quackery
Michael Dixon LVO, OBE, MA, FRCGP has been a regular feature of this blog (and elsewhere). He used to be a friend and colleague until … well, that’s a long story. Recently, I came across his (rather impressive) Wikipedia page. To my surprise, it mentions that Dixon
“has been criticised by professor of complementary medicine and alternative medicine campaigner Edzard Ernst for advocating the use of complementary medicine. Ernst said that the stance of the NHS Alliance on complementary medicine was “misleading to the degree of being irresponsible.”[31] Ernst had previously been sympathetic to building a bridge between complementary and mainstream medicine, co-writing an article with Michael Dixon in 1997 on the benefits of such an approach.[32] Ernst and Dixon write “missed diagnoses by complementary therapists giving patients long term treatments are often cited but in the experience of one of the authors (MD) are extremely rare. It can also cut both ways. A patient was recently referred back to her general practitioner by an osteopath, who was questioning, as it turned out quite correctly, whether her pain was caused by metastates. Good communication between general practitioner and complementary therapist can reduce conflicts and contradictions, which otherwise have the potential to put orthodox medicine and complementary therapy in an either/or situation.”
REFERENCES
31) February 2009, 24. “Academics and NHS Alliance clash over complementary medicine”. Pulse Today.
32) ^ Update – the journal of continuing education for General Practitioners, 7th May 1997
I have little recollection of the paper that I seem to have published with my then friend Michael, and it is not listed in Medline, nor can I find it in my (usually well-kept) files; the journal ‘Update’ does not exist anymore and was obviously not a journal good enough for keeping a copy. But I do not doubt that Wiki is correct.
In fact, it is true that, in 1997, I was still hopeful that bridges could be built between conventional medicine and so-called alternative medicine (SCAM). But I had always insisted that they must be bridges built on solid ground and with robust materials.
Put simply, my strategy was to test SCAM as rigorously as I could and to review the totality of the evidence for and against it. Subsequently, one could consider introducing those SCAMs into routine care that had passed the tests of science.
Dixon’s strategy differed significantly from mine. He had no real interest in science and wanted to use SCAM regardless of the evidence. Since the publication of our paper in 1997, he has pursued this aim tirelessly. On this blog, we find several examples of his activity.
And what happened to the bridges?
I’m glad you ask!
As it turns out, very few SCAMs have so far passed the test of science and hardly any SCAM has been demonstrated to generate more good than harm. The material to build bridges is therefore quite scarce, hardly enough for solid constructions. Dixon does still not seem to be worried about this indisputable fact. He thinks that INTEGRATED MEDICINE is sound enough for providing a way to the future. I disagree and still think it is ‘misleading to the degree of being irresponsible’.
Who is right?
Dixon or Ernst?
Opinions about this differ hugely.
Time will tell, I suppose.
Some chiropractors seem too uninformed, stupid or greedy to stop claiming that spinal manipulation boosts the immune system. In the current situation, this is not just annoying, it is positively dangerous.
Here is a fine example of such a person; he is even so convinced of his views that he felt like giving an interview:
How can/does chiropractic care improve your immune system? What happens to our bodies physiologically when we get chiropractic adjustments?
Chiropractic care addresses the vertebral subluxation. This occurs when a vertebra becomes misaligned. This misalignment can result in irritation to the spinal nerve roots, which exit the spinal cord.
When a spinal nerve root is irritated, it stresses the nervous system — thus the potential to weaken the immune system. When we evaluate the spine for these subluxations and identify a misalignment, chiropractors can adjust the spine to alleviate the irritation to the spinal nerve root. This in turn helps to remove the stress from the nervous system.
If people have problems with their immune systems, can chiropractic care help make them better?
Chiropractic care is not a panacea for disease. Its main role is to remove the interference on the nervous system. The three main stresses on the nervous system are thoughts, traumas, and toxins. These are mainly caused by poor lifestyle choices.
Negative thoughts and self-doubt, physical trauma, and environmental toxins all affect the body in ways that stress the nervous system, thus weakening the immune response. Chiropractic care can address the entire nervous system by not only creating a physiological change, but also inducing a reduction of stress, which results in emotional regulation.
Is there any particular research that gives evidence on how chiropractic care can improve your immune system?
Three past studies suggest that manipulation consistently reduced the production of pro-inflammatory mediators associated with tissue damage and pain from articular structures. Two studies provide evidence that manipulation consistently reduced the production of pro-inflammatory mediators associated with tissue damage and pain from articular structures.
Two studies provide evidence that manipulation may induce and enhance production of the immunoregulatory cytokine IL-2 and the production of immunoglobulins as well.
There are a multitude of clinical studies demonstrating the effects of stress on the body and the correlation between stress and immune function. More double blind, randomized clinical trials need to be conducted on the direct relationship between spinal subluxation and the effect on the immune system. In private practice, we observe the impact that adjusting the spine has on overall wellness and its undeniable effect on boosting the body’s ability to adapt to stress and improve your immune system.
Is there anything else about the physiology of how chiropractic care impacts the immune system that you think is important for readers to know?
Our health is our wealth. Taking responsibility for our wellbeing and being preventative affords the body the best possible chance of protecting itself from illness and disease.
Chiropractic care is rooted in the fundamentals that our negative thoughts, traumas, and toxins can lead to disease. By properly evaluating every patient and addressing their physical and emotional challenges, we as a profession can be the leaders of preventative care and restore health naturally and effectively.
On the one hand this is embarrassing, as it exposes almost everything that is wrong with chiropractic. On the other hand, it is informative, as it demonstrates how deeply some chiropractors are entrenched in platitudes, half-truths and blatant lies. The inevitable question is: do these chiropractors really believe this nonsense, or do they merely promote it because it is good for business?
Whatever the answer may be, one thing is fairly obvious: the ones who are being harmed by such drivel are the patients who lack sufficient critical thinking abilities to look through it. They pay not just with their money, but also with their health.
