You have its maker, GlaxoSmithKline, kicking the ball back to the FDA regarding these newly found risks associated with their product. Take a look at this paragraph directly from the company's web site:
For some people taking Avandia, possible side effects include heart failure or other heart problems. Further information regarding potential heart-related risks is currently under review by the FDA. Talk to your doctor as FDA has made information on potential heart-related risks available to physicians on its website at www.fda.gov.
And a spokesperson for the company reportedly responded to the news of the increased risk of heart failure associated with Avandia by saying the company continues to believe in its safety. (What about Santa Claus and the Tooth Fairy?)
In addition, the company insists that its data shows no increase in heart-failure deaths. But remember how quickly these drugs are rushed through trials and onto the market, I question the accuracy of the company's "data." Especially when you consider that—as I stated previously—they're essentially tested in real-time on patients.
As for the FDA, it should come as no surprise that the regulatory panel was convinced by the company to keep their drug on the market. The FDA has once again capitulated to a Profit Monger, and its only concession to us little folk was to suggest that the drug carry new black-box warnings about heart risks. Mind you—suggest, not insist.
And GlaxoSmithKline, seemingly no worse for the wear, experienced its biggest shares gain after the news that Avandia wouldn't be withdrawn from the market. Just so you realize what was really at stake—this particular drug raked in $3.3 billion last year.
The company's biggest challenge now seems to be in repackaging Avandia to doctors so they'll keep prescribing it. And it'll need to be quick about it if it wants to protect future profits—especially if it is eventually forced to paste a black-box warning on its product.
I can only imagine the foot traffic the pharmaceutical reps will be responsible for creating, beating the path to the doctors' doors with lunches and goodies aplenty.
The onus is being put on doctors to make a decision: Patient or prizes?
In my own clinical experience, for most cases and with a willing patient, diabetes can be successfully treated with diet, exercise and a short list of nutraceuticals (a fancy name for supplements) tailored to the individual. And when I say diet, I don't mean some phony, unsustainable low-fat or super low-carb "diet" that stresses your body and makes you miserable. What I do mean is real, satisfying food with adequate amounts of fat and all of the flavor and eating pleasure you could wish for!
So if you're currently taking either Avandia or Actos, I encourage you to immediately have a frank and open discussion with your doctor about alternatives. Don't even think about leaving his office or being hustled out the door until you're comfortable with the treatment prescribed. Because your risk isn't worth their benefit.
