Mr. Secretary, Reclassify the Statin

Summary

Dear Mr. Kennedy,Picture, if you will, a nation-sized coronary artery: plaque laid down year after year like bureaucratic memos - the lumen of public health narrowing with every missed opportunity. Two days ago, your shop at HHS unfurled the shiny new Request for Information—your 10-to-1 deregulation gauntlet thrown at the feet of every rule that ever gathered dust in the Federal Register. Amid the gewgaws and heavy machinery of federal health policy there sits a single, absurdly obvious lever: reclassify a low-dose statin (say, atorvastatin 10 mg or rosuvastatin 5 mg) from Rx-only to true, Walmart-checkout-aisle OTC. Pull it, and you do more for cardiovascular prevention than a decade of slogan-heavy wellness campaigns.Mother Nature herself runs a permanent, double-blind trial: people born with loss-of-function variants in PCSK9 or ANGPTL3 cruise through life with LDLs in the 20–40 mg/dL range and enjoy 30-plus-percent cuts in coronary risk without obvious downside (1, 2, 3, 4).When biology, randomized evidence, and genetics all hum the same tune… policy should probably dance.Serious muscle injury from statins occurs in <0.1% of users; hepatotoxicity is an order of magnitude rarer. For context, you’re free to purchase orlistat—a drug whose calling card is oily rectal incontinence—straight from Amazon’s shelves. If we are letting consumers gamble their underwear for a few pounds lost, we can surely trust them with the pill that costs pennies and saves hearts.The United Kingdom loosed simvastatin 10 mg (Zocor Heart-Pro) onto pharmacy shelves back in 2004. Uptake was modest—partly price, partly faint-hearted marketing—but no safety alarms rang. America can improve on the British half-measure with more potent, generic molecules and a proper consumer-education blitz.Zocor Heart-Pro: Simvastatin 10 mg was briefly sold OTC in the UK — a rare exception to the statin prescription lock. Most countries never followed.The FDA, by contrast, has kept moving the goalposts for app...