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

Monthly Archives: November 2019

The Telegraph published an article entitled ‘Crack or quack: what is the truth about chiropractic treatment?’ and is motivated by the story of Mr Lawler, the 80-year-old former bank manager who died after a chiropractic therapy. Here are 10 short quotes from this article which, in the context of this blog and the previous discussions on the Lawler case, are worthy further comment:

1. … [chiropractic] was established in the late 19th century by D.D. Palmer, an American magnetic healer.
“A lot of people don’t realise it’s a form of alternative medicine with some pretty strange beliefs at heart,” says Michael Marshall, project director at the ‘anti-quack’ charity the Good Thinking Society. “Palmer came to believe he was able to cure deafness through the spine, by adjusting it. The theory behind chiropractic is that all disease and ill health is caused by blockages in the flow of energy through the spine, and by adjusting the spine with these grotesque popping sounds, you can remove blockages, allowing the innate energy to flow freely.” Marshall says this doesn’t really chime with much of what we know about human biology…“There is no reason to believe there’s any possible benefit from twisting vertebra. There is no connection between the spine and conditions such as deafness and measles.”…

Michael Marshall is right, chiropractic was built on sand by Palmer who was little more than a charlatan. The problem with this fact is that today’s chiros have utterly failed to leave Palmer’s heritage behind.

2. According to the British Chiropractic Association (BCA), the industry body, “chiropractors are well placed to deliver high quality evidence-based care for back and neck pain.” …

They would say so, wouldn’t they? The BCA has a long history of problems with knowing what high quality evidence-based care is.

3. But it [chiropractic] isn’t always harmless – as with almost any medical treatment, there are possible side effects. The NHS lists these as aches and pains, stiffness, and tiredness; and then mentions the “risk of more serious problems, such as stroke”….

Considering that 50% of patients suffer adverse effects after chiropractic spinal manipulations, this seems somewhat of an understatement.

4. According to one systematic review, spinal manipulation, “particularly when performed on the upper body, is frequently associated with mild to moderate adverse effects. It can also result in serious complications such as vertebral artery dissection followed by stroke.” …

Arterial dissection followed by a stroke probably is the most frequent serious complication. But there are many other risks, as the tragic case of Mr Lawler demonstrates. He had his neck broken by the chiropractor which resulted in paraplegia and death.

5. “There have been virtually hundreds of published cases where neck manipulations have led to vascular accidents, stroke and sometimes death,” says Prof Ernst. “As there is no monitoring system, this is merely the tip of a much bigger iceberg. According to our own UK survey, under-reporting is close to 100 per cent.” …

The call for an effective monitoring system has been loud and clear since many years. It is nothing short of a scandal that chiros have managed to resist it against the best interest of their patients and society at large.

6. Chiropractors are regulated by the General Chiropractic Council (GCC). Marshall says the Good Thinking Society has looked into claims made on chiropractors’ websites, and found that 82 per cent are not compliant with advertising law, for example by saying they can treat colic or by using the misleading term ‘doctor’…

Yes, and that is yet another scandal. It shows how serious chiropractors are about the ‘evidence-based care’ mentioned above.

7. According to GCC guidelines, “if you use the courtesy title ‘doctor’ you must make it clear within the text of any information you put into the public domain that you are not a registered medical practitioner but that you are a ‘Doctor of Chiropractic’.”…

True, and the fact that many chiropractors continue to ignore this demand presenting themselves as doctors and thus misleading the public is the third scandal, in my view.

8. A spokesperson for the BCA said “Chiropractic is a registered primary healthcare profession and a safe form of treatment. In the UK, chiropractors are regulated by law and required to adhere to strict codes of practice, in exactly the same ways as dentists and doctors. Chiropractors are trained to diagnose, treat, manage and prevent disorders of the musculoskeletal system, specialising in neck and back pain.”…

Chiropractors also like to confuse the public by claiming they are primary care physicians. If we understand this term as describing a clinician who is a ‘specialist in Family Medicine, Internal Medicine or Paediatrics who provides definitive care to the undifferentiated patient at the point of first contact, and takes continuing responsibility for providing the patient’s comprehensive care’, we realise that chiropractors fail to fulfil these criteria. The fact that they nevertheless try to mislead the public by calling themselves ‘primary healthcare professionals’ and ‘doctors’ is yet another scandal, in my opinion.

