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?


 

France: Negative opinion on homeopathy submitted by the Supreme Health Authority

On several occasions we have reported on the progress of the critical debate on the role of homeopathy in the French health system. In almost breathtaking speed, a protest article of the group #NoFakeMed in Le Figaro has developed into a debate, which in the meantime has yielded statements of the supreme French Medical Association as well as the Academies of the Sciences of Medicine and Pharmacy (in a joint statement), all of which clearly position themselves against the role of homeopathy in the health care system and which have not been lacking in clarity about the unscientificness, ineffectiveness and possibly dangerousness of homeopathy.

The official statements had been requested by the French Minister of Health, Agnés Buzyn, who at the beginning of the debate had expressed herself somewhat nonchalantly ignorant about homeopathy (“if it helps to avoid toxic medicines…”). But then she had promised to follow the final statements of the chambers and academies and above all the recommendation of the highest French health authority, the HAS (Haute autorité de santé) in her final decision. Of course, Mrs. Buzyn played for time, involving all the authorities that could be found in France. But that didn’t quite work out. After little more than a year after the article in Le Figaro, the final opinion of the HAS is now available –  LeMonde reports..

And it’s devastating for homeopathy. Although the HAS speaks of a “disputed” effect of homeopathy, which is not comprehensible according to the statements of the two academies – but that may already be a politically shaded formula. However, the recommendation to Mrs Buzyn is clear: No more refunds for homeopathy in public health.

And the key sentence is unmistakable:

“No studies have demonstrated the superiority of the homeopathic approach in terms of efficacy (…) over conventional treatments or placebo.”

Mrs Buzyn’s decision will be made in June. Before that, the three major homeopathy producers in France, Boiron, Weleda and the lesser-known Lehning, still have the opportunity to bring counter-arguments. Lo and behold – the nagging has already begun. Boiron “beckons” with the loss of 1,000 jobs and the “marginal” costs – in the French cash register system recently 130 million euros annually – would not be of any significance in view of the fact that there are proper placebo effects for it after all… so at least franceinfo. We remind ourselves that nowhere was the cost factor decisive where homeopathy was given its farewell. Besides, we know The body itself can heal in many cases, the natural course of the disease usually also brings healing, placebo may have only a small part in all this, does not heal diseases – and is everywhere, where there is care and attention, completely free to have.

We do not believe that Boiron will be on the verge of ruin only because of the abolition of reimbursement by the social security system.

Be that as it may – it’s going to be exciting and the matter is just before the finish line in France. Let’s simply note that the 200-year-old business model of homeopathy is now falling victim to science and honesty, as it looks. After all, the facts are as indisputable as the existence of the phases of the moon.

Picture credits: Screenshot franceinfo, 15.5.2019

Belgium: Consumer protectors take position – “Homeopathy is ineffective, even dangerous”.

The Brussels Times reports under this title on 15 May 2019 and quotes Simon November, spokesman for the consumer protection organisation “Test Achats”:

“The requirements of effectiveness, safety and quality to bring a product to market and be allowed to use the name of medication are sadly not the same for all products,” commented Simon November, spokesperson for Test-Achats. “Homeopathic products are required to be accompanied by a minimum of documentation, and the working of the product barely has to be proven. And that, while classic medications have to go through an entire process of trials and study panels. We simply cannot accept that difference.”

The Brussels Times continues: “The organisation (Test Achats) describes homoeopathy as ‘quack medicine’, which would be bad enough if it only robbed the patient of money.  But there are conditions where the patient really has no time to lose on products whose effectiveness has not been demonstrated. People who are suffering from very real heart and vascular conditions should immediately seek treatment by a doctor, and with truly effective medication.”

Tell me about it. We also think that the criticism may have to focus even more on the danger potential of homeopathy. They are real dangers – but they rarely become visible and are therefore “out of mind”. The consequences and delays caused by homeopathic “therapies” are not recorded anywhere and ultimately virtually all end up in the case statistics – and deaths – of scientific medicine. There are very few reports about it. And in the famous case reports of the homoeopaths, with which they want to prove “evidence”, such cases are of course not to be found – only those are presented there that have recovered thanks to their self-healing powers and the natural course of the disease.

What is the general situation in Belgium, by the way?

The Federaal Kenniscentrum voor de Gezondheidszorg, the official health information service, has already stated in 2011 in a paper “State of affairs on Homeopathy in Belgium (Stand van zaken van de homeopathie in België):

“From a purely clinical point of view, there is no valid empirical evidence for the efficacy of homeopathy beyond the placebo effect.”

The Belgian skeptics “skepp” reported in detail on their website about this statement under the title “Homeopathy: geen bewijs dat het werkt en toch veel gebruikt” (“Homeopathy: No proof of an effect and still much used”).

It is up to the health insurance funds in Belgium (similar to the “statutory benefits” in Germany) whether they reimburse homeopathy or not. As you would expect, practically everyone does, with a view to the competition, which you just don’t want to give a marketing advantage to. However, there was a collapse of this front in Belgium last year: one of the major insurers announced that it would no longer cover homeopathy reimbursements.

For some time now, the therapeutic use of homeopathy in Belgium has only been reserved for “qualified” people. In 1999, homeopathy, acupuncture, chiropractic and osteopathy were considerably regulated by the so-called “Colla Law”. One may argue, however, whether it is the right way to persuade the therapists of these directions to found professional associations and to believe that this would suffice an already dubious quality aspect. But the actual aim was to prevent the practice of these forms of therapy by non-physician therapists. In fact, in 2014, a royal decree was added and the end of the non-medical practice of these therapies was sealed. The decree regulated

1. homeopathic therapists must be licensed doctors, dentists or midwives.

2. they must have a degree in homeopathy from an (official) university or college.

3. doctors, dentists and midwives may only use homeopathy for evidence-based indications.

Well, yeah. Let’s disregard the last point, which should actually mean the end of homeopathy, if you take it as it stands. Of course nobody does. (This does not mean, of course, that the indications must be evidence-based, but rather the therapies for the indications. But it is exactly written so in the original text.) Well-intentioned, but actually more than half-hearted, sometimes even nothing more than a appreciation of the sugar ball method – if such a regulation came into force in Germany, the Central Association of Homeopathic Physicians would probably celebrate longer…

No, a prerogative for physicians in homeopathy is not a solution at all. Such regulations arise from the illusion that there exists a “qualified” homeopathic therapy. The lever does not have to be applied to the group of persons exercising the method, but to the method itself, as is currently the case in Spain and France. And that is why we would like to thank the Belgian consumer protectors, who have taken just this approach with their recently published statement. Let us hope that in Belgium, too, there will be realised that homeopathy – no matter who is practising it – has no place in the qualified health care of the population.

And German health policy? Instead of attentively reflecting on developments in Europe – and worldwide – and questioning one’s own position, policy continues to hide behind the popularity-“argument”. However, we do not want to accuse health policymakers of not knowing that “popularity” is not a criterion for the validity of medical means and methods. But we criticize them for pretending to be. Belgium may be half-hearted as far as the official attitude to homeopathy is concerned, but Germany is at best chicken-hearted, if at all.


