Drug and biotech companies will be closely watching the upcoming two day advisory committee meeting tomorrow and Wednesday to review the safety of GlaxoSmithKline’s Avandia diabetes drug. At issue is not just this drug’s safety but the FDA’s new methodology and philosophy in handling its analysis of drug safety. Also under scrutiny is whether the FDA will move from it’s Bush Administration de-regulation hands off policies. Two new studies suggest a higher risk of heart attack and stroke from taking the drug. At issue in part is how studies should be done. One study critical of Avandia, the Graham analysis is based on Medicare beneficiaries and compares those taking Avandia and those taking another drug Actos. There are two major forms of studies here–observational studies in which large numbers of individuals are studied via data mining versus the clinical trials which are forward looking studies of individuals taking the drug (and some taking sugar pills). Some have suggested that the outcome of the meetings may be impacted by an FDA trying to re-establish its reputation. What seems to be missing is some sort of analysis of the risks and benefits of Avandia handled objectively. Every drug has risks but as consumers we should be able to make an educated decision based on the benefits. Whatever the decision, a fair and workable process must be created which can protect the public but not hamper the drug developing community.