Special investigation – Vaccine trials on children worse than first thought

The scale of use of children for vaccine trials is much greater than was first thought, writes Conall Ó Fátharta

THE latest revelations that another legacy company of pharmaceutical giant GlaxoSmithKline sponsored a fifth, previously undisclosed, medical trial on children in care here in the 1960s needs to result in action from the Government.

The fact is that the picture now emerging is now far more disturbing than that which compelled the then Fianna Fáil-led government to refer the matter for investigation by the Commission to Inquire into Child Abuse (CICA) in 2000.

Before that inquiry was halted following a 2002 Supreme Court ruling, GlaxoSmithKline (GSK) had confirmed just three trials in the 1960s and 1970s using over 250 children. We now know there were at least five trials in this period — the fifth exposed today by the Irish Examiner.

Indeed, recent revelations have shown that, far from carrying out just four vaccine trials on children in care here, Wellcome (now GlaxoSmithKline) sponsored trials in Ireland now span almost half a century — involving dozens of institutions and thousands of children.

The records released to CICA by GSK have now been returned to the company. The commission retained no copies. Yet, no questions have been answered.

Why are victims finding out about new trials now — through the press? Why did the short-lived inquiry not know a fourth and fifth trial had occurred?

Why did the report of Inter-Departmental Group on Mother and Baby Homes published this year still refer only to three vaccine trials — when a fourth was admitted in 2011 and the 1930-1935 trials of a Burroughs Wellcome vaccine for diphtheria carried out on 2,000 children in residential institutions were uncovered by Michael Dwyer of UCC’s School of History just a month before its publication?

Nor did it mention the 1965 trial of a 5-in-1 vaccine carried out on Philip Delaney at Bessborough mother-and-baby home in Cork. Why did this report claim a total of 123 children in institutional settings were used in the first three acknowledged trials when, in fact, 180 children were used?

The revelation that vaccine trials were carried out on children in mother-and-baby homes and other institutional settings first hit the headlines in the early 1990s.

Questions were raised in the Dáil on the subject, but it wasn’t until 1997 that then health minister Brian Cowen gave assurances that the matter would be examined.

In 2000, the Kiely report confirmed that three trials had been conducted on behalf of the pharmaceutical company the Wellcome Foundation. The institutions involved were Wellcome Laboratories in Britain, the Department of Medical Microbiology in UCD, and the Eastern Health Board.

The first trial took place between December 1960 and November 1961 in four Mother and Baby Homes — St Patrick’s on the Navan Road in Dublin (14 children), Bessborough in Cork (25 children), Castlepollard in Westmeath (six children), and Dunboyne (nine children). Four children from Stamullen baby home in Meath were also used for this trial.

The purpose of the trial was to look at the response the children would have to a 4-in-1 vaccine — diptheria, whooping cough, tetanus, and polio.

The second trial involved 69 children from St Anne’s Industrial School in Booterstown in Dublin being administered an intranasal rubella vaccine. A further 53 children from the wider community in Kilcullen in Westmeath were also used in this trial.

The first two trials were carried out by Professor Irene Hillary and Professor Patrick Meenan from the department of Microbiology in UCD, as well as other doctors.

The third trial involved 53 children in a number of residential institutions in Dublin including St Patrick’s Home, Madonna House, Bird’s Nest, and Boheenaburna. A total of 65 children living at home in Dublin also received the vaccine.

The aim of the third trial was to compare commercially available batches of the 3-in-1 vaccine — Trivax and Trivax D — with that of equivalent vaccines prepared for the trial. There is no published paper or report of this trial, but the Eastern Health Board was aware it was being conducted.

Dr Kiely’s report concluded that, given the reasons which the vaccines sought to counter, the decision to conduct the trials was “acceptable and reasonable”.

However, Dr Kiely said there was a lack of documentation available to clarify whether consent was either obtained or sought from the parents of the children or the managers of the institutions.

However, an entry in the 1962 British Medical Journal concerning the first trial seems to confirm that parental consent was not sought.

“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,” it wrote.

Responding to the Kiely Report in 2000, Prof Hillary said it was her “invariable practice at the time to obtain consent of the competent authority”, be it the mother, the manager, or the medical officer.

However, no record of written consent has been acknowledged. The religious orders who ran the homes involved in the trials have also denied that they authorised any clinical trials.

Of the victims of the vaccine trials who have located their natural mothers, all mothers have said they were not asked for their permission.

In 2000, then minister for children Micheál Martin admitted the Kiely report was “incomplete” and raised “as many questions as it answered”.

