FDA Panel To Weigh Heart Trials For Diabetes Meds

The article is indicating ethical measures from the FDA relating to the risk of developing cardiovascular disease from using type 2 diabetes drug. An interesting idea for medical intervention in which decision making is underway to assess the efficacy of clinical trials either before or after a diabetes drug has been approved and marketed and the drugs are used by...

It will be almost impossible to get any drugs thru the process of approval as the cost to do these studies will be prohibitive.

“A requirement for demonstrating cardiovascular benefit will likely have major implications on the availability of new treatments for type 2 diabetes, because conclusive evidence of a reduced risk of macrovascular complications in type 2 diabetes has not yet been established for any of the currently available antidiabetic medications, including insulin,” The FDA, industry, and the medical community...