GSK to provide ‘enhanced’ data for former mother and baby home residents

More simplified information on trial summary papers for vaccine and infant milk trials

The Bessborough Centre, Blackrock, Cork city – former children’s home operated by the Sacred Heart nuns. Photograph: Provision

The Bessborough Centre, Blackrock, Cork city – former children’s home operated by the Sacred Heart nuns. Photograph: Provision

 

A pharmaceutical firm is to provide an “enhanced information service” for former residents of mother and baby homes regarding vaccine trials that took place between 1934 and 1973.

Glaxo SmithKline (GSK) made the announcement in a statement on Wednesday in response to issues raised following publication of the final report of the commission of investigation into the homes.

It says it is providing a more simplified information request service and has published trial summary documents for nine separate vaccine trials – trials A to G, as referred to in the commission’s report, and two infant-milk formula trials. The material can be accessed on the GSK website.

GSK is made up of two companies which carried out seven different trials in mother and baby homes. The trials, for vaccines including measles, polio and diphtheria were at Bessborough, Pelletstown, Dunboyne and Castlepollard.

The commission found there wasn’t compliance with the relevant regulatory and ethical standards at the time and consent was not obtained from the mothers, the children or their guardians.

Its finding that there was no evidence of injury to the relevant children as a result of the vaccines has been raised in High Court proceedings, yet to be heard, brought by Mari Steed, of Virginia, US, born in the Bessborough Mother and Baby Home, Cork, in 1960 and adopted by an American family in 1961.

Ms Steed claims she was subject to the Quadrivax vaccine trial while in Bessborough and should have been given an opportunity to address the commission’s finding there was no evidence of injury to the relevant children as a result of the vaccines. Being subject to a vaccine injection in the absence of parental consent was contrary to her personal rights, she claims.

GSK said it recognises many survivors are understandably seeking to access their personal information and it has endeavoured to find “a meaningful way” to assist in that regard.

For some years, GSK has provided an information service to survivors who request a search of the records to identify what, if any, personal information GSK holds about them, it said.

Demand for this service – known as a “subject access request” – had increased since the publication of the commission’s report.

GSK said it has worked to simplify the process and details of how to access it are available on its website.

“GSK believes these measures undertaken to simplify the information request service and publish trial summary documents represents the most valuable way to support those seeking further transparency in relation to the trials.”

The company said it wants to ensure that survivors who believe they may have been a participant in a trial are aware they have a statutory right to submit an information request to the company in relation to their personal information.

Names and dates of birth?

The records are not complete for every trial, it stressed. While some of the individual clinical trial records contain important identifying information such as names and dates of birth, this information is not available for all trials.

“This means it is not possible to verify the identity of every participant and part of the reason why GSK has also published trial summary documents with information about the development and, where applicable, the licensing history of the trial products.”

The documentation has been collated from GSK’s archives in London as well as other published sources to evaluate, as far as possible, the history of the vaccine or milk products after their trials were conducted by researchers in mother and baby homes, it added.

Its statement concluded: “GSK would like to re-emphasise its sympathies to the women, children and families affected by the issues raised in the Commission’s report and sincerely hopes the work undertaken to enhance its information service and publish trial summaries will better support those searching for more information about their personal experience or that of a family member.”

Independent TD Denis Naughten saidGSK still has questions to answer. These included why the company “has taken so long to make such a move” and “why it has refused to make a financial contribution for redress to survivors of mother and baby homes, following a request from government”.

GSK was releasing summary documentation already provided by it to the State two decades ago, he said. However, he welcomed its statement survivors have a statutory right to seek their personal information from the company.

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