IOM report highlights ethical standards in advance of FDA rosiglitazone safety meetings

In light of the joint meeting of the Endocrinologic and Metabolic Drugs and the Drug Safety and Risk Management advisory committees to weigh the cardiovascular safety of rosiglitazone scheduled for July 13 and 14, the Institute of Medicine today released a report addressing the ethical and informed consent issues that must be considered when evaluating the potential safety risks of randomized controlled trials.

As previously reported in Endocrine Today, the safety of rosiglitazone has been a controversial topic since a 2007 meta-analysis published in The New England Journal of Medicine concluded that rosiglitazone was associated with a significantly increased risk for MI and death from CV causes. This, in addition to other data, led to an FDA review in November 2007 of the drug’s safety, and a new warning label added to the drug regarding potential myocardial infarctions.

In April 2010, the FDA requested the Institute of Medicine (IOM) respond to five questions about ethical and scientific issues in studying the safety of approved drugs by July 2010. In the report released today, the IOM recommends that the FDA conduct clinical trials only if:

There is a significant question about the public health risks of an approved drug.
There is not enough existing information to assess these risks.
The information cannot be gained through a different kind of study.
The trial is appropriately designed to answer questions about a drug’s efficacy and safety.
The trial minimizes risk to its participants.

According to the report, this is part of a larger study of the scientific and ethical issues involved in conducting studies of the safety of approved drugs. The FDA has requested a final report in 2011.