9. The spokesperson said, “medication, routine imaging and invasive surgeries are all commonly used to manage low back pain, despite limited evidence that these methods are effective treatments. Therefore, ensuring there are other options available for patients is paramount.”…

Here the spokesperson misrepresents mainstream medicine to make chiropractic look good. He should know that imaging is used also by chiros for diagnosing back problems (but not for managing them). And he must know that surgery is never used for the type of non-specific back pain that chiros tend to treat. Finally, he should know that exercise is a cheap, safe and effective therapy which is the main conventional option to treat and prevent back pain.

10. According to the European Chiropractors’ Union, “serious harm from chiropractic treatment is extremely rare.”

How do they know, if there is no system to capture cases of adverse effects?

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So, what needs to be done? How can we make progress? I think the following five steps would be a good start in the interest of public health:

  1.  Establish an effective monitoring system for adverse effects that is accessible to the public.
  2. Make sure all chiros are sufficiently well trained to know about the contra-indications of spinal manipulation, including those that apply to elderly patients and infants.
  3. Change the GCC from a body defending chiros and their interests to one regulating, controlling and, if necessary, reprimanding chiros.
  4. Make written informed consent compulsory for neck manipulations, and make sure it contains the information that neck manipulations can result in serious harm and are of doubtful efficacy.
  5. Prevent chiros from making therapeutic claims that are not based on sound evidence.

If these measures had been in place, Mr Lawler might still be alive today.

 

On 11/11/2019, the York Press reported from coroner’s inquest regarding a chiropractor who allegedly killed a patient. John Lawler suffered a broken neck while being treated by a chiropractor for an aching leg, an inquest has been told. His widow told how her husband was on the treatment table when things started to go wrong. She said he started shouting at chiropractor Dr Arleen Scholten: “You are hurting me. You are hurting me.” Then he began moaning and then said: “I can’t feel my arms.”

Mrs Lawler said Scholten tried to turn him over and then manoeuvred him into a chair next to the treatment table but he had become unresponsive. “He was like a rag doll,” she said. “His lips looked a little bit blue but I knew he was breathing. “I said ‘Has he had a stroke?’ She put his head back and said ‘no, his features are symmetrical’.

When the paramedics arrived, they treated Mr Lawler and to hospital. He had an MRI scan and a doctor told Mrs Lawler that he had suffered a broken neck. She was then informed that her husband was a paraplegic and he could undergo a 14 hour operation which would be traumatic but even before that could happen he “faded away” and died.

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There are, as far as I can see, four issues of interest here:

  1. It could be that Mr Lawler had osteoporosis; we will no doubt hear about this in the course of the inquest. If so, normal force could have led to the fracture, and the chiropractor would claim that she is not to blame for the fracture and the subsequent death of her patient. The question then would be whether she was under an obligation to check whether, in a man of Mr Lawler’s age, his bone density was normal or whether she could just assume that it was. In my view, any clinician applying a potentially harmful therapy has the obligation to make sure there are no contra-indications to it. If that all is so, the chiropractor might have been both negligent and reckless.
  2. Has neck manipulation been shown to be effective for any type of pain in the leg? That’s an easy one: No!
  3. Has the chiropractor obtained informed consent from her patient before commencing the treatment? The inquest will no doubt verify this. As many chiropractors fail to do it, I would not be too surprised if, in the present case, this was also not done. Should that be so, the chiropractor would have been negligent.
  4. One might be surprised to hear that the chiropractor manipulated the neck of a patient who consulted her not because of neck pain but because of a condition seemingly unrelated to the neck. This is an issue that comes up regularly and which is therefore importan; some people might be aware that it is dangerous to see a chiropractor when suffering from neck pain because he/she is bound to manipulate the neck. By contrast, most people would probably think it is ok to consult a chiropractor when suffering from lower back pain, because manipulations in that region is far less risky. The truth, however, is that chiropractors have been taught that the spine is one organ and one entity. Thus they tend to check for subluxations (or whatever name they give to the non-existing condition they all aim to treat) in every region of the spine. If they find one in the neck – and they usually do – they would ‘adjust’ it, meaning they would apply one or more high-velocity, low-amplitude thrusts and manipulate the neck. This could well be, I think, how the chiropractor in the case that is before the court at present came to manipulate the neck of her patient. And this might be how poor Mr Lawler lost his life.

Is there a lesson to be learnt from this tragic case?

Yes, I think there is: if you want to make sure that a chiropractor does not break your neck, don’t go and consult one – whatever your health problem happens to be.

 

 

“Maybe it is as simple as: I enjoyed that treatment, it was worth the amount I spent on it and I feel better.”

