By Conall Ó Fátharta

Wednesday, August 10, 2011 – Irish Examiner.

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.

By Claire O’Sullivan and Conall O’Fatharta
MONDAY, JANUARY 24, 2011

PARTICIPANTS in controversial vaccine trials in mother-and-baby homes have been told by the Department of Health that it can’t give them their medical files or any trial documentation as it is legally bound to return the files to the drugs company.

The files are in the hands of the Laffoy Commission on Child Abuse, which was forced to halt its vaccine trials investigation following a 2002 court case.

Last night, Brenda McVeigh of the commission confirmed that they were “undertaking an examination of all documentation that they have and cataloguing it”. She said no files have yet been returned to Glaxo SmithKline.

A letter from the Department of Health to the Oireachtas Joint Committee on Health and Children, seen by the Irish Examiner, states that the department cannot hand over the documentation to the committee or to participants as legally “it is not possible for that material to be used for any other purpose” other than Laffoy Commission investigations.

“In the circumstances, I understand from the commission that they will be returning all documentation to the source that originally provided it”, the letter read.

The vaccine trials will be discussed by the Joint Committee in private tomorrow.

One of its members, Labour’s Kathleen Lynch, last night said the files have to be handed to the people used in the trials, irrespective of recent court rulings.

“I firmly believe the files must be given to victims as a human right. But until they are handed over and until this is finalised, they must be protected and must not be destroyed by any body or any company,” she said.

Up to 211 children were given the test vaccines in Ireland in the 1960s and 1970s. 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 from that time.

They are also seeking previously unseen files obtained by the Laffoy Commission from medical companies.

The Laffoy Commission was investigating vaccine trials between 1940 and 1987 as part of a separate module. However, the commission’s investigation was brought to a sudden halt after court action taken by the doctors involved in the trials.

Last September, after it emerged that a woman now living in the US was seeking to sue the Sacred Heart Order and Glaxo SmithKline about the administration of the vaccines, the Oireachtas Joint Committee on Health and Children decided to revisit the vaccine trials issue.

The committee wrote to Glaxo SmithKline seeking information on the trials. The company said the documentation contained sensitive personal information and they wouldn’t hand it over without judicial order.

This story appeared in the printed version of the Irish Examiner Monday, January 24, 2011

By Patricia McDonagh

Tuesday January 04 2011

VICTIMS of controversial vaccine trials are taking a High Court case to get confidential records on the medical experiments carried out on them as children in the care of the State.

A Dublin-based solicitor is preparing the action on behalf of Mari Steed (50), now living in the US city of Philadelphia, and Christopher Kirwan (50), from Cork, the Irish Independent has learned.

Vincent Shannon, of Shannons Solicitors, is planning to apply to the High Court for an order of discovery this month to acquire all the victims’ documents from four organisations at the centre of the scandal.

This will include Ms Steed and Mr Kirwan’s medical records, and documents that reveal if consent was given by their mothers for the trials.

More than 211 vulnerable infants and babies, 123 of whom were in the care of the State, took part in three confirmed trials to test new vaccines between 1960 and 1973.

The trials, one of which was carried out in the Sacred Heart Convent in Bessborough, Cork, were conducted by the Wellcome Foundation, whose income came from British drugs maker Burroughs Wellcome — later subsumed into drugs giant GlaxoSmithKline (GSK).

But it remains unclear whether the parents or guardians of the children consented to the trials, or if the foundation complied with Irish licensing legislation.

As well as these tests, details of previously unknown trials were handed over by GSK to the Commission to Inquire into Child Abuse. A brief paragraph in the commission’s third interim report, in January 2004, confirmed the receipt of relevant documents.

It is so far not known how many people were involved, whether children in state care were used for the trials or what medicines were tested.

Mr Shannon said the action, if successful, would compel the Department of Health and Children, the Sisters of the Sacred Heart at Bessborough, GlaxoSmithKline and the Commission to Inquire into Child Abuse to release all records relating to Ms Steed and Mr Kirwan.

If the records show that they have suffered as a result of the trials, Mr Shannon said the case would proceed to ask the court for an apology and damages.

“The proposed action (would) look for medical assistance for the victims’ physical or psychological injury as a result of the trials and damages for breach of their constitutional rights and assault,” Mr Shannon told the Irish Independent.

