MD, PhD, FMedSci, FRSB, FRCP, FRCPEd

progress

As I often said, I find it regrettable that sceptics often say THERE IS NOT A SINGLE STUDY THAT SHOWS HOMEOPATHY TO BE EFFECTIVE (or something to that extent). This is quite simply not true, and it gives homeopathy-fans the occasion to suggest sceptics wrong. The truth is that THE TOTALITY OF THE MOST RELIABLE EVIDENCE FAILS TO SUGGEST THAT HIGHLY DILUTED HOMEOPATHIC REMEDIES ARE EFFECTIVE BEYOND PLACEBO. As a message for consumers, this is a little more complex, but I believe that it’s worth being well-informed and truthful.

And that also means admitting that a few apparently rigorous trials of homeopathy exist and some of them show positive results. Today, I want to focus on this small set of studies.

How can a rigorous trial of a highly diluted homeopathic remedy yield a positive result? As far as I can see, there are several possibilities:

  1. Homeopathy does work after all, and we have not fully understood the laws of physics, chemistry etc. Homeopaths favour this option, of course, but I find it extremely unlikely, and most rational thinkers would discard this possibility outright. It is not that we don’t quite understand homeopathy’s mechanism; the fact is that we understand that there cannot be a mechanism that is in line with the laws of nature.
  2. The trial in question is the victim of some undetected error.
  3. The result has come about by chance. Of 100 trials, 5 would produce a positive result at the 5% probability level purely by chance.
  4. The researchers have cheated.

When we critically assess any given trial, we attempt, in a way, to determine which of the 4 solutions apply. But unfortunately we always have to contend with what the authors of the trial tell us. Publications never provide all the details we need for this purpose, and we are often left speculating which of the explanations might apply. Whatever it is, we assume the result is false-positive.

Naturally, this assumption is hard to accept for homeopaths; they merely conclude that we are biased against homeopathy and conclude that, however, rigorous a study of homeopathy is, sceptics will not accept its result, if it turns out to be positive.

But there might be a way to settle the argument and get some more objective verdict, I think. We only need to remind ourselves of a crucially important principle in all science: INDEPENDENT REPLICATIONTo be convincing, a scientific paper needs to provide evidence that the results are reproducible. In medicine, it unquestionably is wise to accept a new finding only after it has been confirmed by other, independent researchers. Only if we have at least one (better several) independent replications, can we be reasonably sure that the result in question is true and not false-positive due to bias, chance, error or fraud.

And this is, I believe, the extremely odd phenomenon about the ‘positive’ and apparently rigorous studies of homeopathic remedies. Let’s look at the recent meta-analysis of Mathie et al. The authors found several studies that were both positive and fairly rigorous. These trials differ in many respects (e. g. remedies used, conditions treated) but they have, as far as I can see, one important feature in common: THEY HAVE NOT BEEN INDEPENDENTLY REPLICATED.

If that is not astounding, I don’t know what is!

Think of it: faced with a finding that flies in the face of science and would, if true, revolutionise much of medicine, scientists should jump with excitement. Yet, in reality, nobody seems to take the trouble to check whether it is the truth or an error.

To explain this absurdity more fully, let’s take just one of these trials as an example, one related to a common and serious condition: COPD

The study is by Prof Frass and was published in 2005 – surely long enough ago for plenty of independent replications to emerge. Its results showed that potentized (C30) potassium dichromate decreases the amount of tracheal secretions was reduced, extubation could be performed significantly earlier, and the length of stay was significantly shorter. This is a scientific as well as clinical sensation, if there ever was one!

The RCT was published in one of the leading journals on this subject (Chest) which is read by most specialists in the field, and it was at the time widely reported. Even today, there is hardly an interview with Prof Frass in which he does not boast about this trial with truly sensational results (only last week, I saw one). If Frass is correct, his findings would revolutionise the lives of thousands of seriously suffering patients at the very brink of death. In other words, it is inconceivable that Frass’ result has not been replicated!

But it hasn’t; at least there is nothing in Medline.

Why not? A risk-free, cheap, universally available and easy to administer treatment for such a severe, life-threatening condition would normally be picked up instantly. There should not be one, but dozens of independent replications by now. There should be several RCTs testing Frass’ therapy and at least one systematic review of these studies telling us clearly what is what.

But instead there is a deafening silence.

Why?

For heaven sakes, why?

The only logical explanation is that many centres around the world did try Frass’ therapy. Most likely they found it does not work and soon dismissed it. Others might even have gone to the trouble of conducting a formal study of Frass’ ‘sensational’ therapy and found it to be ineffective. Subsequently they felt too silly to submit it for publication – who would not laugh at them, if they said they trailed a remedy that was diluted 1: 1000000000000000000000000000000000000000000000000000000000000 and found it to be worthless? Others might have written up their study and submitted it for publication, but got rejected by all reputable journals in the field because the editors felt that comparing one placebo to another placebo is not real science.

And this is roughly, how it went with the other ‘positive’ and seemingly rigorous studies of homeopathy as well, I suspect.

Regardless of whether I am correct or not, the fact is that there are no independent replications (if readers know any, please let me know).

Once a sufficiently long period of time has lapsed and no replications of a ‘sensational’ finding did not emerge, the finding becomes unbelievable or bogus – no rational thinker can possibly believe such a results (I for one have not yet met an intensive care specialist who believes Frass’ findings, for instance). Subsequently, it is quietly dropped into the waste-basket of science where it no longer obstructs progress.

The absence of independent replications is therefore a most useful mechanism by which science rids itself of falsehoods.

It seems that homeopathy is such a falsehood.

 

 

Homeopathy has always enjoyed a special status in Germany, its country of origin. Germans use homeopathy more often than the citizens of most other countries, they spend more money on it, and they even have elevated it to some kind of medical speciality. In 2003, the German medical profession re-considered the requirements for carrying the title of ‘Doctor of Homeopathy’. It was decided that only physicians who already were specialists in one medical field were allowed to be certified with this title after a post-graduate education and training programme of 6 months, or 100 hours of case studies under supervision plus 160 hours of course work. Many German physicians seem to find this rigorously regulated programme attractive, opted for it, and earn good money with it; the number of ‘doctors of homeopathy’ has risen from 2212 to 6712 between 1993 and 2009.

Personally, I find much of this surprising, even laughable, and have repeatedly stated that even the most rigorously regulated education in nonsense can only result in nonsense. 

Luckily, I am not alone. A multidisciplinary group of experts (Muensteraner Kreis) has just filed an official application with the current 121st General Assembly of the German medical profession to completely abolish the title ‘Doctor of Homeopathy’. Our application itself is a lengthy document outlining in some detail the nature of our arguments. Here, I will merely translate its conclusion:

Even though present in science-business, homeopathy is not scientifically founded. Its basis – potentisation and the simile principle – contradicts scientific facts; homeopathy therefore must be categorised as esoteric. The international scientific community does not interpret the clinical studies of homeopathy as a sufficient proof for its efficacy. Giving an esoteric approach to medicine the veneer of credibility by officially establishing the title ‘Doctor of Homeopathy’ contradicts the physicians’ claim of a scientifically-based medicine and weakens the status of the science-based medicine through blurring the boundaries between science and belief. Problems within science-based medicine must be solved internally and cannot be unburdened onto an unscientific approach to medicine. We consider the abolishment of the ‘Doctor of Homeopathy’ to be urgently indicated.

END OF MY TRANSLATION

I think it would be more than a little over-optimistic to assume that the Assembly will swiftly adopt our suggestion. Perhaps this is also not the intention of our application. In Germany (I learnt my homeopathy in this country), homeopathy is still very much protected by powerful lobby groups and financial interests, as well as loaded with heavy emotional baggage. Yet I do hope that our application will start a discussion which, eventually, will bring a rational resolution to the embarrassing anachronism of the ‘Doctor of Homeopathy’ (Arzt fuer Homoeopathie).

The German medical profession might even have the opportunity to be internationally at the forefront of reason and progress.

Yesterday, a press-release about our new book has been distributed by our publisher. As I hope than many regular readers of my blog might want to read this book – if you don’t want to buy it, please get it via your library – I decided to re-publish the press-release here:

Governments must legislate to regulate and restrict the sale of complementary and alternative therapies, conclude authors of new book More Harm Than Good.

Heidelberg, 20 February 2018

Commercial organisations selling lethal weapons or addictive substances clearly exploit customers, damage third parties and undermine genuine autonomy. Purveyors of complementary and alternative medicine (CAM) do too, argue authors Edzard Ernst and Kevin Smith.

The only downside to regulating such a controversial industry is that regulation could confer upon it an undeserved stamp of respectability and approval. At best, it can ensure the competent delivery of therapies that are inherently incompetent.

This is just one of the ethical dilemmas at the heart of the book. In all areas of healthcare, consumers are entitled to expect essential elements of medical ethics to be upheld. These include access to competent, appropriately-trained practitioners who base treatment decisions on evidence from robust scientific research. Such requirements are frequently neglected, ignored or wilfully violated in CAM.

“We would argue that a competent healthcare professional should be defined as one who practices or recommends plausible therapies that are supported by robust evidence,” says bioethicist Kevin Smith.

“Regrettably, the reality is that many CAM proponents allow themselves to be deluded as to the efficacy or safety of their chosen therapy, thus putting at risk the health of those who heed their advice or receive their treatment,” he says.

Therapies covered include homeopathy, acupuncture, chiropractic, iridology, Reiki, crystal healing, naturopathy, intercessory prayer, wet cupping, Bach flower therapy, Ukrain and craniosacral therapy. Their inappropriate use can not only raises false hope and inflicts financial hardship on consumers, but can also be dangerous; either through direct harm or because patients fail to receive more effective treatment. For example, advice given by homeopaths to diabetic patients has the potential to kill them; and when anthroposophic doctors advise against vaccination, they can be held responsible for measles outbreaks.

There are even ethical concerns to subjecting such therapies to clinical research. In mainstream medical research, a convincing database from pre-clinical research is accumulated before patients are experimented upon. However, this is mostly not possible with CAM. Pre-scientific forms of medicine have been used since time immemorial, but their persistence alone does not make them credible or effective. Some are based on notions so deeply implausible that accepting them is tantamount to believing in magic.

“Dogma and ideology, not rationality and evidence, are the drivers of CAM practice,” says Professor Edzard Ernst.

Edzard Ernst, Kevin Smith
More Harm than Good?
1st ed. 2018, XXV, 223 p.
Softcover $22.99, €19,99, £15.99 ISBN 978-3-319-69940-0
Also available as an eBook ISBN 978-3-319-69941-7

END OF PRESS RELEASE

As I already stated above, I hope you will read our new book. It offers something that has, I think, not been attempted before: it critically evaluates many aspects of alternative medicine by holding them to the ethical standards of medicine. Previously, we have often been asking WHERE IS THE EVIDENCE FOR THIS OR THAT CLAIM? In our book, we ask different questions: IS THIS OR THAT ASPECT OF ALTERNATIVE MEDICINE ETHICAL? Of course, the evidence question does come into this too, but our approach in this book is much broader.

The conclusions we draw are often surprising, sometimes even provocative.

Well, you will see for yourself (I hope).

Doctor Jonas is an important figure head of US ‘Integrative Medicine’. As we discussed in a recent post, he pointed out that many US hospital doctors fail to answer the following questions relating to their chronically ill patients:

  1. “What matters most for this patient?
  2. What is the person’s lifestyle like – their nutrition, movement and sleep?
  3. How does that patient manage their stress?
  4. Does that patient have a good support system at home?
  5. What supplements does that patient take? Has your patient seen any CAM practitioners to cope with their condition?
  6. Why do they want to get well?”

In my previous post, I tried to explain that this is embarrassing – embarrassing for doctor Jonas, I meant.

But Jonas also claims that most US hospital doctors he addressed during his lecture tour, were unable to answer these questions. And that might be embarrassing not for Jonas, but for those physicians. Let’s consider this possibility for a moment.

The way I see it, the doctors in question might not have answered to Jonas for the following reasons:

  • They felt that the questions were simply too daft to bother.
  • They were too polite to tell Jonas what they think of him.
  • They were truly unable to answer the questions.

Here I want to briefly deal with the last category.

I do not doubt for a minute that this category of physician exists. They have little interest in what matters to their patients, don’t ask the right questions, have no time and even less empathy and compassion. Yet nobody can deny that medical school teaches all of these qualities, skills and attitudes. And there is no doubt that good doctors practice them; it is not a choice but an ethical and moral imperative.

So, what went wrong with these doctors?

Probably lots, and I cannot begin to tell you what exactly. However, I can easily tell you that those doctors are not practicing good medicine. Similarly, I can tell you what these doctors ought to do: re-train and be reminded of what medical school has once taught them.

And what about those physicians who advocate ‘integrated medicine’ reminding everyone of the core values of healthcare?

Aren’t they fabulous?

No, they aren’t!

Why?

Because they too have evidently forgotten what they should have learnt at medical school. If not, they would not be able to pretend that ‘integrative medicine’ has a monopoly on core values of all healthcare. Their messages are akin to a new ‘school’ of ship-building insisting that it is beneficial to build ships that do not leak.

What I am trying to say in my clumsy way is this:

DOCTORS WHO PRACTICE BAD MEDICINE SHOULD RE-TRAIN – TOGETHER WITH THOSE PHYSICIANS WHO ADVOCATE ‘INTEGRATIVE MEDICINE‘, BECAUSE THEY BOTH HAVE FORGOTTEN WHAT THEY LEARNT AT MEDICAL SCHOOL.

How often have we heard this? YOU ARE WRONG! MY TREATMENT DOES WORK!!! ONLY THE OTHER DAY, I HAD A PATIENT WHO WAS CURED BY IT.

Take for instance this tweet I got yesterday:

F SThomas‏ @spenthomf

You go too far @EdzardErnst. In fact I was consulted about a child who hadn’t grown after an accident. She responded well to homoeopathy and grew. How much are you being paid for your attempts to deny people’s health choices?

The tweet refers to my last post where I exposed homeopathic child abuse. Having thought about Thomas’ tweet, I must say that I find it too to be abusive – even abusive on 4 different levels.

  1. First, the tweet is obviously a personal attack suggesting that I am bribed into doing what I do. I have stated it many times, and I do so again: I receive no payment from anyone for my work. How then do I survive? I have a pension and savings (not that this is anyone’s business).
  2. Second, it is abusive because it claims that children who suffer from a pathological growth retardation can benefit from homeopathy. There is no evidence for that at all, and making false claims of this nature is unethical and, in this case, even abusive.
  3. Third, if Thomas really did make the observation she suggests in her tweet and is convinced that her homeopathic treatment was the cause of the child’s improvement, she has an ethical duty to do something more about it than just shooting off a flippant tweet. She could, for instance, run a clinical trial to find out whether her observation was correct. I admit this might be beyond her means. So alternatively, she could write up the case in full detail and publish it for all of us to scrutinise her findings. This is the very minimum a responsible clinician ought to do when she comes across a novel and potentially important result. Anything else is my view unethical and hinders progress.

I do, of course, sympathise with lay people who fail to fully understand the concept of causality. But surely, healthcare professionals who pride themselves of taking charge of patients ought to have some comprehension of it. They should know that clinical improvements after a treatment is not necessarily the same as clinical improvement because of the treatment. Is it really too much to ask of them to know the criteria for causality? There is plenty of easy-reading on the subject; even Wikipedia has a good article on it:

In 1965, the English statistician Sir Austin Bradford Hill proposed a set of nine criteria to provide epidemiologic evidence of a causal relationship between a presumed cause and an observed effect. (For example, he demonstrated the connection between cigarette smoking and lung cancer.) The list of the criteria is as follows:

  1. Strength (effect size): A small association does not mean that there is not a causal effect, though the larger the association, the more likely that it is causal.
  2. Consistency (reproducibility): Consistent findings observed by different persons in different places with different samples strengthens the likelihood of an effect.
  3. Specificity: Causation is likely if there is a very specific population at a specific site and disease with no other likely explanation. The more specific an association between a factor and an effect is, the bigger the probability of a causal relationship.
  4. Temporality: The effect has to occur after the cause (and if there is an expected delay between the cause and expected effect, then the effect must occur after that delay).
  5. Biological gradient: Greater exposure should generally lead to greater incidence of the effect. However, in some cases, the mere presence of the factor can trigger the effect. In other cases, an inverse proportion is observed: greater exposure leads to lower incidence.
  6. Plausibility: A plausible mechanism between cause and effect is helpful (but Hill noted that knowledge of the mechanism is limited by current knowledge).
  7. Coherence: Coherence between epidemiological and laboratory findings increases the likelihood of an effect. However, Hill noted that “… lack of such [laboratory] evidence cannot nullify the epidemiological effect on associations”.
  8. Experiment: “Occasionally it is possible to appeal to experimental evidence”.
  9. Analogy: The effect of similar factors may be considered.

And this brings me to my 4th and last level of abuse in relation to the above tweet and most other claims of this nature: being ill-informed and stupid while insisting to make a nonsensical point is, in my view, offensive – so much so that it can reach the level of abuse.

On their website, the British Homeopathic Association (BHA) have launched their annual winter appeal. Its theme this year is ‘building a better future for homeopathy’. The appeal is aimed at the following specific goals:

  • Continuously fighting to retain NHS services in the UK by supporting local patients & groups and providing swift media responses employing experts in areas such as media, politics, law and reputation management for ultimate effectiveness. Currently undertaking a legal challenge to NHS England
  • Establishing charitable homeopathic clinics throughout the UK, with clinics currently in Norwich, York, Bath, Edinburgh and looking at developing other clinics in Liverpool, Wales, Oxford and London in 2018.
  • Making further investment to enhance our digital presence and promotion of key messages.
  • Continuoustly improving our website to make it the place for information on homeopathy from finding practitioners to finding the latest Health & Homeopathy online.
  • Investing in research and education to keep homeopathy strong in the long term, increasing the number of healthcare professionals using homeopathy in their everyday practice.
  • Taking homeopathy to the people and growing our community of supporters with public events, local events and national promotion.

I have to say, I find this almost touching in its naivety. I imagine another lobby group, say the cigarette industry, launching a winter appeal: BUILDING A BETTER FUTURE FOR CIGARETTES.

Do I hear you object?

Cigarettes are unhealthy and not a medical treatment!!!

Quite so! Homeopathy is also unhealthy and not a medical treatment, I would argue. Sure, highly dilute homeopathics do not kill you, but homeopathy easily can. We have seen this on this blog many times. Homeopathy kills when it is advocated and consequently used as an alternative therapy for a life-threatening disease; there is no question about it. And there also is no question about the fact that this happens with depressing regularity. If you doubt it, just read some of my previous posts on the subject.

In any case, an appeal by a medical association should not be for its own benefit (homeopathy); it should be for patients (patients tempted to try homeopathy), I would suggest. So, lets design the goals of an appeal for patients along the lines of the above appeal – except our appeal has to actually be in the best interest of vulnerable patients.

Here we go:

  • Continually fighting to stop homeopathy on the NHS. As homeopathy does not generate more good than harm (no ineffective therapy can ever do that), we have a moral, legal and ethical duty to use our scarce resources such that they create the maximum benefit; and this means we cannot use them for homeopathy.
  • Establishing charitable organisations that educate the public about science and evidence. Too many consumers are still falling victim to the pseudo-science of charlatans who mislead people for their own profit.
  • Making further investments to combating the plethora of unethical misinformation by self-interested quacks and organisations many of which even have charitable status.
  • Continually improving websites that truthfully inform the public, politicians, journalists and others about medicine, science and healthcare.
  • Investing in research and education to keep science and evidence-based medicine strong, for the benefit of vulnerable patients and in the interest of progress.
  • Taking the science agenda to the people and growing the community of science-literate supporters on a local, national and international level.

As I had to follow the lines of the BHA, these goals are regrettably not perfect – but I am sure they are a whole lot better than the BHA original!

This blog is almost entirely about critical thinking as it applies to the realm of alternative medicine, and I have written about it more often than I care to remember. For instance, in one post I concluded that criticism  in alternative medicine is directed almost exclusively towards those who are outside the realm. Criticism from the inside is as good as non-existent.

The consequences of this situation are easy to see for everyone, and they can be dramatic:

  • The journals of alternative medicine publish nothing that could be perceived to be negative for the practice of alternative medicine.
  • Self-critical thinking has no tradition and has remained an almost alien concept.
  • The very few people from the ‘inside’ who dare to criticise alternative practices are ousted and/or declared to be incompetent or worse.
  • No action is taken to initiate change.
  • The assumptions of alternative medicine remain unaltered for centuries.
  • Progress is all but absent.

But what exactly is critical thinking? The ‘Foundation of Critical Thinking‘ defines it as follows: Critical thinking is the intellectually disciplined process of actively and skillfully conceptualizing, applying, analyzing, synthesizing, and/or evaluating information gathered from, or generated by, observation, experience, reflection, reasoning, or communication, as a guide to belief and action. In its exemplary form, it is based on universal intellectual values that transcend subject matter divisions: clarity, accuracy, precision, consistency, relevance, sound evidence, good reasons, depth, breadth, and fairness.

In an article in the Scientific American Heather butler recently provided further clarification. Here is a short extract from this most commendable paper:

START OF QUOTE

Though often confused with intelligence, critical thinking is not intelligence. Critical thinking is a collection of cognitive skills that allow us to think rationally in a goal-orientated fashion, and a disposition to use those skills when appropriate. Critical thinkers are amiable skeptics. They are flexible thinkers who require evidence to support their beliefs and recognize fallacious attempts to persuade them. Critical thinking means overcoming all sorts of cognitive biases (e.g., hindsight bias, confirmation bias).

Critical thinking predicts a wide range of life events. In a series of studies, conducted in the U.S. and abroad, my colleagues and I have found that critical thinkers experience fewer bad things in life. We asked people to complete an inventory of life events and take a critical thinking assessment (the Halpern Critical Thinking Assessment). The critical thinking assessment measures five components of critical thinking skills including verbal reasoning, argument analysis, hypothesis testing, probability and uncertainty, decision-making, and problem-solving. The inventory of negative life events captures different domains of life such as academic (e.g., I forgot about an exam), health (e.g., I contracted a sexually transmitted infection because I did not wear a condom), legal (e.g., I was arrested for driving under the influence), interpersonal (e.g., I cheated on my romantic partner who I had been with for over a year), financial (e.g., I have over $5,000 of credit card debt), etc. Repeatedly, we found that critical thinkers experience fewer negative life events. This is an important finding because there is plenty of evidence that critical thinking can be taught and improved.

Is it better to be a critical thinker or to be intelligent? My latest research pitted critical thinking and intelligence against each other to see which was associated with fewer negative life events. People who were strong on either intelligence or critical thinking experienced fewer negative events, but critical thinkers did better.

Intelligence and improving intelligence are hot topics that receive a lot of attention. It is time for critical thinking to receive a little more of that attention. Keith Stanovich wrote an entire book about What Intelligence Tests Miss. Reasoning and rationality more closely resemble what we mean when we say a person is smart than spatial skills and math ability. Furthermore, improving intelligence is difficult. Intelligence is largely determined by genetics. Critical thinking, though, can improve with training and the benefits have been shown to persist over time. Anyone can improve their critical thinking skills: Doing so, we can say with certainty, is a smart thing to do.

END OF QUOTE

We cannot learn to be intelligent, but we can learn how to think critically. If my blog helps some readers to achieve this aim, I would consider the effort worthwhile.

In 2017, Medline listed just over 1800 articles on ‘complementary alternative medicine’. If you find this number impressively high, consider that, for ‘surgery’ (a subject that has often been branded as less that active in conducting research), there were almost 18 000 Medline-listed papers.

So, the research activity in CAM is relatively small. Vis a vis the plethora of open questions, this inactivity is perhaps lamentable. What I find much more regrettable, however, is the near total lack of investigations into the ethical issues in CAM. In 2017, there were just 11 articles on Medline on ‘ethics and CAM’ (24393 articles on ‘ethics and surgery’).

One of the 11 papers that tackled the ethics directly and that was (in my opinion) one of the best is this article. Here is its concluding paragraph:

When we encounter patients who use or consider the use of complementary and/or alternative medicine, we should respect their autonomy while also fulfilling our obligations of beneficence and nonmaleficence. Physicians should become more knowledgeable about research on CAM therapies and approach discussions in an open, nonjudgmental manner to enhance patient trust. In situations where there is little risk of harm and the possibility of benefit, supporting a patient in their interest in complementary therapies can strengthen the patient-physician relationship. However, when a patient’s desire to utilize alternative therapies poses a health risk, physicians have the ethical obligation to skillfully counsel the patient toward those therapies that are medically appropriate.

I have had a long-lasting and keen interest in the ethics of CAM which resulted in the publication of many papers. Here is a selection:

Problems with ethical approval and how to fix them: lessons from three trials in rheumatoid arthritis.

‘Complementary & Alternative Medicine’ (CAM): Ethical And Policy Issues.

Pharmacists and homeopathic remedies.

No obligation to report adverse effects in British complementary and alternative medicine: evidence for double standards.

Homeopathy, a “helpful placebo” or an unethical intervention?

Advice offered by practitioners of complementary/ alternative medicine: an important ethical issue.

The ethics of British professional homoeopaths.

Evidence-based practice in British complementary and alternative medicine: double standards?

Ethics of complementary medicine: practical issues.

The ethics of chiropractic.

Reporting of ethical standards: differences between complementary and orthodox medicine journals?

Informed consent: a potential dilemma for complementary medicine.

Ethical problems arising in evidence based complementary and alternative medicine.

Complementary medicine: implications for informed consent in general practice.

Ethics and complementary and alternative medicine.

Research ethics questioned in Qigong study.

Informed consent in complementary and alternative medicine.

The ethics of complementary medicine.

For most of the time conducting this research, I felt that I was almost alone in realising the importance of this topic. And all this time, I was convinced that the subject needed more attention and recognition. Therefore, I teamed up with with the excellent ethicist Kevin Smith from the University of Dundee, and together we spent the best part of 2017 writing about it.

Our book is entitled ‘MORE HARM THAN GOOD? THE MORAL MAZE OF COMPLEMENTARY AND ALTERNATIVE MEDICINE’ and will be published shortly by Springer.

Product Details

It is an attempt to highlight some of the most important topics in this broad and under-researched area. While working on it, I was continually struck by the fact that most of the issues we have been struggling with on this blog are, in the final analysis, ethical by nature.

My hope is that, in 2018, we will see many more high quality papers filling the almost total void of ethical perspectives on CAM. In my view, it is unquestionably an area that needs to be addressed with some urgency.

At this time of the year it is customary to look back and highlight some remarkable things that occurred during the last 12 months. Here I will try to identify for each month the most important event. My choice is entirely subjective, and I invite everybody to disagree with it and add other happenings.

JANUARY

The U.S. Food and Drug Administration announced today that its laboratory analysis found inconsistent amounts of belladonna, a toxic substance, in certain homeopathic teething tablets, sometimes far exceeding the amount claimed on the label. The agency is warning consumers that homeopathic teething tablets containing belladonna pose an unnecessary risk to infants and children and urges consumers not to use these products.

FEBRUARY

It has just been reported that the Russian Academy of Sciences (RAS) has labelled homeopathic medicine a health hazard. The organization is now petitioning Russia’s Ministry of Health to abandon the use of homeopathic medicine in the country’s state hospitals, the RBC news outlet reported Monday.

A RAS committee warns that some patients were rejecting standard medicine for serious conditions in favour of homeopathic remedies, a move that almost inevitably puts their lives in danger. The committee also noted that, because of sloppy quality control during the manufacturing processes, some unlicensed homeopathic remedies contain toxic substances which harm patients in a direct fashion.

“The principles of homeopathy contradict known chemical, physical and biological laws and persuasive scientific trials proving its effectiveness are not available,” the committee stated in its report.

MARCH

George Lewith has died on 17 March, aged 67. He was one of the most productive researchers of alternative medicine in the UK; specifically he was interested in acupuncture. If you search this blog, you find several posts that mention him or are entirely dedicated to his work. Undeniably, my own views and research were often very much at odds with those of Lewith.

