ethics
Five years ago to the day, Simon Singh and I published an article in The Daily Mail to promote our book TRICK OR TREATMENT… which was then about to be launched. We recently learnt that our short article prompted a “confidential” message by the BRITISH CHIROPRACTIC ASSOCIATION to all its members. “Confidential” needs to be put in inverted commas because it is readily available on the Internet. I find it fascinating and of sufficient public interest to reproduce it here in full. I have not altered a thing in the following text, except putting it in italics and putting the section where the BCA quote our text in bold for clarity.
CONFIDENTIAL FOR BCA MEMBERS ONLY
Information for BCA members regarding an article in the Daily Mail – April 8th 2008
A double page spread appeared in the edition of the Daily Mail April 8th 2008 on page 46 and 47 and titled ‘Alternative Medicine The Verdict’.
The article was written by Simon Singh and Edzard Ernst and is a publicity prelude to a book they have written called ‘Trick or Treatment? Alternative Medicine on Trial’, which will be published later this month.
The article covers Alexander Technique, Aromatherapy, Flower Remedy, Chiropractic, Hypnotherapy, Magnet Therapy and Osteopathy.
The coverage of Chiropractic follows a familiar pattern for E Ernst. The treatment is oversimplified in explanation, with a heavy emphasis on words like thrust, strong and aggressive. There is tacit acknowledgement that chiropractic works for back pain, but then there is a long section about caution regarding neck manipulation. The article concludes by advising people not to have their neck manipulated and not to allow children to be treated.
CHIROPRACTIC THERAPY
WHAT IS IT? Chiropractors use spinal manipulation to realign the spine to restore mobility. Initial examination often includes X-ray images or MRI scans.
Spinal manipulation can be a fairly aggressive technique, which pushes the spinal joint slightly beyond what it is ordinarily capable of achieving, using a technique called high-velocity, low-amplitude thrust – exerting a relatively strong force in order to move the joint at speed, but the extent of the motion needs to be limited to prevent damage to the joint and its surrounding structures.
Although spinal manipulation is often associated with a cracking sound, this is not a result of the bones crunching or a sign that bones are being put back; the noise is caused by the release and popping of gas bubbles, generated when the fluid in the joint space is put under severe stress.
Some chiropractors claim to treat everything from digestive disorders to ear infections, others will treat only back problems.
DOES IT WORK? There is no evidence to suggest that spinal manipulation is effective for anything but back pain and even then conventional approaches (such as regular exercise and ibuprofen) are just as likely to be effective and are cheaper.
Neck manipulation has been linked to neurological complications such as strokes – in 1998, a 20-year-old Canadian woman died after neck manipulation caused a blood clot which led to stroke. We would strongly recommend physiotherapy exercises and osteopathy ahead of chiropractic therapy because they are at least effective and much safer.
If you do decide to visit a chiropractor despite our concerns and warnings, we very strongly recommend you confirm your chiropractor won’t manipulate your neck. The dangers of chiropractic therapy to children are particularly worrying because a chiropractor would be manipulating an immature spine.
Daily Mail 2008 April 8th.
As we are aware that patients or potential patients of our members will be confronted with questions regarding this article, we have put together some comment and Q&As to assist you.
• Please consider this information as strictly confidential and for your use only.
• Only use this if a patient asks about these specific issues; there is nothing to be gained from releasing any information not asked for.
• Do not duplicate these patient notes and hand out direct to the patient or the media; these are designed for you to use when in direct conversation with a patient.
The BCA will be very carefully considering any questions or approaches we may receive from the press and will respond to them using specially briefed spokespeople. We would strongly advise our members not to speak directly to the press on any of the issues raised as a result of this coverage.
Please note that In the event of you receiving queries from the media, please refer these direct to BCA (0118 950 5950 – Anne Barlow or Sue Wakefield) or Publicasity (0207 632 2400 – Julie Doyle or Sara Bailey).
