CCAOM statement on aristochlia

June 25, 2000

Dear list members,

The following is a copy of a statement drafted for the CCAOM, on the

recent aristochlia affair. I would like to see us make a statement, and I

think this document should be up for discussion. While I agree with a lot

of what is said here, I am very concerned that this letter supports the ban

of such essential medicinals as mu xiang/rx. saussurea, which has no

relationship with aristochlic acid at all.

(sorry, ignore last post. . . . .letter didn't insert properly)

Rose Haywood, Dipl.Ac.(NCCAOM), L.Ac., Dean of Clinical Services

John Pirog, MSOM, Associate Professor of Oriental Medicine

Minnesota Institute of Acupuncture and Herbal Studies at Northwestern

Health Sciences University

The Oriental Medical Profession

Re: FDA Warning on Chinese Herbs

On May 31, 2000, the FDA issued an alert to " all practitioners who

prescribe botanical remedies " warning of the possible presence of

aristolochic acid, a known nephrotoxin and carcinogen, in certain Chinese

herbs and herb products. The Chinese herbs affected by the alert include Ma

Dou Ling, Guang Fang Ji, Han Fang Ji, Mu Tong, Mu Xiang, Xi Xin and Wei

Ling Xian. The warning follows numerous incidents in Belgium and in the

United Kingdom where patients taking formulas containing Mu Tong and Han

Fang Ji as listed ingredients developed renal failure and in some cases,

urothelial carcinoma. A copy of the warning and the affected species can

be found on the FDA website at http://vm.cfsan.fda.gov/~dms/ds-botl2.html.

Practitioners should remove from their pharmacy shelves any herbs that

appear on the FDA Attachment A or Attachment B, and any herbal products

(pills, granules, etc.) that could contain these herbs. This is not an

easy task. You need to know which herbs are in the formulas and which

herbs may have been substituted for herbs contained in the formulas. You

should refer to the FDA list of botanicals in Attachment A and Attachment

B, and consult other herbal references for further information. The list

of common patent remedies mentioned below in not exhaustive. It is up to

each practitioner to carefully verify the contents of any formulas he or

she stocks.

Reports have already begun to circulate in the mainstream press linking

Chinese herbs with kidney failure and cancer. In order to be better

informed on this subject, and to respond accurately to queries from

patients and the press, it is important that we familiarize ourselves with

the scientific literature that has been written about this matter.

Aristolochic acid causes a characteristic pattern of interstitial renal

fibrosis which progresses rapidly to end-stage renal failure and continues

even after the herbal remedy is discontinued (See " Nephropathy caused by

Chinese herbs in the UK " , Lancet August 7, 1999 p. 481).

As you know, it is normal practice in Chinese medicine to interchange

several species for any one designated Chinese herb. Some species are

often preferred over others. The preferred species for Mu Tong, for

example, are Akebia trifoliata, Akebia quinata, Clematis armandi and

Clematis montana, but Aristolochia manshuriensis (also known as Hocquartia

manshuriensis) is commonly used as a low-cost substitute. In the case of

Han Fang Ji, which is represented by Stephania tetrandra, there exists the

possibility of confusion with Guang Fang Ji, which is taken from

Aristolochia fangchi or Cocculus tribolus. Many herbs from the Aristolochia

family contain aristolochic acid, including Aristolochia fangchi and

Aristolochia manshuriensis.

The cases in Belgium began at a weight loss clinic where patients in the

early 1990's were given a dubious cocktail of Western and Chinese herbs

mixed with Western drugs, including fenfluramine, diethylpropion, and

acetazolamide. By 1993, dozens of cases of rapidly progressive renal

failure had been documented in this group of patients. The clinic had been

in business for 15 years and had not experienced any such problems until it

switched to a formula that purportedly contained Stephania tetrandra (Han

Fang Ji). Subsequent analysis confirmed that the formula actually contained

Aristolochia fangchi (Guang Fang Ji), which contains aristolochic acid.

At this point 105 patients treated at the Belgian clinic have developed

nephropathy and 43 have suffered end-stage renal failure requiring dialysis

and transplant. Because of the high risk of urothelial cancer in patients

with this form of nephropathy, 39 patients with non-functioning kidneys

have elected to undergo prophylactic nephrectomy. Among these, 18 cases of

urothelial cancer have been found. Kidney biopsies from these patients were

found to have a pattern of DNA adducts that are typically associated with

exposure to aristolochic acid. (See " Urothelial Carcinoma Associated with

the Use of a Chinese Herb-Aristolochia Fangchi, " New England Journal of

Medicine June 8, 2000).

