Drugs firm hits back in cancer treatment row

Cancer sufferers at a top Dublin hospital were denied a potentially life-saving drug because abstinence was not considered as…

Cancer sufferers at a top Dublin hospital were denied a potentially life-saving drug because abstinence was not considered as a means for female patients to avoid pregnancy, it emerged today.

Lung cancer patients in the Mater were denied the opportunity to test the radical drug Tarceva after its ethics board ruled that advising women to use artificial contraception was at odds with its Catholic ethos.

But the company which offered Tarceva for clinical trial, Roche Products, revealed abstinence was one of many methods women were urged to consider to avoid any risks to the unborn child.

Mark Rogers, managing director of Roche, said the hospital's ethics committee which held up the testing was misinformed.

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"Our primary concern at all times in the developing of new drugs is the safety of patients and the safety of an unborn child," Mr Rogers said.

He said when conducting the trials it was mandatory for women of child bearing age to be adequately warned of the unacceptable nature of pregnancy.

"We have not attempted in any shape or form to impose our views on the Catholic ethos or to trample on the Catholic ethos," he said.

"Clearly amongst the options for contraception is a requirement we include something which is acceptable to the Catholic ethos, and that is amongst other things which may not be acceptable like for example the contraceptive pill or injectable contraceptives or condoms of barrier methods, we also include the word abstinence."

"Abstinence is a term that is used in the patient information leaflet supplied to the ethics committee with respect to this drug trial."

Mr Rogers accused the ethics committee of failing to fully examine the information and advice provided by his company. He insisted there was no reason for any ethics board to knock back any trial that required women to avoid pregnancy.

And he revealed management at the Mater made no approach to his company on the matter.

Two Dublin hospitals, the Mater and St Vincent's, have blocked radical new treatments because encouraging contraception is at odds with their religious ethos.

A statement from the Mater noted: "The Mater Hospital is committed to meeting all its legal requirements with regard to clinical trials while at the same time upholding the principles and ethos of the hospital's mission.

"The absolute requirement of some pharmaceutical companies that women of childbearing age must use contraceptives during trials is not supported by our ethos."

The Tarceva trial is in its final stages at St James' Hospital, Tallaght and other centres. Some evidence has already shown it improves the condition of lung cancer sufferers.