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Fang Ji Rx's Cancers/regulation?

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Stephen:

 

1. What texts do you think should be used in schools (and on our

office shelves) that would address the concerns about this herb and

others in the future?

 

2. What other potential liabilities or hazards with herbal products

may we face in the future?

 

3. When the results are gathered, what steps follow the study you

propose?

 

4. Do you have a website with herbal information?

 

Jim

 

 

 

, stephen@b... wrote:

>

> Would this type of statment from the " professionals " include the

fact that

> in the two most popular materia medicas used by the " professionals "

there is

> no mention of the toxicity concerns centered around aristolochic

acids? Or

> that the Bensky/Gamble MM does not even list aristolochic acid as

a " major

> known ingredient " in aristolochia? Or that the only Caution or

> Contraindication is to " Use cautiously in Deficient Yin patients " ?

OHAI

> published MM by HSU does not list ANY contraindication. The rather

thorough

> MM by You Ping Zhu mentions the toxicity of Aristolochia in a note

at the

> end of its write-up on Stephania. Zhu classifies Aristolochia as

Qing Mu

> Xiang under " Qi regulating herbs " . Aristolochic acids are listed as

> chemical constituents. Mention is made of a study of 56 cases of

malignancy

> TREATED with aristolochic acid A in combination with chemotherapy

and

> radiotherapy. Of the 56 cases 54 had stabel blood cell counts

during

> treatment thus ensuring the successful completion of chemotherapy

and

> radiotherapy, except 2 which had reduced WBC count. Has there been

any news

> communicated to the professional community about the potential for

CANCER or

> KIDNEY FAILURE from the use of Aristolochia?

>

> The reaction patients in the weight loss clinic in Belgum to

Aristolochia

> seems fairly suspect. Why then and there? The combination of

weight loss

> pharmaceuticals and herbs, or some other contributing influence

needs to be

> assessed. The LD50 of Stephania in Mice is listed at 241g/kg in the

> Bensky/Gamble MM. That's obviously very high and communicates high

levels

> of safety to the professionals who use it. In the same book, the

LD50 for

> Aristolochia is only stated for a single chemical component,

trilobine. Not

> enough information to determine the safety of the whole herb.

>

> The NY Times article mentions that ochratoxin A, a carcinogen, is

SOMETIMES

> FOUND in Stephania tetrandra. None of the many materia medicas

that I have

> list this chemical component.

>

> It is my opinion that the " profession " does not have a leg to stand

on in an

> arguement with the FDA that we had this all figured out and were

using it in

> a safe way all along. What evidence is there to support that

claim. In

> fact the opposite seems to be the case, that the profession was not

aware of

> any potential danger and did not warn FDA or the public against the

improper

> use of this ingredient. If the profession wants to do something

> professional with this situation, my suggestion would be to obtain

samples

> of the products in question and do some chemical and toxicology

studies on

> them. Tox studies can be done in China for much less than the US.

I have

> worked with labs in Beijing that do this type of work and can

provide that

> link. Studies should include negative controls using placebo and

positive

> controls using aristolochia to compare with the products that are

said to be

> the problem children. LD50 and even an acute tox 28 day feed study

will not

> be adequate to answer the concerns. I would suggest the following,

using a

> 90 day feed study:

>

> Sub-Chronic toxicity Test

> Ø Appropriate when toxicity concerns and potential liability

problems exist

> Ø 90 day or 12 months

> Ø AEL and specific target organs can be identified

> Ø Weekly body weights and food consumption monitored

> Ø Hematology and clinical chemistry on serum at test termination

> Ø Neurological behavior evaluations at 8th and 12th weeks

> Ø Histology performed on negative control, highest dose group,

and

positive

> controls.

>

> Funding (roughly $30,000) and samples of the products from Europe

would be

> needed.

>

> Stephen Morrissey

>

>

> herb-t@s... [herb-t@s...]

> Sunday, June 11, 2000 12:16 PM

>

> Re: Fang Ji Rx's and Urological

> Cancers/regulation?

>

>

>

> , " " <

> zrosenberg@p...> wrote:

> >

> >

> > I think we need to draft a statement for the profession, act now

> before we

> > have real trouble. We can start by drafting a statement for the

> Chinese

> > Herb Academy, on the need to have herbal medicines regulated by

the

> > profession, and supporting inclusion of herbal medicines from

China

> in

> > state licensing.

> >

> >

>

>

> I agree, but I think we need the support of AAOM to do this and I am

> not sure yet where they stand on this. Dave?

>

> Perhaps if a consensus statement could be developed, it would be an

> appropriate polling question to ask this group.

