June 8, 2013
Did FDA Committee Make the Right Decision?
This will be hotly debated for the next several months. Many people are sure to be asking why now? What safeguards will be taken to prevent the problems that originally caused the limits to be put into effect? Even the original results when recomputed remained almost identical. Until the dust settles on the Food and Drug Administrations actions, we will only have a discussion as to the questionable value of Avandia.
I know several doctors that will start using it again; however, I doubt many patients will accept using Avandia. In my blog recently, I complained about the pill popper generations. I must expand this to doctors as most primary care physicians would rather prescribe pills than insulin. I am aware of many people with type 2 diabetes that are able to manage their diabetes on oral medications and many that are able to manage their type 2 diabetes without medications. Yet many patients need to stack one oral medication on top of another oral medication and still are not managing their diabetes.
Because many doctors are rightfully fearful of hypoglycemia, they will let diabetes do damage and become progressive before they will prescribe insulin. This is the shame of our medical teaching. Yet, not many can become diabetes doctors like Dr. Richard K. Bernstein.
The final decision now awaits the FDA. The FDA has no regulatory deadline by which to make a decision, and it's unclear when the agency will make a ruling, an FDA spokeswoman said. The FDA isn't obligated to follow the advice of its advisory committees, but usually does. Hopefully this time they will leave things alone.
So the wait begins.