This argument between the fans and the critics of so-called alternative medicine (SCAM) might be the key to understanding the two opposing positions. It applies across the board to all the SCAMs that lack solid evidence (which, of course, is most).

  1. The sceptic asks for evidence of effectiveness and finds none that is convincing. He concludes that the SCAM is not evidence-based.
  2. The SCAM enthusiast cannot argue with the evident lack of evidence, but says (as Angela did in a recent comment): “Maybe it is as simple as: I enjoyed that treatment, it was worth the amount I spent on it and I feel better.”

Both positions may well be correct. And both are held with total conviction. Thus, many consumers who are not deeply into SCAM are confused or even bewildered.

So, how can we make sense of this situation?

Let me start with the argument of the SCAM enthusiast. She is, of course, right to sate that she enjoyed reflexology, or aromatherapy, or crystal therapy. She might also enjoy having her hair done, or soaking in a bath, or drinking a glass of champagne. There is nothing wrong with that, and we should all be happy for her.

Enjoying something is often good for you – often but not always. Enjoying a fag isn’t. Enjoying a bottle of whiskey per evening isn’t. Enjoying a drive at neck-breaking speed on a public motorway isn’t. Enjoying sending out hate-mail isn’t. But innocent treats like a foot massage by an aromatherapist probably is!

But none of these things can be considered to be a THERAPY. Feeling better is not necessarily a therapeutic aim.

So, the situation might not be so confusing after all: enjoyments are enjoyments. They are usually fine, and they are often very personal. Some people enjoy being massaged, others don’t. But enjoyments are not therapies. This means that all would be fine, if we stopped calling aromatherapy, reflexology, crystal therapy THERAPIES, and if we stopped calling aromatherapists, etc. THERAPISTS.

Therapies are medical interventions, and as such they need evidence to back them up, evidence that they do something positive to our health. Therapists are healthcare professionals who make therapeutic claims that need evidence to back them up. If that is missing, sceptics are entirely correct to criticise them. In fact, they fulfil a public service when criticising bogus therapies or claims.

So, the confusion mentioned above mainly arises from mislabelling enjoyments as therapies. Lets call aromatherapists, etc. by different names, and the confusion disappears. Let’s stop aromatherapists, etc. making therapeutic claims, and there is no more reason for sceptics to criticise.

When I worked as a junior doctor in a homeopathic hospital, this is what I was told in no uncertain terms: children are ideal patients of homeopathy, because they respond particularly well to it. Most books on the subject confirm this message. The reason for the assumption is as simple as it is simplistic: children are relatively unspoilt by conventional drugs that can hinder the effects of homeopathy.

Many years later, when we conducted one of our clinical trials of homeopathy, we opted for a study with children, because all homeopaths believe in this dogma. For the same reason, it made (homeopathic) sense for the paediatricians of my former medical school (LMU Munich) to run a homeopathic clinic for decades. Not just that, they also taught homeopathy to medical students.

In the course of doing this for such a long time, they did their research and, of course, gathered tons of experience. And what does this wisdom and insight collected over decades reveal? Does it confirm the dogma that kids are excellent homeopathy-responders? Or perhaps does it reject the notion?

The question has just been definitively answered by a (well-hidden) remark in an announcement from the university paediatrics department entitled Integrative Pädiatrie. The original text is below; for those who don’t read German, I will translate:

Our healthcare for children is devoted to a holistic approach which considers biological and psychosocial dimensions of health and disease.

We see positive potential in the use of music, art and humour. Methods from integrative medicine such as mind/body therapies or integrative movement therapy can have curative effects. These and other methods are also being tested in scientific studies.

Homeopathic remedies, however, are not being used in Hanauer’s Paediatric Hospital because, after 200 years of research, it has become clear that the basis of homeopathy is not in accordance with the modern concepts of the natural sciences.

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Unsere Medizin für kranke Kinder ist einer ganzheitlichen Sicht verpflichtet, die neben den biologischen auch psychosoziale Dimensionen von Gesundheit und Krankheit berücksichtigt.

Wir sehen das positive Potential durch den Einsatz von Musik, Kunst oder Humor.  Auch Methoden der “Integrativen Medizin”, wie zum Beispiel die “mind-body-Medizin” oder die Technik der integrativen Bewegungstherapie können eine heilende Wirkung haben. Diese und andere Methoden werden zum Teil auch in wissenschaftlichen Studien geprüft.

Homöopathische Arzneimittel kommen im Dr. von Haunerschen Kinderspital hingegen nicht zum Einsatz, da sich nach über 200 Jahren wissenschaftlicher Forschung klar herausgestellt hat, dass ihre Grundlagen nicht mit dem modernen Verständnis der Naturwissenschaft in Einklang zu bringen sind.