The following points should assist you in answering questions that patients may ask with regard to the safety and effectiveness of chiropractic care. Potential questions are detailed along with the desired ‘BCA response’:
o “The Daily Mail article seems to suggest chiropractic treatment is not that effective”
Nothing could be further from the truth. The authors have had to concede that chiropractic treatment works for back pain as there is overwhelming evidence to support this. The authors also contest that pain killers and exercises can do the job just as well. What they fail to mention is that research has shown that this might be the case for some patients, but the amount of time it may take to recover is a lot longer and the chance of re-occurrence of the problem is higher. This means that chiropractic treatment works, gets results more quickly and helps prevent re-occurrence of the problem. Chiropractic is the third largest healthcare profession in the world and in the UK is recognised and regulated by the UK Government.
o “The treatment is described as aggressive, can you explain?”
It is important to say that the authors of the article clearly have no direct experience of chiropractic treatment, nor have they bothered to properly research the training and techniques. Chiropractic treatment can take many forms, depending on the nature of the problem, the particular patient’s age and medical history and other factors. The training chiropractors receive is overseen by the government appointed regulator and the content of training is absolutely designed to ensure that an individual chiropractor understands exactly which treatment types are required in each individual patient scenario. Gentle technique, massage and exercise are just some of the techniques available in the chiropractor’s ‘toolkit’. It is a gross generalisation and a demonstration of lack of knowledge of chiropractic to characterise it the way it appeared in the article.
o “The article talked about ‘claims’ of success with other problems”
There is a large and undeniable body of evidence regarding the effectiveness of chiropractic treatment for musculoskeletal problems such as back pain. There is also growing evidence that chiropractic treatment can help many patients with other problems; persistent headaches for example. There is also anecdotal evidence and positive patient experience to show that other kinds of problems have been helped by chiropractic treatment. For many of these kinds of problems, the formal research is just beginning and a chiropractor would never propose their treatment as a substitute for other, ongoing treatments.
o “Am I at risk of having a stroke if I have a chiropractic treatment?”
What is important to understand is that any association between neck manipulation and stroke is extremely rare. Chiropractic is a very safe form of treatment.
Another important point to understand is that the treatments employed by chiropractors are statistically safer than many other conservative treatment options (such as ibuprofen and other pain killers with side effects such as gastric bleeding) for mechanical low back or neck pain conditions.
A research study in the UK, published just last year studied the neck manipulations received by nearly 20,000 chiropractic patients. NO SERIOUS ADVERSE SIDE EFFECTS WERE IDENTIFIED AT ALL. In another piece of research, published in February this year, stroke was found to be a very rare event and the risk associated with a visit to a chiropractor appeared to be no different from the risk of a stroke following a visit to a GP.
Other recent research shows that such an association with stroke may occur once in every 5.85 million adjustments.
To put this in context, a ‘significant risk’ for any therapeutic intervention (such as pain medication) is defined as 1 in 10,000.
Additional info: Stroke is a natural occurring phenomenon, and evidence dictates that a number of key risk factors increase the likelihood of an individual suffering a stroke. Smoking, high blood pressure, high cholesterol and family medical histories can all contribute; rarely does a stroke occur in isolation from these factors. Also, stroke symptoms can be similar to that of upper neck pains, stiffness or headaches, conditions for which patients may seek chiropractic treatment. BCA chiropractors are trained to recognise and diagnose these symptoms and advise appropriate mainstream medical care.
o “Can you tell if I am at risk from stroke?”
As a BCA chiropractor I am trained to identify risk factors and would not proceed with treatment if there was any doubt as to the patient’s suitability. Potential risks may come to light during the taking of a case history, which may include: smoking, high cholesterol, contraceptive pill, Blood clotting problems/blood thinning meds, heart problems, trauma to the head etc and on physical examination e.g. high blood pressure, severe osteoarthritis of the neck, history of rheumatoid arthritis
o “Do you ever tell patients if they are at risk?”
Yes, I would always discuss risks with patients and treatment will not proceed without informed consent.
o “Is it safe for my child to be treated by a chiropractor”
It is a shame that the article so generalises the treatment provided by a chiropractor, that it makes such outrageous claims. My training in anatomy, physiology and diagnosis means that I absolutely understand the demands and needs of spines from the newborn baby to the very elderly patient. The techniques and treatments I might use on a 25 year old are not the same as those I would employ on a 5 year old. I see a lot of children as patients at this clinic and am able to offer help with a variety of problems with the back, joints and muscles. I examine every patient very thoroughly, understand their medical history and discuss my findings with them and their parents before undertaking any treatment.
