Friday, September 5, 2008

Red Yeast Rice and the FDA

I read about Red Yeast rice a long time ago and even posted a (now expired) webpage about it here
( ). However, I decided to look it up on google and came across some interesting websites and updates. I want to post some comments on this thread.

First, because red yeast rice was found to contain lovastatin, the FDA made an administrative decision that this dietary supplement (often sold as Cholestin in earlier times) was a regulable drug, and thus removed it from the unregulated shelves of the health food store.

Basically, the FDA decided to ban this drug because it contained a regulated substance. At the time that this happened, there were no studies indicating that it was harmful, no cases of anyone dying from it, and there were studies indicating that it was an effective drug at reducing cholesterol.

Studies using the "original" form of red yeast rice accordingly confirmed significant reductions in cholesterol levels.

Results from a large randomized trial conducted in China, published in the American Journal of Cardiology, show that, in patients with prior myocardial infarctions (heart attacks) who were given an extract made from red yeast rice, the risk of having another heart attack and the risk of dying were reduced by nearly 50%.

In the Chinese Coronary Secondary Prevention Study, nearly 5,000 heart attack survivors received either Xuezhikang (XZK, a red yeast rice extract) or placebo in a double-blinded randomized clinical trial -- neither the patient nor the doctors knew which substance individual patients received. After an average of 4.5 years, patients receiving XZK had a 45% relative reduction in heart attacks and in death.

From my understanding, the Chinese have used Red Yeast rice in their food for at least hundreds of years ( ).

Approximately one year before Baycol was removed from the market in August 2001, its manufacturer Bayer, using FDA data on other statins found that Baycol had 20 times more reports of rhabdomyolysis (an often-fatal destruction of muscle) per million prescriptions than Lipitor, Wolfe stated.
By the time Baycol was banned, there were 1,899 cases of rhabdomyolysis, a significant number having occurred between the time there was unequivocal evidence that FDA should have banned the drug and when it was actually banned a year later.

If memory serves me correctly, some people died from this drug (

Then, in 1999, the FDA ruling on red rice yeast was overturned by the court of the District of Utah

The court basically ruled that, because the substance in Red Yeast Rice occurs naturally in red yeast rice, the FDA can't regulate red yeast rice just because it contains that substance.

But finally, in 2000, the 10th U.S. Circuit Court of Appeals ruled that red yeast rice IS subject to FDA regulation. Since then, the FDA has aggressively gone after companies selling red rice yeast containing lovastatin. While red rice yeast is still available on the grocer's shelf, the stuff that is out there now is apparently fermented using a different process, and apparently (I say "apparently" because it is in fact extraordinarily difficult to find out what dietary supplements do and do not contain) does NOT contain lovastatin.

The FDA seems to be fine with not outlawing drugs that seem to be far more dangerous than Red Yeast Rice.

In an article by Sally Fallon and Mary G. Enig, PhD we are told, “The most common side effect (of statin drugs) is muscle pain and weakness, a condition called rhabdomyolysis, most likely due to the depletion of Co-Q10, a nutrient that supports muscle function.” Rhabdomyalysis is a common, many times lethal, tearing down of the muscle tissue which is then distributed into the bloodstream. The article goes on to say, “Dr. Beatrice Golomb of San Diego, California is currently conducting a series of studies on statin side effects. The industry insists that only 2-3 percent of patients get muscle aches and cramps but in one study, Golomb found that 98 percent of patients taking Lipitor and one-third of the patients taking Mevachor (a lower-dose statin) suffered from muscle problems.

Who's side is the FDA on. It seems like they are siding with the pharmaceutical companies on this one. I googled red yeast rice and the FDA and this came up,

FDA Warns Consumers to Avoid Red Yeast Rice Products Promoted on Internet as Treatments for High Cholesterol
Products found to contain unauthorized drug
"This risk is even more serious because consumers may not know the side effects associated with lovastatin and the fact that it can adversely interact with other medications," said Steven Galson, M.D., M.P.H., director of FDA's Center for Drug Evaluation and Research.

Basically, the FDA is warning people to avoid Red Yeast rice because it can be harmful despite the fact that there are few, if any, studies indicating this. One possibility is that they will try to control the usage of Red Yeast rice even more and they may even try to eliminate the distribution of any information supporting its usage (ie: studies). Sometime in the future, you might find that Google will stop presenting any studies supporting the usage of Red Yeast Rice (and may present a bunch of FDA or other websites discouraging its usage instead. A good example is in the case of science and origins. If you try to google something like, "criticisms of evolution" Google tends to favor websites that support evolution and the ones criticizing it don't seem to be nearly the strongest critical material out there. If I google "criticisms of evolution" I should receive many websites criticizing, or attempting to criticize, evolution near the top. I have to specifically google something like 'Answers in genesis' to get their website) and the FDA, and/or other organizations, may even fabricate studies indicating that Red Yeast rice is more harmful than it really is (and is less helpful than it really is). What does everyone think?