APRIL

A new review of the risks of spinal manipulative therapy (SMT) concluded that it is currently not possible to provide an overall conclusion about the safety of SMT; however, the types of SAEs reported can indeed be significant, sustaining that some risk is present. High quality research and consistent reporting of AEs and SAEs are needed.

MAY

My favourite journal has succumbed to BS. A review that is ‘state of the art’ must fulfil certain criteria; foremost it should be informative, unbiased and correct. The paper I am discussing here has, I think, neither of these qualities. It is entitled ‘Management of chronic pain using complementary and integrative medicine’, and here is its abstract:

Complementary and integrative medicine (CIM) encompasses both Western-style medicine and complementary health approaches as a new combined approach to treat a variety of clinical conditions. Chronic pain is the leading indication for use of CIM, and about 33% of adults and 12% of children in the US have used it in this context. Although advances have been made in treatments for chronic pain, it remains inadequately controlled for many people. Adverse effects and complications of analgesic drugs, such as addiction, kidney failure, and gastrointestinal bleeding, also limit their use. CIM offers a multimodality treatment approach that can tackle the multidimensional nature of pain with fewer or no serious adverse effects. This review focuses on the use of CIM in three conditions with a high incidence of chronic pain: back pain, neck pain, and rheumatoid arthritis. It summarizes research on the mechanisms of action and clinical studies on the efficacy of commonly used CIM modalities such as acupuncture, mind-body system, dietary interventions and fasting, and herbal medicine and nutrients.

JUNE

Scientology seems to have started an aggressive campaign in the UK to promote its cult.

JULY

The NHS seems to be edging towards banning homeopathy.

AUGUST

A group of German experts published a document pointing out that the ‘Heilpraktiker’ has introduced two hugely different quality standards into the German healthcare system. In the interest of the patient and of good healthcare, this double standard must be addressed. We are demanding the profession of the Heilpraktiker either is completely abolished, or is reformed such that it no longer poses a threat to public health in Germany. Our document makes concrete suggestions for such reforms.

SEPTEMBER

It has been announced that Susan and Henry Samueli have given US$ 200 million to medical research at the University of California, Irvine (UCI). Surely this is a generous and most laudable gift! How could anyone doubt it?

OCTOBER

I feel deeply honoured to have received the Ockham Award. It is a generous appreciation of our small efforts in decreasing the ignorance and stupidity that seems to be all around us today – sadly not just in the realm of alternative medicine (but that would be the subject of another blog). I thank everyone who contributed to our blog’s success and hope you keep the comments coming.

NOVEMBER

The RCVS publishes a position paper on alternative medicine for animals: “Homeopathy exists without a recognised body of evidence for its use. Furthermore, it is not based on sound scientific principles. In order to protect animal welfare, we regard such treatments as being complementary rather than alternative to treatments for which there is a recognised evidence base or which are based in sound scientific principles. It is vital to protect the welfare of animals committed to the care of the veterinary profession and the public’s confidence in the profession that any treatments not underpinned by a recognised evidence base or sound scientific principles do not delay or replace those that do.”

DECEMBER

The US Food and Drug Administration proposed a new, risk-based enforcement approach to drug products labeled as homeopathic. To protect consumers who choose to use homeopathic products, this proposed new approach would update the FDA’s existing policy to better address situations where homeopathic treatments are being marketed for serious diseases and/or conditions but where the products have not been shown to offer clinical benefits. It also covers situations where products labeled as homeopathic contain potentially harmful ingredients or do not meet current good manufacturing practices…

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This time of the year is also a good moment for thanking those who made writing this blog an exercise that is fun and hopefully constructive. Happy New Year to all of you.

On their  website, the US Food and Drug Administration (FDA) has recently published a statement on homeopathy which, I think, is important enough to get cited extensively:

… Food and Drug Administration proposed a new, risk-based enforcement approach to drug products labeled as homeopathic. To protect consumers who choose to use homeopathic products, this proposed new approach would update the FDA’s existing policy to better address situations where homeopathic treatments are being marketed for serious diseases and/or conditions but where the products have not been shown to offer clinical benefits. It also covers situations where products labeled as homeopathic contain potentially harmful ingredients or do not meet current good manufacturing practices…

The FDA’s proposed approach prioritizes enforcement and regulatory actions involving unapproved drug products labeled as homeopathic that have the greatest potential to cause risk to patients…  The FDA intends to focus its enforcement authorities on the following kinds of products:

  • products with reported safety concerns;
  • products that contain or claim to contain ingredients associated with potentially significant safety concerns;
  • products for routes of administration other than oral and topical;
  • products intended to be used for the prevention or treatment of serious and/or life-threatening diseases and conditions;
  • products for vulnerable populations; and
  • products that do not meet standards of quality, strength or purity as required under the law.

