Fang Ji Rx's and Urological Cancers/regulation?

[Guest guest]

, " " <

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.

>

[Guest guest]

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 Herbal Medicine, 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?

 

AAOM stands behind having a national standard for herbal training of NCCAOM

or greater fo revery OM licensed practitioner that uses them. We have more or

less worked out wording with the NAOMA (some glitches yet, I think) below:

 

VII. Optional Certification in Herbology

 

1.) Individuals licensed by this board who recommend herbal preparations must

be certified in herbology as per regulations developed by the Board and in

accordance with the criteria in this section.

 

2.) In order to be certified in herbology by the Board, an individual must

provide documentation one of the following:

 

a) NCCAOM certification in Herbology,

 

b) Completion of 450 hours of board approved study in herbal medicine,

including materia medica, formulas, and supervised clinical practice, or

 

c) Licensure as an acupuncturist or Oriental medicine provider in a state

that requires training and passage of an examination in Herbal Medicine, at

the time of licensure, approved by the Board.

 

3) Individuals licensed under this Article who hold a Certification in

Herbology are entitled to advertise to the public as " State Board Certified

in Herbology " .

 

This took a while to hammer out so far and the present glitch is one that

will undoubtedly also warrant discussion here. That is whether we should be

using the words " Chinese herbal medicine " and " Chinese Herbology " or if we

will not require passports for plants coming across the border. (You can

guess the way I lean)

 

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 "

 

How about " members of the CHA support FDA regulation to protect

the public from unsafe herbal medicines as long as the licensed

professionals practicing herbology (certified by an examination in herbal

medicine used by a state regulatory agency) 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.

 

This would be difficult in todays world, where it is either on the shelf or

only available thru MD's, if at all. This will take many years to put

something like this (regulatory agency for herbs) together, and in the

meantime it will will be outlawed, if the medical monopoly has any say in the

matter.

 

I'm not a political animal so I would like to hear other opinions.

 

Contrary to this opinion, politics involves listening to opinions.

Unfortunately, sometimes it involves listening to ALL the opinions. If we

don't speak up as a group, we will be shouted down.

The same thought came up with the purported unionization of acupuncturists in

CA. If the union has 1000 acupuncturists and 700,000 MD's and there was a

disagreement over turf or most anything, who would they side with in the

binding arbitration process?

 

 

DAvid Molony

[Guest guest]

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 [herb-t]

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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[Guest guest]

Stephen, I think your approach is with merit and should commence ASAP__And__

at the same time research is needed into 1. the alleged " inadvertently " use

of " Chinese Herbs " (the What & Why they were doing) 2. the " scientific

research " that correctly identified the cancer causing culprit and 3. the

media lead hysteria against all " Chinese Herbs " .

 

Number 1,2,3 cited above should be very low key BUT very thorough and begin

ASAP. Your idea should be a major announcement by a blue ribbon committee

with funds shown sufficient to establish the truth.

 

This is indeed an opportunity for the TCM Community to be Professional.

 

I stand ready with time and money to help.

 

Ed Kasper L.Ac., Santa Cruz, California

 

 

stephen

[stephen]

Sunday, June 11, 2000 1:08 PM

 

RE: Re: Fang Ji Rx's and Urological

Cancers/regulation?

 

 

 

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 [herb-t]

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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[Guest guest]

to All:

 

We had an interesting seminar with John Chen today at Yo San, and he talked

about the Aristolochic acid Chinese Herb Nephrology problem. It is CRITICAL

that all practitioners be prepared to answer questions about this issue,

because John received at least 50 phone calls last week from public,

journalists, patients, practitioners, etc. His answer is threefold: that in

the Belgian case, the formula was prescribed for the wrong purpose (weight

loss), by MDs not trained in Chinese herbs, and that a wrong herb was

substituted for the correct herb (Guan Fang Ji for Han Fang Ji). A fourth

point is that a water decoction of any Fang Ji will extract very little of

the potentially toxic element, while other preparation methods will be far

more toxic. We all need to be as informed as possible, as this will heat up

soon. He even mentioned there might be something in Time Mag.

 

Julie

[Guest guest]

Stephen, I see your points. But, isn't it critical to remember that only in

clinics which were using Chinese herbs INCORRECTLY and without proper

training, did these cases of nephrotoxicity occur? When we in the profession

use our herbs as we are trained to do, they are safe.

 

Julie

[Guest guest]

I am not an herbalist and nothing that follows is intended as a commentary

on issues related to the specific herbal ingredients, their interactions and

possible side effects.

