banning of Chinese herbal formula in Canada

[Guest guest]

Dear friends,

Here is a letter from Harriet Beinfield pertaining to a product designed

by her and Efrem as a pediatric prescription that was 'banned' in Canada at

the docks. She has asked me to distribute this information freely.

 

 

 

March 6, 2001

 

Dear Colleagues,

 

The Canadian Health Products and Food Branch issued a warning on February

28, 2001 requesting the recall of the Chinese Modular Solutions pediatric

formula Chest Relief. Although there has not been a single complaint or

report of an adverse event, Health Canada alleges that, ³Šthe use of or

exposure to the product will cause serious or adverse health consequences or

death.² Health Canada alleges that this formula is potentially hazardous not

because of any actual harm, but because it contains three ingredients:

Trichosanthes kirilowii seed (gua lou zi), Magnolia officinalis root bark

(hou po), and Fritillaria thunbergii bulb (zhe bei mu).

 

Although Health Canada's objection to this formula is apparently based on

laboratory research, the science does not support the allegation. We do not

agree with the decision of Health Canada, nor do we find their logic,

methodology, and conclusions reasonable or compelling. It is critical for

the Chinese medicine community to understand the process by which such

allegations arise and to appreciate how regulatory policies are often

formulated. An atmosphere of alarm, the public perception of risk, and the

escalation of regulatory restraints on our access to Chinese herbs impacts

the practice of Chinese medicine profoundly in North America.

 

To do no harm is our first ethical principle as health care providers,

regardless of the kind of medicine we practice. As formulators of herbal

products, we are exquisitely sensitive to the quality and safety of our

formulas. Kan Herb Company diligently insures that the highest manufacturing

standards are met and exceeded. Raw materials are examined for botanical

identity and assayed for heavy metal, microbial, pesticide, fungicide, and

herbicide contamination.

 

We are stunned that Chest Relief, a formula that has benefited many hundreds

of children since it was introduced in 1994, is now banned in Canada. Let¹s

examine the evidence upon which this determination was made.

 

A Health Canada agent informed Kan Herb Company that several physicians who

advise that agency determined Trichosanthes, Magnolia, and Fritillaria to be

toxic ingredients based on references that she declined to cite. Chest

Relief contains Trichosanthes seed (not Trichosanthes root), which contains

no toxic compounds. Clearly, the Canadian physicians were unaware of the

distinction between Trichosanthes seed and root. The root contains a

protein called trichosanthin with a variety of established therapeutic uses.

The pure compound, when administered by injection, stimulates uterine

contractions (similar to oxytocin) and is used in China to facilitate

mid-term abortion. Under the name Compound Q, trichosanthin was used by

American physicians as an alternative to anti-viral drugs during the 1980s

to treat HIV/AIDS. Overdoses of trichosanthin can cause liver and kidney

damage as well as damage to the placenta and fetus.

 

Weidong Lu, MD, L.Ac., Chairman of the Chinese Herbal Medicine Department at

the New England School of Acupuncture, explains that trichosanthin is a type

of protein that is inactivated by digestive enzymes or by decocting the herb

in boiling water. Trichosanthin cannot be absorbed as an active protein by

the intestine from either the crude herbal material or the water extract.

He further states that trichosanthin can only exert toxicity via intravenous

or intramuscular injection, and that overdoses of injected Trichosanthes

root may cause allergic reactions that include malaise, sore throat,

headache, swelling, itching, and rashes. He maintains that Trichosanthes

root is non-toxic when consumed orally in appropriate doses. Trichosanthes

seed, however, contains primarily fatty acids, saponins, and resins that

have no known toxicity. Trichosanthes seed contributes mucolytic and

anti-tussive properties and comprises 4 % by weight or 11 mg of the Chest

Relief formula.

 

Dr. Weidong Lu contacted two scientists in China who were in charge of a

study of trichosanthin protein from 1970 to 1980. They confirmed that

trichosanthin, like other proteins, would be inactivated by heat or by

digestive enzymes in the intestine. They emphasized that trichosanthin only

has an abortifacient effect when injected. Again, gua lou ren, the seed of

tian hua fen (Trichosanthes root) does not contain trichosanthin protein.

Dr Lu stated, ³My guess is that those doctors in Canada who decided to ban

the product did not know that trichosanthin is only found in the root of the

herb, not in the seed. What a mistake!²

 

The root bark of Magnolia is known to contain several alkaloids, including

magnocurarine and turbocurarine. When administered by intravenous or

intraperitoneal injection to laboratory animals, these compounds can cause

semi-paralysis of skeletal muscles as well as respiratory paralysis.

Respiratory and muscular paralysis occur in animals when doses of 4-6 g/kg

are administered by injection, roughly 600 to 4,000 times the amount

contained in the recommended daily dose administered orally to a human

child. In an experimental study, the decoction of Magnolia bark was given

to mice orally at a dose of 60g/kg. No abnormal effects were observed in

the mice during the study. Since magno- and turbocurarine represent only

0.07 % by weight of the crude herbal material, 11 mg of Magnolia root bark

(4 % of the formula Chest Relief) contains roughly 0.008 mg of the

alkaloids, a minute quantity. There is no pharmacological information to

suggest that the crude Magnolia root bark or its extracts will produce toxic

effects via oral administration in humans. Magnolia root bark contributes

anti-spasmodic and anti-tussive properties to the Chest Relief formula.

