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THE TRIPLE BURNER - RELATIONSHIP WITH PERICARDIUM

This is the 6th and last instalment of the discussion on the Triple Burner.

6) Relationship between Triple Burner and Pericardium
Although they are interiorly-exteriorly related, the relationship between Pericardium and Triple Burner is somewhat tenuous: such a relationship is more applicable to the channels, rather than to the organs themselves.

The Nei Jing and Nan Jing always refer to the "5 Zang and 6 Fu" (omitting the Pericardium), but also to the "12 channels" (including the Pericardium). Originally the Pericardium was not considered as separate from the Heart; the two were considered a single organ, which is perfectly logical considering their close anatomical relationship. In fact, when the Ling Shu lists the Yuan points of the 5 Zang in chapter 1, it lists Daling (P-7) as the Yuan point of the Heart.1
A passage from Chapter 38 of the Nan Jing makes it clear that the Pericardium and Heart were, in those times, considered as one organ. It says: "The Zang are 5; only the Fu organs are 6: why is that so? The Fu organs are 6 because of the Triple Burner...it has a name but no form, and its channel pertains to the Hand Shao Yang. [The Triple Burner] is a Fu organ and that is why these are 6."2

This passage is revealing because of its starting question: in fact, the very question "the Zang organs are 5, why are there 6 Fu organs?" implies that it is taken for granted that the Heart and Pericardium are part of the same organ and that therefore it is strange that the Fu organs are 6. The answer explains that the Fu organs are 6 due to the existence of the Triple Burner.

However, within the reply, it says that the Triple Burner "has a name but no form" thus implying that the Triple Burner is different from the other regular Fu organs and their total makes 6 only by adding the Triple Burner.3 The passage also makes clear that the Triple "has a name but no form", i.e. it is not really an organ like the others but a complex of functions: however, it does say that there is a channel associated with it.

Chapter 39 of the Nan Jing is even more specific about the fact that the Triple Burner is not actually associated with a Zang organ: "Each of the Zang organs has a Fu one associated with it. The Triple Burner is also a Fu organ but it is not associated with any of the Zang organs. That is why some say that there are only 5 Fu organs."4

Chapter 25 of the Nan Jing specifically addresses the conundrum that there are 11 Internal Organs but 12 channels: "There are 12 channels but 11 Internal Organs (5 Zang and 6 Fu), why? One channel [jing] has two separate vessels [mai] in the Arm Shao Yin [Heart] and Heart Master [Xin Zhu, Pericardium]. The Pericardium has an Exterior-Interior relationship with the Triple Burner, both have a name but no form [you ming er wu xing], and that is why there are 12 channels." This passage is extremely revealing because it confirms that Heart and Pericardium were seen as one, when it says that one channel [jing] has two separate vessels [mai] in the Arm Shao Yin [Heart] and Heart Master [Xin Zhu, Pericardium].

With regard to the question of 5 Zang and 6 Fu, the author of the Nan Jing seems to be playing games with the reader because, in chapter 39, it says that the Zang could be considered to be 6 and the Fu 5! It says: "There are 5 Zang and yet 6 Fu, how is that? One speaks of 6 Fu but they are actually 5. Although one speaks of 5 Zang, there are actually 6. The Kidneys are two Zang: the left is the Kidney and the right is the Ming Men. The Ming Men houses the Spirit (jing shen). In men it stores the Jing in women it houses the Uterus. The Qi of the Ming Men penetrate the Kidneys. That is why there are 6 Zang. How come there are 5 Fu? [That is because] Each Zang is associated with a Fu, the Triple Burner is a Fu but it does not belong to any of the 5 Zang: that is why there are 5 Fu."5

With the development of the channel theory, the Triple Burner was associated with the Pericardium (given their corresponding position on the arm) and their number totalled 12, including the Triple Burner and Pericardium channels.

Although the Pericardium and Triple Burner channels are exteriorly-interiorly related within the 5-Element scheme, this feels like a somewhat "forced" relationship to make a square shape fit in a round hole, i.e. the 5 Elements into 12 Channels. In fact, some Chinese teachers and doctors go so far as saying that the Pericardium and Triple Burner organs are not interiorly-exteriorly related as the other organs are.

As channels, the Pericardium and Triple Burner channels have a close and symmetrical relationship; they occupy symmetrical positions on the arm. The Triple Burner belongs to the Shao Yang channels which are the "hinge" between the Tai Yang and the Yang Ming channels; the Pericardium pertains to the Jue Yin channels which are the "hinge" between the Tai Yin and Shao Yin channels. Being the "hinge" implies that these channels can connect the Yang and Yin channels, i.e. the Triple Burner connects the three Yang and the Pericardium the three Yin.

The Pericardium and Triple Burner channels are symmetrical in so far as the former provides the opening point of the Yin Wei Mai (P-6 Neiguan) and the latter of the Yang Wei Mai (T.B.-5 Waiguan): the Yin Wei Mai links all the Yin channels and the Yang Wei Mai all the Yang ones. This is another reason why the Triple Burner and Pericardium channels connect the three Yang and three Yin of the arm respectively.

The "Medicine Treasure" even says that the Triple Burner is interiorly-exteriorly related to the Ming Men.6 Since the Ming Men is also called the "Minister Fire", this explains the attribution of Triple Burner to Fire and specifically Minister Fire in the 5-Element context. The Pericardium is obviously closely connected to the Heart and naturally belongs to the Fire element, hence the connection between Pericardium and Triple Burner within the Fire Element and their name of "Minister Fire".

The "Selected Historical Theories of Chinese Medicine" clarifies the relationship between the Triple Burner and Pericardium: "The Heart is the Emperor who has a Minister. The Triple Burner cavities are like a capital which houses both the Emperor and the Minister. The Pericardium in the centre of the chest is like a palace that houses only the Emperor. The palace is inside and is Yin, the capital is outside and is Yang; hence the Triple Burner is a Yang organ and the Pericardium a Yin organ".7

In exploring the relationship between Pericardium and Triple Burner, there is an interesting symmetry between the location of the Back-Shu point of Heart and Kidneys (Shao Yin) and those of Pericardium and Triple Burner. The Heart and Kidneys communicate with each other and their Back-Shu points are BL-15 and BL-23 respectively. The Pericardium and Triple Burner’s Back-Shu points are symmetrical in that they are one point above those of the Heart and Kidneys, i.e. BL-14 and BL-22 respectively.





The Back-Shu point of the Pericardium is naturally just above that of the Heart because of the close anatomical connection between the two organs. The Back-Shu point of the Triple Burner is just above that of the Kidneys because of the Triple Burner being the "envoy" or "ambassador" of the Yuan Qi as it emerges from between the Kidneys (see previous blog post).


Clinical application
There are interesting clinical applications of the Triple Burner and Pericardium channels in the mental-emotional sphere.

First, emotional stress makes the physiological Minister Fire of the Kidneys rise and become pathological: when the Minister Fire is pathological, a person has "Heat". All emotions tend to cause Qi stagnation first and stagnant Qi easily generates Heat: that is why, in mental-emotional stress, the tip of the tongue (reflecting the Heart and the Shen) is red. As we have seen above, chapter 38 of the Nan Jing even says that the Ming Men (same as Minister Fire) is the residence of the Spirit (Jing-Shen). Zhu Dan Xi said: "Not a day goes by in people’s lives that the Minister Fire is not stirred."

The Triple Burner and Pericardium channels affect the mental-emotional state because emotional stress makes the Minister Fire rise towards these two channels; therefore when the Minister Fire is aroused by emotional problems and it rises towards the Pericardium and Triple Burner channels, points of these channels can be used to clear Heat and calm the Mind.
In this context, I use particularly P-6 Neiguan to stimulate the movement of the Hun when the person is depressed, or P-7 Daling to calm the Shen when the person is anxious.


There is another interesting clinical application of the Triple Burner and Pericardium points related to their being "hinge" channels, i.e. the Triple Burner (Shao Yang) is the hinge between Tai Yang and Yang Ming and the Pericardium (Jue Yin) is the hinge between Tai Yin and Shao Yin. Being the "hinge" on a psychological level means that these channels are "mediators" in the sense that they can affect a person's capacity to relate to other people and points of these two channels can therefore be used especially for depression: for this, I use T.B.-3 Zhongzhu and P-6 Neiguan.

1. Ling Shu, p 3.
2. Nan Jing, p. 94.
3. Ibid., p. 94.
4. Ibid., p. 95.
5. Nan Jing, p. 110.
6. Wang Xin Hua 1983 Selected Historical Theories of Chinese Medicine (Zhong Yi Li Dai Yi Lun Xuan), Jiangsu Scientific Publishing House, p. 2.
7. Ibid., p. 161.

THE TRIPLE BURNER AS A SYSTEM OF CAVITIES AND A THREE-FOLD DIVISION OF THE BODY 4) and 5)

4) The Triple Burner as a system of cavities
The Triple Burner is a system of body cavities. There are many cavities in the body, some large, some small. For example, the chest cavity, the abdominal cavity, the pelvic cavity, the joint cavities, the space between skin and muscles, the space above the diaphragm, the spaces in between the Membranes, and the spaces between these and the abdominal cavity. Such cavities are called Cou in Chinese medicine; the term Cou is usually used in conjunction with Li meaning "texture". Although the term Cou Li is often used to indicate the space between skin and muscles, such space is only one of the cavities of the body.

The cavities of the body are generally irrigated and lubricated by various fluids and the Triple Burner controls these cavities also because it controls the transformation, transportation and excretion of fluids in all parts of the body. Moreover, the Triple Burner controls the movement of Qi in and out of such cavities. This movement is the "entering and exiting" of Qi in the Qi Mechanism discussed in the last Clinical Tip. The entering and exiting of Qi in and out of the cavities is extremely important both for the proper circulation of Qi and for the transformation and transportation of body fluids in and out of such cavities.

