The INH to MEPs on homeopathy in the EU Medicines Directive

In the meantime, the Spanish government has initiated a wide outreach against pseudomedicine. For example, it no longer wants to accept the medicinal status of homeopathy, wants to ban homeopathy from pharmacies and has already “discontinued” the first batch of homoeopathics which could not present a valid proof of efficacy upon request. England is currently performing a complete “blacklisting”, i.e. a process that means the end of any registration for homeopathic medication with a drug authority.

The EU Medicines Directive does not regulate in detail how exactly the member states deal with homeopathy in health care. However, it does fix two key points: It includes homeopathy in its definition of a medical drug and obliges the states to regulate a simplified registration procedure for homeopathy instead of the usual drug approval. If one seriously wants to dispute the status of homeopathic medicinal products (and thus their privileges), one cannot completely ignore EU law.

Spain knows that. At various levels (including that of the government), there are efforts to achieve a revision of the EU directive on medicinal products in the field of homeopathy. These efforts need support. The INH has therefore addressed the following letter to German MEPs, which is initially intended to provide basic information on the facts of the case and support Spain’s position in the expected discussion. This seems all the more necessary as the European homeopathic manufacturers and associations have for a long time maintained a lobby organisation directly in Brussels, which apparently has quite good material and personnel resources and whose task is to exert direct influence “on the spot”. We do not have such resources, but we do have the facts. And who knows – perhaps one or the other national government will even join Spain and become active in the EU?

______________

Mr. Mrs. …
MEP

by e-mail                                            7 August 2019

Homeopathy in the EU Medicines Directive

Dear Madam / Sir,

The European Medicines Directive (Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use,  Official Journal of the European Community L 311, 28.11.2001) classifies homeopathic preparations as medicinal products and requires national governments to establish a simplified registration procedure outside the otherwise prescribed rules for marketing authorisation for pharmaceutical remedies.

However, the consensus of the worldwide scientific community has long since classified homeopathy as a specifically ineffective sham therapy, the spread and “popularity” of which have completely different bases than those of medical relevance (evidence). In many countries, this insight is now gaining acceptance. It will be in the well-understood interest of the public’s health to take consequences of this. The misguiding of the public that homeopathy is a form of therapy expressly recognised by the legislator and therefore endowed with the credit of efficacy and harmlessness may not be continued.

In this respect, the Kingdom of Spain is already campaigning for an amendment to European pharmaceutical law, which not only grants homeopathic preparations the status of medicinal products by definition, but also grants them the additional privilege of registration (see also http://www.europarl.europa.eu/doceo/document/E-8-2018-004948-ASW_EN.html). This special legal framework has no objective justification, as the EASAC – as official advisor to the EU institutions – clearly stated in its statement of 20.09.2017 (https://easac.eu/publications/details/homeopathic-products-and-practices/).

In the interest of a science-based, honest and patient-oriented health policy, also on behalf of the German Consumer Association e.V. and its regional associations, we ask you to support a revision of the Medicines Directive in the sense described, in order to clear the way for appropriate national regulations under Community law.

You can inform yourself about the scientific status of homeopathy on the (multilingual) website of our association: www.network-homeopathy.info .

Yours sincerely

For the  Information Network Homeopathy

Dr. Natalie Grams – Dr. Ing. Norbert Aust – Dr. Christian Lübbers


 

Open letter to Karin Maag, Member of the Bundestag – Reimbursement of Homeopathy

Mrs. Karin Maag, member of the Health Committee of the German Bundestag, has recently spoken out on several occasions against the reimbursement of homeopathy by the statutory health insurance funds. She did use a number of arguments which, in the opinion of the INH, require clarification. For this reason, Mrs Maag has received the following Open Letter from the Homeopathy Information Network:

______________

Mrs.
Karin Maag MdB
Place of the Republic 1
11011 Berlin

 

Mail to: karin.maag@bundestag.de                                                                 29.07.2019
Informational to: Federal Minister of Health, Mr Jens Spahn

Homeopathy and statutory health insurance

Dear Mrs Maag,

We have learned from the press reporting that in the discussion about the reimbursement of homeopathy by statutory health insurers you have clearly positioned yourself against plans to abolish it. At the same time, however, we can also see from this reporting that you are apparently not sufficiently informed about the aims and arguments of the scientifically based critique of homeopathy and that you also argue in part outside the context of the problem.

We would therefore like to make a few comments on this.

We, the Information Network Homeopathy, raise awareness since 2016 that homeopathy is a sham therapy that has neither ever been able to provide valid proof of efficacy nor to eliminate the incompatibility of its basic assumptions with scientifically proven principles. There is a broad consensus on this in the scientific world. We refer exemplarily to the clear judgement of the EASAC, the advisory board of the Association of European Academies of Science, which was published in 2017.

Against this background, we also see the discussion on the reimbursability of homeopathy by statutory health insurance funds. And against this background we also contradict the thesis that there must be a coexistence of homeopathy and science. Either one recognises the relevance of the scientific evaluation of homeopathy – then the consequences are obvious. Or one doesn’t – then one speaks out in favour of equating facts and opinions.

The core problem lies in the fact that the current reimbursability strengthens the public reputation of homeopathy, which is scientifically and, in our opinion, also unacceptable from the point of view of health policy. It lends additional credibility to the already widespread misconception among the population that homeopathy is a well-established form of therapy, which at any rate must be regarded as equivalent to scientific medicine.

Part of this misconception is that homeopathy is wholly or partly identical with naturopathy. But nothing could be more wrong than an equation of homeopathy and naturopathy. Nothing is “natural” in the esoteric assumption that there is a “principle of similarity” in nature that is related to human interests. There is nothing “natural” about the postulate that through dilution and ritual shaking, a “spiritual medicinal power”, today called “vibrations” or “energy”, will not only pass into the solvent, but will also become essentially “stronger”. There is no doubt that the public has not yet been sufficiently informed about all this.

A solidarity community such as the statutory health insurance needs an intersubjectively defined framework whose criterion is the general advantage. This framework is guaranteed by evidence-based medicine, which requires proof of efficacy of means and methods based on recognised scientific methodology. Homeopathy cannot satisfy this requirement; it is marketed under “medicinal product” only because the Medicines Act exempts it from this requirement.

We are fully aware that, as you are quoted, “many people feel better off taking homeopathic medicines”. The explanations for this have been known for a long time, but they have nothing to do with the specific medical effectiveness of homeopathy. These are contextual effects of various kinds that occur with any kind of treatment, often even with pure attention.

We even see in this one of the central dangers of the application of homeopathy. Anyone who has had “good experiences” with homeopathy with minor health disorders, or perhaps only with mood disorders, runs the risk of relying on it even in the case of more serious illnesses. The patient “conditions” himself to the medically ineffective homeopathy. The associated potential danger is obvious; the more homeopathy is erroneously perceived as a “gentle and side-effect-free” alternative to normal medicine, the less the risks will be perceived.

On the question of reimbursability in the statuary health solidarity system, the cost aspect plays a completely subordinate role, if at all. It is not a question of whether the expenses for homeopathy are “peanuts” or not, not of whether the system can “afford it”. It’s about drawing clear border lines in the matter.

