Many of you will know that JAMA is one of the most respected medical journals. It is therefore surprising that, within the period of a few days, they published not one but two dodgy RCTs of alternative treatments.
The new trial was aimed at determining whether the addition of chiropractic care to usual medical care results in better pain relief and pain-related function when compared with usual medical care alone.
The study was designed as a pragmatic comparative effectiveness clinical trial using adaptive allocation was conducted from September 28, 2012, to February 13, 2016, at three US military medical centres. Eligible participants were active-duty US service members aged 18 to 50 years with low back pain from a musculoskeletal source. The intervention period was 6 weeks. Usual medical care included self-care, medications, physical therapy, and pain clinic referral. Chiropractic care included spinal manipulative therapy in the low back and adjacent regions and additional therapeutic procedures such as rehabilitative exercise, cryotherapy, superficial heat, and other manual therapies.
Primary outcomes were low back pain intensity (Numerical Rating Scale; scores ranging from 0 [no low back pain] to 10 [worst possible low back pain]) and disability (Roland Morris Disability Questionnaire; scores ranging from 0-24, with higher scores indicating greater disability) at 6 weeks. Secondary outcomes included perceived improvement, satisfaction (Numerical Rating Scale; scores ranging from 0 [not at all satisfied] to 10 [extremely satisfied]), and medication use.
In total, 750 patients were enrolled. Statistically significant site × time × group interactions were found in all models. Adjusted mean differences in scores at week 6 were statistically significant in favour of usual medical care plus chiropractic care compared with usual medical care alone overall for low back pain intensity (mean difference, −1.1; 95% CI, −1.4 to −0.7), disability (mean difference, −2.2; 95% CI, −3.1 to −1.2), and satisfaction (mean difference, 2.5; 95% CI, 2.1 to 2.8) as well as at each site. Adjusted odd ratios at week 6 were also statistically significant in favour of usual medical care plus chiropractic care overall for perceived improvement (odds ratio = 0.18; 95% CI, 0.13-0.25) and self-reported pain medication use (odds ratio = 0.73; 95% CI, 0.54-0.97). No serious adverse events were reported.
The authors concluded that chiropractic care, when added to usual medical care, resulted in moderate short-term improvements in low back pain intensity and disability in active-duty military personnel. This trial provides additional support for the inclusion of chiropractic care as a component of multidisciplinary health care for low back pain, as currently recommended in existing guidelines. However, study limitations illustrate that further research is needed to understand longer-term outcomes as well as how patient heterogeneity and intervention variations affect patient responses to chiropractic care.
Regular readers will have spotted it straight away: This trial follows the infamous ‘A+B versus B’ design. It will almost always generate a positive result – so much so that it is a waste of time to run the study because we know its findings before it has started. And if this is so, the trial is arguably even unethical.
The reason is, of course, that the study design does not control for placebo effects. And this means that even an utterly useless treatment will produce a (false-positive) result as long as it generates a placebo effect. Some of the authors of the present study are experienced researchers and clearly know all this. This is why they call their study a ‘pragmatic’ trial. But even with pragmatic trials, one cannot get away with murder!
As far as I can see, there are even two ‘murders’ here:
- The authors stated that their aim was to determine whether the addition of chiropractic care to usual medical care results in better pain relief and pain-related function when compared with usual medical care alone. I would argue that their study did not live up to this aim. As it did not control for placebo effects, it cannot possibly test the effectiveness of chiropractic care per se.
- The authors concluded that their trial provides additional support for the inclusion of chiropractic care as a component of multidisciplinary health care for low back pain. I would argue that this is quite simply wrong. The results are in perfect agreement with the assumption that chiropractic care is a placebo, and few would argue that the inclusion of a pure placebo can be recommended.
Compared to these major issues, my other concerns are mere trivialities:
- The trial tested spinal manipulation plus a whole bunch of physiotherapeutic intervention. I bet my last shirt that the chiro-community will claim that it demonstrated the effectiveness of chiropractic spinal manipulations. Already the very first sentence of the present paper’s discussion section goes into this direction: The changes in patient-reported pain intensity and disability as well as satisfaction with care and low risk of harms favoring UMC with chiropractic care found in this pragmatic clinical trial are consistent with the existing literature on spinal manipulative therapy…
- In their abstract, the authors (several of whom are chiropractors) state that there were no serious adverse effects (the paper is extremely thin on providing details about how adverse effects were assessed, verified, categorised etc.). What about non-serious adverse effects (arguably LBP is a minor condition, so minor adverse effects are relevant!)? In the paper, they enlighten us that of the 43 adverse effects reported by participants receiving UMC with chiropractic care, 38 were described as muscle or joint stiffness attributed to chiropractic care (37 events) or physical therapy (1 event), 1 was reported as indistinct symptoms following an epidural injection, 3 were described as pain, tingling, or sensitivity in an extremity without reference to a specific treatment, and 1 was a lower-extremity burning sensation for 20 minutes following spinal manipulative therapy. In my view, this is sufficiently important to be mentioned also in the abstract.
- The authors remain totally silent when it comes to the discussion of the effect sizes. To me, they seem to be moderate. Are they at all clinically relevant. I feel that the discussion of a PRAGMATIC trial must include this pragmatically important issue.
Guest post by Frank van der Kooy
TCM and the importance of having a Minister of Health with knowledge of health!
You’re sitting on a beach when suddenly not far from you, you notice a commotion. Your fear is confirmed when you see lifeguards dashing into the ocean and moments later they drag a lifeless body of a young child from the waves. Because the lifeguards are well trained, they manage to revive the child, resulting in a collective sigh of relief from the gathered crowd. Happy endings like this make people feel good – it is good news. But this is not where it ends. Suddenly you hear screaming and to your shock you witness something truly amazing. The parents of this boy sprints down the beach, bursts through the crowd, all the while shouting that they will save their child. To your amazement they pull the child, still gasping for air, from the arms of the lifeguards back into the ocean where they hold his head under water until he drowns!
I don’t know if anything like this has ever happened but I’m almost convinced that the crowd, after recovering from their shock, will most likely attack the parents and more people might die that day.
Now, one of the hallmarks of a fake healthcare system is the fact that just about everything works. Think of rhino horn, acupuncture, homeopathy etc. but also something such as slapping therapy – everything works. Surely, if you allow a practitioner into your clinic to provide people, including children, slapping therapy then you acknowledge that it works? If not, you are intentionally misleading your patients (interesting catch 22.) But let me explain the analogy. These parents suffer from a level of delusion that most people simply cannot understand and sadly this type of scenario plays out far more often than most people would like. And if the Chinese Communist Party (CCP) has its way, these tragedies will increase significantly and it might even become quite common. Take for example the tragic slapping death tragedy.
The poor parents were misled into believing that they can cure their 6yo son of diabetes type 1 by attending an expensive ‘slapping therapy’ workshop in Sydney. The child was taken off his medication (out of professional care) and was slapped (allowing the sea to finish the job) in the belief that this will cure him. It did not, and the child died. The slapping therapist and the parents are now facing court, but this should be seen as treating the symptom while the cause, the people responsible for creating this level of delusion, are continuing to relentlessly disseminate their misinformation regarding ‘integrative medicine’.
From the website of ‘Master’ Hongchi Xiao. Left, an 8yo boy who suffers from a serious kidney disease, right, the leg a 13yo suffering from diabetes. The type of injuries caused by the slapping therapy is easily visible (it is unknown if these children survived or how many victims Master Xiao made).
The unseen war that’s being fought
To use war terminology might be a bit far-fetched but I don’t think it’s unreasonable. This war is being fought between an army of pseudoscientists (backed by the CCP and others) and a few scientists (backed by, uhm, no one) and it’s about the ‘integration’ of fake medicine and medical procedures with evidence-based healthcare under the umbrella term – ‘Integrative medicine’. For most people, hitting a young defenceless child to such a degree that he dies of his injuries and/or lack of medication, is surely a heinous crime. But others apparently see this practice to be okay, and these deaths should be considered ‘collateral damage’. After all, many innocent people die in war zones, and although undesirable it is an inadvertent consequence of achieving the greater good – to win the war.
