AVANDIA cual fué el error...?

Over 10 years after the diabetes drug rosiglitazone was approved by regulators, and despite studies on tens of thousands of people, questions remain about its cardiovascular safety. An investigation by the BMJ looks at why this happened.

It was, as one Food and Drug Administration (FDA) adviser put it, a “perfect regulatory storm”—a combination of problematic data, uncertain clinical need, politics, and poor drug company behaviour.

Now, 10 years after its approval by regulators in the United States and Europe, the widely prescribed blockbuster diabetes drug rosiglitazone may be about to fold. Two months ago, in July 2010, the FDA convened a 33 member expert advisory panel to decide whether it should be withdrawn from the market in the light of evidence that it may increase the risk of myocardial infarction. Earlier this year a US Senate finance committee report had detailed concerns about the paucity of evidence to support the use of rosiglitazone and about the way in which the drug was evaluated and licensed.1

At the advisory meeting, members of the public heard a damning analysis of the RECORD trial, commissioned by the European Medicines Agency (EMA) when it approved the drug in 2000 in order to determine its safety. Millions of prescriptions later and with the drug still on the market around the world, this trial and other post-marketing surveillance have failed to resolve the concerns.

To date, the FDA and the EMA have decided that the drug is safe enough to stay on the market. But the story reflects badly on almost everyone involved: the regulators, the manufacturer, GlaxoSmithKline, and the clinical community. It has also raised a host of questions. Why did the regulators accept such poor evidence on benefit and safety for rosiglitazone? Did GlaxoSmithKline mislead the regulators? Should the drug have been licensed in the first place and should it now be withdrawn? Why haven’t patients in the UK and Europe been made aware of the concerns about rosiglitazone’s effects? And is the current drug regulatory system up to the job?

The FDA meeting was held in the open, in front of a packed audience including the world’s media. Ahead of the meeting, the FDA published the 765 page report circulated to panel members.

This is far removed from the secrecy shrouding proceedings at Europe’s regulator, the EMA. The BMJ has talked to a range of experts close to the European regulatory process and submitted a series of Freedom of Information requests to the EMA, but we still have no clear picture of why, after initial rejection in October 1999, the EMA gave market authorisation to rosiglitazone in July 2000 in the absence of new evidence. Neither have doctors and patients been told that in July the UK’s Commission on Human Medicines— in an unanimous vote— advised the Medicines and Healthcare products Regulatory Agency (MHRA) to withdraw the drug. In a statement, the MHRA has confirmed that the evidence now suggests that the risks associated with rosiglitazone outweigh the benefits and “that it no longer has a place on the UK market.” But a “dear doctor” letter sent to UK doctors in July advised doctors to “consider alternative treatments where appropriate.”2 The MHRA said that it used the information provided by the Commission on Human Medicines to push for a UK withdrawal as part of the Europe-wide review by the European Medicines Agency.

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