Dublin's Mater hospital yesterday rowed back on its controversial decision to defer clinical trials of a lung cancer drug.
And despite earlier indications that the trial would not be given the go-ahead by the hospital until a new information leaflet reflecting the hospital's Catholic ethos was prepared for patients taking part in the trial, no changes were made to the patient information leaflet.
The decision to allow the trial proceed was made at a meeting of the hospital board yesterday afternoon.
The original decision last month to defer the trial had been made by a clinical trials advisory group at the hospital, chaired by the hospital's chief executive, Brian Conlan. It had concerns that the information leaflet for women patients taking part ran counter to the hospital's ethos, and the hospital initially indicated this was because participants were required to use artificial forms of contraception.
It said at the time: "The absolute requirement of some pharmaceutical companies that women of childbearing age must use contraceptives during trials is not supported by our ethos.
"The hospital believes that individuals and couples, following their own informed conscience and guided by medical advice, have the right to decide how they will go about avoiding pregnancy."
Then Roche Ireland, sponsor of the trial, confirmed the patient information leaflet it had prepared included abstinence as an acceptable way for women who were taking part to avoid pregnancy. Pregnancy had to be avoided as the drug could harm an unborn child.
Mark Rodgers, managing director of Roche Ireland, said when he heard the Mater's statement, it appeared that the committee which deferred approving the trial "did not examine the full documentation" which his company supplied.
One member of the Mater hospital board told The Irish Times the trial should never have been postponed when the word "abstinence" was included in the patient information leaflet. He was shocked to discover, through the media, that this word had been included.
Following its board meeting last night, the hospital issued a statement saying: "The board of directors of the Mater Misericordiae University Hospital has determined that the clinical trial of the lung cancer treatment Tarceva will proceed. The board has further determined that it is not required to provide additional information to intending participants in the trial."