Slapping therapy is part of the pseudoscientific Traditional Chinese Medicine (TCM) industry, and because of the sheer economic size of this industry, the CCP decided to revive it, protect it and promote it nationally but also internationally. Any critique of TCM within China is met with the long arm of the law. Quite recently a Chinese doctor was jailed for three months after he wrote an opinion piece regarding the dangers of a specific TCM remedy. So, TCM is here to stay and is also one way of how the CCP is exerting its influence overseas.
Their current excursion is to steamroll over science (and the few scientists willing to defend it) via some Australian universities (who in turn derives financial benefit) by creating ‘scientific’ legitimacy for TCM and thereby increase their Australian (and western) market penetration. They use the billions of dollars that Australian universities receive from (Chinese) international students as a silent threat in order to keep these universities in check and dancing to their tune. Via some Australian academics, they have infiltrated and now have the support of Australian regulators and politicians. All in all, it is going quite well with their plans to internationalise TCM.
The main problem is that they have vast resources which most scientists don’t have. Take for example the National Institute of Complementary Medicine (NICM). They’re about 50 people with Western Sydney University (WSU) pumping millions of taxpayer dollars into their coffers every year. Controversial companies such as Blackmores also donates millions and much more money is flowing in from China – all of these resources are being used to integrate dis/unproven complementary and alternative medicine, with a specific focus on TCM. For example; the clinic, Tasly Healthpac, that promoted and hosted the slapping therapy workshop was founded and is managed by Dr Ven Tan whereas Prof Alan Bensoussan, director of the NICM, collaborated with Dr Tan to integrate fake healthcare (slapping, acupuncture, TCM etc.). A MoU was signed between Tasly and the NICM in 2011, which states that the NICM will provide “assistance in the development of an Integrative Care Model: to assist the Tasly Healthpac Centre of Excellence in Integrative medicine so that its structure aims to integrate TCM and western medical diagnostics and treatments in an integrated, patient centred way.”
Clockwise from left. Dr Ven Tan; Master Hongchi Xiao, the slapping therapist; Prof Alan Bensoussan giving a speech in Beijing after receiving a prestigious prize for his work on integrating TCM; the signing of a MoU witnessed by Prof Bensoussan (standing left) and Dr Tan (standing 3rd from the right).
Facing this tsunami of misinformation, and defending the battlefront, you have a few lonely scientists. Nobody is pumping millions into warning people about fake healthcare systems, because there is no money to be made from it, and hence with their meagre resources, they simply do it because their conscience demands it.
I have written about the Australian academics who facilitated the CCPs plans to internationalise TCM, mainly by lobbying for the national registration of TCM practitioners, and also about the Australian politicians (former trade minister Andrew Robb and PM Tony Abbott etc.) who were lobbied to include a free flow of TCM practitioners into Australia under the Free Trade Agreement signed in 2015. TCM producers such as Tong Ren Tang were, of course, elated with this arrangement because “….we will have an increasingly wider road, and open more and more branch stores in Australia.”
In this article, I will focus on the role of the former Minister of Health for New South Wales, Ms Jillian Skinner, and her role in this calamity.Former PM Tony Abbott (red tie) and Dr Ven Tan (to the right of Mr Abbott) here in his capacity as Executive Vice Chairman of the CCP-linked ‘Australia-China Economics, Trade & Culture Association’
The Minister of Health and the tale of two letters
Two letters were sent to Min. Skinner, one warning her about integrating TCM (and other disproven and unproven healthcare systems), the other letter promoting TCM. So which one had an impact?
A word of warning
Any health minister would surely understand the dangers in supporting the principles of TCM which is that disease is caused by disturbances in your (pseudoscientific) life force, or Chi, that flows through ‘meridians’. Inserting needles (acupuncture), taking Chinese herbs or slapping yourself all ‘aim’ to influence and/or restore your life force and cure you of whatever ails you. That some herbs might be beneficial is a given but it is because they contain very specific compounds (and very few do) – this has nothing to do with your life force! Supporting the integration of pseudoscientific healthcare with real healthcare is very dangerous as was illustrated by the slapping therapy death. Hence, one might expect that the minister would be accompanying Dr Tan/Prof Bensoussan to the police station, because something like this should surely not be allowed?
To warn the Minister about the NICMs modus operandi I’ve sent her a letter and attached a 6000-word document detailing my concerns (a shortened version can be found here). It can be summed up as follow:
The NICM supports and promote any form of complementary, alternative or traditional (CAT) medicine and do not advise the public, as claimed, about the dangers of disproven CAT medicines such as homeopathy, TCM etc. because most of their funding depends mainly on misleading the public.
In my email dated 4 February 2016 I stated that; ‘These concerns are of such a nature that I believe the public is in danger of suffering injury or even death as a result. I have shared my concerns with the NICM management as well as the vice-chancellor of WSU (in June 2015). Needless to say, the WSU management do not share my concerns and hence my urgent call on your office to investigate this matter further.’
One example in my letter, to illustrate the problem, was the NICMs response to the well-known NHMRCs report regarding the ineffectiveness and dangers of homeopathy. It is fascinating how they pumped misinformation, via their partner ‘Complementary Medicines Australia’, into the world. Their response, entitled “The Five Fundamental Flaws of the NHMRCs Homeopathy report” is currently being used by homeopaths around the world to ignore the urgent advice that ‘Homeopathy should not be used to treat health conditions that are chronic, serious, or could become serious. People who choose homeopathy may put their health at risk if they reject or delay treatments for which there is good evidence for safety and effectiveness”. The press release ends with the ‘wise’ words “Homeopathy has been around for hundreds of years, and I am sure will be around a lot longer than some of the critics.”
People, including children, die because of this misinformation. But for some reason, the courts only take action when children are involved. Here is another tragic example of a 9-month old baby that died. And just recently the Australian government even ignored the recommendations of a new review and decided that; “Homeopathic products will continue to be sold in Australian pharmacies, despite a long-awaited review warning the government the practice could compromise the health of consumers.” Obviously, their lobbying has been quite successful to date!
But this shows that the NICM and their partners will defend just about any fake ‘medicine’ including TCM because they derive funding from it. This cunning ability to mislead the public, regulators and politicians was at least rewarded with the Bent Spoon award for quackery in 2017 – for what it’s worth.
A letter with impact
The NICMs job regarding TCM is to open the floodgates into Australia (and the world), but to do this they need the support from Australian politicians and hence, Alan and people like Marcus Blackmore (CEO of Blackmores), endlessly lobby politicians (you can read about this here). Here you can find one such letter (May 2014) written by the NICM and send to Min. Skinner. This letter contains the predictable praises of the integrative medicine industry, the ‘importance’ of integrating CAT with conventional healthcare, and the world-class standards of the NICM etc. but there is one sentence that stands out above the rest. And this is what it’s all about;
“….NICM needs this positioning if it is to help consumers and health professionals choose safe and effective complementary medicine (and discard ineffective treatments)…”
If you consider the fact that they were involved with the slapping therapy workshop (people died), their response to the NHMRC Homeopathy report (people died), and even that one of their business partners were send to jail after being caught importing rhino horn into Australia (endangered animals died) – all of the above ineffective remedies or treatments, then this sentence is not misleading, it is a blatant lie.
The slapping therapy death occurred in April 2015, and although I noticed it in the newspaper at the time, I was not aware that the NICM was intricately involved (I was actually quite busy trying to get out of there). What came as a shock a couple of years later was when I accidentally came across a travel itinerary of Min Skinner. It turns out that she invited Dr Tan and Prof Bensoussan to accompany her, not to a police station, but to China in April 2016, barely 2 months after I’ve send my letter to her office. The reason for this trip was to garner support for their plans to integrate TCM with conventional healthcare in Australia. To quote from her travel itinerary “To assist the University of Western Sydney’s National Institute of Complementary Medicine (NICM) secure investor and donor support for the NICM’s integrative Chinese medicine facility medicine/treatment on the Westmead Campus and related complementary medicine research initiatives.”
Left. Minister Skinner (seated in red) signing a MoU with Vice Governor of Shandong Province, the Hon Wang Suilian. Right. Min Skinner (in red) witnessing the signing a MoU between TCM producer Tong Ran Teng and Ramsay Healthcare.
