Vaccine Trials

Vaccine Trials

Wikipedia:

Vaccine trials in some Industrial Schools were to be investigated by the Commission, but were discontinued by the Commission in 2003 following Court judgement. In a statement on their website the Commission said ” The Vaccine Trials Inquiry was a Division of the Investigation Committee. Judicial Review proceedings seeking, inter alia, a declaration that the Order which established the Vaccine Trials Inquiry was ultra vires the Act of 2000, were initiated in November 2003. On 25 November 2003, an undertaking was given to the High Court, by the Commission, that it would not conduct any hearings in relation to the matters within the ambit of the Order, until the matter was settled. The practical effect of this undertaking was that the work of the Division was suspended at that point and never re-commenced, given the subsequent decision of the Court, that the Order was ultra vires the Act.”

Vaccine Trials Division Ruling 5 June 2003

www.childabusecommission.ie/vaccinetrials/documents/

-Ireland’s hidden scandal: child vaccine trial

Irish Independent.

BY PATRICIA MCDONAGH – 20 AUGUST 2010

Suspicions that vaccine trials had taken place on vulnerable Irish children — many of whom were in state care — first surfaced in the early 1990s.

As the current decade dawned, former residents of children’s homes began to publicly raise concerns that they had been the subject of experimental trials.

However, it was not until 1997 that the State gave an assurance that it would formally inquire into the issue.

Brian Cowen, who was then Health Minister, directed the chief medical officer at the Department of Health, Dr James Kiely, to investigate the allegations.

In 2000, a report — entitled the “Report On Three Clinical Trials Involving Babies And Children In Institutional Settings, 1960/61, 1970 and 1973” — was finally drawn up.

The document found that 211 children had been administered vaccines during three separate vaccine trials conducted on behalf of a drugs company, The Wellcome Foundation.

More than 123 of these infants and toddlers were residents in children’s homes in Dublin, Cork and the midlands when the trials took place in the 1960s and 1970s.

Trial one involved 58 children in five children’s homes in Dublin, Cork, Westmeath and Meath. The trial investigated what would happen if four vaccines — diphtheria, pertussis (also known as whooping cough), tetanus and polio — were combined in one overall four-in-one shot.

The trial was published in the ‘British Medical Journal’ in 1962. The final paragraph of it read: “We are indebted to the medical officers in charge of the children’s homes. . . for permission to carry out this investigation on infants under their care.”

Trial two, which was conducted during the summer of 1970, saw 35 children administered with the intra-nasal rubella vaccine.

It involved children from St Anne’s Industrial School in Booterstown, Co Dublin, and children living in the Killucan area of Westmeath.

Published in the ‘Cambridge Journal of Hygiene’ in 1971, the trial attempted to find out if German measles vaccine, administered intranasally, could spread to susceptible contacts.

Both trials were carried out by Professor Irene Hillery and Professor Patrick Meenan, from the department of Medical Microbiology in University College Dublin, and other doctors.

The final trial involved 53 children from institutional homes. The homes were: St Patrick’s Home, Madonna House, Cottage Home, Bird’s Nest and Boheennaburna. A further 65 children living at home in Dublin also took part.

The purpose of the trial was to compare commercially available batches of the three-in-one vaccine, Trivax and Trivax AD, with that of a modified vaccine prepared for the trial.

Dr Kiely’s report said the decision to conduct such clinical trials was acceptable, given the diseases that the vaccines sought to counter.

But, crucially, he insisted the lack of documentation available meant it had not been possible to confirm if consent had been given by the parents or guardians of the children involved or what arrangements were arrived at with managers of the homes.

He added that this lack of information also meant he could not confirm if the Therapeutic Substances Act 1932 had been complied with in relation to the licensing of the trials.
The damning document was laid before the Houses of the Oireachtas on November 7, 2000.

On November 9, the then Health Minister Micheal Martin told the Dail an important part of the probe was to establish if the State had fulfilled its obligations to children in its care.
But he admitted that the report was incomplete.

“It raises as many questions as it answers. Some of those questions go to the heart of our attitudes to children and their rights,” he said at the time

“The report is incomplete because in some areas, the most rigorous interrogation of the system failed to produce documentary records of the trials.”

Mr Martin said the Government had no evidence that any child had contracted a serious illness as a result of the trials.

But he branded the lack of documentation “puzzling” and insisted that the report had to be the “beginning and not the end” of the matter.

The minister referred the report of the investigation to the Commission to Inquire into Child Abuse — known then as the Laffoy Commission.

A government order was subsequently made on June 19, 2001 to provide the commission with the powers to create a separate module to formally investigate the issues involved.

The ‘Vaccines Module’ initially convened a public sitting on January 23, 2002, to outline its terms of reference. It then began investigating the trials.

