I am a long-time user of Red Yeast Rice which I use to control my cholesterol.
10.01.2009 23:02
I am a long-time user of Red Yeast Rice which I use to control
my cholesterol. I’ve never used statin drugs. Recently I learned
from a Wikipedia article1
that Red Yeast Rice is under attack by the U.S. Food and Drug
Administration because of its cholesterol-lowering properties.
The article implied that RYR may be removed from the market at
any time. How does RYR compare with statin drugs in effectiveness,
safety, and cost? Should I be worried about my supply of RYR
being cut off?
A quick answer is that Red Yeast Rice (RYR, aka ‘Red Rice
Yeast’) contains more than half a dozen substances that act like
statin drugs. These, together with several other
yeast-generated substances, regulate cholesterol levels more effectively
and safely than do the single-substance statin drugs sold by
pharmaceutical companies. The cost of using statin drugs varies
tremendously, depending on dosage and brand, but they are
always more expensive than RYR — sometimes incredibly so.
And yes, you should be worried that the U.S.
Food and Drug Administration will cut off your supply of RYR. (More
about that
below.)
Overview
The red-colored yeast Monascus purpureus
is a traditional Chinese food coloring and herbal remedy. The yeast is
grown on wet white rice, which becomes permeated with
the colored yeast. The resulting red rice is dried and
pulverized and the powder sold as a traditional remedy for promoting
blood circulation, soothing upset stomach, and for other
medical purposes.1,2
In Asia the red rice is also sold for dietary consumption as whole red
grains or as a wet paste.1
Red yeast rice has been used medicinally in
China for at least several hundred years3
and has been a food ingredient for about 2000 years. RYR is “a dietary
staple in many Asian countries, including China and
Japan, with typical consumption ranging from 14 to 55
g/person/d (0.5 to 2 oz).”4
This substance could plausibly account for the low level of
cardiovascular disease found in Asian populations.5
Modern RYR supplements are usually extracts
of Red Yeast Rice — unneeded starches and gums have been removed by
alcohol extraction to make the powdered product more
potent, less perishable, and easily dosed. The Chinese name
for such extracted RYR products is Xue Zhi Kang (aka ‘Xuezhikang’).6
RYR inhibits the body’s production of C-Reactive Protein8
The dried yeast contains a family of
compounds (‘monacolins’) that inhibit HMG-CoA reductase (an
enzyme responsible for making cholesterol in the body9).
These inhibitors are similar in chemical structure to the expensive
‘statin’ drugs that are sold as prescription remedies
for high cholesterol. In addition, the red yeast contains a
variety of other medically active compounds, including flavonoids
and sterols, that may contribute to the yeast’s
cholesterol-regulating activity.9,10
The monacolins in RYR also suppress the
body’s production of C-Reactive Protein (‘CRP’). CRP is a protein
involved in inflammation,
and inflammation is considered to be the primary process that
causes plaques to develop in arteries. By suppressing CRP, red
yeast rice appears to be helping to suppress the inflammation
responsible for atherosclerosis.5,9
The efficacy of RYR
Ten or more clinical studies of RYR have been
performed; all have shown that RYR supplementation brings about
significant
reductions in LDL cholesterol and triglycerides — reductions
of at least 30% are achievable in patients with high lipid levels.11
HDL (‘good cholesterol’) increased slightly in at least one study.12
In a 2003 animal study an extract of RYR actually reduced the size of
atherosclerotic plaques in arteries.13
No clinical studies have been performed to
directly compare RYR and statin drugs with regard to their maximum10
potential for improving cholesterol profiles. The results found in
separate studies, however, have given rise to the belief
that RYR is at least as effective as statin drugs, while
causing far fewer side effects. Why should this be? The dose of
lovastatin
provided by RYR supplements is far less than the dose used in
prescription lovastatin drugs — consequently RYR users typically
experience no lovastatin side effects. As for efficacy: the
small size of the lovastatin dose provided by RYR is more than
made up for by the presence of small amounts of various other
substances which dramatically enhance this supplement’s effectiveness.
Miscellaneous facts about RYR
• In a recent experiment with rabbits, a
profound suppression of atherosclerosis development was achieved by a
supplement
combination consisting of RYR, policosanol, and the carotenoid
‘astaxanthin’ (the red substance in salmon and shellfish).14
• Vitamin E has many of the same effects on
cardiovascular disease as RYR, as has been shown in a number of clinical
trials.9
But vitamin E acts through a different mechanism than RYR. It therefore
makes sense to use these two supplements together
to take advantage of synergistic effects.