The abdominal cavity contains the Membranes (Huang): these include the superficial and deep fascia, the mesentery, the omentum and the stroma enveloping all internal organs. The superficial and deep fascia are connective tissues that envelope the muscles. The mesentery is the double layer of peritoneum attached to the abdominal wall and enclosing in its fold the abdominal viscera. The omentum is a fold of peritoneum passing from the stomach to another abdominal organ. The stroma is the framework, usually of connective tissue, of an organ. The Membranes (Huang) have the function of wrapping, anchoring and connecting the organs. In other words, the organs in the abdominal cavity are not in a kind of vacuum connected by acupuncture channels. The occupy a solid space that is surrounded by Membranes. The Triple Burner is responsible for the movement of Qi in and out of the Membranes.

Therefore, when seen as a system of body cavities, the Triple Burner is not an organ but a complex of cavities outside or in between the internal organs. The "Classic of Categories" (Lei Jing, 1624) by Zhang Jing Yue says: "Outside the internal organs and inside the body [i.e. between the skin and the internal organs], wrapping the internal organs like a net, there is a cavity that is a Fu. It has the name of a ditch but the shape of a Fu [Yang organ]."1 He also said: "The Internal Organs have substance; the cavities are like a bag that contains that substance".2 The Selected Historical Theories of Chinese Medicine (Zhong Yi Li Dai Yi Lun Xuan) says: "There is a Minister Fire in the body which moves within the cavities and up and down in between the Membranes: it is called the Triple Burner".3

In the chest cavity, the Triple Burner controls the entering and exiting of Qi which is governed by the Zong Qi. In the abdominal and pelvic cavity, the Triple Burner controls the transportation and transformation of Qi in the Membranes. In the space between skin and muscles, the Triple Burner controls the diffusing of Wei Qi and the entering and exiting of Qi in and out of that space. This function of the Triple Burner regulates the flow of Wei Qi in this space, the opening and closing of pores and sweating. In the joint cavities, the Triple Burner controls the entering and exiting of Qi and fluids in the joint capsules: this contributes to irrigating and lubricating the synovial membranes.

To summarize, the body cavities are:

the chest cavity
the abdominal cavity
the pelvic cavity
the joint capsules
the space between the skin and muscles
the space above the diaphragm
the spaces in between the Membranes
the spaces between the Membranes and the abdominal cavity.

The Triple Burner’s function of controlling waterways, that of governing the movement of Qi and that of controlling cavities are all inter-related and depend on each other. For example, the transformation of fluids depends on the ascending/descending and entering/exiting of Qi in the body cavities.

Clinical application
With regard to the Triple Burner governing the body cavities, I would single out two areas of clinical significance.

a) The first is the "space between the skin and muscles", generally referred to as the Cou Li space (although this term encompasses other spaces too). This is the space where the Wei Qi circulates and where sweat is. We should not interpret "space between skin and muscles" in a strict, Western, anatomical sense: it is not literally the space between skin and muscles in an anatomic sense but in an energetic sense. It is the Exterior of the body where Wei Qi circulates and where the Luo channels course.

The Triple Burner regulates the entering and exiting of Wei Qi and sweat in and out of this space and when its function is normal, sweating is physiological (not too much not too little), Wei Qi circulates normally and protects from invasions of external pathogenic factors. When the entering of Qi prevails over the exiting of Qi, the Cou Li space is said to be "tight" or "closed": when this happens, the person does not sweat enough and, if he or she succumbs to an invasion of Wind, they will not sweat and will have a temperature. When the exiting of Qi prevails over the entering of Qi, the space is said to be "lax" or "open" or "not consolidated". When this happens, the person will suffer from spontaneous sweating and if they suffer an invasion of Wind, they will not have a temperature. They will also be prone to invasions of Wind.
To regulate the Cou Li space one needs to regulate the Triple Burner and the Wei Qi with points such as LU-7 Lieque, LU-9 Taiyuan, L.I.-4 Hegu, ST-36 Zusanli and BL-13 Feishu.
For example, to consolidate the Cou Li space one can use LU-9 Taiyuan, L.I.-4 Hegu, BL-13 Feishu and ST-36 Zusanli. To "relax" the Cou Li space, one can use LU-7 Lieque and L.I.-4 Hegu.

b) The second area of clinical significance is the Qi movement in the abdomen. As discussed above, the abdomen contains the Membranes (Huang) which are the structures that are in between the organs and between these and the skin. When there is stagnation of Qi in the abdomen, this is not only in the channels but also in the Membranes and this contributes to the feeling of distension or fullness of the abdomen.

To regulate the Triple Burner in the abdomen and relax the Membranes, one can use Ren-5 Shimen (Front-Mu point of the Triple Burner), Ren-6 Yuan point of the Membranes (Huang) and BL-22 Sanjiaoshu (Back-Shu point of the Triple Burner).

5) The Triple Burner as a three-fold division of the body
Chapter 31 of the Nan Jing that describes the Triple Burner as the "avenue of water and food" also describes the three divisions of the body: "The Triple Burner is the avenue of water and food, and the beginning and end of Qi. The Upper Burner extends from below the heart and diaphragm up to the mouth of the stomach; it is charge of receiving and it does not discharge. It is treated via the Tan Zhong point [Ren-17] which is 1 cun and 6 fen below the point Yu Tang that is in between the breasts. The Middle Burner is located at the central duct of the stomach [Zhongwan]; it does not extend any further up or down; it controls the processing of water and food and it is treated at the sides of the umbilicus [ST-25?]. The Lower Burner starts above the upper opening of the bladder; it separates the clear from turbid; it controls discharge and it does not intake; it acts as a transmitter. It is treated one inch below the umbilicus [Ren-6 or Ren-5?]. Hence, one speaks of a Triple Burner. It collects at Streets of Qi [Qijie, ST-30].

Chapter 18 of the Ling Shu also describes the three-fold division of the body into three Burners: "The Upper Burner comes out from the mouth of the stomach, it runs along the gullet, passes the diaphragm and spreads in the chest. The Middle Burner comes out at the stomach. The Lower Burner comes out at the lower end of the small intestine and pours into the bladder."

The three-fold subdivision of the body is discussed in several passages of the Nan Jing in conjunction with pulse diagnosis, i.e. assigning the three pulse positions cun, guan and chi to the Upper, Middle and Lower Burner respectively. The Mai Jing (Pulse Classic) also has the same assignment of pulse positions: "The Cun position governs the Upper Burner including the skin and hair up to the hands; the Guan position governs the Middle Burner including the abdomen and back; the Chi position governs the Lower Burner and the lower abdomen up to the feet."

Chapter 18 of the Nan Jing says practically the same: "The Cun position is ruled by Heaven and reflects diseases from the chest to the head; the Guan position is ruled by Person and reflects diseases between the diaphragm and umbilicus; the Chi position is ruled by Earth and reflects diseases from the umbilicus to the feet."

1. Cited in Wang Xue Tai 1988 Great Treatise of Chinese Acupuncture (Zhong Guo Zhen Jiu Da Quan), Henan Science Publishing House p. 46.
2. Wang Xin Hua 1983 Selected Historical Theories of Chinese Medicine (Zhong Yi Li Dai Yi Lun Xuan), Jiangsu Scientific Publishing House, p. 161.
3. Ibid., p. 159.

THE TRIPLE BURNER (3)

In the last Clinical Tip (September 2011) we discussed the role of the Triple Burner as the avenues of fluids, a view deriving primarily from the Nei Jing. In the previous Clinical Tip (August 2011), we discussed that of the Triple Burner as the agent of the Yuan Qi, a view deriving primarily from the Nan Jing. We shall now discuss the view of the Triple Burner in relation to the movement of Qi.

3) The Triple Burner governing movement of Qi
Chapter 38 of the Nan Jing mentions the function of the Triple Burner in governing all Qi in the body. “The Triple Burner stems from the Yuan Qi; it governs all Qi in the body, it has a “name but no form”, it belongs to Hand Shao Yang, it is an external Fu.”1

This short passage summarizes most of the aspects of the Triple Burner:
1) It stems from the Yuan Qi (discussed in the August Clinical Tip).
2) It governs all Qi of the body (we shall see how below).
3) The Triple Burner has “a name but no form”, i.e. it is not an actual organ but a function.
4) It pertains to the Shao Yang with the Gall-Bladder.
5) It is a Fu.

Let us explore now the meaning of the Triple Burner governing the movement of Qi. The movement of Qi in general is called the “Qi Mechanism” (Qi Ji 气 机). This Qi Mechanism consists in the ascending/descending and entering/exiting of Qi in different places and different organs. Each organ has a particular direction of flow of Qi, e.g. Spleen-Qi ascends while Stomach-Qi descends. In each channel, Qi flows in an upward or downward direction. As acupuncturists, we are very familiar with the ascending/descending movement of Qi.

We use this movement every time we insert a distal and a local point to treat a particular problem along a channel. For example, when we use L.I.-1 Shangyang (for example) and L.I.-15 Jianyu to treat a pain in the area of the acromio-clavicular articulation of the shoulder, we are making use of the ascending/descending movement of Qi along the Large Intestine channel. By stimulating the ascending/descending movement of Qi in the channel, we are removing the obstruction and therefore the pain.



We are somewhat less familiar with the “horizontal” movement of Qi, i.e. entering and exiting of Qi. Qi enters and exits in and out of various structures and organs. For example, Qi enters and exits the space between skin and muscles, the Membranes, the joint capsules, and all other cavities. Moreover, Qi “enters and exits” in every part of the body among the Tai Yang, Shao Yang and Yang Ming and among the Tai Yin, Jue Yin and Shao Yin.