SO, PLEASE LEARN TO THINK CRITICALLY, FOLKS!
The U.S. Food and Drug Administration has issued warning letters to four companies for selling unapproved injectable drug products labelled as homeopathic that can pose serious risks to patient health and violate federal law, as part of the agency’s efforts to protect Americans from potentially harmful products that are labelled as homeopathic.
The FDA is particularly concerned about unapproved injectable drug products labelled as homeopathic because they are injected directly into the body, often directly into the bloodstream and bypass some of the body’s key natural defences against toxins, toxic ingredients and dangerous organisms that can cause serious and life-threatening harm. Additionally, unapproved drugs that claim to cure, treat or prevent serious conditions may cause consumers to delay or stop medical treatments that have been found safe and effective through the FDA review process.
“The FDA’s drug approval requirements are designed to protect patients by ensuring, among other things, that drugs are safe and effective for their intended uses. These unapproved injectable drugs are particularly concerning because they inherently present greater risks to patients because of how they are administered,” said Donald D. Ashley, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “These products are further concerning given that they are labelled to contain potentially toxic ingredients intended for injection directly into the body. These warning letters reflect our continued commitment to patient safety.”
No currently marketed drug products labelled as homeopathic have been approved by the FDA for any use and the agency cannot assure these drugs meet modern standards for safety, effectiveness and quality. Products labelled as homeopathic can be made from a wide range of substances, including ingredients derived from plants, healthy or diseased animal or human sources, minerals and chemicals, and they can include known poisons or toxins. These drugs are often marketed as natural, safe and effective alternatives to approved prescription and non-prescription products and are widely available in the marketplace. Additionally, the lack of premarket quality review is particularly concerning for injectable drugs, which generally pose a greater risk of harm to users because the route of administration for these products bypasses some of the body’s natural defences.
The FDA issued the warning letters to Hevert Pharmaceuticals, LLC; MediNatura, Inc.; 8046255 Canada, Inc., doing business as Viatrexx; and World Health Advanced Technologies, Ltd. The products included in the warning letters are new drugs because they are not generally recognized as safe and effective for their labelled uses, and FDA has not approved these products. Some drugs, such as “Enercel,” marketed by World Health Advanced Technologies, Ltd., are intended for serious diseases such as tuberculosis and hepatitis B and C.
Many of the drugs were labelled to contain potentially toxic ingredients such as nux vomica, belladonna (deadly nightshade), mercurius solubilis (mercury), and plumbum aceticum (lead). For example, nux vomica contains strychnine, which is a highly toxic, well-studied poison that is used to kill rodents. The agency is concerned that these potentially toxic ingredients present additional risks of serious harm when delivered directly into the body, including directly into the bloodstream.
Drugs labelled as homeopathic may also cause significant and even irreparable harm if they are poorly manufactured. Viatrexx was also cited for substandard manufacturing practices for sterile drugs.
The foreign manufacturers of the injectable drugs sold by Hervert Pharmaceuticals, LLC; MediNatura New Mexico, Inc.; and Viatrexx were also placed on import alert 66-41 to stop these drugs from entering the U.S.
The FDA has taken steps to clarify for both consumers and industry how the potential safety risks of these products are assessed. On Oct. 24, 2019, the FDA withdrew Compliance Policy Guide (CPG) 400.400 “Conditions Under Which Homeopathic Drugs May be Marketed,” because it was inconsistent with the agency’s risk-based approach to regulatory and enforcement actions. The FDA also issued a revision of its draft guidance, titled Drug Products Labeled as Homeopathic: Guidance for FDA Staff and Industry, for public comment. When finalized, this guidance will explain the categories of homeopathic drug products that we intend to prioritize under our risk-based enforcement approach. In the interim, before the draft guidance is finalized, the FDA intends to apply its general approach to prioritizing risk-based regulatory and enforcement action.
The FDA encourages health care professionals and consumers to report adverse events or quality problems experienced with the use of any of these products to the FDA’s MedWatch Adverse Event Reporting program. To report adverse drug events in animals, see How to Report Animal Drug Side Effects and Product Problems…
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Hevert is of course well known to readers of this blog for their attempt to silence critics of homeopathy in Germany. The FDA’s warning letter refers to their following injectable products:
- “Arnica,”
- “Calmvalera comp.,”
- “Gelsemium comp.,”
- “Hepar comp.,”
- “Lymphaden comp.”
The FDA referred to the following injectable homeopathic products from 8046255 Canada:
- “Articula,”
- “Mesenchyme,”
- “Connectissue,”
- “MuSkel-Neural,”
- “Ouch,”
- “Ithurts,”
- “Adipose,”
- “Systemic Detox,”
- “Hair,”
- “Neuro 3,”
- “Infla,”
- “Collagen,”
- “Prolo,”
- “Lymph 1,”
- “GI,”
- “Neuro,”
- “Arthros,”
- “Male+,”
- “Immunexx,”
- “Relief+,”
- “Intra-Cell,”
- “Facial,”
- “ANS/CNS”.
The FDA warning to World Health Advanced Technologies, Ltd referred to:
- “Enercel AM,”
- “Enercel Forte,”
- “Enercel Max,”
- “Enercel Mist-Nasal,”
- “Enercel Mist Nebulizer,”
- “Enercel PM,”
- “Vanicel,”
- “Enercel Plus,”
- “Enercel Plus IM.”
The FDA warning referred to the following products by MediNatura, and the claims made for them include:
- Zeel Injection Solution: “… treatment of arthrosis/osteoarthritis, and/or rheumatic joint diseases and for the relief of symptoms such as pain and joint stiffness.”
- Traumeel Injection Solution: “… treatment of injuries, inflammatory and degenerative conditions of the musculoskeletal system and for the relief of associated symptoms such as pain.”
- Engystol Injection Solution: “… support of the immune system to reduce severity and duration of symptoms in viral infections, particularly in the early stages of colds and influenza-like illnesses.”
