GlaxoSmithKline & clinical trials on Irish children in residential homes

The Irish Examiner has reported a previously undisclosed clinical trial carried out by Glaxo laboratories on Irish children in the 1960s. According to Conall Ó Fátharta, 

The pharmaceutical giant has previously only admitted to four vaccine trials having ever been carried out in Ireland. In a response issued to RTÉ in 2011, it acknowledged a fourth trial but stated that this was the only other clinical trial sponsored by Wellcome using children in institutions in Ireland.

Michael Dwyer, a UCC historian, has found evidence of a fifth trial and has called for an investigation into these trials. Broadsheet has produced an excellent and detailed timeline of how all of this has unfolded, including various legal challenges over the years. I have reproduced it here in full.

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The revelation of a fifth vaccine trial casts a new light on the statements and denials over the years from GlaxoSmithKline (and before that Wellcome), the Department of Health/HSE and the two UCD medics responsible for administering the vaccines, Patrick Meenan and Irene Hillary

Herewith then an updated timeline of the known medical trials conducted on children in Mother and baby homes in Ireland, the response of successive health ministersand the contemporaneous expansion and investment in Ireland of the medical companies involved in those trials.

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 (“the 1961 trial”) of the effectiveness of the polio vaccine when added to the three-in-one (whooping cough, diphtheria and tetanus) vaccine carried out by Prof Patrick N Meenan and Dr Irene B Hillary (“Meenan and Hillary”) of University College Dublin 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.

1964-5: A further Burroughs-Wellcome trial of a measles vaccine (“the first 1965 trial”) is carried out by Meenan and Hillary on 12 infants aged between nine and 19 months in the Sean Ross Abbey mother-and-baby home in Tipperary.

The same year, another trial of a measles vaccine (“the second 1965 trial”) was carried out by Meenan and Hillary in conjunction with another pharmaceutical company, Glaxo, on 34 children aged between 8 months and just over 2 years. Although the location of the second 1965 trial is not known, its description in the Lancet (August 1965) indicates that it took place in a controlled institutional environment.

It appears that at least one further vaccine trial (“the third 1965 trial”) also took place in 1965. The medical records of Philip Delaney at Bessborough Mother and Baby Home, Cork, note a ‘five in one’ vaccine having been administered to him that year, as part of a vaccine trial.

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 as involved in the trials.

Addressing the Dail, Micheal Martin, Minister for Health, expresses concern about the lack of consent given by or on behalf of the children involved in the trials, stating that it is important “to move heaven and earth to find out… the State must fight fiercely for all of that child’s rights, including bodily integrity. The State does not have the right to view children in care as lesser citizens.”
Mr Martin goes on to reassure the Dail that the trials appear to have had no medically negative consequences for any of the children. In fact, lack of documentation had made it impossible for Dr Kiely to reach a conclusion on this point, he did however reference in the Report possible negative consequences for the children concerned.

The Government subsequently extends the terms of reference of the Commission to Inquire into Child Abuse (“the Child Abuse Commission”), to include the 1961, 1971 and 1973 trials, despite objections that the jurisdiction of the Commission, as set out in the Commission to Inquire into Child Abuse Act 2000, did not permit such a referral.

2001: GlaxoSmithKline announces that it will cut 104 jobs out of a total of 381 at its Dungarvan plant following a decision to transfer the manufacture of Sensodyne toothpaste to its Maidenhead operation in England, describing the move as part of a worldwide review of the group following the merger between Glaxo Wellcome and SmithKline Beecham. IDA Ireland and the Tanaiste, Mary Harney, are called on to create alternative employment in Dungarvan.

2003 : With public hearings relating to the 1961 trial due to commence in June, the Child Abuse Commission issues a direction for the attendance of Professor Patrick Meenan, former head of the Department of Microbiology and Applied Medicine at UCD, who had been involved in the 1961 trial.

