Posted on behalf of Randy Levinson

Well it’s now official. Last week, drug regulators in Europe announced they would pull the plug on Avandia (rosiglitazone, or ‘rosi’, for short) while the US Food and Drug Administration decided to limit sales of the diabetes drug to only those people who can prove they have tried all other treatment options and grasp the increased risk of heart failure the drug can pose.

Needless to say a fair amount of ink has been, and will be, spilled discussing the events that have lead up to these announcements. But what do these regulatory decisions mean for the readers and the editors at Nature Medicine?

Clearly rosi had beneficial effects on diabetes in animal models and in patients, as do other drugs in its class (Thiazolidinediones, also known as TZDs). It’s conceivable the drug might one day be resurrected when its effect on heart risk is fully understood. So there is still room in the metabolism field to continue to explore rosi’s molecular and cellular mechanisms.

But what does it mean in the more near term, especially for our journal? Typically when we receive research manuscripts that have a strong therapeutic angle to them we often ask our authors to include a ‘gold standard’ of therapy in their experiment for comparison, even when the study is solely focused on pre-clinical development. In the metabolism field this often involves using rosi.

But given the new rulings, I wonder if we should ask for another TZD to be used instead, such as pioglitazone (Actos), which has not so far shown the same sort of heart disease risk. I suppose it is fine if the researchers use rosi if the manuscript is solely focused on pre-clinical development, as rosi is highly efficacious, but if they truly want to show that their drug is better than what is currently available in the clinic then last week’s announcement suggests other comparators should be used.