Picture credits: Screenshot Brussels Times 15.05.2019

France: Academies of science position themselves against homeopathy

More than a year ago, the discussion about homeopathy in health care in France began, triggered by the merger of 124 doctors (the #NoFakeMed initiative), who made a clear statement to the public. The waves went up quickly, the public debate flared up, #NoFakeMed members were even sued before the Medical Association – and probably also before the ordinary courts – for the insubordination to stand up against unscientific and specifically ineffective homeopathy. The French health policy, in the person of Health Minister Buzyn, was initially rather cautious (“does no harm, may be useful even if it avoids ‘poisonous’ medicines”), but then came under pressure when the central French Medical Association took a stand against homeopathy. Ms. Buzyn played for time by requesting an expertise from the French Medical Science Academy. We reported here and here.

This expertise has been available since yesterday (25 March 2019). And more: There was a joint communiqué from the medical and pharmaceutical academies. Le Figaro reports.

In a joint declaration (addressed to the government), the boards (of the academies) called for an end to the reimbursement of homeopathy (within the framework of public health) and an end to their teaching at the Faculties of Medicine and Pharmacy.

“End the reimbursement of homeopathy by statutory social security. Note that it is a placebo and inform patients accordingly; indicate on the packaging that there is no scientific evidence of efficacy; no longer accredit a university degree (in homeopathy) in a medical faculty or certificates and diplomas in pharmacy or veterinary education. More than a year after the publication of the Forum (#NoFakeMed) in Le Figaro Santé by 124 doctors, which relaunched a debate as old as the therapy itself, the Medical Academy voted 58 votes in favour (16 against, 8 abstentions) this Tuesday afternoon for a communiqué signed jointly with the Pharmaceutical Academy to reaffirm its positions on homeopathy.

What the Medical Academy had already made clear in 1984, 1987 and 2004 and then via its participation in the Scientific Advisory Board of the Academies of European Sciences 2017 (EASAC), was repeated in the press release adopted on Tuesday: “The state of scientific data does not permit verification of one of the principles of homeopathy (similarity and high dilutions)” (meaning that these principles have unscientific bases), and “meta-analyses could not prove the effectiveness of homeopathic preparations”.

According to Le Figaro, the working group of the Medical Academy takes care not to refer to homeopathy as “medicine” at any point in its text. Yes, she does not even want to accept the term “alternative medicine” (quite rightly, as we find). The working group acknowledges that, according to surveys, the French “believe” in homeopathy and apply it, doctors prescribe it, hospitals integrate it into their range of services. “Social data”, which the two academies “cannot ignore” – but “which can be explained by a lack of knowledge and/or underestimation of the placebo effect with the expectation of an effect – the only possible, but also sufficient explanation for the effects of homeopathy according to the state of the art”. Homoeopathy is therefore at most “initial” for the placebo effect and a conditioning of the patient (after apparent previous successes), but the patient has a right to receive clear and verifiable information.

“We are pleased that both academies are clearly positioned. It is time for government and administrative authorities to take note of this,” says Dr Jérémy Descoux, cardiologist and president of the Fakemed collective, which emerged from the #NoFakeMed forum, which was launched last March. Descoux himself would have liked an even more concise discourse that would have placed the ethical implications of homeopathic prescriptions more at the centre of attention. “To prescribe and deliver homeopathy is to ultimately accept the premises of homeopathy; and when we offer homeopathy to a patient, we are at least ambiguous in our medical ethos towards him,” he says.

Some members of the Academy declared that they had voted against the communiqué – but not out of disagreement on the matter, but out of concern for a text that is still “ambiguous, given our duty to inform the authorities clearly and decisively”.

Well, do we still have to comment on this with regard to German health policy, including the fact that neither the organised medical profession nor other large organisations of the health care system have positioned themselves in a similar way? We are grateful for a multitude of individual voices from these circles who share our criticism of homeopathy, but “officially” we still state a vacuum. The homeopathy lobby uses this vacuum to gain political credit with its unproven claims about the effectiveness of the method and its meaningless appeals to the “popularity” in the general public. The latest activity is even a petition for the – purely insurance and legal – abolition of homeopathy tariffs at some insurance companies, which still affects 562 people throughout Germany. With this grotesque (you can’t call it any other way) about 77,000 signers have already been reached. It is doubtful that the majority of them can see through the background of this propagandistic effort. Will the addressees do it? We very much hope so. And we hope for more – for the return of reason and honesty in matters of homeopathy and health care.

Our appreciation and thanks go to the French skeptics, the small NoFakeMed community, who gave the impetus to the development in their country and helped the facts to victory despite violent hostilities. Let us now hope for the insight of German health policy before Germany makes a fool of itself as a country of homeopathy with eternal status!

Spain – Homeopathy criticism now also government official

We had reported that on 22 June this year, the Madrid Medical Association, de facto the supreme medical association of Spain, issued a very clear declaration against the use of homeopathy in medical practice and referred to the medical obligations in the Code of Ethics of the Spanish Medical Profession.

Now this position is also government official: The Spanish health minister María Luisa Carcedo is quoted by the portal La Vanguardia: ” I will fight the pseudoscience, and homeopathy belongs to it.

The image shows Mrs Maris Luisa Carcedo, Spanish health minister, in her office room
Maria Luisa Carcedo, Spanish health minister

The decisive part of the interview with Minister Carcedo at La Vanguardia translated:

“Q: What about the healers, charlatans and miracle sellers?

A: We will take it up. We’ve had the prosecution take up the use of chlorine bleach as a cure for autism, and we will continue to do so with other things. As soon as we identify a situation that could pose a threat to public health, we will report it. It is our duty as health authorities to take action against those who want to do business at the expense of naivety or by exploiting the faith of part of the population.

Q: Do you include homeopathy in the pseudosciences?

A: Homeopathy is an “alternative therapy” that is not scientifically proven.

Q: More than 600 health professionals have appealed to you to respect their right (within the framework of freedom of therapy) to use homeopathy.

A: Health facilities have a duty to use products with proven efficacy, i.e. medicines that have undergone rigorous clinical trials and criteria. When homeopathic medicinal products provide scientific evidence, they are considered as such. This is not the case at present.

Q: Will you remove homeopathy from pharmacies, propose an increase in VAT … ? What are you going to do?

A: We are working with the Ministry of Science on a strategy to combat pseudosciences. Once this strategy is in place, we will present measures on individual methods/means, but it is clear that it is urgent to raise public awareness and show which products are useful and which are not, and to explain the damage that the decision for an alternative therapy can do.

Most remarkable. Even more noteworthy is a message from the French news channel Franceinfo (in France the discussion about homeopathy in health care is also intensively underway) on its homepage:

“The Spanish Ministry of Health has asked manufacturers (of homeopathic remedies) to subject their products to the same efficacy tests as other medicines.