Medicine is what has been proven to work beyond contextual effects. This defines the boundary between necessary, appropriate and economic care – the object of health insurance according to the social law – and what belongs to the realm of subjective, personal well-being. Which everyone may use for themselves on their own responsibility and at their own expense. We therefore consider it a reversal of the facts to refer insured persons who rightly reject homeopathy as a medical method to health insurers who do not offer their reimbursement.

It is therefore in the interests of the solidarity community that the health insurance reimbursement, which suggests a medical significance of homeopathy, should not be continued. It would be even more desirable if homeopathy were to be deprived of its special status in pharmaceutical law, which exempts it from scientifically based proof of efficacy. It is by no means a question of banning homeopathy. For everyone who wants to use it – informed! – it remains available.

We are therefore convinced that the well-understood patient interest requires a correction of the decision per reimbursement. Of course, regardless of the clear facts, this is also a political matter of balancing rights and interests. We have no doubt, however, that the arguments put forward against reimbursement of homeopathy are so far-reaching and in the public interest that they cannot be outweighed by other particular interests.

For discussions and further information, we are at your disposal at any time in any form you like.

Yours sincerely

For the Homeopathy Information Network

Dr. Natalie Grams.
Dr. Ing. Norbert Aust
Dr. Christian Lübbers

Decision on Homeopathy in France – and Germany? – An Interim Conclusion

An empty bottle symbolizing the French decision against reimbursement of homeopathy with a little wooden shield with the words This week, French Health Minister Agnès Buzyn announced the French government’s decision to remove homeopathy completely from the statutory health insurance scheme by 2021. For a transitional year, the reimbursement rate for homeopathic medicines is to be halved from 30 to 15 per cent. According to Mme Buzyn, she also wants to use this “transitional year” for more information about homeopathy and thus achieve greater acceptance for the decision, until it has a full effect in 2021.

This final decision was preceded within the last 15 months by the most comprehensive evaluation of homeopathy ever carried out in France. In the end, the Haute Autorité Santé made a clear statement: homeopathy lacks a specific efficacy that goes beyond mere contextual effects and thus does not justify a position as a reimbursable medicine in public health care.

The decision of the French government is explicitly based on the undeniable scientific facts, which do not attribute more relevance to homeopathy than any other sham therapy and deliberately puts other aspects such as the “popularity argument”, the “marginal” costs in the health care system but also economic interests of manufacturers aside. Thus, the French government has also decided not to participate further in the maintenance of a public reputation of homeopathy.

The findings on which this Decision is based have been known and validated for a long time. Basically, it is more interesting that and why homeopathy, despite all this, has been able to establish and maintain its reputation and its special position. The development in France once again highlights the factors that played a role in this.

In Germany, as elsewhere, the rise of homeopathy to a veritable industry originated in the late 1970s with its “New Age” affinity, which propagated a misunderstood closeness to nature as well as an indefinite “neomysticism”. In this era, it was possible to label the method sustainably as a “natural, gentle and side-effect-free” alternative to medicine and thus bring it closer to naturopathy. This quickly and sustainably influenced public perception. With the EU Medicines Directive and national regulations such as the German “internal consensus” in the Medicines Act, all this was legitimised. This marked the beginning of a new era of “homeopathic research”, driven by the desire to gain not only formal but also scientific legitimacy.

This “drawing a bill to the future” could not be redeemed. At the end of the 1970s, some defenders of the “special therapeutic directions” may have been personally convinced that proof of the effectiveness and mode of action of homeopathy could already be found. After 42 years of internal consensus and the search for scientific legitimation, this has demonstrably failed. Credit’s run out.

There is no scientifically sound evidence for a plausible mechanism of action of homeopathy, so it is not surprising that all meta-analyses and reviews of efficacy carried out in the last 30 years have revealed no reliable evidence for any indication. That is the actual state of affairs today. And this is the basis of the overdue questioning of homeopathy as part of medicine and as part of medical legislation, the legitimation of which has become untenable.

That is why it is high time – as France has just demonstrated – to draw conclusions from the special position of homeopathy in medicine and pharmaceutical law, which has been shown to be wrong and unjustified. The credit of the method is used up. What could make this more clear than the comprehensive evaluation of the scientific knowledge situation, which was carried out again with great seriousness in France – with “devastating” results, as the French media repeatedly expressed?

In the current discussion about an end to the official legitimization of homeopathy, its representatives either refer back to the untenable positions of the 1970s (“pluralism in medicine”), gloss over, distort or even deny the clear scientific state of knowledge (“there are hundreds of studies….”, “the homeopathic basic research…”) or present completely irrelevant aspects that have nothing to do with the core problem (“restriction of the freedom of therapy”, “paternalism of the responsible patient”, the “peanuts argument” and more).  All this is irrelevant for the objective of homeopathic criticism to help the principles of evidence-based patient-oriented medicine achieve a breakthrough in the public health system. France takes a first step with the withdrawal of reimbursability, Spain and England are already going further by taking homeopathic remedies the official quality as medicine. It is time to draw the consequences in Germany, too, from the fact that the granting of special rights for the “special therapeutic directions” in the Medicines Act, which appear at least partly explainable (if not correct) from the situation at the time of the consultation of this Act, has long since proved to be a wrong way and a dead end.

Homeopathy in Germany is currently still a major obstacle to the consistent implementation of evidence-based medicine in the public health system. It is the anchor of pseudomedicine within drug law. Thus it is a kind of legitimation for a multitude of other, often extremely dangerous pseudomedical methods. It cannot be ruled out at all that the call for the same special rights that are currently granted to homeopathy could also come from other directions. In view of the existing privileged status of homeopathy, there is little that can be argued against.

The legitimacy of the demand to end the special position of homeopathy in medicine and public health stems from all this. This demand is not marginal, forced by any “fanatical opponents”, nor – as recently suggested – a campaign of “economically interested circles”. This demand is a call for integrity and honesty in medicine and for a step towards a reliable and sustainable public health system.

Following the decision in France, Germany is the only country within the EU retaining the reimbursement in statutory health insurance based on a special position for homeopathy in pharmaceutical law.

What’s the matter?


 

Open letter of the INH to the German Federal Minister of Health on the “internal consensus” of the German medical law

Yesterday, on 13.06.2019, German TV satirist Jan Böhmermann so satirically as accurately analysed homeopathy in his programme “Neo Magazin Royale” and thus articulated in his special way the – in our opinion –  widespreaded displeasure about the role of the sham method homeopathy in public health care.

We regard the time as appropriate to turn now with our core concern to the Federal Minister for health. Today he received the following open letter from the INH:


 

Information Network Homeopathy
We explain – you have the choice

 

14 June 2019

Mr
Federal Minister for Health
Jens Spahn
by e-mail

Dear Federal Minister Spahn,

As Information Network Homeopathy, we have been contributing to the public education about the background of homeopathy since 2016 and have also focused on the so-called “internal consensus” of the German Medicines Act.

Yesterday evening, we were able to experience on German television how homeopathy became the subject of prominent satire. For more than 20 minutes Jan Böhmermann burned down a fireworks on homeopathy in his “Neo Magazin Royale”, which – like all good satire – presented nothing but the facts. We regard this as a clear sign that the public reputation of homeopathy, not least supported for decades by the internal consensus, is eroding massively. More and more people see the fact that homeopathy is spent on an effective medical method as an unreasonable anachronism, as science-medical as well as intellectual impertinences.