- Neuralgo-Rheum Injection Solution: “… treatment of nerve pain, soft tissue rheumatism and symptoms of disc protrusion.”
- Lymphomyosot X Injection Solution: “… improvement of lymphatic drainage, the non-specific immune defense, and conditions such as benign hypertrophy of lymph nodes, chronic tonsillitis, tonsillar hypertrophy and lymphatic edema.”
- Spascupreel Injection Solution: “… relief of spasms of the smooth musculature of the gastrointestinal and urogenital tract as well as general muscle spasms.”
The FDA has requested the companies to respond within 15 working days. The letter also states that failure to correct any violations could result in legal action against the company, including seizure and injunction.
Asked for comment, Cliff Clive, founder and CEO for MediNatura, stated that he is disappointed with the FDA’s actions and the company is in the process of developing their response. “The FDAs statements that the MediNatura injectable products present greater risk to consumers is without factual basis,” Clive said. “The MediNatura injectable products are labelled for use only under the care of licensed practitioners [and] are manufactured in [Good Manufacturing Practice]-compliant facilities to assure their quality and sterility.”
Disputing several of the claims made in the letter, Clive noted that rather than protecting patients, “the FDA’s actions threaten to remove valuable alternatives relied upon by medical practitioners in treating their patients. These injections have been used legally by thousands of medical doctors for more than 30 years in the U.S., and in over 50 other countries for more than 60 years, with rigorous monitoring of adverse events,” Clive said. “As a result, there is a substantial amount of epidemiological data which shows that MediNatura’s injection products have a superb safety profile.”
As far as I can see, none of the above-named products are supported by sound evidence. If you ask me, it is time that homeopaths understand what proofs of safety and efficacy amount to, that they stop confusing the public, and that they stop marketing illegal products.
Yesterday, I received a tweet from a guy called Bart Huisman (“teacher beekeeping, nature, biology, classical homeopathy, agriculture, health science, social science”). I don’t know him and cannot remember whether I had previous contact with him. His tweet read as follows:
“Why should anyone believe what Professor Edzard Ernst says, after he put his name to a BBC programme, he now describes as “deception”.”
This refers to a story that I had almost forgotten. It’s a nice one with a ‘happy ending’, so let me recount it here briefly.
In 2005, the BBC had hired me as an advisor for their 4-part TV series on alternative medicine.
The first part of the series was on acupuncture, and Prof Kathy Sykes presented the opening scene taking place in a Chinese operation theatre. In it a Chinese women was having open heart surgery with the aid of acupuncture. Kathy’s was visibly impressed and said on camera that the patient was having the surgery “with only needles to control the pain.” However, the images clearly revealed that the patient was receiving all sorts of other treatments given through intra-venous lines. So, Prof Sykes was telling the UK public a bunch of porkies. This was bound to confuse many viewers.
One of them was Simon Singh. At the time, I did not know Simon (to be honest, I did not even know of him) and was surprised to receive a phone call from him. He politely asked me to confirm that I had been the adviser of the BBC on this production. I was happy to confirm this fact. Then he asked why I had missed such a grave error. I replied that I could not possibly have spotted it, because all I had been asked to do was to review and correct the text of the programme which the BBC had sent to me by email. Before it was broadcast, I had not seen a single passage of the film.
Correcting the text had already led to several problems (not so much regarding the acupuncture part but mostly the other sections), because the BBC was reluctant to change several of the mistakes I had identified. When I told them that, in this case, I would quit, they finally found a way to alter them. But the cooperation had been far from easy. I explained all this to Simon and eventually he asked me whether I would be willing to support the official complaint he was about to file with the BBC. I agreed. This is probably where I used the term ‘deception’ that Mr Huisman mentioned in his tweet.
So, Simon submitted his complaint and eventually won the case.
But this is not the happy ending I was referring to.
During the course of the complaint, Simon and I realised that we were thinking alike and were getting on well. A few months later, he suggested that the two of us write a book together about alternative medicine. At first, I was hesitant. Simon said, “let’s try just one chapter, and see how it works out.” So we did. It turned out to be fun and instructive for both of us. So we did the other chapters as well. The book was published in 2008 and is called TRICK OR TREATMENT. It was published in about 20 different languages and the German version became ‘science book of the year in 2011 (I think).
And that’s not the happy ending either (in fact, it caused a lot of hardship for Simon who was sued by the BCA; luckily, he won that case too).
The real happy ending is the fact that Simon and I became friends for life.
Thank you Bart Huisman for reminding me of this rather lovely story.
‘HOMEOPATHY RESOURCE’ claim they are the online web site for accurate information on homeopathy, homeopaths and homeopathic organizations. On 18 June, they published an article entitled “Another Remarkable Demonstration of Homeopathy’s Effectiveness in Covid-19: ONLY 19 Deaths out of 35 million in Kerala, India”. Here it is in its full beauty:
The State of Kerela India has shown that homeopathy and grassroots health care works dramatically well in epidemic and pandemic situations.. The state, in spite of areas of great density, has reported only 19 deaths. This compares to the UK which has a population of 66 million people but a tragic 41,698 deaths.
The region’s Health Minister Shailaja Teacher has been called the “Coronavirus Slayer” after introducing homeopathy as a primary means of dealing with the epidemic. Kerala India has already come through two Nipah virus epidemics under her watch.
Tactics used by Shailaja included encouraging the use of homeopathy. In a recent media meeting, she talked about the need “to improve the immunity and resistance power of each individual not yet positive to Coronavirus, with the help of Homeopathic/ Ayurvedic medicines. That will help them resist the Coronavirus infection, help them to tide over the infection well, if at all they contract it…… everyone should take Homeopathic & Ayurvedic preventative treatments available.”
