MD, PhD, FMedSci, FSB, FRCP, FRCPEd

ethics

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Adverse events have been reported extensively following chiropractic.  About 50% of patients suffer side-effects after seeing a chiropractor. The majority of these events are mild, transitory and self-limiting. However, chiropractic spinal manipulations, particularly those of the upper spine, have also been associated with very serious complications; several hundred such cases have been reported in the medical literature and, as there is no monitoring system to record these instances, this figure is almost certainly just the tip of a much larger iceberg.

Despite these facts, little is known about patient filed compensation claims related to the chiropractic consultation process. The aim of a new study was to describe claims reported to the Danish Patient Compensation Association and the Norwegian System of Compensation to Patients related to chiropractic from 2004 to 2012.

All finalized compensation claims involving chiropractors reported to one of the two associations between 2004 and 2012 were assessed for age, gender, type of complaint, decisions and appeals. Descriptive statistics were used to describe the study population.

338 claims were registered in Denmark and Norway between 2004 and 2012 of which 300 were included in the analysis. 41 (13.7%) were approved for financial compensation. The most frequent complaints were worsening of symptoms following treatment (n = 91, 30.3%), alleged disk herniations (n = 57, 19%) and cases with delayed referral (n = 46, 15.3%). A total financial payment of €2,305,757 (median payment €7,730) were distributed among the forty-one cases with complaints relating to a few cases of cervical artery dissection (n = 11, 5.7%) accounting for 88.7% of the total amount.

The authors concluded that chiropractors in Denmark and Norway received approximately one compensation claim per 100.000 consultations. The approval rate was low across the majority of complaint categories and lower than the approval rates for general practitioners and physiotherapists. Many claims can probably be prevented if chiropractors would prioritize informing patients about the normal course of their complaint and normal benign reactions to treatment.

Despite its somewhat odd conclusion (it is not truly based on the data), this is a unique article; I am not aware that other studies of chiropractic compensation  claims exist in an European context. The authors should be applauded for their work. Clearly we need more of the same from other countries and from all professions doing manipulative therapies.

In the discussion section of their article, the authors point out that Norwegian  and Danish chiropractors both deliver approximately two million consultations annually. They receive on average 42 claims combined suggesting roughly one claim per 100.000 consultations. By comparison, Danish statistics show that in the period 2007–2012 chiropractors, GPs and physiotherapists (+ occupational therapists) received 1.76, 1.32 and 0.52 claims per 100.000 consultations, respectively with approval rates of 13%, 25% and 21%, respectively. During this period these three groups were reimbursed on average €58,000, €29,000 and €18,000 per approved claim, respectively.

These data are preliminary and their interpretation might be a matter of debate. However, one thing seems clear enough: contrary to what we frequently hear from apologists, chiropractors do receive a considerable amount of compensation claims which means many patients do get harmed.

This investigation was aimed at examining the messages utilised by the chiropractic profession around issues of scope and efficacy through website communication with the public. For this purpose, the authors submitted the website content of 11 major Canadian chiropractic associations and colleges, and of 80 commercial clinics to a mixed-methods analysis. Content was reviewed to quantify specific health conditions described as treatable by chiropractic care. A qualitative textual analysis identified the primary messages related to evidence and efficacy utilised by the websites.

The results show that chiropractic was claimed to be capable of addressing a wide range of health issues. Quantitative analysis revealed that association and college websites identified a total of 41 unique conditions treatable by chiropractic, while private clinic websites named 159 distinct conditions. The most commonly cited conditions included back pain, headaches/migraines and neck pain. Qualitative analysis revealed three prominent themes drawn upon in discussions of efficacy and evidence: grounded in science, the conflation of safety and efficacy and “natural” healing.

The authors concluded that the chiropractic profession claims the capacity to treat health conditions that exceed those more traditionally associated with chiropractic. Website content persistently declared that such claims are supported by research and scientific evidence, and at times blurred the lines between safety and efficacy. The chiropractic profession may be struggling to define themselves both within the paradigm of conventional science as well as an alternative paradigm that embraces natural approaches.

These findings strike me as being similar to the ones we published 4 years ago. At this stage, we had conducted a review of 200 chiropractor websites and 9 chiropractic associations’ World Wide Web claims in Australia, Canada, New Zealand, the United Kingdom, and the United States. The outcome measures were claims (either direct or indirect) regarding the eight reviewed conditions, made in the context of chiropractic treatment: asthma, headache/migraine, infant colic, colic, ear infection/earache/otitis media, neck pain, whiplash (not supported by sound evidence), and lower back pain (supported by some evidence).