Take the shoulder as an example. On the scapula we have Tai Yang (Small Intestine channel), on the lateral side of the arm we have the Shao Yang (Triple Burner channel) and further forward the Yang Ming (Large Intestine channel). Within this zone of the body, the Tai Yang area is on the most Yang area (the scapula), the Yang Ming on the most Yin area (because it is near the Lung channel) and the Shao Yang in the middle: this ties in with the view that the Tai Yang “opens onto the Exterior”, the Yang Ming “opens onto the Interior” and the Shao Yang is “the hinge”. Exactly the same reationship exists in the Yin between Tai Yin (most exterior of the Yin), Jue Yin (the hinge) and Shao Yin (most interior of the Yin).



The “Avenues of Qi” (Qi Jie 气 街) described in chapter 52 of the Ling Shu are another example of the entering and exiting of Qi (“horizontal movement of Qi”): “In the chest Qi has streets; in the abdomen Qi has streets; in the head Qi has streets; in the lower legs Qi has streets. Therefore if [there is a problem with] Qi in the head, stop it at the brain; if [there is a problem with] Qi in the chest, stop it at the front of the chest and at the Back-Shu points; if [there is a problem with] Qi in the abdomen, stop it at the Back-Shu points and at the Chong Mai on the right and left of the umbilicus which is the Moving Qi [or Dong Qi]; if [there is a problem with] Qi in the lower legs, stop it at ST-30 Qichong [here called Qijie] and at BL-57 Chengshan.”2
Notice how it recommends the use of points in the front and the back for each area: in the chest, use the front of the chest and Back-Shu points; in the abdomen Back-Shu points and Chong Mai points; in the legs, ST-30 (front of leg) and BL-57 (back of leg). This suggests a “horizontal” movement of Qi within each area.

The Triple Burner controls the ascending/descending and entering/exiting of Qi in the Qi Mechanism. One of the words most frequently used in Chinese books to describe this function of the Triple Burner is tong 通 which means “free passage”, “to pass through”, “penetrate”: this describes the function of the Triple Burner in ensuring that Qi passes through in the Qi Mechanism, in all the cavities and in all organs. This whole process is called “Qi Transformation by the Triple Burner”: the result of the Qi transformation is the production of Nutritive-Qi (Ying Qi), Defensive-Qi (Wei Qi), Blood and Body Fluids. That is also why the Triple Burner is said to control “all kinds of Qi”.

The “Central Scripture Classic” (Zhong Zang Jing, Han dynasty) says: “The Triple Burner is the three original Qi of the body, it is the Yang organ of clear [Qi], it controls the 5 Zang and 6 Fu, Ying Qi and Wei Qi, the channels and the Qi of the interior and exterior, left and right, above and below. When the Qi of the Triple Burner has free passage, Qi passes freely into interior, exterior, left, right, above and below. The Triple Burner irrigates the body, harmonizes interior and exterior, benefits the left and nourishes the right, it conducts upwards and descends downwards.”3

As mentioned in the previous Clinical Tip, chapter 66 of the Nan Jing also confirms that the Triple Burner controls the movement of Qi in general: “The Triple Burner makes the Yuan Qi separate [into its different functions] and it controls the movement and passage of the 3 Qi [of the Upper, Middle and Lower Burner] through the 5 Zang and 6 Fu.”4 The “3 Qi” are the Qi of the Upper, Middle and Lower Burner: apart from referring generally to all the types of Qi in each Burner, this passage also refers specifically to the Gathering Qi (Zong Qi) in the Upper, Nutritive-Qi (Ying Qi) in the Middle and Defensive-Qi (Wei Qi) in the Lower Burner. Although the Defensive-Qi exerts its influence primarily in the Upper Burner and the superficial layers of the body (the space between skin and muscles), it originates in the Lower Burner from the Ming Men. Chapter 18 of the Ling Shu says: “Ying Qi originates from the Middle Burner; Wei Qi originates from the Lower Burner.”5

Chapter 38 of the Nan Jing also confirms that the Triple Burner exerts its influence on all types of Qi: “The Triple Burner stems from the Yuan Qi: it supports all of the Qi.”6 Chapter 31 confirms the influence of the Triple Burner on the movement of Qi in all parts of the body: “The Qi of the Triple Burner gathers in the avenues of Qi [Qi Jie]”.7 This means that the Triple Burner is responsible for the free passage of Qi in all channels but also all structures (such as cavities) of the body.

Thus, the Triple Burner’s function in governing the movement of Qi is quite similar to the Liver’s free flow of Qi and indeed, there are many similarities. With regard to the movement of Qi, it is useful to compare and contrast this function of the Triple Burner with those of Liver in ensuring the free flow of Qi.

The Liver ensures the free flow of Qi and this aids the ascending and descending of Qi in all organs, and especially in the Stomach, Spleen and Intestines: the Triple Burner's influence on the ascending/descending and entering/exiting of Qi extends to all organs. Moreover, the Triple Burner controls the entering and exiting of Qi in all parts of the body and especially the body cavities: the Liver has no such function in relation to the body cavities.

Clinical application
As the Triple Burner controls the movement of Qi in the Qi Mechanism. Its points may be used in a similar way to the Liver points to ensure the free flow of Qi. The main point I use to move Qi in the Triple Burner is TB-6 Zhigou.


1. Nanjing College of Traditional Chinese Medicine 1979 A Revised Explanation of the Classic of Difficulties (Nan Jing Jiao Shi). People’s Health Publishing House, Beijing, first published c. AD 100, p. 94.
2. 1981 Spiritual Axis (Ling Shu Jing). People’s Health Publishing House, Beijing, first published c. 100 BC, p. 111.
3. Hua Tuo 1985 Classic of the Central Scripture (Zhong Zang Jing), Jiangsu Science Publishing House, Nanjing, p. 39. Written in Han dynasty.
4. Classic of Difficulties, p. 144.
5. Spiritual Axis, p. 52.
6. Classic of Difficulties., p. 94.
7. Ibid., p. 80.

The famous chapter 8 of the Ling Shu

Chapter 8 of the Ling Shu (entitled Ben Shen 本 神) is quoted very frequently, especially its famous opening sentence. I would like to comment briefly on that sentence and propose a different translation of it.

The opening sentence of chapter 8 of the Ling Shu is: Fan ci zhi fa, xian bi ben yu shen 凡 刺 之 法 先 必 本 于 神 and the words mean literally “every needling’s method first must be rooted in Shen”. This sentence is usually translated as: “All treatment must be based on the Spirit”. The implication of this sentence is that all treatment must be based on the Spirit (of the patient), whatever interpretation we give to the word “Spirit”.

I propose an alternative translation with two important differences. Firstly, the text uses the word ci which means “to needle”, not “to treat”. If the text had meant to use the term “to treat”, it would have used the word zhi 治which does occur a lot in both the Su Wen and the Ling Shu. Thus, the first difference is that the first half of the sentence is “when needling” rather than “when treating”: this is an extremely important difference.

The second difference is that the “Shen” referred to here may be interpreted as the Shen of the practitioner, not of the patient. Therefore, the whole sentence would mean: “When needling, one must first concentrate one’s mind [Shen]”. If that “Shen” is the Shen of the practitioner, then “Mind” would be a better translation here.

There are other passages in the Nei Jing that would support this view. For example, chapter 4 of the Ling Shu uses the word “shen” to mean the doctor’s skill in palpation and needling. It says: “When pressing on a channel [the doctor is capable of] understanding the disease: this is called shen.”

This different interpretation of the opening sentence of chapter 8 of the Ling Shu is consistent with two factors. Firstly, the Ling Shu is very much an acupuncture text and therefore the reference to concentrating when needling makes sense. Secondly, the advice to concentrate and focus when needling is also found in many places in the Nei Jing. Indeed, the word “shen” is even used occasionally to mean “needling sensation”. Chapter 16 of the Su Wen says: “In Autumn needle the skin and the space between skin and muscles: stop when the needling sensation [shen] arrives.”

There are many passages in both the Ling Shu and Su Wen that stress the importance of concentrating one’s mind when needling. Indeed, chapter 25 of the Su Wen contains a sentence that is almost exactly the same as the opening sentence of the famous chapter 8 of the Ling Shu. In fact, chapter 25 of the Su Wen contains this sentence: “fan ci zhi zhen, bi xian zhi shen” [凡 刺 之 真， 必 先 治 神]. I would translate this so: “For reliable needling, one must first control one’s mind [shen].” Note the rhyming of “zhen” with “shen”.

The English translation of the Su Wen by Li Zhao Guo simply translates this sentence as “The key point for acupuncture is to pay full attention.”1 This interpretation is corroborated by the other paragraphs in that chapter which give advice as to how to practise needling. In fact, it says that the acupuncturist should not be distracted by people around or by any noise.

Unschuld, in his new translation of the Su Wen, translates this sentence as “For all piercing to be reliable, one must first regulate the spirit.”2 This translation would contradict mine but a footnote in the same book reports the interpretation of Wang Bing (the editor of the Nei Jing): “One must concentrate one’s mind and be calm without motion. This is the central point of piercing.”3

The central point that stems from an analysis of the famous opening sentence of chapter 8 of the Ling Shu is how to translate the word “Shen”: in my opinion, the word “Shen” can have many different meanings and only one of them is “Spirit”. Another translation of “Shen” is that of “Mind” which, in my opinion is appropriate in many contexts.