- Chiropractic is a mature profession and numerous studies clearly demonstrate that chiropractic treatment, including manipulative and spinal adjustment, is both safe and effective.
- Thousands of patients are treated by me and my fellow chiropractors every day in the UK. Chiropractic is a healthcare profession that is growing purely because our patients see the results and GPs refer patients to us because they know we get results!
This article is to promote a book and a controversial one at that. Certainly, in the case of the comments about chiropractic, there is much evidence and research that has formed part of guidelines developed by the Royal Society of General Practitioners, NICE and other NHS/Government agencies, has been conveniently ignored. The statements about chiropractic treatment and technique demonstrate that there has clearly been no research into the actual education that chiropractors in the UK receive – in my case a four year full-time degree course that meets stringent educational standards set down by the government appointed regulator.
Shortly after the article in The Daily Mail, our book was published and turned out to be much appreciated by critical thinkers across the globe — not, however, by chiropractors.
At the time, I did, of course, not know about the above “strictly confidential” message to BCA members, yet I strongly suspected that chiropractors would do everything in their power to dispute our central argument, namely that most of the therapeutic claims by chiropractors were not supported by sufficient evidence. I also knew that our evidence for it was rock solid; after all, I had researched the evidence for or against chiropractic in full depth and minute detail and published dozens of articles on the subject in the medical literature.
When, one and a half weeks after our piece in the Mail, Simon published his now famous Guardian comment stating that the BCA “happily promote bogus treatments”, he was sued for libel by the BCA. I think the above “strictly confidential” message already reveals the BCA’s determination and their conviction to be on firm ground. As it turned out, they were wrong. Not only did they lose their libel suit, but they also dragged chiropractic into a deep crisis.
The “strictly confidential” message is intriguing in several more ways - I will leave it to my readers to pick out some of the many gems hidden in this text. Personally, I find the most remarkable aspect that the BCA seems to attempt to silence its own members regarding the controversy about the value of their treatments. Instead they proscribe answers (should I say doctrines?) of highly debatable accuracy for them, almost as though chiropractors were unable to speak for themselves. To me, this smells of cult-like behaviour, and is by no means indicative of a mature profession – despite their affirmations to the contrary.
Believe it or not, but my decision – all those years ago - to study medicine was to a significant degree influenced by a somewhat naive desire to, one day, be able to save lives. In my experience, most medical students are motivated by this wish – “to save lives” in this context stands not just for the dramatic act of administering a life-saving treatment to a moribund patient but it is meant as a synonym for helping patients in a much more general sense.
I am not sure whether, as a young clinician, I ever did manage to save many lives. Later, I had a career-change and became a researcher. The general view about researchers seems to be that they are detached from real life, sit in ivory towers and write clever papers which hardly anyone understands and few people will ever read. Researchers therefore cannot save lives, can they?
So, what happened to those laudable ambitions of the young Dr Ernst? Why did I decide to go into research, and why alternative medicine; why did I not conduct research in more the promotional way of so many of my colleagues (my life would have been so much more hassle-free, and I even might have a knighthood by now); why did I feel the need to insist on rigorous assessments and critical thinking, often at high cost? For my many detractors, the answers to these questions seem to be more than obvious: I was corrupted by BIG PHARMA, I have an axe to grind against all things alternative, I have an insatiable desire to be in the lime-light, I defend my profession against the concurrence from alternative practitioners etc. However, for me, the issues are a little less obvious (today, I will, for the first time, disclose the bribe I received from BIG PHARMA for criticising alternative medicine: the precise sum was zero £ and the same amount again in $).
As I am retiring from academic life and doing less original research, I do have the time and the inclination to brood over such questions. What precisely motivated my research agenda in alternative medicine, and why did I remain unimpressed by the number of powerful enemies I made pursuing it?
If I am honest – and I know this will sound strange to many, particularly to those who are convinced that I merely rejoice in being alarmist - I am still inspired by this hope to save lives. Sure, the youthful naivety of the early days has all but disappeared, yet the core motivation has remained unchanged.
But how can research into alternative medicine ever save a single life?