Their trip to China also caught the attention of the media because she decided that integrating quackery was more important than solving real health problems in Australia. “Ms Skinner defended the trip, taken with NSW Chief Health Officer Kerry Chant, saying it led to an agreement between Westmead Hospital and Shandong’s Qilu Hospital designed to enhance … understanding of traditional Chinese medicine” and “The MOU will establish formal links between Westmead Hospital and Shandong’s Qilu Hospital and is designed to enhance NSW’s understanding of traditional Chinese medicine.”
But here is a fun fact. Close to 100% of clinical trials on TCM conducted in China gives positive results, coupled to the fact that any scientific criticism of TCM can see you get jailed, then surely, the minister must know that they are dealing with a fake healthcare system? Apparently not, or they just ignore the obvious because the potential economic stimulus seemingly overrides the political risks associated with causing a number of preventable deaths. It is a scary thought that former Min Skinner now serves as a director at the Children’s Cancer Institute (I requested her contact details from the institute in order to give her the opportunity to respond but no response was received thus far.)
But did the NICM break the law?
Min. Skinner eventually responded (Nov 2016) but then only by referring me to the Federal Minister of Health, Sussan Ley (who also resigned around this time), but by then the damage was already done. Clearly, the NICM managed to get funding from China because they will be moving into their new TCM hospital pretty soon. This hospital will be co-occupied (and managed) by the CCP linked Beijing University of Chinese Medicine (BUCM). In their document ‘some brief notes regarding the BUCM collaboration’ they state; “It represents an unprecedented opportunity for the advancement of Chinese medicine in Australia, including the development of the Chinese medicine market in the West; promoting Chinese heritage and culture; and integrating Chinese medicine with the Australian healthcare system.”
But did they do anything illegal? I am no expert in the law but I believe that providing misleading and/or false information to ministers, who then based on this promote the integration of ineffective healthcare might indeed break the law – especially when this results in the death of members of the public. Did they provide former Trade Minister Andrew Robb (discussed here) and Min Skinner with correct and unbiased info about what TCM is? Well, their letter tells me that they did not. As far as I can tell, neither of these former ministers have a background in science, and as such, can easily be misled when it comes to complex scientific issues. But then again, you need to be receptive to these ideas and propaganda, because at the end of the day they signed off on it.
I sometimes just wonder where all of this will end. If organisations such as the NICM (they are not the only ones) are not reeled in now, how will the Australian (or western) healthcare system look like in 10-20 years’ time? They are masters of deceit with a clear intention to mislead the public for the sake of making money. For example; their new TCM ‘hospital’ in Westmead will not be called exactly that, they have chosen a much more mundane and misleading name; ‘Western Sydney Integrative Health Centre’ – it will fool many, because it is right next to the southern hemispheres’ biggest health complex and it is backed by an Australian university to give it even more credibility.
I used the phrase ‘China Power and Influence’ in this article as well as in two previous articles that you can find here and here. But this is only one side of the bigger picture because most people are well aware that China, as an upcoming super-power, wants to exert its influence in various ways in various countries. But I do hope that I’ve managed to highlight that TCM is also part of this and as such, a threat, not only to the health of people, but also wildlife. The reasons why China included TCM in their plans are probably complex and likely multifactorial and I will attempt to deal with this question in a next article.
But the main message that I wanted to get across is that although China is the source of TCM, and hence the problem, any country can quite easily recognise it as such and say; ‘no thank you, we will stick with modern evidence-based healthcare, but will gladly collaborate with you in other areas.’ This has not happened in Australia. And this is the message. There are Australian citizens in positions of power who has gone out of their way to legitimise and normalise TCM in Australia and hence aided the CCP in executing their plans for the sake of, mainly money. Some people are capable of doing strange things for money and some even have the ability to completely switch off their conscience.
All of this is now playing out in Australia (where and how it will end is anyone’s guess), but will this be all that different than what is happening regarding TCM in other western countries? I fear not.
A recent comment by Richard Rawlins stated: “In healthcare, people who act as wannabe doctors and make false claims are quacks. If they make money at it, they are frauds. But fools they are not.”
I hope you agree that this is a notion well-worth exploring a bit closer. Specifically, I want to try and differentiate the ‘fools’ from the ‘frauds’.
Perhaps by listing some of the qualities that characterise the two categories.
The hallmarks of a fraud in medicine are, I think, that a) he is lying and b) he is trying to get at your money (as much of it as possible). By ‘lying’ I mean presenting untruths as facts, despite knowing they are not correct. Essentially, this means that a fraud is dishonest and might even be guilty of a criminal offence (in turn, this means that we ought to be able to take legal action against him).
Frauds are egoistic and do not care much about their clients or the fact that they might cause harm.
By contrast, fools in medicine are naïve and deluded. They are not necessarily dishonest because, even though they tell untruths, they believe them to be true (in a way, fools have fallen for their own lies). Like frauds, fools might also try to get at your money (some of it), but they would claim that they simply need to be paid for their services in order to make a living.
Fools often live under the impression of being altruistic and they are convinced they do a lot of good.
WHO IS WHO?
The distinction between fools and frauds in the realm of alternative medicine is often less than obvious; there is plenty of overlap between the two. I have met hundreds of alternative practitioners and, if I try to retrospectively allocate them into either of the two categories, I run into considerable difficulties. Many belong to neither of them; and most have qualities that are reminiscent of both. But if I was forced to make a binary choice, I would probably put most of them in the camp of fools. Perhaps I was fortunate, but I have not many outright frauds amongst alternative practitioners.
WHO IS MORE DANGEROUS?
Did I say I was ‘fortunate’? Yes, fortunate for not having to deal all that often with dishonest crooks. But in terms of potential for harm, there is nothing fortunate about the fools. For the consumer, frauds are usually easier to recognise than fools, and once identified, they become far less harmful. Fools are often so convinced of their ‘truths’ that desperate patients easily fall for their falsehoods. And this is precisely what constitutes the main danger of fools in (alternative) medicine: they tend to be so convincing and so sure of doing something positive that people tend to find them credible. Consequently, many consumers, patients, politicians, journalists etc. follow their foolish and often harmful advice.
We tend to find frauds immoral and despicable and are often perceive fools as ethically and socially more acceptable. However, considering their potential for doing harm, the fools are frequently far worse than the frauds. I therefore conclude we must be vigilant about frauds but, at the same time, become more weary about fools.
There seem to be plenty of myths and misunderstandings about homeopathy in India.
Homeopathy was first introduced to India by a German doctor from Siebenbuergen, Martin Honigberger (1795 – 1869). He first came to India in 1829 as a conventionally trained physician and treated amongst other personalities the Maharaja Ranjit Singh of Punjab. In 1834, he returned to Europe, met Hahnemann, and became a convert of homeopathy. Subsequently he returned to India, in 1839, and brought homeopathy to this country. Initially, homeopathy was practised mainly by lay practitioners. Mahendra Lal Sircar is said to have been the first Indian who became a homeopathic physician, and he is often called the ‘Hering of India’. The ‘Calcutta Homeopathic Medical College’ was established in 1881 and assumed a crucial role in popularising homeopathy.
Today, we are often being told that homeopathy is incredibly popular in India. For instance, the HINDUSTAN TIMES recently published the following article:
The government on Tuesday said homeopathy is ‘clinically effective’ and there has been a 50 % rise in the number of patients seeking homeopathic treatment in the country in the past five years.
“In India, at 23 Institutes/ Units under the Central Council for Research in Homeopathy (CCRH), there is 50 % more footfall of patients seeking homeopathic treatment during the last five years,” said AYUSH Minister of State (Independent Charge) Shripad Yesso Naik.
“Homeopathy is not a pseudoscience. The conclusion of most comprehensive systematic reviews of studies based on classical homeopathy has concluded that it has a positive and specific effect greater than placebo alone,” he said in a written reply in the upper house.
“Homeopathy is being promoted as it is not only safe and effective but also due to its high acceptance through high quality surveys of use of homeopathy,” said Naik, adding that there is evidence that homeopathy is beneficial.
“There is evidence based data (not anecdotal) with CCRH that warrants the promotion or acceptance of homeopathy in India,” said the Minister.
END OF QUOTE
In my view, this foremost begs one question: How does Shripad Yesso Naik get away with evidently false statements?
The minister describes himself as a ‘business person’ (not sure what this means, but it clearly does not describe a medical expert). Wikipedia has this interesting information on him: On March 25, 2016, Shripad Naik publicly stated he had access to research which proved that diseases such as cancer could be cured by yoga. He further stated that his Ministry was a year away from granting an endorsement to such techniques and research. The statement was challenged by medical researchers and doctors, who advocated caution in claiming a cure to cancer on the basis of unproven and unpublished research.
The AUYSH-ministry (AYUSH stands for ayurveda, yoga, siddha and homeopathy) seems to have the purpose of promoting homeopathy not on the basis of evidence but despite the evidence. For that purpose, it has set up a committee at the Central Council for Research in Homeopathy (CCRH) to “deal with issues related to false propaganda against homeopathy”. They claim to have written to Nobel laureate Venkatraman Ramakrishnan, who correctly stated that homeopathy and astrology were “bogus”… “No one in chemistry believes in homeopathy. It works because of placebo effect”. The director general of the CCRH countered that “The propaganda is coming from the West and it is picked up by newspapers here. They present homeopathy in a disproportionate and negative light, and it creates confusion… ” The CCRH has also been writing letters, rejoinders and counter-editorials to others to combat “false propaganda.”
I do not need to repeat here the evidence on homeopathy (we have dealt with it regularly on this blog); suffice to state that it fails to show that highly diluted homeopathic remedies differ from placebos. This, in turn, means that the accusation of ‘false propaganda’ must be directed not at the sceptics but at the AYUSH-ministry.
And what about the claim that homeopathy is currently so hugely popular in India? It seems that it is bogus too. A recent survey conducted by ‘Indian National Sample Survey Office’ revealed that 90% of the Indian population rely on conventional medicine. Merely 6% trust what the investigators chose to call ‘Indian systems of medicine’, e. g. ayurveda, yoga, siddha and homeopathy, often abbreviated as AYUSH.
The message that seems to emerge from all this is that, in India, homeopathy is being promoted on the basis of exaggerations and untruths – much like in many other countries, I hasten to add.
by Norbert Aust as ‘guest blogger’ and Edzard Ernst
Professor Frass has repeatedly stated that his published criticism of the Lancet meta-analysis has never been refuted, and therefore homeopathy is a valid therapy. The last time we heard him say this was during a TV discussion (March 2018) where he said that, if one succeeded in scientifically refuting the arguments set out in his paper, one would show the ineffectiveness of homeopathy.
In today’s post, we quote the paper Frass refers to, published as a ‘letter to the editor’ (published in the journal Homeopathy) by Frass et al (bold typing), and provide our rebuttal (in normal print) of it:
Even with careful selection, it remains problematic to compare studies of a pool of 165 for homeopathy vs 4200,000 for conventional medicine. This factor of 41000 already contains asymmetry.
We see no good reasons why the asymmetry poses a problem; it does not conceivably impact on the outcome, nor does it bias the results. In fact, such asymmetries are common is research.
Furthermore, it appears that there is discrimination when publications in English (94/110, 85% in the conventional medicine group vs 58/110, 53% in the homeopathy group) are rated higher quality (Table 2).
We cannot confirm that the table demonstrates such a discrimination, nor do we understand how this would disadvantage homeopathy.
Neither the Summary nor the Introduction clearly specify the aim of the study.
The authors stated that they “analysed trials of homoeopathy and conventional medicine and estimated treatment effects in trials least likely to be affected by bias”. It is hardly difficult to transform this into their aim: the authors aimed at analysing trials of homoeopathy and conventional medicine and estimating treatment effects in trials least likely to be affected by bias.
Furthermore, the design of the study differs substantially from the ﬁnal analysis and therefore the prolonged description of how the papers and databases were selected is misleading: instead of analysing all 110 studies retrieved by their deﬁned inclusion and exclusion criteria, the authors reduce the number of investigated studies to ‘larger trials of higher quality’. By using these sub-samples, the results seem to differ between conventional medicine and homeopathy.
This statement discloses a misconception of the approach used in the meta-analysis. The meta-analysis of all 110 trials found some advantages of homeopathy. When the authors performed a sensitivity analysis with high quality and larger studies, this advantage disappeared. The sensitivity analysis was to determine whether the overall treatment effect seen in the initial analysis was real or false-positive. In the case of homeopathy, it turned out to be false (and presumably for this reason, the authors hardly mention it in their paper), whereas for the trials of conventional medicines, it was real. This procedure is in keeping with the authors’ stated aims.
The meta-analysis does not compare studies of homeopathy vs studies of conventional medicine, but speciﬁc effects of these two methods in separate analyses. Therefore, a direct comparison must not be made from this study.
We fail to see the significance in terms of the research question stated by the authors. Even Frass et al use direct comparisons above.
However, there remains great uncertainty about the selection of the eight homeopathy and the six conventional medicine studies: the cut-off point seems to be arbitrarily chosen: if one looks at Figure 2, the data look very much the same for both groups. This holds true even if various levels of SE are considered. Therefore, the selection of larger trials of higher quality is a post-festum hypothesis but not a pre-set criterion.
This is not true, Shang et al clearly stated in their paper: “Trials with SE (standard error) in the lowest quartile were considered larger trials.” It is common, reasonable and in keeping with the authors’ aims to conduct sensitivity analyses using a subset of trials that seem more reliable than the average.
The question remains: was the restriction to larger trials of higher quality part of the original protocol or was this a data-driven decision? Since we cannot ﬁnd this proposed reduction in the abstract, we doubt that it was included a priori.
We are puzzled by this statement and fail to understand why Frass et al insist that this information should have been in the abstract.
However, even if one assumes that this was a predeﬁned selection, there are still some problems with the authors’ interpretation: for larger trials of higher reported methodological quality, the odds ratio was 0.88 (CI 95%: 0.65–1.19) based on eight trials of homeopathy: although this ﬁnding does not prove an effect of the study design on the 5% level, neither does it disprove the hypothesis that the results might have been achieved by homeopathy. For conventional medicine, the odds ratio was 0.58 (CI 95% 0.39–0.85), which indicates that the results may not be explained by mere chance with a 5% uncertainty.
As the outcome failed to reach the level of significance, the null-hypothesis (“there is no difference”) cannot be discarded, and this is sufficient evidence to show that there is no evidence for the effectiveness of homeopathy. The comment by Frass et al seems to be based on a misunderstanding how science operates.
Although the authors acknowledge that ‘to prove a negative is impossible’ the authors clearly favour the view that there is evidence that homoeopathy exhibits no effect beyond the placebo-effect. However, this conclusion was drawn after a substantial modiﬁcation of the original protocol which considerably weakens its validity from the methodological point of view. After acquiring the trials by their original inclusion- and exclusion criteria they introduced a further criterion, ‘larger trials of higher reported methodological quality’. Thus, eight trials (=46% of the larger trials) in the homoeopathy group were left and only six (32%) in conventional medicine group (an odds ratio of 0.75 in favour of homoeopathy).
As explained above, the authors’ reasoning was clear and rational; it did not follow the logic suggested by Frass et al. which confirms our suspicion already mentioned above that Frass et al misunderstood the concept of the Shang meta-analysis.
But the decisive point is that it is unlikely that these six trials are still matched to the eight samples of homoeopathy (although each of the 110 in the original was matched). Consequently, one cannot conclude that these trials are still comparable. Thus, any comparisons of results between them are unjustiﬁed.
Further evidence that Frass et al misunderstood the concept of the Shang meta-analysis.
The rationale for this major alteration of the study protocol was the assumption, that these larger, higher quality trials are not biased, but no evidence or databased justiﬁcation is given. Neither the actual data (odds ratio, matching parameters…) nor a funnel plot (to indicate that there is no bias) of the ﬁnal 14 trials are supplied although these parameters constitute the ground of their conclusion.
Further evidence that Frass et al misunderstood the concept of the Shang meta-analysis.
The other 206 trials (94% of the originally selected according to the protocol) were discarded because of possible publication biases as visualized by the funnel plots. However, the use of funnel plots is also questionable. Funnel plots are thought to detect publication bias, and heterogeneity to detect fundamental differences between studies.
