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A Physician’s View on Legal Aspects of the Contemporary Medical Use of Mercury in Germany

In: Asian Medicine
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Jürgen C. Aschoff Retired from University of Ulm fabri.antiquariat@gmx.de

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This article looks at various legal aspects of different groups of allopathic and homoeopathic remedies in Germany. Differences between allopathic and homoeopathic, approved and registered, and individually prescribed drugs are explained in the context of their availability and whether the legal responsibilities lie with the physicians prescribing the drugs or the pharmacies issuing, mixing, or importing them. Some of these remedies contain mercury in various forms, and the legalities of these mercurial remedies are explained from the practical point of view of a physician working in Germany.

Introduction

When mercury is used as medicine or part of a complex drug formulation, legal aspects, formal frameworks, and clear definitions are of special importance. In Germany, remedies and drugs to cure diseases, disturbances, or disorders of general indisposition and stress are divided officially into allopathic and homoeopathic remedies.1 Apart from chemical and biochemical products, allopathic remedies include the use of phytopharmaceutical products in measurable and standardised amounts. Homoeopathy, on the other hand, makes use of all kinds of substances, such as chemical, mineral, animal, or plant products—even highly toxic or poisonous—but in minimal, quasi-non-measurable amounts; that is, in extremely diluted preparations.

In Germany, four groups of legally prescribed drugs can be distinguished:

  1. ready-to-use ‘approved’ allopathic medications from established ‘Western’ pharmaceutical companies2

  2. ready-to-use ‘registered’ homoeopathic medicines and similar individually prescribed homoeopathic drugs

  3. individually prescribed and blended tcm (Traditional Chinese Medicine) and ayurvedic herbal preparations3,4 and

  4. ready-to-use pills (neither approved nor registered in Germany, but still legally sold) originating from traditional Asian medicine sources and imported in single packages from Asian countries.

In the first and second group, one has to differentiate between so-called ‘approved medicines’ and what are only ‘registered medicines’. ‘Approved medicines’ are defined as ready-to-use drugs that have passed intensive clinical trials; their efficacy as well as their side-effects have been agreed on and are acknowledged by the scientific community. For one such drug, the costs of ‘approval’ run into millions of Euros. If properly used by the physician, the full responsibility for as yet unknown side-effects and dangers for a patient lies with the drug-producing pharmaceutical company and not with the doctor prescribing the drug or the issuing pharmacy. In contrast, ‘registered medicines’ are primarily homoeopathic remedies and similar drugs. This registration procedure is also applicable to ‘traditional herbal medicinal products’ of European traditions, such as valerian, passiflora, etc. They are registered at and controlled by the Central Government Institute for Drugs and Medical Products (BfArM, Bundesinstitut für Arzneimittel und Medizinprodukte). The registration for a homoeopathic remedy is easy and costs relatively little. Certain requirements have to be met for such a registration;5 for example, the handling of the production of a homoeopathic remedy—like wobbling or shaking the ingredients towards the geocentre or the making of a very high dilution. In the final product, no harmful molecules from whatever source should remain. However, according to the homoeopathic theory, the so-called ‘information’ of the primarily used material—a mercury containing mother tincture for instance—is still present in the applied drug. Responsibility again lies with the producing company and not with the doctor prescribing the drug nor the pharmacist issuing the remedy.

Concerning the third group mentioned above, this simplified and less costly ‘registration’ procedure applies also to plant products used in allopathic amounts in medicinal herbal preparations, primarily in Western herbal medicine or naturopathy as well as in the context of tcm or Ayurveda. Among the latter two, plant products require not only an official certificate from the country of origin, but also a certified verification of the ingredients and their quality by the handling pharmacist in Germany. Whether a single plant can be used within Germany depends primarily upon a positive ‘phytotherapeutic monograph’ of the ’Commission E’.6 In this case, the pharmacist takes full responsibility for the quality of the product he is mixing, but not for the dosage. The dosage needs to be prescribed by a doctor for each patient in a personalised manner. When properly mixed by the pharmacist, the final responsibility for the well-being of the patient lies with the medical doctor prescribing the mixture. This means that if the patient suffers from side-effects he can sue the doctor but not the plant producer nor the pharmacist.