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Let’s be clear what exactly the last paragraph means:

  • This institution has bee open to homeopathy for a very long time.
  • They treated children homeopathically.
  • They conducted research in homeopathy.
  • They taught homeopathy to medical students.
  • Eventually, they could no longer ignore what was before their eyes.
  • They stopped using homeopathy.
  • And they discontinued their course of homeopathy.

Why?

Because highly diluted homeopathic remedies are pure placebos – and that is true for children, adults and even animals.

The Sueddeutsche Zeitung reported yesterday that the Bavarian government has given the go-ahead to a major study of homeopathy, and Die Zeit published a similar article. For those who read German, I append the text from the SZ below. For those who don’t, let me give a short summary.

The study is aimed at clarifying whether the use of homeopathic remedies can reduce the use of antibiotics in humans and animals. The vote was carried because of the CDU delegates being in favour. The debate of the project was, however, controversial. Critics stressed that, at best, the study is superfluous and pointed out that the project is negligent because it implies that homeopathics might be effective, whereas the evidence shows the opposite. A SPD delegate stated that he is ‘open moth’, homeopathy works because of the doctor-patient contact and not because of its remedies which are pure placebos.

The project was tabled because some people had worried about antibiotic resistance and felt that homeopathy might be an answer. Some CSU delegates stated that in ENT medicine, there is evidence that homeopathics can reduce the use of antibiotics. Even in cases of severe sepsis, there was good evidence, they claimed.

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Mit einer medizinischen Studie soll die Staatsregierung klären, ob durch homöopathische Mittel der Einsatz von Antibiotika reduziert werden kann. Dies hat der Landtag am Donnerstag mit den Stimmen der Regierungsfraktionen von CSU und Freien Wählern beschlossen. Bei der namentlichen Abstimmung votierten 120 Abgeordnete für den Antrag und damit acht mehr, als die Koalition selbst stellt. Im Plenum löste der Antrag, der im Zusammenhang mit weiteren Maßnahmen gegen sogenannte multiresistente Keime besprochen wurde, teils kontroverse Debatten aus. Kritiker der Homöopathie betonten, dass die Studie bestenfalls überflüssig sei.

“Das Vorhaben der bayerischen Staatsregierung ist fahrlässig, weil es bereits mit der Fragestellung suggeriert, dass homöopathische Mittel wie Globuli multiresistente Keime bekämpfen könnten”, sagte Dominik Spitzer (FDP). Bisher habe keine wissenschaftliche Studie beweisen können, dass homöopathische Mittel allein gegen Beschwerden wirkten.

Auch die SPD-Abgeordnete Ruth Waldmann hatte bereits vor der Debatte zum Ansinnen der CSU gesagt: “Da bleibt einem der Mund offen stehen.” Wenn an Homöopathie “wirklich nachweislich etwas wirkt, dann ist es der Anteil der sprechenden Medizin, der ganzheitliche Blick auf die Patienten”. Das tue vielen Menschen gut. “Und da bin ich auch dafür, das den Leuten zu lassen”, betonte Waldmann. “Aber bei schwerer Sepsis auch nur daran zu denken, diese Kügelchen womöglich anstelle von Antibiotika zu verabreichen”, das könne sie nicht mehr nachvollziehen.

Die CSU-Landtagsfraktion hatte ein Paket von insgesamt fünf Anträgen eingereicht, mit denen sie erreichen will, dass es weniger Todesfälle durch multiresistente Keime gibt. Dazu gehöre es, im Alltag den Antibiotika-Einsatz zu reduzieren, auch in der Landwirtschaft. Fahrlässig eingesetzte Antibiotika werden von Forschern mit als Grund dafür genannt, dass Krankheitserreger resistent werden. In einem dieser Anträge wird die Staatsregierung aufgefordert, per Studie untersuchen zu lassen, wie der Antibiotika-Einsatz reduziert werden kann – und ob dabei womöglich auch homöopathische Präparate eine “positive Rolle” spielen.

Im Bereich der Hals-Nasen-Ohren-Erkrankungen, so die CSU-Abgeordneten, hätten Studien aufzeigen können, “dass durch den Einsatz klassischer Homöopathie sowohl ein Einsatz von Antibiotika vermieden als auch eine Verbesserung der individuellen Infektabwehr erreicht werden konnte”. Auch an schwer septischen Patienten – also Patienten, bei denen das körpereigene Abwehrsystem bereits die Organe und das Gewebe schädigte – habe eine Studie Hinweise darauf gebracht, dass eine homöopathische Behandlung “eine nützliche Behandlungsmethode” darstellen könne.