It has been speculated that the nephrotoxicity of Aristolochia fangchi was

potentiated by the cocktail of Western drugs that the patients were taking.

Since the Belgian cases came to light, however, additional cases of

aristolochic acid nephropathy have been documented in the United Kingdom

and Japan among patients who were not taking Western medications. Two

patients in the UK from two different clinics were being treated for eczema

with a formula that contained Mu Tong. Subsequent analysis revealed that

the form of Mu Tong was Aristolochia manshuriensis, which contains

aristolochic acid. We do not know the formula involved, but Mu Tong is an

ingredient in Xiao Feng San, which can be used for eczema caused by wind

heat and dampness. It should be noted that Xiao Feng San is recommended for

short-term use only; the two patients involved had been taking their

formulae for two years in one case and six years in the other.

Investigators in Japan discovered that there had been ten cases of this

unique nephropathy occurring in this country since 1993, and all patents

were suspected to have taken medicine derived from an Aristolochia species.

Five of these cases were confirmed to have taken an herbal medicine

produced in China and sold by a firm in Osaka. Sales were halted and a

product recall was carried out in 1997. Like the cases in UK, analysis

confirmed that the toxicity was caused by Aristolochia manshuriensis

misidentified as Akebia quinata. It should be added that the Drug

Regulation Department of the German Federal Republic prohibits the sale of

drugs containing aristolochic acid.

We all believe that Chinese herbs that are correctly identified and used

according to the principles of Chinese medicine are quite safe. But as

practitioners, we should definitely be concerned whether the herbs

available to us in the United States have been correctly identified by

suppliers. In the words of John Chen, Pharm.D., O.M.D., " It is the ethical

and legal responsibility of the herbal manufacturer to establish the most

stringent quality control measures to ensure the safety of herbal products,

and it is the duty of practitioners to purchase and dispense herbs from

manufacturers who meet such criteria " (Herbalgram 2000; 48:44-45). In the

wake of this crises, there are several precautions that we as practitioners

of in the United States can take to protect the health of

our patients and also to protect ourselves legally.

1. Until written certificates of analysis can be obtained by suppliers, all

products containing herbs on the FDA list should be removed from our

shelves. The Chinese names of the herbs affected by the recall include:

Han Fang Ji, Mu Tong, Mu Xiang, Xi Xin,

Ma Dou Ling, Guang Fang Ji, Wei Ling Xian

It should be noted that the FDA will soon issue an order to impound these

herbs and any products containing them at the border; we do not know if

these herbs will be available at all in the future. Only a small number of

manufacturers of Chinese herb powders routinely screen their herbs for

chemical markers to confirm accurate species identification. But even this

may not be enough. An FDA Letter to Industry issued on May 16, 2000,

states that it will not release any herbs or herb products suspected to

contain aristolochic acid from impound until the responsible party can

provide " direct analytical evidence that (the herb or herb product) is free

of aristolochic acid. " (FDA Letter to Industry May 16 2000

http://vm.cfsan.fda.gov/~dms/ds-botl1.html)

2. All herbal practitioners should immediately contact their suppliers and

insist on written documentation that any herbs or herb products they have

purchased containing species from the above list are free of aristolochic

acid. This step is needed in order to accurately respond to any queries

from patients (or their physicians) about the safety of the herbs they have

been taking.

3. In the future, make purchases only from those suppliers that can provide

written documentation of laboratory analysis showing accurate species

identification. Quoting Dr Chen again: " *visual inspection is insufficient

for correct identification as the macroscopic physical appearances of the

herbs are often indistinguishable. Laboratory techniques such as

high-performance liquid chromatography, thin layer chromatography, and

liquid-column chromatography must be used to confirm qualitative and

quantitative analyses of the various herbs' chemical profiles. Furthermore,

such examinations must be performed on every batch of herbs: random

examinations will not ensure the safety of all herbal preparations. "

4. It is important to note that aristolochic acid is a normal constituent

of at least some of the herbs on the FDA's list, including Ma Dou Ling and

Guang Fang Ji. The FDA Letter to Industry cited above states that " The FDA

considers any FDA-regulated product containing aristolochic acid to be

unsafe and to be adulterated. " Regardless of how one may feel about the

safety of these herbs, it is clear that we can no longer use any herb or

herb products that contains aristolochic acid.

