Observational evidence for determining drug safety

doi:10.1136/bmj.39491.493252.80

BMJ 2008;336:627-628 (22 March), doi:10.1136/bmj.39491.493252.80

Editorials

Observational evidence for determining drug safety

Is no substitute for evidence from randomised controlled trials

The first 150 words of the full text of this article appear below.

Drug regulators are constantly criticised for their handlingof drug safety. Comment on the activities of the US Food andDrug Administration with regard to drug safety has become particularlyloud and damning. A recent article that proposed sweeping changesto the system criticised the FDA for lacking relevant expertise,being too close to the drug industry, and failing to ensurethat companies deliver on their safety commitments with newdrugs.¹ The main practical recommendation was that systems ofmonitoring and reporting adverse events should be enhanced,highlighting a perceived role for observational studies. Drugsafety is also an important concern in Europe, and the EuropeanCommission Enterprise and Industry Directorate General is consultingwith stakeholders on changes of legislation to strengthen andrationalise pharmacovigilance in Europe.² It describes a strategythat also focuses on observational studies of drug safety. Butcan observational studies alone improve judgments on drug safety?

. . . [Full text of this article]

Nick Freemantle, professor of clinical epidemiology and biostatistics¹, Alar Irs, lecturer in clinical pharmacology²

¹ Health Care Evaluation Group, University of Birmingham, Edgbaston, Birmingham B15 2TT, ² Institute of Pharmacology, University of Tartu, 50411 Tartu, Estonia

N.Freemantle@bham.ac.uk

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Too high a pedestal: Jeffrey K Aronson
BMJ 2008 336: 735. [Extract] [Full Text] [PDF]

The confidence to doubt: Fiona Godlee
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This article has been cited by other articles:

Aronson, J. K (2008). Too high a pedestal. BMJ 336: 735-735 [Full text]

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