The last group of legally prescribed drugs covers ready-to-use preparations in the context of traditional Asian medicines, which are imported mostly from India or China and sold in Germany through official pharmacies. Such imported products are not registered in Germany. They are licensed by a state authority abroad and simply imported to Germany.7 For this last group, the following procedure is required: these ready-to-use pills must have a specific registration number in their country of origin; prescriptions can only be issued in small quantities by a licensed medical doctor, and only for a given single patient; the pharmacist then orders these prescribed pills through an international pharmacy in Germany and delivers them to the patient. Since this is possible only on a small scale and not for the general market,8 no proof of the ingredients or of their purity, etc., is required, and the entire responsibility with regard to the safety of the ingredients lies with the doctor prescribing the pills. No one else is responsible for possible side-effects or any damage to the patient.9 This is known as ‘named patient use’ or ‘compassionate use’ (in German called ‘individueller Heilversuch’).10 I myself made use of this several times in my private practice as a neurologist and psychiatrist when prescribing the Tibetan precious pill Ratna Samphel to individual patients, in order to treat pain syndromes or mental problems resistant to modern Western medicines. It was no problem for these patients to receive Ratna Samphel pills imported for them from a Chinese/Tibetan pharmacy from the People’s Republic of China (prc).

On the Legal Use of Mercury in Germany

With this formal framework in mind, we now look at the actual legal use of mercury in Germany as of 2013.11 Mercury is known and proven for its antiseptic and anti-inflammatory effect, and has been used in this context in Western medicine for centuries.12 It is now on the verge of being completely abandoned and banned due to its toxic side-effects. However, mercury has been used and is still manufactured and sold as part of complex Asian traditional medicines for vitality and longevity, as well as for treating specific diseases.13

Although there are European initiatives and regulations concerning the use of mercury, its legislation differs in individual European countries.14 For mercury products in general, the following legislation applies throughout the eu: Directive 2007/51/ec regarding mercury in measuring and control devices prohibits using mercury in thermometers, barometers, and blood pressure devices since 3 April 2009. Directive 94/62/ec restricts mercury included in packaging waste. The Restriction of Hazardous Substances Directive (RoHS, 2002/95/ec) also restricts the use of six materials, including mercury, in electrical and electronic products.

However, mercury in dental amalgam, which is an alloy of metallic mercury with silver used for tooth fillings, is still legally used in Germany and is even mandated, primarily according to the regulations of the German statutory health insurance. So far, only Sweden, Denmark, and Norway (not in the eu) have banned dental amalgam. On 1 January 2008, Norway banned mercury in dental amalgam fillings and measuring instruments.15 Sweden followed a year later. On 15 January 2009, the Swedish Ministry of Environment announced a total ban of mercury in the country; this also applied to mercury used in dentistry.16

As far as ‘approved’ drugs for internal use are concerned, mercury of any kind is strictly illegal in Germany.17 But as mentioned above, mercury is still used legally in Germany in amalgam dental fillings. A large body of scientific work has not found any harm caused by mercury dental fillings,18 contrary to the complaints of many patients.19 Mercury is also legally applied subcutaneously as Thimerosal in influenza vaccines where mercury in minimal dosages acts as a stabilising and enhancing factor for the efficacy of the vaccine.20 However, there are ongoing discussions on whether these small amounts of mercury are related to the development of autism.21 No other approved medical drug in Germany contains mercury.

A comment here is required on Mercurochrome, a topical applied antiseptic product, which was once widely marketed. Since 2003, it has been forbidden and illegal in Germany,22 but it is still widely used in other parts of the world as an inexpensive external antiseptic to treat small cuts. It definitely contains small amounts of mercury, but no one has linked Mercurochrome to any kind of internal mercury poisoning (presumably because the metal is only present in minimal amounts and only applied externally). Nevertheless, allergic skin reactions might occur very rarely when Mercurochrome is applied topically to the skin. This has been documented and published,23 but without a clear conclusion of whether the minimal amount of mercury itself or other parts of the Mercurochrome fluid were responsible for the allergic reaction.

