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Rosiglitazone in the BMJ

The British Medical Journal this week reviews the product history of rosiglitazone (Avandia®) from initial granting of a product licence in 2000 to the current safety review.

The articles discuss the conduct of the drug manufacturer and the licensing authorities (FDA and EMA). The case is also made for demanding higher quality evidence from drug manufacturers including proof that the new drug is better than existing treatments with an extension to the period of patent protection if needed.

The current process generally means, that at the time of a licence being granted, little is known about the long term effects (both beneficial and harmful) of a drug. Efficacy is demonstrated using easily measurable surrogate measures (such as blood pressure, cholesterol level and glycaemic control) rather than clinically significant outcomes such as reduced rates of deaths and hospital admissions. Identification of rarer side effects is also limited by the relatively small numbers of participants in the clinical studies.

Action: Clinicians with an interest in the on going review of rosiglitazone or who are more widely interested in the process undertaken to grant a drug licence will find this issue thought provoking.