Obesity, Diabetes Prevention, and Angels Dancing on a Pinhead

For persons with obesity and prediabetes, one of the best ways to prevent diabetes onset is quite clear. Treat the obesity to reduce the excess adiposity. The Diabetes Prevention Program established this with a study in the NEJM way back in 2002. A prescription of diet and exercise could cut the risk of diabetes in half. And now we have medicines for obesity that can do even better for diabetes prevention, cutting the risk of progression by more than 90%.

But guidance from FDA, released in draft form recently, seems out of touch with this new reality. Showing that a drug delays the onset of type 2 diabetes “would likely not be sufficient” to establish diabetes prevention as an indication for prescribing an obesity medicine.

“Show Us It Matters”

FDA seems to be setting the bar very high for a diabetes prevention indication. In its guidance, the agency suggests it does not see an intrinsic benefit for preventing diabetes. The agency wants evidence for more than a delayed diagnosis:

“An additional indication for the delay of onset of type 2 diabetes would need to be supported by the establishment of clinical benefit(s) of the delay.

“Benefits on quality of life, disease management burden, or psychosocial functioning could be considered. It is unclear what would constitute a minimum trial duration for a delay or prevention of type 2 diabetes claim, but the magnitude of the benefit of any delay in the onset must be clinically meaningful.”

Valuing Diabetes Prevention

This ambivalence about diabetes prevention from FDA startles us. One does not have to consult very many people living with obesity to learn that preventing type 2 diabetes is very important to people facing this possibility. The disease can be devastating and people living with obesity often know it because they have loved ones who are experiencing it.

So rather academic concerns from FDA about “microvascular outcomes” and “concealed” glycemia seem a lot like rumination about angels dancing on the head of a pin. Such ruminations are not relevant to someone facing the prospect of a diabetes diagnosis.

If FDA sets an excessively high bar for a diabetes prevention indication, everyone loses. Providers can lose sight of an important reason for treating obesity. Patients will lose opportunities for a healthier life, free from the complications of diabetes.

Click here for more on the FDA guidance and here if you feel moved to comment on it. For perspective on the benefits of diabetes prevention, click here.

Angels Appearing; pen, pencil, ink, and watercolor by William Blake / WikiArt

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January 31, 2025