I have mentioned above two possible meanings of “shen” in the Nei Jing, one being the skill of the acupuncturist, the other being the needling sensation. In other passages, “Shen” is closely identified with the Vital Essences of the body: this makes sense given the close integration of body and mind (or spirit) in Chinese medicine. For example, chapter 26 of the Su Wen says: “Blood and Qi are the shen of a person.”4 Chapter 32 of the Ling Shu says: “Shen is the refined Qi of water and grains.”5 Chapter 1 of the Ling Shu says: “Shen is the Upright Qi [Zheng Qi].”6

The next step of this investigation would be to define the nature of “Shen” (Mind or Spirit) in Chinese medicine and how that relates to the ancient Greek or Christian concepts of “Spirit” but this would require a very long enquiry that is beyond the scope of this short piece.

1. Li Zhao Guo (translator) Yellow Emperor’s Canon of Medicine, Library of Chinese Classics, World Publishing Corporation, Xi’an, 2005, p. 335.
2. Unschuld P U and Tessenow H, Huang Di Nei Jing Su Wen – An Annotated Translation of the Huang Di’s Inner Classic – Basic Questions, Vol. I, University of California Press, Berkeley, 2011, p. 428.
3. Ibid., p. 428.
4. 1979 The Yellow Emperor’s Classic of Internal Medicine-Simple Questions (Huang Di Nei Jing Su Wen), People’s Health Publishing House, Beijing. First published c. 100 BC, p. 168.
5. Tian Dai Hua 2005 Spiritual Axis (Ling Shu Jing), People’s Health Publishing House, Beijing. First published c. 100 BC, p. 77.
6. Ibid., p. 3.

THE TRIPLE BURNER (2)

In the previous Clinical Tip (August 2011) we discussed the nature and functions of the Triple Burner as the activator of the Yuan Qi based primarily on the Nan Jing. In this Clinical Tip, I will discuss the second nature of the Triple Burner, i.e. as a system of waterways which is primarily from the Nei Jing.

2) The Triple Burner as a system of waterways
The view of the Triple Burner as a system of waterways is found primarily in the Su Wen but also in the Nan Jing. From this point of view, the Triple Burner is a Fu organ, i.e. it “has a form”. You will remember that the Triple Burner that is the activator of the Yuan Qi has “no form”, i.e. it is a set of functions and not a Fu organ.

Chapter 31 of the Nan Jing describes the Triple Burner as the “avenue of water and food”: “The Triple Burner is the avenue of water and food, and the beginning and end of Qi. The Upper Burner extends from below the heart and diaphragm up to the mouth of the stomach; it is charge of receiving and it does not discharge. It is treated via the Tan Zhong point [Ren-17]. The Middle Burner is located at the central duct of the stomach [Zhongwan]; it does not extend any further up or down; it controls the processing of water and food and it is treated at the sides of the umbilicus [ST-25?]. The Lower Burner starts above the upper opening of the bladder; it separates the clear from turbid; it controls discharge and it does not intake; it acts as a transmitter. It is treated one inch below the umbilicus [Ren-6 or Ren-5?]. Hence, one speaks of Three Burners. It collects at Streets of Qi [Qijie, ST-30]”

This chapter mentions three aspects of the Tripe Burner: first, the Triple Burner as the “avenue of water and food”; secondly, the Triple Burner as the “beginning and end of Qi”; thirdly, the Triple Burner as a three-fold division of the body.

This chapter of the Nan Jing clearly relates the Three Burners to a system of food and fluid digestion, transportation, transportation and excretion. Therefore this function of the Triple Burner would encompass that of the Stomach, Intestines and Bladder. Note that this function of the Triple Burner really has little to do with the Triple Burner channel in the arm: in other words we do not stimulate the transportation, transformation and excretion of food and fluids through the Triple Burner channel but mostly through Ren Mai points: Ren-17 Shanzhong for the Upper Burner, Ren-12 Zhongwan for the Middle Burner and Ren-5 for the Lower Burner. Of course, there are other points too that affect the digestion function of the Triple Burner, such as ST-25 Tianshu for example. These will be listed below.

From the point of view of the Triple Burner as the organ of transformation of fluids and food, there is therefore a convergence of views between the concept of Triple Burner in the Nei Jing and that in the Nan Jing, i.e. between the Triple Burner as an organ and the Triple Burner as a function, even though the starting point of these two classics is different. However, the Nei Jing emphasizes the role of the Triple Burner in its “letting out” function, seeing the three Burners as three avenues of excretion or “letting out”. The Nan Jing, on the contrary, places emphasis on the function of “receiving”, “rotting and ripening” and “excretion” of food and fluids, seeing digestion as a process of “Qi transformation” activated by the Yuan Qi through the intermediary action of the Triple Burner.

Chapter 8 of the “Su Wen” which describes the functions of all the Internal Organs comparing them to “officials”, says: “The Triple Burner is the official in charge of ditches”. This means, that just like the government official who is in charge of irrigation, the Triple Burner is responsible for the transformation, transportation and excretion of fluids. This is one of the most important functions of the Triple Burner. The terms used in Chinese in connection with the Triple Burner influence on the body fluids are often shu which means “free flow” and tong which means “free passage”. Therefore the Triple Burner is like a system of canals and waterways to channel irrigation water through the proper fields and then out: this ensures that body fluids are transformed, transported and excreted properly.

The Triple Burner function in relation to body fluids is closely dependent on its function of controlling the transportation and penetration of Qi (see point 3 below). As described below, the Triple Burner influences the ascending/descending and entering/exiting of Qi in the Qi Mechanism: it is the coordinated and harmonized ascending/descending and entering/exiting of Qi in all organs and structures that ensures that the body fluids also ascend/descend and enter/exit in the proper way in all places. Essentially, the transformation and movement of fluids depends on Qi.

The end result of the complex process of transformation, transportation and excretion of fluids leads to the formation of various body fluids in each of the three Burners. The fluids of the Upper Burner are primarily sweat which flows in the space between skin and muscles; those of the Middle Burner are the fluids produced by the Stomach which moisten the body and integrate Blood; those of the Lower Burner are primarily urine and the small amount of fluids in the stools.
I. The Upper Burner is like a mist
The main physiological process of the Upper Burner is that of distribution of fluids all over the body in the space between skin and muscles by the Lungs in the form of fine vapour. This is an aspect of the Lung diffusing function. For this reason the Upper Burner is compared to a “mist”.
The Ling Shu in chapter 30 says: “The Upper Burner opens outwards, spreads the 5 flavours of the food essences, pervades the skin, fills the body, moistens the skin and it is like mist”.

ii. The Middle Burner is like a maceration chamber
The main physiological processes in the Middle Burner are those of digestion and transportation of food and drink (described as “rotting and ripening”) and the transportation of the nourishment extracted from food to all parts of the body. For this reason the Middle Burner is compared to a “maceration chamber” or a “bubbling cauldron”.

The Ling Shu in chapter 18 says: “The Middle Burner is situated in the Stomach . . . it receives Qi, expels the wastes, steams the body fluids, transforms the refined essences of food and connects upwards with the Lungs”.

iii. The Lower Burner is like a ditch
The main physiological process in the Lower Burner is that of separation of the essences of food into a clean and dirty part, with the excretion of the dirty part. In particular, the Lower Burner directs the separation of the clean from the dirty part of the fluids and facilitates the excretion of urine. For this reason the Lower Burner is compared to a “drainage ditch”.

The Ling Shu in chapter 18 says: “Food and drink first enter the stomach, the waste products go to the large intestine in the Lower Burner which oozes downwards, secretes the fluids and transmits them to the bladder”.

Clinical application
There are many points that stimulate the Triple Burner’s transformation and excretion of fluids. I will list them according to each Burner:

- Upper Burner: Ren-17 Shanzhong, LU-7 Lieque, L.I.-6 Pianli, L.I.-4 Hegu, Du-26 Renzhong (also called Shuigou, i.e. “Water ditch”).
- Middle Burner: Ren-12 Zhongwan, ST-21 Liangmen, Ren-9 Shuifen, Ren-11 Jianli, ST-22 Guanmen, BL-20 Pishu.
- Lower Burner: Ren-5 Shimen, BL-22 Sanjiaoshu, ST-28 Shuidao, BL-23 Shenshu, Ren-6 Qihai, SP-9 Yinlingquan, SP-6 Sanyinjiao, KI-7 Fuliu, BL-39 Weiyang.

When fluids stagnate, Dampness, Phlegm or oedema may arise. In order to activate the Triple Burner to move fluids, I activate each Burner using some of the points above, using more points from the Burner where the fluids stagnate. For example, if there is Dampness in the Lower Burner, I would use several points from those of the Lower Burner plus one or two from the Upper and Middle Burner. This usually means that when I stimulate the transformation, transportation and excretion of fluids, I do not hesitate in using more points than I would normally.

For example, if there is Dampness in the Lower Burner causing a urinary problem I would use these points:
- Lower Burner: Ren-3, Ren-5, BL-22, BL-28, SP-9, BL-39.
- Middle Burner: Ren-9.
- Upper Burner: LU-7.

To give an example from the Middle Burner, if there was Phlegm in the Stomach, I would use these points:
- Middle Burner: Ren-12, Ren-9, ST-21, BL-20, Ren-11.
- Upper Burner: L.I.-4.
- Lower Burner: ST-40, SP-9.