Since about 20 years, I am regularly pointing out that the most important research questions in my field relate to the risks of alternative medicine. I have continually published articles about these issues in the medical literature and, more recently, I have also made a conscious effort to step out of the ivory towers of academia and started writing for a much wider lay-audience (hence also this blog). Important landmarks on this journey include:
- pointing out that some forms of alternative medicine can cause serious complications, including deaths,
- disclosing that alternative diagnostic methods are unreliable and can cause serious problems,
- demonstrating that much of the advice given by alternative practitioners can cause serious harm to the patients who follow it,
- that the advice provided in books or on the Internet can be equally dangerous,
- and that even the most innocent yet ineffective therapy becomes life-threatening, once it is used to replace effective treatments for serious conditions.
Alternative medicine is cleverly, heavily and incessantly promoted as being natural and hence harmless. Several of my previous posts and the ensuing discussions on this blog strongly suggest that some chiropractors deny that their neck manipulations can cause a stroke. Similarly, some homeopaths are convinced that they can do no harm; some acupuncturists insist that their needles are entirely safe; some herbalists think that their medicines are risk-free, etc. All of them tend to agree that the risks are non-existent or so small that they are dwarfed by those of conventional medicine, thus ignoring that the potential risks of any treatment must be seen in relation to their proven benefit.
For 20 years, I have tried my best to dispel these dangerous myths and fallacies. In doing so, I had to fight many tough battles (sometimes even with the people who should have protected me, e.g. my peers at Exeter university), and I have the scars to prove it. If, however, I did save just one life by conducting my research into the risks of alternative medicine and by writing about it, the effort was well worth it.
The most common pronouncement regarding alternative medicine that I have heard over the years from consumers, health care professionals or decision makers with a liking of alternative medicine goes as follows: “I don’t care how it works, as long as it helps.”
At first glance, this argument seems reasonable, logic and correct; it would be foolish, perhaps even unethical, to reject an effective treatment simply because we fail to understand how its effectiveness comes about – this would not be pragmatic and it is not what we do in medicine: aspirin, for instance, was used and helped many patients long before we understood how it worked. However, once we consider the way this notion is regularly used to defend the use of unproven therapies, we see that, in this context, it is fallacious – in fact, if we dissect it carefully, we find that it crams three large fallacies in one tiny sentence.
The first thing we notice is that the argument combines two fundamentally different issues which really should be separate 1) the mechanism of action of a therapy and 2) its clinical effectiveness. The matter gets clearer, if we discuss it not in the abstract, but in relation to a concrete example: BACH FLOWER REMEDIES (BFRs). I could have selected many other alternative therapies but BFRs seem fine, particularly as they have so far received no mention on this blog.
Similar to homeopathic preparations, BFRs are so dilute that they do not contain any active ingredients to speak of (they differ from homeopathic preparations, however, in that they do not follow the ‘like cures like’ principle). Several clinical trials of BFRs have been published; collectively, their results show very clearly that the clinical effects of BFRs do not differ from those of placebo. (This does not stop manufacturers selling and consumers buying them; in fact, BFRs are a thriving business.)
The principles backing up BFRs are scientifically implausible, and even BFR-practitioners would probably admit that they have no scientifically defensible idea how their remedies work. Scientists might add that a mechanism of action of such highly dilute remedies is not just unknown but unknowable; there is no way to explain how they work without re-writing several laws of nature.
The overall situation is thus quite clear: BFRs are not effective and there is no plausible mechanism of action.Yet it is hard to deny that many patients feel better after having consulted a BFR-practitioner (or after self-medicating BFRs), and those satisfied customers often insist: “I don’t care how BFRs work, as long as they help me.”
As previously discussed, symptoms can improve for a range of reasons which are related to any specific therapeutic effect: the natural history of the condition, regression towards the mean, placebo-effects etc. Only rigorously controlled trials can tell us whether the therapy or other factors caused the clinical outcome; our perception alone cannot identify cause and effect.
The fact that thousands of patients swear by BFRs, does therefore not constitute proof for their efficacy. The explanation of the apparently different impressions from experience and the results of clinical trials is therefore simple: the empathetic encounter with a therapist and/or a placebo-effect and/or the natural history of the condition are perceived as helpful, while the BFRs are pure placebos.
