Asides

Red Yeast Rice: Let’s Lower Our Cholesterol With Unknown Amounts of a Statin Drug

Red Yeast Rice sits atop the "Heart Healthy" shelves at Whole Foods, surrounded by other useless "natural" supplements like ubiquinol (Coenzyme Q-10) and reservatrol.
Red Yeast Rice sits atop the “Heart Healthy” shelves at Whole Foods, surrounded by other useless “natural” supplements like ubiquinol (Coenzyme Q-10) and reservatrol.

Over the years I’ve had a number of patients tell me that they prefer to take over the counter (OTC) dietary supplements containing “natural” cholesterol lowering ingredients rather than the statin drug I have prescribed.

Red yeast rice (RYR)  is a common ingredient in these supplements and is promoted widely and enthusiastically across the internet and in supplement or natural food stores for the purpose of lowering cholesterol and heart disease risk.

RYR  has been used for centuries in China for coloring, food and medicine. It is made by fermenting red rice with a specific  type of yeast (Monascus purpureus).

Red yeast rice contains chemicals that are similar to prescription statin medications. One of these, called monacolin K, is chemically identical to  the statin drug lovastatin (brand name Mevacor).

The History Of Statin Drug Development

The history of the discovery and isolation of lovastatin, the first FDA approved statin, is worthy of a digression here as I think it illustrates the process of discovery, isolation and characterization of a chemical that becomes a safe and effective treatment.

Akin Endo,whose research over decades was crucial to discovering statins, writes that he was inspired by Alexander Fleming, who discovered penicillin in the blue-green mold belonging to the genus Penicillium in 1928.

He writes; “Although no metabolites that inhibited any enzymes involved in cholesterol synthesis had been isolated previously, I speculated that fungi like molds and mushrooms would produce antibiotics that inhibited HMG-CoA reductase. Inhibition of HMG-CoA reductase would thus be lethal to these microbes.”

Endo began analyzing thousands of molds and fungi for biologically active chemicals that would inhibit HMG-CoA reductase.

In 1971, after studying 3800 different strains of fungi he found a promising candidate: citrinin. Unfortunately,

“Citrinin strongly inhibited HMGCoA reductase and, furthermore, lowered serum cholesterol levels in rats. However, the research was suspended because of its toxicity to the kidneys. ”

End spent another 10 years isolating another promising HMG-CoA reductase inhibitor, “compactin, ” from mold and studying it in rats and other animals. Compactin demonstrated marked cholesterol lowering properties in dogs and monkeys and in the few humans who received it but the pharmaceutical company he worked for shut down the project after it appeared that in doses 200 x what were considered appropriate, it increased lymphoma risk in dogs.

The large pharmaceutical company, Merck, got wind of Endo’s studies with compactin, studied his data and realized the potential of similar but safer HMG-CoA reductase inhibitors.  Drugs which inhibited HMG-coA reductase were now being termed statins.

Merck set out to find its own statins and in February 1979 isolated a statin very similar to compactin in chemical structure, called mevinolin, from the fungus Aspergillus terreus.

Endo, working separately and also in February 1979, isolated another statin (named monacolin K) from cultures of Monascus ruber.(RYR).In  the fall of the same year, it was confirmed that monacolin K and mevinolin were the same compound (later both changed to lovastatin).

The drug showed dramatic activity in lowering LDL cholesterol, with very few side effects. This led Merck to begin large-scale clinical trials of lovastatin in patients at high risk and long-term toxicity studies in dogs in 1984. The drug dramatically reduced cholesterol levels and was well tolerated. No tumors were detected. In 1987, Merck gained FDA approval  and lovastatin became the first commercial statin.

Since then, six other statin drugs, some of which are synthesized in the laboratory rather than isolated from mold, have been approved for human therapy. These drugs have prevented thousands of heart attacks and contributed to the dramatic drop in cardiovascular deaths seen in developed countries over the last 30 years.

Ryr And Cholesterol Lowering

This brings us back to RYR and its ability to lower cholesterol. Small studies using a version of RYR that contained lovastatin have demonstrated a reduction in cholesterol compared to placebo.

However, because many red yeast rice supplements contained lovastatin (also called monacolin)In May 1998, the FDA ruled that Cholestin (the RYR product used in the studies showing cholesterol lowering benefit) was not a dietary supplement but an unapproved drug.

