Stop the Bill S-722

July 8, 2003

Hi every one,

Bundling herbs with other dietary supplements (as Bill S-722 proposes) is trying to suppress the (Chinese) Herbal Medicine from developing into a professional medicine. We should oppose any such attempt. Otherwise, Chinese Herbal Medicine will never be a professional medicine.

It is very important to stop the Bill S-722. It will be a big setback for if S-722 becomes law.

In order to stop the Bill S-722, a new section has been added to the original "Letter to the Congress". The new added section is as follows. The full letter is available at www.chht.biz in the "Congress Letter" section.

Bob Xu

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3.2 Dietary Supplement Safety Act of 2003 (Bill S. 722)

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In March 2003, Senator Dick Durbin (D-IL) introduced the "Dietary Supplement Safety Act of 2003" (Bill S.722) as an attempt to amend the DSHEA of 1994. The goal of the "Dietary Supplement Safety Act of 2003" (S.722) is consistent with our goal in this letter.

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However, the "Dietary Supplement Safety Act of 2003" (S.722) has not addressed the following issues, and will not solve the problem of DSHEA of 1994:

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(1) FDA Restructuring

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As mentioned above, the root cause of the ephedra event was that the current FDA does not have Doctors of (CMDs) and other experts on herbal medicine in the decision making process on herbal medicine. Therefore, the current FDA failed in both efficacy and safety responsibility on herbal medicine.

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Due to the incompetence and conflict of interest, the current FDA could not provide the public with appropriate directions on herbal medicine policy. So the more power the current FDA has, the more mistakes on herbal medicine policy will occur. In the end, the patients and the public will be harmed as it happened before.

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Therefore, the current FDA should not involve in the herbal medicine policy making process any more. A new "FDA Division of Herbal Medicine" should be established to supervise all herbal medicine related policy.

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However, the "Dietary Supplement Safety Act of 2003" (S.722) has not addressed this issue. Instead, it has given the current FDA more power on herbal medicine regulation. Therefore, the "Dietary Supplement Safety Act of 2003" (S.722) will not solve the root cause of the ephedra event, and should not be passed as an amendment for DSHEA of 1994.

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(2) FDA Regulating Standards and Procedures

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The Chinese Herbal Medicine started from millions or billions of clinical trials first. In addition, the mechanism of the multi-body, non-linear system of Chinese Herbal Medicine is completely different from the mechanism of the pharmaceutical drug system. Therefore, the standards and procedure for the evaluation of Chinese Herbal Medicine should be very different from the current standards and procedures for pharmaceutical drugs.

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For example, pharmaceutical drugs are developed in the labs first. They lack clinical tests, and therefore, it is appropriate and necessary to enforce the clinical trial stages for pharmaceutical drugs. However, herbs were made by nature and were applied to human body first thousands or million years ago before being brought into labs now. All the classic patent Chinese Herbal Medicine and formulas have already been tested clinically for millions and billions times. Another 300 or 500 clinical trials required for pharmaceutical drugs are unnecessary for these Chinese Herbal Medicine formulas. Therefore, the clinical trial step can be simplified and waived for all the classic Chinese Herbal Medicines and formulas. This is very difficult for the current FDA to understand, accept, and implement. However, this could be achieved by qualified CMDs and experts on herbal medicine very effectively and professionally after the new "FDA Division of Herbal Medicine" has been established. Above difference between drugs and herbal medicines on clinical trial step is only one example showing that the regulation on herbal medicine should be very different from the regulation on pharmaceutical drugs. (There are many other regulation differences between herbal medicines and pharmaceutical drugs which we do not have enough space to elucidate in details here.)

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However, the "Dietary Supplement Safety Act of 2003" (S.722) let the current FDA apply the pharmaceutical drugs standards and procedures to the herbal medicine evaluation process. This is inappropriate, inapplicable, and wrong.

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(3) Herbal Classification

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As pointed out in this letter and the Supplement to the Recommendation on in the United States of America (which is available at the website www.chht.biz in the section of "White House"), the major problem in the DSHEA of 1994 is the wrong classification of herbs (professional herbal medicine) into dietary and supplements.

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The "Dietary Supplement Safety Act of 2003" (S.722) has not addressed the wrong herbal classification issue in the DSHEA of 1994, and therefore will not solve the problem surrounding the ephedra event and other herbal safety issues.

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Due to above reasons, the "Dietary Supplement Safety Act of 2003" (S.722) should not be passed as an amendment for DSHEA of 1994. A new amendment for the DSHEA of 1994 which covers all the issues addressed in this letter should be proposed.

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3.3 Necessity of Establishing an Independent "Herbal Medicine" Category

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The major flaw of the DSHEA of 1994 is: It mistakenly classified a highly specialized professional medicine -- herbal medicine (herbs) into dietary supplements.