Back to the notion “I don’t care how this therapy works, as long as it helps” – it turns out to be based on at least three misunderstandings all tightly woven together.
Firstly, it was not the treatment itself that helped, but something else (see above). To imply that the treatment worked is therefore a fallacy.
Secondly, the reference to an unknown mechanism of action is aimed at misleading the opponent: it distracts from the first fallacy (“the treatment is effective”) by super-imposing a second fallacy (that there might be a mechanism of action). Crucially it attempts to wrong-foot the opponent by implying: “you reject something useful simply because you cannot explain it; this is poor logic and even worse ethics – shame on you!”.
BFR-enthusiasts are bound to see all this quite differently. They will probably claim that a placebo-effect is also a plausible mechanism. “Surely” they might say “this means that BFRs are useful and should be widely employed”.
In proclaiming this, they turn the double-fallacy into a triple fallacy. What they forget is that we do not need a placebo to generate placebo-effects. An effective treatment administered with time, compassion and empathy will, of course, also generate a placebo-effect - what is more, it would generate a specific therapeutic effect on top of it. Thus the BFR are quite useless in comparison. There is rarely a good justification for using placebos in clinical routine.
In conclusion, the often-used and seemingly reasonable sentence “I don’t care how it works, as long as it is helpful turns out to be a package of fallacies when used to support the use of unproven treatments.
The ‘Samueli Institute’ might be known to many readers of this blog; it is a wealthy institution that is almost entirely dedicated to promoting the more implausible fringe of alternative medicine. The official aim is “to create a flourishing society through the scientific exploration of wellness and whole-person healing“. Much of its activity seems to be focused on military medical research. Its co-workers include Harald Walach who recently was awarded a rare distinction for his relentless efforts in introducing esoteric pseudo-science into academia.
Now researchers from the Californian branch of the Samueli Institute have published an articles whic, in my view, is another landmark in nonsense.
Jain and colleagues conducted a randomized controlled trial to determine whether Healing Touch with Guided Imagery [HT+GI] reduced post-traumatic stress disorder (PTSD) compared to treatment as usual (TAU) in “returning combat-exposed active duty military with significant PTSD symptoms“. HT is a popular form of para-normal healing where the therapist channels “energy” into the patient’s body; GI is a self-hypnotic from of relaxation-therapy. While the latter approach might be seen as plausible and, at least to some degree, evidence-based, the former cannot.
123 soldiers were randomized to 6 sessions of HT+GI, while the control group had no such therapies. All patients also received standard conventional therapies, and the treatment period was three weeks. The results showed significant reductions in PTSD symptoms as well as depression for HT+GI compared to controls. HT+GI also showed significant improvements in mental quality of life and cynicism.
The authors concluded that HT+GI resulted in a clinically significant reduction in PTSD and related symptoms, and that further investigations of biofield therapies for mitigating PTSD in military populations are warranted.
The Samueli Institute claims to ”support science grounded in observation, investigation, and analysis, and [to have] the courage to ask challenging questions within a framework of systematic, high-quality, research methods and the peer-review process“. I do not think that the above-named paper lives up to these standards.
As discussed in some detail in a previous post, this type of study-design is next to useless for determining whether any intervention does any good at all: A+B is always more than B alone! Moreover, if we test HT+GI as a package, how can we conclude about the effectiveness of one of the two interventions? Thus this trial tells us next to nothing about the effectiveness of HT, nor about the effectiveness of HT+GI.
Previously, I have argued that conducting a trial for which the result is already clear before the first patient has been recruited, is not ethical. Samueli Institute, however, claims that it “acts with the highest respect for the public it serves by ensuring transparency, responsible management and ethical practices from discovery to policy and application“. Am I the only one who senses a contradiction here?
Perhaps other research in this area might be more informative? Even the most superficial Medline-search brings to light a flurry of articles on HT and other biofield therapies that are relevant.
Several trials have indeed produces promissing evidence suggesting positive effects of such treatments on anxiety and other symptoms. But the data are far from uniform, and most investigations are wide open to bias. The more rigorous studies seem to suggest that these interventions are not effective beyond placebo. Our review demonstrated that “the evidence is insufficient” to suggest that reiki, another biofield therapy, is an effective treatment for any condition.
