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.
Every mmol/L that low-density lipoprotein is forced downward chops the risk of myocardial infarction or stroke by roughly 22 percent—the conclusion of the Cholesterol Treatment Trialists’ 170 000-patient meta-analysis:
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.
The FDA, by contrast, has kept moving the goalposts for approval of OTC statin use:
Notice the pattern: every rejection centred on consumer competence, not on statin safety (which the panels broadly conceded). The committees fretted that shoppers would mis-judge their own 10-year ASCVD risk or forget to see a doctor—ironically the very inertia that keeps millions untreated today.
Tech has already torpedoed those fears. In 2021-24 AstraZeneca’s web-app TACTiC studies showed > 96 % concordance between consumer self-selection and clinician judgment for rosuvastatin 5 mg—exactly the “additional condition for non-prescription use” the FDA now invites under its new ACNU rule.
Bottom line: the only things standing between Americans and safe, cheap OTC statins are dusty committee anxieties that pre-date smartphones—and three decades of real-world evidence that statins are among the safest chronic drugs we have.
Say only one percent of the 130 million U.S. adults aged 40-75 grab an OTC statin. That is 1.3 million new users. Apply the CTT risk curve to a conservative 10-year ASCVD baseline of 5 percent and you avert ~14,000 heart attacks and strokes. Value each event at a (ludicrously low) 4 QALYs and you are buying 56,000 quality-adjusted life-years for pocket change. The cost-per-QALY plunges below the price of a fast-food combo meal.
If critics whip out the organic-purist card, remind them that lovastatin was literally purified from red-yeast-rice mold. Statins are fermented corn, just tidied up by medicinal chemistry. The FDA currently bans supplement makers from leaving the active monacolin K fraction in their red-yeast-rice capsules; your deregulatory pen could fix that contradiction overnight.
The ask: bake a statin switch into your inaugural 10-to-1 bundle.
Draft guidance that (a) designates low-dose statins as Generally Recognized as Safe and Effective for primary prevention in adults meeting a clear risk threshold, (b) mandates a pharmacist-screened initial sale (à la pseudoephedrine) if you need a training-wheels phase, and (c) sunsets the pharmacist checkpoint after post-market data confirm what two million patient-years already tell us.
You pledged to Make America Healthy Again by scrapping deadweight regs. Here is a regulation that literally clogs arteries and kills quietly. Strike it, and you will create the kind of overnight, measurable public-health win that presidents put on campaign posters—no new technology, no trillion-dollar appropriations, just one less line in the Code of Federal Regulations.
It is low-hanging fruit, Bobby. Let’s pick it before another heart muscle seizes up waiting for a prescription refill.
Sincerely,
A citizen who prefers his arteries wide and his policy wider
English (US) ·