The debate on homeopathy is cross-border. This is confirmed by Spain’s recent decision. The Spanish Ministry of Health now requires homeopathic manufacturers to subject their products to the same authorisation procedure as conventional medicines so that they can be indicated. If manufacturers refuse, they must indicate on the packaging that the therapeutic effect of the treatment has not been demonstrated. This is an opportunity for homeopathy to have its efficacy recognised. (sic!)”

So, words are very quickly followed by deeds.

In Germany, too, an indication may only be advertised in the case of a marketing authorisation, not a simple registration. However, the Spanish regulation still goes further: The “authorisation procedure” of Commission D at the German BfArM does not necessarily require a science-based authorisation procedure as with “normal” pharmaceutical medicinal products, but also makes an “authorisation” possible in an “internal consensus”. In addition, the positive labelling obligation as a therapeutically unproven means would clearly go beyond the German regulations. The Spanish rules are roughly equivalent to the stricter regulations of the FTC (the consumer protection authority) in the USA since 2017. Approvals based on scientifically valid proof of efficacy are unlikely. One considers: The demand for scientifically proven proofs of efficacy would – transferred to Germany – be tantamount to a lifting of the internal consensus and would make the reimbursability by statutory health insurance funds de facto invalid via the social code!

All we have left is our usual “Ceterum censeo”:

Where is the reaction of the German health system, politics, the medical profession and the other players in self-administration in the health system? To say it once again emphatically: The (scientific) debate about homeopathy is over! And it should be added: The health-political probably also soon – with exception of Germany?!?


Picture credits: La Vanguardia

Infinite Stories – once again to the Australian NHMRC’s 2015 review on homeopathy

The homoeopaths have long since discovered the title of Michael Ende’s well-known work “Die unendliche Geschichte” (“The Infinite Story”) as a quiet motto for themselves, as their constantly repeated “arguments” in favour of homeopathy prove. In a special context, they once again prove impressively that they are not about more than a constant warming up of the familiar on the hearth of rumours and half-truths.

In an article on “Nature and Medicine” Jens Behnke tries to keep the “serious accusations” against the review of the Australian health authority NHMRC, which have been floating freely in the homeopathic universe for more than two years, at operating temperature.

Let us remember that the Australian Health Authority’s review, conducted in rare cases with transparency and explicit involvement of the homeopathic side, is considered to be the most comprehensive study of the effectiveness of homeopathy ever. What was extremely badly received in some circles: Some time after the review was published in 2015, the information circulated that three homeopathic organisations from Australia had lodged a complaint against the NHMRC with Her Majesty’s Ombudsman (the “grievance box” for citizens’ concerns), complaining of “serious shortcomings” in the review. Significantly, the first news of this in Europe appeared in April 2016 (about eight months after the complaint had been lodged) in an institution that – quoting Prof. Ernst – had “often been at war with the truth”. The German Central Association of Homeopathic Physicians immediately circulated this report (original link expired, wording here) and, in particular, coined the word of “deception of the public” which has been recurring ever since.

The British Homeopathy Research Institute picked up this story in Europe, made itself, so to speak, the advocate of the matter and, according to its own statements, also prepared a “paper of evidence”. Since then, the ominous “deficiencies” of the review have been haunting the homoeopathic scene time and again and serve as arguments “against” the criticism of homoeopathy – now, once again, on “Nature and Medicine”.

Which is remarkable:

  • The text of the complaint was never made public,
  • the three complainants in Australia refuse to provide any information upon request (and have since erased any reference to the input from their websites),
  • the Ombudsman does not appear to be moving (a decision normally takes a maximum of three months, the filing date is August 2016 – which is only worth Mr Behnke a succinct final sentence on an alleged “ongoing procedure”) and
  • what has become known about the alleged “shortcomings” of the review has long since been invalidated.

Furthermore it was and is not recognizable in the least, what the known “complaints” are supposed to change in the result of the review – which in the end is no different than all other homeopathy reviews since 1991. Especially not different than the meanwhile three reviews of Robert H. Mathie, his sign employee of the British HRI. Just like the NHMRC, Mathie comes to the conclusion that there is no reliable evidence for homeopathic treatments.

We reported several times, contentwise here and here, to the history here, in detail in the Homöopedia. Compared to the status of these contributions, nothing has simply changed in the matter. Nevertheless, Mr. Behnke considers it necessary to remind the homeopathic fan community once again of the alleged “scandal” about the NHMRC review, which is slowly reminding us of a tabloid report.

In all this, the question is allowed: What is all this about? What is the point of reheating this rumour conglomerate, which has been kept warm on the stove of rumours for far too long? The intention to keep a “never ending story” alive here at the expense of critical voices is obvious. Recently, the – unexplained – fate of the complaint to the Australian Ombudsman has even been joined by a “petition” for “disclosure” of an alleged “first version” of the NHMRC review.

Incidentally, where does the homeopathic faction get its “findings” from on a “first version” of the review – a point apparently perceived as central – and what are the conclusions drawn from it? With the best will in the world, we do not know. In view of the “criticism” on this point, can we perhaps hope in the future for a section under “Nature and Medicine” in which all draft stages of Mr. Behnke’s articles will be published without interruption?

We find this – amazing. Because in the end all this shows a complete lack of interest in a real dissolution of the node protected by the homeopaths. Since when has a complaint to Her Majesty’s citizens’ grief box or a petition based on completely unproven rumours been a form of scientific debate?


Credits: Pixabay Creative Commons Lizenz CC0

France: In the fast lane in the case of homeopathy

The discussion about alternative medical methods in the health system, especially homeopathy, has quickly and apparently sustaining gained momentum in France.

We reported on the request of the National Council of the Medical Chamber of 22 March this year that the National Academy of Medical Sciences and the Ministry of Health should decide on the scientific relevance of “alternative and complementary methods, namely homeopathy”. This was flanked by the #FakeMed medical initiative, which strongly opposed pseudomedicine and all forms of its direct and indirect acceptance and promotion in health care.

The public discussion – also in the media – was intensively taken up afterwards. Health Minister Buzyn, who had expressed herself somewhat indifferently in public after the National Council of the Medical Chamber’s call, came under fire. But even the dissenting votes were not long in coming: The homeopathy lobby in France began to target the physicians’ association #FakeMed as the supposedly weakest link in the chain of critics and to try to shift the matter to both a professional and a legal level. The press, including leading newspapers such as Libération, Le Monde and Le Figaro, reported in part extensively.

Le Monde stated on 25 May 2018 that on 18 May the Academy of Medical Sciences, referring to its earlier opinion of 2004, described homeopathy as “a method developed two centuries ago on the basis of a priori concepts without any scientific basis”. This is not a direct verdict, but at least a very strong position setting, especially as an answer to the initiative of the Supreme Medical Chamber. Le Monde leaves no doubt that this verdict is tantamount to classifying homeopathy as “unscientific”. It might only be a side note that the Association of French Homeopathic Physicians, on the other hand, refers the EPI3 study financed by Boiron, on which we have already made comments here (a detailed discussion on EPI3 worth reading by Dr. Norbert Aust here).  Le Monde refers to this without digression as a “bad study” and quotes the pharmacology professor François Chast: “We are in the world of faith”.