Mercury in Homeopathic Remedies

Among homoeopathic remedies, several hundred different remedies are derived from mercurial sources,24 and are nowadays used legally in Germany in the form of internally taken little pills—so-called Globuli. In Germany, between 1995 and 2005, the turnover from the sales of homoeopathic remedies increased by 81 per cent.25 There are two homoeopathic mercury remedies most commonly used, but according to homeopathic principles of dilution no mercury molecule should exist in the final dilution; they are supposed to carry the mercurial ‘information’ only. The first is Mercurius solubilis Hahnemanni, which is Hydrargyrum oxydulatum nitrico-ammoniatum, i.e. mercury oxide in saltpeter acid, also known as dimercuros ammonium nitrate [2(NH2Hg2) NO3H2O]. This homoeopathic preparation is applied to treat all kinds of eye, mouth, and throat complaints.26 The second, Mercurius vivus, uses metallic mercury (Hg) diluted in large amounts of milk sugar or lactose. This preparation is used for all kinds of skin and mucous problems, and also in treating general psychiatric and mental problems.27 Many single symptoms can also be treated with Mercurius vivus, especially if caused by a psychological disorder. The use of these homoeopathic ‘mercury’ products is definitely legal in Germany and regulated by the German Drug Law of 2012.28

Mercury in TCM, Ayurvedic, and Tibetan Remedies

The legal status of mercury in tcm, ayurvedic, and Tibetan remedies is quite different. In these remedies, such as tcm herbal preparations prepared by pharmacists in Germany,29 mercury is definitely prohibited; it is illegal and cannot be prescribed in Germany.30 Whether and what kind of ingredients are allowed in such preparations is stated in detail in the so-called ‘Pharmaceutical List of Substances’ (Pharmazeutische Stoffliste).31 If such herbal preparations contain even minimal amounts of mercury, the pharmacist selling them can be sued. There have been several publications pointing out the difficulties in proving the ingredients and how often mercury has been discovered.32

Finally, we look at ready-to-use pills, such as so-called ‘precious pills’ or ‘jewel pills’,33 imported from the prc or India. Some of them contain mercury in the form of mercury sulphide (HgS).34 These mercury-containing multi-compound medicines reflect the power, or the potentiated capacity to heal diseases intractable to other agents.35 In Asian medical systems, medicines containing mercury—whether the bhasmas in the rasaśāstra ayurvedic context, or the jewel pills in the Tibetan context36—are associated with some form of mysticism or magic. This is linked to the inclusion of ‘empowered’ ingredients derived from metallic and especially from mercurial sources. The ingredients of each of the 12 known Tibetan jewel pills, for instance, are found in detail in pertinent passages of certain medical texts,37 where it is clearly stated whether mercury should be included and, if so, in which form.

The presence of mercury in these ready-to-use pills from Asia is still virtually legal.38 As mentioned above, any pharmacy in Germany dealing with international drugs can order these pills from India or China. The responsibility lies with the prescribing physician alone. The main problem arises when the list of ingredients is incomplete, even though they have a registration number in their country of origin and contain a package leaflet. Today, whether a precious pill, for example Rinchen Ratna Samphel, from any given pharmaceutical company in Asia contains mercury or not is unknown, even though according to a recipe given to me by Amchi Tashigang, Ratna Samphel pills should contain mercury in the form of mercury sulphide ash or tsotel (btso thal).39 Today, the package leaflets of these pills typically mention only a few ingredients. In contrast to the highly toxic organic mercury compounds,40 mercury sulphide generally tends to be relatively stable and insoluble, and therefore very poorly absorbed.41 To my knowledge and in my opinion, the mercury in these pills is neither harmful nor benificial to the patient; at least there is no scientific proof in humans to prove either case.42 In experiments with mice using the famous cinnabar-containing Chinese traditional pill Angong Niuhuang, no difference was found in the long term when pills made with and without cinnabar were administered.43

Scientific papers have been published internationally covering numerous aspects of toxicity related to mercury44 as well as in relation to environmental contamination.45 In Asia, a number of reports have been published to prove the non-toxicity of mercury in the form of cinnabar in complex Asian medicines.46 But what about proof of any kind of the positive effects of mercury on humans with treatment through Tibetan jewel pills, rasaśāstra medicine of Ayurveda, or the Tian Wang Bu Xin Den pill, the heart-strengthening medicine of the Chinese emperors? My intensive efforts and prolonged communications to find modern scientific or even quasi-scientific studies, reports or trial studies in Tibet, China, or India have failed to bring up any results. So far, I have not seen any convincing publications on traditional Asian medicine covering the positive effects of mercury on humans.

