MD, PhD, FMedSci, FRSB, FRCP, FRCPEd.

regulation

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The World Federation of Chiropractic (WFC) claim to have been at the forefront of the global development of chiropractic. Representing the interests of the profession in over 90 countries worldwide, the WFC has advocated, defended and promoted the profession across its 7 world regions. Now, the WFC have formulated 20 principles setting out who they are, what they stand for, and how chiropractic as a global health profession can, in their view, impact on nations so that populations can thrive and reach their full potential. Here are the 20 principles (in italics followed by some brief comments by me in normal print):

1. We envision a world where people of all ages, in all countries, can access the benefits of chiropractic.

That means babies and infants! What about the evidence?

2. We are driven by our mission to advance awareness, utilization and integration of chiropractic internationally.

One could almost suspect that the drive is motivated by misleading the public about the risks and benefits of spinal manipulation for financial gain.

3. We believe that science and research should inform care and policy decisions and support calls for wider access to chiropractic.

If science and research truly did inform care, it would soon be chiropractic-free.

4. We maintain that chiropractic extends beyond the care of patients to the promotion of better health and the wellbeing of our communities.

The best example to show that this statement is a politically correct platitude is the fact that so many chiropractors are (educated to become) convinced that vaccinations are undesirable or harmful.

5. We champion the rights of chiropractors to practice according to their training and expertise.

I am not sure what this means. Could it mean that they must practice according to their training and expertise, even if both fly in the face of the evidence?

6. We promote evidence-based practice: integrating individual clinical expertise, the best available evidence from clinical research, and the values and preferences of patients.

So far, I have seen little to convince me that chiropractors care a hoot about the best available evidence and plenty to fear that they supress it, if it does not enhance their business.

7. We are committed to supporting our member national associations through advocacy and sharing best practices for the benefit of patients and society.

Much more likely for the benefit of chiropractors, I suspect.

8. We acknowledge the role of chiropractic care, including the chiropractic adjustment, to enhance function, improve mobility, relieve pain and optimize wellbeing.

Of course, you have to pretend that chiropractic adjustments (of subluxations) are useful. However, evidence would be better than pretence.

9. We support research that investigates the methods, mechanisms, and outcomes of chiropractic care for the benefit of patients, and the translation of research outcomes into clinical practice.

And if it turns out to be to the detriment of the patient? It seems to me that you seem to know the result of the research before you started it. That does not bode well for its reliability.

10. We believe that chiropractors are important members of a patient’s healthcare team and that interprofessional approaches best facilitate optimum outcomes.

Of course you do believe that. Why don’t you show us some evidence that your belief is true?

11. We believe that chiropractors should be responsible public health advocates to improve the wellbeing of the communities they serve.

Of course you do believe that. But, in fact, many chiropractors are actively undermining the most important public health measure, vaccination.

12. We celebrate individual and professional diversity and equality of opportunity and represent these values throughout our Board and committees.

What you should be celebrating is critical assessment of all chiropractic concepts. This is the only way to make progress and safeguard the interests of the patient.

13. We believe that patients have a fundamental right to ethical, professional care and the protection of enforceable regulation in upholding good conduct and practice.

The truth is that many chiropractors violate medical ethics on a daily basis, for instance, by not obtaining fully informed consent.

14. We serve the global profession by promoting collaboration between and amongst organizations and individuals who support the vision, mission, values and objectives of the WFC.

Yes, those who support your vision, mission, values and objectives are your friends; those who dare criticising them are your enemies. It seems far from you to realise that criticism generates progress, perhaps not for the WFC, but for the patient.

15. We support high standards of chiropractic education that empower graduates to serve their patients and communities as high value, trusted health professionals.

For instance, by educating students to become anti-vaxxers or by teaching them obsolete concepts such as adjustment of subluxation?

16. We believe in nurturing, supporting, mentoring and empowering students and early career chiropractors.

You are surpassing yourself in the formulation of platitudes.

17. We are committed to the delivery of congresses and events that inspire, challenge, educate, inform and grow the profession through respectful discourse and positive professional development.

You are surpassing yourself in the formulation of platitudes.

18. We believe in continuously improving our understanding of the biomechanical, neurophysiological, psychosocial and general health effects of chiropractic care.

Even if there are no health effects?!?

19. We advocate for public statements and claims of effectiveness for chiropractic care that are honest, legal, decent and truthful.

Advocating claims of effectiveness in the absence of proof of effectiveness is neither honest, legal, decent or truthful, in my view.

20. We commit to an EPIC future for chiropractic: evidence-based, people-centered, interprofessional and collaborative.

And what do you propose to do with the increasing mountain of evidence suggesting that your spinal adjustments are not evidence-based as well as harmful to the health and wallets of your patients?

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What do I take out of all this? Not a lot!

