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EASD: Adverse effects need 'rigorous' review

The potential harm caused by drugs needs to be assessed in systematic analysis of data, according to Professor Rory Holman, University of Oxford, speaking at the EASD meeting

The potential harm caused by drugs needs to be assessed in systematic analysis of data from variable sources according to Professor Rory Holman, University of Oxford, speaking at the European Association for the Study of Diabetes (EASD) meeting.

Citing misleading healthcare coverage from the mainstream media, Prof Holman, part of the Oxford Centre for Diabetes, Endocrinology and Metabolism in the UK, commented: "It is difficult, in an age of increasing information overload concerning existing and new therapies, to discern real health and safety signals from background noise."

He called for a more rigorous approach for opportunistic studies of large-scale medical record databases, stating that there was a lack of consensus on the technique's use in deciding if a drug could be withdrawn on safety grounds.

Prof Holman acknowledged that some attempt had been made to tackle the issue of a drug's adverse effects, referring to the US Food and Drug Administration's (FDA) recently implemented requirement that all new antidiabetic drugs be assessed for cardiovascular safety, but he noted that this approach came at great expense and extended the time before a drug could be licensed.

Specifically, the professor called for the level of clinical and statistical significance of analyses in observational data to be determined before a full-scale investigation was launched.

Reporting guidelines for the media were also recommended, to help distinguish the relative importance of reported study results.

15th September 2011

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