END NOTES
1. 1979 The Yellow Emperor’s Classic of Internal Medicine-Simple Questions (Huang Ti Nei Jing Su Wen). People’s Health Publishing House, Beijing, first published c. 100 BC, p. 59.
2. Medicine Treasure cited in Wang Xin Hua 1983 Selected Historical Theories of Chinese Medicine (Zhong Yi Li Dai Yi Lun Xuan). Jiangsu Scientific Publishing House, p. 2.
3. 1981 Spiritual Axis (Ling Shu Jing). People’s Health Publishing House, Beijing, first published c. 100 BC, p.71.
4. Selected Historical Theories of Chinese Medicine, p. 2.
5. Spiritual Axis, p. 52
6. Selected Historical Theories of Chinese Medicine, p. 2.
7. Spiritual Axis, p. 52

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OPEN LETTER TO JOHN DALLI EU COMMISSIONER FOR HEALTH

OPEN LETTER TO JOHN DALLI, EUROPEAN COMMISSIONER FOR HEALTH BY THE ALLIANCE FOR NATURAL HEALTH
24th June 2011

Dear Commissioner
RE: NON-EUROPEAN TRADITIONAL HERBAL SECTOR IN CRISIS
I was one of four experts attending a forum in the European Parliament on 21st June 2011 considering challenges posed by the Traditional Herbal Medicinal Products Directive (THMPD) (Directive 2004/24/EC). These challenges are particularly acute for genuine, long-standing traditional systems of medicine, and especially those that are of non-European origin. The forum was hosted by Michele Rivasi, Bart Staes, Carl Schlyter, Satu Hassi and Heide Rühle of the Greens/EFA group.
We have reported on the event on our website and the organisers ensured the event was video recorded, streamed live and archived.
As you will be able to see from the record of proceedings, the forum was very usefully organised, primarily in Question & Answer format. Questions were asked by a wide range of interests, ranging from non-governmental organisations (NGOs), such as ourselves, to herbalists, practitioners associations, suppliers, scientists and MEPs.

Lack of clarity in European Commission answers What became astoundingly obvious to the concerned parties present at the forum was the inadequacy of the answers provided by the European Commission representatives, Dr Andrzej Rys, Ms Figuerola Santos and Mr Francesco Carlucci. We are well aware that these representatives were “just doing their jobs”. But when it came to considering the implications of the Directive and its disproportionate impact on long-standing traditions of holistic healthcare, such as those embodied by southern and eastern Asian traditions, their answers were either non-existent or meagre. Even more worrying was the lack of any apparent interest by Ms Figuerola Santos in addressing possible solutions.

The urgent need for clarification I personally asked three questions during the Greens/EFA forum, and felt that the responses were neither illuminating nor helpful. I had been asked by the hosts to prepare queries, and had actually compiled 17 questions, which were submitted to the organisers a few days before the event. These and other questions are now in the hands of MEPs and will be formulated as formal questions to be asked in the Committee of Environment, Public Health and Food Safety (ENVI).
I write this open letter to you in the spirit of transparency, in the hope—given the severity of issues facing the non-European traditional medicine sector in the EU—that you or members of your staff will comment on the concerns I raise in this letter with a view, on the basis that the problems are acknowledged, to considering possible solutions.
Among my questions raised in the forum, I referred to two of the points that you had made in a response to Giles Chichester MEP on 13th April 2011 (Appendix). In the first point, you indicate that all herbal medicinal products sold in the EU now need to be authorised for sale. You will understand that, given the very broad definition of a medicine (as given in Article 1.2 of amending Directive 2004/27/EC), many manufacturers and suppliers are deeply concerned that Member State competent authorities will now regard their products as unregistered medicines. Since most of these products are presently sold predominantly as food supplements, they are at grave risk of being made illegal by default.
In the second point, you claim there are no additional barriers to the registration of Ayurvedic and traditional Chinese medicine (TCM) products, as compared with products from European traditions. These include products associated with the comparatively recent European, and especially German, phytopharmaceutical ‘tradition’. You may have appreciated, from the report on the uptake of the traditional use registration (TUR) scheme by the European Medicines Agency (EMA) in June 2011, that it is primarily products associated with this European phytopharmaceutical system that are successfully gaining registrations. By contrast, not a single product authentic to the Ayurvedic, Unani, TCM, Tibetan, Thai, southern African or Amazonian—or, indeed, any other non-European—system has yet been registered.

Reasons for lack of uptake of TUR registrations among non-European traditions
Following is a brief crystallisation of the reasons why uptake among the non-European traditions has been non-existent until now:
1. Eligibility limitations. Four key obstacles to eligibility include:
a) The traditional use requirement (which requires at least 15 years’ usage within the EU) for individual products locks out many products that may been used for decades, or even centuries or millennia, outside the EU. It also locks out any modification to a formula that might be appropriate given scientific advances or to meet the needs of a particular target population;
b) Indications for the TUR scheme are limited to minor, self-limiting conditions, yet the Asian traditions cover the entire scope of health conditions;
c) Many authentic poly-ingredient herbal products deal with multiple body systems, by virtue of their complex biochemical and bio-energetic actions. Such actions are not recognised in the existing model of pharmaceutical legislation, and there appears to have been no adjustment made to cater for the different indications and mechanisms of action of products associated with long-standing traditions;
d) Products containing significant mineral or animal ingredients are excluded from the TUR scheme, which is currently limited to herbal ingredients only.
2. Technical limitations. The greatest technical hurdle for most authentic traditional herbal medicinal products, which are often whole-herb or aqueous extractions, are the pharmaceutical and stability standards as set out in EMA guidelines. These are considerably more straightforward for single-herb products or limited combinations, where the herb has been well studied in the West, and for which biomarkers have been identified and included in the Committee on Herbal Medicinal Products (HMPC) monograph listing. The HMPC monographs are strongly Euro-centric in terms of their consideration of herbal species: there appears to have been no effort to balance the monographs being produced with ones for herbs that are used more or less exclusively in the major (or minor) non-European traditions. Since many traditions utilise whole-plant material or aqueous extracts, they experience considerably more difficulty in meeting the EMA guidelines for pharmaceutical standards relative to solvent-extracted, European herbal products that are stabilised in a pharmaceutical base that includes synthetic polymers/preservatives (as is the case for the majority of products that have been registered to date).
3. Excessive cost burden. There are great variations in registration fees being charged by Member State competent authorities, varying from around €2,000 to over €50,000 per product. In addition to this are the often much more substantial costs of meeting the pharmaceutical standards, especially stability and genotoxicity testing. You will be aware that a typical total cost for registration of a single product may range from €100,000 to upwards of €250,000. This is not an obstacle for most European phytopharmaceutical manufacturers or suppliers, where typically a narrow range of products sell in high volumes. However, it is a very significant barrier to the long-standing, non-European traditions—and especially the Asian traditions—as their suppliers are often required to carry a range of 100 to 300 distinct products, each selling at relatively low volumes. If the annual revenue for an individual product line is expected to be, say, €5,000, based on an up-front registration cost of €200,000, it would take 40 years to repay the cost of registration. For a supplier that sold a relatively small line of, say, 100 traditional herbal medicines, the total cost of registration, assuming the same total cost of registration, would amount to €20 million. These amounts are unquestionably out of reach of the small-to-medium sized enterprises (SMEs) supplying products associated with non-European traditional systems.
4. Lack of incentive. There are two major factors that create a major disincentive for manufacturers of non-European traditional products to prepare and submit applications for registrations under the TUR scheme. These are:
a). The fact that any SME in the non-European traditional sector, assuming the major technical and eligibility hurdles facing complex, multi-ingredient, non-European products had been overcome, would still only be able to register a handful of products in their full range, owing to the very high fixed costs involved;
b). There is a very real concern, given the broad EU definition of a medicine, that products receiving medicinal licenses under the TUR scheme will set a precedent that will cause Member State regulators to classify equivalent products also as medicines. This is already happening in some Member States, such as Belgium and the UK. So, if a company were to apply for one or two licenses, it may effectively contribute to a situation where all or many of its other products would be rendered illegal. An understandable position from the standpoint of many suppliers, particularly while the borderline between medicinal and food products remains so diffuse, is to continue selling as many herbal products as possible as a category of food (e.g. functional foods or food supplements). In effect, risking a huge amount of money that SMEs in the non-European traditional sector do not have, on a registration scheme which has been built around European phytopharmaceuticals—and not non-European, long-standing traditions—is not generally regarded as a viable business option for these SMEs. Nor is investing in registration under the TUR scheme a viable option for those whose passion or interest is to ensure continued supply of products associated with these non-European traditions to consumers and non-medically qualified practitioners in the EU.
If you consider the legislative history of the THMPD, it is apparent that the Directive was intended to provide an appropriate regulatory regime for products associated with all the major herbal traditions, where these products are sold directly to the consumer. This obviously includes products used in Ayurveda and TCM. Experience so far shows that the THMPD has not achieved its original objective, and some of the most important reasons for lack of uptake of TURs are laid out in the above four points.
While it might be convenient for your Directorate General to blame any problems facing products associated with non-European traditions on the autonomous actions of Member State medicines regulators, the reality is that these national authorities are culling back these traditions using tools provided them by Brussels. The two key death-knells for products that have been selling as food supplements in the various Member States are increasingly:
• The excessively broad definition of a medicine, and in particular its functional limb (Article 1.2(b), Directive 2004/27/EC) that technically turns all effective natural health products into medicines, and;
• Any product containing one or more ingredients that have not had demonstrable significant use in the EU prior to May 1997, under the terms of the Novel Food Regulation (No 258/1997).
Accordingly, it is inappropriate for the European Commission to lay exclusive blame at the door of the Member States.

Citizens demand action by European and national regulators It is apparent that the European Commission and the EMA must look urgently at resolving the situation for these systems of healthcare that are used by many millions of Europeans, and which are indigenous to well over one-third of the world’s population. The response from concurrent French, German and English petitions with over 1.1 million signatories between them, and from over 850,000 signatories to the Avaaz petition on herbal medicines, confirms a highly significant measure of citizen concern. Unfortunately, the European Commission’s lacklustre performance at Tuesday’s forum in the European Parliament has done nothing to suggest that the Commission is keen to resolve the unfolding crisis.
The EMA’s Action Plan for Herbal Medicines 2010-2011 addresses a small number of issues of concern, ignores many others, and has yet to implement a significant proportion of its stated actions.