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Herbal medicines are very different from other dietary supplements. Mixing the professional herbal medicine with other dietary supplements is inappropriate and misleading. (For more information on the classification of herbs, please see the Supplement to the Recommendation on in the United States of America which is available at the website www.chht.biz in the section of "White House".)

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Due to the following reasons, herbal medicine (herb) deserves to be and should become an independent category different from both dietary supplements and pharmaceutical drugs:

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(1) Compositions: Each herb contains dozens of dietary supplements and other chemical ingredients. Currently, many pharmaceutical drugs are obtained from herbs, too. Many pharmaceutical drugs can be found in herbs in various amounts. A herb is in fact a natural product combining many other dietary supplements and pharmaceutical drugs. The herb actually spans and combines both the dietary supplement category and the pharmaceutical drug category. Neither the dietary supplement category nor the pharmaceutical drug category alone can accommodate the herb category. Due to this reason, herb belongs to a very unique category that deserves to be independent of both dietary supplements and pharmaceutical drugs. Therefore, an independent category for herbs -- herbal medicine category -- has to be established.

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(2) Functions: Herbal Medicine in general, and Chinese Herbal Medicine in particular, have been practiced for thousands or million years. Millions and billions of clinical trials prove that Herbal Medicine can prevent, diagnose, treat, and cure diseases and illnesses. These facts separate the Herbal Medicine from other dietary supplements. Therefore, Herbal Medicine should be taken out of the dietary supplements category and be established as an independent category.

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(3) Scope of Practice: Millions and billions of clinical practices of Chinese Herbal Medicine prove that the Chinese Herbal Medicine can be effective for all diseases and illnesses ever existed on earth as long as the diagnosis and treatment procedures are appropriate. This large scope of practice undoubtedly gives Herbal Medicine a unique position which should be different from other dietary supplements.

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(4) Safety: Millions and billions of clinical practices of Chinese Herbal Medicine prove that Herbal Medicine could be very safe if it is administered by qualified Doctors of (CMDs) or other qualified practitioners of Herbal Medicine. Due to this reason, it is inappropriate to place the Herbal Medicine into the pharmaceutical drugs category which is usually much more dangerous and harmful than herbal medicine category.

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Therefore, an independent herbal medicine category should be established.

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In fact, most dietary supplements accidents and safety issues surrounding the DSHEA of 1994 are related to herbs (herbal medicine, more specifically, the ephedra and Chinese Herbal Medicine). Except for herbal medicine (herbs), other dietary supplements in the DSHEA of 1994 should remain intact.

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Because all the problems associated with the DSHEA of 1994 were caused by bundling the professional herbal medicine to dietary supplements category, what need to be done in amending the DSHEA of 1994 is to correct this mistake, take the herbal medicine (herbs) out of the dietary supplement category, and establish a new "herbal medicine" category. The rest of the DSHEA of 1994 should remain effective and continuously applicable to other dietary supplements.

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After taking the herbal medicine (herbs) out of the dietary supplements category, the new "herbal medicine" category needs to be regulated in accordance with the regulation of the profession of Chinese Herbal Medicine. However, the current FDA is not familiar with this new "herbal medicine" category, and should not involve into its regulation. The new "herbal medicine" category should be regulated by the newly established "FDA Division of Herbal Medicine" which is composed of Doctors of (CMD) and other experts on herbal medicine. Because MDs are not familiar with the highly specialized herbal medicine field, and they also have conflict of interest on herbal medicine policy, MDs should not involve into the new "FDA Division of Herbal Medicine".

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In recognizing Chinese Herbal Medicine, one should overcome the regional or ethnic bias. As mentioned above, the word "" refers not only to the in China, but also to the in more than 100 countries around the world. More and more nations are recognizing and honoring . is a world medicine rather than a regional or ethnic medicine restricted within China.

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Even in America, honoring branches of as an independent professional medicine is nothing new. For example, two smaller branches of -- the acupuncture and the chiropractic (the latter probably was developed from 's Tui Na, An Mo, massage, and Zheng Gu therapy, etc.) -- have already won recognition as professional fields in America. Chinese Herbal Medicine, the major branch of , undoubtedly should win a professional medicine status that it deserves.

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July 9, 2003

, " Bob Xu " <bxu21@h...> wrote:

Due to the incompetence and conflict of interest, the current FDA could not

provide the public with appropriate directions on herbal medicine policy.

My reply: I am no politician and I have been accused of utter lack of

diplomacy on many occasions. However it strikes me that much of the

language I have seen in opposition to FDA from various organizations borders

on inflammatory. I am not sure it wins any converts to begin an official letter

to congress by basically calling the opposition stupid. the veracity of that is

another matter altogether. :-)

I think my goal of unfettered access to supplements for my patients is best

achieved through constructive engagement with the enemy, negotiating for

territory, etc. I believe a full on battle will be lost and we will be left

with

nothing. And in order to do this, we have to treat those who we are working

against as well intentioned but misinformed. If you treat people as anything

worse than that, they will generally not work with you, IMO. and since they,

in this case, have all the power, I think it might behoove us to consider a more

conciliatory tone.

