Recent Happenings at the FDA

Time to catch up with the recent happenings over at the FDA.  Seems like they’re always up to something, for better or worse.

Two big announcements this week worth discussing.

Over-the-counter CGM coming soon

Dexcom announced this past week that the FDA approved a continuous glucose monitor (CGM) for over-the-counter (OTC) purchase.  The new CGM, called Stelo, is scheduled to be available on-line in Summer 2024.  Currently, continuous glucose monitors are available only by prescription.  Generally, these CGMs are covered by insurance only for individuals with diabetes, often only for those who require insulin.

Dexcom’s competitor, Abbott, produces the Freestyle CGM.  With a prescription, the Freestyle Libre 2 costs $65 without prescription coverage for a single 14-day sensor, and the newer Libre 3 costs approximately $130 for a 14-day sensor.  Dexcom’s G7 is allegedly $400-500 for a month, covering three (3) 10-day sensors.  Apparently, the Stelo sensor will last up to 15 days, rather than the customary 10 days for the currently available Dexcom sensors.

These tools have revolutionized diabetes management, allowing for integration of these continuous glucose readings with insulin pumps in individuals with type 1 diabetes.  Effectively, this pairing of technologies has allowed the creation of an “artificial pancreas” when the two work in conjunction, aiming to mimic the function of the pancreas secreting insulin in response to elevations in blood glucose.

Aside from those with diabetes, many others want access to CGMs as a tool to optimize their metabolic health.  CGMs are a valuable tool providing a look at real-time glucose readings, allowing one to see the effects of one’s behaviors, be it food intake, activity, sleep, stress, or other factors.  For example, I use one to monitor what happens to my glucose when I do multi-day fasting or test other nutritional strategies.  I also regularly use them with my patients to help them learn how their bodies respond to certain foods.

No word yet on the price, but with competition between Dexcom and Abbott, these prices will likely be competitive and thus be significantly more available to the general public.

New indication for blockbuster weight loss drug

Also, in FDA-related news this week . . . the FDA approved a new indication for the popular weight loss drug, Wegovy (semaglutide) – to reduce the risk of cardiovascular disease in those with obesity or overweight.

Now, this sounds like a big deal, like an important breakthrough that we should be excited about.  I’m here to play the devil’s advocate, however, by saying: “Well, no shit, Sherlock!”  There’s nothing new to see here; anyone who can see the big picture already knew this to be the case.

See, one of the many problems with modern health care is that we treat all of the major categories of Western disease as completely separate entities – heart disease, stroke, hypertension, obesity, diabetes, abnormal lipids, gout, PCOS, inflammation, dementia, cancer, etc.  In fact, that’s exactly how I learned all of these disease processes in my medical training – learn one at a time, each with unique pathology and pathophysiology, each requiring a different set of pharmaceutical treatments.

As I’ve belabored in prior posts, though, these Western diseases are actually all the same disease.  That’s right – each one of the aforementioned diseases is primarily driven by one disease process: Insulin Resistance.

We most certainly know this phenomenon to be true, because we even joke in medicine that we should have a rubber stamper for the typical patient: obese, with high blood pressure, diabetes, and kidney disease, also on cholesterol medication, and on and on.  The reason we keep seeing patients who exhibit all of these diagnoses simultaneously is because they’re just different symptoms of the same disease.  Still, health care behaves as if each disease is an entirely different entity.

So when it comes to Wegovy (semaglutide) being shown to improve cardiovascular disease, I can’t help but groan . . . and feel bad for everyone in health care who still hasn’t figured out that we’re talking about the same disease.  Semaglutide has demonstrated clear benefit in diabetes and in obesity.  Why wouldn’t it also benefit cardiovascular disease risk?  We call diabetes a “risk factor” for cardiovascular disease; we call obesity a “risk factor” for cardiovascular disease; we call hypertension a “risk factor” for cardiovascular disease.  It’s all one and the same, just different manifestations of the same underlying process.

Semaglutide targets all of it – addressing the insulin resistance, the underlying cause of all of these diseases.  So it’s not surprising when reports like this come out.  In fact, we’ll probably see reports about it lowering blood pressure, as well as reducing the risk of dementia and certain cancers.  The data’s coming. . . it’s just a matter of time.

Leave a Reply

Your email address will not be published. Required fields are marked *