Letter to the Congress (Original)

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?

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.

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.

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. 　

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.

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.

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.

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.

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.

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.

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".

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.

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.

(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.

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:

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.

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].