We found evidence that 190 (95%) chiropractor websites made unsubstantiated claims regarding at least one of the conditions. When colic and infant colic data were collapsed into one heading, there was evidence that 76 (38%) chiropractor websites made unsubstantiated claims about all the conditions not supported by sound evidence. Fifty-six (28%) websites and 4 of the 9 (44%) associations made claims about lower back pain, whereas 179 (90%) websites and all 9 associations made unsubstantiated claims about headache/migraine. Unsubstantiated claims were made about asthma, ear infection/earache/otitis media, neck pain.

At the time, we concluded that the majority of chiropractors and their associations in the English-speaking world seem to make therapeutic claims that are not supported by sound evidence, whilst only 28% of chiropractor websites promote lower back pain, which is supported by some evidence. We suggest the ubiquity of the unsubstantiated claims constitutes an ethical and public health issue.

Comparing the two studies, what should we conclude? Of course, the new investigation was confined to Canada; we therefore cannot generalise its results to other countries. Nevertheless it provides a fascinating insight into the (lack of) development of chiropractic in this part of the world. My conclusion is that, at least in Canada, there is very little evidence that chiropractic is about to become an ethical and evidence-based profession.

The question that I hear with unfailing regularity when talking about alternative medicine is WHY IS IT SO POPULAR? I always struggle to find a simple answer – mainly because there is no simple answer. The reasons for patients and consumers to use alternative medicine are complex and multiple. They range from dissatisfaction with conventional medicine to clinging to the last straw. However, one factor is very clearly always involved: the often bafflingly uncritical promotion of quackery by the daily papers – and that even includes those with a reputation for being respectable.

Yesterday’s article in THE TELEGRAPH is as good an example as any. In the following section, I quote excerpts from it and add my own comments in bold. 

It is perhaps easier to list what the naturopath Katrin Hempel doesn’t offer her clients than what she does. Bioresonance and live blood analysis, acupuncture, biopuncture, infusion therapy, oxyvenation…”

Katrin Hempel, B.H.Sc.,ND, Dipl.Ac. describes herself on her website as an energetic, enthusiastic and experienced natural therapist with a great passion and commitment to the health and well-being of her patients. She calls herself a ‘naturopathic doctor’. I am not sure what this actually is but I am fairly sure she has not studied medicine. I do not doubt her enthusiasm, but I do doubt that most of the methods listed above are anything else but pure quackery.

“Germany has a long tradition of natural medicine, so it’s more common to find conventional doctors who have also studied natural medicine and use these modalities. Here we are at least 20 years behind.” That is true only, if one regards the integration of quackery as progress.

“Every cell in the body puts out a certain electromagnetic frequency, that can be measured – a healthy stomach cell sounds different to a healthy brain cell – and the machine can put the right resonance back in, to trigger deep healing.”) This is pure pseudoscience; neither live blood analysis nor bioresonance are supported by good evidence (and don’t even ask about ‘biopuncture’).

The article goes on misleading the reader in the most scandalous way by promoting pure nonsense. To provide a flavour, I will merely cite a few quotes from the ‘naturopathic doctor':

  • “If your digestion isn’t working properly there is a malabsorption of nutrients”
  • “Bioresonance can pick up a condition before it manifests as a disease.”
  • “Bioresonance measures the electromagnetic output of every cell in the body. If there’s any discrepancy with the healthy frequency for that kind of cell that gives a diagnosis.”
  • “Whatever the problem, at root it will be an imbalance in the cells.”

At no point in this article is there an attempt to challenge or critically analyse this bonanza in quackery; THE TELEGRAPH promotion of dangerous nonsense ends with the cheerful footnote informing the reader that one hour with the ‘naturopathic doctor’ will cost from £100. THE TELEGRAPH does not even shy away to print an address for booking a consultation with the ‘naturopathic doctor’.

But is it really all quackery? Yes it is! The article promotes so many unproven methods that I find it hard to choose one for demonstrating how irresponsible it really is. Let’s take life blood analysis (LBA), for instance; here is what I published about LBA some time ago:

The principle of LBA is fairly simple: a drop of blood is taken from your fingertip, put on a glass plate and viewed via a microscope on a video screen. Despite the claims made for it, LBA is by no means new; using his lately developed microscope, Antony van Leeuwenhoek observed in 1686 that living blood cells changed shape during circulation. Ever since, doctors, scientists and others have studied blood samples in this and other ways.