It is important that we do not raise unnecessary alarm. It may well turn

out that all the herbs available in this country have been correctly

identified. For the present, it is best to err on the side of caution in

this issue. Each herb involved in the recall carries different risks and

problems. We need to address them on a case by case basis. We have

assembled below all the information we have to date.

Mu Tong

Caulis Mu Tong is the herb involved in the UK cases. The Bensky Materia

Medica states the following (emphasis added):

Akebia trifoliata (Thunb.) Koidz. var. australis (Diels) Rehd. and Akebia

quintata (Thunb.) Decne. are the plants most often listed in premodern

pharmocopeias as this herb. However, at present in China these plants are

rarely used. Instead, Aristolochia manshuriensis Kom. is most often used,

and then either Clematis armandi Franch. or Clematis montana Buch.-Ham*

Alternate names: Ku Mu Tong, Zi Mu Tong, Bai Mu Tong (Akebia); Guan Mu Tong

(Aristolochia); Chuan Mu Tong (Clematis).

CAUTIONS AND CONTRAINDICATIONS: Contraindicated during pregnancy and in the

absence of interior damp-heat. This herb easily injures the fluids and

should be used with extreme caution in patients with any sign of yin

deficiency. Do not overdose: acute renal failure was reported following a

dose of 60g.

DOSAGE: 3-9g

MAJOR KNOWN INGREDIENTS: akebin, hederagenin, oleanolic acid (Akebia

trifoliata); aristolochic acid, oleanolic acid, hederagenin, calcium,

tannic acid (Aristolochia manshuriensis).

According to Dr. Hong-yen Hsu, writing in Oriental Materia Medica: A

Concise Guide, " In the present market there are over ten kinds of this

plant, among which most frequently used are the dried stems of*

Aristolochia manshuriensis and Akebia quintata. " It should be noted that

Aristolochia manshuriensis or Guan Mu Tong has until recently been

considered a legitimate-although poorer quality-substitute for Ku Mu Tong,

which most of us have learned as " Caulis Akebia. "

We recommend that practitioners check the labels of all their Mu

Tong-containing products to determine which of the above species is

represented. Our own research has found that many products have labels that

make confusing or contradictory statements about the type of Mu Tong being

used. One package of raw Mu Tong contained characters that read " Chuan Mu

Tong " the name for the Mu Tong from the Clematis species (the " safe " form),

but the label in English identifies the herb as " Caulis Hocquartiae " (sic).

Hocquartia manshuriensis is a botanical synonym for Aristolochia

manschuriensis, a species known to contain aristolochic acid.

We recognize that many practitioners believe that they can accurately

identify all raw herbs by visual inspection alone. That is not possible in

the case of Mu Tong. One of the present writers (Rose Haywood) was recently

invited to compare samples of Akebia and Aristolochia collected by the

Royal Botanic Gardens, Kew, a research facility in the United Kingdom that

specializes in botanical identification of Chinese herb species. The two

samples were indistinguishable.

Many powdered concentrates contain Mu Tong. In the case of one popular

brand of powders, the individual Mu Tong is labeled as " Clematis, " but all

the company's Mu Tong-containing formulas list " Hocquartia " on the labels.

Popular formulas that contain Mu Tong include Xiao Feng San, Ba Zheng San,

Dang Gui Si Ni San, Long Dan Xie Gan Tang, and Dao Chi San.

It should be noted that all these formulae are designed for short term

administration. The two cases in the UK involved patients who had been

taking Mu Tong for two years and six years. If a patient who has been

taking Mu Tong containing formulas asks about the safety of his or her

herbs, an accurate response could include the following information:

· The European cases appear to have resulted from Mu Tong that had been

used improperly.

· Formulas that contain Mu Tong in the form of Akebia or Clematis are safe

if these herbs have been accurately identified, the maximum dose has not

been exceeded, and the formula is taken within the narrow time limits and

diagnostic parameters establish by TCM.

· Although the Chinese medical profession believes that Mu Tong is safe if

used properly, the FDA has asked us to discontinue its use, and we are

complying.

In the meantime, it is safest medically as well as legally to take all

forms of Mu Tong off our shelves until we can receive written certification

that the herbs or herb products are free of aristolochic acid.