Now Le Figaro reports that the National Council of the Medical Association has for the first time positioned itself – with a new version of a part of the medical code of honour of the chambers, which – as Le Figaro finds – “does not completely close the door for homeopathy”, probably because of the concessions in complementary measures (which we consider problematic). But pseudomedical means and methods are distinguished from scientific medicine here with unprecedented clarity. The text leaves no doubt that the Chamber does not place it at the discretion of doctors to use unproven methods instead of scientifically proven therapies. This Decision is given below in translated form:

Updating of the generally binding ethical framework by the National Council of the French Medical Chambers:


The medial use of the terms “alternative and complementary medicine”, in particular with regard to homeopathy, maintains an ambiguity which leads to confusion and interpretation disputes.

“Without questioning the freedom of critical or divergent opinions of each individual in the public sphere, the National Council of the Medical Association demands that the Medical Association should be able to take a more pro-active approach to the issue:

  • that the term ‘medicine’ as a prerequisite for any therapeutic procedure first includes a medical process of clinical diagnosis, which may be supplemented by additional examinations with the involvement of competent third parties;
  • that every physician must practice medicine according to scientifically gained knowledge and data both in the making of the diagnosis and in the therapy proposal;
  • that, since the data derived from science are essentially based on continuous development, controversy over a particular method of treatment, whether medical or not, must lead to an up-to-date, impartial and rigorous assessment of the medical service provided by the medical and scientific community.

The National Council therefore affirms that the medical care of a patient must meet the requirements of quality, safety and urgency of care.

A medically recommended treatment can in no case be an alternative to the knowledge gained from science and the state of the art, but it may include an adjuvant or complementary, medical or other prescription, which the doctor will decide to the best of his knowledge and belief in the individual situation after giving the patient fair, clear and appropriate information.

However, the National Council recalls that the Code of Medical Ethics prohibits the presentation of unattended treatment or therapy as safe and therapeutic effective.

This is the ethical framework that applies to the entire medical profession.

Text adopted by the plenary session of the National Council of the Medical Association on 14 June 2018 (original here)”


Despite the reviving resistance of the lobby, it will probably soon become densely for homeopathy in the French health care system. The polite and unmistakable positions of the highest medical association and the highest scientific authority give a “broad hint” in the direction of the Ministry of Health to draw the political consequences from this joint positioning of practical and research medicine.

We take note that the French medical profession represented by its supreme body has taken the initiative to distance itself from pseudomedical methods, in particular homeopathy. And the highest medical scientific authority in the country follows. And that, since in our country the Medical Association did not even consider it necessary to even debate or even vote on the previously intensively discussed abolition of the “additional medical designation of homeopathy”.

Once again we ask: What’s about us in Germany?


Picture credits: Pixabay Creative Commons License

France: Doctors’ collective #FakeMed – a crystal-clear statement on pseudomedicine

A clear message from the French medical profession

On Thursday 12 April 2018, French Health Minister Agnès Buzyn made a brief statement on French television on the question of the reimbursement of homeopathy costs by public health care.

She is ” in favour of maintaining the reimbursement of homeopathy, a medicine that probably has a placebo effect but does no harm. There is an ongoing evaluation of what we call complementary medicine. (…) If they (the methods of “complementary medicine”) continue to be useful (?) without being harmful, they will continue to be reimbursed by social security. (…) The French are attached to homeopathy, it probably (!) has a placebo effect. If she can prevent the use of toxic drugs (she obviously means pharmaceutical drugs…), I think that’s a gain for the general public, it doesn’t hurt”.

A remarkable statement for an oncologist, we note.

But what – at least in Germany – had not become quite so clear anywhere, that is the reason for this statement by Mrs. Buzyn – and we consider that far more significant than the statement itself.

She reacted to an intervention by the National Council of the Medical Chamber on 22 March this year, in which the latter called on the scientific (National Academy of Medical Sciences) and political institutions (Ministry of Health) to decide on the scientific relevance of “alternative and complementary methods, namely homeopathy” – with explicit reference to the statement of the EASAC of September 2017.

In this context, there is the activity of a group of doctors called “#FakeMed”, which entered public with a press release of 28 March 2018, which leaves nothing to be desired in terms of clarity on the subject of pseudomedicine, especially homeopathy, and makes a number of very concrete demands on the Medical Association. We note with great interest and agreement that forces are forming in our neighbouring country which no longer want to accept the continuing and expanding legitimacy of sham therapies, especially homeopathy, unchallenged.

Because of the importance of the declaration from France, we give a translation here in a slightly abbreviated form:

Press Release 28 March 2018:
Fierce debate on alternative practices
The collective #FakeMed proposes:

The Hippocratic Oath is one of the oldest known ethical obligations. He demands a doctor who cares for his patients just as honestly as he does in the best possible way.

These two obligations require a doctor to constantly improve his (medical) knowledge and to inform his patients about what he can reasonably offer and which treatments are unnecessary or contraindicated.

It is not a great art – and usually rewarding – to demonstrate one’s knowledge. But it is much more difficult to recognize and accept one’s limits. One can therefore easily be tempted to offer medical care without a scientific basis. This temptation has always been there. It was and is nourished by charlatans of all kinds who use the moral credit of their qualification and reputation to promote illusory therapies with illusory efficacy.

The commitment to honesty is enshrined in the ethical codes of the medical professions and in the French Health Code. These rules prohibit charlatanry and deception, they require the prescription and execution of treatments for which efficacy has been established. They prohibit the use of obscure products or products whose ingredients are not clearly declared. The National Council of the Medical Association is responsible for ensuring that its members do not promote practices for which there is no scientific proof of benefit or which may even be dangerous. The Council must ensure that doctors do not become commercial agents of unscrupulous industries. It must sanction those who have lost sight of the ethical requirements of their profession. Nevertheless, even in 2018, the Medical Association continues to tolerate practices that contradict its own code of ethics; public institutions promote such practices or even contribute to their funding.

We are now forced to respond clearly and forcefully to the spread of these esoteric practices and the growing public distrust of evidence-based medicine.

Homeopathy, like other so-called “alternative medicine”, is by no means scientific. Their methods are based on beliefs that promise a “wonderful, gentle and safe recovery”. In September 2017, the Scientific Council of the Academies of European Sciences (EASAC) published a report confirming the lack of effectiveness of homeopathy. In most developed countries, doctors are prohibited from prescribing homeopathic medicines.

The so-called “alternative” therapies are ineffective beyond the placebo effect and can even prove to be dangerous. They can be dangerous, because they treat irrelevant symptoms, over-medicate the population (conditioning for ingestion, treatment of pure disorders and mild illnesses not requiring treatment) and create the illusion that any situation can be solved with one of their “treatments”. They can be dangerous because they are based on a fundamental distrust of conventional medicine, as the unjustified polemic about vaccines shows. Finally, they can be dangerous because their application delays necessary diagnoses and treatments, which sometimes leads to dramatic consequences, especially in the treatment of serious diseases such as cancer.