What is new, however, is what today’s “holistic practitioners” claim to be able to do with LBA. Proponents believe that the method provides information “about the state of the immune system, possible vitamin deficiencies, amount of toxicity, pH and mineral imbalance, areas of concern and weaknesses, fungus and yeast”, as another website puts it.

Others dare to be much more concrete and claim that they can “spot cancer and other degenerative immune system diseases up to two years before they would otherwise be detectable”; or say they can diagnose “lack of oxygen in the blood, low trace minerals, lack of exercise, too much alcohol or yeast, weak kidneys, bladder or spleen”. All this would amount to a remarkable discovery if it were true. But it’s not.

No credible scientific studies have demonstrated the reliability of LBA for detecting any of the above conditions. In what was, to the best of my knowledge, the first attempt to assess the value of this method, a practitioner with several years of experience in LBA tested the samples of 110 patients. Twelve had cancer and the task was to identify their samples without knowing further details. The results could hardly have been more disconcerting – just three of the 12 with confirmed cancer were detected, and the authors concluded that the method “does not seem to reliably detect cancer. Clinical use of the method can therefore not be recommended.”

And, in case you do not trust me, here is a recent Advertising Standards Authority ruling on LBA:

London Natural Therapies is in breach of the UK Advertising Standards Code for making unproven claims on its website about Live Blood Analysis. The CAP Compliance team has contacted London Natural Therapies several times about removing claims implying that Live Blood Analysis could be beneficial for Gastro Intestinal Tract Disorders, Allergies and Hormonal Imbalances after the ASA previously ruled that Live Blood Analysis was not effective in detecting/diagnosing those conditions. Despite repeated requests to remove the problem claims, London Natural Therapies continues to feature them on its website, www.londonnaturaltherapies.co.uk. Because of London Natural Therapies continued non-compliance we took the decision to place its details on this section of the ASA website on 26 June 2012. These details shall remain in place until such time as London Natural Therapies has removed or appropriately amended the claims on its website to ensure compliance with the CAP Code.

This is but one of many examples of truly shoddy journalism published in a daily paper that most people would call ‘respectable’. If anyone cares to look at the less respectable end to the journalistic spectrum, the picture gets even more horrific. The points I am trying to make are simple and, I think, important:

  1. Journalists and editors have a responsibility which, in the realm of alternative medicine, they often disregard most scandalously.
  2. Such poorly researched, unbalanced and uncritical articles can cause very serious harm.
  3. The promotion of quackery may be good for selling copy, but it can also quickly ruin the reputation of a paper.

“Dr” Brian Moravec is a chiropractor from the US; he has a website where he describes himself and his skills as follows: I attended Chiropractic College and I am a graduate of Palmer College of Chiropractic in Davenport Iowa. I earned a Bachelor of Science degree as well as my Doctor of Chiropractic degree from Palmer College, which is the first chiropractic college in the world and the origin of our profession. I also attend continuing education seminars designed to keep doctors current with regard to clinical chiropractic, technique and nutrition.

The key to overall health and wellness is to have a healthy nervous system and that is what I do as a chiropractor – I make sure that your spine is functioning at its best so that your nervous system functions at its best. When the nervous system is functioning at 100%, you are a healthier individual that experiences a higher quality of life and health. I know this to be true in myself, my family and my patients.

I go to great lengths to provide my patients with the best chiropractic care I can give. I work with my patients to design a treatment plan that will be effective for their particular condition and specific to their needs. We utilize manual and low force techniques (safe and effective for newborns to seniors), to correct sublaxations in the spine. Chiropractic adjustments remove nerve interference, which allows the body to perform at its best again. I also am available for consultations on nutrition and diet, dietary supplementation and how to minimize the wear and tear on your spine.

[Emphases are mine]

What he does not state is the fact that he also is a nifty e-mail writer!

To my great surprise, I received an e-mail from him which is far too good to be kept for myself. So I decided to share it with my readers; here it is in its full and unabbreviated beauty:

its interesting to see someone with your education, and is a self proclaimed “expert” on alternative medicine, promote so much misinformation with regard to chiropractic care.   fortunately you look old.  and soon will be gone.  I always refer to the few of you anti chiropractic fools left here as “dinosaurs”.   the proof is in the pudding my “friend”.  chiropractic works and will continue to be here for centuries more.   you and others with much much more power than you (the AMA for example) have tried to perpetuate lies and squash chiropractic.  you fail, and they failed, because whatever better serves mankind will stand the test of time.   you’re a dying breed edzard.  thank God.
yours in health,

brian moravec d.c.

