Drug trials 'not halted over contraception’
Consultant oncologist Prof John Crown claimed earlier this month that the Ethics and Medical Research Committee at St Vincent’s raised concerns about a trial for which he sought approval because women taking part would have to use contraception. If women became pregnant during the trial, it could have fatal consequences for the unborn child.
He said the trial went ahead after he protested.
However, the Board of St Vincent’s yesterday denied the claims saying: “The Ethics and Medical Research Committee of the St Vincent’s Healthcare Group wishes to state that no clinical trial or study has been turned down or delayed due to the contraceptive advice or guidelines contained in the applications.”
It said the ethics committee “has advised and continues to advise where indicated, that the patient information leaflet should state that ‘adequate contraception methods should be used’.”
“The ethics committee has maintained and continues to maintain that the form of contraception is a matter to be decided by both the patient and the principal investigator, as appropriate to the individual.”
The ethics committee sought changes in the original wording of patient leaflets in two trials, for lung and breast cancer. In the first trial, the lung cancer trial, the request was reviewed in October 2003 and approved in December 2003 with a change in wording from a requirement on patients to use “acceptable methods of birth control” to the words “use adequate contraceptive methods”
For the breast cancer trial, the review was in January 2004 and approval granted in March 2004. In this case specified contraception methods - “condoms or diaphragms used with spermicidal cream or an intra uterine contraceptive device (coil)” - were omitted.
Last night, the hospital board said many therapeutic trials of new drugs for a variety of medical conditions - including rheumatological, neurological, gastroenterological and oncological - required a reliable form of effective contraception.
An ethics committee has 60 days to decide whether to approve a trial following approval by the Irish Medicines Board (IMB). However, if issues arise during this time which require clarification, the committee can stop the clock until the necessary information is provided. This is not to say the trial has been delayed.
Yesterday, the Board of St Vincent’s insisted it has, at all times, complied with regulations on medical trials as set out by the Department of Health and Children.
Prof Crown has made representations to the Health Minister about the suspension of trials at the hospital by the State regulatory body, the IMB, in autumn 2002.
Minister Mary Harney has asked the Attorney General for advice and guidance on the issue.
