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LETTERS: Paul L Cervi Balancing benefits and harms in health care: Technology to collect and share information about harms already exists BMJ 2004; 329: 457 [Full text]

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Balancing benefits and harms – the role of the Committee on Safety of Medicines

Geofrey Venning   (24 August 2004)

Balancing benefits and harms – the role of the Committee on Safety of Medicines 24 August 2004
Geofrey Venning, MA, BM, BCh, FRCP, FFPM High Wycombe, Buckinghamshire HP13 6QG Send response to journal: Re: Balancing benefits and harms – the role of the Committee on Safety of Medicines	Your contributors rightly emphasize the need for better quantification of adverse reactions to licensed drugs, particularly rare and serious reactions that are not encountered during clinical trials. The role of the Committee on Safety of Medicines (C.S.M.) needs attention. The terms of reference restricted consideration of relative safety. Thus a new drug could be licensed for an indication on the basis of efficacy and safety in clinical trials even if no better than existing therapy, in spite of the risk of rare but serious adverse effects not identified in the trials (1). The balance in this situation is unacceptable. An example of unnecessary suffering arising from such a flawed C.S.M. decision was the licence for the first A.C.E. inhibitor Captopril which permitted use as a first line therapy for hypertension. Although no more effective than existing therapy there were worse harmful effects identified after marketing. It would have been better if the CSM had restricted the licence to patients unresponsive to existing therapy, who would have received a benefit to offset the risk of harm. To protect patients in the future the C.S.M. needs to consider relative efficacy and safety and there should be restrictions on the use of new drugs to licensed indications, with use in other indications limited to properly controlled trials. Licences should also be subject to a specific requirement for ongoing auditing of adverse reactions. When new events occur there is a real issue of false alarms (2). There is a need for verification which may sometimes require case control studies (3). With better systems in place in the future, the government would be in a better position to refute false allegations which may be exaggerated by the media, as has occurred with M.M.R. REFERENCES 1. Venning G. R. Rare and Serious Adverse Reactions. Medical Toxicology 1987;2:235-41 2. Venning G. R. Validity of anecdotal reports of suspected adverse drug reactions: the problem of false alarms. BMJ 1982;284:249-52 3. Venning G. R. Identification of adverse reactions to new drugs IV Verification of suspected adverse reactions. BMJ 1983;286:544-7 Competing interests: None declared