Perhaps mainly this: the WFC is correct when stating that, in the interests of the profession in over 90 countries worldwide, the WFC has advocated, defended and promoted the profession across its 7 world regions. What is missing here is a small but important addition to the sentence: in the interests of the profession and against the interest of patients, consumers or public health in over 90 countries worldwide, the WFC has advocated, defended and promoted the profession across its 7 world regions.

As reported on this blog, the Spanish minister of health want to change the EU law that governs homeopathy. Now the INH has taken action in support of this idea:

THE COMMENT

… the Spanish government … 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?

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THE LETTER TO ALL GERMAN MEPs

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

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IF YOU FEEL LIKE SUPPORTING THIS INITIALIVE, PLEASE WRITE TO YOUR MEP.

According to the European Committee of Homeopathy, the Committee on Health and Consumer Affairs of the Spanish Parliament unanimously adopted a bill in 2009 that recognises homeopathy as a medical act. It urged the government to “take the measures necessary for the exercise of homeopathy exclusively by graduates in medicine and surgery.” On 17 December 2009, the Consejo General de Colegios Oficiales de Médicos (Spanish Medical Council) adopted a resolution that recognised the practice of homeopathy as a medical act.

One decade later, the wind seems to have changed. As reported previously (see here and here), there are now several Spanish initiatives to minimise the damage bogus therapies like homeopathy do to public health. A recent article reported that the Spanish health ministry has been campaigning for a change in the EU law that classifies homeopathic products as medicines. The European Commission seems to be open to the idea.

The criticism of homeopathy in Spain was triggered at least in part by reports of people refusing or abandoning regular treatment in favour of homeopathic products to treat serious diseases like cancer. One of them was Rosa Morillo, who died of breast cancer in 2017, after she refused chemotherapy and sought homeopathic treatments instead, according to El País.

“The problem is the damage that can be done by opting for an alternative therapy that has not demonstrated scientific evidence,” Carcedo, the Sanish health minister, said. She raised the issue again in bilateral talks at the most recent EU health ministers’ meeting in Luxembourg in June. “What we can do is keep up the pressure, because the change in the directive must be done at a European level,” she told El País.

The 2001 EU directive on the code for human medicines states that “homeopathic medicinal products” are eligible for a simplified registration procedure if they are administered orally or externally, have no specific therapeutic indication on their packaging; and are sufficiently diluted to guarantee their safety. Homeopathic products with a specific therapeutic indication, meanwhile, have to get a marketing authorization following the same rules as regular medicines, including providing proof of efficacy.

The envisaged change in EU law would be most welcome, in my view. It would:

  • abolish the current double standards,
  • end the misleading messages to consumers,
  • align the law with the current best evidence,
  • abolish the unfair commercial advantage of homeopathy producers,
  • align the law with ethical imperatives,
  • make a positive contribution to public health,
  • increase trust in EU drug regulation.

But we should not be over-optimistic either. The European homeopathy lobby is powerful and is fighting with its back to the wall.

And what can we do to help? Perhaps writing to your MEP in support of the Spanish initiative might be a good idea?

In 2016, members of the World Federation of Chiropractic Disability and Rehabilitation Committee conducted an international, cross-sectional survey of all 193 United Nation member countries and seven dependencies to describe the global chiropractic workforce in terms of:
  • the availability (numbers and where they are practising),
  • quality (education and licensing),
  • accessibility (entry and reimbursement),
  • acceptability (scope of practice and legal rights).

An electronic survey was issued to contact persons of constituent member associations of the World Federation of Chiropractic (WFC). In addition, data were collected from government websites, personal communication and internet searches. Data were analysed using descriptive statistics.

Information was available from 90 countries in which at least one chiropractor was present. The total number of chiropractors worldwide was 103,469. The number of chiropractors per country ranged from 1 to 77,000. Chiropractic education was offered in 48 institutions in 19 countries. Direct access to chiropractic services was available in 81 (90%) countries, and services were partially or fully covered by government and/or private health schemes in 46 (51.1%) countries. The practice of chiropractic was legally recognized in 68 (75.6%) of the 90 countries. It was explicitly illegal in 12 (13.3%) countries. The scope of chiropractic practice was governed by legislation or regulation in 26 (28.9%) countries and the professional title protected by legislation in 39 (43.3%). In 43 (47.8%) countries, chiropractors were permitted to own, operate, or prescribe x-rays, in 22 (24.4%) countries they were lawfully permitted to prescribe advanced imaging (MRI or CT), and in 34 (38.8%) countries owning, operating or prescribing diagnostic ultrasound was permitted. Full or limited rights to the prescription of pharmaceutical medication were permitted in 9 (10%) countries, and authorization of sick leave was permitted in 20 (22.2%) countries. The care of children was subject to specific regulations and/or statutory restrictions in 57 (63.3%) countries.

