Letter to the Congress

(Original)

Bob Xu, CMD, MS

 

To:                   The United States Congress

From:              Bob Xu, CMD, MS   www.AmericanChineseMedicineAssociation.org

Endorsed by: Acupuncture and Oriental Medicine National Coalition (AOMNC)

RE:                 (1) The Ephedra event;  (2) The FDA Restructuring;  (3) The 1994 DSHEA Amendment;

(4) Insurance Coverage

DATE:            August 2002

 

Dear Honorable Congressional Representatives:

 

The ephedra event has claimed more than a hundred lives in the United States, and has drawn great attention from the media and the public.  Many people are wondering … what caused the ephedra and other herbal incidents?  Why the FDA did not prevent such events from happening beforehand?  How could we prevent similar incidents from happening again?

 

For the best interest of the public, this letter will address these and related issues in order to prevent such incidents from happening again.

 

  1. The Ephedra Event

 

1.1 Background

 

Ephedra is one of the thousands of herbs used in Chinese Herbal Medicine.  In order to understand the ephedra event and other herbal incidents, we need first to understand the Chinese Herbal Medicine (CHM).

 

Due to the long history of the practice of Chinese Medicine, it is very difficult to trace back to its origin.  The earliest books available with established theory on Chinese Medicine were written more than two thousand years ago.  Because books earlier than two thousand years ago were unable to be preserved, there might be earlier books containing established theory on Chinese Medicine that were unavailable now.  Because Chinese Medicine was established through a long-term trial and error process, it took a very long time from the beginning of the practice of Chinese Medicine to the establishment of a complete theory.  Therefore, it is generally estimated that the beginning of the practice of Chinese Medicine might start around hundreds of thousands or even million years ago.

 

During its long history, Chinese Medicine had directly and indirectly influenced the development of many herbal medicines around the globe, including but not limited to the herbal medicines in Japan, Korea, Tibet, Vietnam, Taiwan, Hong Kong, Singapore, Malaysia, Philippines, Indonesia, etc.  Through the Silk Road and other cultural exchanges, Chinese Medicine had been exported to Europe and other continents hundreds and thousands years ago, had been practiced in more than 100 countries around the world, and had influenced the development of many other herbal medicines in regions outside Asia.  The influence of Chinese Medicine on other alternative medicines (including homeopathy, naturopathy, chiropractic, physical therapy, etc.) could be much more profound and significant than most people realize.

 

Therefore, Chinese Medicine is in a very unique position in the Complementary and Alternative Medicine (CAM) family.  Chinese Medicine together with other CAM developed under its influence serve the largest CAM patient population in the world.

 

As a result, Chinese Medicine has become a world medicine.  Today, the term “Chinese Medicine” refers not only to the Chinese Medicine inside China, but also to the Chinese Medicine in other Asian countries, Europe, Africa, America, Australia, etc. more than 100 countries.  The word “Chinese” in Chinese Medicine has lost its original regional or ethnic meaning, and has become an abstract term representing a world medicine.

 

Due to the widespread practice of Chinese Medicine around the globe, many herbal medicine incidents (including the ephedra event) were inevitably involved with Chinese Herbal Medicine (CHM) — the main component of Chinese Medicine.  From Japanese incident to Hong Kong incident, from European incident to American incident, etc., Chinese Herbal Medicine became the foremost target whenever an herbal medicine incident occurred.

 

However, when one analyzes these incidents in more details, one could find that in most cases, these incidents were caused by inappropriate applications and/or the public abuses of herbs rather than the fault of Chinese Herbal Medicine.

 

1.2 The Ephedra Event

 

Ephedra is a common herb that has been used in Chinese Herbal Medicine to treat many diseases and illnesses for hundreds and thousands of years in China and around the globe.  Thousands of years of clinical practice of Chinese Herbal Medicine proves that herbs (including the ephedra) are medicinal materials, and herbs are called “herbal medicines” in China since the beginning of Chinese Medicine.

 

In the United States, however, the ephedra and other herbs currently are classified under the FDA’s foods and dietary supplement category.

 

Doctors of Chinese Medicine (CMDs) feel that this classification is inaccurate, inappropriate, and misleading.  The FDA’s classification of herbs as foods and dietary supplements is in direct contrast to the CMDs’ viewpoint of the medicinal nature of herbs, and may cause the American public to repeat many appalling results due to the harmful herbal side effects.  China learned the hard way (by trial and error) throughout it’s long history, and has incorporated its learning into the professional practice of herbal medicine.  It is inappropriate for people today (in both America and other nations) to repeat the historical lessons in the long history of Chinese Medicine.

 

Due to the inappropriate classification of herbs, many people in America think that the ephedra and other herbs are as safe as the foods and dietary supplements.  Therefore, they take herbs in a way similar to taking the foods and dietary supplements.

 

As mentioned above, herbs are called “herbal medicines” in China.  As “herbal medicines”, there are very strict indications for the application of all herbs.  The ephedra is no exception.  According to the Pharmacopoeia of the People’s Republic of China and other authoritative references on Chinese Herbal Medicine, the indications for the application of ephedra are: (1) Common cold of wind-cold type with aversion to cold, anhidrosis, headache, floating and tense pulse; (2) Cough of wind-cold excessive type with lung-qi obstruction; (3) Asthma of wind-cold type with phlegm retention obstructing the lung-qi; and (4) Edema of wind type with exterior syndrome.

 

Many victims of the ephedra event in America were over-weight/obesity people and athletes.  Neither over-weight/obesity people nor athletes fall into any of above categories.  In other words, there is no indication for these people to take the ephedra from the beginning.  Therefore, the ephedra event and other herbal incidents belong to the public’s inappropriate application and abuse of herbs in nature.  These incidents stemmed from the perceived safety of use that users assumed due to the FDA classification of herbs as foods and dietary supplements.

 

Because herbs are “herbal medicine”, every herb can cause a similar “ephedra” event if let the public abuse the herb.  So if herbs continue to be classified as foods and dietary supplements, many more situations like the ephedra incident will follow, and many more people will become victims of the inappropriate herb classification.  The only solution to prevent similar ephedra events from happening again is to take the herb (herbal medicine) out of the foods and dietary supplements category, establish an independent herbal medicine category, and regulate the profession of herbal medicine.

 

In December 2001 (many months before the report of the ephedra event), in the public’s best interest and to protect the integrity of the profession of Chinese Medicine, the “Recommendation on Chinese Medicine in the United States of America” was submitted to the White House Commission on Complementary and Alternative Medicine Policy.  In addition, a Supplement to the Recommendation on Chinese Medicine in the United States of America was sent in February 2002 [1].

 

That Recommendation and its Supplement explained in details the potential dangerousness of the public practice and abuse of herbal medicines (herbs) under the inappropriate classification of herbs (as foods and dietary supplements), and called upon attention to this important public safety issue.

 

If the issues addressed in that Recommendation and its Supplement had been timely resolved, the ephedra event could be prevented from the beginning, and many people’s lives in the ephedra event could be saved.  Unfortunately, the Recommendation and its Supplement had not drawn enough attention from appropriate authorities at that time, and more than 100 people died of the ephedra event in America.

 

Due to above reasons, the current FDA deserves an official apology to and appropriate compensation for the victims of the ephedra event and other herbal incidents.  It is inappropriate to transfer the target of responsibility to the herbs and take the ephedra as a scapegoat.

 

  1. Proposal:  Establishment of the “FDA Division of Herbal Medicine”

 

The Food and Drug Administration (FDA) has two responsibilities for the public: (a) Efficacy — To provide the public with effective foods and drugs for the promotion of health, prevention of diseases, and treatment of illnesses. (b) Safety — To ensure that the foods and drugs recommended by the FDA are safe to the public.

 

The current FDA has highly successful experiences and records in regulating the foods dietary supplements (except herbs) and pharmaceutical drugs.  It has made great achievements and contributions to the American public and has established a leadership position in the world in above areas.

 

However, after entering into a new area — the herbal medicine field, the current FDA has met many challenges and difficulties.  In fact, all these years’ records indicate that the current FDA actually has failed in both efficacy and safety responsibilities in regarding to the herbal medicine policies.

 

2.1  The Current FDA’s Failures on Herbal Medicine Policy

 

(A) FDA’s Failure on the Efficacy of Herbal Medicine 

 

For many years, the FDA has required that all herbal products make a disclaimer stating that “This product is not intended to diagnose, treat, cure, or prevent any disease”.  This disclaimer requirement is far away from the truth and is in direct contrary to facts, history, and science.

 

During its long history, Chinese Herbal Medicine has been proved to be able to diagnose, treat, cure, or prevent diseases and illnesses millions and billions of times.  Considering China’s population (more than 1.3 billion), considering the widespread practice of Chinese Herbal Medicine (it has been practiced in more than 100 countries), considering the influence of Chinese Herbal Medicine (many nation’s herbal medicines in both Asia and other continents were developed from or influenced by the Chinese Herbal Medicine), and considering the long history of the practice of Chinese Herbal Medicine (more than hundreds and thousands or even million years), Chinese Herbal Medicine and the herbal medicines developed under its influence have already diagnosed, treated, cured, and prevented diseases and illnesses millions and billions times.  Accumulating all the clinical practices throughout the thousands or million years’ history, Chinese Herbal Medicine and other herbal medicines together have probably diagnosed, treated, cured, and prevented the largest patient population in the entire human history.

 

Millions and billions of clinical practices prove that many diseases and illnesses that could not be treated or cured by Western Medicine can be successfully treated and cured by Chinese Herbal Medicine.  However, due to the FDA’s disclaimer requirement, the herbal medicine was labeled as a “folk medicine” and was regarded as non-scientific and ineffective.  As a result, many American patients doubted, refused, hesitated, delayed, and were prevented from seeking Chinese Herbal Medicine treatments.  Many patients have missed the best time and opportunity to seek the treatment by means of a very effective world medicine.  This has led to many patients suffering from diseases and illnesses that initially could be successfully treated or cured by Chinese Herbal Medicine.  Due to the unavailability to get access to the Chinese Herbal Medicine treatments, many patients’ diseases and illnesses had become worsened and deteriorated.  In certain cases, patients ended up in unnecessary death due to the inaccessibility to the effective Chinese Herbal Medicine.

