Thursday, June 16, 2011


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 and 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:

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)

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.

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.

Tuesday, June 7, 2011


It always seems strange that joy should be listed among the emotional causes of disease in Chinese medicine. And yet, it has always been mentioned as an emotional cause of disease since ancient times. Strangely, the Chinese character for “joy” [xi 喜] is the only one of the emotions that is not based on the ‘heart” radical. The character Xi is based on the radical for “drum” plus “mouth”, i.e. beating a drum and singing in happiness. Incidentally, two xi characters next to each other are called “double happiness” and are a symbol of a wedding.

It is interesting that, in the list of emotions as causes of disease, “joy” is always top of the list, followed by anger. For example, these are the emotions listed by Confucius: joy, anger, grief, fear, love, hatred, desire. These are the emotions listed by Lao Zi: joy, anger, worry, sadness, love, hatred, desire. It is interesting that both lists include “love” as an emotional cause of disease! Chen Wu Ze (1174) lists: joy, anger, pensiveness, worry, sadness, fear, shock. These became the widely accepted “7 emotions” of Chinese medicine. Zhang Jie Bin (1624) lists eight emotions: joy, anger, pensiveness, worry, sadness, fright, fear, shock.1

A normal state of joy is obviously not in itself a cause of disease; on the contrary, it is a beneficial mental state which promotes a smooth functioning of the Internal Organs and their mental faculties. The “Simple Questions” in chapter 39 says: “Joy makes the Shen peaceful and relaxed, it benefits the Ying and Wei Qi and it makes Qi relax and slow down.”2 On the other hand, in chapter 2 the “Simple Questions” says: “The Heart … controls joy, joy injures the Heart, fear counteracts joy.”3 Other passages in the Nei Jing clearly refer to joy as a cause of disease. For example, chapter 5 of the “Simple Questions” says: “Joy injures the Heart.”4 Chapter 8 of the “Spiritual Axis” says: “Joy scatters the Heart and deprives it of its residence.”5

Fei Bo Xiong (1800–1879) in “Medical Collection of Four Doctors from the Meng He Tradition” says: “Joy injures the Heart … [it causes] Yang Qi to float and the blood vessels to become too open and dilated …”6

I think that the best (and probably only) way to understand “joy” as an emotional cause of disease is in the light of the three main philosophies of China, i.e. Daoism, Confucianism and Buddhism. I think that “joy” is akin to “desire” and “craving” from the point of view of these three philosophies. Of the three philosophies, Daoism and Confucianism are the main ones because Buddhism was not widespread in China at the time when joy was already considered as a cause of disease, i.e. during the Warring States Period (476-221 BC).

All these three religions (or rather philosophies), for different reasons, advocated emotional restraint and avoidance of “craving” and “desire”. For example, the Daoists shunned social relations and advocated “following the Dao”, “absence of desire” (wu yu) and “non-action” (wu wei). They felt that joy would stop us from following the Dao as much as other emotions such as anger. The great Daoist Zhuang Zi (370-301 BC?) talks about wu qing, i.e. absence of feelings: “What I mean when I say that they [sages] are wu qing (without feelings) is that they do not injure their own persons with likes and dislikes and are always responsive to what is natural without trying to increase life.”7

The ancient Daoist text Nei Ye (Inner Training), older than the Dao De Jing, has this interesting passage on emotions:

The vitality of all people
Inevitably comes from their peace of mind
When anxious, you lose this guiding thread
When angry, you lose this basic point
When you are anxious or sad, pleased or angry,
The Dao has no place within you to settle
Love and desire: still them!
If you are tranquil, you will attain it (the Dao)
If you agitated, you will lose it.8

Indeed, to the Daoists, stimulation has a negative connotation. Zhuang Zi says concisely: “When desire is profound, the force of Heaven is superficial.” This means that desire turns us away from the vitality of Heaven stirring emotions within us that make us stray from the path of the Dao.