Trying to put a square peg in a round hole
The THMPD was enacted in 2004 and fully implemented on 1st May this year. You say that 7 years should have been sufficient time for products to have been registered. But your Directorate-General failed to acknowledge that the registration scheme had been biased toward European phytopharmaceuticals during the entire 7-year transition phase, and against the much more widely adopted non-European traditions, such as the great Asian traditions of Ayurveda and TCM.
These Asian traditions long preceded your regulatory framework. However, Dr Konstantin Keller, first head of the HMPC, and others within the HMPC did very little during the transition phase to facilitate the registration of non-European products. Conversely, Dr Keller had an intimate knowledge of German phytopharmaceuticals, for which he oversaw registration under German national medicines law while he was responsible in his role in the German regulatory authority, BfArM. Experience now demonstrates that the registration scheme is not favourable to products of non-European traditions. Worse than this, the European pharmaceutical regulatory model is increasingly alienating holistic traditions, such as Ayurveda, TCM and anthroposophical medicine, something that is acknowledged in the final paragraph of your predecessor’s experience report of 2008.
It seems that the criticism you now face from some quarters is down to the creation by the EU of what is effectively a European protectionist tool; one that favours certain products of the European phytopharmaceutical system, and discriminates against those of non-European traditional systems of medicine. What the EU has attempted to do is akin to trying to put a square peg in a round hole. So, rather than trying to force non-European products into a European phytopharmaceutical model, would it not have been better to build a regulatory system around the great, long-standing, non-European traditions? But we understand neither the European Commission nor the EMA was ever serious about getting the necessary technical support from China, India or elsewhere, so perhaps we should not be surprised.

The first step: Acknowledging the problem for non-European traditions
Over the years of discussion between the Member States and your predecessors in DG Enterprise, it has been apparent there has been a very low level of willingness to deal with, or even recognise, the type of problems I raise in this letter.
Creating an efficient, fair and non-discriminatory system of regulation would be neither technically nor legally difficult. Together with our colleagues, other scientists, lawyers and stakeholders across Europe, we have many ideas of how the situation could be remedied.
However, I believe I would be wasting your time—as well as my own—if we were to now delve into the detail of our proposals for regulatory reform if you continue to be resistant to any significant change to the existing regulatory regimes facing herbal products in the EU.
In this light, I will end my letter with two requests:
1. Could I please ask for your comment and clarification on the concerns I have expressed in this letter, and in particular, on the four areas I have outlined (above) in which we claim there is a disproportionate obstacle in the way of products associated with long-standing, non-European—as compared with European—systems of medicine?
2. With respect to the European Commission’s recognition of the inappropriate nature of the TUR scheme for holistic systems of medicine (as stated in its 2008 experience report), will your Directorate General now consider as a matter of urgency the feasibility of a new regulatory framework for the practice of such systems?
I greatly look forward to your written response to these two points. I would like to add that should members of your Directorate General be interested in a meeting of experts and stakeholders related to the non-European sector, to discuss both the challenges faced and possible solutions, I would be very happy to arrange this at a mutually convenient time and place.
Yours sincerely
Robert Verkerk

The Triple Burner

The Triple Burner is probably the most widely discussed topic on Chinese medicine and, over the centuries, there have been many different theories on its nature. In this Clinical Tip, I will try to elucidate the main ideas on the nature of the Triple Burner and it will probably take more than one Clinical Tip.

“Burner” is a translation of the word jiao which means “burned” or “scorched”. It is also called “Warmer” while others choose not to translate it and call it the “San Jiao”. Some Chinese doctors distinguish between two basic views of the Triple Burner, one according to which is has “no form” (which is primarily from the Nan Jing) and another according to which it has “a form” (which is primarily from the Nei Jing). Although this distinction is important (and I will expand on it below), I think there are at least four different ways of looking at the Triple Burner, as listed below.

1) The Triple Burner as the activator of the Yuan Qi
2) The Triple Burner as a system of waterways
3) The Triple Burner governing movement of Qi
4) The Triple Burner as a system of cavities
5) The Triple Burner as a three-fold division of the body
6) Relationship between Triple Burner and Pericardium

1) The Triple Burner as the activator of the Yuan Qi
The view of the Triple Burner as the activator of the Yuan Qi derives from the Nan Jing, primarily chapters 8, 38, 62 and 66.

Chapter 8 of the Nan Jing says: “Sometimes the Cun Kou is normal and yet the patient dies. Why is that? The pulses of the 12 channels all originate from the Yuan Qi. This Yuan Qi is the root of the 12 channels, it is the Motive Force [Dong Qi] between the Kidneys, the root of the 5 Zang and 6 Fu and of the 12 channels, the gate of breathing and the origin of the Triple Burner. It is the spirit that guards against pathogenic factors (or evil influences). Such Qi is the root of humankind; if the root is cut stalks and leaves wither. When the Cun Kou is normal but the patient dies, it means that the Yuan Qi has been cut off internally.

This chapter establishes some very important principles. First, it talks about the Yuan Qi: it says that Yuan Qi is between the Kidneys (like the Ming Men) and that it is the root of the 12 channels, the Triple Burner and the 5 Zang and 6 Fu.

Secondly, it makes a very important statement when it says that this Yuan Qi is the “spirit” (shen) that guards against evils. This is a remnant of “demonic” medicine, i.e. the system of medicine in which disease is due to the invasion of evils spirits and the cure is effected by the shaman.

The clinical significance of this chapter is huge. Firstly, it establishes the idea that the Yuan Qi (and therefore the Kidneys) is the root of the 5 Zang and 6 Fu, of the 12 channels and of the Triple Burner.

Secondly, it establishes the relationship between the Triple Burner and the Yuan Qi (and therefore Ming Men). Later in chapter 66, the Nan Jing says that the Triple Burner is the “envoy” of the Yuan Qi in between the Kidneys. In this chapter 8, the Yuan Qi is also called Motive Force or Throbbing Qi or Moving Qi (Dong Qi).

Thirdly, this passage establishes the principle that the Yuan Qi (and therefore the Kidneys) play a role in the resistance to pathogenic factors. Interestingly, it calls the Yuan Qi the shen that protect from pathogenic factors (or evils).

This is of huge clinical significance because it means that our resistance to pathogenic factors depends not only on the Wei Qi and therefore Lungs but also on the Kidneys and the Yuan Qi (and also Jing due to the extraordinary vessels). In any case, Wei Qi stems from the Lower Burner (chapter 18 of the Ling Shu).

This is of clinical significance not only in resistance to pathogenic factors but also in the pathology of allergic asthma and allergic rhinitis, the root of which is also in the Kidneys, the Jing and the Yuan Qi.

Fourthly, this chapter is significant because for the first time it gives the view of the Triple Burner as the “envoy” of the Yuan Qi stemming from between the Kidneys. From this point of view, the Triple Burner allows the Yuan Qi to spring forth from between the Kidneys and perform its role in various parts of the body. For this reason, BL-22 Sanjiaoshu is just above BL-23 Shenshu.



Chapter 38 of the Nan Jing reiterates the relationship between the Triple Burner and the Yuan Qi. It says: “How come there are 5 Zang but 6 Fu? There are 6 Fu because of the Triple Burner which stems from the Yuan Qi. The Triple Burner governs all Qi in the body, it has a “name but no form”, it belongs to Hand Shao Yang, it is an “external Fu” [or “extra Fu”]. That is why there are 5 Zang but 6 Fu.”

This chapter actually describes four separate important aspects of the Triple Burner: first, it is a Fu organ (which brings the count of Fu organs up to 6); secondly, it stems from the Yuan Qi; thirdly, it governs all Qi of the body; fourthly, it has a “name but no form”, i.e. it is a function rather than an organ (which actually contradicts the first point).

The relationship between the Triple Burner and the Yuan Qi is explained also in the rather obscure chapter 62. This says: “The Zang [channels] have 5 jing, ying, shu, jing and he points; but the Fu have 6 [points], why? The Fu are Yang, the Triple Burner moves in the Yang channels, hence it has an additional shu point called Yuan.”

I personally think that the influence of the Triple Burner on the fact that the Yang channels have an extra shu point is due to the relationship between the Triple Burner and the Yuan Qi and to the fact that the Triple Burner “moves among the Yang” as this chapter says. In other words, as the Triple Burner is the envoy of the Yuan Qi and it moves among the Yang, it could be said to “seed” the Yang channels with its Yuan Qi (deriving from the space between the Kidneys). In fact, the Nan Jing says that the Yuan Qi comes out of the space between the kidneys through the envoy of the Triple Burner and goes to the 5 Zang and 6 Fu and the twelve channels. The reason it seeds only the Yang channels is due to the fact that it “moves among the Yang”.

Chapter 66 of the Nan Jing is the main one that discusses the relationship between the Triple Burner and the Yuan Qi. It says: “Below the umbilicus and between the kidneys there is a Throbbing Qi [Dong Qi] which constitutes a person’s life [sheng ming ]. This [Throbbing Qi] is the root of the 12 channels, also called Yuan Qi. The Triple Burner is the envoy of the Yuan Qi [or it allows the Yuan Qi to separate into its different functions]. It is responsible for the passage of the three types of Qi in the 5 Zang and 6 Fu. “Yuan” is a honorary designation of the Triple Burner. Hence the places where its Qi comes to a halt are called “Yuan” [points]. When the 5 Zang and 6 Fu are diseased, select the respective Yuan point.”