 

Inaction and/or withholding information on an effective medicine is inappropriate and irresponsible to patients and the public.  It is also against the basic moral and goal of medicine — fighting diseases and saving lives.

 

Therefore, the FDA’s disclaimer requirement for herbal products is contrary to millions and billions of facts and truths.  This represents the current FDA’s failure on the efficacy of herbal medicine policy.

 

(B) FDA’s Failure on the Safety of Herbal Medicine 

 

The public trusts the FDA and follows the FDA’s directions (on herb classification).  As mentioned above, the current FDA has sent an inappropriate message to the public by telling them that herbs are as safe as the foods and dietary supplements.  This message has led to the public abuse of herbs (including the ephedra) and has claimed over a hundred victims in America.  So the ephedra event and other herbal incidents have actually revealed the serious flaws of the FDA’s inappropriate herbal classification.

 

Therefore, the current FDA failed in the safety responsibility on herbal medicine policy, too.

 

In sum, the current FDA failed in both efficacy and safety responsibilities with regard to the herbal medicine policy.

 

2.2  The Current FDA’s Oscillating Policy on Herbal Medicine

 

After herbal incidents occurred, the causes of these incidents were usually attributed to the toxicity of related herbs and the dangerousness of Chinese Herbal Medicine.  As a result, the FDA oscillated from one extreme (let people take herbs in a way similar to taking dietary supplements which led to the public abuse of herbs) to another (completely ban related herbs so that even Doctors of Chinese Medicine cannot get access to the banned herbs).  The current FDA does not have an appropriate, stable, and consistent policy on herbal medicine.

 

Banning the related herbs is another inappropriate decision the current FDA has made.  Let’s discuss this from several viewpoints.

 

(A) Viewpoint of the Herbs

 

Herbs (including the ephedra) cannot speak.  Herbs have never labeled themselves to be as safe as foods and dietary supplements.  Herbs also have not let the public abuse them.  Herbs today are the same as they were thousands and thousands years ago.  Therefore, herbs (including the ephedra) are innocent and should not be blamed, punished, and banned due to the herbal incidents.

 

(B) Viewpoint of the Profession of Chinese Medicine

 

The profession of Chinese Medicine has never declared that herbs are as safe as foods and dietary supplements.  On the contrary, the profession of Chinese Medicine always stresses that herbs are “herbal medicines“.  As “herbal medicines“, herbs can be very dangerous if taken inappropriately.  The profession of Chinese Medicine always cautions the public not to take herbs at their own decisions.  Therefore, it is inappropriate to target the Chinese Herbal Medicine for the herbal medicine incidents.

 

(C) Viewpoint on Banning Herbs 

 

Illinois decides to ban ephedra.  Other states probably will follow.

 

Banning the ephedra is an afterward-step that does not have preventive function.  All herbs can cause side effects and lead to herbal incidents if the situation of public abuses herbs (herbal medicine) continues.  What we need to do in order to prevent future herbal incidents from happening again is to address the root cause of the ephedra event — inappropriate herbal classification as foods and dietary supplements — so that the public will not abuse herbs in the future.  The most important measurement is to take the herbs (herbal medicine) out of the dietary supplement category, establish a new herbal medicine category, and regulate the profession of herbal medicine.

 

Banning the ephedra is to take an innocent herb as a scapegoat and transfer or shift the target of responsibility.  Because it does not address the root cause of the ephedra event, it will not solve the problem of herbal incidents in the future.

 

The argument to ban the ephedra is that the ephedra is a potential killer.  However, all pharmaceutical drugs are much more potent potential killers than the ephedra if let the public abuse the pharmaceutical drugs.  If the FDA did not regulate chemical drugs and let the public take the drugs by themselves in a way similar to taking foods and dietary supplements, thousands or millions people (much higher than the number of victims of the ephedra event) would become victims of the drugs’ harmful side effects.  Because of this potential dangerousness, should the FDA completely ban all the chemical drugs?  The answer is not.  When the drugs are in the public’s hands, they are very dangerous and are potential killers.  But when the drugs are in qualified MD’s hands, they are safe and life-saving.  What the FDA does appropriately on pharmaceutical drugs is to regulate them, and only let qualified MDs prescribe pharmaceutical drugs.

 

In a similar way, if herbs were not classified as foods and dietary supplements (so that the public will not abuse them), if herbs with potential side effects are regulated as “prescription herbs“, and if only qualified Doctors of Chinese Medicine (CMDs) can prescribe them, they would not be potential killer at all.  Herbal medicines can be dangerous when they are in the hands of the public, but can be very safe and life-saving when they are in the hands of qualified CMDs.  This is true for thousands and thousands years in China and around the globe where Chinese Medicine has been practiced.  It should be true today in America too.

 

In short, banning the ephedra is equal to banning all pharmaceutical drugs.  If the latter should not be proceeded, the former should not be proceeded either.  If pharmaceutical drugs should be regulated rather than banned, the herbal medicines (herbs) should be regulated rather than banned too.

 

In practice, the American Chinese Medicine Association (ACMA) has applied the ephedra (and other herbs that the FDA intends to ban) to many patients to treat different diseases, and has obtained very good therapeutic outcomes without any side effects.

 

All herbs (including ephedra) have already become an integral part of the Chinese Herbal Medicine system.  All herbs (including ephedra) have their therapeutic functions and roles in treating different diseases.  All herbs (including ephedra) are very important in treating diseases that have indications to apply them.  The herbs can be neither toxic nor dangerous if they are administered appropriately by qualified CMDs.  This has been proved clinically in China for thousands and thousands years.  Complete banning of any herbs (including ephedra) is inappropriate and wrong.  If some herbs (including ephedra) are completely banned, many diseases that have indications to apply these banned herbs could not be treated and cured.  In the end, it is the patients who will suffer. The patients and the public will suffer and be harmed due to the lack of access to these herbs that are of crucial importance for treating corresponding diseases.

 

In sum, in the best interest of patients, no herb (including ephedra) should be completely banned, just as no pharmaceutical drug should be completely banned.  Those “dangerous” herbs should be regulated as “prescription herbs” in a way similar to the regulation of prescription drugs.  These herbs should be prescribed by qualified CMDs.  Most other safer herbs can be continuously classified as “over-the-counter herbs“.

 

2.3  Root Cause of the Current FDA’s Failure on Herbal Medicine Policy

 

Now the question is: Why the current FDA failed in both efficacy and safety responsibilities on herbal medicine?  Why the current FDA oscillates between one extreme (informing the public that the herbs are as safe as foods and dietary supplements, which led to the public abuse of Chinese herbs and resulted in many serious incidents) to another extreme (completely banning the related herbs which are very important in treating many diseases)?  Why the FDA made one mistake after another on the herbal medicine policy?  Why the FDA fails to provide the public with consistent policies on the safety and efficacy of herbal medicine?

 

The root cause of all these problems is because the current FDA does not have qualified Doctors of Chinese Medicine (CMDs) or other experts of herbal medicine with equivalent qualifications in its decision making process on herbal medicine.

 

Currently around the globe, the Doctor of Chinese Medicine (CMD) degree is the most comprehensive, systematic, and advanced professional degree in clinical herbal medicine.  It takes 5 or 6 years of intensive and rigorous study and training at the University/College of Chinese Medicine in China (which are parallel to but completely different from the Western medical schools) to obtain a CMD degree.  Because the Chinese Herbal Medicine has a clinical history much longer than that of Western Medicine, the study and clinical training loads at the University/College of Chinese Medicine are extremely high.

 

Due to above facts, Chinese Herbal Medicine is a highly specialized professional medicine.  MDs trained at Western medical schools are far short in the knowledge on Chinese Herbal Medicine.

 

As a highly specialized professional medicine, Chinese Herbal Medicine should be highly regulated.  Because Chinese Herbal Medicine is completely different from Western Medicine, for the best interest of the public and to ensure patient safety, MDs are not permitted to practice herbal medicine in China, and vice versa (It is illegal for CMD to practice Western Medicine, and it is illegal for MDs to practice acupuncture and herbal medicine in China).  Only CMDs are qualified to practice acupuncture and herbal medicine in China.

 

Similarly in America, it is inappropriate, dangerous, and very risky for CMD to practice Western Medicine, and it is also inappropriate, dangerous, and very risky for MDs to practice acupuncture and Chinese Herbal Medicine.

 

Due to the following two reasons, MDs in the FDA without adequate study and training in herbal medicine should avoid involving into the decision making process on herbal medicine policy:

 

(A)  Being Unqualified:  Because it takes 5 or 6 years to obtain a CMD degree at the University/College of Chinese Medicine in China, the Chinese Herbal Medicine is a very specialized professional medicine.  The 4 years of study and training at Western medical schools in America with less than one year or even none study and training in herbal medicine cannot provide enough knowledge for MDs to make appropriate and consistent policy on (Chinese) Herbal Medicine.  Therefore, without adequate training in (Chinese) Herbal Medicine, MDs are not qualified to make decisions on herbal medicine.

 

(B)  Conflict of Interest:  Chinese Herbal Medicine and Western Medicine are long-term competitors with regards to the patient’s market.  If more patients seek the treatment of Chinese Herbal Medicine, fewer patients will seek treatments of Western Medicine.  This has been true for many years in many countries where Chinese Herbal Medicine has been practiced.  Due to this consideration, some MDs might have conflict of interest, and therefore should avoid involving in the decision making process of Chinese Herbal Medicine (This includes the amendment process for the Dietary Supplement Health and Education Act (DSHEA) of 1994, which is closely related with the herbal medicine).  This situation is not unique to Chinese Herbal Medicine and Western Medicine.  It also exists in the relationships between all other competitors.  Some examples include the competition between AT&T and MCI, and the dispute between Microsoft and other software companies.

 

Currently, the FDA does not have qualified CMDs in it.  In other words, the FDA is leading a new field (herbal medicine field) without experts in this field.  It is in an “Outsider leads insider” situation in the field of herbal medicine.  Therefore, making mistakes repeatedly on herbal medicine policy is inevitable for the current FDA.

 

This is the root cause that the current FDA repeatedly made mistakes on the herbal medicine policy, and could not live up to the expectation of the American public.