According to Dr E.S.Rajendran who practices in Kerala “The total number of people who received the homeopathic preventive medicine Ars alb 30 through Kerala government as on June 1st was 10 million. An equal number of people have also received the same through voluntary organisations. The remaining population is expected to receive the preventive medicine in another one month.” This distribution was carried out in each district with the help of resident associations and was achievable because there is a huge demand for homeopathy from the people.
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Do ‘HOMEOPATHY RESOURCE’ really think that this is ‘accurate information’?
Do they feel that it amounts to evidence that homeopathy prevents COVID-19 infections?
Do they believe that it is responsible to promote such a message?
If so, they are more deluded than their homeopathic remedies are diluted!
There is a plethora of factors that might have contributed to the low infection rate in Kerela. Here are some that spring into my mind (in descending order of probability):
- Social distancing measures might have been put in place at the right time.
- Hand-washing might have been better accepted than in the UK.
- Face-masks might have been more common.
- The government might have been less incompetent than the one in the UK.
- The pandemic might be arriving with some delay in Kerela (in the last 2 days the COVID cases have more than doubled in Kerela).
- The hot weather might have inhibited the spread of the infection.
- The Ayurvedic medicine mentioned by the health minister might have worked.
- There might be many more cases due to under-diagnosis and poor testing.
- The holy cows might have prevented infections.
- Homeopathy works dramatically well in epidemic and pandemic situations.
Call me a sceptic, but – whatever turns out to be true (and I sincerely hope that the case numbers stay low in Kerela) – I do not think that ‘HOMEOPATHY RESOURCE’ is providing accurate information with their recent post.
And call me a pessimist, but I fail to see any good evidence to assume that homeopathic remedies have any effect in treating or preventing viral infections. In fact,
HIGHLY DILUTE HOMEOPATHIC REMEDIES ARE PURE PLACEBOS!
This was essentially the question raised in a correspondence with a sceptic friend. His suspicion was that statistical methods might produce false-positive overall findings, if the research is done by enthusiasts of the so-called alternative medicine (SCAM) in question (or other areas of inquiry which I will omit because they are outside my area of expertise). Consciously or inadvertently, such researchers might introduce a pro-SCAM bias into their work. As the research is done mostly by such enthusiasts; the totality of the evidence would turn out to be heavily skewed in favour of the SCAM under investigation. The end-result would then be a false-positive overall impression about the SCAM which is less based on reality than on the wishful thinking of the investigators.
How can one deal with this problem?
How to minimise the risk of being overwhelmed by false-positive research?
Today, we have several mechanisms and initiatives that are at least partly aimed at achieving just this. For instance, there are guidelines on how to conduct the primary research so that bias is minimised. The CONSORT statements are an example. As many studies pre-date CONSORT, we need a different approach for reviews of clinical trials. The PRISMA guideline or the COCHRANE handbook are attempts to make sure systematic reviews are transparent and rigorous. These methods can work quite well in finding the truth, but one needs to be aware, of course, that some researchers do their very best to obscure it. I have also tried to go one step further and shown that the direction of the conclusion correlates with the rigour of the study (btw: this was the paper that prompted Prof Hahn’s criticism and slander of my work and person).
So, problem sorted?
Not quite!
The trouble is that over-enthusiastic researchers may not always adhere to these guidelines, they may pretend to adhere but cut corners, or they may be dishonest and cheat. And what makes this even more tricky is the possibility that they do all this inadvertently; their enthusiasm could get the better of them, and they are doing research not to TEST WHETHER a treatment works but to PROVE THAT it works.
In the realm of SCAM we have a lot of this – trust me, I have seen it often with my own eyes, regrettably sometimes even within my own team of co-workers. The reason for this is that SCAM is loaded with emotion and quasi-religious beliefs; and these provide a much stronger conflict of interest than money could ever do, in my experience.
And how might we tackle this thorny issue?
After thinking long and hard about it, I came up in 2012 with my TRUSTWORTHYNESS INDEX:
If we calculated the percentage of a researcher’s papers arriving at positive conclusions and divided this by the percentage of his papers drawing negative conclusions, we might have a useful measure. A realistic example might be the case of a clinical researcher who has published a total of 100 original articles. If 50% had positive and 50% negative conclusions about the efficacy of the therapy tested, his TI would be 1.
Depending on what area of clinical medicine this person is working in, 1 might be a figure that is just about acceptable in terms of the trustworthiness of the author. If the TI goes beyond 1, we might get concerned; if it reaches 4 or more, we should get worried.
An example would be a researcher who has published 100 papers of which 80 are positive and 20 arrive at negative conclusions. His TI would consequently amount to 4. Most of us equipped with a healthy scepticism would consider this figure highly suspect.
Of course, this is all a bit simplistic, and, like all other citation metrics, my TI provides us not with any level of proof; it merely is a vague indicator that something might be amiss. And, as stressed already, the cut-off point for any scientist’s TI very much depends on the area of clinical research we are dealing with. The lower the plausibility and the higher the uncertainty associated with the efficacy of the experimental treatments, the lower the point where the TI might suggest something to be fishy.
Based on this concept, I later created the ALTERNATIVE MEDICINE HALL OF FAME. This is a list of researchers who manage to go through life researching their particular SCAM without ever publishing a negative conclusion about it. In terms of TI, these people have astronomically high values. The current list is not yet long, but it is growing:
John Weeks (editor of JCAM)
Deepak Chopra (US entrepreneur)
Cheryl Hawk (US chiropractor)
David Peters (osteopathy, homeopathy, UK)
Nicola Robinson (TCM, UK)
Peter Fisher (homeopathy, UK)
Simon Mills (herbal medicine, UK)
Gustav Dobos (various, Germany)
Claudia Witt (homeopathy, Germany and Switzerland)
George Lewith (acupuncture, UK)
John Licciardone (osteopathy, US)
The logical consequence of a high TI would be that researchers of that nature are banned from obtaining research funds and publishing papers, because their contribution is merely to confuse us and make science less reliable.
I am sure there are other ways of addressing the problem of being mislead by false-positive research. If you can think of one, I’d be pleased to hear about it.