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The notion that there might be good evidence for the efficacy of homeopathy in ENT and sepsis is clearly mistaken. On this blog, we have even discussed a tragic case of a child dying because of this erroneous belief. Homeopathy does not work in humans nor in animals as an alternative to antibiotics. And, of course, the notion that there is good, reproducible evidence to show that homeopathy effectively cures sepsis is a most dangerous fallacy. (There have been some experiments along these lines in the Dachau concentration camp, but they cannot seriously mean that!)

As far as I know it is as yet unclear what the precise research questions of the Bavarian project are, how much money will be spent on it (I saw a mention of 400 000 Euros), who is going to conduct the research, etc. No doubt, we will learn all this in due course. Meanwhile, if I may be so bold as to recommend someone for designing the research, I can think of nobody better suited than the only person who truly believes that it can produce a positive result: PRINCE CHARLES.

The Federation of European Academies of Medicine (FEAM) and the European Academies’ Science Advisory Council have issued a joint statement today urging the World Health Organisation (WHO) to clarify how Traditional Chinese Medicine (TCM) and other so-called alternative medicines (SCAMs) should be used.

As we discussed previously, the WHO has included TCM diagnoses in the International Classification of Diseases (ICD). The WHO claim this is not an endorsement, but experts point out that the move will promote TCM and mislead the public into thinking that TCM is safe and effective. Thus consumers might use it as an alternative for effective treatments of serious conditions, in which case they would endanger their lives.

Prof George Griffin, the president of FEAM, was quoted saying “We don’t give drugs and surgical treatments unless there is real evidence that they work and do no damage and basically the feeling is that most of the traditional Chinese medicine drugs are unregulated. They are not tested properly for toxicity. They probably vary greatly between batches produced, for example seaweed, which is the latest, and they may be harmful. The other side of the equation is that they may be deluding patients into thinking they are taking appropriate therapies for serious disease.”

“Multiple risks of harm from herbal ingredients have been documented,” the joint statement warns. Sometimes herbal remedies have been adulterated with chemicals. Interaction with conventional drugs can be a serious threat. And acupuncture, they will say, “is not necessarily harmless”. A review in 2017 as well as numerous papers discussed on this blog (for instance here and here) found injuries to vital organs, infections and other adverse reactions.

Although those who use SCAM are being misled to think of them as originating from small scale enterprises, globally it is big business. “The production and delivery of TCM has become a large industry with estimates of $60bn [£46.5bn] a year and an annual growth rate above 10%,” says the statement.

The statement authors “urge the European Commission and member states to do more to ensure that all medical products and procedures are subject to an appropriate level of evaluation for quality, safety and efficacy consistent with standardised testing procedures”.

Here are further important points from the statement:

  • We agree with the underlying principle that the proponents of TCM and other CAM should be invited to seek the same rigorous assessment as is applied to innovative, evidence-based medicines (from state-of-the-art clinical trials) developed and regulated worldwide.
  • We accept that WHO has tried to make clear that their chapter in ICD-11 on TCM does not refer to, nor endorse, any specific form of treatment (Anon 2019a). However, because of the perceived encouragement created by ICD-11 inclusion of  TCM as a core principle and system of medicine, the qualification may be misconstrued or ignored.
  • We agree that there have been examples where traditional medicine, Chinese or otherwise, has been subjected to thorough preclinical investigation and proven in rigorous clinical trials to contribute significant health benefit. The example of artemisinin therapy for malaria is notable (WHO, 2015). The success of artemisinin as an anti-malaria agent is due to meticulous research in pharmacognosy and medicinal chemistry, combined with clinical trials. Many of the artemisia TCM preparations tested originally had little reproducibility of activity. The compound that has been approved by medicinal product agencies is a chemically modified version of the naturally occurring molecule in order to improve its pharmacokinetic properties. It is well known that many natural products have significant pharmacological activities and provided the basis for much of modern medicine. And, there may be many more such leads to therapeutic benefit. But, none of this means that other claims can be accepted uncritically, even if the objective to ensure access for all to the benefits of medicine is worthy.
  • European patients may be encouraged to self-administer unregulated products or seek unregulated diagnostic procedures outside of the remit and responsibility of public health services. This raises issues for efficacy, particularly if patients delay seeking evidence-based healthcare. There are also serious safety concerns. Multiple risks of harm from herbal ingredients have been documented (e.g. see Byard et al. 2017; Zhou et al. 2019) and in the absence of an approved framework for quality and formulation, adulteration and dose variation may bring additional health risks (Ching et al. 2018). Interaction with other medications is,
    additionally, a serious threat. It is also noteworthy that, contrary to common assumptions, acupuncture is not necessarily harmless (Chan et al. 2017). It is not our present purpose to review the evidence on TCM or to make judgement on particular practices, rather to emphasise the need for consistency in applying common standards to all of medicine. Although there is a very large literature on TCM, we note that clinical studies often fail to meet expected methodological criteria and highquality evidence is often lacking (for example as concluded from a systematic review of the literature on use of Chinese herbal medicines for rheumatoid arthritis, Pan et al. 2017). Follow-up surveillance and procedures for assessing liability, where necessary, may also be weak.
  • European patients may be encouraged to seek diagnosis according to the proffered TCM precepts through public health services, thereby causing additional pressures on limited resources. It is likely that there will be increasing demands for these services across the EU. The European Commission, the EMA and Member State health authorities must revisit their regulatory strategies to ensure that appropriate, evidence-based patient information is readily accessible.
  •  There should be consistent proof underlying the regulatory requirements for scrutiny to demonstrate efficacy, safety and quality for all products and practices for human medicine. There must be verifiable and objective evidence, commensurate with the nature of the claims being made. In the absence of such evidence, a product should be neither approvable nor registrable by national regulatory agencies for the designation medicinal product. The current EU Directive on Traditional Herbal Medical Products (Directive 2004/24/EC amending Directive 2001/83/EC) was established to provide a simplified regulatory approval process for traditional herbal medicines, and national procedures are overseen by the national competent authorities. However, designated categories within this legislation allow treatment based on traditional or well-established use in the absence of robust evidence. Medicinal herbal products registered by the European Medicines Agency for traditional use have the requirement of “bibliographical or expert evidence to the effect that the medicinal product in question, or a corresponding product has been in medicinal use throughout a period of at least 30 years preceding the date of the application, including at least 15 years in the Community”5. Thus, the regulation is essentially to ensure that the product is harmless and there is no real requirement for demonstration of effect. As recommended in our previous assessment of homeopathy (EASAC, 2017) it would now be timely to reassess the validity and value of continuing to allow these simpler regulatory approval categories to apply.
  • Diagnostic procedures should also be evidence-based and include validated diagnostic instruments to provide objective, reliable, reproducible assessment and reduce inter-rater variability. Whatever the diagnostic approach utilised, practitioners should be appropriately trained and audited by professional bodies.
  • Similarly, use of other TCM procedures such as acupuncture should be evidence-based to demonstrate efficacy and safety, and subject to professional standards.
  • Evidence-based public health systems and medical insurance systems should not reimburse products and practices unless they are demonstrated to be efficacious and safe by rigorous pre-marketing testing: a robust evidence base is essential for all medicines.
  • The composition of standardised TCM remedies should be labelled in a similar way to other health products. That is, there should be an accurate, clear, verifiable and simple description of the ingredients and their amounts present in the formulation. TCM diagnostic and therapeutic procedures should, likewise, be clearly explained in patient information literature.
  • Advertising and marketing of TCM products and services must conform to established standards of accuracy and clarity6. Promotional claims for efficacy, safety and quality should not be made without demonstrable and reproducible evidence

This review provides published data on so-called alternative medicine (SCAM)-related liver injuries (DILI) in Asia, with detail on incidences, lists of most frequently implicated herbal remedies, along with analysis of patient population and their clinical outcomes.

Its authors conclude that SCAM use is widely prevalent in Asia and is associated with, among other adverse effects, hepatotoxicity. Both proprietary as well as non-proprietary or traditional SCAMs have been implicated in hepatotoxicity. Acute hepatocellular pattern of liver injury is the most common type of liver injury seen, and the spectrum of liver-related adverse events range from simple elevation of liver enzymes to the very serious ALF and ACLF, which may, at times, require liver transplant.