Correspondence seen by the Irish Independent shows the organisations continue to hold documents on the trials.

GlaxoSmithKline’s legal representative, law firm McCann FitzGerald, said: “We confirm that our client 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.”

Records

The Department of Health said all departmental records were retained “in line with normal procedures”.

A solicitor for the Sisters of the Sacred Heart at Bessborough said files were held in secure storage and it had “no intention” of destroying them.

The commission shut down its investigations into the trials on foot of a court case.

As revealed in the Irish Independent earlier this year, Ms Steed (50) was effectively used as a guinea pig during the ‘four-in-one’ vaccine trials carried out on her between December 1960 and October 1961, in Bessborough, when she was between nine and 18 months old.

Mr Kirwan — who still has marks from the vaccine injections all over his body — was also in Bessborough during that time and claims to have been involved in the trials.

Susan Lohan of the Adoption Rights Alliance said victims had been forced to take action at “great personal expense” because of the State’s failure to investigate the trials.

“Once again the department has to be dragged kicking and screaming to the table. They are cynically avoiding an investigation into this scandal.”

The Department of Health refused to comment last night.

- Patricia McDonagh

By Patricia McDonagh

Monday December 13 2010

THE first proof that unauthorised vaccine trials were carried out on children in the care of the State has emerged in new medical documents obtained during an Irish Independent investigation.

They show one boy was given a controversial and potentially harmful ‘five-in-one’ jab without his mother’s consent, shortly before he was adopted.

Philip Delaney’s medical records provide the first evidence that additional experimental vaccines were administered — without the knowledge of the State — to children in their care.

The revelation has again raised serious questions about the number of vaccine trials carried out on children in the care of the State.

Mr Delaney (45) claims he has suffered a lifetime of ill health after he was treated “like an animal” while in the care of the controversial mother and baby home in Bessborough, Co Cork, in 1965.

His adoptive mother, who witnessed the vaccine being administered, claims she was told it was part of a ‘secret trial’ involving up to 20 children.

The Department of Health last night insisted it never approved the injection, which comprised a combined polio, measles, diphtheria (respiratory disease), whooping cough and tetanus vaccines.

GlaxoSmithKline, the multinational drugs company that carried out three confirmed vaccine trials on 211 children, refused to say if the five-in-one vaccine was carried out on its behalf.

Records

Medical records obtained by Mr Delaney through an adoption agency confirm he was administered the five-in-one vaccine in three stages between August and October 1965.

He was given the first two jabs while in the care of the State in Bessborough.

The third injection took place in the home of his new adoptive mother, Vera Delaney.

The documents state: “The first of your five-in-one vaccination for polio, measles, diphtheria, whooping cough and tetanus was given on the 26th of August, the second on the 25th of September. You were due the third of your five-in-one injection on the 26th October and a note on file indicates that (doctor, who cannot be identified for legal reasons) was going to call to your new home to give you this injection.”

Speaking from his home in Longford, Mr Delaney said he has come up against a wall of silence every time he has attempted to discover the truth behind the trials carried out on him as a baby.

He has suffered chronic asthma all of his life and got measles as a child and wonders if this was the result of the vaccine.

“I feel I was treated like an animal. They thought they might just jab some concoction into a baby without telling anyone,” he told the Irish Independent.

Mr Delaney’s birth mother Margaret Finnegan said she never gave her consent for her child to receive the vaccine. “I was never told he would get the vaccine or asked by a doctor if I agreed with it,” she said.

Senior opposition frontbenchers and campaigners last night called for an independent inquiry into vaccine trials.

“It is unconscionable that, despite being faced with undeniable evidence of trials, the Government continues its cynical indifference against vulnerable children and unmarried mothers,” Susan Loan of the Adoption Rights Alliance said.

Fine Gael deputy leader and health spokesman James Reilly said an independent inquiry would be necessary if the Oireachtas Health Committee, which is currently sourcing material to see if it will launch a formal investigation, was not given all files relating to the vaccine trials.

“It is deeply disturbing that this vaccine was not part of the Department of Health-approved regime and that there is no record of a trial,” he said.

The Department of Health last night insisted it was unaware of any ‘five-in-one’ vaccine trial carried out in the State.

