Bickering and bull surround fate of diabetes drug
A federal drug-advisory committee got together to discuss the question of what to do about Avandia. By some appearances, it would seem that not everyone in the FDA is on the company bandwagon.
The dissenters were outnumbered, and I wasn't surprised to learn that the Big Pharma toadies won the day. They voted to recommend that the popular diabetes drug should remain on the market, despite strong evidence of its increasing heart-attack risk for diabetic patients.
I'm resigned to the fact that these FDA folks would say that the sun is a lukewarm star if their drug-company pals told them to say it. They seem to have absolutely no shame. Their justification for keeping this now more-than-questionable drug on the market? They thought that the recent studies about Avandia's inherent cardiovascular-disease risks were just too sketchy to justify yanking the drug from the market.
As I relayed to you in House Calls a couple of weeks ago, one out of every 50 patients on either Avandia or Actos will develop heart failure within 26 months. To hammer home the point that the drug is dangerous, one of the dissenters on the panel cited an estimate based on recently released studies that Avandia caused over 200,000 heart attacks and strokes over a seven-year period.
I hardly consider 200,000 heart attacks and strokes—some of them resulting in death—to be just a vague detail that can easily be dismissed! Also, bear in mind that there are many diabetics who suffer a host of health problems that can complicate even further their attempts to cope with various side effects of their disease. Now many of them take a pill that is supposed to help them but could kill them instead.
In addition, the same FDA dissenter I mentioned above estimates that for every month Avandia remains on the market 1,600 to 2,200 patients will be at risk of a heart attack or stroke.
It also seems that the FDA and GlaxoSmithKline hadn't communicated previously in order to keep their stories straight. The FDA reports that the drug company told it about these risks but that because of internal debate within the FDA (read: their fear of GlaxoSmithKline), the information never got into the hands of doctors and their patients. Meanwhile, GlaxoSmithKline continues to deny any problems with its drug.
GlaxoSmithKline, while on the one hand vehemently denying that there are any safety issues with Avandia, agreed on the other to add a "black-box" warning on the drug's label regarding the increased cardiovascular risk.
It was also revealed through agency records that Avandia has additional risks associated with it, such as liver failure and an increased risk of fractures.
But I'll bet you won't hear much about that for a while.
In the meantime, skip Avandia. There are other, safer ways to manage your diabetes. I recommend a heart-to-heart talk with your doctor. Frankly, there are very few cases of Type 2 diabetes that don't respond to careful diet and regular, vigorous exercise (including strength training with weights). Otherwise, in my opinion, metformin (Glucophage) is the preferred oral agent for diabetes. But please keep in mind that it can cause a loss of vitamins B12, folate and Coenzyme Q10, so you may need to supplement extra amounts of those nutrients.