 

Placing American patients’ and the public’s life and death into the hands of outsiders in a highly specialized professional medicine is irresponsible and wrong.  This abnormal situation is actually harmful to both parties involved:

 

(1) For the public:  The public is harmed on consideration of both efficacy and safety responsibilities by the inappropriate herbal medicine policies made by the current FDA;

 

(2) For the current FDA:  The reputation of the current FDA is harmed by the outcomes of its repeated mistakes caused by the inappropriate policies on herbal medicine.

 

Generally speaking, Chinese Herbal Medicine has two branches:  herbal medicine practice and herbal medicine research.  Because the herbal medicine practice branch relates to patient’s life and death, it has to be strictly regulated.  To ensure the patient safety and to protect the integrity of herbal medicine, practitioners of Chinese Herbal Medicine should be CMDs or experts with equivalent qualifications on herbal medicine.

 

However, the herbal medicine research branch can be and should be more diversified.  Chinese Herbal Medicine has been practiced as a black-box system for thousands or million years.  It has been proved clinically that Chinese Herbal Medicine has high efficacy and safety when practiced by qualified CMDs.  We understand the black-box system holistically, empirically, and clinically.  However, we still do not understand it analytically.

 

To improve the accuracy, consistency, reproducibility, and repetitiveness of Chinese Herbal Medicine, and to achieve the highest efficacy and safety of Chinese Herbal Medicine, the black-box of herbal medicine needs to be elucidated analytically.  Because the underlying mechanism of herbal medicine involves multi-disciplines, it is encouraged and desired to have MDs, pharmacologists, biologists, chemists, botanists, and experts of many other fields to participate in the herbal medicine research.  The knowledge and expertise brought into Chinese Herbal Medicine by these experts will definitely help elucidate the black-box process of Chinese Herbal Medicine.

 

In some sense, the herbal medicine research is in a reverse direction relative to the pharmaceutical drug research.  In the Chinese Herbal Medicine, the clinical trials on human body were performed first for thousands or million years.  Its efficacy and safety were proved directly on the human body.  After thousands years’ millions and billions successful clinical trials, the herbal medicine now is brought back into the lab to undergo the mechanism study.

 

Due to this reason, the standards and procedures for herbal medicine regulation should be very different from that of the pharmaceutical drugs.  This is one of the reasons that the current FDA should not apply the pharmaceutical drug’s evaluation standards and procedures to the Chinese Herbal Medicine.  (There are other reasons on this topic.  Due to space limit, we could not elaborate them here.)  This is also one of the reasons that call for the establishment of the “FDA Division on Herbal Medicine” (see below).

 

Due to historic reason, there is no medical school in US qualified to issue the CMD degree.  As a result, many practitioners of Chinese Herbal Medicine in America do not have a CMD degree.  For these practitioners, some other qualifications established in America such as the National Certification Commission for Acupuncture and Oriental Medicine (NCCAOM) exams certificates, Dipl. Ac., Licensed Acupuncturists, Lic. Ac., Licensed Herbalists, Dipl. C.H., etc. may be considered as a substitute for the CMD qualification temporarily.

 

However, these qualifications on Chinese Medicine established in America vary greatly in quality.  In addition, most of them do not meet the CMD standards.  So in the long run, for the best interest of patients, to ensure the public safety, and to protect the integrity and uphold the highest standards of Chinese Medicine, the CMD degree qualification requirement still need to be installed for future practitioners of Chinese Herbal Medicine.  To fulfill this requirement, medical schools of Chinese Medicine capable of issuing CMD degree need to be established in America.  This probably can be achieved through an evaluation and selection process from current medical schools of Chinese Medicine existed in America.

 

2.4  Proposal:  Establishment of “FDA Division of Herbal Medicine”

 

Generally speaking, drugs belong to a linear system or a single body, non-linear system.  These systems are mathematically solvable.  The current FDA is equipped with many experts in this area, and can therefore supervise and regulate the drug related issues effectively and satisfactorily.

 

However, herbal medicines belong to multi-body, nonlinear systems.  These systems cannot be solved accurately by current mathematical and scientific methods.  The differential equation groups that describe the behavior of herbal medicine systems can not be solved accurately.  The lack of mathematical tools turns the herbal medicine system into a complex system which is much more complicated than the pharmaceutical system.  In other words, the underlying mechanisms of herbal medicines (herbs) are much more complex than that of the pharmaceutical drugs.  For more details on the complexity of Chinese Herbal Medicine, please see the Recommendation on Chinese Medicine in the United States of America [1].

 

The current FDA does not have CMDs and experts in the area of multi-body, nonlinear, complex herbal medicine systems.  This abnormal situation is very risky to the public and patients.  The ephedra event was just a beginning.  If this “Outsider leads insider” situation continues, more and more “ephedra events” will happen, and more and more people will become victims due to this abnormal situation.

 

In order for the FDA to avoid repeating the policy-making mistakes on herbal medicine, and for the best interest of the public, it is time to reform and restructure the current FDA.  It is highly necessary to establish a new “FDA Division of Herbal Medicine” which will be fully in charge of all aspects of herbal medicine policy in the United States of America.

 

After restructuring, the new FDA will become the “Food, Drug, and Herb Administration (FDHA)“.  The new FDHA will be composed of three divisions: (1) Division of Food and Dietary Supplement; (2) Division of Pharmaceutical Drug; and (3) Division of Herbal Medicine.  All three divisions are parallel to one another.

 

In the new FDHA, the current FDA will become the “Division of Food and Dietary Supplement” and the ” Division of Pharmaceutical Drug”, which will not be in charge of issues relating to herbal medicine.

 

The following two departments are needed in the new FDHA’s “Division of Herbal Medicine”:

 

(A) Department of Theoretical Herbal Medicine

 

As mentioned above, the difficulty in understanding the herbal medicine systems lies at the lack of mathematical tools in elucidating the complex herbal medicine systems.  It is due to this reason, the pharmaceutical control study methods cannot be directly applied to the herbal medicine systems.  As long as mathematical tools become available in describing the complex systems, “control study” on herbal medicine systems (which might be different in format from the current pharmaceutical control study) will be possible.

 

Therefore, theoretical study and mathematical breakthrough are crucial in understanding the underlying mechanisms of the complex herbal medicine systems.  Experts with strong mathematics and physics backgrounds are needed in the “Department of Theoretical Herbal Medicine” of the new “FDA Division of Herbal Medicine” in order to conduct the theoretical research on the complex, nonlinear, multi-body herbal medicine systems.

 

(B) Department of Clinical Herbal Medicine

 

For thousands or even million years, due to the lack of mathematical tools in describing the complex herbal medicine systems, herbal medicine has been practiced empirically in China and other parts of the world.  The reputations of herbal medicine (high efficacy and safety etc.) are mainly established through the practice of CMDs and other practitioners of herbal medicine.  Before the theoretical and mathematical breakthrough could be achieved in herbal medicine, the herbal medicine research will still continuously rely on the empirical study as it did for thousands or even million years in China and around the world.  Therefore, experts on clinical herbal medicine, such as CMDs and other experts with equivalent qualifications on herbal medicine, are needed in the “Department of Clinical Herbal Medicine” of the new “FDA Division of Herbal Medicine”.  By relying on the expertise of CMDs, the new FDHA will obtain the medical knowledge and clinical experiences accumulated for hundreds and thousands or even million years, and will be able to avoid the process of re-inventing the wheel.

 

The above proposal for FDA restructuring should not and will not affect current FDA’s achievements and leadership position on foods and drugs policies.  In fact, the establishment of the new “FDA Division of Herbal Medicine” will help strengthen the FDA’s successful areas (foods and drugs) while improve its short area (herbal medicine).

 

The new “FDA Division of Herbal Medicine”, equipped with experts on both theoretical and clinical branches of herbal medicine, will ensure the new FDHA to provide the public with consistent policy on herbal medicine with appropriate guidelines and directions.  This will help the development of herbal medicine with high efficacy and safety in the United States of America.  In the end, it will also be able to restore the public’s confidence on the new FDA (FDHA).

 

2.5  Necessity of Establishing a New “FDA Division of Herbal Medicine” 

 

The following question may be raised:  Is it necessary to establish a new, independent “FDA Division of Herbal Medicine” specifically for herbs (herbal medicines)?

 

There are many members (such as vitamins, minerals, amino acids, enzymes, etc.) in the dietary supplements category.  The herb is only one of them.  Why should the herb be singled out and granted such a special status?

 

The necessity of establishing a new “FDA Division of Herbal Medicine” rests upon the necessity of establishing an independent herbal medicine (herb) category.

 

The Congress defined the term “dietary supplement” in the Dietary Supplement Health and Education Act (DSHEA) of 1994.  A dietary supplement is a product taken by mouth that contains a “dietary ingredient” intended to supplement the diet.

 

“To supplement the diet” may be appropriate for vitamins, minerals, amino acids, enzymes, etc.  However, it is inappropriate for herbs.  Herbal medicines (herbs) are very different from other dietary supplements.  Other dietary supplements are compounds.  They usually contain very few ingredients.  A herb (herbal medicine), however, is a very complicated medicinal material which usually contains large amount of ingredients.  The term “compound” is no longer an appropriate term for herb.  A herb usually contains a large group of different compounds.  Many ingredients in herbs have medicinal functions rather than simply “To supplement the diet”.  Therefore, herbs should be regarded as medicines (herbal medicines).  The complexity of herbs determines that they should be separated from other dietary supplements.

 

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

 

(1)  Compositions: Each herb contains dozens or even hundreds of other dietary supplements and chemical ingredients.  Some of these chemical ingredients have already become sources of pharmaceutical drugs.  Currently, many pharmaceutical drugs are obtained from herbs.  Other chemical ingredients might become potential candidates for future pharmaceutical drugs.  Many pharmaceutical drugs can be found in herbs in various amounts.  Therefore, a herb is in fact a natural product combining many other dietary supplements and pharmaceutical drugs.  The herb spans, covers, combines, and unites both the dietary supplement category and the pharmaceutical drug category.  Therefore, neither the dietary supplement category nor the pharmaceutical drug category alone can accommodate the herb category.  Due to this reason, the 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 — needs to be established.

