Since the analysis linking the diabetes med to cardiovascular risk was published May 21 in The New England Journal of Medicine, side effect reports to the FDA tripled. The sudden increase reflects the likelihood that many docs were unaware that Avandia may have caused heart problems that weren’t reported previously.
With Avandia, the published analysis likely led to more cases being reported, said Vanderbilt University diabetes specialist Dr. Alvin C. Powers.
“Now, patients and their doctors are much more aware of the possible link between Avandia and cardiovascular disease. This is good — this is going to help us going forward to determine whether or not this drug is safe,” he said.
Glaxo spokeswoman, Mary Anne Rhyne (who I like to think of as an American Alastair Benbow) has, of course, felt compelled to comment – “This is a very well-known phenomenon,” where news reports lead to increased reporting, she said. “It’s good that there’s awareness of the reporting system, but drawing conclusions on such data is inappropriate.”
Fair point I suppose, but just hold on there, what data do you suggest we use Mary Ann?
Maybe data like Glaxo used for Study 329?