The authors concluded as follows: We have provided information about the global chiropractic workforce. The profession is represented in 90 countries, but the distribution of chiropractors and chiropractic educational institutions, and governing legislations and regulations largely favour high-income countries. There is a large under-representation in low- and middle-income countries in terms of provision of services, education and legislative and regulatory frameworks, and the available data from these countries are limited.

The countries where chiropractic is explicitly illegal are the following:

  • Egypt
  • Argentina
  • Columbia
  • Austria,
  • Estonia,
  • Greece,
  • Hungary,
  • Lebanon,
  • Republic of Korea,
  • Taiwan,
  • Turkey.
  • Ukraine.

Forty-two countries (61.8%) have regulations and/or rules under the legislation to provide for registration or licensure of chiropractors. Chiropractors may be available in 90 countries, but 50% percent of these have 10 or fewer chiropractors. Importantly, the care of children is under regulation or restrictions in most countries.

In comparison to similar professions such as physiotherapy, the chiropractic total workforce is small (worldwide 103,469). The World Confederation of Physical Therapy reports an estimated number of 450,000 physical therapists worldwide with the number of physio therapists per capita per 100,000 ranging from 0.19 in Malawi to 282 in Finland.
This survey holds plenty of interesting information. Here is what I found most remarkable:
  • The World Federation of Chiropractic takes 3 years to publish data which, by then, are of course out-dated.
  • In most countries, the chiropractic care for children is restricted.
  • In many countries chiropractic is illegal.
  • In many countries, there are only very few or no chiropractors at all.
  • There are about 4 times more physiotherapists than chiropractors.
  • In 9 countries, chiropractors have the right to prescribe medicines.

Much of the data revealed in this survey suggests to me that the world can do without chiropractors.

The NHS England has stopped paying for homeopathy in 2017. France has just announced to do likewise. What about Germany, the homeland of homeopathy?  

In Germany there are about 150,000 doctors, and around 7,000 specialize in homeopathy. Multiple surveys confirm that Germans do like their SCAMs, particularly homeopathy. Two examples:

  • A 2016 cross-sectional analysis conducted among all patients being referred to the Department of Internal and Integrative Medicine at Essen, Germany, over a 3-year period showed that 35% of the 2,045 respondents reported having used homeopathy for their primary medical complaint.  359 (50.2%) patients reported benefits and 15 (2.1%) reported harm.
  • More recently, a questionnaire survey concerning current and lifetime use of SCAM was distributed to German adults with autism spectrum disorder (ASD). The results suggested that 45% of the respondents were currently using or had used at least one SCAM modality in their life. Homeopathy and acupuncture were most frequently used SCAMs, followed by mind-body interventions.

But since a few years, the German opposition to homeopathy has become much more active. In particular the INH, the GWUP, and the Muensteraner Kreis have been instrumental in informing the public about the uselessness and dangers of homeopathy. The press has now taken up this message and, as this article explains, now the debate about homeopathy has finally reached the political level.

The head of the main doctors’ association and the SPD’s health specialist have called for an end to refunds for homeopathy treatments in Germany. The head of the National Association of Statutory Health Insurance Physicians (KBV), which represents 150,000 doctors and psychotherapists in Germany, recently urged health insurance companies to stop funding homeopathic services. “There is insufficient scientific evidence for the efficacy of homeopathic procedures,” Andreas Gassen told the Rheinische Post. “If people want homeopathic remedies, they should have them — but not at the expense of the community.

Gassen’s comments follow those of the Social Democrat (SPD) health issues specialist and lawmaker Karl Lauterbach who has pressed for a law banning refunds for homeopathy. “We have to talk about it in GroKo,” Lauterbach said earlier this month, suggesting a discussion in the government grand coalition. He said the benefits paid for by insurers should be medically and economically sensible. He has the support of the Federal Joint Committee which decides on what is covered by payments from the statutory health funds.

So, what is going to happen?

As I have written previously, one can only be sure of this:

  • The German homeopathy lobby will not easily give up; after all, they have half a billion Euros per year to lose.
  • They will not argue on the basis of science or evidence, because they know that neither are in their favour.
  • They will fight dirty and try to defame everyone who stands in their way.
  • They will use their political influence and their considerable financial power.

AND YET THEY WILL LOSE!

Not because we are so well organised or have great resources – in fact, as far as I can see, we have none – but because, in medicine, the evidence is invincible and will eventually prevail. Progress might be delayed, but it cannot be halted by those who cling to an obsolete dogma.

 

 

It is not that long ago that I published a post entitled HOMEOPATHY IN FRANCE: A TRIUMPH OF PROFIT OVER REASON. Today, I am pleased to post one with the reverse title.