 

(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 medicinal functions separate the herbal medicine (herb) from other dietary supplements.  Therefore, the herbal medicine (herb) should be taken out of the dietary supplements category and be established as an independent category.

 

(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 herbs (herbal medicine) a unique position that should be different from other dietary supplements.

 

(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 Chinese Medicine (CMDs) or other qualified practitioners of Herbal Medicine.  The safety level and side effects property of herbal medicine are very different from those of pharmaceutical drugs.  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.

 

As a result, 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 Chinese Medicine in the United States of America [1].

 

In the following section, we will discuss in details that the major flaw of the Dietary Supplement Health and Education Act (DSHEA) of 1994” is that it mistakenly classified a highly specialized professional medicine — herbal medicine (herb) into dietary supplements.

 

Based on above considerations, an independent herbal medicine category should be established.  With the establishment of an independent herbal medicine category, an independent “FDA Division of Herbal Medicine” needs to be installed correspondingly to supervise all issues on herbal medicine.

 

  1. Amending the“Dietary Supplement Health and Education Act (DSHEA) of 1994”

 

3.1  Amendment of the 1994 DSHEA

 

The decision to classify herbs as foods and dietary supplements was originally made by the Congress in the Dietary Supplement Health and Education Act (DSHEA) of 1994.  The FDA enforces this law, and the public trusts and follows the FDA.  So the DSHEA of 1994 has been passed on and sent to the public through the current FDA’s guidelines and directions.

 

As mentioned above, herbs are more complicated than both pharmaceutical drugs as well as foods and dietary supplements.  It is inappropriate to classify herbs as foods and dietary supplements.  The DSHEA of 1994 has actually enabled the current FDA to send an inaccurate message to the public by telling the public that herbs are as safe as foods and dietary supplements.  This classification has misled the public and contributed to the increasing occurrence of unfortunate herbal side effect incidents.

 

Considering all the problems and public safety issues associated with the DSHEA of 1994 mentioned above, it is necessary for the Congress to initiate an amendment for the Dietary Supplement Health and Education Act (DSHEA) of 1994, and address the following issues:

 

(1) Remove herbs from the foods and dietary supplements category;

(2) Establish a new, independent category (Herbal Medicine category) for herbs;

(3) Send a clear, accurate, and unambiguous message to the public that herbs are not foods and dietary supplements.  They are herbal medicines.  It could be harmful or dangerous if public take herbal medicines by their own decision.

 

This new “Herbal Medicine” category should be independent of both foods dietary supplements and pharmaceutical drugs categories because:

 

(A)  From the efficacy point of view, herbs in the new “Herbal Medicine” category can prevent, treat, and cure diseases.  This separates the herbs from the foods and dietary supplements.

 

(B)  From the safety point of view, many herbs in the new “Herbal Medicine” category are safe enough that they can be classified as “over-the-counter herbs” as they are now, and become continuously available to the public without prescriptions.  Other herbs (e.g. the ephedra and some herbs which could be abused by the public and could cause serious adverse side effects) in the new “Herbal Medicine” category should be classified as “prescription herbs” which need prescriptions from qualified Doctors of Chinese Medicine (CMDs) or other qualified experts on herbal medicine.  Similar to “prescription drugs”, it is necessary to regulate (rather than ban) the “prescription herbs”.

 

For more details on the appropriate classification of herbs, please see the Supplement to the Recommendation on Chinese Medicine in the United States of America [1].

 

Because most safety 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.

 

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.

 

Corresponding to the establishment of an independent herbal medicine category, a new, independent “FDA Division of Herbal Medicine” should be installed accordingly to supervise and regulate the new herbal medicine category.  The new “FDA Division of Herbal Medicine” should be composed of Doctors of Chinese Medicine (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 without adequate training in herbal medicine should not involve into the new “FDA Division of Herbal Medicine”.

 

One thing needs to be pointed out is that the regulation of Chinese Herbal Medicine is very different from the regulation of pharmaceutical drugs.  Due to the “Bian Zheng Lun Zhi” (one of the fundamental characteristics of Chinese Medicine, i.e. to treat each patient individually based on the individual Zheng), it is impossible to apply a universal herbal medicine or formula for all patients in practice.  Therefore, the CMDs should be empowered with the responsibilities to establish treatment standards and create different formulas for different patients.  For qualified CMDs, it is safe and effective for them to apply all various kinds of herbal medicines and formulas that they believe are appropriate for patients within their expertise.  Qualified CMDs should have full access to all herbs (including the ephedra) and all formulas.  This is the way how the Chinese Herbal Medicine has been practiced and regulated in China.

 

This is a completely new situation that the current FDA has not met before.  Facing this new challenge, a new “FDA Division of Herbal Medicine” should be established in order to install and implement appropriate rules, regulations, and policies on herbal medicine.

 

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

 

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.

 

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:

 

(1) FDA Restructuring

 

As mentioned above, the root cause of the ephedra event was that the current FDA does not have Doctors of Chinese Medicine (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.

 

Because the current FDA has responsibility for the ephedra event, it should make official apology for the victims of the ephedra event, and 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.

 

Because of being unqualified and the 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.

 

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

 

(2) FDA Regulating Standards and Procedures

 

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 procedures for the evaluation of Chinese Herbal Medicine should be very different from the current FDA standards and procedures for pharmaceutical drugs.

 

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 or 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 that we do not have enough space to elucidate in details here.)

 

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.

 

(3) Herbal Classification

 

As pointed out in this letter and the Supplement to the Recommendation on Chinese Medicine in the United States of America [1], the major problem in the DSHEA of 1994 is the inappropriate, misleading, and wrong classification of herbs (professional herbal medicines) as foods and dietary supplements.

 

The “Dietary Supplement Safety Act of 2003” (S.722) has not addressed the wrong herbal classification issue in the DSHEA of 1994.  Therefore, the”Dietary Supplement Safety Act of 2003″ (S.722) will not solve the problem surrounding the ephedra event and other herbal safety issues, and will leave the door open for future herbal incidents to occur.

 

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 theDSHEA of 1994 that covers all the issues addressed in this letter should be proposed.

 

  1. Installing Medical Insurance Coverage for Chinese Herbal Medicine (CHM)

 

4.1 Necessity of Insurance Coverage for CAM

 

Harvard Medical School professors and researchers have conducted several influential national surveys on Complementary and Alternative Medicine in the United States.  Their 1997 survey [2] indicates:

 

“The total visits to CAM (complementary and alternative medicine) providers, 629 million, exceeded total visits to all primary care physicians, 386 million, in 1997.”

 

According to this survey, the CAM became the mainstream medicine in America in 1997.  This fact shows that CAM were very effective, safe, and popular among patients and the public even at a time when most of CAM treatments were not covered by the medical insurance.

 

As mainstream medicine, CAM should be covered by the medical insurance.

 

4.2 Problem of the Term “CAM”

 

Generally speaking, there are two major medicinal systems in the world: the Allopathic Medicine system and the Holistic Medicine system.  The Western Medicine is a representative for the former, and the Chinese Medicine is a representative for the latter.  Most of the Complementary and Alternative Medicine (CAM) members fall into the Holistic Medicine system.

 

The ultimate goal of this “Letter to the Congress” is to open the door for the birth of a “Unified Medicine” (see Section 5. Concluding Remarks).  In order to establish theUnified Medicine, we need first to make clear how many medicines should be unified.

 

One thing needs to be pointed out is that the definition of a professional medicine (such as Chinese Medicine and Western Medicine) is based on the framework of the medicine’s theory, principles, diagnostic techniques, and treatment methods, etc.  It is not based on how many herbs/drugs are used and/or where those herbs/drugs came from.

 

For example, in Western Medicine, each year there are many new drugs being developed.  Some of them are developed in countries other than Western nations.  When a new pharmaceutical drug is developed in China, the new chemical drug cannot be called Chinese Medicine simply because it is developed and/or applied in China.  It still belongs to Western Medicine because its application is directed by the theory of Western Medicine.

 

Similarly, as Chinese Medicine was introduced to many other countries and continents hundreds and thousands years ago, herbs in those countries and regions were introduced and used in the practice of Chinese Medicine there later on.  Although local herbs were introduced into Chinese Medicine there, the applications of herbs in those countries still follow the theory and principle of Chinese Medicine.  Then, the use of local herbs could not change the fact that they were originated from or influenced by Chinese Medicine.  As long as the herbs of those countries and regions are applied under the holistic theory of Chinese Medicine, they should belong to the Chinese Medicine’s Holistic Medicine system.

 

Because Chinese Medicine has the longest history in the CAM family, has the most complete, comprehensive, independent, and systematic theory in the CAM family, was introduced to other countries and continents hundreds and thousands years ago, and has been widely practiced around the globe for long time, the influence of Chinese Medicine on other Complementary and Alternative Medicines could be much more profound and significant than most people realize.

 

Because CAM is a descriptive and inclusive term that contains and compiles many different alternative medicines, the relationships among members of the CAM family are unclear and need to be clarified.

 

The vague term CAM should be discontinued, and medical insurance coverage for CAM should be evaluated and proceeded on a case by case basis.

 

4.3 Relationship Between Chinese Medicine and other CAM members

 

Many sources loosely compile all alternative medicines into CAM assuming that they are parallel to each other and independent of one another.  This is inappropriate and will be destructive to better understanding the Holistic Medicine system.

 

More and more evidences indicate that many Complementary and Alternative Medicines that do not bear names or do not contain terms linking with Chinese Medicine had probably originated, derived, branched, developed from, and/or influenced by Chinese Medicine.

 

The study of historic origins of all CAM members is a huge engineering work requiring cooperation between historians, scientific historians, medical historians, scientists, doctors and practitioners of all CAM fields, etc.  Following are some issues concerning the relationships between Chinese Medicine and other CAM members that demand further systematic studies and research.

 

  1. Chinese Medicine vs. Chiropractic

 

Chiropractic is considered as an independent alternative medicine.  However, more and more evidences indicate that it probably was developed from branches of Chinese Medicine such as Tui Na, An Mo, massage, and Zheng Gu therapy, etc. when Chinese Medicine was introduced to Europe more than 2000 years ago.  Further studies and researches are needed to clarify whether Chiropractic is originated, derived, branched, developed from, and/or influenced by Chinese Medicine.

