Too soon to marketBMJ 1997; 315 doi: https://doi.org/10.1136/bmj.315.7118.1248 (Published 15 November 1997) Cite this as: BMJ 1997;315:1248
Doctors and patients need more information before drugs enter routine use
- Thomas H S Dent (email@example.com), Consultant in public health medicinea,
- Simon Hawke, Senior lecturer in neurologyb
- a North and Mid Hampshire Health Authority, Basingstoke RG24 9NB
- b Division of Neuroscience and Psychological Medicine, Imperial College School of Medicine, London W6 8RP
The present system by which new drugs enter the National Health Service is failing doctors and patients. It leads to prescribing and funding decisions being made on inadequate information, causes duplication of effort, and creates geographical inequities in the availability of drugs. We need a new approach which takes account of relative effectiveness and cost utility.
Drugs in Britain are licensed on the basis of the applicant's evidence of efficacy, acceptable toxicity, and proper manufacture. Much of the information on which the decision is based is unpublished at the time of licensing, although the European licensing body, the Committee for Proprietary Medicinal Products, now publishes summaries of its opinions. Doctors then have to decide whether to prescribe the (often expensive) new drug and health authorities to allow or resist its use. They turn for help to local sources of advice such as drug and therapeutics committees.
The doctors and pharmacists who provide advice at local level suffer from several handicaps. The published evidence is all they …