However, despite this, Mr Martin reassured the Dáil that the trials appeared to have had no medically negative consequences for any of the children involved.

In an effort to deal with the matter, the Government decided to extend the terms of reference of the Commission to Inquire into Child Abuse. This was done despite objections that the trials could not adequately be dealt with by an inquiry looking primarily into physical and sexual abuse.

The ‘Vaccines Module’ of CICA began investigating in early 2002. It obtained documentation from GlaxoSmithKline — the successor of Wellcome — and identified the names and addresses of some of those involved in the trials.

However, the probe was hit with a Supreme Court ruling which upheld Prof Meenan’s challenge against a High Court order directing him to give evidence before the inquiry.

The court also criticised the decision to ask the commission to examine the vaccine trials in the first place, stating they had “only the most tenuous connection, if any, with the appalling social evil of the sexual and physical abuse of children in institutions, which was the specific area into which the commission was established to inquire”.

Mr Justice Hardiman stated that Prof Meenan’s involvement in vaccine trials related only to one trial in 1960/61 and that the issue of the “reputational damage” associated with being involved with a Commission primarily looking at sexual abuse had to be considered.

Following this, Prof Hillary challenged the Government’s order directing an investigation into the vaccine trials. The Government did not appeal this decision. As a result, the work of the Vaccines Module’ ceased in November 2003.

However, those who suspected they were victims of the trials continued to claim that there were far more than three trials carried out by Wellcome here.

The Third Interim Report from CICA in December 2003 confirmed as much when it stated that the documentation it received from GSK “disclosed a considerable amount of information in relation to other vaccine trials conducted in the State”.

When RTÉ’s Prime Time asked the pharmaceutical giant about this statement, it confirmed a fourth trial had taken place in 1965. This trial involved giving differing doses of the measles vaccine to 12 babies aged between nine and 19 months in the Sean Ross Abbey mother-and-baby home in Tipperary.

The firm stated that this fourth trial was the only other clinical trial sponsored by Burroughs Wellcome using children in institutions in Ireland.

However, as the Irish Examiner reveals today, a fifth trial also occurred during this period.

An article in The Lancet in August 1965, discovered by Michael Dwyer of UCC’s School of History, confirms that Glaxo Laboratories Ltd carried out yet another measles vaccine trial on 34 children aged between eight months and just over two years. The trial was carried out by Prof Hillary and Prof Meenan of UCD and AJ Beale of Glaxo Laboratories. It is also the first trial which confirms Glaxo Laboratories involvement in a vaccine trial. All of the other trials were carried out by Wellcome.

Although the report does not mention an institution, it makes reference to the fact that the reaction to the children were monitored by “the adults looking after the children”. It also says examinations were done on the children from day six to 14 at the same time — 6pm — indicating the children were in a group setting.

The Irish Examiner put questions to GSK concerning this trial, what institution it was carried out in and why it failed to disclose this trial in 2011.

The company did not agree that the references in The Lancet amounted to evidence that the trial was carried out on children in care, stating that, in other papers by the same investigator, the author explicitly stated that the study was carried out on children in care. GSK said if it had any evidence that this trial was carried out on children in care, it would have handed it over to the CICA.

On the issue of whether consent was either sought or obtained for this study, GSK stated that any studies were done to the highest ethical and safety standards as a fundamental part of developing and delivering new vaccines to treat and prevent illnesses that were a major public health risk at that time.

“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,” said a statement.

GSK said it had “limited archived documentation” given the trials happened decades ago, but was seeking to investigate the facts. It also confirmed it would fully co-operate with any Government investigation into the issue.

The upcoming Mother and Baby Homes inquiry cannot ignore the issue. Many victims were resident in these homes and deserve answers, justice and all of the information held on them by GSK. Otherwise this state really does view them, even now, as was said in the Dáil in 2000 as “children of a lesser god”.

 

Vaccine trial confirmed by data request

In 2011, GlaxoSmithKline released a data protection request to vaccine trial victim Mari Steed which confirmed she was part of a vaccine trial it carried out half a century earlier.

It also released a dossier indicating that it had been monitoring statements she had been making to the media on the vaccine trials going back almost a decade.

Ms Steed, who was adopted to the US from Bessborough, discovered she was a victim of the trials in the late 1990s when she was trying to trace her natural mother.

A handwritten note on her medical file released to Ms Steed — the Sacred Heart order then ran the home — confirms she was given three injections for the 4-in-1 vaccine, the third of which was “given by Prof Hillary”. This entry is immediately followed by: “Baby to America.”

