Drug company to 'respond fully' to those who seek personal data

By Eilish O'regan
Irish Independent
June 10, 2014

http://www.independent.ie/irish-news/news/drug-company-to-respond-fully-to-those-who-seek-personal-data-30340960.html

GlaxoSmithKline

The Irish Independent broke the story about children receiving animal vaccines from drug company Wellcome in June 2001

A drug company, which has records of children who underwent experimental vaccine trials in baby homes, has said it will "respond fully" to those requesting their own personal data.

A spokeswoman for GlaxoSmithKline (GSK) was commenting after the use of trial vaccines on children in orphanages between 1960 and 1973 re-emerged in the wake the baby deaths controversy at St Mary's mother and baby home in Tuam, Co Galway.

A €2m state probe into the vaccine trials was abandoned in 2006 by former health minister Mary Harney after a court challenge.
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Victor Boyhan, a councillor in Dun Laoghaire Rathdown, who was in the care of the Church of Ireland run Bird's Nest home, yesterday called for an inquiry before an Oireachtas committee into the drugs trials.

A Department of Health report confirmed in 2000 that 123 residents of Dublin children's homes were used in vaccine trials by the Wellcome drug company. It suggested some children used in one trial may have been more susceptible to polio infection as a result.

The trial attempted to discover what would happen if four vaccines – diphtheria, pertussis (also known as whooping cough), tetanus and polio – were combined in a four-in-one shot.

At the time, the standard approach was to administer one combined injection carrying diphtheria, pertussis and tetanus – and a separate polio vaccine.

The Laffoy Commission to Inquire into Child Abuse was asked to investigate the trials, and people with information – on St Patrick's Home, Navan Road, Dublin; St Clare's in Stamullen, Co Meath; St Peter's, Castlepollard, Co Westmeath; Dunboyne mother and baby home, Co Meath; Bessborough mother and baby home, Co Cork; and Mount Carmel Industrial School, Co Westmeath – were asked to come forward.

The Government's inquiry into the conduct of vaccine trials on children in State institutions was deemed invalid by the High Court after a challenge by doctors. A spokeswoman for drug company GlaxoSmithKline said it co-operated fully with the Commission request and provided copies of historic documents that were relevant to that investigation.

It was pointed out that as the trials had taken place many decades ago there was limited documentation.

Trials

"The information related to three vaccine studies carried out in Ireland between 1960 and 1973, by The Wellcome Foundation," she stated.

The children who participated in the trials were recruited from across the community, and included some who lived in children's homes. The Wellcome Foundation conducted its studies fully in accordance with medical and ethical standards of the time, it stated.

"The information that was provided by GSK to the Laffoy Commission contains confidential information. Much of it is particularly sensitive as many of the mothers involved requested that their anonymity be maintained. GSK understands that those who believe they were involved in the trials may want further information, and will respond fully to any requests for personal data from such individuals," she added.

It was claimed the veterinary vaccine (Tribovax-T), from the company Wellcome, may have been administered in error to an Irish child in the early 1970s, in place of a routine immunisation with a combined vaccine against diphtheria, tetanus and whooping cough (Trivax).

"As a result, a thorough investigation was undertaken and concluded that the veterinary vaccine was not administered in error to any child in the early 1970s. The Department of Health accepted the conclusion."

Michael Dwyer, of Cork University's School of History, found that around 2,000 children in care homes may have been given trial diptheria vaccine for the drugs company Burroughs Wellcome between 1930 and 1936.

He said there is no evidence that consent was obtained and no records of how many children may be have been adversely affected.