Han Fang Ji and Guang Fang Ji

Han Fang Ji, taken from Stephania tetrandra S. Moore, is " safe " in the

present context; i.e., it does not contain aristolochic acid. But it is

sometimes used interchangeably with Guang Fang Ji, which in the form of

Aristolochia fangchi does contain aristolochic acid. Guang Fang Ji is

listed as a separate herb in the Bensky Materia Medica. It is Guang Fang

Ji interchanged with Han Fang Ji that caused the illnesses in Belgium.

Practitioners of in the United States should permanently

discontinue the use of Guang Fang Ji. There are many other herbs to replace

it, and the risks of aristolochic acid nephropathy clearly outweigh its

benefits. Although Han Fang Ji is relatively safe, full compliance with

the FDA's warning will require its discontinuation as well. Since Han Fang

Ji is extremely bitter, it is used much in raw or powdered form. One patent

formula that contains Han Fang Ji as a listed ingredient is Plum Flower's

Guan Jie Yan Wan, also called " Joint Inflammation. " The label lists

Stephania as the species used.

If a patient who has been taking Han Fang Ji asks about the safety of his

or her herbs, an accurate response could include the following information:

· The European cases resulted from the misidentification of Han Fang Ji by

the supplier.

· The European cases occurred in a weight loss clinic that was using

Chinese herbs as part of a drug cocktail that included fenfluramine

( " fen-fen " ), a drug that been taken off the market because of toxic side

effects.

· Formulas that contain Han Fang Ji or Fang Ji in the form of Stephania are

safe if these herbs have been accurately identified, the maximum dose has

not been exceeded, and the formula is taken within the narrow time limits

and diagnostic parameters establish by TCM.

· Although the Chinese medical profession believes that Han Fang Ji is safe

if correctly identified and used properly, the FDA has asked us to

discontinue its use and we are complying.

In the meantime, it is safest medically as well as legally to take Han Fang

Ji off our shelves until we can receive written certification that the

herbs or herb products are free of aristolochic acid.

Fortunately, Guang Fang Ji is not commonly used by practitioners in the

United States (at least not knowingly). The primary source of Guang Fang Ji

is Aristolochia fangchi, which contains aristolochic acid. A secondary

source is Cocculus trilobus (Thunb.) DC. If a patient has been knowingly

given Guang Fang Ji, a different response is warranted:

· The primary source of Guang Fang Ji contains aristolochic acid, which has

been associated with kidney failure and cancer after overdose or long term

use. The FDA has asked us to discontinue its use, and we are complying.

In the meantime, it is safest medically as well as legally to take Guang

Fang Ji off our shelves altogether.

Xi Xin

Xi Xin is taken from various Asarum species, including Asarum sieboldii

Miq. or Asarum heteropoides Fr. Schm. var. mandshuricum (Maxim.) Litag..

Asarum is a member of the Aristolochia family. Aristolochic acid is not

listed as an ingredient of Xi Xin in any text available to us, although an

internet search found a site listing Asarum canadense (Canadian Asarum) as

containing aristolochic acid in the leaves. Raw Xi Xin commonly contains

leaves and stems mixed in with the root. Bensky's Materia Medica states

" Use (Xi Xin) with caution in patients with renal problems as it can be

nephrotoxic. "

The recommended dosage for Xi Xin is 1-3g. This dosage is found in Bensky's

Materia Medica as well as Ou Ming's Chinese-English Manual of Commonly-used

Prescriptions in Traditional . It should be noted that Xi

Xin is normally administered in very low dose and for a brief period of

time. Xi Xin was not implicated in any of the cases of nephropathy reported

in Europe. Formulae that include Xi Xin include Du Huo Ji Sheng Tang, Xin

Yi San, Chuan Xiong Cha Tiao Wan, Dang Gui Si Ni San, and Xiao Qing Long

Tang.

If a patient who has been taking Xi Xin asks about the safety of his or her

herbs, an accurate response could include the following information:

· Xi Xin was not the cause of any of the illnesses that occurred in Europe.

· Xi Xin formulas are safe if used in low dosage for a short period of time.

· Although we believe that Xi Xin is safe if used properly, the FDA has

asked us to discontinue its use, and we are complying.

In the meantime, it is safest medically as well as legally to take all raw

Xi Xin and all products containing Xi Xin off our shelves until we can

receive written certification that the herbs or herb products are free of

aristolochic acid. In addition, more research needs to be done to identify

whether the types of Asarum used in Chinese medicine contain aristolochic

acid, and if so, whether it is present in the entire plant or only the

aerial parts.