These practices are also costly for the public purse. Training for such practices takes place in publicly funded structures. “Alternative” consultation hours are opened in hospitals at the expense of other medical services. Some of these treatments are reimbursed by the (loss-making) French health insurance. In France, 30 % of homeopathic medicinal products can be reimbursed (up to 90 % in the Alsace-Moselle region) and enjoy an exceptional status exempting them from proof of efficacy. This will finance a wealthy industry whose representatives have no hesitation in massively insulting those who criticise it (“There is a Ku Klux Klan against homeopathy,” said Christian Boiron, president of the world’s leading company in the industry, in the July 15, 2016 newspaper “Le Progrès”) or simply putting aside the undeniable scientific evidence requirements.

We want to distance ourselves comprehensively from these practices, which are neither scientific nor ethical, but irrational and dangerous.

We call on the French Medical Association and the French authorities to do everything in their power to implement these demands:

Doctors or health professionals are no longer allowed to further promote these “alternative medical” practices with their professional qualifications.
Homeopathy, mesotherapy or acupuncture diplomas are no longer recognised as medical degrees or qualifications.
It must be ensured that medical faculties or institutes providing health training may no longer issue diplomas for medical practice concerning methods without scientific proof of effectiveness.
No more reimbursement for health care, medications or treatments from disciplines that refuse a rigorous scientific assessment.
Promote initiatives aimed at providing information on the nature of alternative therapies, their harmful effects and their real efficacy.
All health professionals must abide by the ethical consequences associated with their profession, which necessarily result from the ineffectiveness and irrationality of pseudomedical methods, by refusing to carry out useless or ineffective treatments. Instead, they must offer treatments according to the recommendations of scientific societies and the latest scientific findings, demonstrate sincerity and honesty to their patients and offer empathetic listening instead of “alternative methods”.

End of quote.

We are very pleased that well-founded and decisive criticism of pseudomedicine, first and foremost of its “driving force” homeopathy, is now growing together into an international activity. For Germany, this means, as we have already stated on several occasions, increased pressure to act if we do not want to fall into a health policy offside internationally and, above all, within the EU.

German health policy, German Medical Association, medical profession: We’re waiting!


Read more on “Respectful Insolence”: https://respectfulinsolence.com/2018/04/13/fake-medicine-science-based-medicine-versus-homeopathy-france/


Picture credits: Screenshot fakemedecine.org

INH’s statement on NHMRC

“Täuschung der Öffentlichkeit”?

Verschiedene Homöopathie-Verbände und -Vereine üben Kritik an der 2015 erschienenen umfangreichen Übersichtsarbeit des medizinischen Forschungsbeirats des australischen Gesundheitsministeriums zur Wirksamkeit der Homöopathie. Man spricht gar von einer “Täuschung der Öffentlichkeit“. Diese Arbeit kam zu einem für die Homöopathie unvorteilhaften Ergebnis: Man fand kein einziges Krankheitsbild, für das die Wirksamkeit einer homöopathischen Therapie zweifelsfrei erwiesen ist.

Angesichts der Ungenauigkeiten (“inaccuracies”) sehe man sich genötigt, beim Ombudsmann der australischen Regierung Beschwerde einzulegen, stellt das Homeopathy Research Institute fest. Bemerkenswert ist, dass die vorgebrachte Kritik sehr an der Oberfläche bleibt und nicht aufgezeigt wird, wie sich die Kritikpunkte auf das Ergebnis des Reviews ausgewirkt haben sollen.

Auf den Punkt gebracht

Die vom HRI vorgebrachten Kritikpunkte sind auf einfache Weise zu widerlegen, indem man die Berichte zum Review liest. Daraus ergibt sich zweifelsfrei:

  • Die Untersuchung fußt in Summe auf der Analyse von 225 Einzelstudien, die nicht nur in Englisch, sondern auch in vielen anderen Sprachen veröffentlicht wurden. Die kleinste Teilnehmerzahl einer Studie betrug vier Probanden.
  • Die Bewertung der Studie erfolgte nach einem Verfahren, das auch von der Welt-Gesundheitsorganisation empfohlen wird.
  • Beim Vorsitzenden der Arbeitsgruppe lag kein Interessenkonflikt vor. Die Person, die einen Interessenkonflikt erklärte, war eins von sieben Mitgliedern der Arbeitsgruppe. An der Arbeitsgruppe war auch eine Apothekerin beteiligt, die einen universitären Forschungsbereich zur Komplementärmedizin leitet, also eine gewisse Affinität zur Alternativmedizin aufweist.
  • Die Beteiligung eines Homöopathen war nach den Regeln des Beirats nicht erforderlich.
  • Selbst wenn es Vorversionen zu diesem Review gab, ist dies für die Methodik und das Ergebnis des vorliegenden Reviews belanglos.
  • In diesem Review wurden die gleichen Ergebnisse erzielt wie in vielen anderen zuvor, darunter auch den beiden Arbeiten von R. T. Mathie von 2014 und 2017, der als persönlichen Hintergrund eine Zugehörigkeit zum HRI angibt. Damit ist auch nicht erkennbar, wo in der Veröffentlichung ein Skandal liegen sollte, wie ihn Frau Bajic, Vorsitzende des Deutschen Zentralvereins homöopathischer Ärzte, ausgemacht haben will.

Die Kritik der Homöopathen ist anscheinend weniger auf eine wissenschaftliche Auseinandersetzung gerichtet, sondern zielt wohl eher darauf ab, dass dem in diesen Dingen unkundigen potenziellen Patienten vorgegaukelt wird, das Ergebnis des Reviews sei durch fragwürdige Einflussnahme dunkler Mächte zustande gekommen. Man nennt dies üblicherweise eine “Skandalisierung”.

Einzelheiten

Da die Diskussion um das Review wahrscheinlich noch einige Zeit andauern wird, sollen hier in einer größeren Zusammenstellung die Grundlagen aufgeführt werden, auf denen die obige Stellungnahme beruht.

Hintergrund

Im Jahr 2015 hat der für die medizinische Forschung zuständige Beirat NHMRC (“National Health and Medical Research Council)” des australischen Gesundheitsministeriums eine umfassende Übersichtsarbeit (“Review”) zur Wirksamkeit der Homöopathie veröffentlicht [1]. Darin kommt man zu dem Endergebnis, dass es kein Krankheitsbild gäbe, für das zuverlässige Nachweise vorlägen, dass die Homöopathie eine über Placebo, also über ein Präparat ohne jeden Wirkstoff, hinausgehende Wirkung entfalte. Man hat sich darum bemüht, die gesamte vorliegende Evidenz klinischer Studien zu sichten, entsprechend umfangreich ist der Bericht ausgefallen: Auf knapp 1000 Seiten ist bis ins Detail dokumentiert, wie man zu der Schlussfolgerung kam.