Another study showed that tactile touch led to significantly lower levels of anxiety. Conventional massage may even be better than HT, according to some trials. The conclusion from this body of evidence is, I think, fairly obvious: touch can be helpful (most clinicians knew that anyway) but this has nothing to do with energy, biofields, healing energy or any of the other implausible assumptions these treatments are based on.
I therefore disagree with the authors’ conclusion that “further investigation into biofield therapies… is warranted“. If we really want to help patients, let’s find out more about the benefits of touch and let’s not mislead the public about some mystical energies and implausible quackery. And if we truly want to improve heath care, as the Samueli Institute claims, let’s use our limited resources for research which meaningfully contributes to our knowledge.
On January 27, 1945, the concentration camp in Auschwitz was liberated. By May of the same year, around 20 similar camps had been discovered. What they revealed is so shocking that it is difficult to put it in words.
Today, on ‘HOCOCAUST MEMORIAL DAY’, I quote (shortened and slightly modified) from articles I published many years ago (references can be found in the originals) to remind us of the unspeakable atrocities that occurred during the Nazi period and of the crucial role the German medical profession played in them.
The Nazi’s euthanasia programme, also known as ”Action T4″, started in specialized medicinal departments in 1939. Initially, it was aimed at children suffering from “idiocy, Down’s syndrome, hydrocephalus and other abnormalities”. By the end of 1939, the programme was extended to adults “unworthy of living.” We estimate that, when it was stopped, more than 70,000 patients had been killed.
Action T4 (named after its address: Tiergarten Strasse 4) was the Berlin headquarters of the euthanasia programme. It was run by approximately 50 physicians who, amongst other activities, sent questionnaires to (mostly psychiatric) hospitals urging them to return lists of patients for euthanasia. The victims were transported to specialized centers where they were gassed or poisoned. Action T4 was thus responsible for medically supervised, large-scale murder. Its true significance, however, lies elsewhere. Action T4 turned out to be nothing less than a “pilot project” for the extinction of millions of prisoners of the concentration camps.
The T4 units had developed the technology for killing on an industrial scale. It was only with this know-how that the total extinction of all Jews of the Reich could be planned. This truly monstrous task required medical expertise.
Almost without exception, those physicians who had worked for T4 went on to take charge of what the Nazis called the ‘Final Solution’. While action T4 had killed thousands, its offspring would murder millions under the trained instructions of Nazi doctors.
The medical profession’s role in these crimes was critical and essential. German physicians had been involved at all levels and stages. They had created and embraced the pseudo-science of race hygiene. They were instrumental in developing it further into applied racism. They had generated the know-how of mass extinction. Finally, they also performed outrageously cruel and criminal experiments under the guise of scientific inquiry [see below]. German doctors had thus betrayed all the ideals medicine had previously stood for, and had become involved in criminal activities unprecedented in the history of medicine (full details and references on all of this are provided in my article, see link above).
Alternative medicine
It is well-documented that alternative medicine was strongly supported by the Nazis. The general belief is that this had nothing to do with the sickening atrocities of this period. I believe that this assumption is not entirely correct. In 2001, I published an article which reviews the this subject; I take the liberty of borrowing from it here.
Based on a general movement in favour of all things natural, a powerful trend towards natural ways of healing had developed in the 19(th)century. By 1930, this had led to a situation in Germany where roughly as many lay-practitioners of alternative medicine as conventional doctors were in practice.This had led to considerable tensions between the two camps. To re-unify German medicine under the banner of ‘Neue Deutsche Heilkunde’ (New German Medicine), Nazi officials eventually decided to create the profession of the ’Heilpraktiker‘ (healing practitioner). Heilpraktiker were not allowed to train students and their profession was thus meant to become extinct within one generation; Goebbels spoke of having created the cradle and the grave of the Heilpraktiker. However, after 1945, this decision was challenged in the courts and eventually over-turned – and this is why Heilpraktiker are still thriving today.
The ‘flag ship’ of the ‘Neue Deutsche Heilkunde’ was the ‘Rudolf Hess Krankenhaus‘ in Dresden (which was re-named into Gerhard Wagner Krankenhaus after Hess’ flight to the UK). It represented a full integration of alternative and orthodox medicine.
‘Research’
An example of systematic research into alternative medicine is the Nazi government’s project to validate homoeopathy. The data of this massive research programme are now lost (some speculate that homeopaths made them disappear) but, according to an eye-witness report, its results were entirely negative (full details and references on alt med in 3rd Reich are in the article cited above).
There is,of course, plenty of literature on the subject of Nazi ‘research’ (actually, it was pseudo-research) and the unspeakable crimes it entailed. By contrast, there is almost no published evidence that these activities included in any way alternative medicine, and the general opinion seems to be that there are no connections whatsoever. I fear that this notion might be erroneous.
As far as I can make out, no systematic study of the subject has so far been published, but I found several hints and indications that the criminal experiments of Nazi doctors also involved alternative medicine (the sources are provided in my articles cited above or in the links provided below). Here are but a few leads:
Dr Wagner, the chief medical officer of the Nazis was a dedicated and most active proponent of alternative medicine.
Doctors in the alternative “Rudolf Hess Krankenhaus” [see above] experimented on speeding up the recovery of wounded soldiers, on curing syphilis with fasting, and on various other projects to help the war effort.
The Dachau concentration camp housed the largest plantation of medicinal herbs in Germany.
Dr Madaus (founder of the still existing company for natural medicines by the same name) experimented on the sterilisation of humans with herbal and homeopathic remedies, a project that was deemed of great importance for controlling the predicted population growth in the East of the expanding Reich.
Dr Grawitz infected Dachau prisoners with various pathogens to test the effectiveness of homeopathic remedies.
Schuessler salts were also tested on concentration camp inmates.
So, why bring all of this up today? Is it not time that we let grass grow over these most disturbing events? I think not! For many years, I actively researched this area (you can find many of my articles on Medline) because I am convinced that the unprecedented horrors of Nazi medicine need to be told and re-told – not just on HOLOCAUST MEMORIAL DAY, but continually. This, I hope, will minimize the risk of such incredible abuses ever happening again.
In my last post, I strongly criticised Prince Charles for his recently published vision of “integrated health and post-modern medicine”. In fact, I wrote that it would lead us back to the dark ages. ”That is all very well”, I hear my critics mutter, “but can Ernst offer anything better?” After all, as Prof Michael Baum once remarked, Charles has his authority merely through an accident of birth, whereas I have been to medical school, served as a professor in three different countries and pride myself of being an outspoken proponent of evidence-based medicine. I should thus know better and have something to put against Charles’ odd love affair with the ‘endarkenment’.
I have to admit that I am not exactly what one might call a visionary; all my life I have been slightly weary of people who wear a ‘vision’ on their sleeve for everyone to see. But I could produce some concepts about what might constitute good medicine (apart from the obvious statement that I think EBM is the correct approach). To be truthful, these are not really my concepts either - but, as far as I can see, they simply are ideas held by most responsible health care professionals across the world. So, for what it’s worth, here it is:
Two elements
In a nut-shell, good medicine consists of two main elements: the science and the ‘art’ of medicine. This division is, of course, somewhat artificial; for instance, the art of medicine does not defy science, and compassion is an empty word, if it is not combined with effective therapy. Yet for clarity it can be helpful to separate the two elements.
Science
Medicine has started to make progress about 150 years ago when we managed to free ourselves from the dogmas and beliefs that had previously dominated heath care. The first major randomised trial was published only in 1948. Since then, progress in both basic and clinical research has advanced at a breath-taking speed. Consequently, enormous improvements in health care have occurred, and the life-expectancy as well as the quality of life of millions have grown to a remarkable degree.
These developments are fairly recent and tend to be frustratingly slow; it is therefore clear that there is still much room for improvement. But improvement is surely being generated every day: the outlook of patients who suffer from MS, AIDS, cancer and many other conditions will be better tomorrow than it is today. Similar advances are being made in the areas of disease prevention, rehabilitation, palliative care etc. All of these improvements is almost exclusively the result of the hard work by thousands of brilliant scientists who tirelessly struggle to improve the status quo.