It obtained documents from GlaxoSmithKline, the successor of Wellcome, which allowed it to definitively identify the homes and people involved in the trials.

Investigators received so much information relating to trial one that they were able to identify the children given the ‘four-in-one’ vaccine.

It also conducted private interviews with witnesses to get a more accurate picture.

But just before the start of public hearings into the first trials, which were due to begin on June 17, 2003, the work of the commission was dealt a severe blow when the Supreme Court ruled that Prof Meenan did not have to give evidence.

Prof Meenan had appealed a High Court order requiring him to comply with the commission’s direction to give evidence about his involvement in the trial.

The inquiry received a further setback when the Government’s order directing the Laffoy Commission probe was held to be invalid by the High Court in November 2003.

Mr Justice Aindrias O Caoimh gave his decision in a challenge brought by Prof Hillery. However, he ruled that other machinery could exist for an appropriate inquiry.

On November 25, 2003, an undertaking was given to the High Court by the commission that it would not conduct any hearings in relation to matters within the ambit of the order.

It had been hoped that the Government would appeal this decision. But on November 2006, Health Minister Mary Harney ordered the vaccine module to be closed down

Now, some of the victims have been left with no alternative but to seek redress in a US court after Ms Harney again firmly ruled out any further inquiries into existing or new allegations.

The victims’ basic requests appear to be far from unreasonable; an apology for what was done to them; full medical screening to see if they have suffered any damaging long-term effects from the trials; and psychiatric counselling to help them get over their ordeal.

But even this, it appears, is beyond the capacity or willingness of the State to deliver.

Irish Independent

‘I was used as a guinea pig in child vaccine scandal’.

The forgotten children of Ireland’s hidden scandal

PATRICIA MCDONAGH – 20 AUGUST 2010
SUSPICIONS that vaccine trials had taken place on vulnerable Irish children — many of whom were in state care — first surfaced in the early 1990s.As the current decade dawned, former residents of children’s homes began to publicly raise concerns that they had been the subject of experimental trials.
However, it was not until 1997 that the State gave an assurance that it would formally inquire into the issue.Brian Cowen, who was then Health Minister, directed the chief medical officer at theDepartment of Health, Dr James Kiely, to investigate the allegations.In 2000, a report — entitled the “Report On Three Clinical Trials Involving Babies And Children In Institutional Settings, 1960/61, 1970 and 1973” — was finally drawn up.

The document found that 211 children had been administered vaccines during three separate vaccine trials conducted on behalf of a drugs company, The Wellcome Foundation.

More than 123 of these infants and toddlers were residents in children’s homes in Dublin, Cork and the midlands when the trials took place in the 1960s and 1970s.

Trial one involved 58 children in five children’s homes in Dublin, Cork, Westmeath and Meath. The trial investigated what would happen if four vaccines — diphtheria, pertussis (also known as whooping cough), tetanus and polio — were combined in one overall four-in-one shot.

The trial was published in the ‘British Medical Journal’ in 1962. The final paragraph of it read: “We are indebted to the medical officers in charge of the children’s homes. . . for permission to carry out this investigation on infants under their care.”

Trial two, which was conducted during the summer of 1970, saw 35 children administered with the intra-nasal rubella vaccine.

It involved children from St Anne’s Industrial School in Booterstown, Co Dublin, and children living in the Killucan area of Westmeath.

Published in the ‘Cambridge Journal of Hygiene’ in 1971, the trial attempted to find out if German measles vaccine, administered intranasally, could spread to susceptible contacts.

Doctors

Both trials were carried out by Professor Irene Hillery and Professor Patrick Meenan, from the department of Medical Microbiology inUniversity College Dublin, and other doctors.

The final trial involved 53 children from institutional homes. The homes were: St Patrick’s Home, Madonna House, Cottage Home, Bird’s Nest and Boheennaburna. A further 65 children living at home in Dublin also took part.

The purpose of the trial was to compare commercially available batches of the three-in-one vaccine, Trivax and Trivax AD, with that of a modified vaccine prepared for the trial.

Dr Kiely’s report said the decision to conduct such clinical trials was acceptable, given the diseases that the vaccines sought to counter.

But, crucially, he insisted the lack of documentation available meant it had not been possible to confirm if consent had been given by the parents or guardians of the children involved or what arrangements were arrived at with managers of the homes.

He added that this lack of information also meant he could not confirm if the Therapeutic Substances Act 1932 had been complied with in relation to the licensing of the trials.

The damning document was laid before the Houses of the Oireachtas on November 7, 2000.

On November 9, the then Health Minister Micheal Martin told the Dail an important part of the probe was to establish if the State had fulfilled its obligations to children in its care.

But he admitted that the report was incomplete.