Das Homeopathy Research Institute, England, (HRI) hat offenbar nunmehr eine förmliche Beschwerde beim Ombudsmann der Regierung Australiens eingereicht [2], worüber der Deutsche Zentralverein homöopathischer Ärzte (DZVhÄ) auf seinen Seiten und in einer Pressemitteilung gleichen Inhalts berichtet [3], die von vielen Internetseiten aufgenommen wurde. Die Österreichische Gesellschaft für homöopathische Medizin (ÖGHM) hatte schon im Juni 2015 eine Kritik an dieser Studie veröffentlicht, in der diese Punkte ebenfalls aufgegriffen werden [4].

Stellungnahme des INH

Eine kritische Auseinandersetzung mit Forschungsarbeiten und deren Ergebnissen ist ein wesentlicher Bestandteil wissenschaftlichen Arbeitens und als solches prinzipiell zu begrüßen. Die Kritik des HRI und die darüber noch hinausgehenden Äußerungen des DZVhÄ und der ÖGHM sind jedoch kein Bestandteil einer akademischen Auseinandersetzung. Die Kritikpunkte sind entweder belanglos, indem sie unbedeutende Details hervorheben, oder grundlegend falsch, wie bereits ein einfaches Nachlesen in der Studie erkennen lässt.

Es spricht eher für als gegen die Studie des NHMRC, dass man seitens der Verfechter der Homöopathie zu solchen zweifelhaften Mitteln greifen muss, um zumindest bei den unkundigen Patienten den Schein zu wahren, es gäbe tatsächlich ernsthafte Gegenargumente. Solche werden üblicherweise in einer wissenschaftlichen Regeln entsprechenden Art und Weise in wissenschaftlichen Journalen veröffentlicht und damit ihrerseits zur Kritik der Wissenschaftsgemeinde gestellt.

Frühere Versionen des veröffentlichten Reviews

Der in 2015 veröffentlichte Bericht ist möglicherweise erst im zweiten Anlauf zustande gekommen. Selbst wenn es vorher eine andere Version gab, wie das HRI – allerdings ohne Belege oder nähere Angaben – behauptet: So what? Was ist an dem vorliegenden Review auszusetzen? Was an dem Review ist alleine dadurch falsch, dass es eine oder mehrere oder eine beliebige Zahl vorheriger Versionen gegeben hat, wenn es sich dabei nicht ohnehin nur um verschiedene Entwürfe gehandelt hat? Eine sachorientierte Kritik würde herausstellen, wo die Unzulänglichkeiten der vorliegenden Studie liegen, welche Schwächen sie enthält. Aber davon ist hier keine Rede.

Dieser Vorwurf stellt alleine einen Appell an den Leser dar, irgendwelche dunkle Machenschaften, vielleicht sogar eine Verschwörung zu unterstellen, insbesondere, wenn man dann – ebenfalls ohne Beleg – in den Raum stellt, die erste Version sei ohne Zweifel wegen eines für die Homöopathie positiven Ergebnisses zurückgewiesen worden. Was angesichts der klar gegen die Homöopathie sprechenden Evidenzlage aus Reviews und Metaanalysen kaum glaubhaft erscheint.

Datenbasis

Das Review beruht auf 176 Studien, die im ersten Durchgang detailliert begutachtet und für das Review ausgewertet wurden [5, S. 5]. Diese Datenbasis wurde ergänzt, indem die australischen Homöopathieverbände und die interessierte Öffentlichkeit weitere Arbeiten vorlegen konnten, die ebenfalls berücksichtigt wurden [5, S. 6]. Dies erweiterte die Datenbasis um weitere 49 Studien [6: S. 10; 7: S. 11 und 12 ], so dass in Summe 225 Einzelstudien im Review ausgewertet wurden.

Nirgends wird in dem Report eine Zahl von 1.800 Studien genannt, auf denen das Review basiere. Dennoch kritisiert das HRI, dass das NHMRC behauptet hätte, es wären 1.800 Studien ausgewertet worden, was in der Tat nicht korrekt wäre. Man muss schon ziemlich lange suchen, bis man diese ominöse Zahl 1.800 findet: Alleine in der Pressemitteilung vom 11. März 2015 [8] wird mitgeteilt, man habe über 1.800 Arbeiten gesichtet, wovon 225 die Einschlusskriterien erfüllt hätten. Was vollkommen zutreffend ist: Die gesamte initiale Literaturrecherche sowie die Einreichungen im Rahmen der öffentlichen Anhörung umfassten tatsächlich insgesamt 1.863 Artikel, Aufsätze, Fallberichte und Studien (einschließlich Mehrfachnennungen), wie sich aus den Angaben in den entsprechenden Teilberichten errechnen lässt [9: S. 22; 6: S. 10; 7: S. 11]. Dass auf diese “Rohmasse” Auswahlkritieren angewandt werden müssen (wofür es internationale Standards gibt, die hier beachtet wurden) liegt auf der Hand.

Einschlusskriterien für Einzelstudien und Bewertung

Alle Einzelstudien wurden einer detaillierten Betrachtung unterzogen, entweder anhand der Angaben in systematischen Übersichtsarbeiten, in denen sie bereits untersucht worden waren, oder im Falle der eingereichten Studien auch in Einzelbewertung [5: S. 14f].

Die Aussagekraft der Einzelstudien wurde im GRADE-Verfahren bewertet, bei dem mindere Qualität und zu kleine Teilnehmerzahl zu einem Urteil ‘nicht belastbar’ führten [5: S. 36]. Als Mindestwert für die Einstufung einer Studie als zuverlässig wurde beim Kriterium der Teilnehmerzahl ein Wert von 150 festgelegt. In der Tat wird dieser Zahlenwert nicht begründet – allerdings ist er wesentlich kleiner als üblich, also den üblicherweise kleinen Studien in der Homöopathie stark entgegenkommend und keineswegs nachteilig. Im GRADE-Handbuch sind 400 Teilnehmer als Richtwert angegeben, ab dem wegen der Teilnehmerzahl eine Studie einen Bewertungsmalus bekommt [10, Kap. 5.2.4.2]. Dass nur wenige Homöopathie-Studien die Qualitäts- und Größenkriterien erfüllten, ist ein generelles Problem, das auch schon in anderen Reviews bemängelt wurde.

Es sei angemerkt, dass das GRADE-Verfahren zur Bewertung der vorliegenden Evidenz von vielen Organisationen angewandt und empfohlen wird, darunter die Welt-Gesundheitsorganisation (WHO) [11].

Die Kritik des HRI, des DZVhÄ und auch anderer Organisationen wie der ÖGHM, Studien unter 150 Teilnehmern wären von der Betrachtung ausgeschlossen gewesen, ist damit völlig haltlos.

Ebenso unsinnig ist die Behauptung, die Studien, die nicht auf Englisch publiziert wurden, seien generell ausgeschlossen worden. In der Aufstellung der eingeflossenen Studien [12] findet man Arbeiten, die auf Französisch, Deutsch, Italienisch, Spanisch, Portugiesisch und Norwegisch veröffentlicht wurden. Lediglich bei den im Zuge der Anhörung eingereichten Arbeiten wurden in Summe 10 Studien wegen der Sprache ausgeschlossen [6: S. 10; 7: S. 11 und 12 ]. Angesichts der insgesamt 225 im Review betrachteten Studien fällt dies wohl eher nicht ins Gewicht.

