MD, PhD, FMedSci, FRSB, FRCP, FRCPEd.

fraud

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As parts of Australia are going back into lock-down because of the increasingly high COVID-19 infection rates, the Chiropractic Board of Australia (CBA) has issued a statement on chiropractors’ claims regarding immunity:

The Board is particularly concerned that during the ongoing COVID-19 pandemic there are claims in advertising that suggest spinal adjustments and/or manipulation can boost or improve general immunity or the immune system.

There is insufficient acceptable evidence to support such claims in advertising. Acceptable evidence mostly encompasses empirical data from formal research or systematic studies, in the form of peer-reviewed publications. Information about what constitutes acceptable evidence for advertising can be found in the Advertising resources section of the Ahpra website.

Advertising that there is a relationship between manual therapy (e.g. spinal adjustments and/or manipulation) and achieving general wellness or boosting or improving immunity contravenes the National Law and the Guidelines for advertising regulated health services.

Although many claims do not directly reference spinal adjustments and/or manipulation preventing or protecting from COVID-19, there is currently greater awareness of immunity issues and the public is seeking information on ways to prevent or protect themselves from the disease. Consequently, there is a greater risk that claims about spinal adjustments and/or manipulation boosting or improving general immunity may be interpreted to be claims about boosting or improving immunity to COVID-19.

Making claims in advertising that spinal adjustments and/or manipulation can boost or improve general immunity or the immune system is likely to result in regulatory action being taken by the Board.

__________________________________

“… IS LIKELY TO RESULT IN REGULATORY ACTION …”???

Come on, pull the other one!

Bogus claims have been made by chiropractors since ages.

Bogus claims are what chiropractors thrive on.

Without them, they would go bust.

Every now and then some regulator makes some noises reminding chiropractors that bogus claims are bogus. But have they EVER taken any action?

Have they ever even INTENDED to take action?

I doubt it.

In fact, statements of this nature seem to be the chiropractic way of sanctioning false claims. The somewhat paradoxical way this works is as follows: chiropractors make bogus claims all the time; we all got so much used to them that hardly anyone bats an eyelash. But every now and then the bogus nature of the claims become noticeable to the wider public – like now with COVID-19 – and some people or organisations take offence. This is clearly not good for the chiro-business or image. Therefore, the professional chiro organisations step in by issuing a statement – like the one above – condemning the claims and threatening action. All the chiros know, of course, what this is about and change absolutely nothing. The desired effect is guaranteed: chiros can carry on as before, but the image is saved and the business can continue.

I very much doubt that, in the coming weeks, the CBA will do much about the many Australian chiropractors who will continue to mislead the public about COVID-19 or any other issues.

Nice window dressing perhaps, but no substance at all.

If you disagree with my view, please send me the details of any decisive regulatory action which the CBA took regarding immunity claims, and I will delete this post.

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, LLCMediNatura, 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.

 

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.

 

In the wake of both the NEJM and the LANCET withdrawing two potentially influential papers due unanswered questions about the source and reliability of the data, one has to ask how good or bad the process of peer review is.

Peer review is the evaluation of work by one or more people with similar competences as the producers of the work (peers). It functions as a form of self-regulation by qualified members of a profession within the relevant field. It normally involves multiple steps:

  1. Authors send their manuscript to a journal of their choice for publication.
  2. The journal editor has a look at it and decides whether to reject it straight away (for instance, because the subject area is not of interest) or whether to send it out to referees for examination (often to experts suggested by the authors of the submission).
  3. The referees (usually 2 or 3) have the opportunity to reject or accept the invitation to review the submission.
  4. If they accept, they review the paper and send their report to the editor (usually following a deadline).
  5. The editor tries to come to a decision about publication; often the referees are not in agreement, and a further referee has to be recruited.
  6. Even if the submission is potentially publishable, the referees will have raised several points that need addressing. In such cases, the editor sends the submission back to the original authors asking them to revise the article.
  7. The authors do their revision (often following a deadline) and re-submit their paper.
  8. Now the editor can decide to either publish it or send it back to the referees asking them whether they feel their criticisms have been adequately addressed.
  9. Depending on the referees’ verdicts, the editor makes the final decision and informs all the involved parties accordingly.
  10. If the paper was accepted, it then goes into production.
  11. When this process is finished, the authors receive the proofs for final a check.
  12. Eventually, the paper is published and the readers of the journal may scrutinise it.
  13. Often this prompts comment which may get published.
  14. In this case, the authors of the original paper may get invited to write a reply.
  15. Finally the comments and the reply are published in the journal side by side.