I am encouraged to see that he recognises my education but do wonder why his upbringing obviously failed so dismally teach him even a minimum of politeness, tact, or critical thinking. It is disappointing, I think, that he does not even mention what he perceives as my lies about his beloved chiropractic. So sad, I am sure it would have been fun to debate with him.

‘Healing, hype or harm? A critical analysis of complementary or alternative medicine’ is the title of a book that I edited and that was published in 2008. Its publication date coincided with that of ‘Trick or Treatment?’ and therefore the former was almost completely over-shadowed by the latter. Consequently few people know about it. This is a shame, I think, and this post is dedicated to encouraging my readers to have a look at ‘Healing, hype or harm?’

One reviewer commented on Amazon about this book as follows: Vital and informative text that should be read by everyone alongside Ben Goldacre’s ‘Bad Science’ and Singh and Ernt’s ‘Trick or Treatment’. Everyone should be able to made informed choices about the treatments that are peddled to the desperate and gullible. As Tim Minchin famously said ‘What do you call Alternative Medicine that has been proved to work? . . . Medicine!’

This is high praise indeed! But I should not omit the fact that others have commented that they were appalled by our book and found it “disappointing and unsettling”. This does not surprise me in the least; after all, alternative medicine has always been a divisive subject.

The book was written by a total of 17 authors and covers many important aspects of alternative medicine. Some of its most famous contributors are Michael Baum, Gustav Born, David Colquhoun, James Randi and Nick Ross. Some of the most important subjects include:

  • Compassion
  • Quackademia
  • Impartiality
  • Ethics
  • Politics
  • Holism
  • Vitalism
  • Placebo

As already mentioned, our book is already 6 years old; however, this does not mean that it is now out-dated. The subject areas were chosen such that it will be timely for a long time to come. Nor does this book reflect one single point of view; as it was written by over a dozen different experts with vastly different backgrounds, it offers an entire spectrum of views and attitudes. It is, in a word, a book that stimulates critical thinking and thoughtful analysis.

I sincerely think you should have a look at it… and, in case you think I am hoping to maximise my income by telling you all this: all the revenues from this book go to charity.

In 2004, I published an article rather boldly entitled ‘Ear candles: a triumph of ignorance over science’. Here is its summary:

Ear candles are hollow tubes coated in wax which are inserted into patients’ ears and then lit at the far end. The procedure is used as a complementary therapy for a wide range of conditions. A critical assessment of the evidence shows that its mode of action is implausible and demonstrably wrong. There are no data to suggest that it is effective for any condition. Furthermore, ear candles have been associated with ear injuries. The inescapable conclusion is that ear candles do more harm than good. Their use should be discouraged.

Sadly, since the publication of this paper, ear candles have not become less but more popular. There are about 3 000 000 websites on the subject; most are trying to sell products and make claims which are almost comically misguided; three examples have to suffice:

I said ALMOST comical because such nonsense has, of course a downside. Not only are consumers separated from their cash for no benefit whatsoever, but they are also exposed to danger; again, three examples from the medical literature might explain:

  • Otolaryngologists from London described a case of ear candling presenting as hearing loss, and they concluded that this useless therapy can actually cause damage to the ears.
  • A 50-year-old woman presented to her GP following an episode of ear candling. After 15 minutes, the person performing the candling burned herself while attempting to remove the candle and spilled candle wax into the patient’s right ear canal. On examination, a piece of candle wax was found in the patient’s ear, and she was referred to the local ear, nose, and throat department. Under general aesthetic, a large mass of solidified yellow candle wax was removed from the deep meatus of the ear. The patient had a small perforation in her right tympanic membrane. Results of a pure tone audiogram showed a mild conductive hearing loss on the right side. At a follow-up appointment 1 month later, the perforation was still there, and the patient’s hearing had not improved.
  • case report of a 4-year-old girl from New Zealand was published. The patient was diagnosed to suffer from otitis media. During the course of the ear examination white deposits were noticed on her eardrum; this was confirmed as being caused by ear candling.

I should stress that we do not know how often such events happen; there is no monitoring system, and one might expect that the vast majority of cases do not get published. Most consumers who experience such problems, I would guess, are far to embarrassed to admit that they have been taken in by this sort of quackery.

It was true 10 yeas ago and it is true today: ear candles are a triumph of ignorance over science. But also they are a victory of gullibility over common sense and the unethical exploitation of naive hope by greedy frauds.

When someone has completed a scientific project, it is customary to publish it [‘unpublished science is no science’, someone once told me many years ago]. To do so, he needs to write it up and submit it to a scientific journal. The editor of this journal will then submit it to a process called ‘peer review’.

