Mr. Secretary, Reclassify the Statin

One regulatory stroke could save more American lives than a decade of health campaigns. You have the pen.

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.

1. Causality carved in stone tablets

• 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.

2. Safety so boring it is practically soporific

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.

OTC drugs like orlistat and NSAIDs cause 50–100× more serious adverse events than low-dose statins—yet only statins require a prescription.

3. There is precedent of statins being OTC

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 approval of OTC statin use:

Despite five attempts over nearly two decades- the FDA has not approved statins for OTC use (2000; 2005; 2007; 2015).

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.

4. Even a rounding-error uptake pays out in health dividends

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 change¹. The cost-per-QALY plunges below the price of a fast-food combo meal.

5. Natural enough for the supplement aisle

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.

Red yeast rice contains monacolin K, chemically identical to lovastatin. The FDA bans it in supplements if present above trace levels—Rx status applies either way.

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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

1. The 2020 ACS table S0101 pegs the U.S. 40-to-75-year cohort at ~129 million souls; if a mere 1 percent (≈1.3 million) picked up an OTC 10 mg simvastatin, and we assume a baseline 10-year ASCVD risk of 5 percent (the lower edge of the ACC/AHA 'borderline-risk' band), about 65,000 MIs or strokes would loom on the horizon.

Clip that risk by 22 percent—the LDL-lowering dividend documented in the Cholesterol Treatment Trialists meta-analysis for a 1 mmol/L drop—and you sidestep roughly 14,000 events.

How much life is that? Global Burden of Disease disability weights put the quality-of-life hit of an acute MI at 0.40-ish and long-term stroke at 0.27; spread over a typical 15-to-20-year remaining lifespan, that’s ≈4 QALYs lost per event—a mid-range figure used in many CVD cost-utility models.

Multiply and you’re buying ~56 000 quality-adjusted life-years for what is essentially pharmacy pocket change.