Mu Xiang

The most common source of Mu Xiang is Saussurea lappa Clark. (also known as

Aucklandia lappa Decne); in this form it is called Guang Mu Xiang. There is

a variety of this herb known as Chin Mu Xiang, which is taken from

Aristolochia debilis Sieb. et Zucc. or Aristolochia contorta Bunge, both of

which contain aristolochic acid. It would be very rare for Guang Mu Xiang

to be substituted with Chin Mu Xiang. Furthermore, these two herbs have a

very different appearance and flavor, so there is little chance of

misidentification.

In all likelihood, the Mu Xiang products on our shelves are quite safe. But

unlike the other herbs on the list, Mu Xiang appears in many tonic formulas

such as Gui Pi Tang designed for long-term administration. If the Mu Xiang

were to contain Aristolochia, the risk of kidney failure would be much

greater. Thus it is better to discontinue the use of Mu Xiang and Mu

Xiang-containing products until documentation can be provided by suppliers

that they are free of aristolochic acid.

Popular formulae containing Mu Xiang include Xiang Sha Yang Wei Tang, Xiang

Sha Liu Jun Zi Tang, Gui Pi Tang, Xiao Feng San, and Bu Shen Jian Pi Tang.

If a patient who has been taking Mu Xiang asks about the safety of his or

her herbs, an accurate response could include the following information:

· Mu Xiang is a very safe herb that has never been associated with any

toxic problems.

· Although it is highly unlikely that Mu Xiang could be confused with any

toxic species, the FDA has asked us to discontinue its use, and we are

complying.

Ma Dou Ling

Ma Dou Ling is taken from Aristolochia debilis Sieb. et Zucc. or

Aristolochia contorta Bge. Both species contain aristolochic acid. This

herb is extremely bitter and is infrequently used in Western practices.

Bensky's Materia Medica warns: " May cause nausea and vomiting if the dosage

is too large. " Because of its bitterness, Bensky recommends substitution of

Fructus Trichosanthis (Gua Lou). Given what we now know about aristolochic

acid toxicity, this substitution should become the norm.

If a patient who has been taking Ma Dou Ling asks about the safety of his

or her herbs, an accurate response could include the following information:

· Ma Dou Ling contains aristolochic acid which has been associated with

kidney failure and cancer after overdose or long term use. The FDA has

asked us to discontinue its use, and we are complying.

Wei Ling Xian

Wei Ling Xian comes from Clematis chinensis Osbeck, Clematis hexapetala

Pall., or Clematis uhcinata Champ. It is not in the Aristolochia family,

does not contain aristolochic acid, and is never substituted by species

containing aristolochic acid. Up to 30g can be safely used to dissolve fish

bones stuck in the throat. Nevertheless, all the above Clematis species

have been placed on the FDA's " Attachment B - Species That May be

Adulterated with Aristolochic Acid. " This appears to be a matter of guilt

by association; perhaps because one form of Mu Tong is Clematis. Although

we see no danger in using Wei Ling Xian, it is best to handle it like the

rest of the above herbs. If patients who have been taking Wei Ling Xian ask

about the safety of their herbs, a response could include the following

information:

· Wei Ling Xian has a long history of safe use, even at high dosages. It

has not been linked to aristolochic acid toxicity either here or abroad.

The FDA has asked us to discontinue its use as a precautionary measure, and

we are complying with that request.

What Is the Next Step?

There are many questions that remain unanswered. How stable is aristolochic

acid? How well does it survive the boiling process? If boiling reduces its

presence, does that mean that crude powders are less safe than powdered

extracts or decoctions? Is it more soluble in alcohol or water? Could other

herbs in the formula such as Gan Cao or Sheng Jiang reduce its toxicity?

Did the concomitant use of Western drugs contribute to the nephrotoxicity

of the Belgian cases, and are there other herb-drug combinations that could

cause the same problem? What were the herb formulae involved in the

Japanese and UK cases, and how were they administered? Why did the

practitioner continue to dispense them for such a long period of time? Is

it possible for a practitioner to distinguish herbs like Aristolochia,

Akebia and Clematis by microscopic examination or simple chemical analysis?

We often cite the long history of Chinese medicine as proof of its safety.