This chapter is the main source for the view of the Triple Burner as the “envoy” of the Yuan Qi: it allows the Yuan Qi to emerge from the space between the Kidneys and it facilitates the Yuan Qi’s differentiation into its different functions in different places.

Thus, the Triple Burner “mobilizes” the Yuan Qi by making it differentiate into its different forms to perform different functions in different places and organs. It is through the Triple Burner that the Yuan Qi can perform its functions. The Yuan Qi is closely related to the Ming Men and shares its role of providing the heat necessary to all the body’s functional activities.

The following are examples of functions carried out by the Yuan Qi which are aided by the Triple Burner:

• The Yuan Qi provides the heat necessary to the Spleen to transform and transport food essence and to the Kidneys to transform fluids. The Middle Burner makes sure that Yuan Qi reaches and assists the Spleen to transform and transport food essences and the Lower Burner ensures that Yuan Qi warms the Kidneys to transform fluids
• The Yuan Qi facilitates the transformation of Gathering Qi (Zong Qi) into True Qi (Zhen Qi). It can do this through the action of the Upper Burner in transporting Qi through the various passages in the chest.
• The Yuan Qi facilitates the transformation of Food-Qi (Gu Qi) into Blood in the Heart. The Upper Burner ensures the smooth passage and transportation of Qi in the chest for this transformation to take place.

Thus, the Triple Burner helps the Yuan Qi to differentiate itself into different forms to perform different functions in different places.

The relationship between the Triple Burner and the Yuan Qi of the Kidneys is reflected in the location of the Back-Shu point of the Triple Burner (BL-22 Sanjiaoshu) just above the Back-Shu point of the Kidneys (BL-23 Shenshu).

From this point of view, the Triple Burner has “no form”, i.e. it is a function and not an actual Fu organ. The Nan Jing says succintly: “It has a name but no form” (you ming wu xing).

Clinical Application

The relationship between the Triple Burner and the Yuan Qi has important clinical applications. It means that the Yuan Qi performs its warming and facilitating function through the Triple Burner. Thus, if we want to activate the Yuan Qi in the different Burners we need to activate the Triple Burner as well and the points I use are as follows:

- Upper Burner: Ren-17 Shanzhong to stimulate the diffusing and descending of Lung-Qi and warm the Lungs
- Middle Burner: Ren-12 Zhongwan and Ren-9 Shuifen to stimulate the descending of Stomach-Qi, the transportation and transformation (yun hua) by the Spleen and the rotting and ripening by the Stomach.
- Lower Burner: Ren-5 Shimen and BL-22 Sanjiaoshu to stimulate the transportation, transformation and excretion of fluids in the Lower Burner.

For example, in case of Dampness in the Lower Burner and specifically in the Kidneys and Bladder causing urinary problems occurring against a background of Kidney-Yang deficiency, one can use Ren-5 Shimen and BL-22 Sanjiaoshu to activate the Triple Burner (or specifically Lower Burner) and Ren-4 Guanyuan and BL-23 Shenshu to tonify the Kidneys and the Yuan Qi. Note how Ren-4 and BL-23 (related to Kidneys) are just below Ren-5 and BL-22 respectively (related to Triple Burner) reflecting the view that the Yuan Qi emerges from between the Kidneys through the Triple Burner.

SEXUAL LIFE IN CHINESE MEDICINE

Chinese medicine has always stressed the importance of excessive sexual activity: in this article, I would like to bring to your attention two factors:
- The distinction between men and women in sexual activity
- Insufficient sexual activity as a cause of disease

When discussing sexual activity, Chinese books never distinguish between men and women. There are substantial differences in the sexual physiology of men and women so that excessive sexual activity is less of a cause in disease in women than it is in men. The reason lies in the nature of Tian Gui.

Tian Gui is the generative essence that renders men and women fertile. It is mentioned in the very first chapter of the Su Wen: “When a girl is 14 Tian Gui arrives, the Ren Mai is open, the Chong Mai is flourishing, menstruation starts and she can conceive”. For boys, “When a boy is 16, Kidney-Qi is strong, Tian Gui arrives, sperm is discharged, Yin and Yang are in harmony and he can fertilize.” Thus, Tian Gui is the essence that allows women to conceive and men to fertilize: in women, it is the ova, in men, sperm. Tian Gui is a direct manifestation of Kidney-Jing. In men, loss of sperm therefore implies a loss of Jing and therefore excessive (too frequent) sexual activity may diminish Jing; in women, during sexual activity there is no corresponding loss of Jing as they obviously do not lose ova during sexual activity and therefore there is no corresponding loss of Jing.

While Chinese books always mention excessive sexual activity as a cause of disease, they never mention insufficient sexual activity as a possible cause of disease. This has not always been so as, during past dynasties, all sex manuals explicitly said that sexual activity is essential for the health of both men and women. Indeed, sexual abstinence was viewed with suspicion (as Buddhist nuns were).

Some Chinese doctors considered lack of sex and sexual frustration as a major cause of emotional stress in women. Sexual desire depends on the Minister Fire and a healthy sexual appetite indicates that this (physiological) Fire is abundant. When sexual desire builds up the Minister Fire blazes up and Yang increases : the orgasm is a release of such accumulated Yang energy and, under normal circumstances, it is a beneficial discharge of Yang-Qi which promotes the free flow of Qi. When sexual desire builds up, the Minister Fire is stirred: this affects the Mind and specifically the Heart and Pericardium. The Heart is connected to the Uterus via the Uterus Vessel (Bao Mai) and, in women, the orgasmic contractions of the uterus discharge the accumulated Yang energy of the Minister Fire.

When sexual desire is present but does not have an outlet in sexual activity and orgasm, the Minister Fire can become pathological, accumulate and give rise both to Blood Heat and to stagnation of Qi in the Lower Burner. This accumulated Heat will stir the Minister Fire further and harass the Shen, while the stagnation of Qi in the Lower Burner can give rise to gynaecological problems such as dysmenorrhoea.

Of course, if sexual desire is absent, then lack of sexual activity will not be a cause of disease. Conversely, if one abstains from sexual activity but the sexual desire is strong, this will also stir up the Minister Fire. Thus, the crucial factor is the mental attitude and sexual desire.

With regard to sexual frustration, Qing dynasty’s Chen Jia Yuan wrote very perceptively about some women’s emotional longing and loneliness. Among the emotional causes of disease he distinguishes “worry and pensiveness” from “depression”. He basically considers depression, with its ensuing stagnation, due to emotional and sexual frustration and loneliness. He says: “In women...such as widows, Buddhist nuns, servant girls and concubines, sexual desire agitates [the mind] inside but cannot satisfy the Heart. The body is restricted on the outside and cannot expand with the mind [i.e. the mind longs for sexual satisfaction but the body is denied it]. This causes stagnation of Qi in the Triple Burner and the chest; after a long time there are strange symptoms such as a feeling of heat and cold as if it were malaria but it is not. This is depression”.
Although the above thoughts derive from Dr Chen’s clinical experience with servant girls, Buddhist nuns and concubines and should therefore be seen in the social context of the Qing dynasty, they also have relevance to our times as he is essentially talking about sexual frustration and loneliness and his reference to widows confirms this (in old China widows were shunned and seldom remarried). He perceptively refers to sexual craving agitating the body but not finding a satisfaction in the Heart and mind: besides sexual frustration, he is also referring to emotional frustration and craving for love.

Thus, considering the social position of women in ancient China and the frequency of the above-mentioned emotional frustration, it is no wonder that Qi stagnation occupies such a central place in women’s pathology, and emotional stagnation in women was often the result of sexual frustration, separation, loss and loneliness: these are the recurrent "anger" in Chinese medicine books.

Sexual frustration was a common cause of disease especially from the Song dynasty onwards as Confucianists frowned upon sexual activity and believed that it should be carried out in secret and that there should be no public display of affection (as in modern China). The current pruderie of Chinese medicine and society is clearly a result not so much of the Communist influence but of the Qing dynasty's Confucian influence. It is important to understand, however, that these rules did by no means imply that sex was a “sin” and woman was the origin of such sin as in the Christian view. The Confucianist abhorrence of sexual philandering was determined mainly by the fear that promiscuity might disrupt the sacred family life.

i. Eight Secret Books on Gynaecology, p.152.

EUROPEAN PARLIAMENT LOBBY FOR HERBAL MEDICINE

EMERGENCY FORUM, BRUSSELS, 21st June to save herbal medicine: be there or view on internet
The Alliance for natural Health, the European Parliament CAM Interest Group and other campaign groups will be in the European Parliament in Brussels to question European regulators, along with concerned Members of the European Parliament (MEPs), over how they are handling herbal products in Europe. The questions will be raised in an emergency forum organised by Greens MEPs.

But this is your chance to ask your own questions! If you can make it to Brussels, please be there. It would be amazing to stuff the seminar room full of concerned citizens to really show European regulators the extent and depth of concern.

If you can get to the European Parliament in person next Tuesday for around midday in readiness for a 13:00h start, you will need to register by sending your full name, address, your passport number and date of birth to michele.rivasi@europarl.europa.eu and satu.hassi@europarl.europa.eu by 16:00h Central European Time, Friday 17 June 2011. It would be wonderful to see as many of you there as possible! Access to the European Parliament can be gained via the Altiero Spinelli entrance on Rue Wiertz 60, B-1050 Brussels (see ASP on map).

If you can't be there, you'll be able to watch the debate live between 13:00-16:00h Central European Time via the following livestream link:
http://greenmediabox.eu/live/thmpd/

We know this is very short notice - but this is an emergency conference, and the scheduling, venue and details have only just been agreed and received by us, which is why we have wasted no time getting this out to you.

Please get this message out as widely as possible to all those you know in Europe (and beyond of course for those who want to view the livestream) who are as concerned as we are.