The construction of the so-called internal consensus in Paragraph 38 of the AMG represents nothing less than the partial reversal of the meaning of the AMG into its complete opposite: Instead of applying intersubjective scientific standards to everything that “pharmaceuticals” want to be, it creates an incomprehensible protective space for remedies of “special therapeutic directions” – a “black hole” in pharmaceutical law – by expressly dispensing with evidence of efficacy.

The lack of intersubjectivity in it is obvious: no one can comprehend the healing promises of homeopathy (or anthroposophy) according to objective standards. After more than 200 years, it remains with claims that could never be verified in any way according to intersubjective criteria. This is the undeniable state of the art of science, which the legal situation nonsensically contradicts – and this contradictions serve the interested circles as a false justification for their untenable positions.

It is time that the legislator no longer provides an apparent legitimation for this and revises the internal consensus of the AMG. In the right understanding, there is only one medicine: the one that works. The one that can scientifically answer the question “Where is the proof?”. In addition, there is no need and no place for somewhat “alternative”, “complementary” or “integrative” in medicine. The dividing line between medicine and non-medicine is the proven effectiveness according to scientific standards. Homeopathy has remained beyond this boundary for over 200 years and cannot invoke more than a legal fiction.

We have no doubt about your personal attitude to the problem and are convinced that our concern is in good hands with you, given the energy you have shown in your office so far. In view of the circumstances described and current developments, give up the political restraint that has so far left the internal consensus untouched! Take the initiative to put an end to the unspeakable anachronism of the internal consensus and to subject to the same rules all remedies that strive access to the market as a pharmaceutical. A factually untenable legal fiction should no longer be the basis for errors and misinformation about homeopathy and should no longer serve to discredit the state of science and those who publicly represent it. Particular interests casted in legal structures should be a thing of the past, especially if they contradict the facts.

We are at your disposal at any time with our expertise in any form you like.

Respectfully

For the Homeopathy Information Network

Dr. med. Natalie Grams (Head / Spokeswoman)
Dr. med. Christian W. Lübbers (Spokesman)
Dr. Ing. Norbert Aust (Spokesman)


 

Open letter to the Prime Minister of Mecklenburg-Western Pomeriana on her patronage of the Homeopathic Medical Congress 2019

The picture shows the Chancelly of state and the Castle (residence of county parliament), Schwerin, Mecklenburg-Western Pomeraina
Chancelly of state and Castle (residence of county parliament), Schwerin, Mecklenburg-Western Pomeraina

This year’s Homeopathic Medical Congress of the Central Association of Homeopathic Physicians will take place in Stralsund from 29 May to 1 June 2019. As usual with such meetings, the DZVhÄ assured itself also this time again of the support in the policy, by offering  the patronage over the meeting to the Prime Minister of the country Mecklenburg-Western Pomerania. Of course there is also a well-meaning greeting connected with it.
In (bad) tradition, the Prime Minister followed this wish. The greeting was published on the website of the medical congress.

The INH feels compelled to send the following open letter to Prime Minister Mrs. Schwesig:


To the

Minister President of the State of Mecklenburg-Western Pomerania
Mrs. Manuela Schwesig
– State Chancellery –
Schloßstr. 2-4
19053 Schwerin

Dear Prime Minister,

From various sources we could see that you have taken over the patronage of the Homeopathic Medical Congress of the German Central Association of Homeopathic Physicians taking place in May 2019 in Stralsund. We are also familiar with your greeting to the Congress.

We have a critial view on both the assumption of patronage and the greeting to the congress. Allow us to explain the reasons for this below. We consider it important to make representatives of politics familiar with our concern, an enlightened approach to the subject of homeopathy, and to explain our motives.

Since 2016, we, the Information Network Homeopathy, its members and supporters, have been explaining that homeopathy is a sham therapy that has neither ever been able to provide valid proof of its effectiveness nor to eliminate the incompatibility of its basic assumptions with scientifically proven principles. There is a consensus on this among almost the entire world’s scientific community. To illustrate this, we refer as one voice among many to the 2017 judgement on homeopathy by EASAC, the Advisory Council of the Association of European Academies of Science:

Scientific mechanisms of action—where we conclude that the claims for
homeopathy are implausible and inconsistent with established scientific concepts.
Clinical efficacy—we acknowledge that a placebo effect may appear in individual patients but we agree with previous extensive evaluations concluding that there are no known diseases for which there is robust, reproducible evidence that homeopathy is effective beyond the placebo effect. ”

As a consequence, in more and more countries homeopathy no longer finds a place within scientifically based medicine and public health systems. In this connection, reference is made to the end of the prescribability of homeopathic remedies in England, which is now followed by the inclusion of homeopathic remedies in the blacklist of the British Ministry of Health, so that they can no longer be registered as medicines.

In particular, we draw attention to current developments in France and Spain. In both countries, the professional associations and scientific academies of both medicine and pharmacy have clearly distanced themselves from homeopathy and demanded that it no longer be given a place in the public health system. In Spain, the current government has already taken concrete measures to remove homeopathy from therapeutic practice. In France the political decision on this is currently pending, the recommendations of the chambers and the academies of science leave nothing to be desired in terms of clarity: homeopathy is medically worthless to potentially harmful.

In the USA, the Food and Drug Administration, in consultation with the FTC, is in the process of creating an increasingly stringent regulatory framework for homeopathic medicines. Consumer protection organisations are currently suing distributors of homeopathic medicines for fraud. In Australia, the possibility of covering homeopathy through private supplementary insurance was even abolished by law in 2017. In Austria, the compulsory elective subject homeopathy at the MedUni Vienna was recently cancelled without replacement, the “Homeopathic Emergency Outpatient Clinic” was closed and the accumulated research work in these areas was rejected by the Scientific Council of the MedUni as “unscientific”.

Many other political and scientific organizations in other countries have also positioned themselves against homeopathy as part of medicine and health care.

The extraordinarily effective homeopathic lobby in Germany has apparently succeeded in keeping such developments at bay. The danger of isolation of German health policy in the circle of EU partner countries in particular can no longer be dismissed here.

The efforts of the relevant lobby to present homeopathy as a proven form of therapy essentially equivalent to scientific medicine are manifold and extensive. This alone does not change the facts, the broad scientific consensus that considers homeopathy only as a relic of medical history and not as a justified part of modern health care.

Here now the circle closes for the occasion of this writing. The Central Association of Homeopathic Physicians is one of the pillars of homeopathic advocacy in Germany. He is very interested in public reputation. Of course, in view of the massively dwindling importance of the pre-scientific homeopathic method in Europe and worldwide, it is of great importance to obtain the patronage of high-ranking political representatives for the homeopathic congresses, for example.

However, this only strengthens the public reputation of homeopathy, which is scientifically and, in our opinion, unacceptable from the point of view of health policy, and leads to a consolidation of the already all too widespread assumption among the population that homeopathy is a recognised form of therapy, which should at any rate be regarded as equivalent to scientific medicine.