 

  1. Chinese Medicine vs. Tibet Medicine

 

Some sources single Tibet Medicine out as an independent alternative medicine.  Tibet Medicine uses local, Tibetan herbs.  However, Tibet Medicine employs many Chinese Medicine’s theory, methods, techniques, etc.  Therefore, Tibet Medicine was probably developed from and influenced by Chinese Medicine even though it uses many local Tibetan herbs.  Further studies and researches are needed to clarify whether Tibet Medicine originated, derived, branched, developed from, and/or influenced by Chinese Medicine.

 

  1. Chinese Medicine vs.Naturopathic Medicine

 

Naturopathic Medicine is regarded as an independent alternative medicine by many sources.  However, Naturopathic Medicine uses many concepts and theories of Chinese Medicine.  Although it introduces and uses many American and European herbs, its theory and concepts were closely related to Chinese Medicine.  As mentioned above, using local herbs does not justify a new medicine.  Therefore, further studies and researches are needed to clarify whether Naturopathic Medicine is originated, derived, branched, developed from, and/or influenced by Chinese Medicine.

 

  1. Chinese Medicine vs. Homeopathy

 

Homeopathy is regarded as an independent alternative medicine developed from Europe.  However, Chinese Medicine was introduced to Europe more than 2000 years ago.  Homeopathy only has a few hundred years history.  It was developed in an environment in which Chinese Medicine had been practiced for over thousand years in Europe.  Then what was the influence of Chinese Medicine on it?  Further studies and researches are needed to clarify whether Homeopathy originated, derived, branched, developed from, and/or influenced by Chinese Medicine.

 

  1. Chinese Medicine vs. Ayurvedism

 

Similar to Tibet Medicine, Ayurvedism uses many India local herbs, and is regarded as an independent alternative medicine.  However, some issues need further clarifications:

 

(a) There are close relationships between India Medicine and Chinese Medicine.  Even Yoga is similar to several types of qi gongs practiced in China [Note: China has dozens and hundreds of different types of qi gongs.  Yoga only falls into a few of them.].  The close relationships between the two medicines indicate that there might be influences between them.  A question is raised: In which direction does the influence exert between the two medicines?

 

(b) It was reported that more than 2300 years ago, India regarded the pain as a demon and thought it was the God’s punishment on human beings.  India Medicine was not available for pain treatment at that time.  However, at that time, Chinese Medicine already had mature practice and theory on pain treatments in addition to treatments for many other diseases and illnesses.  This indicates that Chinese Medicine developed earlier than Ayurvedism.

 

(c) Chinese Medicine was introduced to and practiced at most Asian nations near India for hundreds and thousands years.  Most Asian nations use Chinese Medicine.  A question is raised: Is India similar to other Asian nations or is it an exception?

 

(d) Chinese Medicine is a closed medicinal system.  In other words, Chinese Medicine developed within China territory without introduction of other medicines.  Therefore, India Medicine either developed independently or developed from Chinese Medicine.  But it could not be the opposite.

 

To make clear of above issues, further studies and researches are needed to clarify whether Ayurvedism was originated, derived, branched, developed from, and/or influenced by Chinese Medicine from China directly or via other Asian nations that had been using Chinese Medicine for long time.

 

Facing above situations, the following issues need to be addressed:

 

How many Complementary and Alternative Medicines are independent medicines?

 

How many Complementary and Alternative Medicines were originated, derived, branched, and/or developed from, or influenced by the Chinese Medicine?  

 

Is it true that the world Holistic Medicine system was originated from Chinese Medicine? 

 

To answer these questions, complete, systematic, and objective studies on the history of all Complementary and Alternative Medicines are needed, important, and meaningful.

 

If a CAM is developed from or influenced by Chinese Medicine (as the Tibet Medicine, Chiropractic, and many other alternative medicines might do), this relationship should be identified, recognized, and honored.  Recognition of this relationship will:

 

(1) help elucidate the organizational structure within the CAM family;

(2) help better understand the logic and theory of entire Holistic Medicines system;

(3) help establish a more systematic medicinal theory for Holistic Medicine system;

(4) help improve the efficacy and safety of the practice of CAM and Holistic Medicines;

(5) protect the intellectual property rights of one of the most influential world medicine system — Chinese Medicine — from being infringed;

(6) help establish the Unified Medicine — the future medicine of our human being.

 

No matter how many CAM members were developed from or influenced by Chinese Medicine, Chinese Medicine’s status in the world Holistic Medicine system is unshakeable.  As the most systematic, comprehensive, time-tested, and highly effective holistic medicine in the world, Chinese Medicine has been respected and honored by the World Health Organization (WHO), the United Nations (UN), and has been practiced in more than 100 countries around the globe.  From Asia to Europe, from Africa to America, millions and billions of people have been using Chinese Medicine in treating diseases, preventing illnesses, and saving lives.

 

Chinese Medicine, which includes Chinese Herbal Medicine (CHM), Acupuncture, and many other branches of Holistic Medicine, has become increasingly popular in the United States too.  Similar to the patients in over 100 countries around the world, more and more Americans are benefiting from Chinese Medicine in treating all kinds of diseases and illnesses: from diabetes to cancer, from depression to AIDS, etc., all diseases and illnesses existed in Western Medicine can be treated, improved, and/or cured by Chinese Herbal Medicine.  Chinese Herbal Medicine is providing the American public with a whole new world of medicine in promoting health, treating diseases, and curing illnesses.  Just as a special report in the Newsweek magazine (December 2, 2002) states:  “Researchers are finding that traditional Chinese medicine may have a lot to offer.”

 

Recently, many insurance companies have covered the treatment of acupuncture.  However, unlike acupuncture, Chinese Herbal Medicine, the major component of Chinese Medicine, has not received similar recognition from insurance companies.  Because herbs are classified as foods and dietary supplements, and are not subject to the regulation of medicines, insurance companies are not willing to cover herbal treatments.  With the absence of both insurance coverage and regulation of herbal medicine, numerous patients are unable to afford professional administration of herbal treatments, yet the attempts at self-cures had resulted in many dangerous herbal incidents due to inappropriate application or abuse of Chinese herbs.  Consequently, in many cases the important benefits of Chinese herbs are not fully realized for lack of careful administration, and harmful herbal side effects had resulted.

 

Currently, “Does medical insurance cover the Chinese Herbal Medicine?” is the most frequently asked question from the patients.

 

Because the cost of Chinese Herbal Medicine is usually lower than the cost of Western Medicine, the insurance coverage for Chinese Herbal Medicine treatments will lower the overall medical cost in America.  In addition to the high efficacy, Chinese Herbal Medicine will provide a more affordable treatment choice for most Americans.  In the end, it will help solve the high cost problem facing the American health care system.  Due to this reason, we ask you to initiate a bill to address the issue of insurance coverage for Chinese Herbal Medicine.

 

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

 

In fact, honoring branches of Chinese Medicine as an independent professional medicine is not foreign to Americans.  For example, two smaller branches of Chinese Medicine — the acupuncture and the chiropractic — have already won recognition as professional fields in America.  Chinese Herbal Medicine, the major component of Chinese Medicine, undoubtedly should win a professional medicine status that it deserves.

 

  1. Concluding Remarks

 

Reviewing the hundreds and thousands or even million years history of China and Chinese Medicine, what is happening today is really a very short episode.  History is a mirror.  Everything inappropriate or wrong will not last long.  Facts and truths eventually will prevail.  This has been proved repeatedly in the long human history.  Today will not make an exception.  Therefore, we are confident that all the inappropriate situations mentioned in this letter will be corrected.  It is only a matter of time.

 

Chinese Medicine and Western Medicine are two of the most influential medicines in the entire human history.  Both medicines have made great contributions to the survival, prosperous, and civilization of human beings.  They stepped across the borders of their origins (China and Western nations) long time ago, have been helping and serving people of foreign countries, have become world medicines, and belong to the mankind.

 

Although Chinese Medicine and Western Medicine are competitors, they should be cooperators in front of their common enemies — disease and illnesses.  It is inappropriate for Western Medicine to block and resist the Chinese Medicine.  It is also inappropriate for Chinese Medicine to look down upon and replace the Western Medicine.

 

Both Chinese Medicine and Western Medicine have merits as well as shortcomings.  In fighting diseases and saving lives, there is only one medicine — the one that works the best for the patients, no matter what it is named.  The best therapeutic outcome will be achieved when the Chinese Medicine and Western Medicine cooperate with each other and complement one another to form a “Unified Medicine” that combines the merits of both medicines.  Let the Unified Medicine be born.

 

We deeply believe that solutions to above issues will be in the best interest of patients and the American public.  Therefore, we ask that for the best interest of the American public, you initiate a bill to address the issues mentioned in this letter.

 

Thank you.

References

  1. Xu B. Recommendation on Chinese Medicine in the United States of America  to the White House Commission on Complementary and Alternative Medicine Policy.  American Chinese Medicine Association (ACMA) Publication Issue Dec 2001.

 

  1. Eisenberg DM, Davis RB, Ettner SL, Appel S, Wilkey S, Rompay MV, and Kessler RC. Trends in Alternative Medicine Use in the United States, 1990-1997: Results of a Follow-up National Survey,JAMA. 1998; 280: 1569 – 1575.