Ms Steed’s natural mother Josephine, who passed away last year, always stated that she was never asked for her permission, nor was she aware that vaccines were being trialled on her daughter during her time in Bessborough.

The 4-in-1 trial took place between December 1960 and November 1961 in four mother-and-baby homes. The purpose of the trial was to look at the response the children would have to a 4-in-1 vaccine — diptheria, whooping cough, tetanus, and polio.

Following her data protection request, Ms Steed was astounded to discover that GSK had kept a substantial file on her — and not all of it related to her medical records.

Referred to as “GSK 36” in parts of the documents released to her by the pharmaceutical firm, the records confirm her participation in the trial. However, she was astounded to discover the firm also had a file monitoring media appearances she made talking about the issue.

This included press cuttings from a range of newspaper interviews given by Ms Steed — some almost a decade apart.

Also included were typed transcripts from a number of different radio interviews. These included an interview with PJ Coogan on Cork radio station 96FM and an extract from a news bulletin on the station where she was quoted.

Ms Steed said the fact that the pharmaceutical giant was monitoring her public statements was “shocking”, although “not entirely surprising”.

“It was somewhat shocking to realise that GSK had been keeping such data on me, although not entirely surprising,” she says. “Just prior to receiving my DPA reply from GSK, I had received my entire file from the HSE South, which included a six-page dossier that Sister Sarto of Bessborough had kept on me, noting similar media references and untoward comments regarding my search for my mother.”

Ms Steed said she was aware of a number of Bessborough adoptees who had made DPA requests from GSK, but said she was not aware of anyone else that has had their participation in a vaccine trial formally confirmed by the company.

“I personally know one individual who came forward as part of the initial Laffoy investigation, but has not filed a request under DPA as far as I know; and of course, one other who participated in the Prime Time investigation,” says Ms Steed. “Many more have unexplained marks and scarring on their bodies, including outside areas where vaccines would typically be given.

“And every person I know, among hundreds, who were adopted from Ireland to the US, reported that as children we all came up as testing positive for TB during routine childhood doctor visits, despite not actually suffering from it. This anomaly has never been able to be explained by our family practitioners here in the US.”

The Philadelphia woman said the fact that the vaccine issue has never been fully investigated defied belief, and said many US adoptees were considering going to the courts unless the issue was included in the upcoming Mother and Baby Home inquiry.

“Failing that, I believe there are enough of us to move forward through the courts on the matter, including the EU court and potentially the UN,” says Ms Steed.

“There seems to be an inexplicable reluctance on the part of the Irish legal community to represent victims of such trials and proceed with cases. Although we are now making inroads to US law firms who have handled legal cases against GlaxoSmithKline and may be willing to provide representation.”

 

Waiting for some answers

Mari Steed is one of the few people that knows she was used in a vaccine trial. Others are not so lucky.

For people such as Christopher Kirwan, the wait for answers goes on.

He has written to numerous ministers of children to no avail. He has also written to GSK and to the Sacred Heart Sister — both of which have told him he was not used in any vaccine trial carried out in Bessborough.

A investigation by the Data Protection Commissioner in 2011 also confirmed that neither GSK nor the records then held at Bessborough indicated that he was part of a vaccine trial. That would be fine if the Cork man didn’t have eight unexplained scars on his arms and legs.

Mr Kirwan was born in Bessborough in November 1960 and was adopted the following June. He was in Bessborough during the period of the first Burroughs Wellcome vaccine trial, and even had his photo taken with Mari Steed as a baby.

Despite his scars, his records simply state that he was inoculated for the BCG and smallpox and that no documentation indicating he was part of those trials.

Mr Kirwan believes he was involved in a vaccine trial of some form as the marks on his body do not make sense for someone who just received two inoculations. His adoptive mother told him that when he left Bessborough as a child he had bandages on his arms. “I just want answers,” he says.

Philip Delaney has also been told he was not part of any vaccine trial, despite his medical records indicating he was give three injections of a 5-in-1 vaccine for polio, measles, diptheria, whooping cough, and tetanus. Beneath the record showing this injection, the words “Contact Dr Hillary, Dublin” are crossed out.

His adoptive mother told Prime Time in 2011 that she was told by a doctor who came to take the blood in a follow-up visit that Mr Delaney was one of 20 babies used for a trial for a 5-in-1 vaccine and that the babies were not supposed to have been given up for adoption.

“The Government are saying there have been no ill effects,” says Mr Delaney. “How do they know? Because they don’t know about this trial.”

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