“No information on the 1965 trial referred to was identified and the department is not in a position to answer any of the detailed questions raised.

“The department does not propose to carry out any further investigations,” a spokesman said.

GlaxoSmithKline also refused to comment on the revelations.

“Since the Laffoy Commission, GSK has not received any official requests for information and we cannot comment or speculate on any future actions,” a spokeswoman said.

A spokeswoman for Bessborough also said she could not comment on why the vaccine was administered.

- Patricia McDonagh

Irish Independent

Friday, 27 August 2010
The Belfast Telegraph

The Irish government was told about secret vaccine trials at least six years ago but has refused to investigate them ever since.

Pharmaceutical giant GlaxoSmithKline — the firm that was behind controversial vaccine trials on children in state care during the 1960s and 1970s — handed over records relating to the tests to a child-abuse inquiry in 2004.

The revelations have piled pressure on the Republic’s Health Minister Mary Harney to launch an independent probe into the contents of the documents.

The Irish Department of Health admitted last night that its officials have been “in discussions” with the Commission to Inquire into Child Abuse about what to do with the records.

While the documents only show that “other vaccine trials” took place, it is so far not known how many other people were involved, whether children in state care were used for the trials or what medicines were tested.

Victims, adoption groups and opposition parties are now demanding a full investigation into all the vaccine trials on children in state care.

GlaxoSmithKline declined to comment. Its silence has raised serious concerns about the nature of the medical tests.

Those concerns have deepened as the department has so far failed to answer questions on the issue.

This newspaper put a series of questions to Ms Harney’s officials this week. No answers were forthcoming.

The questions included:

* How many vaccine trials in total were conducted?
* Were children in care used in the trials and what consent was given for this?
* What, if any, are the long-term medical effects of the trials on the victims?
* Why has the State refused to investigate the contents of the files?
* Why has the Department of Health still not made a decision on what to do with the documents, despite being aware of them for a number of years?
* As part of its work, the commission requested information on three confirmed trials carried out by The Wellcome Foundation, a company that later merged with other firms to create GlaxoSmithKline.

These trials involved 211 infants and babies and were carried out in mother and baby homes and children’s residential homes across the country in order to test new vaccines.

It remains unclear whether the parents or guardians of the children involved had consented to the trials or whether the company had complied with Irish licensing legislation.

As well as these tests, details of further, previously unknown trials, were also handed over to the commission by GlaxoSmithKline. A brief — and unreported — paragraph in the commission’s Third Interim Report, published in January 2004, confirmed the receipt of the additional documents.

“The documentation discovered by GlaxoSmithKline also disclosed a considerable amount of information in relation to other vaccine trials in the State,” the report said.

It stated that no decision had been taken on whether the extra trials could be investigated. In the end, no such investigation took place.

In June 2006, Ms Harney instructed departmental officials to discuss with the commission what should be done with the documents.

A spokeswoman for the commission confirmed that no decision was ever made.

The commission is not at liberty to release the files publicly without the approval of the department.

Adoption agencies last night led calls for an independent inquiry into the vaccine trials.

Susan Lohan, co-founder of the Adoption Rights Alliance, said: “I’m flabbergasted that the State and the adoption authority didn’t know the extent to which vaccine trials were being used in this country.

“I am calling on the Government to ask the commission to hand over this new evidence to an independent inquiry, where it can be investigated immediately and authoritatively.”

Fine Gael children’s spokesman Charlie Flanagan said: “The Government needs to direct the commission to hand over this new evidence to be examined by the Oireachtas Health Committee.

“Then, based on the outcome of this, a national investigation needs to be held in order to gauge the extent of the vaccine scandal.”

A spokeswoman for the commission said last night that it was prevented from investigating the vaccine trials on foot of two court cases taken by the doctors involved in the tests.

The vaccine module of the commission was closed down by Health Minister Mary Harney in 2006 on foot of that legal action.

Ms Harney said the issue of the vaccine trials was no longer a matter for the commission, which issued a report last year and is no longer investigating abuse claims.

She refused to comment on the calls for an independent inquiry or for the referral of the documents to the Oireachtas Health Committee.

