red yeast rice, correction

[Guest guest]

Sorry Ed and All,

 

I meant to say this does " not " prevent companies from importing Hong

Qu and selling it as the whole grain, not in extract form.

 

Emmanuel Segmen

 

 

>

> Hi Ed,

>

> Note that Merck won their case on appeal after losing their case in

> the lower courts ... against companies selling supplement extracts

of

> Hong Qu, red yeasted rice, and claiming content of Lovastatin.

This

> however does prevent companies from importing and selling the whole

> grain version of Hong Qu. You can buy a pound of it for under

$2 ...

> less than the cost of shipping. This format is not an extract,

> rather it is red-yeasted rice.

>

> Merck lost in the lower court because red-yeasted rice had already

> been in the American marketplace before the research they sponsored

> at UCLA. The statin molecules are naturally occuring molecules,

and

> and the lower court judge decided they were not subject to patent.

> Merck won on appeal because the supplement companies were using the

> word Merck coined for the effective molecule they had found:

> lovastatin. Supplement companies had been putting that word on

their

> labels, and this spefically constituted the " infringement " allowing

a

> victory for Merck on appeal. Many a groan went up both in the

> Western science community as well as in the CM and supplement

> communities with this ruling. Merck still effectively has

a " patent "

> on these naturally occuring molecules though in reality they only

> have won a right to the name they coined. The FDA banned the

> offending company's extract of Hong Qu.

>

> So buy red-yeasted rice if you want as the whole grain upon which

the

> yeast has grown. Nice for coloring your food and good tasting.

This

> is not the herb that was used in formulas that lowered cholesterol

in

> formulas that originally got Merck's attention. It was the herb

that

> researchers used at UCLA as biomass for looking for interesting

> molecules. Reading the papers in their bibliography would give you

a

> clue as to why they decided to follow along that trail. Bottom

line

> is that red-yeasted rice is on the market and pretty inexpensive.

>

> Why not use other formulas from clinical experience in the main TCM

> hospitals in mainland China? Patients won't have to deal with the

> side effects of pharmacologically active single molecules.

>

> We've covered this territory a couple of times before in various

> venues. My apologies for so much reiteration.

>

> Respectfully and in friendship,

> Emmanuel Segmen

>

> > > Sun, 30 Jan 2005 14:11:40 -0800

> > > " Ed Kasper LAc " <eddy@h...>

> > > RE: Abusive Use of Xiao Chai Hu Tang in Japan

> > >

> > > Attillio, Acupuncturist, Herbalist, TCM practioner - although

> duly trained and competent in the precise use of Xaio Chai Hu Tang

> may not prescribe 'drugs " .

> > >

> > > Sho-saiko-to (Xaio Chai Hu Tang) a simple (yet eloquent)

Chinese

> herbal formula from the Shang Hun Lun, is currently undergoing

> clinical phase II trial in the U.S. specifically for hepatitis C.

> This trial is under the Investigative New Drug (IND) category from

> the FDA and is being conducted at Memorial Sloan-Kettering Cancer

> Center in New York.

> > >

> > > " new drugs " under section 201(p) of the Act [21 USC 1321(p)]

may

> not be legally marketed in the U.S. without prior FDA approval as

> described in section 505(a) of the Act [21 USC 355(a)]. FDA

approves

> ___a new drug__ on the basis of scientific data submitted by a

> __drug__ sponsor to demonstrate that the ___drug__ is safe and

> effective.

> > >

> > > Under the Act, as amended by the Dietary Supplement Health and

> Education Act (DSHEA), dietary supplements may be legally marketed

> with truthful and non-misleading claims to affect the structure or

> function of the body (structure/function claims), if certain

> conditions are met. However, claims that dietary supplements are

> intended to prevent, diagnose, mitigate, treat, or cure disease

> (disease claims), excepting health claims authorized for use

> > > by FDA, cause the products to be drugs.

> > >

> > > Xaio Chai Hu Tang, in this case with be specific to hepatitis,

> > > Ginseng would be specific to diabetes Hong Gu (fermented Red

> Rice) specific to cholesterol. Because red yeast extract contains

> lovastatin, the Food and Drug Administration (FDA) has successfully

> banned red yeast RICE from open store shelves, arguing that it's

> really a drug, needing a doctor's prescription.(source

> http://www.wholehealthmd.com/news/viewarticle/1,1513,29,00.html)

> > >

> > > Ed Kasper LAc. Santa Cruz, CA

> > >