Friday, 25 November 2016

Qualified to judge?

One of the claims that is frequently made by some homeopaths is that the ASA has used expert witnesses who are not in a position to draw conclusions about homeopathy because they have no qualifications in homeopathy. It is often an accusation made of anyone who criticises homeopathy.

Not Occult
Occult can be defined as "knowledge of the hidden". It seems apt in this context as some have accused homeopathy of being "occult" in the common sense of the word.

The idea put forward that homeopathy can only be judged by those "qualified" in homeopathy is strange. There is a vast amount of "information" (some of which is wildly contradictory) on homeopathy in the public domain. Many out-of-copyright books can be found on the internet, including those by Hahnemann, etc. There are many other resources too that cast light on the various modern practices of homeopathy. Also, there is David Colquhoun's FOIA request which obtained course materials from a now defunct BSc Homeopathy course.

Whether one accepts the tenets of homeopathy, there is nothing mysterious about it. Gaining a "qualification" in homeopathy (certainly in the UK) does not confer some special status. Homeopathy is not a mystery religion nor is it an esoteric order with levels of initiation. There is no secret knowledge imparted on "qualification". At best, you get to put a few letters after your name of questionable status.

Homeopathy is in reality a form of vitalism

Plausibility
There are three elements in considering plausibility.

Firstly, the vitalistic homeopathic concept of "dis-ease" -
...they are solely spirit-like (dynamic) derangements of the spirit-like power (the vital principle) that animates the human body.
Hanhnemann posited that disease was caused by invisible, intangible forces called miasms (apologies for the gnomic language), which is not quite like miasmatic theory. Hahnemann died before germ theory had become accepted. Whether he would have revised his thinking in the light of the work of Pasteur and Koch is moot. But what is clear is that many of his followers did not revise their thinking. James Tyler Kent said -
The microbe is not the cause of disease. We should not be carried away by these idle allopathic dreams and vain imaginations but should correct the √Član vital.
and
The bacteria is an innocent feller, and if he carries disease he carries the Simple Substance which causes disease, just as an elephant would.
The degree to which modern homeopaths reject germ theory varies and there does seem to be tremendous confusion in some - miasms get mixed up with germ theory, genetic conditions and other causes in an opaque and muddied mishmash. There is also the problem of a public that largely accepts germ theory (and other causes) even if vitalism still has some hold on the popular imagination (qv Star Wars and its concept of the "Force").

Secondly the linked concepts "susceptibility" and "suppression".

There is nothing particularly controversial in stating various factors such as genetics, environment, lifestyle and current health status play a role in the likelihood of developing a certain condition. These factors can make you more susceptible to contracting disease. For example, if you have lowered immune system function, the more likely you are to develop pathogenic infections and the more likely to experience serious symptoms whilst others maybe be totally asymptomatic. However, the homeopathic concept of susceptibility is somewhat different. Do read that article carefully as clearly demonstrates how different the ideas are. Some other homeopaths would also stress the moral/spiritual aspects of susceptibility - the "vital force" is essentially spiritual. Morality and spirituality are strongly linked in some minds.

Again, homeopaths can become very confused between modern ideas of risk factors in health and the homeopathic notion of susceptibility.

Suppression is basically the idea that if you treat a symptom with conventional medicine, you do not address the cause. That cause left untreated will manifest itself in more and probably more serious symptoms. For example, if you apply a soothing cream to an itchy rash, you will develop a more serious "dis-ease" like psoriasis. This idea is at the heart of many homeopaths antipathy towards conventional medicine. Of course, when a homeopathic remedy is used to alleviate a symptom, it does not cause suppression.

Some conditions have no cure. Often the best that conventional medicine can do is help manage the condition in such a way as allow the best quality of life for the patient. This can involve lifestyle advice, etc. There can be conflict between the concept of homeopathy being able to cure almost anything if only the right remedy can be found and acknowledging medical reality.