By guest blogger Loretta Marron
Although assumed to be traditional, what we know today as ‘Traditional Chinese Medicine’ (TCM) was invented in the 1950s for political reasons by then Chairman Mao. It has since been proclaimed by Xi Jinping, now life-President of the People’s Republic of China, as the “jewel” in the millennia of Chinese civilization.
In May this year, Xi “announced plans to criminalise criticism of traditional Chinese medicine”. Speaking out against TCM could land you years in prison, prosecuted for “picking fights to disturb public order” and “defaming” the practice.
With the industry expected to earn $420 billion by the end of 2020, covid-19 has provided Xi with a platform to promote unproven, potentially harmful TCM. To keep these profits filling Chinese coffers, the World Health Organization (WHO) remains silent and those challenging TCM are silenced.
In January, the late Dr Li Wenliang was arrested and gaoled for warning China about covid-19. Li was one of up to nine people who were disciplined for spreading rumours about it. As the virus silently spread around the world, Beijing told the WHO that there was ‘no clear evidence’ of spread between humans.
As their death toll passed 1,000, Beijing’s response was to remove senior officials and to sack hundreds over their handling of the outbreak. With the support of the WHO, claims continue to be made that TCM “has been proved effective in improving the cure rate”, denying the simple fact that “patients would have recovered even if they hadn’t taken the Chinese medicine”.
With cases now heading for 8 million, and over four hundred thousand people confirmed dead world-wide and with economies in free-fall, Beijing continues, “to protect its interests and people overseas; to gain leadership of international governance”,for financial gain, to aggressively use its national power. Under the guise of ‘International Aid’, during the pandemic, Beijing promoted treatments based on unproven traditional medicine, sending TCM practitioners to countries including Italy, France and Iran.
Countries challenging Beijing can expect claims of racism and financial retaliation.
Back in 2016, the Chinese State Council released a “Strategic Development Plan for Chinese Medicine (2016-2030)”, seeking to spread ‘knowledge’ into campuses, homes and abroad.
In July 2017, a law promising equal status for TCM and western medicine came into effect. Provisions included encouragement to China’s hospitals to set up TCM centres. “The new law on traditional Chinese medicine will improve global TCM influence, and give a boost to China’s soft power”.
In 2019, after strong lobbying by the Chinese Communist Party (CCP), WHO added a chapter on TCM to their official International Classification of Diseases (ICD-11). In China, doctors are now instructed to prescribe traditional medicine to most patients.
While Chinese herbs might have exotic names, they are, once translated, often the same as western herbs, many of which might have significant interactions. WHO fails to acknowledge any drug interactions.
In 1967, Mao launched Project 523 to find a cure for chloroquine-resistant malaria. Over 240,000 compounds had already been tested and none had worked. Trained in pharmacology and modern western methods, Tu Youyou used the scientific method to test sweet wormwood, a herb traditionally used in China for fever, where she developed a useful artemisinin derivative for resistant malaria. The drug has saved millions of lives. In 2015 she won the Nobel Prize for her work. However, Tu’s work is not a blanket endorsement of TCM: without the years of research, she would not have been successful.
TCM is commercially driven. Criticism of remedies is often blocked on the Internet in China, and critics have been jailed. The majority of TCM’s are not tested for efficacy in randomized clinical trials. Clinical trials are usually of poor quality and serious side effects are underreported. China has even rolled back regulations as Beijing forcefully promotes TCM’s as an alternative to proven western medicine. An increasing number of prestigious research hospitals now prescribe and dispense herbs that may cause drug interactions alongside western medicine for major illness patients.
TCM’s are not safe. Most systematic reviews suggest that there is no good or consistent evidence for effectiveness, negative results aren’t published, research data are fabricated and TCM-exports are of dubious quality.
If the benefits of herbal remedies are to be realised, good clinical studies must be encouraged.
TCM is not medicine. It’s little more than a philosophy or a set of traditional beliefs, about various concoctions and interventions and their alleged effect on health and diseases.
To stop misleading the world with what Mao himself saw as nonsense, and to mitigate future pandemics, WHO can and should remove all mention of TCM other than to state that it is unproven and could be dangerous.
The Lightning Process (LP) is a commercial programme developed by Phil Parker based on ideas from osteopathy, life coaching and neuro-linguistic programming. It has been endorsed by celebrities like Martine McCutcheon and Esther Rantzen, who credits it for her daughter’s recovery from ME. Parker claims that LP works by teaching people to use their brain to “stimulate health-promoting neural pathways”. One young patient once described it as follows: “Whenever you get a negative thought, emotional symptom, you are supposed to turn on one side and with your arm movements in a kind if stop motion, just say STOP very firmly and that is supposed to cut off the adrenaline response.”
Allegedly, the LP teaches individuals to recognize when they are stimulating or triggering unhelpful physiological responses and to avoid these, using a set of standardized questions, new language patterns and physical movements with the aim of improving a more appropriate response to situations. The LP involves three group sessions on consecutive days where participants are taught theories and skills, which are then practised through simple steps, posture and coaching.
A few days ago, someone asked my help writing to me: Norwegian newspaper is attacking patients for objecting to a clinical trial of the lightning process which is horrible quackery. LP is being backed by some people in Norwegian health authorities. Could you bring attention to how disgraceful this is please? I promised to look into it. Hence this post.
My searches located just one single trial. It seems to be the only controlled clinical study available. Here it is:
Design: Pragmatic randomised controlled open trial. Participants were randomly assigned to SMC or SMC+LP. Randomisation was minimised by age and gender.
Setting: Specialist paediatric CFS/ME service.
Patients: 12-18 year olds with mild/moderate CFS/ME.
Main outcome measures: The primary outcome was the the 36-Item Short-Form Health Survey Physical Function Subscale (SF-36-PFS) at 6 months. Secondary outcomes included pain, anxiety, depression, school attendance and cost-effectiveness from a health service perspective at 3, 6 and 12 months.
