Vaccine Trials: Dark chapter that needs answers
IN June 2014, media reports which became the subject of public discussion revealed Burroughs Wellcome-sponsored vaccine trials in Ireland were far more widespread, and were undertaken over a much longer period than was previously known.
Further investigations now reveal that a systematic series of Wellcome-sponsored vaccine trials were conducted in children’s institutions over a period of almost 50 years from 1930 to 1977, sanctioned and overseen by state-salaried medical officers and academics.
Reports of Burroughs Wellcome-sponsored vaccine trials in Ireland first came to light in the 1990s. Three trials involving 268 children in private and institutional settings were subsequently investigated under a division of the Commission to Inquire into Child Abuse (CICA) in 2000.
However, the investigation ceased in 2003 following a High Court challenge taken by Irene Hillary and Patrick Meenan, Department of Medical Microbiology, UCD, who oversaw the trials during the 1960s and 1970s.
Multinational pharmaceutical giant, GlaxoSmithKline (GSK), who merged with Wellcome laboratories in the 1980s, made substantial historical documentation available to the ill-fated vaccine trial module. Following the collapse of the investigation, calls were made for this documentation to be handed over to people used in institutional trials, however, CICA determined that records supplied to the Vaccine Trials Division could not be used for any other purpose, were dismantled, and returned to their original sources.
An RTÉ Prime Time investigation 2011 featured a statement from GSK asserting that one further vaccine trial sponsored by their ‘legacy company’ was undertaken at the Sean Ross mother-and-baby home in Co Tipperary in 1964, and that this was the limit of Wellcome’s involvement in vaccine trials in Ireland.
However, findings published in today’s Irish Examiner reveal that this was not the case. In the earliest known trials, conducted between 1930 and 1935, Wellcome’s APT anti-diphtheria vaccine was administered to 2,051 children in 24 residential institutions in Dublin, Cork, and Tipperary and to more than 40,000 children among the general child population.
The administrators of the institutions involved are said to have given their full consent to the trials and include State-run orphanages, mother-and-baby homes, an institute for the deaf and dumb, and hospitals. Although sections of the media assert that religious congregations who ran the residential institutions involved received remuneration for their consent, there is no evidence to substantiate such claims.
It is more likely that resident medical officers informed religious orders in charge of such institutions that children under their care were being treated under a general immunisation scheme. In fact, evidence suggests parents and guardians of children in public, private, and institutional spheres involved in trials were kept in the dark with regard to the highly-experimental and potentially lethal nature of the vaccines administered to children in their care.
While commentators are quick to judge religious congregations, there has been little or no attention given to the medical and scientific communities who facilitated trials. These include State-paid institutional medical officers, State-paid municipal and county medical officers, and State-paid academics.
In short, any future investigation should focus not on religious congregations, but on the medical and scientific community, not on denominational administrators of residential institutions, but on the salaried medical personnel who bore ultimate responsibility for the health and wellbeing of children in state care.
This may be the very reason why Minister James Reilly and the Department of Children and Youth Affairs seem determined to exclude the issue of historical vaccine trials from the much anticipated Commission of Inquiry into mother-and-baby homes.
While a section of the department’s report of the inter-departmental group on mother-and-baby homes did address the three known Wellcome-sponsored trials investigated and abandoned under the CICA, there is no acknowledgement of new revelations which became the focus of national and international media attention and elicited a commitment from then-minister Charlie Flannagan to include vaccine trials in any future inquiry earlier this year.
Former health minister Micheál Martin has stated that previous efforts to set up an inquiry to investigate historical vaccine trials met with considerable resistance from within the Department of Health, where concerns relating to the reputation of the doctors and academics who undertook trials were articulated, as well as fears surrounding the question, ‘What more will be found?’ It seems clear similar concerns persist and permeate today.
Vaccine trials now in the public domain were conducted before the introduction of the Control of Clinical Trials Act 1987, and in this sense, they were not illegal or unlawful. They were governed by what amounted to little more than a ‘utilitarian ethic’, where the benefits to the many which flowed from human experimentation was considered as justification for the lack of a full appreciation of the rights of trial subjects, particularly in regard to obtaining their consent for participation in research.
However, there are further ethical issues to be explored. British pharmaceutical companies conducted vaccine trials on children in Ireland because they were debarred from doing so under legislation in Britain. So who decided that Irish children were creatures of lesser standing, bereft of the rights and special protection afforded their British counterparts?
Who decided that vulnerable Irish children in state care should be exposed to the unnecessary risks associated with experimental vaccines? Were institutional ‘guardians’ properly placed to allow children to be used as ‘experimental material’ in vaccine trials? If so, was their decision made in the best interest of the children or was it to satisfy scientific and commercial concerns?
The survivors of this particularly dark chapter of our history deserve answers, their experiences acknowledged, a full inquiry into the horrific treatment meted out to them by agents of this State, and, they deserve an apology.