It has taken a few years (compared to the UK where it has taken a few decades, it was nevertheless fast), but now it is done. Very briefly, this is what happened:

  • In 2014, our book was published in French. I might be fooling myself, but I do hope that it helped starting a ball rolling in France where, up to then, homeopathy had enjoyed a free ride.
  • Subsequently, French sceptics began raising their voices against quackery in general and homeopathy in particular.
  • In 2018, they got organised and 124 doctors published an open letter criticising the use of alternative medicine as dangerous practised by charlatans of all kinds.
  • In the same year, the Collège National des Généralistes Engseignants, the national association for teaching doctors, pointed out that there was no rational justification for the reimbursement of homeopathics nor for the teaching of homeopathy in medical schools stating that It is necessary to abandon these esoteric methods, which belong in the history books.
  • Also in 2018, the University of Lille announced its decision to stop its course on homeopathy. The faculty of medicine’s dean, Didier Gosset, said: It has to be said that we teach medicine based on proof – we insist on absolute scientific rigour – and it has to be said that homeopathy has not evolved in the same direction, that it is a doctrine that has remained on the margins of the scientific movement, that studies on homeopathy are rare, that they are not very substantial. Continuing to teach it would be to endorse it.
  • In 2019, the French Academies of Medicine and Pharmacy have published a document entitled ‘L’homéopathie en France : position de l’Académie nationale de médecine et de l’Académie nationale de pharmacie’. It stated that L’homéopathie a été introduite à la fin du XVIIIe siècle, par Samuel Hahnemann, postulant deux hypothèses : celle des similitudes (soigner le mal par le mal) et celle des hautes dilutions. L’état des données scientifiques ne permet de vérifier à ce jour aucune de ces hypothèses. Les méta-analyses rigoureuses n’ont pas permis de démontrer une efficacité des préparations homéopathiques. The academies concluded that no French university should offer degrees in homeopathy, and that homeopathy should no longer be funded by the public purse: “no homeopathic preparation should be reimbursed by Assurance Maladie [France’s health insurance] until the demonstration of sufficient medical benefit has been provided. No university degree in homeopathy should be issued by medical or pharmaceutical faculties … The reimbursing of these products by the social security seems aberrant at a time when, for economic reasons, we are not reimbursing many classic medicines because they are more or less considered to not work well enough …”
  • Only weeks later, the French health regulator (HAS) has recommended with a very large majority (only one vote against) for the discontinuation of the reimbursement of homeopathic products.
  • The health minister, Agnès Buzyn, announced “Je me tiendrai à l’avis de la Haute Autorité de santé”.
  • Consequently, the powerful French homeopathy lobby created political pressure in multiple ways, including a petition with over 1000000 signatures and the last minute press-release below.

It is important, I think, to use this occasion for considering the main arguments of the homeopathy lobby in their defence of homeopathy.

  1. Homeopathy is effective. This argument is demonstrably false and can only be made, if one abuses the published evidence. One way to demonstrate this is to look at the official verdicts from around the globe.
  2. Homeopathy may only be a placebo, but it prevents patients taking dangerous drugs instead. This argument is tricky but wrong. If patients are ill, they need an effective therapy and not homeopathy. If they are not ill, they need reassurance and not a placebo. We need to educate the public and doctors to understand this simple message rather than pulling wool over their eyes.
  3. Discontinuing homeopathy is an undesirable curtailment of our freedom of choice. This is a pseudo-argument, because nobody forbids anyone using homeopathy. All we advocate is that the public purse should only pay for effective treatments. Any other strategy means that we jeopardise funds for effective therapies.
  4. Homeopathy employs over 1000 workers, and any cut in reimbursement would jeopardise these jobs. This argument is also tricky (and it is probably the one that created a headache for politicians). It is, however, spurious. Firstly, job preservation is only a good thing, if the jobs in question are worth preserving. If they serve no good service to the public, they are probably not worth preserving. (We don’t need to all start smoking, for instance, in order to preserve the jobs in the tobacco industry.) Secondly, the argument contradicts the other arguments of the homeopathy lobby. If homeopathy were effective and helpful, people would carry on buying homeopathics regardless of any cut in reimbursement. Thirdly, I suspect the figure of > 1000 will turn out to be hugely exaggerated. Fourthly, arguments of this kind are deeply regressive; they have historically stood in the way of progress whenever an innovation was inescapable (think of the industrial revolution, for instance), and they have never succeeded.

To contemplate these arguments carefully is important, I feel, because this will help other rational thinkers to fight for progress, optimal healthcare and good science. There is still plenty of quackery out there. So, let’s celebrate the French triumph (à votre santé, Agnès Buzyn!!!) – and then roll up our sleeves and get cracking!

