Avandia side effect reports to FDA have tripled

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?

About these ads

2 Responses to “Avandia side effect reports to FDA have tripled”

  1. Matthew Holford Says:

    LOL. I suppose if one is desperate to take a plus from Mary-Anne’s comments, one could say that at least she’s not pretending that she gives a shit about patient reporting, unlike the MHRA, bleating on about Yellow Cards, and then ignoring them!

    Matt

  2. truthman30 Says:

    Mary Anne Rhyne… How could anyone take such blatant PR -speak as anything but rhetorical damage limitation nonsense ..

    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.”

    How many times can a drug company get away with harming patients without being brought to book? …

    They denied there were problems with Myodil , yet they paid out and gagged those damaged by that GSK product in the 90′s ..( it was eventually pulled from the market)

    They denied there were problems with Seroxat , yet we know they have paid out and gagged in the US for their deceitful and fraudulant practices with Paxil there…

    They were charged with Fraudulant marketing of Ribena this year …

    And now we have Avandia …

    GSK’s products and conduct speaks for itself…
    The spin of Mary Anne Rhyne serves only to reinforce their attitude … They are out of touch with their patients and customers, and the public can see through their propoganda …


Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s

Follow

Get every new post delivered to your Inbox.

Join 85 other followers

%d bloggers like this: