The science and politics of medicines control

Abraham, John (2003) The science and politics of medicines control. Drug Safety, 26 (3). pp. 135-143. ISSN 01145916

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Drug development and regulation are often presented as purely matters of technical science. In this paper it is argued that, in principle, toxicology, clinical pharmacology and pharmacovigilance in drug testing and regulation are necessarily a combination of science and politics. This has important implications for how one attempts to make progress in drug regulation, such as in interpreting technical evidence and in the setting of regulatory standards with which evidence should be evaluated. In practice, drug testing and regulation are shown to be hybrids of science and politics. Moreover, drawing on existing empirical evidence, it is suggested that this mixture currently, and for some time, has had the wrong ingredients for optimal drug safety and public health outcomes. For example, too often the balance of the scientific doubts about drug safety are weighed to the interests of manufacturers rather than to those of patients and public health, while some scientific standards with which drug safety is to be interpreted are being reshaped in ways that give insufficient priority to the protection of public health. Finally, it is proposed that: drug regulation should include comparative efficacy testing; regulatory agencies should conduct some key tests, charging the costs to industry and without duplication; and the regulatory system should be less secretive and more accountable to public scrutiny. Greater efforts should be made to eliminate experts' conflicts of interest within the regulatory process.

Item Type: Article
Schools and Departments: School of Law, Politics and Sociology > Sociology
Depositing User: John Abraham
Date Deposited: 06 Feb 2012 18:41
Last Modified: 15 Jun 2012 12:00
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