FDA Strikes Again!

[Guest guest]

http://www.newstarget.com/022046.html

 

NewsTarget.com printable article

Originally published September 20 2007

FDA Moves To Shut Down Red Yeast Rice Distributors Online

by Bradley R. Chappell

 

(NewsTarget Citizen Journalism Report) On August 9th the FDA issued a

warning to the public against buying or consuming three red yeast

rice products sold on the internet. The FDA stated as their primary

reasons for this action; “The products may contain an unauthorized

drug that could be harmful to health. The products are promoted as

dietary supplements for treating high cholesterol.â€

 

The FDA goes on to list the “potentially harmful products†and the

companies involved; Swanson Healthcare, Nature’s Value, Kabco and

Sunburst Biorganics. The letter states, “FDA testing revealed the

products contain lovastatin, the active pharmaceutical ingredient in

Mevacor, a prescription drug approved for marketing in the United

States as a treatment for high cholesterol.†It goes on to

say,†“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.

These red yeast rice products are a threat to health because the

possibility exists that lovastatin can cause severe muscle problems

leading to kidney impairment.â€

 

In keeping with FDA policy warning letters were sent to Swanson and

Sunburst Biorganics advising them to halt promotion and sales of the

products at the risk of further legal action.

 

At face value this would seem to be nothing more than a caring,

compassionate act of a Government organization, intent on your safety

and health. But is there more to it than this?

 

An uneasy alliance

 

In a News Target article by Jessica Fraser she states, “Red yeast

rice has been used for over 1,000 years in China to improve

circulation and treat indigestion and diarrhea. It is made from rice

fermented by a red yeast known as Monascus purpureus and is

frequently used as a food preservative and food color, as well as a

spice and a component of rice wine.â€.

 

According to research on PubMed red yeast rice consists of 14

monacolin compounds such as monacolin K, a natural lovastatin. Some

scientists believe that these other monacolins, along with its

naturally occurring unsaturated fatty acids and anti-oxidants, may

work together favorably with lovastatin to enhance its cholesterol-

lowering effects, as well as its ability to lower triglycerides and

increase HDL cholesterol. This is red yeast rice in its natural state

of which the average daily consumption in Asia is 14 to 55 grams per

person.

 

Enter, the FDA policies. According to FDA, Swanson's products, if

taken as advertised on the company's website, provide more than 5 mg

of lovastatin daily, or half the lowest-recommended daily dose of FDA-

approved formulations of the drug.

 

FDA stated that Sunburst's product, Cholestrix, is advertised as

containing " 1.35% of naturally occurring lovastatin, " with two

tablets daily providing 10 mg of the drug. Sunburst’s website

featured an image of the Cholestrix bottle with the label clearly

stating that the product is " Standardized to Contain 1.35%

Lovastatin. "

 

FDA contends that traditional red yeast rice contains, at the most,

trace levels of lovastatin and described the purported supplements as

unapproved drugs that have been " enhanced " with lovastatin, which has

been regulated as a drug since 1987. Since none of the other

companies that manufacture red yeast rice have concentrated their

product through standardization they have been able to fly under the

FDA radar. Most have a recommended dosage of 600 to 1200mg a day,

which is about 10% of what they consume on a daily basis in Asia.

 

The second issue addresed by the FDA was the companies' websites

making claims that the red yeast products are intended for the

diagnosis, cure, prevention or treatment of diseases. Supplement

makers and distributors are prohibited under the federal Food, Drug,

and Cosmetic Act from making such claims for their products; unless

you manufacture Traditional evidently. There is a

concentrated red yeast rice formulation called Xuezhikang which,

according to research, “could readjust human blood-fat levels and

long term use could lower the occurrence rate of the disease by over

45 percent and the recurrence rate of non-fatal myocardial

infarctions by some 60 percent.†Yet as of this date they are free to

advertise their claims freely on the internet.

 

A statin by any other name

 

The primary issue for the FDA seems to be the danger of accidental

abuse of the very dangerous drug, lovastatin, even though a person

would have to take twice as much to equal one dose of Mevacor. Aside

from which, people use alternative methods of healing to get away

from pharmaceuticals, not as an adjunct, therefore it is unlikely

health conscious people would be using Mevacor and the red yeast rice

together.

 

The FDA is correct; there is a definite proven danger to using statin

drugs. 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.â€

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.†When your

doctor says, “Let me know if you have any discomfort in your calves

or back so we can adjust your dosageâ€, this is what he is watching

out for.

 

Many times the side effects take time to manifest. Here is one case

Fallon and Enig relate concerning Mevacor (lovastatin); “ John

Altrocchi took Mevacor for three years without side effects; then he

developed calf pain so severe he could hardly walk. He also

experienced episodes of temporary memory loss.â€

 

More often, however, the debilitating side effects of statin drugs

are much quicker to manifest as in the case of Bayer’s short lived

contribution to the market Baycol, which was approved in 1997 and

voluntarily pulled from the market a short 4 years later. (Take note

of the fact that Bayer chose to withdraw this drug after 60

rhabdomyolysis related deaths and not at the prompting of the FDA).

 

The headlines of a news release dated August 8, 2001 read “BAYER

VOLUNTARILY WITHDRAWS BAYCOL†which claimed, â€FDA today announced

that Bayer Pharmaceutical Division is voluntarily withdrawing Baycol

(cerivastatin) from the U.S. market because of reports of sometimes

fatal rhabdomyolysis, a severe muscle adverse reaction from this

cholesterol-lowering (lipid-lowering) product. The FDA agrees with

and supports this decision.â€

 

Duane Graveline MD MPH Former USAF Flight Surgeon, Former NASA

Astronaut and Retired Family Doctor states, “In August 2001 the

statin drug, Baycol, was removed from the market after causing at

least 60 deaths. As a result, the safety of all statin drugs has

subsequently come into questionâ€. (For a complete history of Baycol

from pre-market strategies, through FDA complicity and into the post-

withdrawal litigation read the Journal of Medical Marketing (2007)

article by Reinhard Angelmar)

 

In my research I was unable to find even one case of red yeast rice

related death or debility but as a health consultant I would advise

anyone considering using RYR to ere on the side of caution and seek

professional advice.

 

To sum up, the FDA may have had a legitimate reason to come down on

these companies for making claims that only the FDA approved drug

companies can legally make but it is up to you to decide if the FDA

was actually safeguarding our health or simply guarding their own

fiscal interests.

 

 

About the author

My name is Bradley R. Chappell. I have been a welcome speaker in

Southern Arizona for the past 10 years on subjects concerning

Constitutional liberties, the FDA/AMA involvement in setting health

policies in America, herbal therapeutics and Chinese medicine and

philosophy. I am presently involved in researching Homeopathic and

Flower Essence healing models. I am best known and trusted for my

depth of research and integrity.

[Guest guest]

This is just yet another reason why the FDA needs some serious change

if the agency is to serve any useful purpose. Its incessent

meandering to all of its master's wishes ... is enough to make any

freedom loving - truth oriented good ol fashioned American nauseos to

their stomach. Personally, I feel the US of A would be just fine with

outright abolishing the FDA. It seems at this point the corruption is

so systemically spread through the organization that any hopes to

" save " it is wishful thinking at best.