Drug safety and the safety of patients: the challenge to medicine and health from permissive expert risk assessments of triazolam (Halcion)
Titel:
Drug safety and the safety of patients: the challenge to medicine and health from permissive expert risk assessments of triazolam (Halcion)
Auteur:
Abraham, John
Verschenen in:
Health, risk & society
Paginering:
Jaargang 4 (2002) nr. 1 pagina's 19-29
Jaar:
2002-03-01
Inhoud:
When assessing the risks and benefits of medical drugs, the approach may be precautionary or permissive. If these different approaches actually influence the analysis and interpretation of technical medical data, then they are not merely a matter for discussion among philosophers, but should be debated by those concerned about medical risks and public health. To examine the interaction between expert risk-benefit assessments of drugs, on the one hand, and permissive/precautionary approaches, on the other, the triazolam (Halcion) case is scrutinised. Specifically, the assessments of triazolam by the FDA's 1992 Psychopharmacological Drugs Advisory Committee (PDAC) and the National Academy of Sciences' 1997 Institute of Medicine (IoM) are analysed. Both the PDAC and the IoM exhibited permissiveness towards triazolam. The PDAC gave priority to anecdotal evidence about triazolam in use, when assessing efficacy, but to controlled clinical trial data, when assessing safety. In each instance the types of data which favoured triazolam were given priority. While a lack of compelling evidence of efficacy from clinical trials was regarded as insufficient to negate the drug's benefits, compelling evidence from clinical trials was required to confirm signals of lack of safety. The IoM and the PDAC avoided the problem of patient safety in 'the real world' by limiting their conclusions to the safety of the drug under the conditions of use recommended on the label. Whether or not a society adopts a precautionary or permissive approach to the risk assessments of new technologies is not merely a matter for technical experts and science, it is also a social and political matter. A precautionary approach to drug safety could yield different expert assessments. It might require compelling evidence of drug efficacy where good alternative therapies exist; integrate how a drug can be used safely into evaluation of controlled clinical trial data; and put more emphasis on the correlation between disaggregated clinical trial data and spontaneous reports of adverse drug reactions.
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