But FDA advisors are too scared about the possible risks of the drugs to allow diabetics and doctors to see how they work in the real world.
"Several committee members said they could have voted either way.
“I changed my mind about four times in the last 10 seconds,” said Erica H. Brittain, a statistician at the National Institutes of Health who voted no. "
The fate of a new drug should be decided by FDA's Hamlets?
The biggest safety concern was that in clinical trials, patients who got the drug were more likely to develop breast and bladder cancers than those in the control groups.
About 0.4 percent of women taking the drug got breast cancer, compared with 0.1 percent of the women in the control groups. About 0.3 percent of men getting the drug got bladder cancer, compared with about 0.05 percent of men in the control groups.
The numbers were very small, however, making it hard to draw definitive conclusions. Bristol-Myers and AstraZeneca argued that many of the cancers occurred too soon to have been caused by the drugs."
And get this:
"The committee members agreed that more study of the possible cancer risks and other safety questions would be needed. Those who voted no mainly believed that the studies needed to be done before approval, even though that might delay approval by years. "
How many people will die from diabetes related complications because this medicine is not approved in order to organize trials that will likely never resolve the issue?
This is pathetic. The advisory committee members are being haunted by the ghost of Steve Nissen.