A few days ago, I reported that the German homeopathy manufacturer Hevert has taken legal action against German critics of homeopathy. This caused a storm of protests on twitter, in the press and even on TV. Hevert has remained silent in all this, but now a spokesperson and part owner of the firm, Mr Mathias Hevert, has given an interview to ‘Pharma Relations’ in an attempt to explain and justify Hevert’s position.

The interview does not tell us much, except for one particular passage:

Frau Grams hat sich meines Wissens nach gar nicht konkret auf die Produkte der Firma Hevert bezogen. Warum fühlten Sie sich dennoch aufgerufen, sozusagen stellvertretend für die Branche juristische Schritte einzuleiten?

Da homöopathische Arzneimittel neben pflanzlichen und schulmedizinischen Präparaten einen wichtigen Teil des breiten Hevert-Sortiments darstellen, fühlen wir uns bereits seit der Firmengründung 1956 eng mit der durch Pastor Emanuel Felke begründeten Komplexmittel-Homöopathie verbunden. Seit Monaten beobachten wir, wie die Homöopathie von Meinungsbildnern in den Sozialen Medien, der Presse und dem Fernsehen undifferenziert und ohne wissenschaftliche Grundlage denunziert wird. In Großbritannien wurden bereits einflussreiche Lobbygruppen aktiv, um die Homöopathie als Ganzes und ohne differenzierte Betrachtung der Datenlage zu verunglimpfen. Mit ihren Bemühungen schafften sie es sogar, die Politik zu gesetzlichen Einschränkungen des Feldes zu drängen. Um ähnliches in Deutschland – dem Mutterland der Homöopathie – zu verhindern, geht Hevert entschlossen gegen ungerechtfertigte und nicht fundierte Diskreditierungen der Homöopathie durch Lobbygruppen und andere Meinungsbildner vor.

Here is my translation of the bit that concerns me:

Q: Frau Grams has, as far as I know, not even concretely referred to the products of Hevert. Why do you still feel compelled to start legal procedures, so to speak for the sector?

A: … We observe since months how homeopathy is being denounced in an undifferentiated manner and without a scientific basis by opinion leaders in social media, the press, an on TV. In England, influential lobby groups have been active to denigrate homeopathy as a whole and without differentiated consideration of the data. Through their efforts, they have even managed to force politicians to implement legal restrictions in this area…

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I must admit, I find this response quite extraordinary!

I am not aware of anyone or any group in England denigrating homeopathy without differentiated consideration of the data. All we did was to point out what the best available evidence tells us, exercise our critical thinking abilities, and report facts. And I do strongly object anyone claiming otherwise. In fact, I ask myself whether the above remarks by a representative of a manufacturer of homeopathics are not libellous and thus actionable.

What do you think?

PS

But perhaps I have misunderstood something; in this case, could Mr Hevert please name the UK critics he had in mind when he made these comments?

This press-release caught my attention:

Following the publication in Australia earlier this year of a video showing a chiropractor treating a baby, the Health Minster for the state of Victoria called for the prohibition of chiropractic spinal manipulation for children under the age of 12 years. As a result, an independent panel has been appointed by Safer Care Victoria to examine the evidence and provide recommendations for the chiropractic care of children.

The role of the panel is to (a) examine and assess the available evidence, including information from consumers, providers, and other stakeholders, for the use of spinal manipulation by chiropractors on children less than 12 years of age and (b) provide recommendations regarding this practice to the Victorian Minister for Health.
Members of the public and key stakeholders, including the WFC’s member for Australia, the Australia Chiropractors Association (AusCA), were invited to submit observations. The AusCA’s submission can be read here

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This submission turns out to be lengthy and full of irrelevant platitudes, repetitions and nonsense. In fact, it is hard to find in it any definitive statements at all. Here are two sections (both in bold print) which I found noteworthy:

1. There is no need to restrict parental or patient choice for chiropractic care for children under 12 years of age as there is no evidence of harm. There is however, expressed outcome of benefit by parents70 who actively choose chiropractic care for their children … 

No evidence of harm? Really! This is an outright lie. Firstly, one has to stress that there is no monitoring system and that therefore we simply do not learn about adverse effects. Secondly, there is no reason to assume that the adverse effects that have been reported in adults are not also relevant for children. Thirdly, adverse effects in children have been reported; see for instance here. Fourthly, we need to be aware of the fact that any ineffective therapy causes harm by preventing effective therapies from being applied. And fifthly, we need to remember that some chiropractors harm children by advising their parents against vaccination.

2. Three recent systematic reviews have focused on the effectiveness of manual therapy for paediatric conditions. For example, Lanaro et al. assessed osteopathic manipulative treatment for use on preterm infants. This systematic review looked at five clinical trials and found a reduction of length of stay and costs in a large population of preterm infants with no adverse events (96).

