Contraception is not essential for drugs trial
The spokesperson stated that “the absolute requirement of some pharmaceutical companies that women of childbearing potential must use contraceptives during trials is not supported by our ethos”.
The comments were made in the context of the ongoing row over the initiation of the clinical trial with the cancer drug Tarceva (erlotinib), reported in the media.
Roche, who market Tarceva and who are the sponsors of the trial in question, wish to clarify its position.
As with many anti-cancer drugs the effects of Tarceva (erlotinib) on an unborn baby are unknown and are likely to be harmful. This is particularly true for new medications or medications in development which did not have wide population exposure.
Thus patients with reproductive potential who are eligible for this trial must agree not to become pregnant.
This is clearly explained in the patient information leaflet and consent form which is given to patients and which must be signed prior to participation in the study. On the leaflet, the following is stated: “To participate in this study you must agree to use an effective method of birth control to prevent pregnancy. Women must not be pregnant, become pregnant or breast-feed whilst taking part in this trial. The drugs used in this trial are likely to affect your unborn baby. Therefore, all women must either be postmenopausal, surgically sterile or practising an acceptable method of effective birth control - examples, barrier method (condoms, diaphragm); oral, injectable, or implant birth control; or ABSTINENCE (my emphasis) - while on treatment and for three months thereafter.
A pregnancy test will need to be done before starting the study. A repeat pregnancy test must be done if any periods are missed or the menstrual cycle becomes very irregular.
The international Tarceva trial is being conducted in accordance with the principles of good clinical practice. In any clinical trial, patient safety is paramount.
Under international guidelines patients have the right to the fullest information about any risks in order to make an informed decision about their participation. Consistent with current legislation, permission to conduct the trial was sought and secured from a nationally recognised ethics committee, namely the St James’s/Meath & Adelaide Research Ethics Committee, and the Irish Medicines Board.
The St James’s/Meath & Adelaide committee, which was chosen as the national chief investigator for the trial, is resident in St James’s Hospital.
The wording regarding reproductive risks was approved by both bodies. It should be noted that, in the approved wording, abstinence is regarded as an acceptable form of birth control.
Thus the comments attributed to the Mater spokesperson that use of contraceptives is an absolute requirement by pharmaceutical companies is not accurate. At the time of writing no correspondence has been received by the company from the Mater ethics committee requesting removal of any clause in the approved patient information leaflet.
Dr Edwin Carr
Director of Medical Affairs
Roche Products (Ireland) Ltd
3004 Lake Drive
City West
Naas Road
Dublin 24