 

Fritillaria bulb is known to contain sixteen different alkaloids that

comprise up to 0.4 % of the herb by weight. When administered by

intravenous injection to rabbits or cats, these alkaloids will produce

respiratory depression in doses of 8-12 mg/kg. Fritillaria comprises 11 %

by weight or 30 mg of the orally administered Chest Relief formula. This

equals 0.1 mg of alkaloid per tablet, only 1/80th to 1/120th the amount

injected into laboratory animals. Fritillaria bulb contributes mucolytic

and anti-tussive properties to the Chest Relief formula.

 

Even the highest daily dose of Chest Relief recommended to children could

not produce the adverse effects observed in laboratory animals. In fact,

none of the reference literature suggests that oral administration of these

herbs, in commonly prescribed dosages, poses any health risk. To the

contrary, these three herbs are among the most commonly used for effectively

treating a wide spectrum of respiratory ailments in adults and children. To

allege that the presence of minuscule quantities of proteins or alkaloids

confer a high risk of producing harmful effects in humans is without

corroborating scientific evidence.

 

There is always risk, not only in medicine, but in the course of daily life.

Some children have an anaphylactic reaction to peanuts. Many foods are

sprayed with carcinogenic and teratogenic chemicals. Strawberries are

sprayed with methyl bromide, a toxin that can trigger severe and chronic

respiratory distress, particularly in children whose playgrounds border

agricultural land. It has been virtually a losing struggle to convince the

regulatory agencies mandated to protect our health to remove thousands of

household chemicals and food contaminants from our homes and markets,

despite clear scientific evidence of harm. Our water, air, and soil often

harbor contaminants that make our environment questionably secure. Safety

and risk are always relative, never absolute.

 

According to a study by Bruce Pomeranz et al published in JAMA (1998),

adverse events associated with prescription drugs were the fourth leading

cause of death in the United States. The results of 39 studies of harmful

drug reactions suggest that they could affect as many as 2.2 million

hospital patients a year, causing 106,000 deaths. This is equivalent to 4.6

per cent of all recorded deaths. An average of 6.7% of all hospitalized

patients experience a fatal drug reaction each year, according to the study.

These figures are probably conservative, since the study did not include

patient outcomes linked to errors in drug administration, overdoses, drug

abuse and therapeutic failures.

 

Compared to FDA approved over-the-counter (OTC) drugs for children, Chinese

herbal medicine is extremely low risk and possibly more effective. According

to the American Academy of Pediatrics (AAP), there are no well-controlled

scientific studies that support the efficacy and safety of narcotics and

cough suppressants in children. Recognized harmful effects of

over-the-counter cough remedies for children include: rapid heart beat,

abnormal heart rhythms, sleeplessness, high blood pressure, vomiting, and

seizures from decongestants; breathing problems, sedation, excitability,

upset stomach, rapid heart beat, abnormal heart rhythms, seizures, dry

mouth, and blurred vision from antihistamines; respiratory inhibition from

cough suppressants; and upset stomach, sleepiness, headache, and rash from

expectorants.

 

Those who evaluate issues of herbal safety for governmental agencies appear

to have little or no training in herbal pharmacology, pharmacognosy, or the

clinical practice of herbal medicine, yet they wield the hammer of

scientific authority to condemn it. The formula Chest Relief has not

provoked a single complaint or report of an adverse reaction‹neither is it

compromised by a litany of possible side effects like those listed for OTC

respiratory medicines. Based on the evidence, or lack thereof, it appears

that Chest Relief is being inappropriately banned.

 

We have limited power to modify the restrictive policies of regulatory

agencies, so we must comply with their decrees. But to allow ourselves,

through fear, to accept alarmist distortions, unsubstantiated allegations,

and misinformation published by those agencies is a fatal error.

 

It is our duty as Chinese medicine professionals to become articulate,

knowledgeable, and skillful advocates for our own medicine. This means that

in addition to educating ourselves and our patients, we must reach out to

the public and the health care community through concerted and persistent

efforts to provide the best information possible. We must support,

initiate, and evaluate bona fide efforts to investigate and illuminate the

safety and effectiveness of Chinese medicine through laboratory and clinical

studies. While waiting for data, it is imperative that we learn to respond

quickly and aggressively to negative reporting, overcoming defensiveness and

gloomy resignation. We must believe in ourselves along with the evidence,

all the more so when others doubt us.

 

Respectfully,

 

Efrem Korngold, L.Ac., O.M.D.

Harriet Beinfield, L.Ac.

[Guest guest]

on 3/7/01 1:54 PM, at zrosenberg wrote:

 

> Dear friends,

> Here is a letter from Harriet Beinfield pertaining to a product designed

> by her and Efrem as a pediatric prescription that was 'banned' in Canada at

> the docks. She has asked me to distribute this information freely.

>

>

 

I am saddened to read this. I have been working on a pediatric line myself.

Now I wonder if I should back off the project. The climate out there is

increasingly hostile.

Cara