Carnes et al.’s 2018 systematic review focused on unsettled, distressed and excessively crying infants following any type of manual therapy. Of the seven clinical trials included, five involved chiropractic manipulative therapy; however, meta-analyses of outcomes were not possible due to the heterogeneity of the clinical trials. The review also analysed an additional 12 observational studies: seven case series, three cohort studies, one service evaluation survey, and one qualitative study. Overall, the systematic review concluded that small benefits were found. Additionally, the reporting of adverse events was low. Interestingly, when a relative risk analysis was done, those who had manual therapy were found to have an 88% reduced risk of having an adverse event compared to those who did not have manual therapy (97).

A third systematic review by Parnell Prevost et al. in 2019 evaluated the effectiveness of any paediatric condition following manual therapy of any type and summarizes the findings of studies of children 18 years of age or younger, as well as all adverse event information. While mostly inconclusive data were found due to lack of high-quality studies, of the 32 clinical trials and 18 observational studies included, favourable outcomes were found for all age groups, including improvements in suboptimal breastfeeding and musculoskeletal conditions. Adverse events were mentioned in only 24 of the included studies with no serious adverse events reported in them (98).

(96) Lanaro D, Ruffini N, Manzotti A, Lista G. Osteopathic manipulative treatment showed reduction of length of stay and costs in preterm infants: A systematic review and meta-analysis. Medicine (Baltimore). 2017; 96(12):e6408 10.1097/MD.0000000000006408.

(97) Carnes D, Plunkett A, Ellwood J, Miles C. Manual therapy for unsettled, distressed and excessively crying infants: a systematic review and meta-analyses. BMJ Open 2018;8:e019040. doi:10.1136/bmjopen-2017-019040.

(98) Parnell Prevost et al. 2019.

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And here are my comments:

(96) Lanaro et al is about osteopathy, not chiropractic (4 of the 5 primary trials were by the same research group).

(97) The review by Carnes et al has been discussed previously on this blog. This is what I wrote about it at the time:

The authors concluded that some small benefits were found, but whether these are meaningful to parents remains unclear as does the mechanisms of action. Manual therapy appears relatively safe.

For several reasons, I find this review, although technically sound, quite odd.

Why review uncontrolled data when RCTs are available?

How can a qualitative study be rated as high quality for assessing the effectiveness of a therapy?

How can the authors categorically conclude that there were benefits when there were only 4 RCTs of high quality?

Why do they not explain the implications of none of the RCTs being placebo-controlled?

How can anyone pool the results of all types of manual therapies which, as most of us know, are highly diverse?

How can the authors conclude about the safety of manual therapies when most trials failed to report on this issue?

Why do they not point out that this is unethical?

My greatest general concern about this review is the overt lack of critical input. A systematic review is not a means of promoting an intervention but of critically assessing its value. This void of critical thinking is palpable throughout the paper. In the discussion section, for instance, the authors state that “previous systematic reviews from 2012 and 2014 concluded there was favourable but inconclusive and weak evidence for manual therapy for infantile colic. They mention two reviews to back up this claim. They conveniently forget my own review of 2009 (the first on this subject). Why? Perhaps because it did not fit their preconceived ideas? Here is my abstract:

Some chiropractors claim that spinal manipulation is an effective treatment for infant colic. This systematic review was aimed at evaluating the evidence for this claim. Four databases were searched and three randomised clinical trials met all the inclusion criteria. The totality of this evidence fails to demonstrate the effectiveness of this treatment. It is concluded that the above claim is not based on convincing data from rigorous clinical trials.

Towards the end of their paper, the authors state that “this was a comprehensive and rigorously conducted review…” I beg to differ; it turned out to be uncritical and biased, in my view. And at the very end of the article, we learn a possible reason for this phenomenon: “CM had financial support from the National Council for Osteopathic Research from crowd-funded donations.”

(98) Parnell et al was easy to find despite the incomplete reference in the submission. This paper has also been discussed previously. Here is my post on it:

This systematic review is an attempt [at] … evaluating the use of manual therapy for clinical conditions in the paediatric population, assessing the methodological quality of the studies found, and synthesizing findings based on health condition.

Of the 3563 articles identified through various literature searches, 165 full articles were screened, and 50 studies (32 RCTs and 18 observational studies) met the inclusion criteria. Only 18 studies were judged to be of high quality. Conditions evaluated were:

      • attention deficit hyperactivity disorder (ADHD),
      • autism,
      • asthma,
      • cerebral palsy,
      • clubfoot,
      • constipation,
      • cranial asymmetry,
      • cuboid syndrome,
      • headache,
      • infantile colic,
      • low back pain,
      • obstructive apnoea,
      • otitis media,
      • paediatric dysfunctional voiding,
      • paediatric nocturnal enuresis,
      • postural asymmetry,
      • preterm infants,
      • pulled elbow,
      • suboptimal infant breastfeeding,
      • scoliosis,
      • suboptimal infant breastfeeding,
      • temporomandibular dysfunction,
      • torticollis,
      • upper cervical dysfunction.