 

Acknowledgements

Since August 2002, many people have provided valuable feedbacks, comments, and suggestions on the Letter to the Congress.  Especially, we would like to thank the following contributors (They are listed in the order of names, and we apologize for being unable to mention everyone here):

Claudette Baker, L.Ac., Former President, American Association of Oriental Medicine (AAOM); Board Member, AAOM Herbal Medicine Committee; President, Illinois Acupuncture Association
Richard A. Freiberg, DOM, DAc, NMD, President, Acupuncture and Oriental Medicine National Coalition (AOMNC)
Man Han, Lic. Ac., MJ Acupuncture
Liansheng Jiang, Siemens
Andy Kuhn, Sr. Technical Recruiter, Kanbay Incorporated
Tze-chung Li, Ph.D., Professor and Dean Emeritus, Dominican University; President, Chiamonline, Inc.
Lincoln Lockhart, MBA, Former Senior Product Management, Lucent Technologies
Bonnie J. McLaren, Coordinator, Small Business Development Center, College of DuPage
David Molony, Lic. Ac., Dipl. Ac. & C.H. (NCCAOM), Vice President, Executive Director for Professional Affairs, American Association of Oriental Medicine (AAOM)
Ming-Ming Pan Molony, Lic. Ac., CMD, Board Member, Chinese Medicine Advisory Council, American Association of Oriental Medicine (AAOM)
Dean Mouscher, Lic. Ac., Executive Director, Illinois Acupuncture Federation
Brad Repsold, Network Administrator, Donald Bruce & Co.
Cheng Robert Tang, System Administrator, Donald Bruce & Co.
Hovey Williams, III, M.S., L.P.C., The Safe
Jim Yu, Ph.D., Lucent Technologies
Chun-Su Yuan, M.D., Ph.D., Director, Tang Center for Herbal Medicine Research, Pritzker School of Medicine, University of Chicago

 

 

Letter to the Congress – Follow-Up (1)  

American Chinese Medicine Association (ACMA)

Bob Xu, CMD, MS

 

To:        United States Congress

From:    American Chinese Medicine Association (ACMA)

www.AmericanChineseMedicineAssociation.org

Re:        (1) Ephedra Event Follow-up; (2) Amendment of Medical Practice Act;

(3) Amendment of Federal Food, Drug, and Cosmetic Act; (4) On Herbal Ban vs. Herbal Regulation

Date:     February 16, 2004

 

Dear Honorable Congressional Representatives:

 

In August 2002, in response to the widely publicized Ephedra event and the inappropriate attitudes towards a number of Chinese herbs, practitioners of Chinese Medicine, and Chinese Herbal Medicine, Dr. Bob Xu of the American Chinese Medicine Association (ACMA) initiated a “Letter to the Congress” [1] to clarify confusion along with other issues relative to theEphedra event in order to prevent similar incidents from happening again.

 

On February 11, 2004, the Food and Drug Administration (FDA) issued a final rule prohibiting the sale of dietary supplements containing ephedrine alkaloids (Ephedra) because such supplements present an unreasonable risk of illness or injury.

 

As a follow up of the previous “Letter to the Congress”, this letter serves as a response from the ACMA to the FDA’s action on the Ephedra event and related issues.

 

  1. Background

 

The original “Letter to the Congress” has addressed many issues relating to the Ephedra event, which include medicine in general and Chinese Herbal Medicine (also called traditional Chinese herbal remedies, traditional Asian medicine, and Oriental Medicine [2]) in particular.  Among those issues, four are as follows:

 

(1)   Abuse of Ephedra

 

Based on the Pharmacopoeia of the People’s Republic of China and other authoritative references on Chinese Herbal Medicine, the “Letter to the Congress” explained in detail that there are rigorous indications for the application of Ephedra.  If people ingest Ephedra without appropriate indications, serious side effects might result.  Many victims of the Ephedraevents in America took Ephedra for weight loss and sport performance enhancement.  However, neither weight loss nor sports performance enhancement fall into any of the appropriate categories of indications for Ephedra.  Obese people and athletes should not take Ephedra for those purposes.  Therefore, the Ephedra events occurred in part due to the wrong application of Ephedra to weight loss and athlete performance enhancement.  So the nature of the Ephedra event belongs to public abuse of Ephedra used in a misguided fashion – which is a medicinal material used in Chinese Herbal Medicine.

 

(2)   Regulating Ephedra

 

The “Letter to the Congress” stated that Ephedra, together with some other herbs used in Chinese Herbal Medicine, should not be categorized simply as dietary supplements.  They are herbal medicines in nature.  For patients with the appropriate indications for applying these Chinese herbal medicines, they can be life saving.  However, as medicinal materials, they can cause severe side effects (including deaths) if the uninformed or misinformed public abuses or misuses them.

 

The complete ban of Ephedra will potentially harm patients and the public when those patients have indications needing the application of Ephedra or any of its alkaloids.  Therefore,Ephedra should be regulated as a “prescription herb” or “professionally recommended herb” [3] authorized for use primarily by qualified practitioners of Chinese Herbal Medicine, rather than be completely banned.

 

In the best interests of public health, welfare, and safety along with protecting the integrity of Chinese Herbal Medicine, the “Letter to the Congress” emphasized that Chinese Herbal Medicines should be regulated and be available ONLY to Doctors of Chinese Medicine (CMD) and other qualified practitioners of Chinese Herbal Medicine.  It is inappropriate for the public to have freedom of access to some of these Chinese herbal medicines.  In the meantime, it is also inappropriate for these Chinese herbal medicines to be prescribed, recommended, or administered by other health care providers who lack the appropriate and sufficient education and training in Chinese Herbal Medicine.

 

(3)   Inappropriate Classification of Herbs

 

Historically, Chinese Herbal Medicine has accumulated millions of clinical cases and experiences.  Based on these facts, the “Letter to the Congress” elucidated in detail the inappropriate classification of a number of these herbs into the dietary supplement category.

 

Herbs, or ‘Materia medica’ used in Chinese Herbal Medicine, are very important medicinal materials or herbal medicines, which have been used to treat diseases and illnesses for thousands of years.  They belong to a special category, which differs, in some cases, from both food dietary supplements and western pharmaceutical drugs.

 

To clarify the confusion and to prevent similar incidents from occurring again, the “Letter to the Congress” recommended the separation of some herbs from food dietary supplements, and the establishment of an independent “herbal medicine” category within the domain of practitioners of Chinese Herbal Medicine [1].

 

(4)   Disclaimer Dilemma

 

For many years, the FDA has required that all herbal products make a disclaimer stating, “This product is not intended to diagnose, treat, cure, or prevent any disease”.

 

Based on thousands of years of clinical practice of Chinese Herbal Medicine, the “Letter to the Congress” pointed out that this disclaimer is in direct opposition to the facts and truths, which have existed in the long-term practice of Chinese Herbal Medicine.  This disclaimer has caused a dilemma for both the profession of Chinese Herbal Medicine and within the FDA.

 

The above noted four issues, and the other issues addressed in the original “Letter to the Congress”, are of significant importance to millions of patients, the American public, the profession of Chinese Herbal Medicine, and to the FDA.  Any actions towards resolving above issues are of positive benefit for all parties.

 

  1. FDA’s Action

 

The FDA’s final rule publicized on February 11, 2004 states:

 

“… Therefore, we conclude that dietary supplements containing ephedrine alkaloids labeled or used for weight loss present an unreasonable risk.”

 

“… Therefore, we conclude that the use of dietary supplements containing ephedrine alkaloids to enhance athletic performance for any duration of use present an unreasonable risk.”

 

“… The final rule does not apply to conventional food products that contain ephedrine alkaloids. …”

 

“…This final rule does not affect the use of Ephedra preparations in traditional Asian medicine (Note: “traditional Asian medicine” is an inappropriate term for “Chinese Herbal Medicine” [2]), although we considered the comment’s views and information on the use of Ephedra in traditional Asian medicine in the context of their possible relevance to the risks of dietary supplements containing ephedrine alkaloids.  This rule applies only to products regulated as dietary supplements (See 62 FR 30678 at 30691).  Traditional Asian medicine practitioners do not typically use products marketed as dietary supplements. …”

 

“… Moreover, even if we could say that the absence of recorded adverse events with the use of Ephedra in traditional Asian medicine was due to its safety for that use rather than due to a lack of mechanism for reporting, the history of use of Ephedra in traditional Asian medicine primarily for the treatment or mitigation of respiratory illness cannot provide assurance about the safety of dietary supplements containing ephedrine alkaloids for other uses.”

 

Based on the info available, the FDA’s final rule is a positive initiative towards resolving the above four issues raised in the original “Letter to the Congress”.

 

The FDA’s final rule addresses the above four issues in the following ways:

 

(1)   The FDA banned the inappropriate applications of Ephedra products to weight loss and athlete performance enhancement.  This directly addresses the first issue mentioned above:Abuse of Ephedra.

 

(2)   The FDA banned the public from getting access to dietary supplements containing ephedrine alkaloids, which, qualitatively does not ban the use of Ephedra preparations (which also contain ephedrine alkaloids) in the practice of Chinese Herbal Medicine.  This is in fact to regulate Ephedra instead of completely banning it.  This addresses the second issue mentioned above: Regulating Ephedra.

 

(3)   The FDA acknowledges, “Traditional Asian medicine practitioners do not typically use products marketed as dietary supplements”.  This actually differentiates the dietary supplements containing ephedrine alkaloids from the Ephedra preparations used in Chinese Herbal Medicine.  In other words, the FDA recognizes that dietary supplements and Chinese herbs (herbal medicines) are different in nature.  This in fact separates the Chinese herbs (herbal medicines) from the dietary supplements.  This is a good beginning to remove Chinese herbs (herbal medicines) from the dietary supplement category.  This addresses the third issue mentioned above: Inappropriate Classification of Herbs.

 

(4)   The FDA’s final rule states that “…the history of use of Ephedra in traditional Asian medicine primarily for the treatment or mitigation of respiratory illness …”.  This acknowledges that the Ephedra used in Chinese Herbal Medicine can treat respiratory diseases.  This recognizes that Ephedra has medicinal functions and properties, and cannot be used simply as a dietary supplement, which does not contain medicinal functions and properties.  This differentiation of Ephedra under different settings respects the medicinal status ofEphedra and Chinese Herbal Medicine.  By honoring the medicinal status of Chinese Herbal Medicine, the FDA implies that Chinese Herbal Medicine can diagnose, prevent, and treat diseases.  Thus, the FDA has avoided the dilemma caused by the previous disclaimer with respect to Chinese Herbal Medicine.  This addresses the fourth issue mentioned above: Disclaimer Dilemma.

 

We welcome the FDA’s initiatives towards resolving the above four issues addressed in the original “Letter to the Congress”.  These initiatives will hopefully open channels of dialogue and communication between the FDA and the profession of Chinese Herbal Medicine.  They will further lead to building a constructive relationship between the FDA and the profession of Chinese Herbal Medicine, which will benefit not only the FDA and the profession of Chinese Medicine, but also millions of Americans who seek health care and treatments by means of Chinese Medicine in general.

