[From top: Professor Patrick Meenan and Professor Irene Hillery; Michael Martin, Brendan Howlin, Brian Cowen and Mary Harney; Logo of GlaxoSmithKline which took over Burroughs Wellcome in 2000]
A timeline of the known medical trials conducted on children in Mother and baby homes in Ireland, the response of successive health ministers and the contemporaneous expansion in Ireland of the medical companies involved in those trials.
Grab a tay..
1930-5: Burroughs-Wellcome trials (“the 1930-35 trials”) of the APT (Alum-Precipitated Toxoid) vaccine for diphtheria carried out on 2000 children in residential institutions. Stage 1 of the trials took place in 1930 and include 405 children in residential institutions in Cork City, most likely the St Joseph’s Industrial School for Boys, run by the Presentation Brothers, and St Finbarr’s Industrial School for Girls, run by the Sisters of the Good Shepherd. Children taking part in Stage 1 suffer severe adverse reactions. Stage 2 of the trials takes place in 1934 and includes 320 children from residential institutions. Again adverse reactions are recorded. Stage 3 takes place in 1934 and involved 250 children from an unidentified institution for boys and Stage 4 takes place in 1935 and involves 360 children from St Vincent’s Industrial School, Goldenbridge, St Joseph’s School for Deaf Boys, Cabra, and St Saviours’s Dominican Orphanage, Lower Dominic Street.
1961: Burroughs-Wellcome trial of the effectiveness of the polio vaccine when added to the three-in-one (whooping cough, diphtheria and tetanus) vaccine carried out on 58 children in residential institutions only one of which (Bessborough, Co Cork) is identified. 28 of these children receive the proposed quadruple vaccine, with 30 getting the separate three-in-one and polio vaccines. The study concludes that there is a lower polio antibody response in those given the quadruple vaccine, and that it may, therefore, be less effective. Sixteen of 25 infants from one home develop vomiting, diarrhoea and fever after their second immunisation. Their symptoms last a few days before complete recovery. Some 36 infants from both groups are subsequently identified as having an inadequate polio antibody response, and receive booster doses. There is no further follow-up of the children involved.
1965: Trial of a ‘five-in-one’ vaccine carried out on Philip Delaney at Bessborough Mother and Baby Home, Cork.
1971: Burroughs-Wellcome trial (“the 1971 trial”) of intra-nasally injected rubella vaccine carried out by Burroughs Wellcome on 69 children in unidentified residential institutions. 11 children with no rubella antibodies and one with receive the intra-nasal vaccine, while six others without antibodies are used to monitor whether the vaccine virus was transmitted. There is no follow-up.
1973: Burroughs-Wellcome trial (“the 1973 trial”) of a modified three-in-one (diphtheria, whooping cough and tetanus) vaccine is carried out on 53 children (including mentally and physically handicapped children) in residential institutions in Dublin (St Patrick’s Home, Madonna House, the Cottage Home, the Bird’s Nest and Bohernabreena), all of whom receive the modified vaccine. The trial also includes 65 children living at home, 61 of whom receive the original vaccine. Some of the residential institutions mistakenly believe that their residents are getting the original vaccine.
1977-1984: Following concerns as to the safety of the three-in-one vaccine generally, then Health Minister Michael Woods sets up an Expert Medical Group (“the Expert Medical Group”) to deal with applications by persons alleging to have been brain damaged by the three-in-one vaccine. There are 93 applicants, 16 of which were offered ex gratis payments with 77 applications being declined. It is not known whether or not any of the applicants included children who had formed part of the 1973 trial or indeed whether or not the Expert Medical Group considered the 1973 trial at all.
1979: Construction of new £1.25 million Wellcome Ireland Limited factory in Tallaght commences.
1981: The Irish Times reports that since 1975 the Wellcome Foundation has donated £240,000 to Irish veterinary research.
1992 :Supreme Court decision in Best v Wellcome, a case successfully brought by Kenneth Best for brain damage caused by a batch of the original three-in-one vaccine. Chief Justice Liam Hamilton found Burroughs-Wellcome to have been negligent and awarded Best £2.75 million.
1993: The then Minister for Health Brendan Howlin, through his private secretary, writes to a former resident of one of the homes used in the 1973 trial, stating that the Department of Health had inquired and was satisfied there was no added risk whatsoever to the children who received the vaccines. It iremains unclear whether or not Mr Howlin was referring to the inquiry carried out by the Expert Medical Group, which as stated focused on the three-in-one vaccine generally, or a separate inquiry.
1995: Burroughs-Wellcome merges with Glaxo to form Glaxo-Wellcome. At the time of the merger Burroughs-Wellcome employs 30 people at its Irish distribution centre in Tallaght. Glaxo employs 100 people at its manufacturing facility in Rathfarnham. It also carries out packing, distribution and some research activities at its Dublin plant. Glaxo’s Irish operation records an annual profit of just under £2 million.
1997 :As a result of an investigation by the Irish Independent, the involvement of children in residential institutions in the 1973 trial is made public for the first time.
In response, the Department of Health states that all affected persons who had requested information had been provided with a full copy of their files by the Expert Medical Group in 1977-84. However most if not all of the institutionalised children part of to the 1973 trial – even if aware of having been subjected to the vaccine – would have been too young to have made an application to the Group during this period.
1998 Minister for Health Brian Cowen refers the issue of vaccine trials on children in residential institutions to the Chief Medical Officer, Dr Jim Kiely, for the purpose of compiling a Report on the 1961, 1971 and 1973 trials (“the Vaccine Trials Report”).
2000 In January, Glaxo-Wellcome merges with Smith Kline Beecham to form GlaxoSmithKline. Newspaper reports of the merger, which is described as unlikely to result in job losses in Ireland, state that Smith Kline Beecham has two manufacturing plants in Ireland, one at Ringaskiddy, Co Cork and the other at Dungarvan, Co Waterford, employing more than 660 people, as well as a Dublin-based marketing and sales operation employing 130 people. Glaxo is described as employing 110 people in Ireland – packaging, sales and distribution and in drug testing. It is also stated that Glaxo has recently approached IDA Ireland for exploratory talks about establishing a manufacturing plant from which to serve the European market, although no definite proposal has yet been put forward.
In November the Vaccine Trials Report is furnished to the Oireachtas. Little or no documentary evidence of the trials is available from Glaxo-Wellcome, the Department of Health or any of the residential institutions identified by the consultant who conducted the trials, Dr Irene Hillery. Continue reading