That is why the core concern of the homeopathy information network is that homeopathy should no longer be given public credibility or a place in the public health system – especially with regard to the good treatment of children to which you referred. We do not consider the current situation to be scientifically or ethically justifiable. A “therapy” that does not have more to show than the contextual effects (especially placebo) that occur with any kind of attention – even non-medical – cannot be justified as a medical therapy. It should also not be allowed to hide the fact that homeopathy is incorrectly offered and advertised by its representatives as specifically effective drug therapy.

Medicine today defines itself as that which can prove specific effects beyond the “background noise” of the always present placebo effect. Contrary to the perpetuated claims of the homeopathic interest groups and their self-referring events such as the “Homeopathic Medical Congress”, homeopathy cannot do this – and is therefore not a factor for the goal of a generally more human approach to patients in medicine, which we consider to be very desirable.

We would be pleased if we had opened a perhaps not so familiar view on the topic of homeopathy for you. The fact is that the general perception of homeopathy is currently characterised by decades of unchallenged influence by interested circles. Homeopathic criticism is as old as the method itself. However, it was not until 2016 that the Homeopathy Information Network was established as the first independent association of interests, whose members pursue the common goal of educating the general public about homeopathy on the basis of scientific facts.

It is clear to us that as a high state representative you must do justice to a broad pluralistic spectrum of social groups. We, the undersigned, would, however, ask you to refrain in the future from giving additional nourishment to the false and inappropriate public image of homeopathy through – undoubtedly well-meaning – commitment.

Scientifically founded as well as generally understandable sources of information for the classification of homeopathy as a disproved method from pre-scientific times are extensively available. We would also like to draw your attention to the information provided on the website of the Homeopathy Information Network. If you wish, representatives of the information network would also be happy to meet you in person.

Yours sincerely

For the Homeopathy Information Network

Dr. Natalie Grams.
Dr. Norbert Aust
Dr. Christian W. Lübbers


Picture credits: Private / own picture

What does the German “internal consensus” mean?

This text describes the topic “Homoeopathy in German Pharmaceutical Law”.

The picture symbolizes the In 1976, consultations began on a fundamental reorganisation of German pharmaceutical law. By and large, the state’s involvement in the pharmaceutical industry previously consisted of little more than a “registration” of drugs placed on the market under the responsibility of pharmaceutical manufacturers.

It had taken a long time for the legislature to consider its own responsibility in the field of drug supply. A trigger for this was the thalidomide scandal of the 1960s. This terrible process, in which neither the manufacturer nor the state authorities presented a particularly happy picture, gradually led to a growing awareness of the need for action – yet it still took 17 years before a fundamental reorganisation took place.

The basic approach of the new Medicines Act was to replace the mere registration with an “approval procedure” for pharmaceutical medicinal products and to link this to scientifically substantiated evidence of efficacy and side effects. The parliamentary and extra-parliamentary discussion dragged on for more than two years – in the end, the “Medicines Act 1978” (Arzneimittelgesetz) was passed. This marked a move away from a largely individual-empirical based therapy towards a drug therapy on as objective a basis as possible. All old remedies already registered at that time were subjected to a subsequent approval procedure, and many were no longer approved – often to the chagrin of doctors who had been using these remedies for a long time for “empirical medicine”. Even the pharmaceuticals marketed in the former GDR at the time of reunification were subject to such a subsequent approval procedure.

So far, so remarkable. So are all available medicines based on scientifically proven efficacy?

Not at all.

A very active parliamentary and also extra-parliamentary lobby succeeded in obtaining special rights for the “Erfahrungsheilkunde” ( experience medicine), to which apart from homeopathy anthroposophy and herbal medicine were added (how these three are connected is a story in itself). At that time it could be suggested to the parliamentarians in the context of the upcoming “innovations” that the “empirical medicine” of these directions pursues a completely different “approach” and that the principle of scientific proof, so to speak, bypasses the “peculiarities” of these directions. The parliamentary paper at that time speaks volumes and is quite interesting to read. [1]

Many parliamentarians may have been aware that the demand for proven effective drugs has nothing to do with “pluralism in science” and “a fundamentally different approach”, but represents nothing more than a self-evident basic consensus for health care. On the other hand, the representatives of the homeopathic and anthroposophical lobby will have been fully aware that the demand for scientific proof of efficacy would have meant the end for their remedies on the pharmaceutical market. Which, incidentally, was basically an admission that the homeopaths’ claims about the efficacy of their remedies and their great benefit to the patient were not substantially. So it was about something.

And so it came to a complete break with what had actually been the intention of the new law, in favour of what at that time was called “empirical medicine” and understood itself to be a kind of “separate medicine”. Special rules in the AMG established homeopathy, anthroposophy and phytotherapy (herbal medicine) as “special therapeutic directions” and granted them special rights. The proof of efficacy according to recognized scientific methods, actually the purpose and intention of the law for everything that wanted to trade as a drug, was waived on for these remedies.

In order to preserve the appearance of state regulation, it was decided that special commissions were to be set up at the Federal Institute for Drugs and Medical Devices (which at the time was still called differently) for the “special therapeutic directions”. For homeopathics, this is still Commission D today.

The old instrument of simple “registration” was retained for the medicinal products of these “directions”, as long as they were not to be marketed and advertised with a medical indication – as a purely administrative procedure in Division 4 of the BfArM. This department decides whether a remedy is homeopathic at all (of course the simple registration is extraordinarily “popular”) and, according to its own statements, makes this dependent on the “manufacturing process”, i.e. on the application of the principle of potentiated basic substance. In addition, safety and compliance with best practice rules during production are checked.

Those manufacturers who wish to advertise with an indication, i.e. information on areas of application, can submit an “application for approval”. The Commission D has to decide on this application. It bases its decision on “homeopathic knowledge material”, the evaluation of which is reserved for the “experts in the therapeutic direction” within Commission D. The Commission is therefore not responsible for the objective scientific evaluation of this material. On the contrary, such is suspended in favour of an “internal”, i.e. always subjective, expert assessment. In this way the “special therapeutic directions” are namely protected from the requirements of objective science, but at the same time, they also lack any possibility of invoking on this.

To clarify once again: the task of Commission D (and the commissions for the other special therapeutic directions) is not the evaluation of the approved applications of efficacy according to objective scientific criteria, as is the case for normal pharmaceuticals. No, the internal group of “experts” who have the “medical expertise in the therapeutic direction” will decide on the approval and thus the market access of homeopathic medicinal products with indications. Among themselves. In a joint consensus. According to personal perception, opinion or “experience”, according to “internal evidence” instead of intersubjective, generally valid criteria. This situation has remained unchanged since 1978 – on the homepage of Department 4 of the BfArM there is still talk of the relic of “scientific pluralism in the field of drug therapy”, which the legislation (40 years ago) had expressly provided for. Already at that time an anachronism that should not have been followed. [2]

This is the so often invoked “internal consensus” which still privileges homeopathy (and the other “special directions”) in an unacceptable way, even erecting a real protective fence around it. From the legal point of view – and in the general public’s perception – the remedies of the “special therapeutic directions” are just as much “drugs” as any pharmaceutical product that has undergone a testing and approval process that often takes years (only about eight per cent of all new developments in the pharmaceutical industry make it to approval in the first place). Homeopathy – and anthroposophy – are obviously doing their utmost to maintain this special legal regulation. This is because of their integration into the health care system and social security law depends directly on it.

