the pharmaceutical company. The health board co-operated with the company in carrying out a comparative 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.
Prior to the study being undertaken, Wellcome, the company supplying the vaccine, submitted a detailed Protocol to the NDAB, to which the board raised no objection. This was done on a voluntary basis as there was no statutory requirement to do so. The study proceeded on this basis. A total of 116 children were involved — 59 children being in the community and 57 children from two children's homes in the Dublin area. The children participating in this study were due to be immunised with DPT vaccine as part of the national immunisation programme. The results of the study were inconclusive, in that no significant difference between the vaccines emerged.
I am not aware of any other similar studies or trials involving children in orphanages but I have asked all health boards to report on the situation to the Department as a matter of urgency. When this information is received I will review the situation and decide what further action, if any, should be taken.
I have asked Glaxo Wellcome to provide a comprehensive report on the relevant studies. They have undertaken to provide such a report at the earliest possible date which I will make available to the Deputies.