When I asked traditional doctors in Asia about such studies, the simple answer I received most of the time was: ‘We know it works, we don’t need scientific proof.’ Some mention the practice going back to Nāgārjuna, an Indian chemist or alchemist who is claimed to have received instructions on mercury through divine blessings. He wrote famous treatises on mercury.47 Therapeutic effects of mercury-containing medicines are still widely trusted in Asia,48 and mercury, largely in the form of cinnabar, is still used in these medicines.

In conclusion, to my knowledge there exists as yet not a single scientific work that proves any positive effect from the therapeutically intended internal use of mercury in human beings. However, there are two fascinating recent publications, from 201149 and 2013.50 Both have been prospective studies from Sweden and the usa, relating health features to mercury levels, mostly derived from fish consumption and/or dental amalgam fillings. In Sweden, 1,400 women were followed up for 32 years, and 200,000 men and women were followed up for 30 years in the usa. The latter study showed a trend of lower acute myocardial infarct (ami) if the subjects had higher mercury levels in their toe-nails, and the Swedish study showed a significantly lower level of fatal heart attacks corresponding to slightly higher serum mercury levels (associated with increased numbers of amalgam tooth-fillings). Non-fatal heart attacks and cerebral strokes were not associated with higher mercury levels.51

I conclude with a general comment regarding mercury. In the future, all forms of mercury might be generally forbidden, and therefore also mercury in all types of Western or Asian traditional medicines might be banned unless these medicines will be exempt because of their ‘traditional use’.52

1 dab 2012 (Deutsches Arzneibuch).

2 This includes individually prescribed medication, which is then mixed by the pharmacist. Though found rarely today, the responsibility here lies with the prescribing doctor.

3 Drugs from other medical traditions, for example from Africa or South America, could also be prescribed, but are rather irrelevant in today’s medical society in Germany because hardly in use. Popular herbs or ‘Heilkräuter’ are not included here, since they are free to be sold even outside pharmacies and do not need a prescription.

4 ps 2010 (Pharmazeutische Stoffliste). In this pharmaceutical list of substances, all legal ingredients are listed.

5 See the German Drug Law (amg 2011, Arzneimittelgesetz), which follows eu directives: newly revised laws on the circulation of drugs (dated 12 December 2005 BGBl [Bundesgesetzblatt] I, p. 3394), last amendment of article 5 (dated 20 April 2013, BGBl I, p. 868). See §5 section 5 on ‘Registration of Drugs’ and §38 on the ‘Registration of Homeopathic Remedies’, which states that homeopathic remedies must either be registered by the BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte) without details on their area of application, or be licensed with details on their area of application (Bundesministerium der Justiz 1976). The BfArM is incorporated into the licensing procedure for drugs in the eu (eu 2007).

6 bga 2013 (Bundesgesundheitsamt). These monographs are listed online; for example, at url: <http://buecher.heilpflanzen-welt.de/BGA-Commission-E-Monographs/>, last accessed 20 October 2013.

7 The legal background is covered by §73 section 3 of the amg (amg 2011) and is also published in great detail by Pharmore GmbH 2012.

8 Compare Schwabl, this issue.

9 On these legalities in Germany, see who 2001, pp. 95–7.

10 Within the eu, there are different regulations. For Germany, the relevant part is § 21 section 2 of the amg (amg 2011). See also No. 6 of the eu regulations ‘Guideline on Compassionate Use of Medicinal Products, Pursuant to Article 83 of Regulation (ec) No 726/2004’. url: <http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2009/10/WC500004075.pdf>, last accessed 22 October 2013.

11 The only heavy metal covered in this article is mercury. Adulteration and/or contamination of traditional Asian drugs or herbal preparations with mercury is also a widely publicised issue, but not discussed here. For an overview, see Posadzki, Watson, and Ernst 2013.

12 See, for example, Goldwater 1972.

13 See, for example, Prakash, this issue.

14 See also Schwabl, this issue.

15 Edlich et al. 2008.

16 Press release of 15 January 2009 by the Ministry of the Environment. See url: <http://www.government.se/sb/d/11459/a/11855>, last accessed 20 October 2013.