Saturday October 09 2010

A woman used in infancy as a “guinea pig” in controversial vaccinations has said all files relating to the secret trials remain “in limbo” and are unable to be accessed as a result of a legal injunction.

Mari Steed (50), an American woman whose experience of the secret four-in-one vaccine trials was revealed by the Irish Independent in August, yesterday expressed grave concern over the protection of the records relating to the trials conducted on institutionalised children in the early 60s by the Wellcome Foundation, now GlaxoSmithKline.

The files had been handed over to the Ryan Commission, formerly the Laffoy Commission into child abuse, by GlaxoSmithKline.

Mari Steed was involved in the first trial, which sought to find out what would happen if four vaccines were combined in one jab.

“I got up to four different shots of the vaccine. My mother later told me that I reacted by vomiting after one jab,” she said.

The Commission to Inquire into Child Abuse (CICA) began investigating the vaccine trials in 2001. But, following legal action by two doctors involved in the trials, deemed to be too elderly and frail to take part in a court case, the investigation by the Commission into this aspect of how children in institutions were treated was brought to a standstill.

Ms Steed yesterday claimed the files were now “locked up” in the offices of the Commission.

“Nobody has done anything with these files. They are still in the offices of the Laffoy Commission,” she said. “We don’t know what is going to happen — the files are in limbo and nobody can access them.”

Ms Steed, along with several others, is currently preparing a class action in the US against the drug company responsible for the tests.

Ms Steed, who was adopted by an American family at the age of 18 months and has lived in the States ever since, was administered the vaccine while she and her mother resided at the Bessborough Mother and Baby Home in Cork, run by the Sacred Heart Convent.

- Nicola Anderson

Irish Independent

Tuesday September 14 2010

It seems quite extraordinary that it should fall to a Dail committee to demand that the Department of Health and multinational pharmaceutical companies release files relating to vaccine trials on Irish babies in state care.

If someone in the department is concealing relevant facts, it is a disgrace. Two weeks have passed since this matter of considerable concern was brought into the public domain, yet the response from the department has been minimal.

The Committee on Health and Children chairman has said that the content of the files, when examined, may make a formal inquiry necessary.

An Irish Independent investigation revealed details of vaccine tests carried out on very young children in state institutions without their mothers’ consent. The nature of some of the tests was known but, more alarmingly, some of the drugs being tested remain a mystery . . . or perhaps a secret.

The vaccine trials were discovered years ago by the Commission to Inquire into Child Abuse and confidential “discussions” about them are known to have gone on behind closed doors.

A number of questions now need to be answered by the relevant government agencies — and they ought to be voluntarily forthcoming. What was the nature of all the trials? How many children were subjected to them and what consent was sought?

These are living, breathing citizens and they have a right to know what they were subjected to.

By Patricia McDonagh

Tuesday September 14 2010

A Dail committee has formally asked the Department of Health and all multinational drugs companies to hand over files relating to controversial vaccine trials carried out on children in state care.

The Joint Oireachtas Committee on Health and Children has written to the department and firms such as GlaxoSmith-Kline to extract information “as a matter of urgency”.

The move follows revelations in a recent Irish Independent investigation into vaccine trials carried out on vulnerable children in the 1960s and 1970s.

The decision to officially search for information about the controversial trials was decided during a brief private meeting last week.

Committee chairman, Fianna Fail TD Sean O Fearghail, said members may call for a formal investigation after a detailed examination of the files.

The move was broadly welcomed by victims and opposition politicians last night.

However, they criticised the Department of Health for failing to launch its own investigation into the trials — and for its refusal to apologise to survivors.

More than 211 vulnerable infants and babies — 123 of whom were in the care of the State — took part in three confirmed trials to test new vaccines between 1960 and 1973.

The trials were carried out by the Wellcome Foundation, a company that later merged with other firms to create GlaxoSmithKline.

However, it remains unclear whether the parents or guardians of the children had consented to the trials, or if the company had complied with Irish licensing legislation.

As well as these tests, details of further, previously unknown, trials were also handed over to the Commission to Inquire into Child Abuse by GlaxoSmithKline.

A brief — and unreported — paragraph in the commission’s Third Interim Report, published in January 2004, confirmed the receipt of relevant documents.

It is, so far, not known how many people were involved, whether children in state care were used for the trials or what medicines were tested.

And — as revealed by the Irish Independent — despite the publication of this report six years ago, the Government has refused to investigate this new evidence.

Mr O Fearghail said the committee was anxious to obtain as much information about the issue as possible.

“We want to fully brief ourselves on the issue. We are looking for that information as a matter of urgency and will decide what course of action to take when we examine the information,” he added. “One of the options would be to launch an inquiry.”

The committee received a formal request to probe the issue from Fine Gael health spokesman Dr James Reilly three weeks ago.

Welcoming the latest development, Dr Reilly said he was “delighted” the committee was looking into the matter.

Fianna Fail TD Charlie O’Connor, who is also on the committee, called on officials to ensure all information was disclosed.

Truth

“The Department of Health should cooperate with the committee,” he said

However, Adoption Rights Alliance spokeswoman Susan Lohan insisted the move by the committee should just be the start of uncovering the truth.

“It is astonishing that it has taken the initiative from an Oireachtas committee to drive this investigation forward,” she said. “The move is a welcome one, but even if a formal investigation is launched by the committee, this should be followed by an independent inquiry.”

Author and campaigner Paddy Doyle added: “An investigation into vaccine trials on children in the care of religious orders and the State must happen, and urgently.”

“The matter is too serious to be kept away from the many people who are worried that they may have been used as guinea pigs.”

The Department of Health last night again insisted that Health Minister Mary Harney would not open an inquiry into the trials.

The department said it was unable to confirm if it was aware of further vaccine trials conducted by other drug companies.

- Patricia McDonagh

Irish Independent

By Juno McEnroe

Saturday, August 28, 2010 Irish Examiner.

THE commission inquiring into secret vaccine trials has said it remains in the dark about what to do with a room full of files, amid calls for an independent inquiry into how children were tested.

A legal challenge nearly seven years ago effectively closed down an inquiry into the testing of vaccines.

The Commission to Inquire into Child Abuse, which originally headed up the vaccine inquiry, said yesterday: “We have no legal authority with the documents other than just to return them. We have everything catalogued and ready to go when the department decides what it wants done with it.”

Its spokesperson said Health Minister Mary Harney had given no instructions on what should be done with the files. The Department of Health last night said discussions were ongoing with the commission regarding the trial files.

A department report previously found that at least 211 children in orphanages and mother and baby homes took part in four-in-one vaccine trials in the 1960s and 1970s.

Former residents of orphanages and mother and baby homes have called for an independent inquiry into the trials and one woman has already begun legal action against the drugs company involved.

Fine Gael last night demanded Ms Harney initiate an independent inquiry and bypass the legal constraints which closed it down.

This story appeared in the printed version of the Irish Examiner Saturday, August 28, 2010

Friday August 27 2010

THE Government must disclose all that is known about controversial vaccine trials carried out on children in the care of the State in past decades.

Our initial reports centred on Mari Steed, now aged 50, and three others who are to take legal action in the US courts against a multinational pharmaceutical company, on whose behalf the trials were conducted.

Ms Steed was subjected to the trial in the Sacred Heart Convent in Bessborough, Co Cork, when she was between nine and 18 months old, without her mother’s consent.

There were a number of such trials. The first involved 58 children in five children’s homes and the object was to discover what might happen if four vaccines, diphtheria, whooping cough, tetanus and polio, were combined in one overall 4-in-1 shot.

Another known trial involved 35 children who were administered the intra-nasal rubella vaccine.

A third involved 53 children in five institutions. It compared commercially available batches of the 3-in-1 vaccine with a modified vaccine prepared for the trial.

The subjects of these trials are understandably upset to discover that they were effectively used as guinea pigs when they were little more than babies, but at least they know the nature of the vaccines administered to them and the clear scientific purpose of what were, effectively, experiments.

Today we report that records of previously unknown vaccine trials were discovered years ago by the Commission to Inquire into Child Abuse and that there have been confidential “discussions” about them for several years now, but mystery surrounds the nature of those trials.

A number of questions need to be answered by the relevant government agencies, not least of which are what was the nature of all the trials, how many children in state care were subjected to them and what consent was sought?

Given the level of official reticence to date, an independent public inquiry may be needed to get to the truth.

Irish Independent
27th August 2010