In 2010, the FDA required that the results of a
controversial clinical study on Avandia be reexamined and re-adjudicated. Duke
University did the re-adjudication and found that the risks for heart-related
events were virtually the same as in the original study. Because these new
results reaffirmed the drug manufacturer’s original findings, FDA advisory
panelists voted to recommend removing or modifying Avandia’s highly restrictive
label and distribution system—even though many world governments have banned
the drug, and there is a great deal of evidence that it is extremely dangerous.
The FDA is not obligated to follow its advisory committee’s
recommendation, though they usually do so. Moreover, there is no regulatory
deadline by which they have to make a decision. If there is enough public
pressure, perhaps this will force the FDA to reject the advisory committee’s
decision on Avandia—or at least postpone any action indefinitely. Please send
your message to the FDA about the dangers of Avandia.
Please personalize and add your own comments if you have time!
Dear [Decision Maker],
Sincerely,[Your Name] [Your Address] [City, State ZIP]