Last week the FDA gathered experts to determine what kind of studies need to be performed on diabetes drugs. Specifically, they discussed whether or not these diabetes drugs help or hurt the heart of the patient taking them. Many people with diabetes also have heart problems as a complication of the disease, so it’s important that diabetes drugs don’t compound damage to the heart.
Current FDA procedure
In order to be FDA-approved, a diabetes drug must first pass a study to determine if the medication can prevent heart attacks and other problems. If it doesn’t actively improve heart health, the drug might not make it past clinical trials.
How the guideline started
The methodology dates back to a decade ago when several diabetes drugs made headlines due to unsafe side effects of the heart. Since then, the FDA has increased/changed the guidance for what drugs are and are not safe to lower blood sugar in diabetic patients.
William Chong, acting director of the Division of Metabolism and Endocrinology Products said, “We now have eight clinical trials conducted under the guidance. All eight have demonstrated no excess cardiovascular risk with any of the therapies studied. t seems apropos to review what we have learned and consider what changes to the approach, if any, are necessary.”
But some worry this strict guideline of simultaneously lowering blood sugar and actively improving heart health is hampering future drug creation. This creates a problem for consumers as they have fewer drugs to choose from, and the ones available have higher price tags.
In fact, an analysis from BioCentury found that the number of new diabetes drugs being tested in clinical trials fell from 36 in 2009 to 12 in 2017. Drug trials on the whole have shifted away from common problems like diabetes, toward rare diseases and cancer where there is less drug competition and higher price tags. As a result, the FDA is reconsidering the strict guideline in order to give patients and doctors more options.