Cost comparison
The expensive way to lower the body’s LDL
cholesterol levels is to use brand-name ‘statin’ drugs. There are six
prescription
statins currently on the market in the U.S. Although prices
vary dramatically depending on who is selling them, the following
prices represent the low end of the price range for
non-generic statins:
Lipitor® (atorvastatin) $78/month
Lescol® (fluvastatin) $64/month
Mevacor® (lovastatin) $60/month
Pravachol® (pravastatin) $95/month
Zocor® (simvastatin) $83/month
Crestor® (rosuvastatin) $91/month
Several of these are now available as generic drugs, at
prices around $20/month.
Red Yeast Rice extracts cost even less than
generic statin drugs. For example, LifeLink’s Red Rice Yeast Extract
costs about
$17/month.
These cost comparisons do not take into
account the cost of dealing with side effects. It should be kept in mind
that the
statin drugs, whether brand-name or generic, contain fairly
high dosages of single substances and therefore have more serious
side effects than RYR which contains low doses of many active
substances.
The FDA does intend to cut you off
The U.S. Food and Drug Administration is
indeed committed to eliminating the public’s access to Red Yeast Rice,
particularly
the RYR extracts since these are effective alternatives
to the statin drugs. The FDA has a track record of trying to eliminate
products that
compete for sales with products of the medical and
pharmaceutical industries.
Accordingly, in 1998 the FDA made a major
move against RYR: it announced that an RYR extract called ‘Cholestin’
(sold by Pharmanex,
Inc.) was an unapproved drug rather than a supplement, and
ordered Pharmanex to stop selling it. Pharmanex took the FDA to
court and won15
— but only temporarily. A later court decision sided with the FDA, and
so Cholestin was removed from the U.S. market. (Pharmanex
later reformulated Cholestin using no RYR. But with the key
ingredient gone, the product’s credibility has been impacted.
It’s a pity that FDA officials cannot be personally sued for
damages.)
In the years following the Cholestin action
the FDA has been conducting a low-level harrassment campaign against the
supplement
industry to discourage the sale of RYR products. The agency
occasionally sends out threatening letters to selected supplement
marketers and forces them to destroy their inventories,16,17
but it hasn’t made any concerted effort to shut down RYR sales. Why is
the FDA using a low-level approach here instead of
the SWAT-team approach that it
has used in other situations? My speculation is that the agency is
reluctant to anger too many
RYR users at the same time since that could lead to media
attention, with users telling reporters that the FDA is killing
people by denying them access to effective, affordable
treatments for dangerous cholesterol problems.
Meanwhile, the pharmaceutical company Merck
& Co. has made more than one attempt to get FDA approval for an
over-the-counter, low-dose lovastatin product (‘Mevacor®’), and
has been turned down. Why? Two reasons: first, the agency
considers the American people incompetent to make self-treatment
decisions. As one FDA consultant put it, “Diet and exercise …
may be thought to be less important if the primary strategy
seems to be a statin drug.”18
Second, the agency does not want to set a precedent for allowing people
to obtain highly effective drugs without having to
hire a physician to prescribe them. “The panel felt that
over-the-counter approval of Mevacor would lead to scores of other
products to reduce bad cholesterol, tame high blood pressure,
and keep diabetes in check.”19
Heaven forbid that we should have such choices!
Cautions
RYR, like the statin drugs, suppresses the
body’s levels of CoQ10 (coenzyme Q10, a substance required for
metabolism).20,21
Users of RYR should therefore also use a CoQ10 supplement.
Pregnant women should avoid using RYR or any
statin drug.22,23
Sudden termination of RYR usage can have a
significant rebound effect on C-Reactive Protein, LDL and HDL. (The same
is true
for statin drugs.) RYR users who want to stop using RYR —
especially those with severe cardiovascular disease — should therefore
reduce the dosage of RYR gradually over a period of about a
week.8
Contraindications for lovastatin: pregnancy,
nursing, liver or kidney impairment, co-administration with niacin,
gemfibrozil,
cyclosporin, azole antifungals, erythromycin, clarithromycin,
nefazodone, protease inhibitors.9,22
Recommended reviews about RYR
For a good overview of the subject of Red
Yeast Rice I recommend the following review articles: Patrick,924,
Raloff25,
Wikipedia1,
Lee26
Heber
Disclaimer: The information provided in
this “Ask Dr. Zarkov” article contains no medical advice whatsoever — it
contains
biological information. Nothing in the article
constitutes an effort to persuade readers to use, or not to use, this
biological information as a
basis for action.
