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
Tuesday, August 30, 2011
Saturday, August 20, 2011
Obstetrics and Gynaecology in Chinese Medicine - 2nd edition
We are pleased to announce the publication of the second edition of Obstetrics and Gynaecology in Chinese Medicine by Giovanni Maciocia.
Obstetrics and Gynaeclogy in Chinese Medicine is a complete and detailed textbook of this speciality in Chinese medicine with the pattern diagnosis and treatment with acupuncture and Chinese herbs. The author bases his exposition on modern and ancient Chinese books, always integrated with his long clinical experience. The book deals in depth with gynaecological disorders, diseases of pregnancy and diseases after childbirth. It is complemented by a chapter on childbirth written by an experienced midwife/acupuncturist practising in the busy maternity unit of a UK hospital.
The book deals with the diagnosis and treatment of 64 women's disorders including menstrual irregularities, diseases during pregnancy and diseases after childbirth.
The second edition has been completely revised and new formulae added; in addition, the author discusses the diagnosis and treatment of endometriosis, polycystic ovary and myoma.
www.giovanni-maciocia.com/books/english/obstetrics.html
www.amazon.com/Obstetrics-Gynecology-Medicine-Giovanni-Maciocia/dp/0443104220/ref=sr_1_1?ie=UTF8&qid=1313884728&sr=8-1
Obstetrics and Gynaeclogy in Chinese Medicine is a complete and detailed textbook of this speciality in Chinese medicine with the pattern diagnosis and treatment with acupuncture and Chinese herbs. The author bases his exposition on modern and ancient Chinese books, always integrated with his long clinical experience. The book deals in depth with gynaecological disorders, diseases of pregnancy and diseases after childbirth. It is complemented by a chapter on childbirth written by an experienced midwife/acupuncturist practising in the busy maternity unit of a UK hospital.
The book deals with the diagnosis and treatment of 64 women's disorders including menstrual irregularities, diseases during pregnancy and diseases after childbirth.
The second edition has been completely revised and new formulae added; in addition, the author discusses the diagnosis and treatment of endometriosis, polycystic ovary and myoma.
www.giovanni-maciocia.com/books/english/obstetrics.html
www.amazon.com/Obstetrics-Gynecology-Medicine-Giovanni-Maciocia/dp/0443104220/ref=sr_1_1?ie=UTF8&qid=1313884728&sr=8-1
Wednesday, August 10, 2011
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
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
Tuesday, August 2, 2011
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.
“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.
Monday, July 11, 2011
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.
- 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.
Thursday, June 16, 2011
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.
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.
Sunday, June 12, 2011
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.
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.
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