What does ‘peer review’ entail? Well, it means that 2-3 experts are asked to critically assess the paper in question, make suggestions as to how it can be improved and submit a recommendation as to whether or not the article deserves to be published.

Peer review has many pitfalls but, so far, nobody has come up with a solution that is convincingly better. Many scientists are under pressure to publish [‘publish or perish’], and therefore some people resort to cheating. A most spectacular case of fraudulent peer review has been reported recently in this press release:

SAGE statement on Journal of Vibration and Control

London, UK (08 July 2014) – SAGE announces the retraction of 60 articles implicated in a peer review and citation ring at the Journal of Vibration and Control (JVC). The full extent of the peer review ring has been uncovered following a 14 month SAGE-led investigation, and centres on the strongly suspected misconduct of Peter Chen, formerly of National Pingtung University of Education, Taiwan (NPUE) and possibly other authors at this institution.

In 2013 the then Editor-in-Chief of JVC, Professor Ali H. Nayfeh,and SAGE became aware of a potential peer review ring involving assumed and fabricated identities used to manipulate the online submission system SAGE Track powered by ScholarOne Manuscripts™. Immediate action was taken to prevent JVC from being exploited further, and a complex investigation throughout 2013 and 2014 was undertaken with the full cooperation of Professor Nayfeh and subsequently NPUE.

In total 60 articles have been retracted from JVC after evidence led to at least one author or reviewer being implicated in the peer review ring. Now that the investigation is complete, and the authors have been notified of the findings, we are in a position to make this statement.

While investigating the JVC papers submitted and reviewed by Peter Chen, it was discovered that the author had created various aliases on SAGE Track, providing different email addresses to set up more than one account. Consequently, SAGE scrutinised further the co-authors of and reviewers selected for Peter Chen’s papers, these names appeared to form part of a peer review ring. The investigation also revealed that on at least one occasion, the author Peter Chen reviewed his own paper under one of the aliases he had created.

Unbelievable? Perhaps, but sadly it is true; some scientists seem to be criminally ingenious when it comes to getting their dodgy articles into peer-reviewed journals.

And what does this have to do with ALTERNATIVE MEDICINE, you may well ask. The Journal of Vibration and Control is not even medical and certainly would never consider publishing articles on alternative medicine. Such papers go to one of the many [I estimate more that 1000] journals that cover either alternative medicine in general or any of the modalities that fall under this wide umbrella. Most of these journals, of course, pride themselves with being peer-reviewed – and, at least nominally, that is correct.

I have been on the editorial board of most of the more important journals in alternative medicine, and I cannot help thinking that their peer review process is not all that dissimilar from the fraudulent scheme set up by Peter Chen and disclosed above. What happens in alternative medicine is roughly as follows:

  • a researcher submits a paper for publication,
  • the editor sends it out for peer review,
  • the peer reviewers are either those suggested by the original author or members of the editorial board of the journal,
  • in either case, the reviewers are more than likely to be uncritical and recommend publication,
  • in the end, peer review turns out to be a farcical window dressing exercise with no consequence,
  • thus even very poor research and pseudo-research are being published abundantly.

The editorial boards of journals of alternative medicine tend to be devoid of experts who are critical about the subject at hand. If you think that I am exaggerating, have a look at the editorial board members of ‘HOMEOPATHY’ (or any other journal of alternative medicine) and tell me who might qualify as a critic of homeopathy. When the editor, Peter Fisher, recently fired me from his board because he felt I had tarnished the image of homeopathy, this panel lost the only person who understood the subject matter and, at the same time, was critical about it (the fact that the website still lists me as an editorial board member is merely a reflection of how slow things are in the world of homeopathy: Fisher fired me more than a year ago).

The point I am trying to make is simple: peer review is never a perfect method but when it is set up to be deliberately uncritical, it cannot possibly fulfil its function to prevent the publication of dodgy research. In this case, the quality of the science will be inadequate and generate false-positive messages that mislead the public.

My 2008 evaluation of chiropractic concluded that the concepts of chiropractic are not based on solid science and its therapeutic value has not been demonstrated beyond reasonable doubt. It also pointed out that the advice of chiropractors often is dangerous and not in the best interest of the patient: many chiropractors have a very disturbed attitude towards immunisation: anti-vaccination attitudes till abound within the chiropractic profession. Despite a growing body of evidence about the safety and efficacy of vaccination, many chiropractors do not believe in vaccination, will not recommend it to their patients, and place emphasis on risk rather than benefit.

