"Sure," she told the panel, "the study may show that one drug is better than another regarding efficacy, but it isn't designed to show whether a drug is associated with a particular safety risk."
"The latter question is not one the drug companies will spend money to answer," Ms Menzies noted.
"If there is a lesson from the events of the last weeks and years," Dr Buse told the panel, "perhaps it is that upon filing a New Drug Application, pharmaceutical manufacturers should make every effort to develop an adequately-powered independently-executed study that examines clinically meaningful endpoints such as heart attack or loss of vision."
"In parallel with regulatory approval," he stated, "such a study should be reviewed with attention to design, oversight, funding plan and timeline, recognizing that such studies are very expensive and will take many years to complete."
"Direct to consumer advertising and medical marketing," he added, "should be constrained until such studies are completed."
Dr Psaty also told the Committee that: "Direct-to-consumer advertising increases demand for drugs, some of which, like Avandia, may have been incompletely evaluated."
At the hearing, FDA Commissioner Andrew von Eschenbach announced that the FDA has asked the drug makers to add a black box warning about the risk of congestive heart failure to the labels of Avandia and Actos.
Persons seeking legal advice regarding Avandia can contact Baum Hedlund Law Firm at: (800) 827-0087; http://www.baumhedlundlaw.com/
