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Supplement Perspectives

The Cholesterol Conundrum: Co-Pay vs. Self-Pay

In the late 1980’s a consumer health book with an incendiary title was published that fostered a meteoric rise of two dietary ingredients: oat bran, and a vitamin and generic drug: niacin (AKA nicotinic acid). Niacin was validated as a blood lipid-lowering drug in 1955. One of the coauthors (the late Abram Hoffer, MD) of this 1955 study was also a pioneer of orthomolecular medicine, (and his son John has continued in a similar vein, with an emphasis on vitamin C,at McGill University).

The 8-Week Cholesterol Cure book, since edited and released in further editions by its now posthumous author, espoused a compelling tactic to cure high blood cholesterol: take an appropriate, escalating dose of modified (sustained, time-released) release niacin.

The evidence laid out by Bob Kowalski was rather inspiring back then, with the Coronary Drug Project indicating that pharmacologic niacin dosing reduced both cardiovascular event risk and overall mortality; niacin is one of the rare nutrients whose nutritional dose—10-20 mg/day—effects are wholly distinct to its pharmacologic dose—500 – 4,000 mg/day—effects. The “book” achieved national, enduring best-seller status, spawned perhaps hundreds of sustained release (SR) niacin SKUs (all but one NOT subjected to safety and efficacy testing), and inspired perhaps over 100,000 consumers to buy and try such a product. A side effect of the popularity of this dietary supplement/“natural OTC drug” was an alarming uptick of chemical hepatitis (AKA non-infectious liver injury), even resulting in liver failure that merited organ transplantation.

Notably, oat bran and SR niacin (as a dietary supplement) were exalted to blockbuster status in the late 80’s to early 90’s but a few years after the first statin drug (Mevacor®; lovastatin), developed by Merck after extracting the drug from a soil-derived fungus, was approved by the FDA in 1987. Several years later, two former Merck scientists/brothers of Chinese descent give birth to Pharmanex in Southern California, shepherding the transfer of Asian fungal fermented food lore into a dietary supplement known as red yeast rice (formerly called Cholestin®).

The fate of Cholestin is contentious and perhaps was the final breath of life from a dietary supplement or food designed (or intended) to favorably change blood cholesterol. Phytosterols and stanols, hailed by pharma, food, and dietary supplement companies, have floundered and failed in North America. What “heart health” ingredient has had enduring, robust success—save those with long chain omega-3 fatty acids?

One element: the statin factor is formidable. Lipitor, once the biggest selling drug in the world and now off patent, can be had for as low as a $4.00 co-pay per month, for the branded/non-generic version. Another statin, Crestor®, can be had for as low as $18.00/month. What would be the outcome if the majority of North Americans (even some that shop at the Super Naturals like Whole Foods) were presented with this binary offer?

“Behind door number 1 is a tiny pill you take once a day, has some side effects (like liver injury, and muscle weakness and pain, the latter which may respond to a dietary supplement, by the way…), costs between $5-20/month (assuming you have a drug co-pay plan), and has been directly shown to lower your risk of having a (first or second) heart attack, OR behind Door number 2 is a trio of large pills that you have to take once or twice daily, combined with a “clean diet”, has mild side effects (stomach upset, belching, gas), costs between $30-80/month, and has never been shown to directly lower your risk of having a (first or second) heart attack.”

The answer is tacit, and underscores why I counsel companies or entrepreneurs with an “abandon ship” urging if they ask what I think about chasing the cholesterol category.

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