Results: We recruited 100 participants, of whom 51 were randomised to SMC+LP. Data from 81 participants were analysed at 6 months. Physical function (SF-36-PFS) was better in those allocated SMC+LP (adjusted difference in means 12.5(95% CI 4.5 to 20.5), p=0.003) and this improved further at 12 months (15.1 (5.8 to 24.4), p=0.002). At 6 months, fatigue and anxiety were reduced, and at 12 months, fatigue, anxiety, depression and school attendance had improved in the SMC+LP arm. Results were similar following multiple imputation. SMC+LP was probably more cost-effective in the multiple imputation dataset (difference in means in net monetary benefit at 12 months £1474(95% CI £111 to £2836), p=0.034) but not for complete cases.
Conclusion: The LP is effective and is probably cost-effective when provided in addition to SMC for mild/moderately affected adolescents with CFS/ME.
The trial was designed as an ‘A+B versus B’ study which practically always generates a positive outcome. It did not control for placebo effects and is, in my humble view, worthless and arguably unethical. It certainly does not warrant the conclusion that LB is effective or cost-effective.
I do not doubt that the LP-children improved, but I see no reason to believe that this had anything to do with LP. It could have been (and most likely was) caused by the intense attention that these kids received over three days. Giving them a daily ice-cream and some kindness might (and probably would) have produced even better outcomes.
So, what do we call a therapy for which numerous, far-reaching claims are being made, which is based on implausible assumptions, which is unproven, and for which people have to pay dearly?
The last time I looked, it was called quackery.
The Foundation for Integrated Health (FIH) does no longer exist. But it is historically important, in my view. So, I decided to do some research in order to document its perplexing history. In the course of this activity, I found that someone had beaten me to it. This article that does the job very well; I therefore take the liberty of copying it here and adding a few points at the end:
The Foundation for Integrated Health (FIH) was a controversial charity run by Charles, Prince of Wales, founded in 1993. The Foundation promoted complementary and alternative medicine, preferring to use the term “integrated health”, and lobbied for its inclusion in the National Health Service. The charity closed in 2010 after allegations of fraud and money laundering led to the arrest of a former official.
History
Prince Charles established the charity in 1993 to explore “how safe, proven complementary therapies can work in conjunction with mainstream medicine”. [1]
Dr Michael Dixon was appointed the Foundation’s medical director. From 2005 to 2007, FIH received a grant from the Department of Health to help organise the self-regulation of complementary therapies. There had been concern that with a large proportion of the public turning to complementary approaches, there were few safeguards in place to ensure that non-statutorily regulated therapists were safe, trained and would act in an appropriate way. FIH worked to bring together the representative bodies of many complementary professions to talk and agree standards. [2] The result was the formation of the Complementary and Natural Healthcare Council (CNHC) which had hoped to register 10,000 practitioners of complementary medicine by the end of 2009 but which by September 2009 had succeeded in enrolling less than a tenth of that number due to lack of interest on the part of some of their professional associations. The Department of Health is currently continuing to fund the CNHC but future funding will be dependent on substantial progress being made towards the target (which has now been reduced to 2,000). Alternative medicine campaigners argued that the move toward regulation conferred undue respectability on unproven and possibly unsafe complementary & alternative medicine (CAM) approaches.
FIH also worked with medical schools to increase the understanding of complementary approaches amongst new doctors and ran an annual awards ceremony for integrated health schemes both within the medical world and in the community.
The papers of the Foundation for Integrated Health are held at the Wellcome Library, Archives and Manuscripts, and are available for consultation by appointment. Further details about the collection can be found on the Wellcome online catalogue. [3]
Controversy
The Prince of Wales has demonstrated an interest in alternative medicine, the promotion of which has occasionally resulted in controversy. [4] In 2004, the Foundation divided the scientific and medical community over its campaign encouraging general practitioners to offer herbal and other alternative treatments to National Health Service patients, [5] [6] and in May 2006, The Prince made a speech to an audience of health ministers from various countries at the World Health Assembly in Geneva, urging them to develop a plan for integrating conventional and alternative medicine. [7]
In April 2008, The Times published a letter from Professor Edzard Ernst that asked the Prince’s Foundation to recall two guides promoting “alternative medicine”, saying: “the majority of alternative therapies appear to be clinically ineffective, and many are downright dangerous.” A speaker for the foundation 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.” [8] Ernst has recently published a book with science writer Simon Singh condemning alternative medicine called Trick or Treatment: Alternative Medicine on Trial . The book is ironically dedicated to “HRH the Prince of Wales” and the last chapter is very critical of his advocacy of “complementary” and “alternative” treatments. [9]
The Prince’s Duchy Originals have produced a variety of CAM products including a “Detox Tincture” that Ernst has denounced as “financially exploiting the vulnerable” and “outright quackery“. [10] In May 2009, the Advertising Standards Authority criticised an email that Duchy Originals had sent out to advertise its Echina-Relief, Hyperi-Lift and Detox Tinctures products saying it was misleading. [11]
In Ernst’s book More Good Than Harm? The Moral Maze of Complementary and Alternative Medicine he and ethicist Kevin Smith call Charles “foolish and immoral” and “conclude that it is not possible to practice alternative medicine ethically”. Ernst further claims that the private secretary of the Prince contacted the vice chancellor of Exeter University to investigate Ernst’s complaints against the “Smallwood Report” which the Prince had commissioned in 2005. While Ernst was “found not to be guilty of any wrong-doing, all local support at Exeter stopped, which eventually led to my early retirement.” [12]
Lobbying allegations
The Prince personally wrote at least seven letters [15] to the Medicines and Healthcare products Regulatory Agency (MHRA) shortly before they relaxed the rules governing labelling of herbal products such as the ones sold by his duchy, a move that has been widely condemned by scientists and medical bodies. [16]
On 31 October 2009 it was reported that Prince Charles had personally lobbied Health Secretary Andy Burnham regarding greater provision of alternative treatments on the NHS. [10]
Charity Commission complaint
Fraud allegations and closure
In 2010, following accounting irregularities noted by the foundation’s auditor, it was reported that the Metropolitan Police Economic and Specialist Crime Command had begun an inquiry into alleged fraud. [18] Within weeks, two former officials at the Prince’s Foundation were arrested for fraud believed to total £300,000. [1] [19] Four days later, on 30 April 2010, the foundation announced [20] that it would close. The foundation stated that its closure was the result of the fraud allegations. [21]
The charity’s finance director, accountant George Gray, was convicted of theft totalling £253,000 and sentenced to three years in prison. [22] [23]
Rebranding as “The College of Medicine”
Following the disbanding of the Prince’s Foundation, many of the individuals and organisations involved launched a new organisation in late 2010 called The College of Medicine, with which the Prince of Wales was not overtly involved. Several commentators writing in The Guardian and The British Medical Journal, have expressed the opinion that the new organisation is simply a re-branding of the Prince’s Foundation, [22] [24] [25] [26] [27] describing it as “Hamlet without the Prince”. [28]
In support of this connection with Prince Charles, alternative medicine critic and pharmacologist David Colquhoun has argued that the College (originally called “The College of Integrated Health”) is extremely well-funded [29] and seemed from the beginning to be very confident of the Prince’s support; explicitly describing its mission as “to take forward the vision of HRH the Prince of Wales”. [30]
These claims have been contested by the College. [31]
- 1 2 Robert Booth (26 April 2010). “Prince Charles’s aide at homeopathy charity arrested on suspicion of fraud”. London: guardian.co.uk.