Further evidence that Frass et al misunderstood the concept of the Shang meta-analysis.
New evidence suggests that both of these common beliefs are badly ﬂawed. Using 198 published meta-analyses, Tang and Liu demonstrate that the shape of a funnel plot is largely determined by the arbitrary choice of the method to construct the plot. When a different deﬁnition of precision and/or effect measure was used, the conclusion about the shape of the plot was altered in 37 (86%) of the 43 meta-analyses with an asymmetrical plot suggesting selection bias. In the absence of a consensus on how the plot should be constructed, asymmetrical funnel plots should be interpreted cautiously.
Further evidence that Frass et al misunderstood the concept of the Shang meta-analysis.
These ﬁndings also suggest that the discrepancies between large trials and corresponding meta-analyses and heterogeneity in metaanalyses may also be determined by how they are evaluated. Researchers tend to read asymmetric funnel plots as evidence of publication bias, even though metaanalyses without publication bias frequently have asymmetric plots and meta-analysis with publication bias frequently have symmetric plots, simply due to chance.
Perhaps we should mention that the senior author of the Lancet meta-analysis, Mathias Egger, is the clinical epidemiologist who invented the funnel plot and certainly knows how to use and interpret it.
Use of funnel plots is even more unreliable when there is heterogeneity. Apart from the questionable selection of the samples there is a further aspect of randomness which further weakens their conclusion: the odds ratio of the eight trials of homoeopathy was 0.88 (CI 0.65–1.19), which might be signiﬁcant around the 7–8% level. Actually, the reader might be interested to know at which exact level homeopathy would have become signiﬁcant. Thus, there is no support of their conclusion any more when you shift the level of signiﬁcance by mere, say 2–3%.
What number of grains is required to build a heap? Certainly there is such a limit. Five grains are not a heap, five billion are. But if you select any specific value, you will find it hard to explain if one grain less changes the characteristic of a heap to become a number of grains only. Same here. If p = 0.05 is the limit of significance, p = 0.05001 is not significant, let alone, when p is 2-3%higher than that.
In addition, with such controversial hypotheses the scientiﬁc community would tend to use a level of signiﬁcance of 1% in which case the odds ratio of the conventional studies would not be signiﬁcant either.
The level of 5% is commonly applied in medical research; it is the accepted standard. Frass et al also apply it in their studies; but here they want to change it. Why, to suit their preconceived ideas?
From a statistical point of view, the power of the test, considering the small sample sizes, should have been stated, especially in the case of a nonsigniﬁcant result.
This might have been informative but is rarely done in meta-analyses.
Above all, the choice of which trials are to be evaluated is crucial. By choosing a different sample of eight trials (eg the eight trials in ‘acute infections of the upper respiratory tract’, as mentioned in the Discussion section) a radically different conclusion would have had to be drawn (namely a substantial beneﬁcial effect of homeopathy—as the authors state).
Further evidence that Frass et al misunderstood the concept of the Shang meta-analysis.
The authors may not be aware that larger trials are usually not ‘classical’ homeopathic interventions, because the main principle of homeopathy, individualization are difﬁcult to apply in large trials. In this respect, the whole study lacks sound understanding of what homeopathy really is.
This is a red herring; firstly the authors did not aim to evaluate individualised homeopathy. Secondly, Frass et al know very well that clinical homeopathy is not individualised and regarded as entirely legitimate by homeopaths. And finally, the largest trial of individualised homeopathy included in Mathie’s review of individualized homeopathy had 251 participants.
So, why has so far no rebuttal of this ‘letter to the Editor’ been published? We suspect that the journal Homeopathy has little incentive to publish a critical response, and critics of homeopathy have even less motivation to submit one to this journal. Other journals have no reason at all to pursue a discussion started in ‘Homeopathy’. In other words, Frass et al were safe from any rebuttal – until today, that is.
A man is caught paying with fake money – gets arrested.
A man sells false insurance policies – gets arrested.
A man sells phoney investments – gets arrested.
A man traffics ‘diamonds’ made of glass – gets arrested.
A man flogs a car that does not work – gets arrested.
A silversmith fakes the hallmarks on jewellery – gets arrested.
A man sells TV sets that are faulty – gets arrested.
A man fakes labels of expensive wines – gets arrested.
A man is caught trafficking fake medicines – gets arrested.
A man is caught printing fake bank notes – gets arrested.
A man insists on changing monopoly money for real money – gets arrested.
A MAN PRESCRIBES ‘MEDICINES’ THAT CONTAIN NO ACTIVE INGREDIENTS – HE IS CALLED A HOMEOPATH.
A PHARMACY SPECIALISES IN MANUFACTURING SUCH ‘MEDICINES’ – THEY ARE GIVEN A ROYAL WARRANT.
On this blog, we are all fond of what homeopathy-guru DUllman tells us (see for instance here, here and here). It seems only fair, therefore, to show you an excerpt of his latest article, particularly as it is on the highly topical subject of the flu:
Scientific Evidence That Homeopathy Works for the Flu
There are several scientific studies published in peer-reviewed medical journals that have confirmed Oscillococcinum’s efficacy. One large study of 487 patients found that almost twice as many patients who were given Oscillococcinum recovered from the flu within 48 hours as those given a placebo (17 percent versus 10 percent).10 …
A different group of researchers conducted a randomized, double-blind study involving 372 patients (188 treated with Oscillococcinum and 187 with placebo) of both sexes, ranging in age from 12 to 60, who presented rectal temperature ≥ 100.4 F, muscle pains, headache, or at least one of the following symptoms: shivering, chest pain, spine pain, coughing, irritation of nasal mucosa or feeling of malaise.12
Patients received three tubes of Oscillococcinum or placebo each day (morning, noon and night) for three days. The results of this trial show a highly statistically significant difference between the two groups, for what concerns disappearance of symptoms after 48 hours (19.2 percent in the Oscillococcinum group versus 17.1 percent in the placebo group) and improvement in symptoms (43.7 percent vs 38.6 percent for placebo) ) (p = 0.0028).
Moreover, the frequency of use of concomitant medicines was slightly higher for the placebo group, as was also the use of multiple medicines. Only 13.8 percent of the Oscillococcinum group used two or three drugs (analgesics and antirheumatics), against 19.6 percent in the placebo group.
Another parameter considered was the percentage of patients able to return to work, which was higher in the Oscillococcinum group, both two days after the onset of the illness (16.3 percent against 9.3 percent) and after four days, with highly significant differences.
Homeopathic Treatment Reduced Length of Influenza Illness
The Cochrane Collaboration is an internationally respected group of researchers who evaluate scientific studies. In 2004, they reviewed seven studies using Oscillococcinum in the treatment or prevention of influenza.13 Four treatment trials (n = 1,194) and three prevention trials (n = 2,265) were evaluated.
Only two studies had sufficient information to complete data extraction fully, and both of these studies only evaluated the use of this medicine in the treatment of influenza or influenza-like conditions (the two studies mentioned above were the two studies that were evaluated).
Oscillococcinum treatment reduced length of influenza illness by 0.28 days (95 percent confidence interval 0.50 to 0.06). Oscillococcinum also increased the chance of a patient considering treatment effective (relative risk 1.08; 95 percent CI 1.17, 1). This review also concluded that the number of days needed to return to work were significantly reduced by 0.49 days (95 percent CI 0.89-0.08) compared to the control (average of 4.1 days).
The relative risk from treatment was 0.60 (0.37-0.98), meaning that the proportion of patients treated with Oscillococcinum who considered the treatment to be useless was 0.6, relative to 1.0 for the placebo (a significant difference of 40 percent). The authors of this research review considered these results “promising,” though not strong enough to warrant a general recommendation to use Oscillococcinum for “first-line” treatment of influenza or influenza-like syndromes.
As for the use of Oscillococcinum in the prevention of the flu, the researchers concluded that it was not effective. However, it should be highlighted that the company that makes Oscillococcinum does not market this medicine for “prevention” of the flu, only for the treatment of it (and for “influenza-like” syndrome).
