Tag Archives: Medical Trials

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RTE R1’s Morning Ireland today reported on pharmaceutical company GlaxoSmithKline’s links with Sligo Institute of Technology and its plans to expand its Stiefel plant in Co Sligo (above).

GlaxoSmithKline, in its previous incarnation Burroughs Wellcome, was the company which carried out vaccine trials on children in care homes throughout Ireland in 1930, 1932, 1934, 1935, 1961, 1965, 1971 and 1973.

Its 2009 decision to close the Stiefel Laboratory was reversed in 2012 following the return of records relating to the trials by the Child Abuse Commission.

In 2010 the Oireachtas Committee on Health and Children requested these records from Glaxo Smith Kline, which indicated that although prepared to hold the records for the foreseeable future, it would not hand them over without a court order.

The government has yet to state whether or not the proposed inquiry into mother and baby homes will include vaccine trials carried out in these homes.

Previously: Medical Trials And Children Of Lesser Gods

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[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

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[Professors Meehan and Hillary, above and the report by the Chief Medical Officer]

Below is a link to a November 2000 report by the then Chief Medical Officer [Dr Jim Kiely] regarding trials conducted on children in mother and child homes.

This is the report the Irish Times reported yesterday that the Department of Health is having difficulty tracking down.

It concerns the state allowing Wellcome to carry out medical trials in care homes in the early 1960s up to 1973.

The trials were overseen by Professor Patrick Meehan and Professor Irene Hillary both attached to the Medical Microbiology Department at University College Dublin.

The report runs to a brisk, readable if ghoulish 45 pages and we highly recommend it should you have the time and an interest in these matters.

The contents – known to at least four health ministers – reveal not just a cover-up (with laughable collective amnesia and no paper trail at all) but a reminder that certain medical professionals enjoyed playing god as much as the next nun.

Report here

Previously: Medical Trials And The Law

Guinea Pigs

Thanks Turlough O’Riordan

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In 2001, the Commission to Inquire into Child Abuse was given the task of enquiring into the issue of vaccine trials on children in institutions.

This inquiry stopped, because of what the website of the Commission describes as a ‘judicial review’ case before the High Court.

We asked Legal Coffee Drinker what it’s all about.

Broadsheet: “Legal Coffee Drinker: What’s it all about?”

LCD: “The Commission to Inquire into Child Abuse Act 2000 set up a Commission (“the Child Abuse Commission”) to inquire into the abuse of children in institutions. In 2001 an Order [the Child Abuse Act, 2000 (Additional Functions) Order, 2001 (S.I. No. 280 of 2001)] was passed extending the functions of the Commission to include certain vaccine trials carried out on children in institutions by, among others, two doctors, Irene Hillary and Patrick Meenan. Both doctors brought cases against the Commission. In 2003, the Supreme Court heard an application by Patrick Meenan in which he sought and was granted an order quashing a direction of the Commission that he attend at a public hearing. The Supreme Court in passing raised issues as to the entitlement of the Commission to consider the vaccine trials and following on this Irene Hillary brought a High Court case successfully challenging the validity of the 2001 Order. As a consequence the Commission no longer had jurisdiction to examine the issue of vaccine trials and their inquiry on this point had to stop.”

Broadsheet: “Why exactly was the 2001 Order held invalid?”

LCD: “Because under the 2000 Act, the government only had power to direct the Commission to inquire into instances of ‘abuse’ within the meaning of Section 1 of the Act. The definition of ‘abuse’ in Section 1 was as follows:- (a) the wilful, reckless or negligent infliction of physical injury on, or failure to prevent such injury to, the child, (b) the use of the child by a person for sexual arousal or sexual gratification of that person or another person,(c) failure to care for the child which results in serious impairment of the physical or mental health or development of the child or serious adverse effects on his or her behaviour or welfare, or (d) any other act or omission towards the child which results in serious impairment of the physical or mental health or development of the child or serious adverse effects on his or her behaviour or welfare. The courts took the view that vaccine trials did not come within this definition, at least if no concrete proof of adverse effects was available.”

Broadsheet: “And was this an irreparable mistake? Could something not have been done to correct it, after the above decisions?”

LCD: “Yes of course. It would have been open to the Oireachtas, following the High Court decision holding the 2001 Order invalid, to pass an Act widening the definition of abuse in Section 1 of the 2000 Act to to definitively include vaccine trials. It would of course also have been open to the Oireachtas to set up a separate Commission to deal with the vaccine trials. There is nothing in either of the decisions above to prevent this; the court’s findings in both cases was simply that there was no jurisdiction to consider vaccine trials under the Child Abuse Act as it stood.”

Broadsheet:  “Can you explain why In 2010 then Minister for Health [Mary Harney] in the the Oireachtas  when asked why no attempt had been made to investigate the matter further stated:-‘Having carefully considered both the Court judgments and the High Court decision I decided that no further investigation would be carried out. It is considered that it was very likely that any further investigation would experience similar difficulties to those encountered by the Commission.'”

LCD:” I’m not sure why she thought that, given that the difficulties encountered were entirely due to the drafting of the 2000 Act, which could have been amended by the Oireachtas by an amending Act at any time – in fact an Act amending other aspects of the 2000 Act was passed in 2005! Perplexing…”

Broadsheet: “What do you think about the decision to include the vaccine trials within the remit of the Commission to begin with?”

LCD: [drains coffee] “I think it was unfortunate that the government who made this decision did not read the definition of ‘abuse’ in the Act and seek to widen it before doing so. It should have been obvious, given the wording of Section 1, that this was going to present problems which might – as ultimately happened – result in an issue of significant importance – and much debate at the time – failing to get any resolution.”

Broadsheet: “Plus ça change…”

LCD: “Right. Are we done?

Broadsheet: “Yes. Thanks Legal Coffee Drinker. Just a bit of French there. Sorry.”

Earlier: Guinea Pigs