In case you wonder where this odd behaviour comes from, you best look into the history of chiropractic. D. D. Palmer, the magnetic healer who ‘invented’ chiropractic about 120 years ago, left no doubt about his profound disgust for immunisation: “It is the very height of absurdity to strive to ‘protect’ any person from smallpox and other malady by inoculating them with a filthy animal poison… No one will ever pollute the blood of any member of my family unless he cares to walk over my dead body… ” (D. D. Palmer, 1910)

D. D. Palmer’s son, B. J. Palmer (after literally walking [actually it was driving] over his father’s body)  provided a much more detailed explanation for chiropractors’ rejection of immunisation: “Chiropractors have found in every disease that is supposed to be contagious, a cause in the spine. In the spinal column we will find a subluxation that corresponds to every type of disease… If we had one hundred cases of small-pox, I can prove to you, in one, you will find a subluxation and you will find the same condition in the other ninety-nine. I adjust one and return his function to normal… There is no contagious disease… There is no infection…The idea of poisoning healthy people with vaccine virus… is irrational. People make a great ado if exposed to a contagious disease, but they submit to being inoculated with rotten pus, which if it takes, is warranted to give them a disease” (B. J. Palmer, 1909)

Such sentiments and opinions are still prevalent in the chiropractic profession – but today they are expressed in a far less abrupt, more politically correct language: The International Chiropractors Association recognizes that the use of vaccines is not without risk. The ICA supports each individual’s right to select his or her own health care and to be made aware of the possible adverse effects of vaccines upon a human body. In accordance with such principles and based upon the individual’s right to freedom of choice, the ICA is opposed to compulsory programs which infringe upon such rights. The International Chiropractors Association is supportive of a conscience clause or waiver in compulsory vaccination laws, providing an elective course of action for all regarding immunization, thereby allowing patients freedom of choice in matters affecting their bodies and health.

Not all chiropractors share such opinions. The chiropractic profession is currently divided over the issue of immunisation. Some chiropractors now realise that immunisations have been one of the most successful interventions ever for public health. Many others, however, do still vehemently adhere to the gospel of the Palmers.  Statements like the following abound:

Vaccines. What are we taught? That vaccines came on the scene just in time to save civilization from the ravages of infectious diseases. That vaccines are scientifically formulated to confer immunity to certain diseases; that they are safe and effective. That if we stop vaccinating, epidemics will return…And then one day you’ll be shocked to discover that … your “medical” point of view is unscientific, according to many of the world’s top researchers and scientists. That many state and national legislatures all over the world are now passing laws to exclude compulsory vaccines….

Our original blood was good enough. What a thing to say about one of the most sublime substances in the universe. Our original professional philosophy was also good enough. What a thing to say about the most evolved healing concept since we crawled out of the ocean. Perhaps we can arrive at a position of profound gratitude if we could finally appreciate the identity, the oneness, the nobility of an uncontaminated unrestricted nervous system and an inviolate bloodstream. In such a place, is not the chiropractic position on vaccines self-evident, crystal clear, and as plain as the sun in the sky?

Yes, I do agree: the position of far too many chiropractors is ‘crystal clear’ – unfortunately it is also dangerously wrong.

A remarkable article about homeopathy and immunisation entitled THE IMMUNISATION DILEMMA came to my attention recently. Its abstract promised: “evidence quantifying the effectiveness of vaccination and HP (homeoprophylaxis) will be examined. New international research describing and analysing HP interventions will be reported. An evidence-based conclusion will be reached.”

Sounds interesting? Let’s see what the article really offers. Here is the relevant text:

…evidence does exist to support claims regarding the effectiveness of homeopathic immunisation is undeniable.

I was first invited to visit Cuba in December 2008 to present at an international conference hosted by the Finlay Institute, which is a W. H. O.-accredited vaccine manufacturer. The Cubans described their use of HP to control an outbreak of leptospirosis (Weilʼs syndrome – a potentially fatal, water-born bacterial disease) in 2007 among the residents of the three eastern provinces which were most severely damaged by a severe hurricane – over 2.2 million people [7]. 2008 was an even worse year involving three hurricanes, and the countryʼs food production was only just recovering at the time of the conference. The HP program had been repeated in 2008, but data was not available at the conference regarding that intervention.

I revisited Cuba in 2010 and 2012, each time to work with the leader of the HP interventions, Dr. Bracho, to analyse the data available. Dr. Bracho is not a homeopath; he is a published and internationally recognised expert in the manufacture of vaccine adjuvants. He worked in Australia at Flinders University during 2004 with a team trying to develop an antimalarial vaccine.

