Editorial
Dermatology 2007;214:105–107
DOI: 10.1159/000098566
‘Soft Medicine’ Is Not Always Soft:
The Original Sin of German Drug
Legislation
Rudolf Happle
Department of Dermatology, Philipp University of Marburg, Marburg, Germany
Today ‘alternative medicine’, also called natural heal-
ing or complementary medicine, is very popular and big
business in Western countries. In volume 214, issue 1, of
Dermatology, Meyer et al. [1] from Regensburg, Germa-
ny, report a case of cutaneous pseudolymphoma caused
by a phytotherapeutic drug derived from the rhizome of
black cohosh (Cimicifuga racemosa). Because rather often
drugs used in regular medicine also give rise to unwant-
ed effects, one might argue that in this respect there is no
substantial difference between regular and alternative
medicine. However, physicians adhering to alternative
medicine will not agree and say that ‘natural’ drugs are
far less harmful.
I shall not discuss the question whether the black co-
hosh is effective in alleviating menopausal complaints
[2]. Rather, I should like to inform European dermatolo-
gists about the bizarre way in which this herb and other
phytotherapeutic remedies are licensed and listed in the
official German pharmacopoeia [3].
People in Western countries are continuously indoc-
trinated by the media that alternative drugs are ‘soft med-
icine’ and, therefore, innocuous. Patients are well aware
of the potentially serious side effects when taking regular
drugs, but feel rather safe when trying alternative reme-
dies. The paper by Meyer et al. [1] reminds us that ‘pure-
ly natural’ drugs like the black cohosh may also be dan-
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gerous. Recent reports indicate that this herb can even
cause hepatic failure requiring liver transplantation [4].
Moreover, the report by Meyer et al. [1] spotlights the
unbelievable absurdness of the dichotomous drug legisla-
tion prevailing in Germany at present. In 1976, German
authorities created two different laws for two different
categories of drugs [5]. The law referring to regular drugs
is very strict and demands rigorous testing for efficacy
and possible side effects. Conversely, the law referring to
the ‘particular therapeutic concepts’ in terms of homeo-
pathic drugs, anthroposophical remedies and phytother-
apy is rather soft. No rigorous testing for effectiveness
and safety is necessary, and even nonmedical practitio-
ners (‘Heilpraktiker’) have a seat and vote in the commis-
sions supervising such remedies [5].
The Mistletoe, a Bizarre Anthroposophical Drug
Privileged by German Law
In today’s Germany, anthroposophists exert their po-
litical influence even in the highest ranks of the govern-
ment and medical boards [5], which is why the mistletoe
has found its way into the list of medical drugs that are
officially approved in Germany.
161.116.100.129 - 2/4/2019 8:33:07 PM
Rudolf Happle, MD
Department of Dermatology, University of Marburg
Deutschhaus-Strasse 9
Universitat de Barcelona
DE–35033 Marburg (Germany)
Tel. +49 6421 286 2908, Fax +49 6421 286 2898, E-Mail happle@med.uni-marburg.de
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 Many German melanoma patients strongly believe [11]. To use an expression coined by Karl Popper, this is a
that injections of mistletoe extract exert a beneficial ef- classical example of ‘oracling irrationalism’ [12], but this
fect in fighting against malignant cells. A careful clinical astounding concept has gained entry into the present edi-
trial, however, performed according to the rules of evi- tion of the official German pharmacopoeia.
dence-based medicine, has convincingly shown that the
mistletoe drug Iscador
is completely ineffective in mel-
anoma patients [6]. Such scientific results do not inhibit Romanticism
the continuous prescription of this drug for cancer pa-
tients, because the mistletoe belongs to the group of an- The present German legislation regarding phytothera-
throposophical drugs that are protected by German law peutic drugs can be explained to a large degree by a re-
from any scientific research regarding efficacy or side ef- vival of romanticism [13]. Nonscientific, holistic doc-
fects. Experimental studies providing evidence that mis- trines are now fashionable in all Western countries.
tletoe extracts may even exert harmful effects [7] are Around the year 1800, romanticism was born in Germa-
therefore disregarded in clinical practice. ny as a countermovement to the rationalistic enlighten-
In the official German pharmacopoeia (‘Rote Liste’) of ment imported from England and France. Magic day-
the year 2005, the mistletoe preparation Iscador is men- dreams, fantastic ideas and pristine naturalness were
tioned under the heading ‘Cytostatic drugs, other anti- highly esteemed in both art and lifestyle during that pe-
neoplastic remedies and protective drugs’ [3]. The drug riod of time. A similar vogue of romantic irrationalism
is applied ‘according to the anthroposophical therapeutic reigns in our days, and German politicians of various
concept: enhancement of energies of forming and inte- camps continuously try to get aboard the bandwagon. For
gration for the dissolution and reintegration of growth this reason, phytotherapeutic drugs and other ‘alterna-
processes having become independent, prophylaxis of tu- tive’ remedies are now privileged by German law.
mor recurrences’. In fact, according to present knowledge
the drug is neither cytostatic nor antineoplastic nor pro-
tective. There is no rationale to use this irrational drug in Can Europe Help to Get Rid of This Law?
cancer patients.
The idea to use the mistletoe as a remedy against can- For obvious reasons, the present German drug legisla-
cer was advanced by Rudolf Steiner who created ‘anthro- tion does not meet the European standards. There is no
posophy’ about 100 years ago, a holistic, nonscientific hope that things will change soon. But may we expect that
doctrine [8]. Contemporary followers of this esoteric in a far future European authorities will be able to help
master cultivate a sort of anti-intellectual veneration of the German society to create a new, fair and equitable
‘nature’ with the intention to ‘surmount’ rational think- drug legislation in which the same demands and rights
ing by bizarre, irrational concepts that will never be are allocated to all medical drugs? You may say that such
judged correctly by ‘outsiders’ [9]. optimism is naïve. Anyway, let me confess that I have this
According to Rudolf Steiner’s dictum our earth has dream.
passed, in previous developmental periods, a ‘lunar state’.
The mistletoe is a heritage from these earlier develop-
mental stages of our planet. This parasite is unable to set-
tle in the ground but has to proliferate on another living
organism. In anthroposophical medicine symbolism
plays a pivotal role. The mistletoe is a parasite growing in
spherical form, and this is a symbol of malignant growth.
It grows without a relationship to time because its leaves
remain green even in wintertime. From this holistic sym-
bology Rudolf Steiner inferred that the mistletoe can cure
cancer [10]. The anthroposophical physician Leroi stated
in 1983: ‘The mistletoe absorbs the lunar-terrestrial ether
but subsequently, with a decidedly light-seeking gesture,
turns to the whole vicinity and with this attachment to
the light defeats in itself the tendency to grow rampant’
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106 Dermatology 2007;214:105–107 Happle

Universitat de Barcelona
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 References
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‘Soft Medicine’ Is Not Always Soft
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Universitat de Barcelona
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