There is nothing in German pharmaceutical law that is more in need of reform.


Edit: Specified and extended on 5 July 2019

Open Letter by the GWUP Science Board and the INH to Melanie Huml, Secretary of State for Health, Bavaria

On 13 December 2018, the CSU parliamentary group in the Bavarian state parliament published a press release entitled “Naturopathy should be more firmly anchored at Bavarian universities”. This corresponded both with a similar parliamentary motion from the middle of the year and without doubt with the decision of the state government of Baden-Württemberg to establish a chair for “Naturopathy and Integrative Medicine” in Tübingen.

The press release makes it clear that it was much more about homeopathy than about naturopathy – the well-known misinterpretation of both terms was the basis for the whole meeting. Two representatives of homeopathy – the chairwoman of the Hahnemann Society and a clinical pratician from an institution of the LMU Munich who was co-financed by the Foundation for Nature and Medicine (formerly Carstens Foundation) – had spoken to the parliamentary group and apparently found an open ear for their lobbying for homeopathy (“so popular with people”). The Bavarian Minister of State for Health, Mrs. Melanie Huml, was also present.

This procedure caused the science advice of the GWUP and the INH to send the Minister of State and the parliamentary groups in the Bavarian federal state parliament the following open letter:

Mrs. Minister of State
Melanie Huml
Bavarian State Ministry of Health and Care
Haidenauplatz 1
81667 Munich, Germany


E-mail: poststelle@stmgp.bayern.de

(For information to the health policy spokespersons of all fractions and as an open letter on www.netzwerk-homoeopathie.info)

Homoeopathy in Health Care and Universities – CSU Group Press Release 13.12.2018

Dear Mrs. Minister of State,

From the above-mentioned press release of the CSU parliamentary group in the Bavarian state parliament we can see that there – in your presence – representatives of the pseudomethode “homoeopathy” have made representations in order to take representatives of Bavarian state politics for a promotion of their method with the aim of a stronger anchoring in health and higher education policy.

We, the science advice of the society for the scientific investigation of Parawissenschaften (GWUP), hold the goal direction conceived there into the eye both health and universitypolitically for missed.

The Hom?opathie is after world-wide scientific consensus a sham therapy, which could furnish neither ever a valid proof of efficacy, nor the incompatibility of its basic assumptions with scientifically in the best way occupied bases clear out. It is therefore our concern that homeopathy should no longer be given public credibility or a place in the public health system and that it should only be given a place in the medical-historical part of the curricula at universities.

A “therapy” that does not have more to show than the contextual effects (especially placebo) that occur with any kind of attention – even non-medical – cannot be justified as a medical therapy. It should also not be allowed to hide the fact that homeopathy is incorrectly offered and advertised by its representatives as specifically effective drug therapy.

To illustrate this internationally widely recognised position, we refer to the 2017 decision on homeopathy by EASAC, the advisory board of the Association of European Academies of Science:

“(We conclude from our research) that the claims on homeopathy are implausible and contrary to established scientific principles.
We acknowledge that a placebo effect may occur in individual patients, but we agree with earlier detailed studies and conclude that there are no known diseases for which there is robust and replicable evidence that homeopathy is effective beyond this placebo effect.

The international study situation is clear. In the meantime, ten systematic reviews, including those of homeopathy representatives, have shown that there is no evidence for any single indication of homeopathy. How could it be any different for a method that partly violates natural laws?

Even false arguments such as those repeatedly put forward in favour of homeopathy cannot change this. Neither is a “popularity” of homeopathy in the population a justification for unscientific and specifically ineffective methods in health care and university curricula, nor can the method be attributed to naturopathy. The latter is a downright “urban legend” that has been propagated by interested parties for decades.

This is probably the most deeply rooted error about homeopathy in the public. Homoeopathy is a conceivably “artificial” thought construct, which is based among other things on the esoteric ideas of the effect of “spiritual forces”. It thus contradicts the basic idea of naturopathy, which assumes a real effect of natural entities (light, air, sun, herbal extracts…).

We therefore feel compelled to raise our voices against any influence that could strengthen the position of homeopathy in public and political perception due to such misinformation, as the establishment of a chair would undoubtedly be. Rather, we are of the opinion that both a sustainable health system and the future higher education of physicians are dependent on the principles of evidence-based medicine and not to promote unscientific methods. Anything else would be a step backwards, a waste of resources and the opposite of a health policy that sees itself as modern.

Medicine is pragmatic and open to new findings, like any good science. This leads to – and has always led to – that methods, regardless of their origin or age, are included in the canon of medicine if they can prove a specific effectiveness according to scientific criteria. If they cannot do this, they are not entitled to the predicate “medicine” even with the attributes “alternative”, “complementary” or “integrative”. Furthermore, it should be warned against equating “naturopathy” with these terms.

In this context, the experience at the Medical University of Vienna, which had introduced homeopathy as a subject in order to teach a critical approach to the method, seems important to us. This has not proved successful, but has even turned into the opposite. The appearance of representatives of homeopathy as lecturers (and allegedly “experts”) led to the fact that in teaching the concrete application of the method instead of the scientific-critical view came to the fore. From our point of view a critical examination of the teachings of “alternative medicine” would be quite sufficient if one shows in the basic subjects to what extent such doctrines of salvation contradict the critical-rational scientific view inherent in the higher education system.

We point out that the MedUni Vienna recently drew the consequences from this and cancelled the homoeopathy lectures. University Rector Markus Meier distanced himself in this context from unscientific procedures and charlatanry. This is just one example – there is an increasingly critical approach to homeopathy internationally on a broad front, also and above all in EU partner countries.

From this point of view, in our opinion, the idea should also be seen that a chair is explicitly required for “integrative” or “complementary” medicine, as articulated in the motion for a resolution to the Bavarian Parliament of 10.07.2018 (Bill to Bavarian parliament 17/23310).

We would like to sensitize you as the minister of the Free State of Bavaria responsible for health policy to this topic. The intensified – in particular political – activities of the homoeopathic lobby, which obviously go back to the increasing, justified criticism of the homeopathic method, causes us concern. In our view, it would be fatal to hold on to, or even further strengthen, the pseudo-method of homeopathy, both in terms of good general health care and in terms of strengthening the population’s competence in health issues, which undoubtedly need to a great extent.

Thank you for your attention.

Yours sincerely,
the Science Council of the Society for the Scientific Investigation of Parasciences and the Information Network Homeopathy

Dr.-Ing. Norbert Aust
Prof. Dr. Michael Bach
Lydia Benecke
Prof. Dr. Dr. Ulrich Berger
Prof. Dr. Peter Brugger
Udo Endruscheit
Prof. Dr. Edzard Ernst
Thomas Fraps
Prof. Dr. Dittmar Graf
Dr. Natalie Grams.
Prof. Dr. Wolfgang Hell
Prof. Dr. Dieter B. Herrmann
Prof. Dr. Johannes Köbberling
Prof. Dr. Martin Lambeck
Dr. Nikil Mukerji
Dr. Rainer Rosenzweig
Prof. Dr. Dr. Gerhard Vollmer
Prof. Dr. Barbro Walker
Dr. Christian Weymayr
Dr. habil. Rainer Wolf

Open letter of the INH to the Siemens health insurance company (SBK)

In the context of the discussion on the reimbursement of homeopathy by statutory health insurance funds, the CEO of SBK drew attention to himself on Twitter with the “argument” that the small amount spent on homeopathy in his company was ultimately irrelevant “from an insurance point of view”. After this position had been contradicted on Twitter, SBK published a “Background Information: Homeopathy at the SBK” on its website and explicitly referred to this as part of the debate.