In 2012, a new analysis of research on Oscillococcinum in the treatment of influenza was conducted by the Cochrane Collaboration, and their conclusion was more conservative than previous analyses by this organization.14
The 2012 analysis concluded, “Although the results from four other clinical trials (total of 1196 participants) suggested that Oscillococcinum relieved flu symptoms at 48 hours, this might be due to bias in the trial methods.” In other words, even though two of these studies were double-blind, randomized and placebo controlled, these studies did not achieve the higher caliber of standards of research, thereby enabling the possibility of bias in the results….
- 10 Ferley, JP, Zmirou, D, D’Admehar, D, et al., A Controlled Evaluation of a Homoeopathic Preparation in the Treatment of Influenza-like Syndrome, Britis [sic]
- 11 Anonymous. Quadruple-Blind (editorial). Lancet. April 22, 1989, 333, 8643: 914.
- 12 Papp, R. Schuback, G. Beck, E, et al, Oscillococcinum in Patients with Influenza-like Syndromes: A Placebo Controlled Double-blind Evaluation, British [sic]
- 13 Vickers A, Smith C. Homoeopathic Oscillococcinum for preventing and treating influenza and influenza-like syndromes. Cochrane Database Syst Rev. 2004;
- 14 Mathie RT, Frye J, Fisher P. Homeopathic Oscillococcinum® for preventing and treating influenza and influenza-like illness. Cochrane Database of Syste [The link given by Ullman does not work. The correct link is here.]
END OF QUOTE
It is perhaps not unusual for DUllman to fail noticing that Vickers review [ref 13] has long been withdrawn. It is, however, highly unusual for DUllman not to accuse the authors of the current Cochrane review of bias. After all, they concede that the effect might be an artefact due to bias! In fact, their published conclusions (in both the 2012 and 2015 reviews; the latter was not mentioned by DUllman at all) are quite different from DUllman’s interpretation:
There is insufficient good evidence to enable robust conclusions to be made about Oscillococcinum(®) in the prevention or treatment of influenza and influenza-like illness. Our findings do not rule out the possibility that Oscillococcinum(®) could have a clinically useful treatment effect but, given the low quality of the eligible studies, the evidence is not compelling. There was no evidence of clinically important harms due to Oscillococcinum(®).
The reason why DUllman is so unusually restrained seems obvious: the authors of the review are some of the most vociferous promoters of homeopathy who he knows well and they are pals: Fisher, Frye, Robert Mathie.[For those who are interested, their COI statements (which might explain the rather off conclusion ‘Our findings do not rule out the possibility that Oscillococcinum(®) could have a clinically useful treatment effect…’) are here:
Robert T Mathie: Dr Mathie is Research Development Adviser, British Homeopathic Association. He was a member of the International Scientific Committee on Homeopathic Investigations, which ceased its committee activities in July 2013.
Joyce Frye: Dr. Frye received partial salary support from Standard Homeopathic Company, which terminated June 2013 and honoraria from the International Scientific Committee on Homeopathic Investigations, which was dissolved in July 2013.
Peter Fisher: I am Expert Adviser on Complementary and Alternative Medicine to the National Institute for Health and Clinical Excellence (NICE), which may take an interest in the evidence in this review. I am Editor in Chief of an international, peer-reviewed journal dedicated to homeopathy. All payments and reimbursements for lectures have been from universities or professional or learned societies. None of these lectures has been dedicated to the subject of this review. Some meetings have been supported by grants from commercial interests, including the manufacturer of the product that is the subject of the review.]
Moreover, DUllman does not mention how dismal the quality of the RCTs really is. Here is the quality rating by Mathie et al:
And here is the crucial quote from the review: The standard of trial reporting was poor or very poor.
But this might just be nit-picking. What is much more important in my view is this:
- Even at the most optimistic interpretation of the findings, these results are clinically meaningless. Their effect size is minute and therefore not relevant.
- If we consider the prior probability of less than one molecule of duck liver per universe (more on Oscillococcinum here) having any effect at all, the results (which DUllman calls ‘highly significant’) are not statistically significant at all.
My conclusions are simple:
- Oscillococcinum is a placebo (a fact that has been affirmed by several US judges).
- DUllman is great fun but not a great scientist (also confirmed by a US judge):…The Court found Mr. Ullman’s testimony to be not credible. Mr. Ullman’s bias in favor of homeopathy and against conventional medicine was readily apparent from his testimony. He admitted that he was not an impartial expert but rather is a passionate advocate of homeopathy…
Today, Price Charles celebrates his 69th birthday. Gun salutes will mark the occasion but he is said to celebrate in private. As in previous years, I take this occasion to update my tribute to him. Charles is one of the world’s most outspoken proponent of alternative medicine and attacker of science. He therefore has a prominent place on this blog.
His love affair with all things alternative started early in his life.
As a youngster, Charles went on a journey of ‘spiritual discovery’ into the wilderness of northern Kenya. His guru and guide at the time was Laurens van der Post (later discovered to be a fraud and compulsive fantasist and to have fathered a child with a 14-year old girl entrusted to him during a sea voyage). Van der Post wanted to awake Charles’ mind and attune it to the vitalistic ideas of Carl Jung’s ‘collective unconscious’, and it is this belief in vitalism that provides the crucial link to alternative medicine: virtually every form of alternative therapies is based on the assumption that some sort of vital force exists. Charles was so taken by van der Post that, after his death, he established an annual lecture in his honour (the lecture series was discontinued after Van der Post was discovered to be a fraud).
Throughout the 1980s, Charles lobbied for the statutory regulation of chiropractors and osteopaths in the UK. In 1993, this finally became reality.
Osteopathy has strong Royal links: Prince Charles is the President of the GOsC; Princess Diana was the President of the GCRO; and Princess Anne is the patron of the British School of Osteopathy (statement dated 2011).
In 1982, Prince Charles was elected as President of the British Medical Association (BMA) and promptly challenged the medical orthodoxy by advocating alternative medicine. In a speech at his inaugural dinner as President, the Prince lectured the medics: ‘Through the centuries healing has been practised by folk healers who are guided by traditional wisdom which sees illness as a disorder of the whole person, involving not only the patient’s body, but his mind, his self-image, his dependence on the physical and social environment, as well as his relation to the cosmos.’ The BMA-officials ordered a full report on alternative medicine which promptly condemned this area as implausible nonsense.
In 1993, Charles founded his lobby group which, after being re-named several times, ended up being called the ‘Foundation for Integrated Health’ (FIH). It was closed down in 2010 amidst allegations of money laundering and fraud. Its chief executive, George Gray, was later convicted and went to jail. The FIH had repeatedly been a little economical with the truth.
In 2000, Charles wrote an open letter to The Times stating that…It makes good sense to evaluate complementary and alternative therapies. For one thing, since an estimated £1.6 billion is spent each year on them, then we want value for our money. The very popularity of the non-conventional approaches suggests that people are either dissatisfied with their orthodox treatment, or they find genuine relief in such therapies. Whatever the case, if they are proved to work, they should be made more widely available on the NHS…But there remains the cry from the medical establishment of “where’s the proof?” — and clinical trials of the calibre that science demands cost money…The truth is that funding in the UK for research into complementary medicine is pitiful…So where can funding come from?…Figures from the department of complementary medicine at the University of Exeter show that less than 8p out of every £100 of NHS funds for medical research was spent on complementary medicine. In 1998-99 the Medical Research Council spent no money on it at all, and in 1999 only 0.05 per cent of the total research budget of UK medical charities went to this area…
In 2001, Charles worked on plans to help build a model hospital of integrated medicine. It was to train doctors to combine conventional medicine and alternative treatments, such as homeopathy, Ayurvedic medicine and acupuncture, and was to have have up to 100 beds. The prince’s intervention marked the culmination of years of campaigning by him for the NHS to assign a greater role to alternative medicine. Teresa Hale, founder of the Hale Clinic in London, said: “Twenty-five years ago people said we were quacks. Now several branches, including homeopathy, acupuncture and osteopathy, have gained official recognition.” The proposed hospital, which was due to open in London in 2003/4, was to be overseen by Mosaraf Ali, who runs the Integrated Medical Centre (IMC) in London. But the hospital never materialised. This might be due to Mosaraf Ali falling in disrepute: Raj Bathija, 69 and from India, went for a massage at the clinic of Dr Mosaraf Ali and his brother Imran in 2005 after suffering from two strokes. However, he claims that shortly after the treatment, his legs became pale and discoloured. Four days afterwards, Mr Bathija was admitted to hospital, where he had to have both legs amputated below the knee due to a shortage of blood. According to Mr Bathija, Dr Ali and his brother were negligent in that they failed to diagnose his condition and neglected to advise him to go to hospital. His daughter Shibani said: “My father was in a wheelchair but was making progress with his walking. He hoped he might become a bit more independent. With the amputations, that’s all gone.” Dr Ali was sued (if anyone knows the outcome of this case, please let me know).