In 2012 we accessed the raw leptospirosis surveillance data, comprising weekly reports from 15 provinces over 9 years (2000 to 2008) reporting 21 variables. This yielded a matrix with 147 420 possible entries. This included data concerning possible confounders, such as vaccination and chemoprophylaxis, which allowed a careful examination of possible distorting effects. With the permission of the Cubans, I brought this data back to Australia and it is being examined by mathematicians at an Australian university to see what other information can be extracted. Clearly, there is objective data supporting claims regarding the effectiveness of HP.

The 2008 result was remarkable, and could only be explained by the effectiveness of the HP intervention. Whilst the three hurricanes caused immense damage throughout the country it was again worse in the east, yet the three homeopathically immunised provinces experienced a negligible increase in cases whilst the rest of the country showed significant increases until the dry season in January 2009 [8].

This is but one example – there are many more. It is cited to show that there is significant data available, and that orthodox scientists and doctors have driven the HP interventions, in the Cuban case. Many people internationally now know this, so once again claims by orthodox authorities that there is no evidence merely serves to show that either the authorities are making uninformed/unscientific statements, or that they are aware but are intentionally withholding information. Either way, confidence is destroyed and leads to groups of people questioning what they are told…

Final Conclusions

The attacks against homeopathy in general and HP in particular will almost certainly continue. If we can achieve a significant level of agreement then we would be able to answer challenges to HP with a single, cohesive, evidence-based, and generally united response. This would be a significant improvement to the existing situation.

 

Reference 7 is the following article: Bracho G, Varela E, Fernández R et al. Large-scale application of highly-diluted bacteria for Leptospirosis epidemic control. Homeopathy 2010; 99: 156-166. The crucial bit if this paper are as follows:

A homeoprophylactic formulation was prepared from dilutions of four circulating strains of Leptospirosis. This formulation was administered orally to 2.3 million persons at high risk in an epidemic in a region affected by natural disasters. The data from surveillance were used to measure the impact of the intervention by comparing with historical trends and non-intervention regions.

After the homeoprophylactic intervention a significant decrease of the disease incidence was observed in the intervention regions. No such modifications were observed in non-intervention regions. In the intervention region the incidence of Leptospirosis fell below the historic median. This observation was independent of rainfall.

The homeoprophylactic approach was associated with a large reduction of disease incidence and control of the epidemic. The results suggest the use of HP as a feasible tool for epidemic control, further research is warranted.

The paper thus describes little more than an observational study. It shows that one region was less affected than another. I think it is quite clear that this could have many reasons which are unrelated to the homeopathic immunisation. Even the authors are cautious and speak in their conclusions not of a causal effect but of an “association”.

The 2012 data cited in the text remains unpublished; until it is available for public scrutiny, it is impossible to confirm that it is sound and meaningful.

Reference 8 refers to this article: Golden I, Bracho G. Adaptability of homœoprophylaxis in endemic, epidemic and stable background conditions. Homœopathic Links 2009; 22: 211-213. I have no access to this paper (if someone does, please fill us in) but, judging from both its title and the way it is described in the text, it does not seem to show reliable data about the efficacy of homeopathic immunisation.

So, is it true that “evidence does exist to support claims regarding the effectiveness of homeopathic immunisation”?

I do not think so!

Immunisation is by no means a trivial matter; wrong decisions in this area have the potential to cost the lives of millions. Therefore proofs of efficacy need to be published in peer-reviewed journals of high standing. These findings need then be criticised, replicated and re-criticised and re-replicated. Only when there is a wide consensus about the efficacy/safety or lack of efficacy/safety of a new form of immunisation, can it be generally accepted and implemented into clinical practice.

The current consensus about homeopathic immunisation is that it is nothing less than dangerous phantasy. Those who promote this quackery should be publicly exposed as charlatans of the worst kind.

Yesterday, BBC NEWS published the following interesting text about a BBC4 broadcast entitled ‘THE ROYAL ACTIVIST’ aired on the same day:

Prince Charles has been a well-known supporter of complementary medicine. According to a… former Labour cabinet minister, Peter Hain, it was a topic they shared an interest in.

“He had been constantly frustrated at his inability to persuade any health ministers anywhere that that was a good idea, and so he, as he once described it to me, found me unique from this point of view, in being somebody that actually agreed with him on this, and might want to deliver it.”
Mr Hain added: “When I was Secretary of State for Northern Ireland in 2005-7, he was delighted when I told him that since I was running the place I could more or less do what I wanted to do.***
“I was able to introduce a trial for complementary medicine on the NHS, and it had spectacularly good results, that people’s well-being and health was vastly improved.