>

> something like " members of the CHA support FDA regulation to protect

> the public from unsafe herbal medicines as long as the licensed

> professionals practicing herbology in their legal scope remain

exempt

> from all such regulations "

>

> In the past, I have proposed a new category of regulated substances

> such as " crude drugs " to distinguish potentially dangerous " herbs "

> from

> extremely safe food supplements like vitamins and minerals,

> flavonoids,

> glucosamine, etc. I have no interest in restricting the latter

group

> of products at all. However, I would rather see some herbs off the

> public market as long as they were still on my shelves.

>

> And while herbs can certainly be used responsibly by laypeople, that

> is

> highly questionable here in america without any continuous tradition

> of

> use and the general perception that herbs are safe and that any

> products in the store are probably regulated. I owned a health food

> store for a few years and these erroneous perceptions are almost

> ubiquitous amongst the general public.

>

 

> >

>

>

>

> --

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>

> Chronic Diseases Heal - Chinese Herbs Can Help

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James Ramholz [OMJournal]

Sunday, June 11, 2000 4:34 PM

 

Re: Fang Ji Rx's Cancers/regulation?

 

 

Stephen:

 

1. What texts do you think should be used in schools (and on our

office shelves) that would address the concerns about this herb and

others in the future?

 

TEXTS: ALL OF THEM. THE MORE INFORMATION AND PERSPECTIVES THE BETTER.

TOXICOLOGY HOWEVER IS NOT WELL ADDRESSED BY ANY TEXT BECAUSE CHINESE MEDICAL

RESEARCH INSTITUTIONS AROUND THE WORLD HAVE NOT PURSUED THIS AREA IN ANY WAY

CLOSE TO WHAT WOULD PASS FOR CREDIBLE RESEARCH AT THE FDA OR IN COURT AS A

DEFENDANT IN A LAW SUIT

 

2. What other potential liabilities or hazards with herbal products

may we face in the future?

 

ONE CONCERN IS THE LACK OF EDUCATION ABOUT QA/QC METHODS, EXTRACTION

MANUFACTURING, AND RAW MATERIAL SELECTION ISSUES IN HERBAL TRAINING. DO YOU

KNOW WHAT LEVELS OF HEAVY METALS ARE IN YOUR PRODUCTS, WHAT THE ALLOWABLE

LIMITS FOR THESE CONTAMINANTS ARE IN FOODS REGULATED BY THE US GOV.?

 

3. When the results are gathered, what steps follow the study you

propose?

 

I'M NOT PUBLIC RELATIONS OR POLITICALLY INCLINED, BUT BEING A SOURCE OF

USEFUL DATA ON THE SAFETY OF OUR PROFESSION COULD BE USED IN BOTH OF THOSE

WAYS

 

4. Do you have a website with herbal information? SORRY.

 

Jim

 

 

 

, stephen@b... wrote:

>

> Would this type of statment from the " professionals " include the

fact that

> in the two most popular materia medicas used by the " professionals "

there is

> no mention of the toxicity concerns centered around aristolochic

acids? Or

> that the Bensky/Gamble MM does not even list aristolochic acid as

a " major

> known ingredient " in aristolochia? Or that the only Caution or

> Contraindication is to " Use cautiously in Deficient Yin patients " ?

OHAI

> published MM by HSU does not list ANY contraindication. The rather

thorough

> MM by You Ping Zhu mentions the toxicity of Aristolochia in a note

at the

> end of its write-up on Stephania. Zhu classifies Aristolochia as

Qing Mu

> Xiang under " Qi regulating herbs " . Aristolochic acids are listed as

> chemical constituents. Mention is made of a study of 56 cases of

malignancy

> TREATED with aristolochic acid A in combination with chemotherapy

and

> radiotherapy. Of the 56 cases 54 had stabel blood cell counts

during

> treatment thus ensuring the successful completion of chemotherapy

and

> radiotherapy, except 2 which had reduced WBC count. Has there been

any news

> communicated to the professional community about the potential for

CANCER or

> KIDNEY FAILURE from the use of Aristolochia?

>

> The reaction patients in the weight loss clinic in Belgum to

Aristolochia

> seems fairly suspect. Why then and there? The combination of

weight loss

> pharmaceuticals and herbs, or some other contributing influence

needs to be

> assessed. The LD50 of Stephania in Mice is listed at 241g/kg in the

> Bensky/Gamble MM. That's obviously very high and communicates high

levels

> of safety to the professionals who use it. In the same book, the

LD50 for

> Aristolochia is only stated for a single chemical component,

trilobine. Not

> enough information to determine the safety of the whole herb.

>

> The NY Times article mentions that ochratoxin A, a carcinogen, is

SOMETIMES

> FOUND in Stephania tetrandra. None of the many materia medicas

that I have

> list this chemical component.

