16 November 2000
It has been one of the great blessings of my medical life that I have never had to deal with the vaccination of the Irish public. Vaccination campaigns appear to be advertised by the Department of Health with inadequate stocks of vaccine available as in the present chaos of flu vaccination. Family doctors at other times have their surgery fridges overflowing with vaccines so that some of the stock has to be kept in the domestic fridge between last night's lasagne remains and today's cheese cake. All are encouraged to try to increase the childhood immunisation uptake but, in view of the frequency with which cases are taken against doctors on the grounds that the vaccination caused some serious problems, one can understand doctors' anxiety about court cases to come, even when their efforts were in the very best interests of the individual child as well as the community.
The Joint Committee on Health and Children is at present looking at all aspects of vaccination. At the same time both Houses of the Oireachtas have been considering three trials carried out between 30 and 40 years ago on DPT, Polio and Rubella. Some of the children vaccinated in these trials were in mother and baby homes or children's homes at the time. For nearly ten years the now adults have sought their medical records. It is ridiculous that this time lag should have happened and must have caused them unnecessary frustration and anxiety.
The doctors involved in the trials have had an anxious time also, and as the Minister for Health and Children, Micheál Martin, said in the Dáil their professional reputations must be protected, too.
As I put on the record of the Seanad I know both the first and second authors of the trials discussed in the Report by the Chief Medical Officer, Dr. Jim Kiely. Professor Irene Hillary and Professor Patrick Meenan are two of the finest research workers we have had in this country in the areas of virology and micro biology. It has been asked why would an English company want to do clinical trials in Ireland. We have a first class reputation for reliable ethically conducted trials and, in this case, Professor Meenan was a WHO world authority on polio. Their international reputations bring great credit to Irish Medicine. I also know Dr. Pearl Dunleavy, the public health specialist, a former senior employee of the Eastern health Board. Her commitment to the health of the people of Dublin and the surrounding countries was always of the highest level. Looking at her letters to Wellcome in the file one can see of her concern for children. All three are now retired and this, however, is a "look back" at trials which occurred 30 to 40 years ago.
Communicable diseases used to account for 25% of deaths in Ireland fifty years ago. These diseases included Diphtheria, Influenza, Polio, Measles and Whooping Cough. Improved socio-economic conditions and the development of new drugs have been important in the reduced mortality from infectious diseases but the public health policy here of immunising children against serious communicable diseases has been vital.
Immunisation against Diphtheria, pertussis and tetanus began here in 1952/53 and against polio in 1957. The number of cases of all these diseases rapidly declined to a fraction of pre-immunisation levels. We have become complacent about the seriousness of these conditions until we have an epidemic such as occurred with measles this year. Due to our poor immunisation record with MMR (measles, mumps and rubella) hundreds of children got measles and some died. It is easy to forget that one million children die of measles internationally each year when we have had no deaths until now for years. Tens of thousands of cases of Diphtheria have occurred in Eastern Europe and Russia recently. How long before we have one here?
Two of the vaccine trials at the centre of this controversy were to try to minimise the discomfort of local reactions for children from DPT and polio vaccination, which was then by injection. The aim was entirely benevolent, done in the best interests of the child and the community at large. Children from the community in general and from mother and baby homes and children's homes who would have been entitled to vaccination took part in the trials.
Remembering Polio vaccination was introduced into Ireland in 1957 on foot of a terrible polio epidemic, the First trial described in the report was carried out in 1960 to '61 sought to see if adequate immunity could be induced in children by combining polio vaccine (it was then an injectable vaccine only) in the same syringe as the DPT vaccine so that one and not two injections were required. One group of children received two injections, one in each arm, the other group only one. The results of the trial showed that neither method was producing sufficient immunity in the children so booster doses were needed. This was of advantage to individual children and the community.
The Third Trial, described in the report by the Chief Medical Officer, is the second one on DPT. It took place in 1973. The Chief Medical Officer of the EHB, Dr. Pearl Dunleavy, was anxious about the number of local reactions, sore arms, amongst babies who were given the standard DPT. A vaccine with only 75% of the organisms in the standard one was produced by Wellcome. Permission to use this vaccine was given by the late Dr. Alene Scott of the then National Drugs Advisory Board. Children, all in mother and baby homes, were vaccinated with this. The reason the variant, as the Minister described it in the Dáil, was given to the children in the homes was, I suspect, because they could all be observed by the same person after four hours rather than going from house to house in the community. Other groups of children were immunised with the standard vaccine. The results of the trial showed no significant difference between the local reactions or the antibody response in the two groups.
The trial called the Second Trial in the report was on a different vaccine - Rubella. This was introduced in Ireland in 1971. Rubella - German Measles - causes a 50% increase in the rate of spontaneous abortion in pregnant women who become infected in the 1st three months of pregnancy. If the pregnancy does continue 70% of those will suffer from Congenital Rubella Syndrome and be born with permanent disabilities such as blindness, deafness, brain damage and/or heart defects. Before Rubella vaccination 1 in 1,000 babies suffered from the Congenital Rubella Syndrome. The trial was to see if it was possible to successfully immunise children by giving them the vaccine by intra-nasal spray rather than injection. The trial showed that indeed this was possible but, sadly for the children of the world, doctors and nurses found it easier to give children injections than the slightly more time consuming nasal spray, so injections continued.
The now adult people are querying if consent was given for their inclusion in these trials. There were no ethics committees then. Up to 1987 there was no legislation covering clinical trials in Ireland. The Medical Council's ethical guidelines and the Helsinki Declaration on Human Rights were followed by doctors here and I would have to admit that there was a much more paternalistic approach to informed consent. Two of the trials were published in prestigious journals and this would not have happened if anything unethical was involved. The Third Trial was not published because the difference between the two groups was not significant. There was secrecy in the sixties regarding single motherhood. I am President of Cherish, the single mothers’ organisation which started in the sixties and I am well aware how girls and young women felt then about extra marital pregnancies. Society was very hard on them and Deputy Marian Maginnis, speaking in the Dáil, had a point when she said how little their views would have been considered and she did point out that neither they nor their children were thanked for their co-operation.
The doctor who vaccinated these babies in the homes was not attached to these homes so she must have got permission from someone to enter the premises. She didn't break down the doors. Whether the consent was proper I cannot say but the medical officers of the homes involved cannot have thought she was there on a routine visit to vaccinate the children because she was an academic and not attached to the homes in a clinical capacity. Professor Meenan is a barrister as well as a medical practitioner - he held the licence under the 1931 Act to import the vaccines and no-one has suggested anything illegal was done.
Similar trials with the vaccines were being carried out, I believe, in Cardiff and Bristol under the medical Research Council, at that time and may have been taking place in other countries as well. It is essential that such trials take place and we in Ireland must be involved.
In a statement issued recently Professor Hillary said she is prepared to go before the Joint Committee, which is already considering childhood immunisation, or the Laffoy Committee or both, if required. I am sure all involved will welcome her openness.
Senator Mary Henry, MD