- ↑ Regulating complementary therapies – Prince’s Foundation for Integrated Health
- ↑ “Wellcome Library Western Manuscripts and Archives catalogue”. Archives.wellcomelibrary.org. Retrieved 2015-09-07.
- ↑ Barnaby J. Feder, Special To The New York Times (9 January 1985). “More Britons Trying Holistic Medicine — New York Times”. Query.nytimes.com. Retrieved 2008-10-12.
- ↑ Carr-Brown, Jonathon (14 August 2005). “Prince Charles’ alternative GP campaign stirs anger”. The Times. London. Retrieved 11 March 2009.
- ↑ Revill, Jo (2004-06-27). “Now Charles backs coffee cure for cancer”. London: The Observer. Retrieved 2007-06-19.
- ↑ Cowell, Alan (2006-05-24). “Lying in wait for Prince Charles”. The New York Times. Retrieved 2009-10-15.
- ↑ Henderson, Mark (17 April 2008). “Prince of Wales’s guide to alternative medicine ‘inaccurate‘“. London: Times Online. Retrieved 2008-08-30.
- ↑ Singh, S. & Ernst, E. (2008). Trick or Treatment: Alternative Medicine on Trial. Corgi.
- 1 2 Tim Walker (31 Oct 2009). “Prince Charles lobbies Andy Burnham on complementary medicine for NHS”. London: Daily Telegraph. Retrieved 2010-04-01.
- ↑ “Duchy Originals Pork Pies”. The Quackometer Blog. 11 March 2009.
- ↑ Ernst, Edzard (2018). “Why Did We Call Prince Charles Foolish and Immoral?”. Skeptical Inquirer. Committee for Skeptical Inquiry. 42 (3): 8–9.
- ↑ Charity Commission. The Prince’s Foundation for Integrated Health, registered charity no. 1026800.
- ↑ The Prince’s Foundation for Integrated Health – 2007 accounts (PDF), Charity Commission, retrieved 2010-04-30
- ↑ “HRH “meddling in politics““. DC’s Improbable Science. March 12, 2007.
- ↑ Nigel Hawkes & Mark Henderson (September 1, 2006). “Doctors attack natural remedy claims”. The Times. London.
- ↑ Booth, Robert (19 March 2010). “Prince Charles health charity accused of vendetta against critic”. London: The Guardian.
- ↑ Delgado, Martin; Young, Andrew (4 April 2010). “Police probe into missing £300k at Prince Charles’ charity after bosses fail to file accounts”. Daily Mail. London.
- ↑ “Prince Charles charity to close amid fraud inquiry”. BBC News. 30 April 2010.
- ↑ Robert Booth (30 April 2010). “Prince of Wales’s health charity wound up in wake of fraud investigation”. The Guardian.
- ↑ Laura Donnelly (15 May 2010). “Homeopathy is witchcraft, say doctors”. London: The Telegraph.
- 1 2 Ian Sample (August 2, 2010). “College of Medicine born from ashes of Prince Charles’s holistic health charity”. London: The Guardian.
- ↑ Peter Dominiczak (20 August 2010). “Three years jail for accountant at Charles charity who stole £253,000”. Evening Standard. Archived from the original on 30 June 2011. Retrieved 2 February 2011.
- ↑ Jane Cassidy (15 June 2011). “Lobby Watch: The College of Medicine”. British Medical Journal. 343: d3712. doi:10.1136/bmj.d3712. PMID 21677014.
- ↑ David Colquhoun (12 July 2011). “The College of Medicine is Prince’s Foundation reincarnated”. British Medical Journal. 343: d4368. doi:10.1136/bmj.d4368. PMID 21750061.
- ↑ James May (12 July 2011). “College of Medicine: What is integrative health?”. British Medical Journal. 343: d4372. doi:10.1136/bmj.d4372. PMID 21750063.
- ↑ Edzard Ernst (12 July 2011). “College of Medicine or College of Quackery?”. British Medical Journal. 343: d4370. doi:10.1136/bmj.d4370. PMID 21750062.
- ↑ Nigel Hawkes (2010). “Prince’s foundation metamorphoses into new College of Medicine”. 341. British Medical Journal. p. 6126. doi:10.1136/bmj.c6126.
