Red yeast rice
The idea that you might need lifetime drug therapy can be frightening. It’s understandable to ask questions of your prescriber when medication is recommended – why a drug might be necessary, what benefits and harms might be expected, and whether there are non-drug approaches that could eliminate the need for daily medicine. It’s natural (ha) to ask about alternatives. Successful marketing has led to the promotion (and assumption) that dietary supplements and natural health products can be acceptable substitutes for drugs, without the long list of possible side effects. Herbal products are categorized in many countries as a form of dietary supplement when (at best) they are effectively impure, unstandardized drugs. Red yeast rice is a supplement that is promoted as a “natural” cholesterol-lowering remedy as potentially effective as the “statin” group of drugs. And that statement has some truth to it: some brands of red yeast rice have been tested and have indeed been shown to reduce cholesterol, like statin drugs. That’s because one of the active ingredient in red yeast rice is the prescription cholesterol drug, lovastatin. This isn’t necessarily adulteration: Lovastatin is naturally occurring in red yeast rice (a powerful endorsement of pharmacognosy). The main difference between red yeast rice and the prescription drug lovastatin (or Mevacor) is that the drug product has been isolated, purified and standardized to give a reliable dose into the body with each pill.

The belief that “natural” is preferable to anything “synthetic” is actively promoted by the supplement industry, and it’s sometimes referred to as the appeal to nature fallacy: Anything that comes from natural sources (especially if it’s organic) is believed to be good, helpful, and non-toxic, and anything that is synthesized is therefore artificial, unnatural, and dangerous. Nature represents a remarkable drug synthesis lab, and there are many commercially-manufactured drugs that are identical to, or based on, natural sources. But being “natural” has no relationship to whether a particular chemical is safe to humans or effective to treat a specific condition. Many natural products are toxic (e.g., botulism, strychnine, tetanus, poison ivy, and arsenic). When we need reliable and predictable treatments, however, drug products are far more consistent and reliable than any dietary supplements. Not only are drug products standardized and tested to contain and deliver a specific dose of medicine, the same products undergo testing in clinical trials to understanding their benefits (and harms). Dietary supplements undergo little if any pre-market testing and there is little evidence to suggest that dietary supplements consistently meet any reasonable quality manufacturing standard.

A new study has looked at red yeast rice supplements, and the effects of FDA-mandated manufacturing standards that were expected to improve the quality and consistency of supplements. What researchers found was that the strength and composition of red yeast rice products continue to be unpredictable, and there is no assurance for consumers they’re actually getting what they think they’re buying.

Supplement or drug: Why bother lowering cholesterol?

“Statins” are a class of drugs (which include lovastatin) that reduce LDL cholesterol. There’s two general uses for statin therapy: primary prevention (avoiding a first heart attack or stroke), and secondary prevention (using a statin in someone that has already had a heart attack or stroke to reduce the risk of another cardiovascular event). There is good evidence that statins reduce the risk of heart attacks and strokes, when used for both primary and secondary prevention. Much of the debate on the usefulness of statins has focused on the absolute benefit when used in lower-risk groups. This is a fair question, and one that I’ve discussed at length previously. But what is not in question is that statins have been proven to reduce the risk of heart attacks, stroke, and death.

There are no symptoms to high cholesterol. Lowering cholesterol won’t make us feel better today. The only reason to take a drug or supplement that targets cholesterol is because we expect it to lower the risk of heart disease: heart attacks, strokes, and death. Statins drugs lower cholesterol and are proven to reduce the risk of heart attacks and strokes. In theory, red yeast rice should have the same effect, if the active ingredient is the same. But if it’s not present, there’s no reason to expect it will do anything useful or beneficial. If we’re taking it for years, we need the assurance that it is consistent, reliable, and will lower the risk of heart disease. But there is real cause for concern according to a new study by Pieter Cohen and associates, in a paper published in the European Journal of Preventive Cardiology entitled “Variability in strength of red yeast rice supplements purchased from mainstream retailers.” This was a straightforward quality assessment of red yeast rice supplements purchased at Whole Foods, GNC, Walgreens and Walmart. Tablets were analyzed for the active ingredient of monacolin K (i.e., lovastatin) using standardized methods. In testing 28 brands, here’s what they found:

  • no brand actually specified how much monacolin K was present per tablet
  • two brands, when tested, had no monacolin K present at all
  • in the remaining 26 brands, the per-tablet quantity varied from 0.09mg to 5.48mg of monacolin K per 1200mg tablet, a 120-fold difference
  • following the labelled directions, the effective drug dose would range from 0.09mg to 10.94mg per day
  • only two of the 28 brands cautioned against concurrent use with statin drugs

As Harriet Hall noted in a past post, the FDA had previously concluded that red yeast rice products that contained more than 4mg of lovastatin were unapproved drugs. This study found that 21% of the brands studied contained >4mg of lovastatin per daily dose. Unfortunately for consumers, there’s no way to tell. The only red yeast rice products that are legally permitted for sale contain little, if any lovastatin, so they are in effect, ineffective for the intended purpose. Products that do contain significant lovastatin doses are in violation of FDA regulations and are not legally allowed for sale. The consumer has nothing to go on at all, as there is no way to tell the actually quantity of lovastatin in any brand of red yeast rice. Ironically, prescription strength lovastatin is far less expensive than red yeast rice. A three-month prescription will cost you about $10, and you’ll be assured you’re actually getting what you pay for.

Safety concerns

Given red yeast rice may contain prescription-level amounts of lovastatin, it should logically contain the same warnings and cautions as prescription lovastain. The side effects from red yeast rice are consistent with prescription statins. However, none of this information is routinely made available to consumers, who may not even realize that they may be consuming prescription-strength lovastatin that’s labelled as a supplement. And because there’s no way to predict if lovastatin levels are actually consistent in supplements, then there’s no way to determine if the supplement is actually doing anything.

Supplement or drug?

Red rice yeast extract is a natural but crude source of the statin drug lovastatin. If you want to lower your cholesterol and be confident that you’re actually reducing your risk of heart attacks and strokes, take a statin drug. If you want to spend more, prefer products with no obvious quality control, and don’t mind paying more for an active ingredient that may or may not actually be in the bottle, then take red yeast rice. Why red rice yeast extract would be preferred over a drug product is unclear, unless one puts a priority on something “natural” over something that’s standardized, predictable, and demonstrated to be effective. If you need lovastatin, take the drug lovastatin, rather than a supplement that may-or-may-not actually contain lovastatin.

Posted by Scott Gavura