But what if the species we now use are different from those contained in

classical formulations? Dang Gui Si Ni San comes from the Shang Han Lun,

and thus it enjoys a nearly two thousand year history of safe use. But if

the species of Mu Tong used in the Han Dynasty was Akebia, how can we be

sure that the modern formulas substituting Aristolochia are equally safe?

There are many forms of aristolochic acid. Are some more toxic than others?

-and if so, which species contain the most toxic forms? Are there any

plants outside the Aristolochia family that contain aristolochic acid? Can

we be sure that the nephrotoxic agent is aristolochic acid alone, or are

there other chemicals within the plants that contributed to the toxic

effects? What other dangerous plant chemicals are in Chinese herbs that we

don't know about?

While it is painful to part with an important herb like Mu Xiang, we should

remember that Chinese medicine is highly flexible and there are. There are

many substitutions that can replace the recalled herbs.

There are deep and disturbing issues involved here. While we have been

trained that incorrect use of Chinese herbs can harm the patient, how many

of us suspected that exceeding short-term administration limits carried the

risk of herb-induced cancer? I wonder how many of us would have interpreted

statements such as " easily injures yin " as a warning of the risk of renal

failure? A purely TCM understanding of herbal function may no longer be

enough.

Many of us have grown up in this field thinking that Mu Tong is Mu Tong and

Fang Ji is Fang Ji, and that the long lists of alternate Latin names in our

textbooks should concern researchers rather than clinicians. The

aristolochic acid crisis has made it clear that we can no longer make these

assumptions. We will need to become far more adept at botanical and

phamocognostic science if our profession is to survive. When we see a word

like " Hocquartia " on a label, we should recognize the danger that it

implies.

At a clinical level, Chinese herbalism is an exacting and meticulous art,

demanding very extensive training and a wide range of knowledge and skills.

As herbal practitioners, we agonize over every little decision in the

process of selecting therapy. We think long and hard over which formula to

prescribe, what modification to use; which combinations to include and

which to avoid. What is the best dosage? Are there any contraindications?

Are we certain of the diagnosis? Should such and such an herb be

dry-roasted or honey roasted?

But the herbal trade that supplies us with our raw materials is all too

often characterized by sloppiness, mislabeling, misidentification, hidden

ingredients, and undisclosed substitutions of species. It is time that we

as a profession take control. The safe supply of herbal materials should be

dominated by professionals, not merchants. While there exist a small number

of honest and scrupulous herb suppliers, they must compete in an

unregulated marketplace where there never seems to be a shortage of

herbalists willing to buy products without asking hard questions.

As a result, it is our profession that will now be answering the hard

questions-questions about safety posed by the general public, the press,

government regulators, even our own patients. The scrutiny is

well-deserved. This is a time for serious reflection, not knee-jerk

defensiveness. The nephropathy cases in Belgium have been the subject of

frequent articles and updates in the professional allopathic literature,

including Lancet and New England Journal of Medicine, dating back to 1993.

The term " Chinese Herb Nephropathy " has since been enshrined as an official

syndrome in the Western medical literature. But in all this time, how many

articles on this subject have you seen in the Oriental medical journals in

this country? How many lectures and updates have been presented at our

conventions? Why has this issue arisen only now in the U.S. when the

European cases have been in the medical literature for ten years?

Some of you may feel that the regulations the FDA will almost surely impose

on our profession will be unfair, and that the precautionary measures

recommended in this memorandum are overkill. But if after the Belgian

cases, these same measures had been taken by practitioners in the UK, two

people would not now be needing kidney transplants.

Pacific College: Building the Future of Oriental Medicine

--------------------------------

Jack Miller, L.Ac., M.A.Ed. | Web Page: www.ormed.edu

President | E-Mail: jmiller

Pacific College of Oriental Medicine | Toll free: 1-800-729-0941

San Diego - 7445 Mission Valley Rd., San Diego, CA 92108

New York - 915 Broadway, 3rd Floor, NY, NY 10010

Chicago - 3725 N. Southport, Chicago, IL 60613

--------------------------------

June 25, 2000

Thanks for this reprint. The letter is excellent and points to the fact that

natural or Classical Chinese does not mean safe. On the other hand we need

to also put things in perspective, and remember for example, that NSAIDs are

implicated in 20,000 deaths in the US alone (many due to Kidney failure as

well). For us as a profession however, this is a clear massage that we can

no longer except historical data blindly and assume that we never do no

harm.

Alon Marcus

-

" " <zrosenberg

Sunday, June 25, 2000 8:28 AM