Musculoskeletal conditions, including low back pain and headache, were evaluated in seven studies. Only 20 studies reported adverse events.

The authors concluded that fifty studies investigated the clinical effects of manual therapies for a wide variety of pediatric conditions. Moderate-positive overall assessment was found for 3 conditions: low back pain, pulled elbow, and premature infants. Inconclusive unfavorable outcomes were found for 2 conditions: scoliosis (OMT) and torticollis (MT). All other condition’s overall assessments were either inconclusive favorable or unclear. Adverse events were uncommonly reported. More robust clinical trials in this area of healthcare are needed.

There are many things that I find remarkable about this review:

      • The list of indications for which studies have been published confirms the notion that manual therapists – especially chiropractors – regard their approach as a panacea.
      • A systematic review evaluating the effectiveness of a therapy that includes observational studies without a control group is, in my view, highly suspect.
      • Many of the RCTs included in the review are meaningless; for instance, if a trial compares the effectiveness of two different manual therapies none of which has been shown to work, it cannot generate a meaningful result.
      • Again, we find that the majority of trialists fail to report adverse effects. This is unethical to a degree that I lose faith in such studies altogether.
      • Only three conditions are, according to the authors, based on evidence. This is hardly enough to sustain an entire speciality of paediatric chiropractors.

Allow me to have a closer look at these three conditions.

      1. Low back pain: the verdict ‘moderate positive’ is based on two RCTs and two observational studies. The latter are irrelevant for evaluating the effectiveness of a therapy. One of the two RCTs should have been excluded because the age of the patients exceeded the age range named by the authors as an inclusion criterion. This leaves us with one single ‘medium quality’ RCT that included a mere 35 patients. In my view, it would be foolish to base a positive verdict on such evidence.
      2. Pulled elbow: here the verdict is based on one RCT that compared two different approaches of unknown value. In my view, it would be foolish to base a positive verdict on such evidence.
      3. Preterm: Here we have 4 RCTs; one was a mere pilot study of craniosacral therapy following the infamous A+B vs B design. The other three RCTs were all from the same Italian research group; their findings have never been independently replicated. In my view, it would be foolish to base a positive verdict on such evidence.

So, what can be concluded from this?

I would say that there is no good evidence for chiropractic, osteopathic or other manual treatments for children suffering from any condition.

_________________________________________________________________

The ACA’s submission ends with the following conclusion:

The Australian Chiropractors Association (ACA) intent is to improve the general health of all Australians and the ACA supports the following attributes to achieve this:

      • The highest standards of ethics and conduct in all areas of research, education and practise
      • Chiropractors as the leaders in high quality spinal health and wellbeing
      • A commitment to evidence-based practice – the integration of best available research evidence, clinical expertise and patient values
      • The profound significance and value of patient-centred chiropractic care in healthcare in Australia.
      • Inclusiveness and collaborative relationships within and outside the chiropractic profession…

After reading through the entire, tedious document, I arrived at the conclusion that

THIS SUBMISSION CAN ONLY BE A CALL FOR THE PROHIBITION OF CHIROPRACTIC SPINAL MANIPULATION FOR CHILDREN.

I am sure this press-release of today will be of interest:

Good Thinking, a charity which aims to promote science and challenge pseudoscience, is bringing the action after the PSA acknowledged that multiple members of the Society of Homeopaths continue to offer CEASE therapy – a purported treatment for autism which is targeted particularly at children and which relies on the false notion that autism is caused by vaccination, and can be cured with homeopathic treatments, high-dosage Vitamin C, and dietary restriction.

The PSA has acknowledged that CEASE therapy is potentially harmful and conflicts with the advice of the NHS in several respects, including with regard to the childhood vaccinations for potentially life-threatening conditions. Nevertheless, the PSA decided on April 1st to approve the Society of Homeopaths’ accreditation for a further year.

Michael Marshall, Project Director of Good Thinking, said: “By being part of the PSA’s Accredited Voluntary Register scheme, the Society of Homeopaths and its members – including those who practice CEASE therapy – can point to the PSA’s logo on their websites and marketing materials as a sign that they are competent, trustworthy and safe. But that badge, and the credibility and legitimacy it confers, only carries any meaning if the PSA takes seriously their duty to protect the public from harmful practices.

“For the PSA to acknowledge that members of the Society of Homeopaths are offering a treatment that the PSA themselves recognise as harmful, and which is targeted at a particularly vulnerable group, and to then reaccredit them all the same makes a mockery of the PSA’s whole accreditation scheme. For PSA accreditation to mean anything at all, the public needs to be confident that when the PSA identify potentially harmful therapies, they take the necessary steps to protect the public, rather than accepting it and, effectively, endorsing it”.

