The accompanying NEJM editorial hammered the drug's maker. While noting there were flaws in the study, “in view of the potential cardiovascular risks... the rationale for prescribing [Avandia] is unclear.”Assuming its findings are valid, they indicate “a major failure” of drug monitoring in the U.S., the editorial said. NEJM here.
I hope the impact of that clearly damning statement makes its way to Joe Citizen.
Congressmen John Dingell Bart Stupack have said they would launch an inquiry into what they called the failure of the manufacturer as well as the FDA to warn diabetics about possible risks associated with the drug.
The FDA's newly issued safety alert states:
“Patients who are taking Avandia, especially those who are known to have underlying heart disease or who are at high risk of heart attack, should talk to their doctor about this new information as they evaluate the available treatment options for their type 2 diabetes,”
Can it get any worse for the FDA? My best is yes. It has not yet hit rock bottom.