Pressures on regulatory agencies by diabetologists to approve rosiglitazone, and failures by the agencies to act swiftly on emerging safety information are also highlighted in the report.

Two experts comment on today's report.

Professor Nick Freemantle at the University of Birmingham, calls for an overhaul in the standards of regulatory trials to minimise the risk of a similar situation occurring in other clinical areas in the future. "In order to learn from our mistakes, we must improve the quality of safety data from clinical trials on all new health care interventions, not just antidiabetic drugs," he says.

Professor John S.Yudkin of University College London believes doctors must focus on what matters to patients. "Ten years after the release of rosiglitazone, we still cannot accurately quantify the harm to which we were exposing our patients," he says. He admits that some of the blame lies with clinicians for not insisting on better proof of long-term benefit, and adds: "We need to be absolutely certain that our long term treatments for type 2 diabetes are not causing the very harm they are meant to prevent. And if the regulatory bodies do not insist on clear evidence of greater benefit than harm, they are failing in their basic purpose."

Source: BMJ-British Medical Journal