Die Aussage von DZVhÄ und ÖGHM suggeriert dem Leser mithin etwas völlig Falsches, nämlich dass eine große Anzahl von Studien ausgeschlossen worden wäre, letztendlich nur 5 (!?) Studien in die Betrachtung eingeflossen seien.

Man könnte seitens der Homöopathen durchaus diskutieren, ob das angewandte Verfahren angemessen war oder das Ergebnis dadurch verfälscht wurde, alleine, das passiert nicht. Dass eine große Anzahl von Studien wegen zu kleiner Teilnehmerzahl oder Veröffentlichung in einer nicht-englischen Sprache vollkommen unberücksichtigt blieb, ist falsch, wie man sich mit einfachen Mitteln, nämlich durch Lesen des Reviews, vergewissern kann. Man fragt sich, für wie einfältig die Homöopathen ihre Kunden und besonders ihre Kritiker halten, ein solches derartig einfach zu entkräftendes Argument einzuführen.

Interessenkonflikt

Der Vorsitzende des Ausschusses, der die Arbeit begleitet hat (HWC – Homeopathy Working Committee), war Prof. Glasziou von der Bond-Universität in Queensland [5, S. 31]. Ursprünglich sollte Prof. Brooks von der Universität Melbourne die Leitung übernehmen, aber aufgrund eines Interessenkonflikts erfolgte eine Umbesetzung und Brooks arbeitete als einfaches Mitglied im HWC mit. Der Interessenkonflikt bestand darin, dass er Mitglied in einer Vereinigung “Friends of Science in Medicine” war, einer Vereinigung, die die wissenschaftliche Ausrichtung der Medizin fördern will und daher Positionen gegen die Alternativmedizin vertritt [13].

Und jetzt muss man sich einmal vergegenwärtigen: Eine Vereinigung wie das HRI wird praktisch ausschließlich von Therapeuten und Einrichtungen finanziert [14], die mit der Homöopathie ihr Geld verdienen. Man fördert Forschungsvorhaben und Studien zur Homöopathie, veröffentlicht selbst entsprechende Arbeiten, beispielsweise die letzten Reviews zur Homöopathie von Mathie et al. 2014 und 2017. Ausgerechnet dieses HRI kritisiert an einem 1.000-Seiten-Review, zu dem sicher mehrere Dutzend Menschen beigetragen haben, dass ein einziger Mitarbeiter des das Projekt steuernden Ausschusses einen möglichen Interessenkonflikt offengelegt hat – der darin bestehen soll, dass er einer Vereinigung für Wissenschaftlichkeit in der Medizin angehört? Wie lächerlich ist das denn?

Substanzielle Kritik hingegen würde aufzeigen, wie eine solche Voreingenommenheit, die hier übrigens noch nicht einmal auf wirtschaftlichen Interessen beruht, das Ergebnis hätte beeinflussen können. Beispielsweise wo das Design anfällig dafür war, etwa indem Entscheidungsspielräume gegeben wären, die zu einer Verfälschung in Richtung auf negative Ergebnisse hätten ausgenutzt werden können. Aber nichts dergleichen wird genannt. Auch hier zielt das Argument wohl auf den Leser, der wieder dunkle Machenschaften vermuten kann. Stichwort Skandalisierung.

Zusammensetzung der Arbeitsgruppe

Die Arbeitsgruppe zur Leitung der Untersuchung, das HWC, umfasste sieben Personen einschließlich des Vorsitzenden [5 S. 31 f]. Neben ausgewiesenen Wissenschaftlern der konventionellen evidenzbasierten Medizin (Allgemeinmedizin, Rheumatologie, Neurologie) fanden sich darin ein Vertreter der australischen Vereinigung der Krebskranken, eine Apothekerin, ein weiterer Forscher und ein Regierungsvertreter. Die Apothekerin ist Leiterin für Lehre und Forschung zur Komplementärmedizin an der Griffith University in Gold Coast, Queensland, und ist Mitglied der Gesellschaft für Forschung zu medizinischen Pflanzen und Naturprodukten.

Die Untersuchungen bestanden in einer Suche nach einschlägigen Literaturstellen zur Wirksamkeit der Homöopathie sowie in der Auswertung der gefundenen Daten zur Qualität der Studien, der Teilnehmerzahl sowie Krankheitsbild und Ergebnis. Letzteres wurde durch externe Dienstleister, die Firmen OPTUM und ARCH, vorgenommen.

Da es sich bei diesem Review also nicht um eine Leitlinie oder Therapieempfehlung handelt, ist ein Spezialist für Homöopathie entbehrlich [18, S. 4]. Die niedergelegten Daten zutreffend zu extrahieren erfordert kein spezielles Fachwissen, über das nur Homöopathen verfügen.

Die Regeln des NHMRC sehen natürlich vor, dass bei der Erstellung von Behandlungsleitlinien Vertreter der anzuwendenden Therapieform in der Arbeitsgruppe vertreten sein müssen, was sich ohne weiteres von selbst versteht. Aber beim bloßen Datensammeln und Auswerten ist dies nicht erforderlich.

Die entsprechende Kritik des HRI ist also nicht gerechtfertigt, zumal auch hier nicht dargelegt wird, wie denn jemand mit homöopathischen Fachkenntnissen zu anderen Ergebnissen hätte kommen können.

Schlussfolgerung

Die Kritik des HRI am Review der australischen Gesundheitsbehörde ist recht oberflächlich und berührt den Inhalt der Studie nur am Rande. Beim Leser soll ganz offensichtlich der Eindruck hervorgerufen werden, diese Arbeit sei aufgrund dunkler, gegen die Homöopathie gerichteter Machenschaften zustande gekommen. Eine substantielle Kritik unterbleibt vollkommen, es wird kein einziger sachlicher Aspekt der Studie diskutiert, der einen Einfluss auf das Ergebnis hätte haben können. Das HRI übt zwar Kritik an der Mindestanzahl von 150 Teilnehmern für eine belastbare Studie – was vom DZVhÄ auch noch falsch zitiert wird – bleibt aber ein Argument schuldig, warum diese im Vergleich zum originären GRADE-Verfahren recht entgegenkommende Festlegung ungerechtfertigt sein soll.

Es bleibt abzuwarten, wie die Entscheidung des angerufenen Ombudsmannes der australischen Regierung ausfallen wird. Seine Aufgabe ist aber weniger die Auseinandersetzung mit wissenschaftlichen Ergebnissen, sondern der Schutz australischer Bürger und Vereinigungen vor ungerechtfertigter Benachteiligung durch Regierungsbehörden. Wenn man dort die wissenschaftlichen Grundlagen betrachtet, dann dürfte das HRI wenig Aussicht haben, mit seiner Beschwerde etwas zu erreichen.