The whole process takes time, sometimes lots of time. I have had papers that took almost two years from submissions to publications. This delay seems tedious and, if the paper is important, unacceptable (if it is not important, it should arguably not be published at all). Equally unacceptable is the fact that referees are expected to do their reviewing for free. The consequence is that many referees do their reviewing less than well.

When I was still at Exeter, I had plenty of opportunity to see the problems of peer review from the reviewers perspective. At a time, I accepted about 5 reviews per week, and in total I surely have reviewed over 1000 papers. I often recommended inviting a statistician to do a specialist review of the stats. Only rarely were such suggestions accepted by the journal editors. Very often I recommended rejecting a submission because it was rubbish, and occasionally, I told the editor that there was a strong suspicion of the paper being fraudulent. The editors very often (I estimate in about 50% of cases) ignored my suggestions and comments and published the papers nonetheless. If the editor did follow my advice to reject a paper, I regularly saw it published elsewhere later (usually in a less well-respected journal). Several times, an author of a submission contacted me directly after seeing my criticism of his paper. Occasionally this resulted in unpleasantness, once or twice even in threats. Eventually I realised that improving the publications in the realm of SCAM was a Sisyphean task, became quite disenchanted with all this and accepted less and less reviews. Today, I do only very few.

I had even more opportunity to see the peer review process from the author’s perspective. All authors must have suffered from unfair or incompetent reviews and most will have experienced the frustrations of the endless delays. Once (before my time in alternative medicine) a reviewer rejected my paper and soon after published results that were uncannily similar to mine. In alternative medicine, researchers tend to be rather emotional about their subject. Imagine, for instance, the review you might get from Dana Ullmann of a trial of homeopathy that fails to show what he believes in.

Finally, since 40 years, I have also had the displeasure of experiencing peer review as an editor. This often seemed like trying to sail between the devil and the deep blue sea. Editors want to fill their journals with the best science they can find. But all too often, they receive the worst science they can imagine. They are constantly torn by tensions pulling them in opposite directions. And they have to cope not just with poor quality submissions but also with reviewers who miss deadlines and do their work badly.

So, peer review is fraught with problems! The trouble is that there are few solutions that would keep a better check on the reliability of science. Peer review, it often seemed to me, is the worst idea, except for all others. If peer review is to survive (and I think it probably will), there are a few things that could, from my point of view, be done to improve it:

  1. Make it much more attractive for the referees. Payment would be the obvious thing – and by Jove, the big journals like the LANCET and NEJM could afford it. But recognising refereeing academically would be even more important. At present, academic careers depend largely of publications; if they also depended on reviewing, experts would queue up to do it.
  2. The reports of the referees should get independently evaluated according to sensible criteria. These data could be conflated an published as a criterion of academic standing. Referees who fail to to a good job would spoil their chances to get re-invited for this task.
  3. Speed up the entire process. Waiting months on months is hugely counter-productive for all concerned.
  4. Today many journals ask authors for the details of experts who are potential reviewers of their submission and then send the paper in question to them for review. I find this ridiculous! No author I know of has ever resisted the temptation to name people who are friends or owe a favour. Journals should afford the extra work to find who the best independent experts on any particular subject are.

None of this is simple or fool-proof or even sure to work well, of course. But surely it is worth trying to get peer-review right. The quality of future science depends on it.

Cochrane reviews have the reputation to be the most reliable evidence available anywhere. They are supposed to be independent, rigorous, transparent and up-to-date. Usually, this reputation is justified, in my view. But do the 54 Cochrane reviews of acupuncture quoted in my previous post live up to it?

If one had to put the entire body of evidence in a nutshell, it would probably look something  like this:

TOTAL NUMBER OF SYSTEMATIC REVIEWS = 54

POSITIVE CONCLUSIONS BASED ON MORE THAN ONE HIGH QUALITY STUDY = 2

FAILURE TO REACH CONVINCINGLY POSITIVE CONCLUSIONS = 52

The two positive reviews are on:

1) prevention of migraine

2) prevention of tension-type headache

Both of the positive reviews are by Linde et al.