18 Rathore, Singh, and Pant 2012.

19 Gottwald et al. 2001; Malt et al. 1997.

20 Ball, Ball, and Pratt 2001.

21 See, for example, Bazzano et al. 2012.

22 Reimann 2003.

23 Galindo et al. 1997; Lerch and Bircher 2004.

24 Gutman 1964.

25 Grill and Hackenbroch 2010, p. 60.

26 Hahnemann 1830, pp. 347–55.

27 See Frey in Krapp and Longe (eds) 2005; Hahnemann 1830, pp. 347–55.

28 dab 2012.

29 Schäfer 2005.

30 Cooper et al. 2007.

31 ps 2010.

32 An overview of such publications can be found in Ihrig et al. 2004.

33 Aschoff and Tashigang 2009.

34 The six most powerful jewel pills containing mercury in the form of mercury sulphide ash or tsotel (btso thal) are: Rinchen Drangjor, Rinchen Ratna Samphel, Rinchen Mangjor, Rinchen Tsajor, Rinchen Tsodru Dashel, and Rinchen Wangril. Aschoff and Tashigang 1997, 2009.

35 Dole and Paranjpe 2006.

36 Mipham Namgyal 1986.

37 For some of these descriptions, see Aschoff and Tashigang 2009.

38 The legal background is covered by §73 section 3 of the German Drug Law (amg), and is published in great detail by Pharmore GmbH, 2012.

39 Aschoff and Tashigang 2009, pp. 76–8.

40 Clarkson and Magos 2006.

41 See Gochfeld 2003, for the absorption of various types of mercury by the body.

42 The following databases have been searched for any relevant information: Medline and Embase (the most important medical databases), Scopus, Scifinder, Pubmed (covering the world of medicine in general), Indmed (for all kinds of Indian publications in medicine), TCM Herbal Medicine Database (mainly plants covered), SciDev Traditional Medicine, and Ayurvedic Research Database.

43 Ye et al. 2003.

44 Magos and Clarkson 2006.

45 Azevedo, Furieri, and Vassallo 2012.

46 Liang and Shang 2005.

47 See Dominik Wujastyk 1984 and also Dagmar Wujastyk, this issue.

48 Kellogg 2002.

49 Mozaffarian et al. 2011.

50 Bergdahl et al. 2013.

51 Ibid.

52 The Zero Mercury Working Group (zmwg) began a campaign against mercury in November 2004 through the European Environmental Bureau (eeb) in collaboration with the Mercury Policy Project. For details, see url: <http://www.zeromercury.org>, last accessed 8 November 2013. Traditional use of mercury has been exempted in the un ban. See url: <http://www.un.org/apps/news/story.asp?NewsID=43963&Cr=mercury&Cr1#.UkvDctJmh8E>, last accessed 20 October 2013.

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  • 12

    See, for example, Goldwater 1972.

  • 15

    Edlich et al. 2008.

  • 18

    Rathore, Singh, and Pant 2012.

  • 19

    Gottwald et al. 2001; Malt et al. 1997.

  • 20

    Ball, Ball, and Pratt 2001.

  • 21

    See, for example, Bazzano et al. 2012.

  • 22

    Reimann 2003.

  • 23

    Galindo et al. 1997; Lerch and Bircher 2004.

  • 24

    Gutman 1964.

  • 25

    Grill and Hackenbroch 2010, p. 60.

  • 26

    Hahnemann 1830, pp. 347–55.

  • 29

    Schäfer 2005.

  • 30

    Cooper et al. 2007.

  • 33

    Aschoff and Tashigang 2009.

  • 35

    Dole and Paranjpe 2006.

  • 36

    Mipham Namgyal 1986.

  • 39

    Aschoff and Tashigang 2009, pp. 76–8.

  • 40

    Clarkson and Magos 2006.

  • 41

    See Gochfeld 2003, for the absorption of various types of mercury by the body.

  • 43

    Ye et al. 2003.

  • 44

    Magos and Clarkson 2006.

  • 45

    Azevedo, Furieri, and Vassallo 2012.

  • 46

    Liang and Shang 2005.

  • 48

    Kellogg 2002.

  • 49

    Mozaffarian et al. 2011.

  • 50

    Bergdahl et al. 2013.

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