In June, Mr Justice Smyth grants an application by the Commission for an enforcement order against Professor Meenan, stating that he was “a significant and important person” at the time and it was neither unfair nor unreasonable of the Commission to have described him as a central witness. Mr Justice Smyth notes that the Commission had invited Professor Meenan’s solicitors to apply publicly to exclude him on health and other grounds from giving evidence.

In July, it is announced that GlaxoSmithKline will invest E7 million in a new research and development laboratory at its operations in Carrigaline, Co Cork, that will create 10 graduate level jobs. The Tanaiste, Mary Harney, welcomes the announcement as further proof of the Republic’s emergence as a leading player in pharmaceuticals.

In August, the Supreme Court, in a judgment delivered by Hardiman J, allows Professor Meenan’s appeal, holding that requiring him to make a public application to be excused is unreasonable and fails to show sufficient sensitivity to the very great effort participation in the public forum sought might represent to a man in his 87th year. The Court also expresses the view that the vaccine trials were not ‘abuse’ within the meaning of this term as used in the 2000 Act, raising questions as to the jurisdiction of the Child Abuse Commission to consider this issue. The Court draws attention to the very eminent reputation of Professor Meenan as a former barrister and Professor of Medicine at University College, Dublin.

In September, Judge Mary Laffoy resigns as Chair of the Child Abuse Commission, accusing the Government of delaying and obstructing the inquiry.

In December, the Third Interim Report from the Child Abuse Commission states that the documentation received from GlaxoSmithKline discloses “a considerable amount of information in relation to other vaccine trials conducted in the State”. Following a query by Prime Time, Glaxo Smith Kline states that the only trials carried out by Burrough-Wellcome – in addition to the three trials already in the public record, was the first 1965 trial at Sean Ross mother and baby home. It makes no mention of the second 1965 trial carried out by Glaxo; nor does it mention the third vaccine trial of the same year involving Philip Delaney.

2004: In Hillery v Minister for Education, Mr Justice O’Caoimh holds that the Commission has no jurisdiction to consider the question of vaccine trials, for the same reason as the Supreme Court in Meenan, namely that the vaccine trials are not ‘abuse’ within the meaning of the 2000 Act. However he states that there may be issues relating to the trials which could be the subject of an appropriate form of inquiry carried out by other machinery.

Meanwhile, the Interim Report of the Child Abuse Commission, published prior to the judgment in Hillery, references the receipt of documentation from Wellcome evidencing vaccine trials additional to the 1961-1971 and 1973 trials.

2005: Minister for Health, Mary Harney, announces that there is to be no further examination of vaccine trials, saying that this is not possible following the Meenan and Hillery decisions. However this assertion by Ms Harney conflicts with the dicta of Mr Justice O’Caoimh in Hillery above.

2006: It is announced that GlaxoSmithKline will part fund a €13.7 million project at University College Cork on research into gastro-intestinal diseases. The project, which will create 50 jobs, is also tunded by IDA Ireland. Speaking at the launch in UCC, Minister for Enterprise, Trade and Employment Micheál Martin describes the project as a major breakthrough in the promotion of drug discovery research.

Discussions commence between the Child Abuse Commission and the Department of Health regarding return of the documentation obtained by the Commission in the course of its inquiry into the vaccine trials.

2008: It is announced that GlaxoSmithKline is to create 50 new jobs with an €30m investment in the expansion of its existing over-the-counter (OTC) pharmaceutical manufacturing facility in Dungarvan, Co. Waterford.

2009: In November, it is announced that GlaxoSmithKline will close Stiefel Laboratories in Sligo, purchased by it in July, with the loss of 250 jobs.

2010: The Irish Independent reports that Mari Steed, a former resident of the Bessborough Mother and Baby home, is to take an action against Wellcome in the U.S. courts and against the Sacred Heart Order in the Irish courts.

Further newspaper reports reference a number of additional victims, and additional vaccine trials, including John Barrett who alleges that unidentified tests were carried out on him at the Lota Industrial School, and Philip Delaney, the documented subject of the third 1965 trial involving the ‘five in one’ vaccine. GlaxoSmithKline neither confirms nor denies Mr Delaney’s assertion, and the Department of Health deny all knowledge of the third 1965 trial.