European double standards for drugs and herbal medicines

The following is an interesting report of the 3-year struggle to get the European Medicines Agency (EMA) to release data on clinical trials that it was bound by European law to release. It is interesting that European agencies (such as the EMA) cite protection of drug companies commercial interest for not divulging data, while, when it comes to herbal manufacturers, they claim to “protect the consumer”. When I hear that a regulatory agency aims to “protect the consumer” alarm bells ring. (For US practitioners: the EMA is the European equivalent of the FDA.)

BMJ 2011; 342:d2686 doi: 10.1136/bmj.d2686 (Published 10 May 2011)

OPENING UP DATA AT THE EUROPEAN MEDICINES AGENCY
Peter C Gøtzsche, professor
Anders W Jurgensen, PhD student

Nordic Cochrane Centre, Rigshospitalet and University of Copenhagen, Dept 3343, Blegdamsvej 9, DK-2100 Copenhagen Ø, Denmark

Widespread selective reporting of research results means we do not know the true benefits and harms of prescribed drugs. Peter Gøtzsche and Anders Jørgensen describe their efforts to get access to unpublished trial reports from the European Medicines Agency.

Doctors cannot choose the best treatments for their patients despite the existence of hundreds of thousands of randomised trials. The main reason is that research results are being reported selectively. Comparisons of published drug trials with unpublished data available at drug regulatory agencies have shown that the benefits of drugs have been much over-rated and the harms under-rated. Comparisons of trial protocols with published papers have also shown widespread selective reporting of favourable results.

Selective reporting can have disastrous consequences. Rofecoxib (Vioxx) has probably caused about 100,000 unnecessary heart attacks in the United States alone, and class 1 antiarrhythmic drugs probably caused the premature death of about 50,000 Americans each year in the 1980s. An early trial found nine deaths among patients taking the antiarrhythmic drug and only one among those taking placebo, but it was never published because the company abandoned the drug for commercial reasons.

Allowing researchers access to unpublished trial reports submitted to drug regulatory agencies is important for public health. Such reports are very detailed and provide more reliable data than published papers, but it has been virtually impossible to get access to them. We eventually succeeded in getting access to reports held by the European Medicines Agency (EMA) after three years of trying. Our case has set an important precedent, and we summarise here the process and the arguments.

Our application for access
On 29 June 2007 we applied for access to the clinical study reports and corresponding protocols for 15 placebo controlled trials of two anti-obesity drugs, rimonabant and orlistat. The manufacturers had submitted the reports to the EMA to obtain marketing approval in the European Union. We explained that we wanted to explore the robustness of the results by adjusting for the many missing data on weight loss and to study selective publication by comparing protocols and unpublished results with those in published reports.

The information was important for patients because anti-obesity pills are controversial. The effect on weight loss in the published trials is small, and the harms are substantial. People have died from cardiac and pulmonary complications or have experienced psychiatric disturbances, including suicidal events, and most of the drugs have been deregistered for safety reasons.

A basic principle in the European Union is to allow its citizens the widest possible access to the documents its agencies possess. But there are exemptions, and the EMA refuses access if disclosure would threaten commercial interests unless there is an over-riding public interest. We argued in our first letter to the EMA that secrecy was not in the best interests of the patients because biased reporting of drug trials is common. Furthermore, we had not found any information that could compromise commercial interests in 44 trial protocols of industry initiated trials we had reviewed previously.

Protection of commercial interests
Protection of commercial interests was the EMA’s over-riding argument. It would undermine the protection of commercial interests to allow us access, it said, as the documents represented the full details of the clinical development programme and the most substantial part of the applicant’s investment. Competitors could use them as a basis for developing the same or a similar drug and gather valuable information on the long term clinical development strategy of the company to their own economic advantage.

We explained that the clinical study reports and protocols are based on well known principles that can be applied to any drug trial; that the clinical study reports describe the clinical effects of drugs; and that nothing in the EMA’s guidelines for preparation of such reports indicates that any information included in them can be considered a trade secret. The trial protocols are always sent to the clinical investigators, and it is unlikely that companies would have left in any information that could be of commercial value (such as a description of the drug synthesis). We also noted that the clinical study reports and trial protocols represent the last phase of drug development, which has been preceded by many years of preclinical development. Other companies could hardly use them as a basis for developing similar drugs. In fact, unpublished trial data are generally less positive than published ones, and competitors would therefore be less likely to start drug development if they had access to the unpublished results. Other companies are more likely to be interested in in vitro, animal, and early human studies, and drug companies have no problems with publishing such studies because the results may attract investors.

The European ombudsman, P Nikiforos Diamandouros, considered that commercial interests might be at stake but noted that the risk of an interest being undermined must be reasonably foreseeable and not purely hypothetical. He could not see that access would “specifically and actually” undermine commercial interests. He inspected the relevant reports and protocols at the EMA and concluded that the documents did not contain commercially confidential information. He therefore criticised the EMA’s refusal to grant us access.

Over-riding public interest in disclosure
Even if commercial interests were undermined by disclosure, access would still have to be granted if there was an over-riding public interest. The EMA argued that it could not identify any over-riding public interest and remarked that the evaluation of safety and efficacy of drugs is its responsibility—the EMA constantly monitors drugs and updates its assessment reports and requires changes in product information as appropriate.

We considered this insufficient. Monitoring adverse effects reported by doctors to drug agencies would not have revealed that rofecoxib causes heart attacks. Few such events are reported, and heart attacks are common in people with arthritis. Postmarketing passive surveillance systems can therefore usually not detect whether a drug leads to more heart attacks than expected; randomised trials are needed for this.

We provided more evidence of the detrimental effects of selective publication but to no avail. The EMA continued to claim that we had not documented the existence of an over-riding public interest. We noted that we could not prove this in this specific case because we were denied access to the data, but we drew attention to the fact that the total number of patients in the main clinical studies of orlistat differed according to the source of the information: published reports, the EMA’s website, and the website of the US Food and Drug Administration.

The ombudsman indicated that we had established an over-riding public interest, but he did not take a definitive stance on whether an over-riding public interest existed because this question needed answering only if disclosure undermined commercial interests. He asked the EMA to justify its position that there wasn’t an over-riding public interest, but the EMA avoided replying by saying that we had not given evidence of the existence of such an interest. We believe that we had. Furthermore, the EMA’s argument was irrelevant. A suspect asked for his alibi on the day of the crime doesn’t get off the hook by asking for someone else’s alibi.

Administrative burden
According to the EMA, the redaction of (unspecified) “personal data” would cause the EMA a disproportionate effort that would divert attention from its core business, as it would mean redacting 300,000-400,000 pages. This was surprising. The Danish Drug Agency had not seen the workload as a problem when it granted us access to the reports for the anti-obesity drug sibutramine, which was locally approved in Denmark. The 56 study reports we received comprised 14,309 pages in total, and we requested only 15 study reports from the EMA (the pivotal studies described in the European Public Assessment Reports (EPARs) on rimonabant and orlistat). The ombudsman declared that the EMA had overestimated the administrative burden involved.

Worthlessness of data after redaction
The EMA argued that, “as a result of the redaction exercise, the documents will be deprived of all the relevant information and the remaining parts of them will be worthless for the interest of the complainant.”

From what we know of clinical trial reports and protocols it struck us as odd that they would contain so much personal data that the documents became worthless. The ombudsman noted that the requested documents do not identify patients by name but by their identification and test centre numbers, and he concluded that the only personal data are those identifying the study authors and principal investigators and to redact this information would be quick and easy.

The EMA also remarked that a possible future release of the assessment reports of the EMA’s Committee for Medicinal Products for Human Use and the (co)rapporteur assessment reports “could satisfy the request of the complainants.” These reports were not available and they would have been worthless to us because they are merely summaries used for regulatory decisions.

Maladministration
The EMA was completely resistant to our arguments and those from the ombudsman. However, after the ombudsman accused the EMA of maladministration in a press release on 7 June 2010, three years after our request, the EMA reversed its stance. The EMA now gave the impression that it had favoured disclosure all the time, agreed with the ombudsman’s reasoning, and noted that the same principles would be applied for future requests for access but that it would consider the need to redact part of the documents.

The EMA’s last letter was unclear: “The Agency will do its utmost to implement its decision as quickly as possible, in any case within the next 3 months at the latest. The Agency will keep the European Ombudsman promptly informed of the exact implementation date.”

It was not clear whether the three months was the deadline for sending the reports to us, for implementing its new policy, or both. We received the data we requested from the EMA on 1 February 2011, which in some cases included individual patient data in anonymised format, identified by individual and test centre numbers.

Concluding remarks
According to the EMA’s responses to the ombudsman, the EMA put protecting the profits of the drug companies ahead of protecting the lives and welfare of patients. Moreover the EMA's position is inconsistent because it resisted requests to give access to trial data on adult patients while providing access to data on paediatric trials, in accordance with EU legislation. The Declaration of Helsinki gives authors the duty to make publicly available the results of their research on humans. The declaration also says that, “Medical research involving human subjects must . . . be based on a thorough knowledge of the scientific literature.” If the knowledge base is incomplete, patients may suffer and cannot give fully informed consent9 and research resources are wasted. The EMA should be promoting access to full information that will aid rational decision making, not impede it.

Our case sets an important precedent. On 30 November 2010 the EMA declared it would widen public access to documents, including trial reports and protocols. We recommend that the FDA and other drug regulatory agencies should follow suit. Access should be prompt—for example, within three months of the regulator’s decision—and documents should be provided in a useful format. Drug agencies should get rid of the huge paper mountains and require electronic submissions from the drug companies, including the raw data, which should also be made publicly available.