The Information Network Homeopathy feels compelled to comment on this publication with an open letter to SBK, which is given below:

 

To the
Siemens Company Health Insurance Fund (SBK)

By e-mail (info@sbk.org)

09.01.2018

Open letter of the information network Homöopathie on the publication of the SBK “Background information: Homeopathy at the Siemens company health insurance fund”

Ladies and Gentlemen,

your institution is one of the many health insurance companies that reimburse the costs of homeopathic treatment, which has been under discussion for some time. On Twitter, your CEO drew additional attention by putting forward the “peanuts” argument, i.e. the opinion that the low expenditure on homeopathy was not a significant part of the total expenditure anyway. This has already been contradicted on Twitter to the extent that this is not the only, not even a priority aspect in the demand that homeopathy no longer be reimbursed by health insurance funds.

Thereafter, you have clarified your point of view on homeopathic reimbursement (https://www.sbk.org/themen-standpunkte/hintergrundinformation-homoeopathie/ ), for which we would like to thank you first of all, because this enables a discourse. In the following we therefore deal with what you state in your clarification and orient ourselves on the headings of the various points as used in your publication:

1. To what extent does the Siemens Company Health Insurance Fund (SBK) cover treatment by homeopaths?

At this point, you inform us that you offer a separate optional tariff for homeopathic services (“pharmaceutical tariff”), which is actuarially self-supporting (i.e. the area of statutory services “for all” is not affected).

However, this information is incomplete.

According to the information on the SBK website, this only applies to the drug part, i.e. the globules; the medical treatment part of homeopathy is covered by a selective contract with the management company of the Central Association of Homeopathic Physicians as part of the statutory benefits, as is the case also with other health insurance funds, and thus also affects all insured persons who have no “interest” in homeopathy.

Even in the case that homeopathy would be a complete part of an optional tariff offer: The health insurance funds, especially the statutory ones, are important players in the health care system. We can certainly see that the legislator – unlike in the vast majority of industrialised countries – has not (yet) consistently implemented the orientation of public health towards evidence-based medicines and methods. Unfortunately, indeed. However, it cannot then be the task of the health insurance funds to undermine the confidence of their policyholders in rational medicine by offering a “vendor’s tray” of unscientific and ineffective methods, not even within the framework of a “voluntary tariff”, and thereby make a not insignificant contribution to the irrationality and hostility towards science that unfortunately prevails anyway. Apart from the fact that such offers, understood correctly, should actually be an ethical problem for health insurance companies.

One should bear in mind that the offer of unscientific methods with the authority of a statutory health insurance directly threatens the necessary further development of the health system in terms of performance, effectiveness and sustainability. Homeopathy is the “entry point” for the acceptance of further pseudomedical methods and often correlates with things like vaccination “skepticism” (perhaps less in the medical profession, but basically very well). Thus homeopathy is the dividing line beyond which there is a danger of further attention by patients to more dangerous pseudomedical methods. The responsibility of the statutory health insurance funds here is considerable. They should send a clear signal against such tendencies.

2. To what extent has the effectiveness of homeopathy been proven and what is SBK’s opinion of studies which consider homeopathic treatment to be free of effects?

“It is true that there are no scientific studies which clearly prove the efficacy of homeopathic medicinal products, but this does not mean that they couldn’t be effective.” This sentence in your publication opens the door to any arbitrariness and has nothing to do with a scientific-rational view on the problem. As the INH has just stated in its article “Scientists claim that homeopathy is impossible“, the “reverse conclusion” quoted by you is an absolute empty statement – simply because the ineffectiveness (impossibility) of something can in principle not be proved. Homoeopathy, however, has the scientifically conceivably highest improbability against itself that it could ever succeed in proving its effectiveness, let alone in explaining a mechanism of action that is compatible with the state of scientific knowledge. It is highly implausible, contradicts everyday experiences and is also incompatible with natural laws. Any explanatory model of homeopathy would require a massive revision of the valid and proven scientific view of the world. One cannot therefore – especially not as a health insurance company that should position itself credibly and seriously towards its policyholders – retreat to the Hamlet argument of “There is between heaven and earth…”.

In response, it should be sufficient to quote once again the summary of EASAC, the Advisory Board of the European Academies of Science:

“[We conclude]  that the claims for homeopathy are implausible and inconsistent with established scientific concepts.
We acknowledge that a placebo effect may appear in individual
patients but we agree with previous extensive evaluations concluding that there are no known diseases for which there is robust, reproducible evidence that homeopathy is effective beyond the placebo effect.”

We conclude from our research that the claims about homeopathy are implausible and contrary to established scientific principles.
We recognize that individual patients may have a placebo effect, but we agree with previous detailed studies and conclude that there is no known disease for which there is robust and replicable evidence that homeopathy is effective beyond this placebo effect.”

This is the valid statement of the scientific world on homeopathy. The position you have formulated is thus untenable according to generally valid rational standards.

3. Why is it not a problem for the SBK to pay for an unprovable form of treatment (= homeopathy), while this is not possible with glasses, for example?

In fact, the statutory health insurance funds are not allowed under German social insurance law to replace homeopathy reimbursements with benefits for spectacles and higher grants for dental prostheses. This is well known to the Homeopathy Information Network and has been explained in detail in an article on its website. Nevertheless, we understand that this is often mentioned as a wish by policyholders who reject homeopathy.

Here, too, we encounter a fundamental misunderstanding in your argumentation when you refer to the possibility granted by law to include homeopathy in the catalogue of statuory benefits. As also mentioned in the article from the INH website quoted above, no health insurance company is forced to do so. You yourself write that reimbursement of the special therapeutic directions is “not excluded” – but that brings your consideration to an end. However, the Federal Social Court has already decided several times that the same criteria of “necessity, economic efficiency and expediency” must be applied to the means of special therapeutic directions (homeopathy, anthroposophy, phytotherapy) as to all other drugs. A relevant social-legal commentary states in agreement: “An advantage of drugs of the special therapy directions with the consequence that quality and effectiveness of the achievements do not correspond to the generally recognized conditions of the medical realizations … contradicts … the legal defaults”.

Already in point 2 it was stated that homeopathy, according to worldwide scientific judgement, contradicts established scientific principles and that there is no reliable and reproducible evidence of specific efficacy for any disease. Such a method can never meet the social security reimbursement requirements of “necessity, cost-effectiveness and expediency” – in our opinion, any health insurance fund that reimburses homeopathy by way of statutory benefits is moving on very thin ice under the current legal situation. In this context, we see interest in the fact that you describe homeopathy as an “unprovable form of treatment” in your statement.

