consensus statement draft

[Guest guest]

3. The actual total number of all serious adverse Chinese herbal incidents is a mere fraction of those caused by the highly regulated (and thus supposedly safe) pharmaceutical market.

>>>>what they will say about this one is that only about 0.2% of the us population is using these herbs thus a few cases is actually very serious. For example 8% of us population is using an NSAID at any given time.

.. Nevertheless, certain herbs have been implicated in serious adverse effects worldwide. While these incidents involved OTC sales and practice by those not trained in TCM, the fact remains that there is no way to currently regulate the sales of Chinese herbs such that the public could be distinguished from licensed practitioners (I am actually waiting for comment from the FDA on this one).

>>>the problem of having only professionals use these herbs is that it makes the herbs medicinal. All medicinal have to go through FDA safety and efficacy which will be impossible to do

Alon

 

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cha

Saturday, July 08, 2000 10:02 AM

consensus statement draft

The following is a summary of my perception of the consensus of the CHA membership on the issue of herb safety in general and AA toxicity in specific. Please comment over the next month, then we will take a vote and then we can submit this to the FDA. Everything should be considered tentative till the final resolution. 1. TCM has a long history of concern with medicinal toxicity. Many herbs are prohibited for long term use or restricted to certain dosages. Other herbs are processed to reduce or eliminate inherent toxicity. 2. The actual safety record of licensed practitioners of chinese herbology in the US is exemplary. All serious adverse incidents have involved OTC sales and practice by those not trained in TCM (such as medical doctors) 4

5. In the case of aristolochic acid toxicity, the risk of certain herbs to be freely available to the general public outweighs the harm done to the profession of TCM if such herbs are banned 6. However, we insist that the FDA identify specific toxic herbs using a latin botanical standard of herb identification and biochemical analysis of samples to verify AA as a standard component thereof. Anything else would harm our livelihood without due process and thus constitute a taking by the federal government. 7. We strongly oppose any attempt to ban herbs solely on the basis of their chinese names.* 8. We support the proposed rule banning AA containing herbs which have been identified according to modern scientific standards of pharmacognosy, as detailed in #6 above. 9. We also support the proposed rule that if there is a question of herbal identification (and thus safety) that such question may be satisfactorily addressed by providing certificates of analysis proving the absence of AA. 10. We request that this issue of AA toxicity be formally identified as such in FDA publications and no longer referred to as Chinese Herb Nephropathy. This implication, which does irreparable harm to our profession ignores the actual fact that to this date only a handful of the hundreds of herbs used commonly in TCM have been even remotely implicated in causing kidney damage. 11. To the contrary, a substantial body of basic animal research demonstrates many herbs may actually have beneficial effects on the kidneys. *For example, we have researched Xi Xin and found that the species we use is not the one listed by the FDA. Han fang ji ( stephania) contains no AA. The incorrect substitute (guan fang ji) does. We support a ban on guan fang ji and required COA's for han fang ji to avoid confusion. Though it is simple to differentiate visually between Guan Mu Tong (Aristolochia) and Chuan Mu Tong (Clematis), we support the requirement of COA's for herbs labeled mu tong to avoid confusion. Chinese Herbal Medicine, a voluntary organization of licensed healthcare practitioners, matriculated students and postgraduate academics specializing in Chinese Herbal Medicine, provides a variety of professional services, including board approved online continuing education.

[Guest guest]

In a message dated 7/8/00 1:04:22 PM, herb-t writes:

 

<< *For example, we have researched Xi Xin and found that the species we

use is not the one listed by the FDA.

Han fang ji ( stephania) contains no AA. The incorrect substitute (guan

fang ji) does. We support a ban on guan fang ji and required COA's for

han fang ji to avoid confusion. Though it is simple to differentiate

visually between Guan Mu Tong (Aristolochia) and Chuan Mu Tong

(Clematis), we support the requirement of COA's for herbs labeled mu

tong to avoid confusion.

>>

 

For example, there are lots of white pills on the market as pharmaceuticals

and OTC drugs. If one of them has been found to be dangerous, do they take

them all off the market?

DAVE

[Guest guest]

 

> Please comment over the next month, then we will take a

> vote and then we can submit this to the FDA.

 

I hope I haven't missed the deadline on this.

 

> 2. The actual safety record of licensed practitioners of chinese

> herbology in the US is exemplary. All serious adverse incidents have

> involved OTC sales and practice by those not trained in TCM (such as

> medical doctors)

 

Or profit-first/health-second commercial enterprises.

 

> 3. The actual total number of all serious adverse chinese herbal

> incidents is a mere fraction of those caused by the highly regulated

> (and thus supposedly safe) pharmaceutical market.

 

This line of reasoning probably isn't going to fly. Although perhaps

true, the FDA is not in the business of comparing one product to another

to determine a baseline justice. Each product gets its own law, or

policy. If my big brother gets to go to the movies, then I should be

able to go too, right? That's the reasoning inherent in this statement.

I don't think that FDA cares about what other products are doing in

regards to this AA issue, only the herbs.

 

> 7. We strongly oppose any attempt to ban herbs solely on the basis of

> their chinese names.*

 

Yeah, that works for me.

 

> 10. We request that this issue of AA toxicity be formally identified

> as such in FDA publications and no longer referred to as Chinese Herb

> Nephropathy. This implication, which does irreparable harm to our

> profession ignores the actual fact that to this date only a handful of

> the hundreds of herbs used commonly in TCM have been even remotely

> implicated in causing kidney damage.

 

How about suggesting a new name: " quick profit nephropathy " or in

regards to the side effects that are brought about by pharmaceuticals:

" Western Drug Death. "

 

> *For example, we have researched Xi Xin and found that the species we

> use is not the one listed by the FDA.

 

Which Xi Xin has the AA and which hasn't? (Latin names, and pinyin if

they're different.)

 

--

Al Stone L.Ac.

<AlStone

http://www.BeyondWellBeing.com

 

Pain is inevitable, suffering is optional.

 

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