{"id":1891,"date":"2024-03-10T21:18:00","date_gmt":"2024-03-11T05:18:00","guid":{"rendered":"https:\/\/revitalizemetabolichealth.com\/?p=1891"},"modified":"2024-03-10T21:18:00","modified_gmt":"2024-03-11T05:18:00","slug":"recent-happenings-at-the-fda","status":"publish","type":"post","link":"https:\/\/revitalizemetabolichealth.com\/recent-happenings-at-the-fda\/","title":{"rendered":"Recent Happenings at the FDA"},"content":{"rendered":"

Time to catch up with the recent happenings over at the FDA.\u00a0 Seems like they’re always up to something, for better or worse.<\/p>\n

Two big announcements this week worth discussing.<\/p>\n

Over-the-counter CGM coming soon<\/h3>\n

Dexcom announced<\/a> this past week that the FDA approved a continuous glucose monitor<\/a> (CGM) for over-the-counter (OTC) purchase.\u00a0 The new CGM, called Stelo, is scheduled to be available on-line in Summer 2024. \u00a0Currently, continuous glucose monitors are available only by prescription. \u00a0Generally, these CGMs are covered by insurance only for individuals with diabetes, often only for those who require insulin.<\/p>\n

Dexcom\u2019s competitor, Abbott, produces the Freestyle CGM.\u00a0 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.\u00a0 Dexcom\u2019s G7 is allegedly $400-500 for a month, covering three (3) 10-day sensors.\u00a0 Apparently, the Stelo sensor will last up to 15 days, rather than the customary 10 days for the currently available Dexcom sensors.<\/p>\n

\"\"<\/p>\n

These tools have revolutionized diabetes management, allowing for integration of these continuous glucose readings with insulin pumps in individuals with type 1 diabetes. \u00a0Effectively, this pairing of technologies has allowed the creation of an \u201cartificial pancreas\u201d when the two work in conjunction, aiming to mimic the function of the pancreas secreting insulin in response to elevations in blood glucose.<\/p>\n

Aside from those with diabetes, many others want access to CGMs as a tool to optimize their metabolic health.\u00a0 CGMs are a valuable tool providing a look at real-time glucose readings, allowing one to see the effects of one\u2019s behaviors, be it food intake, activity, sleep, stress, or other factors. \u00a0For example, I use one to monitor what happens to my glucose when I do multi-day fasting or test other nutritional strategies.\u00a0 I also regularly use them with my patients to help them learn how their bodies respond to certain foods.<\/p>\n

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.<\/p>\n

New indication for blockbuster weight loss drug<\/h3>\n

Also, in FDA-related\"\" news this week . . . the FDA approved a new indication<\/a> for the popular weight loss drug, Wegovy (semaglutide<\/a>) \u2013 to reduce the risk of cardiovascular disease in those with obesity or overweight.<\/p>\n

Now, this sounds like a big deal, like an important breakthrough that we should be excited about.\u00a0 I\u2019m here to play the devil\u2019s advocate, however, by saying: \u201cWell, no shit, Sherlock!\u201d\u00a0 There\u2019s nothing new to see here; anyone who can see the big picture already knew this to be the case.<\/p>\n

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 \u2013 heart disease, stroke, hypertension, obesity, diabetes, abnormal lipids, gout, PCOS, inflammation, dementia, cancer, etc.\u00a0 In fact, that\u2019s exactly how I learned all of these disease processes in my medical training \u2013 learn one at a time, each with unique pathology and pathophysiology, each requiring a different set of pharmaceutical treatments.<\/p>\n

As I\u2019ve belabored in prior posts<\/a>, though, these Western diseases are actually all the same disease.\u00a0 That\u2019s right \u2013 each one of the aforementioned diseases is primarily driven by one disease process: Insulin Resistance.<\/p>\n

\"\"<\/p>\n

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.\u00a0 The reason we keep seeing patients who exhibit all of these diagnoses simultaneously is because they\u2019re just different symptoms of the same disease.\u00a0 Still, health care behaves as if each disease is an entirely different entity.<\/p>\n

So when it comes to Wegovy (semaglutide) being shown to improve cardiovascular disease, I can\u2019t help but groan . . . and feel bad for everyone in health care who still hasn\u2019t figured out that we\u2019re talking about the same disease.\u00a0 Semaglutide has demonstrated clear benefit in diabetes and in obesity.\u00a0 Why wouldn\u2019t it also benefit cardiovascular disease risk?\u00a0 We call diabetes a \u201crisk factor\u201d for cardiovascular disease; we call obesity a \u201crisk factor\u201d for cardiovascular disease; we call hypertension a \u201crisk factor\u201d for cardiovascular disease.\u00a0 It\u2019s all one and the same, just different manifestations of the same underlying process.<\/p>\n

Semaglutide targets all of it \u2013 addressing the insulin resistance, the underlying cause of all of these diseases.\u00a0 So it\u2019s not surprising when reports like this come out.\u00a0 In fact, we\u2019ll probably see reports about it lowering blood pressure, as well as reducing the risk of dementia and certain cancers.\u00a0 The data\u2019s coming. . . it\u2019s just a matter of time.<\/p>\n","protected":false},"excerpt":{"rendered":"

Time to catch up with the recent happenings over at the FDA.\u00a0 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.\u00a0 The new CGM, called Stelo, is scheduled to be available on-line in Summer 2024. \u00a0Currently, continuous glucose monitors are available only by prescription. \u00a0Generally, these CGMs are covered by insurance only for individuals with diabetes, often only for those who require insulin. Dexcom\u2019s competitor, Abbott, produces the Freestyle\u2026<\/p>\n","protected":false},"author":2,"featured_media":1896,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"om_disable_all_campaigns":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[86],"tags":[135,170,73,57,9],"blocksy_meta":"","aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/revitalizemetabolichealth.com\/wp-json\/wp\/v2\/posts\/1891"}],"collection":[{"href":"https:\/\/revitalizemetabolichealth.com\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/revitalizemetabolichealth.com\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/revitalizemetabolichealth.com\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/revitalizemetabolichealth.com\/wp-json\/wp\/v2\/comments?post=1891"}],"version-history":[{"count":5,"href":"https:\/\/revitalizemetabolichealth.com\/wp-json\/wp\/v2\/posts\/1891\/revisions"}],"predecessor-version":[{"id":1899,"href":"https:\/\/revitalizemetabolichealth.com\/wp-json\/wp\/v2\/posts\/1891\/revisions\/1899"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/revitalizemetabolichealth.com\/wp-json\/wp\/v2\/media\/1896"}],"wp:attachment":[{"href":"https:\/\/revitalizemetabolichealth.com\/wp-json\/wp\/v2\/media?parent=1891"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/revitalizemetabolichealth.com\/wp-json\/wp\/v2\/categories?post=1891"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/revitalizemetabolichealth.com\/wp-json\/wp\/v2\/tags?post=1891"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}