One more word on the objection that even in the field of “normal” medicine, ineffective drugs and methods are paid for: A health insurance company shouldn’t do that either. However, the legal situation here is different: every statutory health insurance fund is for “normal” pharmaceutical drugs and therapeutic methods bound by the approval decisions of the Federal Joint Committee for Drugs and Medicines: What the Federal Joint Committee allows in this area is by law standard benefit of the statutory health insurance funds. It is inconclusive and unreasonable to play this fact off against the reimbursement of homeopathy, for which or against which each statuary insurance fund can decide for itself.

4. What are the annual costs of homeopathic treatments for the contributor?

Here we come to the initial argument, which has led users on Twitter to criticize the statement made by your CEO in this regard. It should suffice to point out that the exclusion of homeopathy from the British public health system was associated with the explicit statement of the NHS (National Health Service) that it was not – not even secondary – a matter of cost savings, but rather of “lack of clinical efficacy” and the resulting “low cost-effectiveness”, i.e. the non-existent cost-benefit ratio. Because: Nothing is always too expensive. From the statements of the other government agencies that removed homeopathy from their health systems in 2017 (Australia and Russia), we also couldn’t find that costs played a role, let alone a decisive one. The same shall apply to the statement of the Scientific Advisory Board of the European Academies of Sciences (EASAC) quoted above. Once more, it is about honesty and probity towards patients, credibility and the best possible care within the healthcare system. The statutory health insurance funds should play a pioneering role in this and not focus on the “wishes” of the insured, but on objectifiable standards. Nihil nocere – above all, do not harm, this old Hippocratic principle also applies here. And damage is – as explained – produced in many ways when statutory health insurers handle homeopathy with their authority as a proven effective method.

5. Why does the SBK not rather reduce the additional contribution (above regular taxes) for policyholders instead of further paying for homeopathic treatments?

The comments made under point 4 make it unnecessary to comment on this matter. Of course, we do not wish to endorse the ‘peanuts’ argument that EUR 1.1 million would not ultimately be important. Every euro of contributions from insured people must be used with due care in the interests of honesty towards the members. For example, the money would be very well spent on voluntary therapies for very rare diseases or similar cases. But this doesn’t affect our core concern.

Concluding remark

In principle, we oppose a strategy of health insurance companies to drive on a “competition” that has gone out of control with a “magic shop” full of things that are ineffective, but are “desired” by a certain clientele. The original idea of health policy, to initiate competition within the statuary insurance system via rationalisation effects and the level of contributions, has – as the merger of many health insurance funds makes clear – certainly had its results. However, we consider it fundamentally wrong to extend this to “competition for benefits” as a means of “catching customers”. We also consider it completely out of the question that ineffective and potentially dangerous methods such as homeopathy should be used for this purpose.

Yours sincerely

Information Network Homeopathy

Dr. Natalie Grams.
Dr. Norbert Aust
Dr. Christian Lübbers
Udo Endruscheit


 

Homeopathy as “refugee aid” – a medical and ethical problem!

Under the flag “Homeopathy for refugees in Germany” the “Homeopaths Without Borders” together with the initiative “Homeopathy in Action” advertise a nationwide network of homeopathy offers for the “treatment of refugees”. Again and again, related “offers” appear in refugee aid associations which – obviously in complete ignorance of the relevant connections – misinterpret and gladly accept such things as meaningful offers of help.

So one can read for example in an announcement of such an association:

… “Unfortunately, tablets are far too often desired and used to alleviate the symptoms. There are far too few therapy places for psychotherapeutic treatments. In the second part of the evening, we would like to present two free therapy offers from the field of natural medicine.
Dr. med. … and Mrs. …, alternative practitioner, will present the project “Homeopathy for refugees in Germany”.
Every Friday doctors and non-medical practitioners offer homeopathic treatments in the rooms of … as a holistic treatment method for physical and mental problems, if necessary also with the support of interpreters.
… The treatment leads to a reduction of stress and stress symptoms and has a balancing, relaxing effect, so that many people can cope better with stress and thoughts of trauma afterwards.

The activities of the “homoeopaths without borders” (a name trying to benefit from the good name of the “doctors without borders”) were not so long ago criticized in West Africa. There they were consistently rejected with their request to treat Ebola with homeopathy. Apparently, offers under the flag of humanitarian aid is part of the business model of the Homeopaths without Borders. The Süddeutsche Zeitung also reported on corresponding activities in the Munich area.

Quite apart from the therapeutic worthlessness of these “measures”, the question arises whether there is a particular ethical problem besides the medical one.

The fact is: People in need of help from a foreign culture, who as a rule cannot be regarded as “responsible and informed patients” in the sense of our health system, are literally recruited for homeopathic “methods”. People who have to deal with severe traumas – which is explicitly the “goal” of the actions of homeopaths without borders. There is no question about it: providing all these people with psychologically and psychotherapeutically professional care is an almost unsolvable task. But the offer of a sham therapy can’t be a solution! With traumatized people, often children?

Certainly one or the other superficial “success” will occur, precisely because of the psychologically occupied overall situation. But an improper treatment of mental disorders does not solve the problem. Neither is there a careful differential diagnosis (“trauma” is not a diagnosis), nor is anything lastingly done for the patient, nor does one gain knowledge about possible external or self-endangerment due to a psychological disorder. In the age group mainly affected here, one may have to reckon with borderline disorders, whose treatment with sham drugs is hair-raising. We do not like to remember the treatment of the assassin of Ansbach (German small city, where it came to a crime with causing death) with a completely inadequate “therapy” – here by a non-medical practitioner, with a devastating result.

In our opinion, the unspecific “treatment” of severe mental illnesses with homeopathic placebos instead of guideline-oriented drugs goes beyond any tolerable framework. Especially in cases of severe depression, the absence of a specific effective treatment can even be fatal in the worst case because of possible suicide risk. It is not unusual for a traumatised or severely depressed person to be able to undergo therapy at all only with the help of preliminary medication treatment individually adjusted by a specialist.

Even the aspect of the placebo effect must be viewed critically in this context. The language barrier and the origin from a different culture, also and especially in connection with psychological problems, make it seem largely unpredictable whether and how a placebo effect will occur. Since the patients, in this case, might even perceive the “treatment” as overly invasive or authoritarian, even a nocebo effect is conceivable.

Is it really so impossible to provide low-threshold help offers (skills) for those affected instead of idly watching how not only ineffective, but dangerous illusory therapies are offered here? And shouldn’t it be possible – as it happens also for German-speaking patients particularly in emergency situations or in “waiting position” – to publish information brochures in the appropriate languages and age-appropriately, which can help concerning first of all to understand one’s experience and to see that also other humans experience similar after comparable experiences?

Our opinion:

Here the consequence of the social reputation and political “ennobling” of homeopathy becomes visible in a devastating way. Under the guise of helpfulness and support for refugee initiatives, the “Homeopaths without Borders” spread their propaganda for ineffective treatment methods. In this particular case extremely irresponsible. The credulous refugee aid associations, which serve here as vehicles for the transport of the “message homeopathy”, cannot estimate the consequences of these “offers of help” at all and rely on the “good reputation” of homeopathy and the willingness to help shown. There is probably no legal means to prevent this. As always, this is rooted by the fact that homeopathy is anchored in the public health system.
Which indeed sets us apart from the states of West Africa.
Shouldn’t this finally be revised in view of such excesses?