 

I do want to make a couple of general observations and comments that

I hope can be of use in contemplating, designing and implementing a

strategy to resolve the scene. I have worked in public relations, mass

media and communications management and these remarks are largely

given from that perspective.

 

A member of the Rothschilds, one of Europe's preeminent banking familys,

allegedly

remarked that " the time to buy real estate is when there's blood running

in the streets. " Regardless of how you relate to such sentiments, it brings

an important point to light, namely that every situation no matter how dire,

contains an opportunity.

 

Three years ago or so, there was a major public health issue related to

the lead in calcium supplements. I happened to be involved in a negotiation

with the fellow who controls the largest manufacturer of calcium supplements

in the country. He had the greatest potential exposure to the impending

catastrophe. He chose to turn the whole affair to his advantage. He

took the initiative in lobbying and public promotion of quality standards

and procedures to " clean up the scene and protect the public. "

 

He stood on a precipice, about to be identified as the guy who makes

85% of the lead-strewn calcium, and he emerged from the whole affair

as a hero.

 

I wasn't involved in this whole thing, but took note of it at the time as

a classic example of how one's difficulties can become one's opportunities.

I'd say we have one now.

 

One final note from Confucian texts: when the archer misses the bullseye,

he turns his attention to himself.

 

Ken

[Guest guest]

Julie et al.

I would hope and agree that correct use would minimize risk. However from

the statements that I have read by John Chen, he claims that the incorrect

substitution of Aristolochia for Stephania is part of the reason for the

toxic reaction. This implies his agreement that Aristolochia is toxic and

can cause kidney damage and cancer in the high percentage of those weight

loss patients. If we accept that as true, and it is not listed as a toxic

substance in our materia medicas, it could be reasonably argued by

regulators as to how much more informed can our choices be regarding the

safety of Chinese herbal medicines we give to patients, than the untrained

self-medicator. This opens us up to many questions regarding the safety of

nearly ALL the other ingredients in the materia medica that also lack

credible tox data.

 

In China, Stephania is predominately, perhaps entirely, wildcrafted as

opposed to cultivated. This, and because of the similarity of its

appearance, and its historic interchangability with aristolochia, is why

there is concern about the misrepresentation of ingredient. John Chen's

statement about the extraction method influencing the toxicity of the

finished product relative to the raw material is valid. However I believe

it unlikely that the " bad batch " was extracted with anything other than

water.

 

I would still propose that the only way to resolve the issue is to undertake

the appropriate analytical chemistry and toxicology studies. And I find it

hard to believe that this has not been done. I have asked some colleagues in

Beijing to do a lit search of the Chinese tox data on Stephania and

Aristolochia. I'll post the results. But if anyone can get their hands on

any of the suspect material, which unfortunately could be long gone, that

would offer the best opportunity to obtain real answers. Although, without

it, tox research on aristolochia and stephania would help clarify some key

concerns.

 

Regarding the proposed response from the profession, that's fine. Probably

won't hurt. However it may be naive to think that regulators will entrust

the safety concerns of these ingredients to practitioners that are not

legally allowed to extract, analyze and monitor patient's blood and urine

samples to ensure that Chinese herbs are not causing deleterious

asymptomatic effects.

 

Stephen Morrissey

 

 

juliej8 [juliej8]

Sunday, June 11, 2000 9:05 PM

 

Re: Re: Fang Ji Rx's and Urological

Cancers/regulation?

 

 

Stephen, I see your points. But, isn't it critical to remember that only in

clinics which were using Chinese herbs INCORRECTLY and without proper

training, did these cases of nephrotoxicity occur? When we in the profession

use our herbs as we are trained to do, they are safe.

 

Julie

 

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Chronic Diseases Heal - Chinese Herbs Can Help

[Guest guest]

The First Law: Physician Do No Harm.

When suspicion arises we must take action.

If and when the public have doubts we must dispel those doubts in certain,

clear and tangible methods that the public grasps. Excuses are not

acceptable.

 

Think about this: If our actions in all instances are Proper and guided by

Principles (regardless of the outcome) the public will turn towards us in

trust and faith. Seeking Blame or Excuses the public will turn away.

 

We do not have to have One Voice.

We do need to speak one message - that is demanded.

 

If/When regulation comes about, By OUR actions rules will be demanded either

because 1. the public fears us or 2. the public trusts us and are seeking to

protect their children from abusing substances.

 

BTW, Weight Loss has been the scourge of western drugs as well as Chinese

herbs for millennium.

 

Ed Kasper L.Ac., Santa Cruz, California