Confucianists believed that the true “gentleman” (a mistranslation of the term jun zi that actually applies to both men and women) is not stirred by emotions because these cloud his or her true nature. They used the image of a pond with a muddy bottom. If the water is very still, it becomes clear: if we stir the bottom, the water becomes turbid. The pond is our human nature which is naturally “clear”; if we are stirred by emotions, these will cloud our human nature. Consider this passage from Xun Zi (a Confucianist philosopher, 312-230 BC): “It is ever so that the Heart-Mind [Xin] is naturally full, naturally born and naturally perfected. Should its function be impaired, it is certain to be due to sorrow and happiness, joy and anger, desire and profit-seeking. If we can rid ourselves of sorrow and happiness, joy and anger, desire and profit-seeking, the Heart-Mind [Xin] will revert to its flawless state.”9

The Buddhists considered desire and craving as the very root of human suffering. Greed (excessive desire), hatred and ignorance are at the centre of the Wheel of Life and greed is strangely symbolized by a rooster. According to them, our very existence begins out of the desire and craving of a mind in the Bardo state (the period after death and before the next reincarnation): the mind desires the warmth of a womb and it reincarnates. Later on in life, desire causes our mind to try to grasp objects like a monkey sways from tree to tree (that is why the Buddhist Wheel of Life has, among others, the image of a monkey on a tree).

So, what relevance has this view of “joy”, “desire” and “craving” to us in the 21st century? I think that these emotions are indeed causes of disease and I would call the modern equivalent of these emotions “overstimulation”. I think that this, rather than “joy”, would probably be the best translation of xi. Our society indeed bombards us with objects of craving and it artificially creates “desire” and “craving” through advertising; on the other hand, it provides and fosters substances that overstimulate us.

We are all “overstimulated” by entertainment, frenetic lifestyle, consumerism, coffee, tea, tobacco, alcohol, TV, video games, “recreational drugs”, medicinal drugs, and sexual stimulation.

The main stimulant drugs are:
• Caffeine
• Nicotine
• Cocaine
• Amphetamines
• Prescription drugs e.g. Ritalin® (Methylphenidate), Adderall® (amphetamine and dextroamphetamine), Dexedrine® (dextroamphetamine), Strattera® (atomoxetine), Focalin® (Dexmethylphenidate) etc.

Interestingly, antidepressants are not actually stimulants and do not usually lead to “joy”. My experience with depressed patients on anti-depressants is that these drugs “blunt” all emotions; they do somehow lift depression but at the expense of alertness and enthusiasm. Indeed, some anti-depressants are used for anxiety with some effect.

I think that the ‘blunting” effect of anti-depressants is reflected in the resulting pulse, i.e. a pulse that feels “stagnant” and does not have the healthy “wave” of the normal pulse. It is not Wiry, not Tight but I describe it as “stagnant” and “reluctant”. While most authors see anti-depressants as mood-elevating and stimulants, I do not share that view and the pulse qualities described above seem to confirm this.

Overstimulation, in the broad sense indicated above, makes the Heart larger. This leads to excessive stimulation of the Heart, which in time, may lead to Heart-related symptoms and signs. These may deviate somewhat from the classical Heart patterns. The main manifestations would be palpitations, over-excitability, insomnia, restlessness, talking a lot and a red tip of the tongue. The pulse would typically be slow, slightly Overflowing but Empty on the left Front position. It may seem strange that “joy” or overstimulation makes the pulse slow. This is because overstimulation makes the heart larger and therefore slows down circulation (shock, by contrast, makes the heart smaller).

The points I use for overstimulation are HE-7 Shenmen, P-7 Daling, Du-19 Houding, Ren-15 Jiuwei.

1. Zhang Jie Bin (also called Zhang Jing Yue) 1982 Classic of Categories (Lei Jing), People’s Health Publishing House, Beijing, p. 424. First published in 1624.

2. 1979 The Yellow Emperor’s Classic of Internal Medicine-Simple Questions, p. 221.

3. Tian Dai Hua 2005 The Yellow Emperor’s Classic of Internal Medicine - Simple Questions p. 38.

4. Ibid., p. 38.

5. Spiritual Axis, p. 25.

6. Medical Collection of Four Doctors from the Meng He Tradition, p. 40.

7. Ames RT and Hall DL A Philosophical Translation of the Dao De Jing, Ballantine Books, New York, 2003, p. 47.

8. Roth H Original Tao, Columbia University Press, New York, 1999, p. 94.

9. Lee J Xunzi and Early Chinese Naturalism, State University of New York Press, Albany, 2004, p. 35.

Thursday, June 2, 2011

Petition to save herbal medicine in Europe

To European practitioners and public: please sign this petition from the Alliance for Natural Health to save herbal medicine in Europe. Bring the battle to your elected representatives: they, not the so-called regulatory agencies, are ultimately responsible to reverse this gross infringement of our freedoms.

An EU directive has banned many herbal medicines, denying us safe remedies and feeding the profits of big pharma. Let's raise a massive outcry to push the Commission to reverse the Directive. Let's get to 1 million voices to save herbal medicine. Add your name here: