quote:


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.

quote:


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

quote:


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.

quote:


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.

quote:


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

quote:


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.

quote:


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.

quote:


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.

quote:


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.

quote:


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.

quote:


A study at UCLA School of Medicine confirmed red yeast rice's natural cholesterol-busting abilities. In a rigorous double-blind, randomized trial, this supplement significantly reduced total cholesterol compared with a placebo. Among 83 people who took red yeast rice for 12 weeks, total cholesterol dropped by an average of 16% (from approximately 250 to 210)... cholesterol remained at about 250 in the 41 people who were given a placebo. There also was a positive impact on LDL cholesterol and triglyceride levels.

These results were published in The American Journal of Clinical Nutrition in 1999.

quote:


The move comes after the USC published the results of a survey it conducted amongst FDA scientific staff which indicates that nearly one fifth of respondents 'have been asked, for non-scientific reasons, to inappropriately exclude or alter technical information or their conclusions in a FDA scientific document'.

The survey also showed that 61 per cent of respondents knew of cases where 'department of health and human services or FDA political appointees have inappropriately injected themselves into FDA determinations or actions.'
...
Firstly there is the fact that the FDA is influenced by significant legislation fees from companies that last year added $380m to the coffers, with the largest contributors making up some of the biggest and most influential consumer companies in North America.

Secondly, and perhaps most influential of all, there is the fact that the FDA is free-standing and not accountable to congress, a fact that leaves the agency more open to outside influences.

quote:


But criticism of the agency has not fallen upon deaf ears.

In response to the publication of the UCS report and an ensuing public outcry, the FDA says it is introducing measures that will increase transparency within its advisory committee, which in turn should dispel any assertions that the process is open to non-scientific influences.

quote:


...more than a third of the FDA's scientists lack confidence in the safety and effectiveness of the drugs they approve for sale ... Two-thirds of the Food and Drug Administration's scientists perceive significant shortcomings in their agency's monitoring of prescription medications once they hit the market.

...a 2001 government survey ... revealed that 66%, roughly two out of three, of the FDA's front-line research scientists were either "not at all confident" or only "somewhat confident" in the agency's practices with regard to monitoring a drug's safety once past the approval process. And remember, this survey is SEVERAL YEARS OLD...
...
It's a shame that so many have to die or be stricken with heart attacks or strokes before even this kind of lame-duck measure is taken, but an even bigger shame is the message this sends to the drug companies...

Unless the drug you're making kills or maims 100,000 people or more, you can keep selling it, and nobody's the wiser.

quote:


The Food and Drug Administration voted overwhelmingly to keep the diabetes drug Avandia on the market, despite its known deadly effects. Two FDA committees met yesterday in Gaithersburg, Maryland, to consider whether the drug -- which has led to the deaths of 80,000 people -- should be pulled from the marketplace.

The FDA does not deny that the drug is dangerous.
...
The dangers of Avandia are well documented and are not news to the FDA. In May, the New England Journal of Medicine published a study that found Avandia increases the risk of heart attacks. But FDA officials already knew that; indeed the drug's maker, GlaxoSmithKline LLC, based in London, told the agency of the risk two years ago. However, the FDA failed to pass along the warning to the one million Americans who already take the drug.
...
Dr. David Graham, a drug safety officer with the FDA's Office of Surveillance and Epidemiology, estimates that Avandia has caused as many as 205,000 heart attacks and strokes, some of them fatal, between 1999 and 2006. Graham's analysis indicates that since Avandia was approved, some 80,000 patients have died from the drug's side effects. For every month that Avandia is sold, he said, 1,600 to 2,200 patients will suffer more of these events.

quote:


Following the death of as many as 60,000 Americans from COX-2 inhibitors (source: British Medical Journal, author Dr. David Graham, FDA drug safety researcher), an FDA advisory panel has now voted to allow the drugs to return to the market with full FDA safety approval. The fact that a single COX-2 drug has reportedly killed more Americans than the entire Vietnam War is apparently not sufficient for the FDA to characterize it as unsafe.

quote:


In 2006, the Union of Concerned Scientists (UCS) and Public Employees for Environmental Responsibility (PEER) distributed a 38-question survey to 5,918 FDA scientists to examine the state of science at the FDA. The results paint a picture of a troubled agency: hundreds of scientists reported significant interference with the FDA's scientific work, compromising the agency's ability to fulfill its mission of protecting public health and safety.
...
In September 2006, the National Academies Institute of Medicine released a report critical of the FDA and its ability to protect the public from unsafe drugs. In a section discussing the poor handling of scientific disagreement, the report mentioned the UCS survey result indicating that hundreds of agency scientists had been pressured to approve a drug despite reservations about safety.

quote:


"Scientific discourse is strongly discouraged when it may jeopardize an approval. . . . Whenever safety or efficacy concerns are raised on scientific grounds . . . these concerns are not taken seriously."

"First class scientists are leaving the FDA, and recruiting new ones will be very difficult."

—selected FDA survey essay repsonses

quote:


In a truly astonishing survey just released by the Union of Concerned Scientists, the Food and Drug Administration's own scientists describe the agency as an environment of intimidation, censorship and scientific fraud. A survey of 997 FDA scientists revealed that forty percent feared "retaliation" for voicing safety concerns over prescription drugs in public. Over one-third of the scientists didn't even feel safe expressing safety concerns inside the agency, behind closed doors!

quote:


The Canadian Heart and Stroke Foundation is taking courageous steps in trying to ban junk foods -- the kind of steps you'd never see U.S. government departments take since they've been corrupted by the influence of food manufacturers and junk food companies.

quote:


The dietary supplement industry collectively spends approximately $1.8 million per year on lobbying. For perspective, the top three industries that spend the most on lobbying are insurance companies ($120 million), electric utilities ($92 million) and drug manufacturers ($91 million). Of course, these industries are many times larger than the dietary supplement industry, which is currently at around $22 billion, so we would expect those industries to spend more.

quote:

ORIGINAL: Bettawrekonize
Apparently, Some Red Yeast Rice Still Contains Lovastatin

quote:


At 9:10 a.m. on Wednesday, September 17th, 2003 the Federal Drug Administration (FDA) suspended most activities at our fulfillment center in Louisiana. They have deemed the above products questionable in the United States of America. They believe that our products are not safe for human consumption. The FDA is currently testing the products they have taken from our facility. They have accused us of making health claims for our products, such as claiming they could cure, prevent or treat a disease even though we have a disclaimer on almost every page and each product label stating: “To U.S. Users Only: The statements made on this page have not been evaluated by the U.S. Food & Drug Administration. The viewing of this page in your country is for historic and educational purposes only. This product is not intended to diagnose, treat, cure, or prevent any disease.”

quote:


"Many of the Web sites targeted today are jeopardizing the health and safety of consumers with outlandish promises and false hope," said FTC Chairman Timothy J. Muris. "Unfortunately, examples of questionable products being peddled on the Web abound, and the Federal Trade Commission, with its partners, will step up its efforts to protect consumers from these compelling, but deceptive health claims."

quote:


This blatant abuse of authority, of course, requires no evidence of injury and/or bodies, while the thousands of deaths from approved drugs and other medical procedures strangely keep going on and on. This inconsistently is hardly a concern for this agency - just look at the sloppy inconsistencies in the raid below - clearly this has more to do with the protecting their pharma cronies than us!

quote:


The health freedom community is up in arms over a possible new interpretation of FDA regulations that would bar any nutritional supplement from being sold over state lines if it contains ingredients that have ever been approved for scientific studies.
..
The American Association for Health Freedom (www.HealthFreedom.net) issued a warning on November 25, which stated that the FDA's regulatory changes "...may mean that all food products, including dietary supplements, could be barred from being marketed if they have been the subject of published clinical studies."

quote:


His response says that the interpretation of FDA rules is misguided and alarmist, and no new rules have been put into place at all. Thus, it risks the credibility of the health freedom movement to cry wolf over a non-issue.

quote:

ORIGINAL: ManimalX
Dude,

I have never heard of Red Yeast Rice, but you deserve a medal or something. Being the only continuous poster to your own three month old thread is what I call dedication!