In 2003, Prince Charles’ FIH launched a five-year plan which outlined how to improve access to alternative therapies.
In 2004, Charles publicly supported the Gerson diet as a treatment for cancer and Prof Baum, an eminent oncologists, was invited to respond in an open letter to the British Medical Journal: …Over the past 20 years I have treated thousands of patients with cancer and lost some dear friends and relatives to this dreaded disease…The power of my authority comes with knowledge built on 40 years of study and 25 years of active involvement in cancer research. Your power and authority rest on an accident of birth. I don’t begrudge you that authority but I do beg you to exercise your power with extreme caution when advising patients with life-threatening diseases to embrace unproven therapies.
In 2005, the ‘Smallwood-Report’ was published; it had been commissioned by Charles and paid for by Dame Shirley Porter to inform health ministers. It stated that up to 480 million pounds could be saved, if one in 10 family doctors offered homeopathy as an “alternative” to standard drugs for asthma. Savings of up to 3.5 billion pounds could be achieved by offering spinal manipulation rather than drugs to people with back pain. Because I had commented on this report, Prince Charles’ first private secretary asked my vice chancellor to investigate my alleged indiscretion; even though I was found to be not guilty of any wrong-doing, all local support at Exeter stopped which eventually led to my early retirement. ITV later used this incident in a film entitled THE MEDDLING PRINCE, I later published a full account of this sad story in my memoir.
In a 2006 speech, Prince Charles told the World Health Organisation in Geneva that alternative medicine should have a more prominent place in health care and urged every country to come up with a plan to integrate conventional and alternative medicine into the mainstream. But British science struck back. Anticipating Prince Charles’s sermon in Geneva, 13 of Britain’s most eminent physicians and scientists wrote an “Open Letter” which expressed concern over “ways in which unproven or disproved treatments are being encouraged for general use in Britain’s National Health Service.” The signatories argued that “it would be highly irresponsible to embrace any medicine as though it were a matter of principle.”
In 2008, The Times published my letter asking the FIH to withdraw two guides promoting alternative medicine, stating: “the majority of alternative therapies appear to be clinically ineffective, and many are downright dangerous.” A speaker for the FIH countered the criticism by stating: “We entirely reject the accusation that our online publication Complementary Healthcare: A Guide contains any misleading or inaccurate claims about the benefits of complementary therapies. On the contrary, it treats people as adults and takes a responsible approach by encouraging people to look at reliable sources of information… so that they can make informed decisions. The foundation does not promote complementary therapies.”
In 2009, the Prince held talks with the health Secretary to persuade him to introduce safeguards amid a crackdown by the EU that could prevent anyone who is not a registered health practitioner from selling remedies. This, it seems, was yet another example of Charles’ disregard of his constitutional role.
In the same year, Charles urged the government to protect alternative medicine because “we fear that we will see a black market in herbal products”, as Dr Michael Dixon, then medical director of Charles’ FIH, put it.
In 2009, the health secretary wrote to the prince suggesting a meeting on the possibility of a study on integrating complementary and conventional healthcare approaches in England. The prince had written to Burnham’s predecessor, Alan Johnson, to demand greater access to complementary therapies in the NHS alongside conventional medicine. The prince told him that “despite waves of invective over the years from parts of the medical and scientific establishment” he continued to lobby “because I cannot bear people suffering unnecessarily when a complementary approach could make a real difference”. He opposed “large and threatened cuts” in the funding of homeopathic hospitals and their possible closure. He complained that referrals to the Royal London homeopathic hospital were increasing “until what seems to amount to a recent ‘anti-homeopathic campaign’”. He warned against cuts despite “the fact that these homeopathic hospitals deal with many patients with real health problems who otherwise would require treatment elsewhere, often at greater expense”.
In 2009, it was announced that the ‘College of Integrated Medicine’ (the name was only later changed to ‘College of Medicine’, see below) was to have a second base in India. An Indian spokesman commented: “The second campus of the Royal College will be in Bangalore. We have already proposed the setting up of an All India Institute of Integrated Medicine to the Union health ministry. At a meeting in London last week with Prince Charles, we finalized the project which will kick off in July 2010”.
In 2010, Charles publicly stated that he was proud to be perceived as ‘an enemy of the enlightenment’.
In 2010, ‘Republic’ filed an official complaint about FIH alleging that its trustees allowed the foundation’s staff to pursue a public “vendetta” against a prominent critic of the prince’s support for complementary medicines. It also suggested that the imminent closure of Ernst’s department may be partly down to the charity’s official complaint about him after he publicly attacked its draft guide to complementary medicines as “outrageous and deeply flawed”.
In 2010, former fellows of Charles’ disgraced FIH launched a new organisation, The College of Medicine’ supporting the use of integrated treatments in the NHS. One director of the college is Michael Dixon, a GP in Cullompton, formerly medical director of the Foundation for Integrated Health. My own analysis of the activities of the new college leaves little doubt that it is promoting quackery.
In 2011, after the launch of Charles’ range of herbal tinctures, I had the audacity to publicly criticise Charles for selling the Duchy Herbals detox tincture which I named ‘Dodgy Originals Detox Tincture’.
In 2011, Charles forged a link between ‘The College of Medicine’ and an Indian holistic health centre (see also above). The collaboration was reported to include clinical training to European and Western doctors in ayurveda and homoeopathy and traditional forms of medicine to integrate them in their practice. The foundation stone for the extended campus of the Royal College known as the International Institution for Holistic and Integrated Medicine was laid by Dr Michael Dixon in collaboration with the Royal College of Medicine.
In 2012, Charles was nominated for ‘THE GOLDEN DUCK AWARD’ for his achievements in promoting quackery. However, Andrew Wakefield beat him to it; Charles certainly was a deserving runner-up.
In 2013, Charles called for society to embrace a broader and more complex concept of health. In his article he described a vision of health that includes the physical and social environment, education, agriculture and architecture.
In 2013, Charles’ Highgrove enterprise offered ‘baby-hampers’ for sale at £195 a piece and made a range of medicinal claims for the products it contained. As these claims were not supported by evidence, there is no way to classify them other than quackery.
By 2013, the ‘Association of Osteomyologists’ were seeking to become regulated by statute, with the help of Prince Charles as their patron. The chairman and founder of this organisation was knighted for services to alternative medicine. Osteomyologists encourage the use of techniques including cranio-sacral therapy and claim that “we all know that Colleges, Institutions, and Medical Practitioners, are brain washed from the very outset into believing that their discipline is the only way to go.”
In November 2013, Charles invited alternative medicine proponents from across the world, including Dean Ornish, Michael Dixon, chair of College of Medicine, UK and Issac Mathai of Soukya Foundation, Bangalore, to India for a ‘brain storm’ and a subsequent conference on alternative medicine. The prince wanted the experts to collaborate and explore the possibilities of integrating different systems of medicines and to better the healthcare delivery globally, one of the organisers said.
In June 2014, BBC NEWS published the following 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. On this blog, I have pointed out that the research in question was fatally flawed and that Charles, once again, overstepped the boundaries of his constitutional role.
In 2015, two books were published which are relevant in this context. My memoir A SCIENTIST IN WONDERLAND recounts most of my dealings with Charles and his sycophants, including how an intervention from his first private secretary eventually led to the closure of my department. The book by Catherine Meyer CHARLES, THE HEART OF A KING is far less critical about our heir to the throne; it nevertheless severely criticises his stance on alternative medicine.
In October 2015, the Guardian obtained the infamous “black spider memos” which revealed that Charles had repeatedly lobbied politicians in favour of alternative medicine (see also above).
