Rosiglitazone: What went wrong
A BMJ investigation into the top-selling diabetes drug rosiglitazone (Avandia) raises concerns about its safety and the whole system by which drugs are evaluated, regulated, and promoted around the world.
BMJ Editor in Chief, Dr Fiona Godlee, believes that the drug should not have been licensed and should now be withdrawn. She also calls for more robust regulatory processes and better access to the raw data used to license drugs to allow scrutiny by the scientific community.
The investigation reveals that in July the Commission on Human Medicines advised the MHRA to withdraw the drug as the "risks of rosiglitazone outweigh its benefits and that it no longer has a place on the UK market".
In light of these concerns, doctors are also advising that no new patients should be started on rosiglitazone, and patients already taking it should be reviewed and alternative treatments considered. Those at higher risk of heart disease should be advised to stop taking the drug.
Rosiglitazone, manufactured by Glaxo SmithKline (GSK) was approved by the US Food and Drug Administration (FDA) in 1999 and by the European Medicines Agency (EMA) in 2000 to help lower blood sugar levels in patients with type 2 diabetes.
Since its approval, several studies have suggested that rosiglitazone may lead to a small overall increase in the risk of heart attacks, but in July an FDA scientific advisory panel recommended that it was safe enough to stay on the market.
In her report, Dr Deborah Cohen investigations editor of the BMJ, obtained documents under the Freedom of Information Act that note a paucity of evidence during the European approval process and outline concerns from some panel members about the long term risks and benefits of rosiglitazone. Other experts have since remarked on the poor evidence base and lack of long term data on cardiovascular safety.
The report also raises concerns about the quality of the data used by GSK to show that rosiglitazone did not lead to increased heart problems compared to other diabetes drugs, the lack of publicly available trial results for independent scientific scrutiny, a lack of transparency in the European system, and the ability of the European regulator to assess individual patient data.