“It raises as many questions as it answers. Some of those questions go to the heart of our attitudes to children and their rights,” he said at the time

“The report is incomplete because in some areas, the most rigorous interrogation of the system failed to produce documentary records of the trials.”

Mr Martin said the Government had no evidence that any child had contracted a serious illness as a result of the trials.

But he branded the lack of documentation “puzzling” and insisted that the report had to be the “beginning and not the end” of the matter.

The minister referred the report of the investigation to the Commission to Inquire into Child Abuse — known then as the Laffoy Commission.

A government order was subsequently made on June 19, 2001 to provide the commission with the powers to create a separate module to formally investigate the issues involved.

The ‘Vaccines Module’ initially convened a public sitting on January 23, 2002, to outline its terms of reference. It then began investigating the trials.

It obtained documents from GlaxoSmithKline, the successor of Wellcome, which allowed it to definitively identify the homes and people involved in the trials.

Investigators received so much information relating to trial one that they were able to identify the children given the ‘four-in-one’ vaccine.

It also conducted private interviews with witnesses to get a more accurate picture.

But just before the start of public hearings into the first trials, which were due to begin on June 17, 2003, the work of the commission was dealt a severe blow when the Supreme Court ruled that Prof Meenan did not have to give evidence.

Prof Meenan had appealed a High Court order requiring him to comply with the commission’s direction to give evidence about his involvement in the trial.

The inquiry received a further setback when the Government’s order directing the Laffoy Commission probe was held to be invalid by the High Court in November 2003.

Mr Justice Aindrias O Caoimh gave his decision in a challenge brought by Prof Hillery. However, he ruled that other machinery could exist for an appropriate inquiry.

Redress

On November 25, 2003, an undertaking was given to the High Court by the commission that it would not conduct any hearings in relation to matters within the ambit of the order.

It had been hoped that the Government would appeal this decision. But on November 2006, Health Minister Mary Harney ordered the vaccine module to be closed down.

Now, some of the victims have been left with no alternative but to seek redress in a US court after Ms Harney again firmly ruled out any further inquiries into existing or new allegations.

The victims’ basic requests appear to be far from unreasonable; an apology for what was done to them; full medical screening to see if they have suffered any damaging long-term effects from the trials; and psychiatric counselling to help them get over their ordeal.

But even this, it appears, is beyond the capacity or willingness of the State to deliver.

Irish Independent

RELATED ARTICLES

Victim in legal battle over infant drug trial

Vaccine trial files will not be transferred to HSE

Wednesday, August 10, 2011

By Conall Ó Fátharta

FILES relating to controversial vaccine trials carried out on children at a Mother and Baby Home run by the Sacred Heart Convent in Bessboro in Cork will not be transferred to the HSE.

In a letter seen by the Irish Examiner to one of the victims of the trials, Maureen Downey Hickey, who was later adopted to the US, the HSE confirmed that while it is to receive 15,000 adoption files from Bessboro, it “has been advised that immunisation records will continue to be the responsibility of the order”.

The Irish Examiner reported last week that as the former adoption agency has not applied for accreditation, and is not compelled to do so under the Adoption Act, its adoption files will remain the private property of the order and cannot be inspected by the Adoption Authority.

More than 210 infants and babies, some 123 of whom were in the care of the state, took part in three confirmed trials to test vaccines between 1960 and 1973.

A number of people sent to the US for adoption and adopted domestically have recently filed requests under the Data Protection Act, asking for medical files and any evidence of their participation in the trials run by the Wellcome Foundation — whose income came from British drugs maker Burroughs Wellcome, which was later subsumed into GlaxoSmithKline.

Now adults, the participants say the drugs were given without parental consent and they have spent years trying to access their medical files and pharmaceutical information.

The office of the Data Protection Commissioner confirmed it has been in touch with the Sacred Heart Sisters Order and was satisfied it is the data controller in this instance and is therefore subject to and has responsibilities under the Data Protection Act.

The Sisters of the Sacred Heart Order could not be contacted for comment last night.

One of the victims of the trials at Bessboro, Mari Steed, said it was “unacceptable” that files containing her medical history could be deemed the private property of a religious order.

“The idea that immunisation records cannot be transferred with the adoption files and are privately owned by the religious order in question is an absolutely unacceptable scenario,” Ms Steed said. “They were merely the broker or subcontractor for my care. Ultimately, the state contracted their services in shipping me to the USA.”

The Adoption Rights Alliance called on the Government to reinstate the inquiry and said “questions must be asked as to why the Sacred Heart Adoption Society did not supply the HSE with the files relating to vaccine trials”.

The Laffoy Commission on Child Abuse was investigating vaccine trials between 1940 and 1987 as part of a separate module.

However, the investigation was brought to a sudden halt after court action was taken by the doctors involved in the trials.

© Irish Examiner Ltd. All rights reserved

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