 

  1. Problems to be Resolved

 

In resolving the above four issues, we found that three problems relating to legislation are still entangled.  These problems are confusing not only to patients and the public, but also to the profession of Chinese Medicine and the FDA.  Because legislative issues are beyond the capacity of the FDA, these three problems continue to seriously affect the normal operation of the FDA, which in turn affects the profession of Chinese Herbal Medicine and millions of American patients.

 

(1) Definition of the Dietary Supplement

 

Congress defined the term “dietary supplement” in the Dietary Supplement Health and Education Act (DSHEA) of 1994.  A dietary supplement is defined as a product taken by mouth that contains a “dietary ingredient” intended to supplement the diet.  Here, “an herb or other botanical” are included into the dietary supplement category.

 

As pointed out in the original “Letter to the Congress”, the 1994 DSHEA has made a mistake by including herbs in the dietary supplement category [1].  This can only be rectified by having Chinese Medicine professionals who have expertise in Chinese Herbal Medicine to work with the FDA to develop criteria and standards of efficacy and safety for herbal medicines.

 

According to this definition, both the extract form of Ephedra and the raw herb (plant) form of Ephedra would be classified as a dietary supplement.

 

The FDA’s Final Rule on Ephedra, published on February 11, 2004, took a great step by removing the raw herb (plant) Ephedra, as used in the practice of Chinese Herbal Medicine, from the dietary supplement category.  In doing so, the FDA made a right and courageous step.  We applaud the FDA’s action because removing some herbs from the dietary supplement definition is in the right direction.  However, since the law regarding the definition of dietary supplements has not yet been changed, the FDA is unable to advance further in this direction.

 

Redefining the dietary supplement by removing some herbs (herbal medicines) completely away from the dietary supplement category is the most important task in amending the 1994 DSHEA [1].  The definition of dietary supplements, therefore, ought not to include Chinese Herbal Medicine.

 

(2) Medical Practice Act

 

During our contact with the FDA, the FDA acknowledged that Chinese herbs have medicinal functions in treating diseases and curing illnesses.  However, the FDA further pointed out that due to historic reasons, this fact might conflict with state Medical Practice Acts, which govern the practice of medicine in the respective states and are outside the regulatory jurisdiction of the FDA.

 

As a result, a new dilemma has been generated.  On one hand, the FDA’s final rule acknowledges that Chinese Herbal Medicine can treat and cure diseases.  On the other hand, state Medical Practice Acts do not provide a legal status for Chinese Herbal Medicine to diagnose, treat, and cure diseases.

 

We contend, therefore, that the Congress should resolve this dilemma by enacting legislation that would preempt state regulation of the practice of Chinese Herbal Medicine in state Medical Practice Acts.

 

This is another legislative issue to be resolved by the Congress.

 

(3) Federal Food, Drug, and Cosmetic Act

 

Due to historic reasons, the “Federal Food, Drug, and Cosmetic Act” has not included herbal medicine in it.  The FDA’s Final Rule on Ephedra, however, acknowledges the medicinal usage of the raw herb Ephedra in Chinese Herbal Medicine.  This decision by the FDA, in the context of the Federal Food, Drug and Cosmetic Act, makes it difficult for the FDA to classify medicinal Chinese herbs into an appropriate category.  It ended up that the FDA separated the raw medicinal Chinese herb Ephedra from the dietary supplement category, and placed it into the food category instead.  This is in fact a short-term solution to a long-term problem.

 

By definition, foods are not classified to have medicinal functions and properties.  Therefore, food is an inappropriate category to accommodate the raw Chinese herbal medicines that are medicinal materials in nature.  As explained in detail in the original “Letter to the Congress”, a new “Herbal Medicine” category is necessary in order to re-classify some of the herbal medicines [1].  We contend, therefore, that an amendment of the “Federal Food, Drug, and Cosmetic Act”, which reflects this re-classification, becomes necessary.

 

Facing the above situation, in which legislation lags behind the FDA’s action, we appreciate the FDA’s understanding about Chinese Herbal Medicine.  In order, therefore, to resolve the difficulty, which exists in current law, vis-à-vis the proper classification of Chinese Herbal Medicine, we ask the Congress to introduce appropriate bills to provide the legal basis for the FDA to operate more efficiently, and for Chinese Herbal Medicine to be practiced more freely and effectively.  In the end, millions of American patients will have the healthcare freedom and convenience to seek the treatment of one of the world’s most time-tested medicines — Chinese Herbal Medicine.

 

  1. Legislation Actions

 

From the above discussion, we can see that legislative action is now necessary to amend and enact several laws.

 

(1)   Amendment of DSHEA

 

This is a very important amendment relating not only to the profession of Chinese Herbal Medicine, but also to the FDA, patients, and the public safety.  In the previous “Letter to the Congress” we elucidated in detail the necessity to amend DSHEA [1].  To save space, we will not repeat this amendment here.

 

(2)   Federal Preemption of State Medical Practice Acts

 

By honoring the medicinal status of Chinese Herbal Medicine, by separating and removing some Chinese herbs from the dietary supplement category, and by establishing an independent category for herbal medicine, Chinese Herbal Medicine would therefore be granted a professional medicine status.  This medicinal status, however, would be in conflict with states Medical Practice Acts.

 

In order to resolve this conflict, it is necessary to enact federal legislation that would preempt state Medical Practice Acts and provide federal protection for the professional medicine status of Chinese Herbal Medicine in the United States, and its recognized trained practitioners.

 

State Medical Practice Acts were originally enacted several dozen years ago.  At that time, except for allopathic medicine, there was no other medicine, which existed in the United States. Therefore, in state Medical Practice Acts, the term “medicine” means exactly the same as “allopathic medicine”.  Chinese Medicine and other alternative medicines were not included in the term “medicine” when the State Medical Practice Acts were first enacted.

 

Therefore, there existed an assumption in the usage of the term “medicine” when these state laws were first passed that the term “medicine” was equivalent to the term “allopathic medicine”.  This assumption permeates state Medical Practice Acts.  In other words, the term “medicine” in state Medical Practice Acts actually refers to “allopathic medicine” only.  It does not include Chinese Medicine or other alternative medicines

such as Chiropractic or Naturopathic medicine.

 

Today, many years later, after Chinese Herbal Medicine and other alternative medicines have grown in the United States, both the connotation and the extension of the term “medicine” have evolved.  The term “medicine” today includes not only allopathic medicine, but also Chinese Herbal Medicine, as well as many other Complementary and Alternative Medicines.  So the term “medicine” today is quite different from the term “medicine” as originally used in the state Medical Practice Acts when they were first enacted.  In America today, the term “medicine” is no longer equivalent to “allopathic medicine”.  The former is much larger than the latter.

 

In order to resolve this confusion and conflict between Chinese Herbal Medicine and other Complementary and Alternative Medicine with the state Medical Practice Acts, it is necessary for the Congress to preempt state Medical Practice Acts by redefining the term “medicine” used in the state Medical Practice Acts as “allopathic medicine” only.

 

(3)   Amendment of the “Federal Food, Drug, and Cosmetic Act”

 

Historically the “Federal Food, Drug, and Cosmetic Act” did not include herbal medicine. It was based solely on allopathic medicine.

 

Today, there are two medicinal systems co-existing in the world:  allopathic medicine (led and represented by Western Medicine) and holistic medicine (led and represented by Chinese Medicine).  Herbal medicine is an independent medicine parallel to pharmaceutical drugs in treating diseases and curing illnesses.  More and more people are seeking herbal medicine treatments.  Therefore, Chinese Herbal Medicine should be included in the “Federal Food, Drug, and Cosmetic Act” in order to include the holistic, herbal medicine system into this important law on healthcare.

 

As elucidated in detail in the original “Letter to the Congress”, herbal medicine should be separated from the food dietary supplement category.  It is also completely different from pharmaceutical drugs.  Therefore, an independent “herbal medicine” category should be established [1].  Herbal medicine should be regulated under its own rules and regulations instead of merely copying the pharmaceutical drug’s rules and regulations.

 

In order to achieve this goal, an amendment to the “Federal Food, Drug, and Cosmetic Act” is needed in order to set up standards to regulate the profession of Chinese Herbal Medicine based on the rules and regulations of this profession.  After establishing an independent category of Chinese Herbal Medicine, we propose that the new “Federal Food, Drug, and Cosmetic Act” become “Federal Food, Drug, Herb, and Cosmetic Act”.  This is the legislative counterpart of the proposal to establish an independent “FDA Division of Herbal Medicine” and restructure the current FDA to “Food, Drug, and Herb Administration (FDHA)” [1].

 

(4)   Remaining Issues

 

Besides the issues mentioned above regarding the FDA’s Final Rule on Ephedra, there are many other issues raised in the previous “Letter to the Congress,” which have not yet been resolved.  Those issues can be appropriately addressed after the above fundamental issues have been satisfactorily resolved.

 

  1. On Herbal Ban vs. Herbal Regulation

 

Currently, there is a bill in the US House (H. RES. 435) and a bill in the Senate (S. RES. 260) regarding to the ban of dietary supplements containing ephedrine alkaloids.  These two bills have the following problems:

 

(1) Usage

 

These bills have not made detailed distinction between the public abuse of ephedra and the professional practice use of ephedra in Chinese Medicine (FDA mentioned it as Traditional Asian Medicine).

 

The former is very dangerous, has claimed over hundred lives in America, and should be prohibited.  The latter, however, has been practiced very safely for over hundreds and thousands years.

 

Prohibition of the former should not involve the latter, which has been treating diseases and saving lives for millions and billions of patients around the globe.

 

      (2)   Format

 

These bills have not made detailed distinction between ephedrine alkaloids contained in pure extract format of dietary supplement ephedra and the raw Chinese herb format of ephedra.

 

The former is in pure extract format, similar to manufactured chemicals and pharmaceuticals, and does not belong to Chinese Herbal Medicine anymore.  It has lost its status as Chinese herbal medicine, and is equivalent to chemical drugs.  The profession of Chinese Herbal Medicine does not recognize the former as Chinese Herbal Medicine although it is extracted from Chinese herbs.