SCAM-related liver injury is one among the major causes for hepatotoxicity, including ALF and ACLF worldwide, with high incidence among Asian countries. Patient outcomes associated with SCAM-DILI are generally poor, with very high mortality rates in those with chronic liver disease. Stringent regulations, at par with that of conventional modern medicine, are required, and may help improve safety of patients seeking SCAM for their health needs. Regional surveillance including post-marketing analysis from government agencies associated with drug regulation and control in tandem with national as well as regional level hepatology societies are important for understanding the true prevalence of DILI associated with SCAM. An integrated approach used by practitioners combining conventional and traditional medicine to identify safety and efficacy of SCAMs is an unmet need in most of the Asian countries. Endorsement of scientific methodology with good quality preclinical and clinical trials and abolishment of unhealthy publication practices is an area that needs immediate attention in SCAM practice. Such holistic standard science-based approaches could help ameliorate liver disease burden in the general and patient population.

I congratulate the authors to this excellent paper. It contains a wealth of information and is well worth reading in full. The review will serve me as a valuable source of data for many years to come.

The U.S. Food and Drug Administration (FDA) issued another warning about homeopathy. Here are some of the most relevant excerpts:

… Homeopathic products … are marketed without FDA review and may not meet modern standards for safety, effectiveness, quality and labeling. FDA uses a risk-based approach to monitor these products and to evaluate reports of adverse effects.

… Homeopathic drug products are made from a wide range of substances, including ingredients derived from plants, healthy or diseased animal or human sources, minerals and chemicals, including known poisons. These products have the potential to cause significant and even permanent harm if they are poorly manufactured, since that could lead to contaminated products or products that have potentially toxic ingredients at higher levels than are labeled and/or safe, or if they are marketed as substitute treatments for serious or life-threatening diseases and conditions, or to vulnerable populations. In addition, some products may be labeled as homeopathic that do not conform to traditional homeopathic principles.

As the homeopathy industry continues to grow at a rapid pace, we want to clarify for both consumers and industry how we assess the potential safety risks of these products. That’s why in 2017, the FDA issued a draft guidance discussing our, risk-based enforcement approach to drug products labeled as homeopathic. Today, we are taking two new steps toward clarifying this approach.

First, we have revised the 2017 draft guidanceExternal Link Disclaimer to provide further information around our approach and are asking for public input on the revised draft. The draft guidance details a risk-based enforcement policy prioritizing certain categories of homeopathic products that could pose a higher risk to public health, including products with particular ingredients and routes of administration, products for vulnerable populations, and products with significant quality issues. We encourage the public to review this revised draft guidance and comment before it is finalized. We will consider feedback gathered through this new public comment period, the more than 4,500 comments interested stakeholders submitted on the original 2017 draft guidance, and information gleaned from a 2015 public hearing on the current use of homeopathic drug products. When finalized, this guidance will help provide transparency regarding the categories of homeopathic drug products that we intend to prioritize under our risk-based enforcement approach.

Second, the agency is withdrawingExternal Link Disclaimer the Compliance Policy Guide (CPG) 400.400, entitled “Conditions Under Which Homeopathic Drugs May be Marketed.” Risk is an important driver of the FDA’s regulatory and enforcement actions for all drug products, including homeopathic drug products. Since the issuance of CPG 400.400 in 1988, the FDA has encountered multiple situations in which homeopathic drug products posed a significant risk to patients, even though the products, as labeled, appeared to meet the conditions described in CPG 400.400. However, CPG 400.400 is inconsistent with our risk-based approach to regulatory and enforcement action generally and therefore does not reflect our current thinking. Therefore, it is appropriate to withdraw CPG 400.400 at this time.

… the FDA has issued warning letters to companies who produce homeopathic drug products for significant violations of current good manufacturing practice (CGMP) regulations and various other violations. So far in 2019, we’ve issued more than 10 warning letters to companies for violations concerning homeopathic products. Recently, we issued warning letters to Kadesh Inc., U.S. Continental Marketing, Inc., Fill It Pack It Inc. and Bershtel Enterprises LLC dba WePackItAll, which had jointly manufactured and packaged eye drops produced in non-sterile conditions which could result in serious eye infections. These warning letters should alert all companies that homeopathic drug products must be manufactured and labeled in accordance with the requirements of the Federal Food, Drug, and Cosmetic Act and agency regulations…

_________________________________________________

If you ask me, ‘homeopathic drug products’ is a misleading name. A drug is defined as a medicine or other substance which has a physiological effect when ingested or otherwise introduced into the body. But highly diluted homeopathics do not contain a substance that has physiological effects.

They should be called

  • homeopathics,
  • homeopathic pseudo-drugs,
  • homeopathic placebos,
  • or fake drugs.

And their labels should make it clear that:

  • these products contain no active ingredients,
  • and have not been shown to work beyond placebo.

That would be the type of honest and transparent information which consumers deserve and have a right to.

