BMJ  2004;328:518-520 (28 February), doi:10.1136/bmj.328.7438.518

Education and debate

Synthesising licensing data to assess drug safety

Klim McPherson, visiting professor in public health epidemiology1, Elina Hemminki, research professor2

1 Nuffield Department of Obstetrics and Gynaecology, Research Institute, Churchill Hospital, Oxford OX3 7LJ, 2 National Research and Development Centre for Welfare and Health, Health and Social Services, PO Box 220, 00531, Helsinki, Finland

Correspondence to: K McPherson klim.mcpherson@obstetrics-gynaecology.oxford.ac.uk

Small randomised trials conducted for licensing purposes should record data on adverse results and be made public

The first 150 words of the full text of this article appear below.

The safety of drugs is important. For full information we need to assess not only the immediate effects but also unexpected longer term effects on serious disease like coronary heart disease or cancer, especially for drugs that will be widely used. Reliably assessing the safety of drugs, however, is fraught with problems such as rare events, long follow up, strong vested interests, and biased reporting. The example of hormone replacement therapy and risk of cardiovascular disease shows some of the problems and presents useful lessons.

Observational studies and trials on intermediate cardiovascular variables indicated that oestrogen and progesterone supplements might protect menopausal women from cardiovascular disease as well as menopausal symptoms. The evidence was convincing. For example, the nurses' study of 120 000 women followed for 30 years estimated the adjusted relative risk for coronary heart disease at 0.47 (95% confidence interval 0.32 0.69) for women currently taking hormone replacement . . . [Full text of this article]

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