Vaccine trials: Reparations and consent not only points of conflict between Government and GSK

Before Minister for Children Roderic O’Gorman met GlaxoSmithKline for talks on the mother-and-baby homes report in April 2021, the drug group sent an “agenda” to his office.

Unmentioned in the company’s list of meeting topics was the question of reparations for 1,148 children sent from the homes for clinical trials on the products of two predecessor companies – a top priority for the Minister.

The vaccine and infant milk trials in question, carried out between 1934 and 1973, involved the Wellcome Foundation or Glaxo Laboratories, separate companies now in GSK that sought commercial gain from products tested on children.

The children were from homes in Pelletstown, on the Navan Road, Dublin; Bessborough in Cork; Dunboyne, Co Meath; Castlepollard, Co Westmeath; and Sean Ross Abbey, Co Tipperary. The vaccines were for diphtheria; measles; a four-in-one product combining a polio vaccine with triple-vaccines for diphtheria, tetanus and pertussis; a “quintuple” five-in-one measles vaccine; and another diphtheria-tetanus-pertussis vaccine. There were two trials for infant milk products.

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The Commission of Investigation report was unambiguous: “It is clear that there was not compliance with the relevant regulatory and ethical standards of the time as consent was not obtained from either the mothers of the children or their guardians and the necessary licences were not in place.”

Despite such criticism and in defiance of pressure from O’Gorman for reparations, GSK has always refused to countenance such payments.

The commission’s report cast light on “appalling” infant mortality rates in the homes, saying the harsh treatment mothers and babies received was “supported by, contributed to and condoned by” institutions of the State and churches. It found “no attempt seems to have been made to seek the consent of parents or guardians” of children in clinical trials.

Publishing the report, the Minister promised financial redress for survivors and pressed church leaders and GSK to give money. But he hit a wall with GSK – and prolonged talks with Catholic and Church of Ireland bodies show no sign of a breakthrough.

[ Redress scheme for survivors of mother and baby homes approved by Dáil ]

[ Mother and Baby Homes redress time limit ‘commodifies suffering’, Boyd Barrett tells Dáil ]

Although the Dáil last week approved a €800 million redress scheme, O’Gorman was criticised for excluding survivors who spent fewer than six months in homes and those who had been “boarded out”.

There appears to be little prospect of GSK changing its stance on reparations.

O’Gorman’s department refused Freedom of Information access to dozens of files on its engagements on redress with church bodies, on the basis that the matter was still subject to a deliberative process. But the release of GSK files suggests deliberations with the company have stopped, without any commitment on reparations.

The company pledged to provide more access to information about trials, but not money for participants. “While we acknowledge the perspective of the Minister and others on the issue of reparations, we believe these measures represent the most valuable way to support those seeking further transparency in relation to the trials,” it said in reply to questions for this article.

GSK insists personal responsibility for the way trials were conducted lay only with “independent” Irish researchers, all deceased, and not with companies that made the products under examination.

The researchers named by GSK in correspondence with the Minister were: the late Patrick Meenan, professor of medical microbiology at UCD and head of the National Virus Reference Laboratory in the university; the late Dr Irene Hillery, public health practitioner and UCD medical microbiology lecturer; the late Dr Victoria Coffey, paediatrician, medical researcher and Trinity College Dublin lecturer; and the late Dr Margaret Dunleavy, medical researcher and public health doctor specialising in childhood immunisation.

Before meeting GSK two years ago, however, O’Gorman was advised to stress the corporate responsibility and moral obligation on the company to “do the right thing” on reparations. “There is no doubt that there was a commercial interest in the outcome of these trials,” his briefing note said.

But the company refused to yield, holding fast to its stance after O’Gorman called for a rethink at the meeting.

“The trials described in the commission’s report were bone fide and conducted by a number of experienced researchers,” GSK told The Irish Times, reiterating points made to the Minister.

[ GSK urged to consider reparations over vaccine trials at mother and baby homes ]

“Importantly, there is no evidence that adverse injuries were experienced by children involved in these trials.”

Reparations were not the only point of conflict between the Government and GSK: the company spurned demands to proactively “share” information on the trials with participants and refused to provide health screening.

Asked whether its stance on information had changed, GSK said it recognised many people were “understandably” seeking to access their personal data.

“However, we have significant ethical concerns about contacting individuals without their prior consent to provide them with unsolicited information regarding the trials,” it said.

“We are also concerned there could potentially be individuals involved who have no knowledge that they or their family members were resident in a mother-and-baby home. In addition, the records may also contain details of individuals who were subsequently adopted, making verification of their identity by GSK impossible.”

[ GSK offers upbeat outlook as demand for vaccines fuels profit ]

The company’s stance on screening was equally firm: GSK was “not clear” on the type of screening sought or on how it would assist former residents seeking reassurance.

“Any screening process would require that trial participants undergo physical examinations, tests and/or a review of their medical records,” it said.

“We do not believe there is any medical basis in these circumstances to offer such health screening to individuals today who were participants in clinical trials that took place so long ago. Furthermore, it would not be possible to make any definitive link between vaccines received in childhood and medical conditions that may have materialised much later in life.”

Five decades after the last clinical trials and two years after the commission’s report, not one corporate or church institution has been held to account financially for their role in the affair.