Randbemerkung

Das Review des australischen Gesundheitsministeriums kommt mit anderer Methodik und größerer Datenbasis praktisch zum gleichen Ergebnis wie die beiden Reviews, die Mathie in den Jahren 2014 und 2017 veröffentlicht hat [15, 16]. Auch dort fand man keine zuverlässigen Studien, die den Qualitätsanforderungen für einen “low risk of bias” vollumfänglich entsprochen hätten und gleichzeitig eine Wirksamkeit des Homöopathikums über Placebo hinaus zeigten. Dabei hatte man noch nicht einmal die Anzahl der Teilnehmer als ein Bewertungskriterium herangezogen:

“Individuell verschriebene Homöopathika zeigen möglicherweise einen kleinen spezifischen Behandlungseffekt.[…] Die generell geringe und unklare Qualität der Nachweise verlangt es aber, diese Ergebnisse vorsichtig zu interpretieren.” [15]

“Die Qualität der vorliegenden Nachweise ist gering. […] Zuverlässige Nachweise aus krankheitsspezifischen Meta-Analysen liegen nicht vor, weshalb diesbezügliche Schlussfolgerungen nicht möglich sind.” [16]

Schon Linde kommt in seinem Review von 1998 zu dem Schluss [17]:

“Wir fanden [in den betrachteten] Studien jedoch nur unzureichende Nachweise, dass Homöopathie für irgendein Krankheitsbild eine klare Wirksamkeit aufweist.”

Liebe Frau Bajic, lieber DZVhÄ: Worin liegt jetzt der Skandal, den Sie darin sehen, dass die Australier diese sicher nicht auf Voreingenommenheit gegen die Homöopathie beruhenden Ergebnisse vollumfänglich bestätigen und ihren Bericht veröffentlichen? Und was ist die korrekte Studienlage, auf die Sie hinweisen? Entschuldigen Sie, Ihr Forschungsreader zur Homöopathie, den Sie zitieren, hält einer eingehenderen Betrachtung ebenso wenig stand wie die vorgebrachte Kritik an der NHMRC-Studie, aber das ist hier nicht das Thema.

Für das INH: Dr. Norbert Aust


Quellen und Literatur

Bild: Fotolia_129323079_XS

Alle Links und Webseiten abgerufen am 12. Mai 2017

[1] NHMRC Statement on Homeopathy and NHMRC Information Paper – Evidence on the effectiveness of homeopathy for treating conditions, Webseite mit Download aller Teile des Berichts, Link: https://www.nhmrc.gov.au/guidelines-publications/cam02

[2] NN: The Australian Report, Webseite des Homeopathy Research Institute, Link: https://www.hri-research.org/resources/homeopathy-the-debate/the-australian-report-on-homeopathy/

[3] NN: Australische Homöopathie-Studie: “Eine Täuschung der Öffentlichkeit”, Webseite des Deutschen Zentralvereins homöopathischer Ärzte, Link: http://www.homoeopathie-online.info/australische-homoeopathie-studie-eine-taeuschung-der-oeffentlichkeit/

[4] Dellmour F: Australische “Studie”: Falsches Spiel mit dem Evidenzbegriff, Webseite der Österreichischen Gesellschaft für homöopathische Medizin, http://www.homoeopathie.at/wp-content/uploads/2015/06/Dellmour_Australische_Studie_2015_Vollversion.pdf

[5] NN: NHMRC Information Paper – Evidence on the effectiveness of homeopathy for treating health conditions, March 2015, Link: https://www.nhmrc.gov.au/_files_nhmrc/publications/attachments/cam02a_information_paper.pdf

[6] NN: Effectiveness of Homeopathy for Clinical Conditions: Evaluation of the Evidence, Review of Submitted Lietrature, Link: https://www.nhmrc.gov.au/_files_nhmrc/publications/attachments/cam02g_reviewofsubmittedliterature140408.pdf

[7] NN: Effectiveness of Homeopathy for Clinical Conditions: Evaluation of the Evidence – Review of Literature from Public Submissions, Link: https://www.nhmrc.gov.au/_files_nhmrc/publications/attachments/cam02j_review_literature_public_submissions.pdf

[8] NN: NHMRC releases statement and advice on homeopathy, Pressemeldung vom 11. März 2015, Link: https://www.nhmrc.gov.au/media/releases/2015/nhmrc-releases-statement-and-advice-homeopathy

[9] NN: Effectiveness of Homeopathy for Clinical Conditions: Evaluation of the Evidence, Overview Report, Link: https://www.nhmrc.gov.au/_files_nhmrc/publications/attachments/cam02i_homeopathyoverviewreport140408.pdf

[10] Schünemann H, Brozek J, Guyatt G, Oxman A: GRADE Handbook, Handbook for grading the quality of evidence and the strength of recommendations using the GRADE approach, Updated October 2013, Link: http://gdt.guidelinedevelopment.org/app/handbook/handbook.html#h.qoxhi6qajv5t

[11] NN: The Grading of recommendations Assessment, Development and Evaluation (GRADE) Approach, Eintrag in der englischen Wikipedia, Link: https://en.wikipedia.org/wiki/The_Grading_of_Recommendations_Assessment,_Development_and_Evaluation_(GRADE)_approach

[12] NN: List of systematic reviews and primary studies already considered by NHMRC, Link: https://www.nhmrc.gov.au/_files_nhmrc/publications/attachments/cam02f_listofconsideredevidence140407.pdf

[13] NN: History, Webseite der Vereinigung “Freinds of Science in Medicine”, Link: http://www.scienceinmedicine.org.au/index.php?option=com_content&view=article&id=114&Itemid=158

[14] NN: Our Supporters, Webseite des Homeopathy Research Institute, Link: https://www.hri-research.org/support-hri/collaborations/

[15] Mathie RT, Lloyd SM. Legg LA, Clausen J et al.: Randomised placebo-controlled trials of individualised homeopathic treatment: systematic review and meta-analysis, Systematic Reviews (2014) 3:142, DOI 10.1186/2046-4053-3-142

[16] Mathie RT, Ramparsad N, Legg LA, Clausen J et al: Randomised, double blind, placebo controlled trials of non- individualised homeopathic treatment: systematic Review and meta-analysis, Systematic Reviews (2007) 6:63, DOI 10.1186/s13643-017-0445-3

[17] Linde K, Clausius N, Ranirez G, Melchart D et al.: Are the clinical effects of homeopathy placebo effects? A meta-analysis of placebo controlled trials, The Lancet (1997); 350: 834-843

[18] NN: Summary of key issues: Draft information paper on homeopathy – expert review comments, Link: https://www.nhmrc.gov.au/_files_nhmrc/publications/attachments/cam02e_expert_review_comments.pdf


Zum Weiterlesen:

http://edzardernst.com/2017/04/ombudsman-investigates-flawed-homeopathic-study/

https://keineahnungvongarnix.com/2017/04/20/skandal-verschwoerung-gegen-homoeopathie-oder-doch-nicht/

http://scienceblogs.de/gesundheits-check/2017/04/17/auferstehung-von-den-toten-auch-homoeopathen-feiern-ostern/

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