>

> It is my opinion that the " profession " does not have a leg to stand

on in an

> arguement with the FDA that we had this all figured out and were

using it in

> a safe way all along. What evidence is there to support that

claim. In

> fact the opposite seems to be the case, that the profession was not

aware of

> any potential danger and did not warn FDA or the public against the

improper

> use of this ingredient. If the profession wants to do something

> professional with this situation, my suggestion would be to obtain

samples

> of the products in question and do some chemical and toxicology

studies on

> them. Tox studies can be done in China for much less than the US.

I have

> worked with labs in Beijing that do this type of work and can

provide that

> link. Studies should include negative controls using placebo and

positive

> controls using aristolochia to compare with the products that are

said to be

> the problem children. LD50 and even an acute tox 28 day feed study

will not

> be adequate to answer the concerns. I would suggest the following,

using a

> 90 day feed study:

>

> Sub-Chronic toxicity Test

> Ø Appropriate when toxicity concerns and potential liability

problems exist

> Ø 90 day or 12 months

> Ø AEL and specific target organs can be identified

> Ø Weekly body weights and food consumption monitored

> Ø Hematology and clinical chemistry on serum at test termination

> Ø Neurological behavior evaluations at 8th and 12th weeks

> Ø Histology performed on negative control, highest dose group,

and

positive

> controls.

>

> Funding (roughly $30,000) and samples of the products from Europe

would be

> needed.

>

> Stephen Morrissey

>

>

> herb-t@s... [herb-t@s...]

> Sunday, June 11, 2000 12:16 PM

>

> Re: Fang Ji Rx's and Urological

> Cancers/regulation?

>

>

>

> , " " <

> zrosenberg@p...> wrote:

> >

> >

> > I think we need to draft a statement for the profession, act now

> before we

> > have real trouble. We can start by drafting a statement for the

> Chinese

> > Herb Academy, on the need to have herbal medicines regulated by

the

> > profession, and supporting inclusion of herbal medicines from

China

> in

> > state licensing.

> >

> >

>

>

> I agree, but I think we need the support of AAOM to do this and I am

> not sure yet where they stand on this. Dave?

>

> Perhaps if a consensus statement could be developed, it would be an

> appropriate polling question to ask this group.

>

> something like " members of the CHA support FDA regulation to protect

> the public from unsafe herbal medicines as long as the licensed

> professionals practicing herbology in their legal scope remain

exempt

> from all such regulations "

>

> In the past, I have proposed a new category of regulated substances

> such as " crude drugs " to distinguish potentially dangerous " herbs "

> from

> extremely safe food supplements like vitamins and minerals,

> flavonoids,

> glucosamine, etc. I have no interest in restricting the latter

group

> of products at all. However, I would rather see some herbs off the

> public market as long as they were still on my shelves.

>

> And while herbs can certainly be used responsibly by laypeople, that

> is

> highly questionable here in america without any continuous tradition

> of

> use and the general perception that herbs are safe and that any

> products in the store are probably regulated. I owned a health food

> store for a few years and these erroneous perceptions are almost

> ubiquitous amongst the general public.

>

 

> >

>

>

>

> --

----

> Make PayPal your friend.

> Sign up today and get a $5 bonus.

> http://click./1/5024/9/_/542111/_/960747376/

> --

----

>

> Chronic Diseases Heal - Chinese Herbs Can Help

 

 

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Chronic Diseases Heal - Chinese Herbs Can Help

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<< What texts do you think should be used in schools (and on our

office shelves) that would address the concerns about this herb and

others in the future?>>

 

If Bensky has become the anointed materia medica it is due for an

extensive revision that does far more than translate. If we can't get

it, we'd better look for another. Duke's USDA database frequently has

more information on constituents. Many herbs have been extensively

studied in Germany, Russia, the US and other western countries but the

information is not referenced in the pharmacological and clinical

research sections.

 

For instance, sheng ma's entry contains nary a word obout the hormonal or

antispasmodic uses of cimicifuga, extensively referenced in the West,

even to mentioning whether or not there is a species difference in this

respect. With overestrogenated western patients (meat, dairy, plastics,

pesticides and HRT), this information is important. Bo he has no mention

in the contraindications sections of the inability of children under two

to process menthol. Guang fang ji DOES contain the information that

aristolochic acid is a major known ingredient but does not reference

toxicological concerns: the toxicity reference is for injected trilobine

which is not listed among the major known ingredients.

 

Stephen is right that we are sitting ducks for regulation when our major

modern texts omit mention (even for refutation) of widely known side

effects or toxilogical concerns, let alone references to modern research.

 

And I would suggest that Kent's _Basics of Toxicology_ be present in all

school libraries and referenced in the appropriate herb courses.

 

Karen Vaughan

CreationsGarden

***************************************

" Medicine...the only profession that labours incessantly to destroy the

reason for its existence. " James Bryce 1914

 

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