As a result,  Pharmanex removed RYR from Cholestin. Since that ruling, the FDA has written warning letters to several other dietary supplement manufacturers to remove drug claims or eliminate red yeast rice with high lovastatin levels from their products, including Heart and Cholesterol (Mason Vitamins, Miami Lakes, Florida)  Cholestrix (Sunburst Biorganics, Baldwin, New York), Red Yeast Rice and Red Yeast Rice/Policosanol Complex , and Red Yeast Rice (Nature’s Way Products Inc, )

A study in 2010, found levels of monacolins varying one-hundred fold in 12 RYR preparations available commercially (total monacolins (0.31-11.15 mg/capsule), monacolin K (lovastatin) (0.10-10.09 mg/capsule), and monacolin KA (0.00-2.30 mg/capsule).

Even more worrisome was that four products had elevated levels of citrinin. You remember citrinin, don’t you? That is the chemical that Endo initially identified as a candidate for cholesterol lowering drug but rejected because it was causing kidney failure in his rats.

Because of limited government oversight and variable manufacturing processes, one can also expect that the same manufacturer will have marked variation of monacolin content and citrinin from batch to batch or bottle to bottle.

Problems With Alternative Medicine In General

These problems with RYR supplements are typical of all supplements.As the the authors wrote

“Our results highlight an important issue with red yeast rice and many other alternative medicines: the lack of standardization of active constituents. Standardization of ingredients is difficult for several reasons: (1) There are variable growth and/or culture conditions and differences in harvesting and processing among manufacturers; (2) medicinal agents from natural sources are complex substances with many chemical constituents, many of which have unclear roles in their pharmacologic activity; and (3) different manufacturers may standardize products to amounts of 1 or 2 chemicals thought to be active ingredients, while other constituents are not standardized and may also have biologic and pharmacologic activity.”

One has to ask, given this background, why would a patient choose to take a “natural” OTC supplement containing an unknown amount of both a). Effective cholesterol lowering chemicals and b)potentially toxic extraneous chemicals over the precisely formulated, carefully regulated, fully studied, pure statin drug available by prescription.

It’s especially baffling to me when one considers that lovastatin comes from RYR. Thus it would have to be considered “natural.”

Akira Endo spent decades carefully identifying the effective and safe chemical portion of RYR. It is now available as a generic costing pennies per pill.

We know exactly how many milligrams you are consuming. We know what benefits to expect and what side effects can occur based on studies in hundreds of thousands of patients who have taken a similar dosage.

You are much better off taking the prescribed statin drug than RYR.

skeptically yours,

ACP

A

Yogurt and Your Heart: Part I. The No Fat Frozen Yogurt Scam

tpyogurtYogurt: Heart healthy in its natural state

The Skeptical Cardiologist is a big fan of yogurt. I prefer yogurt in its unadulterated state, 3.5 to 5% milk fat, no sugars added at the factory. Preferably sourced from a local dairy where the cows range freely and eat grass. In this form, yogurt is a very healthy, nutrition-dense, vitamin- enriched food that supplies calcium, essential vitamins, protein and fats.

Yogurt, like all full fat dairy products (with the possible exception of butter) does not increase the risk of heart disease. In fact, some epidemiologic studies show that yogurt consumption is associated with lower risk of heart attacks. It is also associated with less weight gain over time .Because these observational studies can never prove causation we cannot conclude that eating yogurt will reduce our risk of cardiovascular disease or help us lose weight, but certainly there is nothing to suggest that it contributes to heart disease or obesity.

Small prospective, randomized studies (the best kind) show that yogurt consumption may lower blood pressure and raises the good or HDL cholesterol. Again, these studies donʼt prove eating yogurt is healthier but they should make everyone comfortable eating the full fat yogurt.

The Frozen Yogurt Scam: Substitute Sugar and Chemicals for Dairy Fat

Yogurt has a reputation as being a “healthy snack.” Sales of yogurt are increasing rapidly with Greek and frozen yogurt, in particular, showing spectacular growth.

Unfortunately, a great hoax has been perpetrated on the American public. Following advice generated from organizations like the American Heart Association and the USDA government nutritional guidelines, with the idea that they are making healthier choices, Americans are choosing yogurt that is nonfat or low-fat.

When the fat is taken out of yogurt, almost invariably sugar in one form or another is added in by the food industry to enhance flavor and make it palatable.