Allow me to raise just a few further critical points:

  1. If I counted correctly, 19 of the 54 reviews are authored entirely by Chinese authors. Why could this be a problem? One reason could be that many Chinese authors seem to be biased in favour of acupuncture. Another reason could be that data fabrication is rife in China.
  2. Many if not most of the primary studies are published in Chinese. This means that it is impossible for most non-Chinese co-authors of the review as well as for the referees of the paper to check the accuracy of the data extraction.
  3. I counted a total of 15 reviews which were by authors who one could categorise as outspoken enthusiasts of acupuncture. In these cases, one might be concerned about the trustworthiness of the review’s conclusion.
  4.  Many (some would say most) of the reviews cover subject areas which are frankly bizarre. Who would, for instance, consider acupuncture a plausible treatment for Glaucoma, Mumps or chronic hepatitis B?
  5. Despite almost all of the reviews demonstrating that there is no good reason to recommend acupuncture for the condition in question, hardly any of them draw a transparent, helpful and clear conclusion. One example might suffice: the review of acupuncture for hordeolum concluded that “Low‐certainty evidence suggests that acupuncture with or without conventional treatments may provide short‐term benefits for treating acute hordeolum…” Its Chinese authors reached this conclusion on the basis of 6 primary studies (all from China) which were all of lousy quality. In such a case, the only justified conclusion would be, in my view, something like this: THERE IS NO RELIABLE EVIDENCE …

Despite these serious limitations and avoidable confusions, the totality of the evidence from these 54 Cochrane reviews does send an important message: there is hardly a single condition for which acupuncture is clearly, convincingly and indisputably effective. What I find most regrettable, however, is that the Cochrane Collaboration allowed the often biased review authors to obscure this crucial message so thoroughly. One needs a healthy portion of critical thinking to get through to the truth here – and how many fans of acupuncture possess such a thing?

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.

Have you ever noticed that, according to its proponents, many forms of so-called alternative medicine (SCAM) must be applied a long time before there is a noticeable benefit?

As so often, homeopathy is a good example. If you consult a homeopath, she will, in all likelihood, explain that it would be unwise to expect immediate effects. The treatment needs to be taken for weeks; perhaps she even needs to change the prescription once or twice. And the longer you have suffered from your illness, the longer it will take to get rid of it. Sometimes it takes years!

Those homeopathy-fans who have experienced instant effects will, of course, disagree. But these cases are almost certainly due to the placebo response which is known to be fast. The majority of patients will be told to persevere and show patience.

And unquestionably some patients will eventually experience a reduction of symptoms. Thus the homeopaths is proven correct: homeopathy takes time to work!

But hold on, how plausible is this explanation?

Let’s assume a child is cured of asthma after many months of religiously taking the prescribed homeopathic remedies. Is the cure due to the treatment, or might there be other phenomena at play? The most obvious explanation by far is the fact that children frequently grow out of diseases like asthma. So, this and other self-limiting conditions are not good examples.

What about a disease that is clearly not self-limiting? What about a MS patient who feels much improved after taking his homeopathic remedies for three months? Again, the best explanation for the improvement would be the natural history of the disease. The severity of the symptoms of many conditions fluctuate in such a way that there will be periods of relative well-being followed by deterioration.

And what, if we are dealing with a disease that normally gets progressively worse over time, if untreated ? What if a cancer patient claims to be cured after months of homeopathic therapy? Such cases do not exist! The few such ‘cures’ that have been reported have explanations that are unrelated to homeopathy. They are due to one of the three phenomena:

  • false diagnosis,
  • concomitant treatments,
  • spontaneous recovery.

It turns out that the notion of homeopathy (or any other SCAM) requiring a long period of time until the benefit kicks in is mostly a myth.

Well, perhaps not entirely!

The benefit of SCAM does unquestionably need time before a significant benefit ($$$, £££) for the SCAM provider kicks in. So, let’s not sneer at the notion. Let’s be positive. Let’s recognise the reason why the myth is being kept alive. We all must make a living!