July 9, 2003

> , "Todd" wrote:

> >Due to the incompetence and conflict of interest, the current FDA could not >provide the public with appropriate directions on herbal medicine policy. > >My reply: I am no politician and I have been accused of utter lack of >diplomacy on many occasions. However it strikes me that much of the >language I have seen in opposition to FDA from various organizations borders >on inflammatory. I am not sure it wins any converts to begin an official letter >to congress by basically calling the opposition stupid. the veracity of that is >another matter altogether. :-) > >I think my goal of unfettered access to supplements for my patients is best >achieved through constructive engagement with the enemy, negotiating for >territory, etc. I believe a full on battle will be lost and we will be left with >nothing. And in order to do this, we have to treat those who we are working >against as well intentioned but misinformed. If you treat people as anything >worse than that, they will generally not work with you, IMO. and since they, >in this case, have all the power, I think it might behoove us to consider a more >conciliatory tone. > >Todd

My viewpoints:

(1) I am not politician either. If politics does not attack me, I will not launch the counterattack. Unfortunately, as Doctors of , we are frequently attacked unreasonably by politics. For example, the ephedra event and other herbal incidents deprived of our right to get access to the ephedra and some other herbs. For thousands or millions years, this is the first time that the Doctors of cannot get access to certain herbs due to political reason. This will become a very shameful episode in the history of . What happened to in America are out of political or business considerations instead of medicinal or scientific considerations. We want to avoid politics, but we cannot. So we have to adopt the Chinese saying: Ji Lai Zhi, Ze An Zhi. The goal of the “Letter to the Congress” is to produce a “Politics-free” environment for in America.

(2) Throughout the “Letter to the Congress”, there is no single word such as “stupid” etc. The whole “Letter to the Congress” is based on facts, truths, and reasoning. The strongest word in the letter might be the “incompetence”. This is based on detailed facts and truths: “It is illegal for MDs to practice Chinese Herbal Medicine in China now. It takes 5 or 6 years intensive study and training at University/College of to learn Chinese Herbal Medicine. 4 years Western Medical School study with less than 1 years or zero year study on herbal medicine is incompetent to make policy on herbal medicine…” However, if you feel the word “incompetent” is too strong, I am open to change it to another softer word which could still convey similar meaning (I don’t want to lose meanings in the change).

(3) Since the letter covers wide ranges in both time (back to millions years) and space (around the world), it is inevitable to have some parts inaccurate or incorrect, even though I have tried to avoid such things to happen. As always, I am very open to all critics, comments, or suggestions as long as they provide and list facts and truths to justify their viewpoints. I go by and highly respect facts and truths.

(4) I understand your wishes to have a complete freedom on herbal trade. However, today is very different from 10 years ago when DSHEA of 1994 was passed. Now with more than 120 people’s lives in the ephedra event, it’s impossible to continuously claim “Herbs are safe” and “We don’t need regulation. We want free trade on herbs, etc.” Regulation on herbs is inevitable. Otherwise, with so many victims of herbs, criminal investigations might be launched against the people who still make such irresponsible claims.

(5) I disagree with you respectfully on the saying that a full battle will make us lost and left us nothing. I think we have a 99% or higher chance of winning the battle because we have nothing (power) but facts and truths. As you said, our competitor has all the power now. However, power is not the final judge. In history, there is only one final judge: facts and truths. This has been proved repeatedly in China’s history. I don’t think today will make an exception. In fact, today’s American democratic system is much more friendly to us, to facts and truths than China’s system (We have much more freedom to express our opinions here than in China). This will facilitate the process for facts and truths to achieve the final win.

(6) Recently, I have contacted the IL Attorney General’s office about the unfair treatments and practices towards (Including the wide range of topics mentioned in the “Letter to the Congress” and everything happened under the inappropriate Medical Practice Act). The Attorney General’s office indicated that the unfair treatments and practices towards probably have violated the Anti-trust law. Similar to the anti-trust lawsuit against the Microsoft, every practitioners and doctors of can launch the anti-trust lawsuits against any unfair treatments and practices towards . The legal lawsuit is not our first choice, but we don’t promise giving it up if we are continuously mistreated and deprived of the rights to practice . With this legal weapon at hand, you and all other doctors and practitioners of should not fear any retaliation anymore. (I know some MDs fully support . So even within our competitors, there are differences.) I believe the current power will not retaliate or misuse their power again.

Based on above discussion, you should be confident that there is nothing to fear. The facts and truths will prevail. We should win and we will win.

Bob XuMSN 8 helps ELIMINATE E-MAIL VIRUSES. Get 2 months FREE*.