Authors: Monika Kreusel, Udo Endruscheit


Picture: Fotolia_106344027_XS1

On the developments in the USA and the demands of the FTC

Typical brown glass bottle with the well-known homeopathic remedy A bad day for homeopathy: On November 15, 2016, the U.S. Federal Trade Commission (FTC) issued its statement that in future, over-the-counter homeopathic remedies will have to be labelled as the product’s efficacy is not proven – unless, of course, the manufacturer can provide such evidence. As expected, the German homeopathy associations reacted immediately by pointing out that this demand could not be transferred to Germany. This wouldn’t also be necessary, as the German Medicines Act already would have stricter requirements than those resulting from the requirements of the FTC in the USA.

Requirements of the FTC

The FTC considers it necessary that manufacturers of products should only be allowed to claim that their products are suitable for the treatment of certain health conditions if they have an appropriate basis for doing so. This applies to over-the-counter (OTC) medicines, dietary supplements or food, including homeopathic preparations for self-medication of complaints that would also disappear on their own (“self-limiting”, e.g. a cold – only such can be sold freely in the USA). It was further concluded that health claims for homeopathic products are generally not based on modern scientific methods. For giving health, safety or efficacy claims, manufacturers need proper and reliable evidence, which in the case of medicinal products require well-done human clinical trials. However, these requirements are not met by the vast majority of OTC homoeopathic medicinal products, which is why corresponding claims of efficacy are misleading.

This misleading of customers can be remedied by the fact that manufacturers state the following in their marketing materials:
1. “There is no scientific evidence that the product works.”
2. “The products claims are based only on theories of homeopathy from the 1700s that are not accepted by most modern medical experts.”)

It is expressly pointed out that it is not permissible to compensate the reference to the lack of evidence by other claims or references. Since the indication of a field of application and the simultaneous reference to the lack of evidence could also be confusing, the manufacturers would have to check by means of surveys whether the information was understood by the customers.

Comments of the German Homeopathy Associations

The Verband der klassischen Homöopathen Deutschlands (Association of Classic Homeopaths – VKHD) and the Deutsche Zentralverein homöopathischer Ärzte (Central Association of Homeopathic Practicioners – DZVhÄ) are in agreement that the situation in the USA cannot be transferred to Germany. In Germany, homeopathic medicinal products are subject to pharmacy duty and, as registered medicinal products, are not sold under indication. As a result, they claim that there are already now stricter requirements than those resulting from an implementation of the FTC requirements in the USA.

We will not go into the usual misinformation that can be found on the homoeopath websites, such as that there is sufficient evidence or that homoeopathy is subject to examination. Simply for space reasons.

Comment of the INH

In principle, VKHD and DZVhÄ are certainly right: The situation in the USA is not directly comparable with the situation in Germany in detail – but is the matter settled? Certainly not.

The aim of the FTC is to ensure fair competition, which in the case of pharmaceuticals in particular means that customers are not misled as to the nature of what they are purchasing.

It is true that in Germany not the same methods are used as in the USA – but aren’t consumers also deceived about the nature of homeopathic remedies? Shouldn’t measures also be taken in Germany to prevent this deception? These may be different from those in the USA – but the claim that there are no explanatory models or evidence for a mode of action is certainly also necessary in Germany. Currently such is nowhere to be found.

Unlike in the USA, no indication is given for registered homeopathics in Germany. But does not the mere statement that the product sold is a medicinal product in the first place and, unlike in the USA, may only be sold in a pharmacy, lead much more astray than a manufacturer’s statement on a product in a supermarket could ever do?

Even if they do not specify any indications, the manufacturers in Germany have nevertheless found sufficient ways to overturn the ban on advertising with indications for registered homeopathic remedies. Simply stating that the product is a pharmacy-only product will raise the question in the patient as to what it can be used for or against. And the manufacturers will certainly be happy to help finding an answer. Doctors, pharmacists, non-medical practitioners, midwives are trained there:

Screenshot: Expert circles of the DHU on their website
Image 1: Expert circles of the DHU on their website

Extract from the range of specialist midwifery services with additional information on homeopathy for children
Image 2: Extract from the range of specialist midwifery services

Pharmacies then logically advertise in their displays with the information on homeopathics, which the manufacturers are not allowed to name directly. One sponsors relevant lectures by pharmacists, doctors, alternative practitioners on the application of homeopathy in the spring, in the flu season, in old age, on journeys etc..:

Screenshot: Events offered and promoted by the DHU for individuals
Image 3: Events offered and promoted by the DHU for individuals

The number of guidebooks on self-medication is immense, divided into all possible fields of application for humans, animals and plants. On the Internet, relevant websites are promoted by means of advertisements:

Screenshot: Sponsored guide page
Image 4: Sponsored guide page

Summary

Wee see, it is no need at all that an indication appears on the package insert. This “knowledge” is widespread and freely available – and this is increased by the manufacturers to the best of their ability. All this is presented to the customer as true and justified by the statement ‘Homeopathic medicine – pharmacy compulsory’ – even though it’s sugar only.

The requirements in Germany are not stricter than in the USA; on the contrary, the misleading of the consumer in Germany is much stronger than it was ever the case in the USA considering the overall system. There it was a pure manufacturer’s statement for which a homeopathic remedy can be used, and at least skeptical consumers will have been just as suspicious of such statements in the advertising country USA as they were of the praises of other products, which are supposed to make slim, eternally young, beautiful and of course healthy.

However, the situation in Germany is that pharmaceutical law encourages quackery in homeopathy by promoting what makes a remedy appear to be an effective medicine – pharmacy duty – but at the same time refrains from demanding what makes a remedy a remedy at all, namely demonstrable efficacy. The fact that universities, medical chambers and health insurance companies additionally strengthen this impression by dealing with homeopathy has a much greater potential for deception than manufacturers statements in the USA ever had.

In Germany, in view of this, even more far-reaching demands must be made in order to eliminate the deception of the consumer:

  • Marking of packages with the clear name of the product
  • Specification of the quantity of ingredients in an absolute unit of mass
  • Disclaimer that the efficacy of the product has not been demonstrated and that an efficacy would be contrary to scientific knowledge
  • Identical warning notices in the self help literature, “Quickfinders” and in relevant Internet pages as well as at lecture events
  • Elimination of the waiver of a proof of efficacy for homeopathies in pharmaceutical law
  • Abolition of the pharmacy obligation for homeopathic remedies for which there is no proof of efficacy according to recognised scientific standards
  • Elimination of the ‘additional designation homeopathy’ and further training offers for doctors
  • Elimination of the reimbursement for homeopathic therapies within the statutory health insurance
  • Elimination of homeopathy courses in the licensing regulations and in the curricula of the universities

Only when these points have been implemented will we have a situation like that which is now to be achieved in the USA through the FTC demands.


Author: Dr. Norbert Aust


Supplement, 07.07.2019

The implementation of the FTC’s demands is sluggish in the USA, to put it mildly. In contrast to decisions of the Food and Drug Administration (FDA), the publications of the FTC are not directly legally binding. As expected, this leads to a high degree of ignorance among most manufacturers.

However, the FDA confirms that it is preparing a basic regulation with legal force for homeopathics and related products that will probably include the demands of the FTC. We will report in due course.


Picture credits: Screenshots, Photo: Wikipedia Commons Bhavesh Chauhan