GSK must do much more than release trial summaries – Naughten

In Health, News by Denis Naughten

GSK cannot just brush over its responsibility to those involved in the nine vaccine and infant milk trials in mother and baby homes by merely releasing summary documentation which it already provided to the State two decades ago, Denis Naughten TD has stated.

Deputy Naughten, a long time campaigner seeking full disclosure from both the State and GSK on the vaccine trials, said: ”While I want to acknowledge the release of this information to the people involved in the trials by the company, GSK has many more questions to answer. The first of which is why has it taken so long to make such a move?

“The company needs to also answer why it has refused to make a financial contribution for redress to survivors of mother and baby homes following a request from Government?”

Denis Naughten added: “I also set out a number of key questions for the company when I spoke on the Commission Report last January in Dáil Eireann, when I pointed out ‘children were treated as little more than human pincushions’. I am reiterating my call that we need clear answers and apologies from GSK

“However,  I do want to acknowledge that GSK has stated that it wants to make survivors  aware they have a statutory right to submit an information request to the company in relation to their personal information. It’s just a pity that the State has not taken the same approach to these very same records.

“Back in 2012 the documents provided by GSK, the religious orders that were responsible for these homes and the State agencies involved in these clinical trials were returned to the original owners by the Department of Education.

“The Commission of Investigation into Mother and Baby Homes then sought these records again following its establishment. Yet we are still waiting for those involved in the trials to get access to information that was originally collected two decades ago at the time of the original vaccine trial inquiry that was suspended in July 2003 following a Supreme Court Judgement.

“Government also needs to live up to its responsibilities and notify those who it is aware were involved in these trials and we need to see urgent action to release relevant personal information.

“It is just not enough to release birth information, including birth certificates, the State needs to be far more open to providing information that could be critically important to a person’s medical care,” concluded Denis Naughten.


Editor’s Note:

Extract from speech in Dáil Éireann last January:


GlaxoSmithKline has many questions to answer. Why did the scientific publications on UK and Nigerian trials specifically make reference to consent, yet these references were conveniently left out of the very same publications on trials based on Irish children? Why was Ireland seen as a soft option for trials involving children in institutions? Clearly, such trials could not take place in the UK. That would that have been the case in Ireland, based on the regulatory and legal system that was in place at the time. However, because of a lack of enforcement in Ireland, they were happy to proceed. Paragraph 34.122 states:

On 5 September 1968, Dr Coffey told Dr Burland [from Glaxo Laboratories] that she had come up against ‘the usual complications’ while trying to arrange to field-trial Glaxo’s measles vaccine in Dublin.

The response from Glaxo was very interesting. According to the report:

Dr Burland advised Dr Coffey to liaise with Dr Hillery as ‘she may be able to suggest a way in which you could overcome the problems you have encountered’.

In other words, there could be a way to get around the law of the land and the refusal of the Department of Health to sanction this trial. GlaxoSmithKline needs to clarify why these formulations were not placed on the market on a commercial basis. Was it because they were not effective in actually preventing the diseases that they were supposed to? If that was the case, it would have impacted on the subsequent immunity of the children involved in these studies. Were children outside of homes, either in Ireland or the UK, subjected to the battery of needles that the children in these homes were? There was multiple administration of vaccine doses, and multiple blood sampling procedures took place. As a matter of urgency, there must now be an engagement with GlaxoSmithKline on behalf of the children who were involved in these trials. As a very first step, it must provide a clear and unequivocal apology and forthright answers. It must also put in place financial support package in place for those exploited by ignoring their basic fundamental right of bodily integrity. GlaxoSmithKline benefited financially from this research. It was happy enough to ensure that those who conducted the trials also benefited from it. It needs now to live up to its responsibilities to the victims.

see full speech here:

Children were treated as little more than human pincushions