Reputation Management Online

If you’re a diabetic, your doctor would have told you this  - “With Diabetes your chances for heart diseases are now higher”!

So what happens if your medication prescribed for diabetes also comes with an added risk for cardiovascular disease? Scary? Yes it is! And this is what’s happening with GlaxoSmithKline’s Avandia or  rosiglitazone.

A Senate Finance Committee report had some hard-hitting words for GSK and this was what was said:

GlaxoSmithKline, knew the type 2 diabetes drug had possible harmful cardiac effects several years before a 2007 New England Journal of Medicine study initially raised concerns about Avandia.

It all began three years ago when Dr. Steven E Nissin conducted a study and found that Avandia raised the risk of heart disease and this snowballed into a Congressional inquiry and report resulting in a drop in stock value for GSK. NYT reported the following:

A Congressional investigation released Saturday concluded that GlaxoSmithKline had threatened scientists who tried to point out Avandia’s risks, and internal memorandums from the Food and Drug Administration show that some government health officials want Avandia withdrawn. The drug is still being taken by hundreds of thousands of patients, and sales last year were $1.19 billion.

GlaxoSmithKline has today fired a rebuttal and has in its 30-page “white paper” response made it very clear that:

It has been “proactive in investigating the safety data” of rosiglitazone and has kept all regulatory agencies, including the FDA, aware of its investigations.

They have even gone on to say that they rumours of them trying to silence people were simply efforts made to ensure the right information goes out about their product.

Avandia is a very popular drug for Diabetes and for the hundreds of thousands using it everywhere nothing couldn’t be scarier than this. The best advice we can give is to contact your doctor and not decide things yourselves.

As for GSK, trying to arm-wrestle out of this with a 30-page rebuttal may not be enough. Coming clean on research results funded by them and allowing this to be evaluated or going back to the lab to improve the medicine maybe the way to go.

Finally the word from FDA : The FDA warns that patients who are taking Avandia should be monitored for signs and symptoms of heart failure, including excessive and rapid weight gain, difficulty breathing and/or swelling. “This work is ongoing and no new conclusions or recommendations about the use of rosiglitazone in the treatment of type 2 diabetes have been made at this time,” the agency announced.

While GSK handles this reputation management problem, what transpires next should be interesting indeed! Watch this space for updates!