Abstract

PIP: The suggestion, raised by Benagiano, that regulatory authorities should act only after publication of the relevant data would have serious public safety consequences. Where possible, the UK Committee on Safety of Medicines (of which the author is chair) coordinates its regulatory positions with publication of the relevant data. For example, the Committee was able to ensure that publication of the meta-analysis of hormone replacement therapy and breast cancer risk coincided with advice to prescribers and patients through use of the Epinet system and the Internet. In the case of findings of a venous thromboembolism risk associated with use of third-generation oral contraceptives, however, regulatory action had to be taken in advance of study publication. The urgency was based on the expectation that 100-150 cases of venous thromboembolism and 1-2 deaths would be prevented per year by careful prescribing of these formulations. The recommendation that regulatory authorities delay action further ignores the fact that drug regulation incorporates a process of peer review far more rigorous than that of any scientific journal.