Drug trial gets go-ahead after leaflet conflict

A DUBLIN hospital has reversed a controversial decision to postpone a cancer drug trial it deferred because patient information leaflets contained wording at odds with its Catholic ethos.

Last night the board of directors of the Mater Misericordiae University Hospital (MMUH) issued a statement saying the clinical trial of the lung cancer treatment Tarceva could now proceed.

In a significant climbdown, the board of directors decided it would “not be necessary to provide additional information to intending participants in the trial”, even though this was given as the reason for the trial’s deferral.

Previously, a spokesperson for the hospital said the reason the trial was deferred by the clinical trials advisory group, chaired by Mater chief executive Brian Conlan, was to give time to a sub-group of the board to draft the wording of an extra information leaflet for trial participants which would fit with the Mater ethos.

The sub-group consisted of Fr Kevin Doran, secretary to the Catholic Bishops Bioethics Committee, Mater chairman John Morgan - who is also chair of the board of directors - and a nurse tutor, Sr Eugene Nolan.

It was expected this information would be provided to the patient in tandem with the pharmaceutical company’s patient information leaflet.

The board has decided this will not be necessary.

The decision to postpone the drug trial was made on September 29.

The patient information leaflet which caused the controversy stated that female participants in the Tarceva trials - a drug considered capable of prolonging life in those with advanced lung cancer - would have to agree to use birth control since the drug could affect an unborn child.

The advice that women use barrier contraception clashed with the hospital’s ethos, although the leaflet did say abstinence was acceptable.

Last night, the Mater spokesperson said the decision by the board of directors to allow the trial proceed without the need for additional patient information did not mean all trials would now automatically get the green light.

He said it did not represent a fundamental change in the clinical trial start-up process and that the advisory group could still defer a trial if they considered it appropriate.

This is despite the fact that new EU legislation governing clinical trials means once a trial is approved by the Irish Medicine’s Board and one hospital’s ethics committee, it is deemed to be approved nationwide.

The Tarceva trial is already underway in Beaumont and Tallaght hospitals.

Last night chief executive of the Irish Clinical Oncology Research Group (ICORG), Dr Brian Moulton, said they welcomed the decision and looked forward “to the Mater being involved in all trials going ahead”.

“In the end, the right thing has happened here and I look forward to a situation where all hospitals will look positively on research and smooth the way for other trials.”

Cancer specialist at St Vincent’s Hospital, Dr John Crown, who alleges that he too clashed with the ethics committee at St Vincent’s over ethos issues, also welcomed the Mater decision.

Tarceva is manufactured by drug multination Roche, who reported the product as one of three drugs behind a seven percent growth in its pharmaceuticals division global market share for the first half of 2005.