This sounds like a project for the new software being built for the FDA to run some studies against the Medicare data base. This would serve to relate information on the existing drugs used and queries set up to select the desired results. Granted such studies would not be 100% fool proof, but it would certainly be the case to lend some additional information. With new drugs on the market and relatively no information, this may not offer a lot of information, unless the drugs can be compared to those already on the market with some of the same active ingredients and compounding agents to perhaps serve as a projection. There is always the other side of the coin too, if one were not taking the medications, where would their blood sugar levels be and so on. BD
The FDA is summoning a panel of experts to consider whether drug makers should be forced to study the cardiovascular effects of diabetes drugs. It’s a complicated question that raises some thorny (and interesting) issues.
Diabetes dramatically raises the risk of serious cardiovascular problems such as heart attacks and strokes. So it stands to reason that a drug that controls the blood-sugar swings that are the defining feature of diabetes should also lower cardiovascular risk. “What specific cardiovascular assessments should be required as part of the approval process for drugs and biologics developed for the treatment of type 2 diabetes, and why?”