Controversy over vaccine trial files

PARTICIPANTS in controversial vaccine trials in mother-and-baby homes have been told by the Department of Health that it can’t give them their medical files or any trial documentation as it is legally bound to return the files to the drugs company.

The files are in the hands of the Laffoy Commission on Child Abuse, which was forced to halt its vaccine trials investigation following a 2002 court case.

Last night, Brenda McVeigh of the commission confirmed that they were “undertaking an examination of all documentation that they have and cataloguing it”. She said no files have yet been returned to Glaxo SmithKline.

A letter from the Department of Health to the Oireachtas Joint Committee on Health and Children, seen by the Irish Examiner, states that the department cannot hand over the documentation to the committee or to participants as legally “it is not possible for that material to be used for any other purpose” other than Laffoy Commission investigations.

“In the circumstances, I understand from the commission that they will be returning all documentation to the source that originally provided it”, the letter read.

The vaccine trials will be discussed by the Joint Committee in private tomorrow.

One of its members, Labour’s Kathleen Lynch, last night said the files have to be handed to the people used in the trials, irrespective of recent court rulings.

“I firmly believe the files must be given to victims as a human right. But until they are handed over and until this is finalised, they must be protected and must not be destroyed by any body or any company,” she said.

Up to 211 children were given the test vaccines in Ireland in the 1960s and 1970s. Now adults, the participants say the drugs were given without parental consent and they have spent years trying to access their medical files and pharmaceutical information from that time.

They are also seeking previously unseen files obtained by the Laffoy Commission from medical companies.

The Laffoy Commission was investigating vaccine trials between 1940 and 1987 as part of a separate module. However, the commission’s investigation was brought to a sudden halt after court action taken by the doctors involved in the trials.

Last September, after it emerged that a woman now living in the US was seeking to sue the Sacred Heart Order and Glaxo SmithKline about the administration of the vaccines, the Oireachtas Joint Committee on Health and Children decided to revisit the vaccine trials issue.

The committee wrote to Glaxo SmithKline seeking information on the trials. The company said the documentation contained sensitive personal information and they wouldn’t hand it over without judicial order.

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