Look at radio stations and television. It used to be much less controlled by single entities with a single agenda/ point of view and it used to be much more controlled by many many entities with various points of views criticizing each other on all sorts of subjects. Then, the FCC greatly reduced the amount of regulation which made more stringent control reducing the freedom of speech taking place over the airwaves much easier to attain ( ). In the 1970,'s no one would have thought that single entities would have so much control over our freedom of speech over the airwaves. Yet, now we see that they are increasingly having more and more control over our freedom of speech over the airwaves and censoring anything that they disagree with (for example, you will probably never hear about this red yeast rice issue over the airwaves, and there is an array of other issues that you should be aware of that hardly ever make it on public television). Could it be that, sometime in the future, they may have similar controls over our freedom of speech over the internet? What does everyone think? I strongly encourage other entities to make their own search engines to help counter this problem and hopefully they will fight any lawsuits against them for displaying websites that question what is commonly promoted by the secular community (ie: sites encouraging the legalization (and usage) of Red Yeast rice for those who could benefit from it (and sites displaying studies showing the benefits of Red Yeast Rice and cites questioning the legitimacy of the FDA)). We also need to make sure that our society is set up such that those that fight for our freedom of speech (ie: fight lawsuits that may challenge it. This is especially true in the case of science and origins where public schools censor anything that may question naturalism and naturalistic philosophies like evolution) will win (we need to make sure those making the decisions (ie: judges) will vote in a way that encourages academic freedom, open inquiry, and freedom of speech).

In 2006 Liu et al published a meta-analysis of clinical trials (Chinese Med 2006;1:4-17). The article cited 93 published, controlled clinical trials (91 published in Chinese). Total cholesterol decreased by 35 mg/dl, LDL-cholesterol by 28 mg/dl, triglycerides by 35 mg/dl, and HDL-cholesterol increased by 6 mg/dl. Zhao et al reported on a four-year trial in people with diabetes (J Cardio Pharmacol 2007;49:81-84). There was a 40-50% reduction in cardio events and cardio deaths in the treated group. Ye et al reported on a four-year trial in elderly Chinese patients with heart disease (J Am Geriatr Soc 2007;55:1015-22). Deaths were down 32%. There is at least one report in the literature of a statin-like myopathy caused by red yeast rice (Mueller PS. Ann Intern Med 2006;145:474-5). An article in the June 15, 2008, issue of the American Journal of Cardiology found that red yeast rice may provide benefits beyond those provided by statins. The researchers reported that the benefits seemed to exceed those reported with lovastatin alone.[1]

The prescription drugs called statins that are being taken by so many people are life-threatening. Bayer's drug Baycol had to be removed from the market in August, 2001 because it caused over 100 deaths. Yet, the FDA wants to force you to take these drugs rather than the much safer RYR.
I have been taking CholesteSure by Natrol* with my physician's knowledge and he is very happy with the results of the lowering of my cholesterol. I tried one of the drug companies' cholesterol lowering drugs last November, 2000 and almost died. I had an allergic reaction and my doctor told me to stop taking it. I did. He said we would just monitor my cholesterol and for me not take any prescription medications. I decided to do a little research on the web and found many studies done on Red Yeast Rice. I talked to my doctor in January, 2001 and he agreed that I should try it. I did and after 3 months my total cholesterol dropped down from 286 to 225. I have had no side effects. Also my blood pressure is lower. * Editor's note: Due to FDA pressure, Natrol no longer carries Red Yeast Rice products.

The statin drugs do lower cholesterol, but the reason drug companies spend so much money to market synthetic or modified substances is that they cannot patent natural substances. When it was discovered that the statin-like molecule in red-yeast-rice occurred naturally, FDA should have withdrawn the patent on Mevacor.

However, the rule of FDA on red yeast rice that it should be withdrawn, is not correct since cholestin found in red yeast rice is a natural substance and falls under the protection of the Dietary Supplement Health and Education Act.

Of course, the FDA can remove any substance that poses a health risk from the market , natural or otherwise, but their actions on this product clearly shows their bias against dietary supplements and their favorable treatment of drugs.

The study, a 12-week, double-blind, placebo-controlled study conducted at UCLA, involved 83 volunteers taking a proprietary red yeast rice supplement. Main outcome measures were total cholesterol, total triacylglycerol, and HDL and LDL cholesterol measured at weeks 8, 9, 11 and 12. Total cholesterol concentrations decreased significantly in the red yeast rice-treated group compared with the placebo-treated group. LDL cholesterol and total triacylglycerol were also reduced with the supplement.8

"LDL (bad cholesterol) levels dropped 15 percent among patients taking the red yeast supplement over an eight-week period," said Dr. Heber. "A 15 percent reduction is highly significant. Individuals following a very strict diet—without taking a cholesterol lowering supplement—can only expect to lower their cholesterol by 10 percent at most."

A second study, directed by Dr. James Rippe of Tufts University School of Medicine in Boston, found similar results. Doctors in 12 medical practices across the country put 233 people on red yeast rice for eight weeks. Their cholesterol levels fell from an average of 242 to 206.

7. Heber D. Natural Remedies for a Healthy Heart. Garden City Park, NY: Avery; 1998.)

8. Cholesterol-lowering effects of a proprietary Chinese red-yeast-rice dietary supplement. Heber D, Yip I, Ashley JM, Elashoff DA, Elashoff RM, Go VL, Am J Clin Nutr 1999 Feb 69:2 231-6

It has been used in Chinese medicine since at least 800 A.D. for various purposes and to remove "blood blockages."

Some American pharmaceutical company gets ahold of this stuff and extracts the specific chemical that lowers cholesterol, goes through the FDA, it's good stuff, few side-effects and the patent goes through.

Now, since red rice yeast is sold as a supplement (and has a controlled drug in it,) the FDA calls it illegal and bans it's sale. Allegedly, the only supplements of it that you can get do not contain the statin any longer. It is banned in it's original form.


This is truly wrong and disturbing. This is the equivalent of a pharmaceutical company patenting the "drug" that cures scurvy (vitamin C) and getting the FDA to ban the sale of all citrus fruit and other foods that contain vitamin C.

Also see