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Abstract:
The tragic results for the babies of patients prescribed thalidomide, although they can indeed be termed "side" effects, hardly warrant so slight an epithet, and Dr Joyce in his paper would like the term to be dropped in favour of "additional" effects of drugs. Despite extensive clinical trials before drugs are put before the prescribing doctor, side effects cannot be entirely anticipated or eliminated, and indeed many are not harmful. However, it is important, Dr Joyce argues, for information to the doctor from the patient and from the doctor to the manufacturer to be collected and evaluated. Only in this way can effects of drugs other than those intended be drawn to the notice of the manufacturer. The commentary by two practising physicians emphasizes the ambiguities in the descriptive literature accompanying a new drug. Dr Herxheimer and Dr Higgs would like to see some sort of panel to be established to reassess drugs in the light of observations on their effects and "side" effects on patients, a task which the existing Committee on Safety of Medicines could not at the moment undertake. A medical need for a new drug should be established before it is manufactured, let alone offered to the general practitioner.