Shape magazine (Iʼm choosing this magazine as representative of the kind of health information available online and in print on this topic) ran an article with the following headline:

The Healthiest Froyo Orders at Pinkberry, Baskin Robbins, and More Get your frozen yogurt fix without downing an entire mealʼs worth of calories

The teaser line read as follows:

Frozen yogurt may offer a healthier alternative to ice cream, but it can be easy to fall into a calorie trap when you load up on rich flavors and toppings. Check out our cheat sheet to see which froyo combos to order at popular chains. Each one is low in fat and calories—so you can enjoy a guilt-free summer treat!

The number one recommendation was for a sugar and carbohydrate bonanza with the title: “Pinkberry’s Strawberry Classic,” which contains the following nutritional ingredients:

pinkberryNonfat milk, sugar, strawberry flavor (strawberries, sugar, water, natural flavors, fruit and vegetable juice [for color], guar gum, sodium citrate), nonfat yogurt (pasteurized nonfat milk, live and active cultures), nonfat yogurt powder (nonfat milk, culture), fructose, dextrose, natural flavors, citric acid, guar gum, maltodex- trin, mono- and diglycerides, rice starch

Sugar is listed twice and overall there are 23 ingredients that have been added to make this pale imitation of real yogurt palatable. Ironically, Pinkberry claims to have “real” yogurt but the only thing I could tell from their website is the following:

Pinkberry is made with REAL nonfat milk, not from cows treated with rBST hormones, and REAL nonfat yogurt, among many other natural ingredients.

The Shape magazine article recommends you add real strawberries plus a “balsamic glaze” and estimates the total calories as 165 with 144 of which are provided by sugar (36g).

Pinkberry lists the nutritional content for a small cup (5 oz) of pink berry strawberry classic as 110 calories, 22 grams of sugar and 4 grams of protein.

The Skeptical Cardiologist does not recommend this as a “healthy snack” because of the massive amount of sugar, unrefined carbohydrates, and added chemicals. Michael Pollan’s Food Rules are violated multiple times with this ultraprocessed concoction including “Avoid foods with more than 5 ingredients” and” avoid foods which have some form of sugar (or sweetener) listed among the top 3 ingredients”.

Eat Real Food Not Ultraprocessed Industrial Concoctions

photoIn contrast to the typical nonfat frozen yogurt  sugar nightmare, a 5 oz serving of whole milk yogurt from Traders Point Creamery has 90 calories total, 5 grams of fat, 7 total grams of carbohydrate and 5 grams of protein.

There are four ingredients listed on the glass bottle for Traders Point Creamery whole milk yogurt: organic whole milk, organic skim milk, live cultures, and probiotic cultures. The cows are also pastured raised and grass-fed.

This is a yogurt I can recommend.

The food industry routinely presents us with ultra-processed, “food-like” substances that are promoted as more healthy but contain added sugar and refined carbohydrates to enhance taste and promote excess consumption. When we consume sugar added by food processing, we are consuming calories without any nutritional value.

There is no science that tells us that substituting sugar for dairy fat is better for you or for your heart. Several lines of evidence suggest excess consumption of sugar and refined carbohydrates contribute to obesity, inflammation and may increase cardiovascular and chronic disease risk. The high glycemic index and resulting spike in blood sugar may trigger hormonal responses that increase inflammation and fat storage.

America’s obesity epidemic seems to have developed as Americans, following dietary guidelines not based in science, began seeking out low-fat substitutes for real foods. Thus, we have witnessed the explosion of fat-free or low-fat frozen yogurt as food marketers and the obliging “health” media trumpeted the health benefits of these products with no evidence to support the claims.

Being the skeptical cardiologist I have to point out that there has been a shameless, unsubstantiated over-hype of the benefits of yogurt in all sorts of areas including immunity, “digestive health,” bladder cancer, and eczema. I’ll review the health benefits (if any) of the “probiotic” or “prebiotic” features of yogurt and the growth of Greek yogurt in future posts.

Full Disclosure: I have no connections with and receive no support from any food industry sponsored organization. I’m not selling anything. I’m just an unbiased cardiologist seeking the truth so I can make evidence-based recommendations on diet to my patients.  I do eat Traders Point Creamery yogurt and drink their milk but have no other connection to the whole organic yogurt I featured in the pictures.  I have, however, visited their farm and can attest to the fact that the cows are grazing in a pasture and are well treated.