RE: red yeast rice, xiao chai hu tang

[Guest guest]

Ed -

 

I read that article you linked to, but I'm puzzled to find that red yeast

rice is readily available all over the net, and, according to a patient who

brought in a bottle, healthfood stores as well. Maybe the FDA reversed its

decision, because there is no effective ban currently in place. Maybe it

only applies to marketing/prescribing by non-MDs for cholesterol. You could

treat people with it for phlegm, damp-heat, etc. legally, as you've

mentioned previously.

 

Also, going back to earlier in this topic, from what I have read, the main

danger of xiao chai hu tang is combining it with interferon. It has an

additive effect, and can be lethal. Since in Japan, patients tend to take

lower doses of herbs relative to either China or the US, I sincerely doubt

that the cases of pneumonia(?) were due solely to the xiao chai hu tang,

even if not prescribed via pattern differentiation. But I'd have to see the

data to see if they controlled for pharmaceuticals. I doubt it, given past

cases - i.e. the aristolochic acid scare, and the kava kava scare, and the

ma huang scare......

Their drugs are interacting poorly with our herbs, and not the other way

around.

 

Benjamin Hawes, MAOM, Lic. Ac.,

 

CORTEZ FAMILY ACUPUNCTURE

1430 E. Main Street, Suite #4

Cortez, CO 81321

(970) 565-0230

 

 

 

>

> Message: 2

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

> " Ed Kasper LAc " <eddy

> 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

>

>

[Guest guest]

Benjamin. I agree with you. I did write to the FDA and asked specifically

but have not heard back.

My concern is that treating cancer, cholesterol, or any disease with

alternative medicine moves the focus away from (possible affective)

treatment to merits of qualifications of treatment. Medicinal herbalists

get trapped in western terminology which is specific to western diseases

AND of which medicinal herbalists by definition are not qualified in.

For example " pseudomyxomaperitonei " . According to the (USA) FDA only

qualified medical doctors and prescription drugs can legally treat diseases

. Specifically. a medicinal herbalist MAY NOT treat diabetes with

Ginseng. A medicinal herbalist MAY treat, and actually cure, thirsting and

wasting with Ginseng.

 

I believe we should discuss pseudomyxomaperitoneias as dampness/phlegm

stagnation in the lower jiao.

[i agree with the (USA) FDA] in that medicinal herbalists should do a

complete differential diagnosis. From that perspective as medicinal

herbalists we would be able to better determine which formula and treatment

stragary. How much time to pursue a herbal solution. Which formula pre and

post surgery. Which to assist recovery, or attempt recovery after the MD and

surgeons, as in most cases of pseudomyxomaperitonei give up.

 

Ed Kasper LAc. Santa Cruz, CA

 

 

 

 

Mon, 31 Jan 2005 14:09:07 -0700

" Benjamin Hawes " <ben_laura

RE: red yeast rice, xiao chai hu tang

 

Ed -

 

I read that article you linked to, but I'm puzzled to find that red yeast

rice is readily available all over the net, and, according to a patient who

brought in a bottle, healthfood stores as well. Maybe the FDA reversed its

decision, because there is no effective ban currently in place. Maybe it

only applies to marketing/prescribing by non-MDs for cholesterol. You could

treat people with it for phlegm, damp-heat, etc. legally, as you've

mentioned previously.

 

Also, going back to earlier in this topic, from what I have read, the main

danger of xiao chai hu tang is combining it with interferon. It has an

additive effect, and can be lethal. Since in Japan, patients tend to take

lower doses of herbs relative to either China or the US, I sincerely doubt

that the cases of pneumonia(?) were due solely to the xiao chai hu tang,

even if not prescribed via pattern differentiation. But I'd have to see the

data to see if they controlled for pharmaceuticals. I doubt it, given past

cases - i.e. the aristolochic acid scare, and the kava kava scare, and the

ma huang scare......

Their drugs are interacting poorly with our herbs, and not the other way

around.

 

Benjamin Hawes, MAOM, Lic. Ac.,

 

CORTEZ FAMILY ACUPUNCTURE

1430 E. Main Street, Suite #4

Cortez, CO 81321

(970) 565-0230

 

 

 

>

> Message: 2

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

> " Ed Kasper LAc " <eddy

> 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

>

>

[Guest guest]

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

> >

[Guest guest]

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

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

>>>>>Emanuel

Merck wan their appeal only against one company and therefore one can still get

it easily. Second, the natural red yeast rice you can by for 2$ has extremely

low monocholine (statines) content and would do nothing for cholesterol levels.

The variety that is used clinically is not the same animal. It is highly

concentrated and may actually be spiked with pharmaceutical lovastatin

Alon

 

 

[Guest guest]

cholesterol levels

>>>At the same time we should keep in mind that the mechanism of action of

statines probably has nothing to do with cholesterol. Statines are good

anti-inflammatory medication specific for the cardiovascular tissues and can

reduce C-reactive p (a marker of inflammation) which is probably why they are

useful clinically. High cholesterol level may be a marker for the body

attempting to repair inflammatory conditions. All statines are toxic but the

benefit clearly outweighs the harm, unless you are one of the unlucky ones.