Meanwhile, documentation relating to the investigation into vaccine trials referred to by Brendan Howlin in 1993 cannot be found. It is unclear whether or not this documentation relates to the 1977-1984 Working Group or some other investigation.

Following a formal request by Fine Gael health spokesman James, Reilly, the Joint Oireachtas Committee on Health and Children writes to the Department of Health, GlaxoSmithKline and other pharmaceutical firms asking them to hand over all files on vaccine trials carried out on children in residential institutions “as a matter of urgency” stating they may call for a formal investigation after a detailed examination of the files.

2011: GlaxoSmithKline confirms that it “continues to hold records relating to the Irish vaccine trials conducted by The Wellcome Foundation Limited and intends to do so for the foreseeable future” but refuses to hand these records over without a judicial order.

The Department of Health states that all departmental records (except presumably those relating to the missing inquiry referenced by Brendan Howlin) are retained “in line with normal procedure”. It writes to the Child Abuse Commission stating that the Commission cannot hand over documentation to the Oireachtas committee or to participants since legally “it is not possible for that material to be used for any other purpose” other than … Commission investigations and that they should return all documentation to the source that originally provided it”. The Commission states that it is currently engaged in cataloging the documentation and has not commenced returning it.

The HSE confirms that while it is to receive 15,000 adoption files from Bessborough, it “has been advised that immunisation records will continue to be the responsibility of the order”. The Sisters of the Sacred Heart at Bessborough say that their files are held in secure storage and they have “no intention” of destroying them.

In July, GlaxoSmithKline announces that 150 workers at its Dungarvan plant are to be made redundant.

2012: In August, the Child Abuse Commission announces that it has commenced the return of material supplied to the Vaccine Trials division to its original sources.

In October, GlaxoSmithKline reverses its decision to shut Stiefel Laboratories in Sligo, saving 120 jobs.

2014: In June, reports of a mass baby grave and evidence of high infant mortality at a mother and baby home in Tuam, Co Galway, reawaken public concern regarding treatment of children in care, bringing the vaccine trial issue once again to the forefront..

Dr Kevin McCoy, a former member of the Chlld Abuse Commission, and former Chief Inspector of the Inspectorate of Social Services in Northern Ireland, states that to his knowledge and belief Child Abuse Commission documentation relating to the vaccine trials has been retained and is to be housed in the National Archives for 75 years before limited access to it is allowed.

Also in June 2014, Michael Dwyer of Cork University’s School of History, uncovers references in British Medical Journal to the 1930-35 diphtheria vaccine trials cited at the start of this timeline. GlaxoSmithKline’s response is as follows:- ‘The activities that have been described to us date back over 70 years and, if true, are clearly very distressing. ‘We would need further details to investigate what actually took place, but the practices outlined certainly don’t reflect how modern clinical trials are carried out. We conduct our trials to the same high scientific and ethical standards, no matter where in the world they are run.’

In November 2014, Mr Dwyer identifies, in the Lancet, reference to the second 1965 vaccine trial carried out by Meenan and Hillary in conjunction with Glaxo. In response, GlaxoSmithKline denies that this trial was carried out on children in care, despite references to its subjects residing in an institutional environment, saying that if it had any evidence to this effect it would have handed it over to the Child Abuse Commission. On the issue of whether consent was either sought or obtained for this study, GlaxoSmithKline states that “The studies of The Wellcome Foundation vaccines were conducted by independent healthcare professionals. The children who participated in the trials were recruited from the community and those living in children’s homes. The methodology and results of at least two of the studies were published in respected journals.”

A search in a medical journal archive discloses a comprehensive list of all published trials carried out by Meenan and Hillary in the 1950s, 60s and 70s. They do not appear to include the third 1965 trial involving the ‘five in one’ vaccine administered to Philip Delaney. There may have been other vaccine trials carried out, which were not published.

To date, neither Meenan, Hillary, GlaxoSmithKline, University College Dublin or the Department of Health have given a comprehensive list of these trials.

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