Thirdly, the theory of homeopathic "cure".  At the heart of it, yes, correcting imbalances in the vital force caused by miasmatic influence but how? Especially in the light of how homeopathic remedies are prepared? It is assumed that most readers will know - if you do not, follow the link. A few theories (in no particular order) associated with homeopathic cure -
  • "Like cures like" or the law of similars - the concept that a substance that causes symptoms in a healthy individual can cure disease with the same symptoms.
  • Law of Simplex - only a single remedy to be given in a period of time (which is a matter of debate how long it should be).
  • Minimum dose - The quantity of a medicine which is though smallest in quantity produces the least possible excitation of the "vital force" and yet sufficient to effect the necessary change in it. Or something along those lines.
  • Potentisation - A "process by which the medicinal properties which are latent in natural substances while in their crude state, become awakened and developed into activity to an incredible degree." The "energetic essence" or "dematerialised spiritual force" is transferred from the original substance by a process of sequential dilution and mechanical agitation. This aspect of homeopathy that draws the most criticisms regarding plausibility. Homeopathic remedies are often created from substances that have been so diluted that the probability of them containing even a single molecule of the original substance is infinitesimal - for practical purposes zero. This linked to the idea that the more dilution occurs, the more powerful the remedy is, which draws even more criticism.
  • Doctrine of Proving - This needs to be considered in the context of the Law of Similiars. "Proving" is a not a clinical trial in the common sense of the phrase. There are no controls, the "symptoms" recorded not only relate to the physical but also the emotional and psychological. Indeed, many homeopaths place great store on dreams experienced.
  • Direction of Cure - This is linked to the idea that homeopathy often doesn't "cure" with use of a single remedy. Over time, different remedies are given, alleviating different symptoms. More recent symptoms are "cured" first, older symptoms later. "Cure" often works from vital organs to less vital organs, from the centre to the circumference, from above downwards. "Dis-ease" if often seen as being like an onion, "cure" peels away layers of symptoms and causation.
  • Aggravation - The justifications of aggravations are too long to go into here. In short, selecting the wrong remedy or wrong potency can induce "artificial disease". Most would call these side effects.
  • Healing Crisis - In homeopathic terms, this could be thought of the appearance of suppressed symptoms. It can be thought of terms of feeling worse as a result of toxins (actual or spiritual/moral) being released before they are expelled from the body. Certain medical treatments can do this but it is called a side effect.
  • Totality of Symptoms - Homeopathic remedies are often selected on the basis of comparing a patient's symptoms, one by one, with symptoms listed in a Repertory. Suggested remedies for each symptom are compared (of which there can be many) and in theory the remedy that is listed with the majority of symptoms is chosen. Computerised repertories exist which reduce the need to trawl through pages of a book. However, the symptoms used can be as baroque as the ones mentioned in provings and many of them would be thought by most to be irrelevant.
The Man on the Clapham omnibus is a legal fiction who is a reasonably educated and intelligent but nondescript person, against whom the defendant's conduct can be measured. It would be reasonable to ask the question as to whether such an individual when presented with a concise description of core homeopathic theories would find them plausible? Would they not see contradictions in them or the disdain for conventional medicine? If the line is taken that such a person lacks the "qualifications" to make such a judgment then either the explanation is insufficient clear or a piece of information is missing. The point is made again that there is nothing particularly mysterious about the tenets of homeopathy.

It is possible to ignore the question of plausibility. Some homeopaths say they do not know how homeopathy works, but they insist that it does. A pragmatic viewpoint even if does invalidate much of what homeopaths are taught - it involves ditching all the theory. Pragmatically, if homeopathic remedies are efficacious, who cares how they work?

Efficacy
Efficacy is a difficult concept for some. It has a specific meaning in this context -
It is used in pharmacology and medicine to refer to both the maximum response achievable from a pharmaceutical drug in research settings, and to the capacity for sufficient therapeutic effect or beneficial change in clinical settings.
Effectiveness, whilst synonymous with efficacy in the common sense of the word, also has a specific meaning -
Effectiveness refers to "how the drug works in a real-world situation," and is "often lower than efficacy because of interactions with other medications or health conditions of the patient, sufficient dose or duration of use not prescribed by the physician or followed by the patient, or use for an off-label condition that had not been tested."
Efficacy is determined by clinical trials. They can take various forms but the "gold standard" is considered the Randomised Controlled Trial (RTC). There are forms of clinical trials as well but they are considered less powerful (although they can provide useful results). A fuller discussion of clinical trials is beyond the scope of this blog. Nevertheless, the quality of a clinical trial is down to two main factors - the design of the trial to eliminate potential bias (although this does not help with reporting bias) and the size of the trial. It also helps if the outcomes are physically measurable as opposed to subjective scoring of subject experience - quantitative rather that qualitative.

The Man on the Clapham omnibus certainly would lack the specialist skills and knowledge to evaluate a trial design, detect any problems with bias, and interpret the results as would a member of the ASA or the vast majority of homeopaths (if any) for that matter. So obviously, it would make sense for the ASA to use an external expert. If the objection is again raised of lack of homeopathic "qualifications" and accusations of bias are made, the difficult is that some with homeopathic "qualifications" would be unlikely to have the right skills and knowledge and even if they did, they would be open to questions of confirmation bias especially in assessing trials that had confirmation bias themselves.

Effectiveness? There are ways to study this but without the benchmark of efficacy, the measure would have little meaning. Off-label use is another matter though and beyond the scope of this blog.

Clinical trials - a bad fit?
It is often said that clinical trials, especially RCTs are a bad fit for homeopathy. Homeopathy treats the person not the disease, the totality of symptons, etc or whatever any of that means. There is some truth in that designing a trial/study to measure the efficacy of homeopathy is difficult - which will be discussed later.

One problem with any clinical trial of homeopathy is cost. Organisations that provide research grants have criteria in assessing any potential trial. Plausibility certainly is one.  Whilst some homeopathic medicine manufacturers are large and extremely profitable, they do not seem to disburse funds for large scale trials. Smaller trials are possible but would lack statistical power.

Another problem with any clinical trial are the ethics of giving patients with a more serious pre-existing condition a placebo. This would limit clinical trials to minor self-limiting conditions.

It may also be the case that some homeopaths believe that a single positive study that has sufficient size, statistical power and significance would validate the whole of homeopathy, especially if it was replicated. However unlikely this might appear, even if it happened it would not. It would apply to a single remedy. Such a trial might be better as a three-armed trial - placebo, remedy A and remedy B.

One of the problems with trials of homeopathy is that is very likely that the consultation would enhance any potential effect from the remedies (placebo or not). This study comes to the conclusion that homeopathy remedies have no effect in patients with rheumatoid arthritis but the consultation does, albeit on secondary outcomes. It has been long suggested that this might well be the case (see here for another take on that). A homeopathic consultation is much longer than a GP appointment, for example, and has a much broader scope. The validity of the trial is not a question to be addressed here (for one thing it is small) but certainly it does provide a potential model for future trials involving other conditions. It would also be useful to compare, perhaps, homeopathic consultations with a sham homeopathic consultation or talking therapies.

Certainly not a conclusion that would please some homeopaths. 

There are homeopathic medicines that are widely available over the counter (OTC) and can be sold by any retail outlet - they are on the General Sales List (GSL). Some even have indications for use. The Human Medicines Regulations 2012 allow this without any need for evidence of efficacy. This is unlikely to change - there is no requirement for them to undergo clinical trails. But a homeopathic medicine that made claims beyond "traditionally used in homeopathy for minor self-limiting condition X" would need to. 

Homeopathy has a concept of the genus epidemicus. Unfortunately, it is difficult to find a succinct definition but...
A remedy which is found to be curative in the majority of cases of the same disease (e.g. epidemics). Hahnemann taught that the genus epidemicus remedies should be chosen by the uncommon characteristic symptoms of all the patients not the common symptoms of the epidemic disease.
Which would certainly be amenable to RCTs although the ethics of performing one during an epidemic would highly question. The concept of the genus epidemicus is often associated with homeoprophylaxis.
Homeoprophylaxis (HP) is the use of potentized substances in a systematic manner to prevent the development of the characteristic symptoms of disease.
In other words, homeopathic immunisation. Again, amenable to RCTs although there would be ethical problems. Homeoprophylaxis is very controversial even amongst homeopaths. Trials have been done, the ethics of which raise serious questions.

Confirmation bias and cognitive dissonance
It is clear that in presenting evidence of the efficacy of homeopathy, many homeopaths are very selective in which trials and studies they pick and ignore all the rest. The quality of the trials and studies they pick are immaterial to them, that is even if they have the ability to determine the quality of them. Of the eight homeopaths mentioned in the Quackometer blog, none appear to have any kind of biomedical qualification.

It also seems to be the case that anyone who presents evidence contrary to their point of view is presumed to be biased. Either you are with them, or against them. Which is a false dichotomy. Saying that there is currently, on balance, no compelling evidence that homeopathic remedies have any effect greater than placebo is in fact a neutral position. It leaves open the door to future evidence. "Homeopathy does not work" is not a neutral position. Saying that the purported mechanism of action is implausible as it would violate what is currently known of physics, chemistry and biology is also a neutral position. 

The letter on the Quackometer blog could be read to imply conspiracy on the part of some. It is not unknown for homeopaths to invoke conspiracy theories, especially regarding vaccination and "Big Pharma" (although that is not to discount the malfeasance on the part of pharmaceutical companies). The psychology of conspiracy theories is interesting in itself.

The letter also contains ad hominem criticisms that are irrelevant to the question of whether speech is being restricted. Ad hominem tu quoque.

Homeopathy on trial?
Whilst there have been UK court cases that have involved homeopaths either as defendants or witnesses, research has not revealed a case where a homeopath has been put on trial for the practice of homeopathy. Research has not revealed a case where a non-medically qualified (lay) homeopath has been called as an expert witness. Nor has it revealed a case where a court has been asked to decide on the validity of homeopathy.

There is unlikely ever to be one. The practice of homeopathy in itself is not illegal.

Solutions
Obviously anyone who wishes to make a judgment on homeopathy needs a "qualification" in homeopathy. Fortunately, there are several ways to do this. Boiron offer online training. It's also possible to purchase qualifications up to a Ph.D from a diploma mill. Or you could knock one up on your computer using grandiloquent language, print it out and frame it. This would remove any objections by homeopaths, surely? There are homeopaths practicing who do have diploma mill "qualifications".

Joking aside, homeopaths need to understand the different between pure and commercial speech, promotion and editorial, fact and opinion. That there is a need to self-censor when promoting homeopathic services and medicines to the public. It is the price of doing business. Separation of activities is key. Write books, articles, forum posts, etc and they are free speech (subject to the legal limitations - and be careful of unbalanced coverage of unlicensed homeopathic medicines in more public fora though). It is linkage that is the problem. Also beware that email newsletters can be problematic.

Returning to the question of "qualifications" - publicly stating that someone is in no position to make judgments on the plausibility and efficacy of homeopathic services and medicines can have the effect of reducing your own credibility with potential consumers. It also implies that consumers can not rationally choose a homeopathic service or medicine without in depth knowledge of homeopathy. It is better not to make such statements.

6 comments:

  1. Not knowing why a particular treatment "works" or not isn't actually too much of an issue in medicine as, for example, it is still not known how many anaesthetic drugs (e.g. volatile agents). However, the inescapable fact is that when tested in clinical trials of sufficient rigour (in terms of statistical power and clinical significance), homeopathy fails to show benefit beyond placebo. The homeopathy literature is littered with positive results from small, grossly underpowered and clinically insignificant trials. Homeopaths then use special pleading to claim the trials process was not appropriate for testing their "remedies", ignoring the fact that there have been many homeopaths involved in the design of the trials. They then whine when meta-analyses and reviews show that when the results of the small trials are pooled and analysed using well-established scientific methodologies, their "remedies" are no better than placebo. This is perhaps well illustrated by the woops of delight from homeopathy when a meta-analysis by Linde et al seemed to show benefit for homeopathy. They then cry foul when a subsequent re-analysis by Linde et al showed that homeopathy is no better than placebo. And then there's their reaction to the Australian NHMRC report on homeopathy. Scientifically, this report is "game over" for homeopathy, but it's the zombie apocalypse of medicine - it refuses to go away. Too many people have invested their time, energy and money into it that the cognitive dissonance is too hard to handle. So much of their assessment of the efficacy relies on reports of how the patient feels rather than (or indeed in spite of) being based on objective data. The problem here is that people may feel better purely because of the placebo effect yet still be at great risk from the actual disease, particular chronic illnesses which have a natural cycle, when regression towards the mean becomes a key component of any improvement noted. That homeopaths fail to, or refuse to, grasp such essential issues in the treatment of illnesses is their biggest failing. Not knowing why a treatment works (or not) is perhaps less of an issue - it wasn't known for many years why an antibiotic worked for some infections but ot others, but science has now sorted this out. Homeopathy is still stuck in Hahnemann's era in this respect.

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    Replies
    1. 1. "the inescapable fact is that when tested in clinical trials of sufficient rigour (in terms of statistical power and clinical significance), homeopathy fails to show benefit beyond placebo."

      Edzard Ernst book:

      'Several well-conducted clinical studies of homeopathy with positive results have been published. It is therefore not true to claim that there is no good trial evidence at all'

      2. 'The homeopathy literature is littered with positive results from small, grossly underpowered and clinically insignificant trials.'

      Yeah, and Clinical research not?
      http://www.bmj.com/content/328/7438/485.2

      'drug companies to GPs in Germany has shown that about 94% of the information in them has no basis in scientific evidence.'

      Is a tiny example of the ground.

      3. "Ignoring the fact that there have been many homeopaths involved in the design of the trials.'

      This was only applied when the RCT are based on complex homeopathy, not individualized.

      4. "They then whine when meta-analyses and reviews show that when the results of the small trials are pooled and analysed using well-established scientific methodologies, their "remedies" are no better than placebo."

      Again, false.

      https://systematicreviewsjournal.biomedcentral.com/articles/10.1186/2046-4053-3-142

      'Medicines prescribed in individualised homeopathy may have small, specific treatment effects. Findings are consistent with sub-group data available in a previous ‘global’ systematic review... New RCT research of high quality on individualised homeopathy is required to enhance the totality of reliable evidence and thus enable clearer interpretation and a more informed scientific debate.'

      5. " when a meta-analysis by Linde et al seemed to show benefit for homeopathy. They then cry foul when a subsequent re-analysis by Linde et al showed that homeopathy is no better than placebo."

      False. Quote from original Linde paper (1999):

      'Our analyses provide clear evidence that in the study set in-
      vestigated more rigorous trials tended to yield smaller effect
      sizes.. The results are comparable to those from similar analyses in conventional medicine... it becomes obvious that there is no clear linear relationship between these two parameters'

      This point is coherent with my response from point 1 and 4.

      6. "And then there's their reaction to the Australian NHMRC report on homeopathy"

      NHMRC Report is biased. The definition is very funny:

      'Homeopathy is a type of complementary and alternative medicine. It is based on two main ideas: that
      substances that may cause illness or symptoms in a healthy person can, in very small dose'

      'Homeopathy is a type of complementary and alternative medicine that is commonly used in Australia
      and around the world. It is based on two premises:
      • that substances that may cause illness or symptoms in a healthy person can, in very small doses,
      treat those symptoms in a person who is unwell, and
      • that highly diluted preparations retain a ‘memory’ of the original substance. Homeopathic
      medicines are prepared by taking a substance (e.g. plant, animal material, or chemical), diluting
      it in water or alcohol, then forcefully hitting the container against a hand or a surface. This process
      is repeated several times.'

      From Ernst E:

      'Moreover, not all homeopathic remedies are highly diluted and thus some can contain pharmacologically active compounds for affecting human health; they cannot therefore be classified as implausible.'

      More?
      Ernst contradictions below:

      http://explicandoalexplicador.blogspot.com/2016/02/el-sacerdocio-de-la-ciencia-xxxviii.html

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    2. "Yeah, and Clinical research not? "
      Tu quoque fallacy. Or, in this case, motes and beams.
      That some clinical research is poorly and/or fraudulently conducted (e.g. Wakefield) does not magically make homeopathy more effective than placebo, nor does it validate bad homeopathic research.

      Delete
    3. Anachic troll

      The tu quoque fallacy is valid only if the opponent try to valide homeopathy with this. The link were only for comparation purposes.

      The poor "blog posts" as the Uk "lawyer" (the guy is a not real lawyer) were not debunks, are a big straw man fallacies.

      Delete
    4. The profile makes clear that the author is not a lawyer. It is not necessary to have a legal qualification in order to be able to understand the implications of law.

      Delete
  2. Your points are accepted.

    The mechanism of action of a particular molecule not being understood would not prevent the testing of similar or derived molecules. It is plausible. It is not plausible to expect that something similar to or derived from something that has no effect to have an effect.

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