 

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]

Between 2005 and 2007 the charity’s annual turnover was about £1.2 million. [13] In 2007 it received significant funding from The Prince’s Charities Foundation, and a £300,000 grant from the Department of Health for the regulation of complementary medicine. [14]

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

In March 2010, the political organisation Republic, which campaigns for an elected head of state, registered a complaint with the Charity Commission for England and Wales over a possible breach of charity regulations, suggesting that the foundation’s staff had pursued a public vendetta against Ernst. [17]

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. Robert Booth (26 April 2010). “Prince Charles’s aide at homeopathy charity arrested on suspicion of fraud”. London: guardian.co.uk.
  2. ↑ Regulating complementary therapies – Prince’s Foundation for Integrated Health
  3. ↑ “Wellcome Library Western Manuscripts and Archives catalogue”. Archives.wellcomelibrary.org. Retrieved 2015-09-07.
  4. ↑ 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.
  5. ↑ Carr-Brown, Jonathon (14 August 2005). “Prince Charles’ alternative GP campaign stirs anger”The Times. London. Retrieved 11 March 2009.
  6. ↑ Revill, Jo (2004-06-27). “Now Charles backs coffee cure for cancer”. London: The Observer. Retrieved 2007-06-19.
  7. ↑ Cowell, Alan (2006-05-24). “Lying in wait for Prince Charles”The New York Times. Retrieved 2009-10-15.
  8. ↑ Henderson, Mark (17 April 2008). “Prince of Wales’s guide to alternative medicine ‘inaccurate. London: Times Online. Retrieved 2008-08-30.
  9. ↑ Singh, S. & Ernst, E. (2008). Trick or Treatment: Alternative Medicine on Trial. Corgi.
  10. Tim Walker (31 Oct 2009). “Prince Charles lobbies Andy Burnham on complementary medicine for NHS”. London: Daily Telegraph. Retrieved 2010-04-01.
  11. ↑ “Duchy Originals Pork Pies”The Quackometer Blog. 11 March 2009.
  12. ↑ Ernst, Edzard (2018). “Why Did We Call Prince Charles Foolish and Immoral?”. Skeptical Inquirer. Committee for Skeptical Inquiry. 42 (3): 8–9.
  13. ↑ Charity CommissionThe Prince’s Foundation for Integrated Health, registered charity no. 1026800.
  14. ↑ The Prince’s Foundation for Integrated Health – 2007 accounts (PDF), Charity Commission, retrieved 2010-04-30
  15. ↑ “HRH “meddling in politics. DC’s Improbable Science. March 12, 2007.
  16. ↑ Nigel Hawkes & Mark Henderson (September 1, 2006). “Doctors attack natural remedy claims”The Times. London.
  17. ↑ Booth, Robert (19 March 2010). “Prince Charles health charity accused of vendetta against critic”. London: The Guardian.
  18. ↑ 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.
  19. ↑ “Prince Charles charity to close amid fraud inquiry”BBC News. 30 April 2010.
  20. ↑ Robert Booth (30 April 2010). “Prince of Wales’s health charity wound up in wake of fraud investigation”The Guardian.
  21. ↑ Laura Donnelly (15 May 2010). “Homeopathy is witchcraft, say doctors”. London: The Telegraph.
  22. Ian Sample (August 2, 2010). “College of Medicine born from ashes of Prince Charles’s holistic health charity”. London: The Guardian.
  23. ↑ 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.
  24. ↑ Jane Cassidy (15 June 2011). “Lobby Watch: The College of Medicine”British Medical Journal343: d3712. doi:10.1136/bmj.d3712PMID   21677014.
  25. ↑ David Colquhoun (12 July 2011). “The College of Medicine is Prince’s Foundation reincarnated”British Medical Journal343: d4368. doi:10.1136/bmj.d4368PMID   21750061.
  26. ↑ James May (12 July 2011). “College of Medicine: What is integrative health?”British Medical Journal343: d4372. doi:10.1136/bmj.d4372PMID   21750063.
  27. ↑ Edzard Ernst (12 July 2011). “College of Medicine or College of Quackery?”British Medical Journal343: d4370. doi:10.1136/bmj.d4370PMID   21750062.
  28. ↑ Nigel Hawkes (2010). “Prince’s foundation metamorphoses into new College of Medicine”341. British Medical Journal. p. 6126. doi:10.1136/bmj.c6126.
  29. ↑ 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.
  30. ↑ David Colquhoun (29 October 2010). “Don’t be deceived. The new “College of Medicine” is a fraud and delusion”.
  31. ↑ 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 Journal343: d4364. :10.1136/bmj.d4364.    21750060.

_________________________________________________

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.
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