The Society of Homeopaths has been part of the PSA’s Accredited Voluntary Register scheme since 2014. The PSA’s decision to accredit the Society of Homeopaths and its subsequent decisions to re-accredit have been the subject of criticism from both autism rights campaigners and those who support evidence-based medicine.

Marshall said: “The PSA encourage members of the public to choose healthcare practitioners which belong to one of its accredited registers, and even have a tool on their site to find accredited practitioners. That advice is fundamentally undermined by the fact that a patient could, via the PSA’s list of accredited practitioners, find themselves consulting with a homeopath who discourages vaccination and believes they can cure children of autism.”

Good Thinking’s action has drawn support from autism campaigners, such as Emma Dalmayne: “We as autistic people, are bombarded with the discriminatory rhetoric that we are in need of a cure. CEASE is not a cure for our neurological difference, and it is proven to be extremely harmful. The PSA should not endorse the Society of Homeopaths while their members offer this harmful therapy. The Society of

Homeopaths are at present allowing their members to mislead the public, which in turn puts vulnerable autistic children in harm’s way.”

If Good Thinking’s Judicial Review is successful, the PSA will likely be required to revisit their decision to reaccredit the Society of Homeopaths, this time paying proper regard to the need to protect the public and in particular autistic children who are the main targets for CEASE therapy.

As a small charity, Good Thinking have appealed for support in funding their Judicial Review, and are urging supporters to contribute to their crowdfunding campaign, at crowdjustice.com/case/gts-cease-psa/.

Additional Quotes:

· Simon Singh, Science Writer and Chair of Good Thinking: “Only this week we saw Prince Charles become a patron of the Faculty of Homeopathy. We have become accustomed to Prince Charles endorsing dangerous quackery, but we expect more of the PSA. The credibility of the PSA is at stake when it allows the Society of Homeopaths to retain accredited status despite their members offering this clearly harmful therapy.”

· Laura Thomason, Project Manager, Good Thinking: “Since 2017 we have raised concerns with the PSA about Society of Homeopaths members practicing CEASE therapy, and how we felt the actions they took to protect the public were wholly inadequate. We were therefore shocked and dismayed to see the PSA reaccredit the Society of Homeopaths, and believe their decision to do so, in the absence of any real sign from the Society that they are taking the protection of autistic children seriously, to be unlawful.”

· Professor Edzard Ernst: “According to the ‘like cures like’ principle of homeopathy, Dr Tinus Smits, the Dutch homeopath who invented CEASE, claimed that autism must be cured by applying homeopathic doses of the substances which allegedly caused the condition. CEASE therapists thus ‘detoxify’ all assumed causative factors – vaccines, regular medication, environmental toxic exposures, effects of illness, etc. – with homeopathically prepared substances that were administered prior to the onset of autism. The assumptions of CEASE therapy fly in the face of science. There is also no clinical evidence that CEASE therapy is effective in curing autism or alleviating its symptoms. By misleading desperate parents that CEASE therapy works, homeopaths can do untold harm.”

I have reported about the French activities against homeopathy before (see here and here). Yesterday, this article brought considerable more clarity into the situation. Here is my (not entirely literal) translation and below the French original:

Unsurprisingly, the French health regulator (HAS) has voted on Wednesday with a very large majority (only one vote against) for the discontinuation of the reimbursement of homeopathic products. This decision, which is not denied by the health ministry, will be officially announced this Friday morning by the president of the authority, Prof Dominique Le Guludec, during a press conference. Then it will be up to the health minister, Agnès Buzyn, to decide or not on the discontinuation of reimbursement.

I will follow the advice of the health authority‘ the health minister declared only recently. This advice is the direct consequence of a first meeting of the commission which took place in Mid May and gave an opinion that already went into that direction. The laboratories concerned had the right to be heard and to present their view. Obviously this was not convincing.

______________________________________________________________

Sans surprise, la Commission de la transparence de la Haute autorité de santé a voté ce mercredi à la très grande majorité (une seule voix contre) le déremboursement des produits homéopathiques. Cette décision, que ne dément pas le ministère de la Santé, sera annoncée officiellement vendredi matin par la présidente de la Haute Autorité de santé, la professeur Dominique Le Guludec, au cours d’une conférence de presse. A charge ensuite à la ministre de la Santé, Agnès Buzyn, de décider ou non ce déremboursement.

«Je me tiendrai à l’avis de la Haute Autorité de santé», a encore récemment déclarée la ministre. Cet avis est la conséquence directe d’une première réunion, qui s’est tenue à la mi mai, de la dite Commission, qui avait alors rendu un avis transitoire, allant clairement dans ce sens. Comme le stipule le processus, les laboratoires concernées avaient le droit d’être entendus et de se défendre. Manifestement, ces derniers n’ont pas convaincus.

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