 

The latter has always been used in combination with many other raw herbs to form a formula, which will offset and suppress the side effects of ephedrine alkaloids contained in it, and has been proved to be very safe in millions and billions of clinical practices.

 

      (3)   Dosage

 

These bills have not made detailed distinction between the application of pure extract ephedrine alkaloids at relatively high dosage and the application of Chinese herbal formula that contain trace amount of ephedrine alkaloids.

 

The former, due to its pure format, can be applied in very high dosage that could be very harmful and dangerous.

 

The latter — trace amount of ephedrine alkaloids used in Chinese herbal formula, is very different from the former.  The dosage of the ephedrine alkaloids contained in the raw herbs and formulae are very low relative to the former.  In addition, the toxicity and side effects of the trace amount of ephedrine alkaloids have been offset and suppressed by other herbs in the formula.  Therefore, the latter is very safe, and should not be treated in the same way as the former.

 

      (4)   Ephedra vs. Other Chinese Herbs

 

These bills have not made detailed distinction between ehpedra and other raw Chinese herbs containing trace amount of ephedrine alkaloids.

 

The term “dietary supplements containing ephedrine alkaloids” in these bills has not differentiated the amount of ephedrine alkaloids to be regulated.  Then, “any amount” could be assumed.  This would lead to target dozens and hundreds of Chinese herbs and formulae that contain trace amount of ephedrine alkaloids.

 

In addition to ephedra, another herb that is targeted is ban xia (rhizoma pinelliae).  The list will be growing to very long if one follows above mindset to treat Chinese herbs.

 

The long history of Chinese Medicine has never met current situation before: began with public abuse of one herb; then followed by ban of dozens or hundreds of herbs and formulae containing ingredient of the abused herb.  Both the former (abuse of herb) and the latter (ban of related herbs) should not happen from the beginning.  If we can prevent the former, the latter will be out of the question.  Unfortunately, current solution is to use a new mistake (the latter) to cover up the existing mistake (the former).

 

In fact, most, if not all, pharmaceutical drugs can be found with various amounts (from trace to moderate) in Chinese herbs.  Then why Chinese Herbal Medicine has been practiced very safely for thousands of years by qualified doctors and practitioners of Chinese Medicine?  The answer is that the ingredients of pharmaceutical drugs existed in Chinese herbs have very different purities from the pharmaceutical drugs manufactured in the labs.  The combination of many different ingredients in one herb, and further in a well-designed formula help buffer, offset, and suppress the side effects of most pharmaceutical drugs existed in the herb or formula.

 

For the same chemical ingredient (for example, the ephedrine alkaloids), its toxicity and side effects completely depend on its format.  Its toxicity and side effects can reach that of the pharmaceutical drug’s level if it’s in a pure extract form (as in the ephedra dietary supplement extract) although it is extracted from raw Chinese herbs.  However, its toxicity and side effects are very low when it’s in the raw herb format.  Furthermore, its toxicity and side effects can be reduced to non-observable if it is applied appropriately in a well-designed formula by qualified doctors and practitioners of Chinese Medicine.

 

Therefore, from the safety viewpoint, all Chinese herbs (including ephedra and ban xia) should be regulated (public should not get access to them) rather than banned (doctors and practitioners of Chinese Medicine should be able to get access to them).

 

From the efficacy viewpoint, ephedra, ban xia, and all other Chinese herbs and formulae are very important in treating diseases and saving lives for millions and billions of patients around the world.  If these Chinese herbs containing various amounts of ephedrine alkaloids are banned, millions of patients will suffer due to lack of these herbs.  Some of them will end up with undue death due to inaccessible to these life-saving herbs.

 

Therefore, from the efficacy viewpoint, these Chinese herbs (ephedra, ban xia, etc.) should be regulated (public should not get access to them) rather than banned (doctors and practitioners of Chinese Medicine should have full access to them).

      (5)   Exemption for Chinese Herbal Medicine

 

Unlike the FDA’s final rule, these bills have not made exemption for the professional use of Chinese herbs containing various amounts of ephedrine alkaloids in the professional practice of Chinese Herbal Medicine.

 

As mentioned above, Chinese herbs containing various amounts of ephedrine alkaloids have been proved to be very safe in the professional practice of Chinese Herbal Medicine for thousands of years.  Professional practice use of Chinese herbs containing ephedrine alkaloids has never been a problem in the profession of Chinese Herbal Medicine.  It is the recent public abuse of Chinese herbs containing ephedrine alkaloids that brought up this issue and other problems.  Therefore, what is needed is to regulate (prevent the public from getting access to Chinese herbs containing ephedrine alkaloids) rather than to completely ban (in which professionals of Chinese Medicine also cannot get access to these herbs) Chinese herbs containing ephedrine alkaloids

      (6) Pharmaceutical Research vs. Herbal Medicine Research

 

The two bills rely on many pharmaceutical studies and research on Chinese herbs.  This approach is inappropriate.

 

As pointed out in the original “Letter to the Congress” [1] and the ” Recommendation on Chinese Medicine in the United States of America.” [3], the herbal medicine system is completely different from the pharmaceutical system.  It is inappropriate to apply conclusions obtained in the pharmaceutical system directly to the herbal medicine system.  For pharmaceutical system, the single body or linear system nature usually will generate severe toxicity and side effects.  For herbal medicine system, the multi-body, non-linear system nature usually will be able to offset and suppress the toxicity and side effects.

 

Another flaw of the pharmaceutical studies and research on herbal medicine is that they violate the fundamental characteristics of Chinese Herbal Medicine — Bian Zheng Lun Zhi.  The ephedra event actually originated from some pharmaceutical research on ephedra conducted around 70s.  Those pharmaceutical research on ephedra were reliable from the pharmaceutical viewpoint.  However, because they did not follow Bian Zheng Lun Zhi, their conclusions were invalid from the Chinese Herbal Medicine viewpoint.  It is inappropriate, inaccurate, and misleading to draw those conclusions based simply on pharmaceutical research on ephedra.  Unfortunately, many people followed those conclusions, and became victims of ephedra event.

 

Therefore, the conclusions drawn from pharmaceutical studies cannot be applied to herbal medicine system directly.  Well-designed herbal medicine research based on Bian Zheng Lun Zhi should be conducted in order to reach reliable and valid conclusions on herbal medicine system.

 

In order to achieve this, another issue addressed in the original “Letter to the Congress” need to be resolved.  It is necessary to establish an independent “FDA Division of Herbal Medicine” in order to supervise and regulate the studies and research of herbal medicine system [1].  Accordingly, the “Federal Food, Drug, and Cosmetic Act” should be amended in order to provide a legal status for professional herbal medicine in America (see above).

 

More detailed discussions and information on herbal ban vs. herbal regulation are available at [1,3].

 

In sum, from both safety and efficacy viewpoints, Chinese herbs containing ephedrine alkaloids form an integral part of the Chinese Medicine system, and are very important in fighting diseases and saving lives for millions of patients.  It is necessary to introduce bills to regulate, rather than to ban, Chinese herbs containing ephedrine alkaloids so that the public abuse of these herbs will be prohibited, while the professionals of Chinese Medicine are still able to use these herbs to fight diseases and save lives.

 

Due to above reason, the bills H. RES. 435 and S. RES. 260 need to be revised in order to incorporate above viewpoints and to resolve these issues appropriately and professionally.

 

  1. Acknowledgements

 

Around August 2002 and a few months thereafter, due to lack of understanding about the nature of the Ephedra event, the media associated the Ephedra event with Chinese herbs and Chinese Herbal Medicine, which left people and the public with an impression that Chinese herbs were toxic and that Chinese Herbal Medicine was dangerous.  As a result, many patients and the public feared not only Ephedra, but also all Chinese herbs and Chinese Herbal Medicine.  The reputation and image of Chinese Herbal Medicine were severely damaged.  If that situation were to continue, the future of Chinese Herbal Medicine would be unpredictable.  The original “Letter to the Congress” was initiated in direct response to that situation and its impact on Chinese Herbal Medicine.

 

We noticed that the media’s inappropriate attitude towards Chinese herbs and Chinese Herbal Medicine had changed after the original “Letter to the Congress” was submitted to The New York Times, CNN, The Associated Press, The Chicago Tribune, to radio stations, etc.  Today, media coverage of the Ephedra event and the environment surrounding Chinese herbs and Chinese Herbal Medicine is more objective and constructive than in August 2002.  We would therefore like to thank everyone in the media whose time, understanding, and work have directly and/or indirectly led to these positive changes.

 

We also noticed that since the initiation of the original “Letter to the Congress”, some positive changes have taken place in the FDA surrounding the Ephedra event (see the four issues mentioned above).  These changes will benefit not only the profession of Chinese Herbal Medicine and the FDA, but also millions of Americans.  As a follow-up to the original “Letter to the Congress”, we would like to thank the members and their staffs in the U.S. House, the U.S. Senate, the U.S. House Committee on Energy and Commerce – Subcommittee on Health, the U.S. Senate Committee on Health, Education, Labor and Pensions, and Secretary Thompson of Health and Human Services for their time, understanding, and work that helped to bring about these positive changes.  Thanks also to the Honorable Congresswoman Judy Biggert and her staff for their time and understanding on issues addressed in the original “Letter to the Congress”.

 

Finally, ACMA would like to thank Dr. Richard Freiberg, President, Acupuncture and Oriental Medicine National Coalition (AOMNC); Mr. Robert Marcus, Marcus & Associates; and Dr. David Molony, Vice President, American Association of Oriental Medicine (AAOM) for valuable discussions and feedbacks on this follow-up letter.

 

 

References:

 

  1. Xu, B.  Letter to the Congress.  American Chinese Medicine Association (ACMA) Publication Issue Aug 2002. http://www.americanchinesemedicineassociation.org

 

  1. Xu, B.  On Chinese Medicine vs. Oriental Medicine. American Chinese Medicine Association (ACMA) Publication Issue May 2003.http://www.americanchinesemedicineassociation.org

 

  1. Xu, B.  Recommendation on Chinese Medicine in the United States of America.  American Chinese Medicine Association (ACMA) Publication Issue Dec 2001. http://www.americanchinesemedicineassociation.org