Medical Council ‘sidesteps issue’ in drug trial row

THE Irish Medical Council has said the decision by St Vincent’s Hospital and the Mater Hospital to postpone life-saving drug trials because the drug involved required the use of contraceptives is not a matter for them because it is covered by each hospital’s contract.

However, the Irish Hospitals Consultants Association (IHCA) has accused the council of failing to protect the public interest and “sidestepping the issue”.

The Medical Council Ethics Committee had pointed to section 8.11 of the consultants’ common contract, which deals with ethical principles in non-health board hospitals and contractually obliges a consultant to adhere to the ethos of the hospital where they work.

Such ethical clauses are not in health board hospital contracts but are usually present in contracts for voluntary hospitals, generally with a Catholic background, such as the Mater, St Vincent’s, Our Lady’s Hospital for Sick Children in Crumlin and the Mercy University Hospital in Cork.

The clause, known to many as the ‘Bishop’s Clause’ was first put in contracts in the early 1980s.

“This is primarily a contractual matter in voluntary hospitals as they have this ethical clause. It is therefore not a matter for the Medical Council,” said Medical Council Ethics Committee Chairman, Mr Hugh Bredin.

Applications were made to both Dublin hospitals to trial Tarceva, a new cancer treatment, on patients. However, it was reported they were turned down because the research teams were recommending the use of contraceptives as experimental cancer treatment could have a potentially fatal effect on an unborn child.

The IHCA has criticised the Medical Council’s stance.

“The Medical Council should be the protector of the public interest. This is a medical matter and not just an ethical issue. Such sidestepping is typical of the Medical Council,” said IHCA secretary-general Finbarr Fitzpatrick.

Meanwhile, Mark Rogers, the managing director of Roche Pharmaceuticals, the company behind Tarceva, has said that the Mater should have no issue with the trials as their documentation suggests abstinence as a method of avoiding pregnancy.

“We have not imposed the use of contraception on patients. It is not our view to impose our views on a Catholic ethos or trample on a Catholic ethos. Amongst the options for contraception that we suggested were the contraceptive pill, injection, barrier and abstinence,” he said.

Such options, Mr Rogers said, were included in the patient information leaflet used for this trial.