In 2016, speaking at a global leaders summit on antimicrobial resistance, Prince Charles warned that Britain faced a “potentially disastrous scenario” because of the “overuse and abuse” of antibiotics. The Prince explained that he had switched to organic farming on his estates because of the growing threat from antibiotic resistance and now treats his cattle with homeopathic remedies rather than conventional medication. “As some of you may be aware, this issue has been a long-standing and acute concern to me,” he told delegates from 20 countries “I have enormous sympathy for those engaged in the vital task of ensuring that, as the world population continues to increase unsustainably and travel becomes easier, antibiotics retain their availability to overcome disease… It must be incredibly frustrating to witness the fact that antibiotics have too often simply acted as a substitute for basic hygiene, or as it would seem, a way of placating a patient who has a viral infection or who actually needs little more than patience to allow a minor bacterial infection to resolve itself.”
In 2017, the ‘College of Medicine’ mentioned above was discretely re-named ‘College of Medicine and Integrated Health’
In the same year, Charles declared that he will open a centre for alternative medicine in the recently purchased Dumfries House in Scotland.
As I am writing this update, Prince Charles is facing a backlash over a letter he wrote in 1986 in which he urged the US to “take on the Jewish lobby” and blamed “the influx of foreign Jews” for the unrest in the Middle East. The chairman of the Campaign Against Antisemitism has called the letter “disturbing” and the comments as “unmistakably anti-Semitic”. But that is, of course, another story.
Prince Charles’ dedication to quackery is remarkable. As every year, on his birthday he deserves credit for the hard work he has put into it. The late Christopher Hitchens repeatedly wrote about this passion, and his comments are, in my view, unsurpassable:
We have known for a long time that Prince Charles’ empty sails are so rigged as to be swelled by any passing waft or breeze of crankiness and cant. He fell for the fake anthropologist Laurens van der Post. He was bowled over by the charms of homeopathic medicine. He has been believably reported as saying that plants do better if you talk to them in a soothing and encouraging way… The heir to the throne seems to possess the ability to surround himself—perhaps by some mysterious ultramagnetic force?—with every moon-faced spoon-bender, shrub-flatterer, and water-diviner within range.
HAPPY BIRTHDAY YOUR ROYAL HIGHNESS
On their website, the ASA yesterday published a statement about chiropractic. It outlines which claims UK chiropractors are allowed to make and which are likely to get them into conflict with the ASA. Here are a few excerpts (my comments are added in bold):
Chiropractic is a healthcare profession that focuses on diagnosis, treatment and prevention of mechanical disorders of the musculoskeletal system, with special emphasis on the spine. It emphasises manual therapy including spinal manipulation and other joint and soft-tissue manipulation, and includes exercises, and health and lifestyle counselling…
Why not say as it is: more than 90% of patients consulting a chiropractor will receive spinal manipulations. Therefore the best way to define chiropractic is by its hallmark intervention. Using vague language like ‘manual therapy… exercises, and health and lifestyle counselling’ creates big problems and opens the door to all sorts of therapeutic claims (see below).
In 2017 the ASA carried out an evidence review on the use of multi-modal approaches used in Chiropractic in treating sciatica, whiplash and sports injuries as well as the treatment of babies, children and pregnant women as specific patient groups. The subsequent ASA Guidance explains in more detail the types of claims (including phraseology) that are likely to be acceptable for chiropractors to make in their advertising and those which are not. We recommend chiropractors consider this CAP advice and the ASA Guidance together when making treatment claims in advertising.
Based on all evidence submitted and reviewed to date, the ASA and CAP accept that chiropractors may claim to treat the following conditions:
- Ankle sprain (short term management)
- Elbow pain and tennis elbow (lateral epicondylitis) arising from associated musculoskeletal conditions of the back and neck, but not isolated occurrences
- Headache arising from the neck (cervicogenic)
- Inability to relax
- Joint pains
- Joint pains including hip and knee pain from osteoarthritis as an adjunct to core OA treatments and exercise
- General, acute & chronic backache, back pain (not arising from injury or accident)
- Generalised aches and pains
- Mechanical neck pain (as opposed to neck pain following injury i.e. whiplash)
- Migraine prevention
- Minor sports injuries and tensions
- Muscle spasms
- Plantar fasciitis (short term management)
- Rotator cuff injuries, disease or disorders
- Shoulder complaints (dysfunction, disorders and pain)
- Soft tissue disorders of the shoulder
I am puzzled by this list; for most indications, there is no good evidence at all – unless, of course, we consider chiropractic to consist of ‘manual therapy… exercises, and health and lifestyle counselling’ (see above). But, in this case, the list is still very odd because it would then need to include practically all conditions that can affect humans. Or does anyone know of many diseases that cannot benefit from ‘health and lifestyle counselling’?
…As regulated health professionals, chiropractors may refer to treating specific population groups such as pregnant women, children and babies. However, at present there is a limited or negative evidence base for the effectiveness of chiropractic (here the ASA use the term ‘chiropractic’ not as defined above but as a type of therapy which I think is correct but most chiros object to) in treating conditions specific to those groups, such as colic or morning sickness.
Consequently, references to treatment for symptoms and conditions that are likely to be understood to be specific to babies, children or pregnant women are unlikely to be acceptable unless the marketer holds a robust body of evidence…
And why should this be? Is ‘health and lifestyle counselling’ not effective for these conditions? Clearly it is! So this restriction is illogical.
I think, the ASA got themselves into a major muddle here. The only way to sort it out is to define chiropractic by its main therapy, spinal manipulation, and judge it by the proven risks and benefits of this intervention. (A surgeon will also often give ‘health and lifestyle counselling’, but this does not mean that surgery is indicated for migraine, common cold, asthma etc.)
And if we follow this approach, we instantly see that the ASA list of allowed claims makes no sense whatsoever!
‘Chiropractic is safe’ is a statement by Dr Arleen Scholten (see below) and thousands of other chiropractors like her. This sentence seems to be a nice marketing slogan – but sadly it is far removed from reality:
- chiropractic causes mild to moderate adverse effects in about 50% of all patients;
- in addition, it caused many much more serious complications, including deaths.
How many such serious events have occurred is anyone’s guess. The reason for this uncertainty is that there is no monitoring system that would give us this information. About 500 serious complications have been published in the medical literature. But these published cases are just the tip of a much bigger iceberg. We have shown that under-reporting is close to 100%.
This means that the vast majority of these cases remain completely undocumented. Some appear in the popular press, like the one recently published in the DAILY MAIL:
A chiropractor has been arrested on suspicion of manslaughter after a retired bank manager died following treatment for backache.
John Lawler, 80, was undergoing routine treatment at a private clinic when he lost consciousness and appeared to have become paralysed from the shoulders down. He was taken straight to hospital but died the next day as a result of a ‘traumatic spinal cord injury.’
His wife of 55 years, Joan Lawler, 81, was in the chiropractor’s clinic with her husband and witnessed the incident. Police are investigating to establish whether or not criminal negligence was a factor in his death.
Dr Arleen Scholten, 40, the chiropractor who treated Mr Lawler, was arrested by police on suspicion of manslaughter and released pending further inquiries.
Mr Lawler, a former Barclays Bank manager, was an active and healthy grandfather who lived in York. It is understood he was taken ill on his third visit in a week to Chiropractic 1st – a clinic within walking distance of the family home. He was seen by Dr Scholten, a chiropractor and director of the company, on Friday, August 11 and was undergoing treatment on his back when the unexpected and fatal problem occurred.
Mr Lawler was taken to York District Hospital by ambulance before being transferred to Leeds General Infirmary when the seriousness of his condition became clear.
END OF QUOTE
DOCTOR Scholten tells us on her website that we get to help people who suffer from a variety of health issues. Naturally, chiropractic helps traditional neck and back problems, but chiropractic has also produced wonderful results with a variety of organic and systemic problems. Chiropractic is safe.*** Chiropractic is natural. And Chiropractic works!
Doctor Scholten also informs us that our children were all adjusted the day they were born, 2 were homebirths and I continue to check their spines regularly. There is a saying in Chiropractic ‘If the twig is bent so grows the tree’.
Say no more!
(*** my emphasis)