 

 

This came a few days ago, completely out of the blue. To be honest, I did not even know what the BOOK AUTHORITY is. So, I looked them up; this is what they say about themselves:

BookAuthority is the world’s leading site for nonfiction book recommendations, helping you find the best books on various topics to develop your skills

It covers topics that range from startups, marketing and finance, through javascript, artificial intelligence and bitcoin, to fitness, history and personal development.

BookAuthority uses a proprietary technology to identify and rate the best nonfiction books, using dozens of different signals, including public mentions, recommendations, ratings, sentiment, popularity and sales history. This includes maintaining the most comprehensive collection of book recommendations from domain experts such as Elon Musk, Warren Buffett, Prof. Daniel Kahneman, Sheryl Sandberg, and David Allen.

Only the very best books are featured on BookAuthority. To keep our site objective and unbiased, ratings are calculated purely based on data. We do not accept requests to feature a book, nor are we doing business with publishers or authors.

BookAuthority serves millions of book recommendations every month, was ranked #1 on ProductHunt, and has been featured on CNN, Forbes and Inc.
If you are a blogger, feel free to check out our tools for bloggers.

It does not happen often but, today, I am speechless.

The Society of Homeopaths (SoH) is the UK’s professional organisation of lay-homeopaths, therapists who treat patients without having studies medicine. This is what they say about themselves:

Everyone needs a healthcare professional they can trust – one who’s trained to rigorous standards, bound by a strict code of ethics, and subject to independent regulation. That’s what the Society of Homeopaths stands for. We’re the UK’s largest group of professional homeopaths, and the only dedicated register accredited by the Professional Standards Authority, an independent body set up by the government to protect the public.

We work to uphold standards of homeopathic care, support our members in their practices, and help their patients back to good health. We ensure that the letters RSHom are your guarantee of a well-trained, registered and insured professional homeopath.

This sounds fine, but is any of this true? Because of their dubious activities endangering public health, the SoH has attracted my attention many times before (for instance here, here and here). Today, they made national headlines.

It has been reported that Linda Wicks, chair of the Society of Homeopaths (S0H), has shared a series of bizarre petitions claiming that childhood immunisations are unsafe, and calling for The Medicines and Healthcare products Regulatory Agency (MHRH) to be disbanded. Mrs Wicks also posted a petition supporting Andrew Wakefield, the disgraced former doctor who falsely linked the MMR vaccine to autism. It claimed that the scientific establishment’s rejection of his flawed research was ‘the greatest lie ever told’.

Mrs Wicks, a Cornwall-based lay-homeopath and owner of the Linda Wicks Homeopathy Clinic in Truro, has been an adviser to the society for 16 years. She was appointed to the SoH chair in April. She has used her Facebook account to spread ‘anti-vaxx’ propaganda for years. Mrs Wicks must now consider whether such to resign.

Two other members of the board of directors of the SoH are also under pressure to quit. One of them, Francis Treuherz, used his Facebook feed to share a petition describing Mr Wakefield as a ‘hero’ who ought to be ‘honoured’ with the Nobel Peace Prize. In 2016 Treuherz endorsed a campaign urging the then education secretary Justine Greening to ‘STOP vaccination’ of schoolchildren against flu.

The flu petition was shared on Facebook by a third member of the SoH’s board, Maggie Dixon, who owns a homeopathic clinic in Bath. Mrs Dixon works as a member of the ‘team of practitioners’ at Ainsworths, the homeopathic pharmacy boasting of royal warrants from the Queen as well as Prince Charles.

It seems clear to me that the behaviour of Wicks, Treuherz and Dixon endangers public health and is deeply unethical. Considering what the SoH say about themselves (see above), it looks like a bad joke. In my view, it is incompatible with holding an office in a professional organisation of healthcare professionals.

Homeopathy does not have a good name when it comes to advising the public responsibly. Such behaviour is hardly going to improve this situation. The recent call of NHS leaders to stop the accreditation of homeopaths in the UK seems therefore well-justified.

Mrs Wicks meekly apologised yesterday, saying: ‘I regret my association with these petitions and any confusion this may have caused, and I have removed the page which allegedly showed this historic material.’ Confusion? At this stage, I must conclude that she is joking!

The SoH said it was working to improve communication standards ‘with clearer guidelines’. Improve communication standards. Yes, definitely, they are taking the Mikey!

Mr Treuherz and Mrs Dixon did not comment.

So, should they resign?

Would that save the reputation of the SoH?

Is there any reputation to save?

WHAT DO YOU THINK?

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