Last chance power drive
Okay…so it’s not what doctors and nutritionists had in mind when they sounded the alarm about the diabetes epidemic.
Still, the FDA may have found out a new way to dramatically decrease the number of diabetics in this country…
By putting them on a drug that might literally kill them.
Dumb and dumber
After it was proven that Avandia caused strokes and heart attacks in type 2 diabetics, the FDA finally restricted its use in 2011. These days, only “certified” doctors can prescribe it. And they can only give it to patients who respond poorly to other treatments. Their one last option is to go all-in with this dangerous drug.
But that was then…
Last week, an FDA panel voted to “relax” market restrictions for Avandia.
Panelists based their recommendation on a new analysis of a 2009 Avandia study called Record. Incidentally, GlaxoSmithKline (the maker of Avandia) paid for Record. And they paid for the new analysis of data.
So they’re finally getting their money’s worth.
A majority of panel members say the study doesn’t show increased risk of heart attacks. (This contradicts other studies that reveal heart attack risk.) But Record DID show that heart failure risk doubled.
So you may not be more likely to have a heart attack but you are 200% more likely for your heart to actually fail.
And yet, somehow more than half of these supposed experts voted to ease up on poor Avandia.
Are they insane? Well…here’s a clue. One panelist said, “There remains considerable uncertainty, but I do favor loosening the restrictions.”
So, “considerable uncertainty” about life-threatening side effects doesn’t faze this panelist at all.
Alright…let’s loosen them. That seems reasonable. But before we do, everyone on the panel who voted “yes” should have to take it — and give it to their mothers — for a year. Along with the brass at GSK.
Think they will? Well, consider this…
Last year, Glaxo executives pled guilty to criminal charges of withholding safety data from the FDA, including data on Avandia. They paid a $3 billion fine. That’s the biggest fraud fine ever.
Ironically, they didn’t even NEED to withhold it. The FDA clearly doesn’t care.
In fact, they left Avandia on the market even though researchers estimate that 48,000 people experienced a stroke, heart failure, or death that could be attributed to taking Avandia instead of Actos, another type 2 diabetes drug.
Now…who in his right mind would let his mother use Avandia? (Or sister or uncle or friend or mailman?)
“Glaxo’s Avandia Scores FDA Victory” Thomas M. Burton, The Wall St. Journal, 6/6/13, online.wsj.com