- ↑ David Colquhoun (July 25, 2010). “Buckinghamgate: the new “College of Medicine” arising from the ashes of the Prince’s Foundation for Integrated Health”. DC’s Improbable Science.
- ↑ David Colquhoun (29 October 2010). “Don’t be deceived. The new “College of Medicine” is a fraud and delusion”.
- ↑ Lewith, G. T.; Catto, G; Dixon, M; Glover, C; Halligan, A; Kennedy, I; Manning, C; Peters, D (12 July 011). College of Medicine replies to its critics”. British Medical Journal. 343: d4364. :10.1136/bmj.d4364. 21750060.
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This article is, as far as I can see, factually correct. I might just add some details:
- Dixon became medical director of the FIH only a few months before it had to close.
- The FIH was also involved in Prince Charles’ complaint about me alleging I had breached confidence in relation to the Smallwood report, even though the FHI had officially nothing to do with the report.
- Mr Smallwood told me that, at that stage, Prince Charles considered the FIH to be ‘a waste of space’.
- Some time ago, the College of Medicine quietly re-named itself as the ‘College of Medicine and Integrated Health’.
- Prince Charles recently became the patron of the College of Medicine and Integrated Health.
Guest post by: Loretta Marron
In March 1991, the Australian College of Allergy published an article in the Medical Journal of Australia (MJA) about a ‘bioresonance’ device for allergy testing. Titled “VEGA testing in the diagnosis of allergic conditions”, it stated that it was “an unorthodox method of diagnosing allergic and other diseases” with “no established scientific basis” and “no controlled trials to support its usefulness”.
The article raised concerns that this test “may lead to inappropriate treatment and expense to the patient and community”. VEGA is one of nearly 30 ‘energy medicine’ devices, some of which continue to cite Therapeutic Goods Administration (TGA) ‘listing numbers’.
Sometime costing more than $34,000, the sponsors tell practitioners that they can earn up to $150,000 annually with these computerised devices. Referring to ‘bioresonance’ as “the medicine of the future”, they claim that all toxins, viruses and bacteria have unique ‘frequency patterns’, which, when ‘neutralised’ by the device, restore the patient to health. They may also claim that it can cure addictions to alcohol, cocaine, crack, nicotine, heroin, opiates, cannabis, spice, ‘legal highs’ and other medications. Some claim that it can cure cancer, hay fever, allergies, auto-immune diseases, behavioural problems, smoking addiction and that they can kill parasites – the list goes on.
The devices are ‘based’ on acupuncture, homeopathy and ‘quantum physics’. More than 60 reviews in the Cochrane Collaboration (the ‘Gold Standard’ for evidence-based Medicine), have failed to find robust evidence for clinically significant outcomes for acupuncture for any disease or disorders. The National Health & Medical Research Council concluded, “there are no health conditions for which there is reliable evidence that homeopathy is effective” and quantum physics “is not at work”. In February 2020, nearly 30 years after that MJA article, the TGA’s cancellation of two of these devices saw the last of them removed from their register, but not from permissible advertising or practice.
From 2014 to 2018, Friends of Science in Medicine (FSM) had repeatedly written letters and submissions to the TGA asking for these devices to be investigated. Meeting with the national manager in 2016, we were told that these devices could not be cancelled because they were ‘biofeedback’ devices, which had a legitimate place in health care. In 2018, FSM sourced comments from informed experts here and overseas. These disputed the ‘biofeedback’ claim. FSM sent screenshots from more than 200 websites to the TGA advertising complaints. In 2019, after issuing a warning on bioresonance, the TGA closed the complaints and commenced an ‘education campaign’. They also engaged a credible Australian scientific organisation to review the evidence provided by eight ‘sponsors’ of 12 bioresonance’ devices listed in the Australian Register of Therapeutic Goods).
All devices have now been cancelled by their sponsors or by the TGA. The ‘education campaign’ continues. Even though the devices are still widely used, and courses still being run, FSM considers this a modestly satisfactory outcome.
Informed opinions:
Biofeedback:
o Michelle G Aniftos BCN, FCCLP, QEEGD, MEd, MPsych (Clinical), GradCertClinNeurophysiology, Fellow, Biofeedback Certification International Alliance, &
o Dr Tania M. Slawecki, PhD. Energy and the Environment Laboratory (formerly Materials Research Lab), Penn State University, USA (Author of “How to Distinguish Legitimate Biofeedback/Neurofeedback Devices”;
Electronic devices:
o Dr Stephen J Roberts, BSc ARCS DIC PhD. Consultant on electronic devices;
Psychology:
o Emeritus Professor Joseph P Forgas, AM, DPhil, Dsc (Oxford), FASSA, Scientia Professor, Psychology, UNSW &
Alternative medicine:
o Emeritus Professor Edzard Ernst MD, PhD, FMed Sci, FSB, FRCP, FRCP(Edin)
Their comments include the following:
· Ms Aniftos: “Having reviewed the specifications of the BICOM device, I find that its inclusion on the ARTG as a ‘biofeedback device’ is erroneous”;
· Dr Slawecki: “the BICOM device does not fit the criteria of a legitimate biofeedback device”;
· Dr Roberts: “The claims of how the BICOM and CyberScan work are preposterous.”Quantum physics” is not at work”;
· Professor Forgas: “The BICOM is NOT a biofeedback device and should be cancelled”; “The description of this device makes it crystal clear that it cannot possibly have any effective diagnostic or therapeutic function, and certainly has nothing at all to do with biofeedback.
“The claims made for the device amount to the worst kind of psychological manipulation, and their sole purpose is to mislead and exploit vulnerable people for financial gain. As a civilised society, we should not allow this kind of immoral exploitation to continue and the device should be banned forthwith”;
· Professor Ernst: “Bioresonance is not biologically plausible, not of proven effectiveness, potentially harmful and associated with exorbitant costs. I cannot recommend it for anyone or any purpose”.