Examples of products that may be subject to the enforcement priorities in the draft guidance are infant and children’s products labeled to contain ingredients associated with potentially significant safety concerns, such as belladonna and nux vomica; and products marketed for serious conditions, such as cancer and heart disease.

While the FDA considers comments to the draft guidance, the FDA intends to examine how the agency is implementing its current compliance policy. Given the concerns about the proliferation of potentially ineffective and harmful products labeled as homeopathic, the FDA will consider taking additional enforcement and/or regulatory actions, consistent with the current enforcement policies, which also align with the risk-based categories described in the draft guidance, in the interest of protecting the public…

Until relatively recently, homeopathy was a small market for specialized products. Over the last decade, the homeopathic drug market has grown exponentially, resulting in a nearly $3 billion industry that exposes more patients to potential risks associated with the proliferation of unproven, untested products and unsubstantiated health claims. During this time, the FDA has seen a corresponding increase in safety concerns, including serious adverse events, associated with drug products labeled as homeopathic. In addition, the agency has also found an increasing number of poorly manufactured products that contain potentially dangerous amounts of active ingredients that can create additional risks.

In September 2016, the FDA warned against the use of homeopathic teething tablets and gels containing belladonna, a toxic substance that has an unpredictable response in children under two years of age, after the products were associated with serious adverse events, including seizures and deaths, in infants and children. An FDA lab analysis later confirmed that certain homeopathic teething tablets contained elevated and inconsistent levels of belladonna. A similar issue occurred in 2010 when Hyland’s Teething Tablets were found to contain varying amounts of belladonna. An FDA inspection of that product’s manufacturing facility indicated substandard control of the product’s manufacturing.

The FDA has issued warnings related to a number of other homeopathic drug products over the past several years. These include certain homeopathic zinc-containing intranasal products that may cause a loss of sense of smell, homeopathic asthma products that have not been shown to be effective in treating asthma and various homeopathic drug products labeled to contain potentially toxic ingredients, like nux vomica, which contains strychnine (a highly toxic, well-studied poison often used to kill rodents).

“Homeopathic products have not been approved by the FDA for any use and may not meet modern standards for safety, effectiveness and quality,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “The draft guidance is an important step forward in the agency’s work to protect patients from unproven and potentially dangerous products.”…

The FDA is not alone in reexamining its approach to homeopathy. In November 2016, the Federal Trade Commission (FTC) announced a new enforcement policy explaining that they will hold efficacy and safety claims for over-the-counter homeopathic drugs to the same standard as other products making similar health claims. Notably, the FTC said that companies must have competent and reliable scientific evidence for health-related claims, including claims that a product can treat specific conditions…

END OF QUOTE

US homeopaths were quick to respond, as reported here:

The National Center for Homeopathy’s board of directors stated:

The National Center for Homeopathy supports the FDA’s efforts to ensure safety and good manufacturing practices in the industry. We are committed to working with industry partners to protect consumer access to homeopathic medicines, and we are hopeful that this action will not impede access. Homeopathic medicines are safe, gentle and effective when products are manufactured in accordance with HPUS (Homoeopathic Pharmacopoeia of the United States) guidelines under CGMPs (Current Good Manufacturing Practices). We welcome the opportunity to educate consumers and healthcare professionals about the unique aspects of homeopathic medicine.

Of course, the unique aspect of homeopathic medicines undoubtedly is that they usually contain no active molecules and therefore do not work. But somehow, I doubt that the NCH was thinking of telling consumers the truth.

The NCH statement is tame in comparison with the NCH’s response to the FDA’s actions during the homeopathic teething investigation last year. Prior to the recall, the FDA issued a warning to consumers, which the NCH dubbed as “arbitrary and capricious.” The NCH went on to say that the FDA’s warning led to “exaggerated fear mongering” in the media and a “public scare” that threatened access to homeopathic products. “[G]roups interested in seeing homeopathy destroyed continue to hammer away at the system—making exaggerated claims that create misunderstandings about and limit consumer access,” the NCH wrote [emphasis theirs].

And this response is tame compared to what a prominent US homeopaths claimed at the time:

“It’s time to hold these people accountable. There are laws in every country against officials taking bribes and malfeasance in office. Write to your legislators and demand that they investigate and bring these criminals to justice. Send them the links to hundreds of homeopathy studies, including disease prevention with homeopathy, at the end of this article.   Tell them that the regulatory agencies are protecting Pharma profits, not the public.

Meanwhile, let us insist that pharmaceutical drugs be labeled honestly, like this:

“This drug was tested by the same company that profits from it, and which company has been fined millions of dollars in the past for lying about test results. This drug does not cure any medical condition, but only suppresses symptoms which may ultimately make the patient sicker. This drug has already  killed or injured X  number of people.”

The outrage is understandable for two reasons, I think:

  1. even homeopaths cannot deny that the days of unchecked claims are counted;
  2. against rage of this sort homeopathic remedies are obviously not working.
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