“And when he learnt about this he was really enthusiastic and tried to persuade the Welsh government to do the same thing and the government in Whitehall to do the same thing for England, but not successfully,” added Mr Hain.

*** obviously there is no homeopathic remedy for megalomania (but that’s a different story)

Oh really?

A TRIAL?

SPECTACULARLY GOOD RESULTS?

NO KIDDING?

Let’s have a look at the ‘trial’ and its results. An easily accessible report provides the following details about it:

From February 2007 to February 2008, Get Well UK ran the UK’s first government-backed complementary therapy pilot. Sixteen practitioners provided treatments including acupuncture, osteopathy and aromatherapy, to more than 700 patients at two GP practices in Belfast and Derry.   

The BBC made an hour long documentary following our trials and tribulations, which was broadcast on BBC1 NI on 5 May 2008.

Following the successful completion of the pilot, the results were analysed by Social and Market Research and recommendations were made to the Health Minister

Aims and Objectives 

The aim of the project was to pilot services integrating complementary medicine into existing primary care services in Northern Ireland. Get Well UK provided this pilot project for the Department for Health, Social Services and Public Safety (DHSSPS) during 2007.

The objectives were:

  • To measure the health outcomes of the service and monitor health improvements.
  • To redress inequalities in access to complementary medicine by providing therapies through the NHS, allowing access regardless of income.
  • To contribute to best practise in the field of delivering complementary therapies through primary care.
  • To provide work for suitably skilled and qualified practitioners.
  • To increase patient satisfaction with quick access to expert care.
  • To help patients learn skills to improve and retain their health.
  • To free up GP time to work with other patients.
  • To deliver the programme for 700 patients.

Results 

The results of the pilot were analysed by Social and Market Research, who produced this report.

The findings can be summarised as follows: 

Following the pilot, 80% of patients reported an improvement in their symptoms, 64% took less time off work and 55% reduced their use of painkillers.

In the pilot, 713 patients with a range of ages and demographic backgrounds and either physical or mental health conditions were referred to various complementary and alternative medicine (CAM) therapies via nine GP practices in Belfast and Londonderry. Patients assessed their own health and wellbeing pre and post therapy and GPs and CAM practitioners also rated patients’ responses to treatment and the overall effectiveness of the scheme.

Health improvement
• 81% of patients reported an improvement in their physical health
• 79% reported an improvement in their mental health
• 84% of patients linked an improvement in their health and wellbeing directly to their CAM treatment
• In 65% of patient cases, GPs documented a health improvement, correlating closely to patient-reported improvements
• 94% of patients said they would recommend CAM to another patient with their condition
• 87% of patient indicated a desire to continue with their CAM treatment

Painkillers and medication
• Half of GPs reported prescribing less medication and all reported that patients had indicated to them that they needed less
• 62% of patients reported suffering from less pain
• 55% reported using less painkillers following treatment
• Patients using medication reduced from 75% before treatment to 61% after treatment
• 44% of those taking medication before treatment had reduced their use afterwards

Health service and social benefits
• 24% of patients who used health services prior to treatment (i.e. primary and secondary care, accident and emergency) reported using the services less after treatment
• 65% of GPs reported seeing the patient less following the CAM referral
• Half of GPs said the scheme had reduced their workload and 17% reported a financial saving for their practice
• Half of GPs said their patients were using secondary care services less.

Impressed? Well, in case you are, please consider this:

  • there was no control group
  • therefore it is not possible to attribute any of the outcomes to the alternative therapies offered
  • they could have been due to placebo-effects
  • or to the natural history of the disease
  • or to regression towards the mean
  • or to social desirability
  • or to many other factors which are unrelated to the alternative treatments provided
  • most outcome measures were not objectively verified
  • the patients were self-selected
  • they would all have had conventional treatments in parallel
  • this ‘trial’ was of such poor quality that its findings were never published in a peer-reviewed journal
  • this was not a ‘trial’ but a ‘pilot study’
  • pilot studies are not normally for measuring outcomes but for testing the feasibility of a proper trial
  • the research expertise of the investigators was close to zero
  • the scientific community merely had pitiful smiles for this ‘trial’ when it was published
  • neither Northern Ireland nor any other region implemented the programme despite its “spectacularly good results”.

So, is the whole ‘trial’ story an utterly irrelevant old hat?

Certainly not! Its true significance does not lie in the fact that a few amateurs are trying to push bogus treatments into the NHS via the flimsiest pseudo-research of the century. The true significance, I think, is that it shows how Prince Charles, once again, oversteps the boundaries of his constitutional role.

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