But the task is, of course, huge and virtually endless. We therefore need to be patient and remind ourselves how very young medicine’s marriage with science still is. To change direction at this stage would be wrong and lead to disastrous consequences. To doubt the power of science in generating progress displays ignorance. To call on “ancient wisdom” for help is ridiculous.
Art
The ‘art of medicine’ seems a somewhat old-fashioned term to use. My reason for employing it anyway is that I do not know any other word that captures all of the following characteristics and attributes:
Compassion
Empathy
Sympathy
Time to listen
Good therapeutic relationships
Provision of choice, information, guidance
Holism
Professionalism
They are all important features of good medicine – they always have been and always will be. To deny this would be to destroy the basis on which health care stands. To neglect them risks good medicine to deteriorate. To call this “ancient wisdom” is grossly misleading.
Sadly, the system doctors have to work in makes it often difficult to respect all the features listed above. And sadly, not everyone working in health care is naturally gifted in showing compassion, empathy etc. to patients. This is why medical schools do their very best to teach these qualities to students. I do not deny that this endeavour is not always fully successful, and one can only hope that young doctors make career-choices according to their natural abilities. If you cannot produce a placebo-response in your patient, I was taught at medical school, go and train as a pathologist!
Science and art
Let me stress this again: the science and the art of medicine are essential elements of good medicine. In other words, if one is missing, medicine is by definition not optimal. In vast areas of alternative medicine, the science-element is woefully neglected or even totally absent. It follows, that these areas cannot be good medicine. In some areas of conventional medicine, the art-element is weak or neglected. It follows that, in these areas, medicine is not good either.
My rough outline of a ‘vision’ is, of course, rather vague and schematic; it cannot serve as a recipe for creating good medicine nor as a road map towards improving today’s health care. It is also somewhat naive and simplistic: it generalises across the entire, diverse field of medicine which problematic, to say the least.
One challenge for heath care practitioners is to find the optimal balance between the two elements for the situation at hand. A surgeon pulling an in-grown toenail will need a different mix of science and art than a GP treating a patient suffering from chronic depression, for instance.
The essential nature of both the science and the art of medicine also means that a deficit of one element cannot normally be compensated by a surplus of the other. In the absence of an effective treatment, even an over-dose of compassion will not suffice (and it is for this reason that the integration of alt med needs to be seen with great scepticism). Conversely, science alone will do a poor job in many others circumstances (and it is for that reason that we need to remind the medical profession of the importance of the ‘art’).
We cannot expect that the introduction of compassionate quacks will improve health care; it might make it appear more human, while, in fact, it would only become less effective. And is it truly compassionate to pretend that homeopathic placebos, administered by a kind and empathetic homeopath, generate more good than harm? I do not think so. The integration of alternative medicine makes sense only for those modalities which have been scientifically tested and demonstrated to be effective. True compassion must always include the desire to administer those treatments which demonstrably generate more good than harm.
Conclusion
I must admit, I do feel slightly embarrassed to pompously entitle this post “a vision of good medicine”. It really amounts to little more than common sense and is merely a reflection of what many health care professionals believe. Yet it does differ significantly from the ‘integrated health and post-modern medicine’ as proposed by Charles – and perhaps this is one reason why it might not be totally irrelevant.
Since homeopathy was invented by Samuel Hahnemann about 200 years ago, a steadily growing group of critics have raised their voices more and more loudly. Usually they come from doctors or scientists and only rarely from the legal profession.
Yet, there are exceptions: an Australian barrister and professor of law has published an analysis of “a series of criminal, civil, disciplinary and coronial decisions from difference countries in relation to homeopathic medicine where outcomes have been tragic”. He concludes that “there is an urgent need for reflection and response within the health sector generally, consumer protection authorities, and legal policy-makers about the steps that should be taken to provide community protection from dangerous homeopathic practice”.
He also questions whether homeopathy can ever be registered alongside other health care professionals:
“Until such time as homoeopathy can scientifically justify its fundamental tenets,… it cannot be said that its claims for therapeutic efficacy can be justifiable. This leaves the profession not just exposed to criticisms,… but potentially open to consumer protection actions directed toward whether its representations are false, misleading and deceptive, to civil litigation when its promises have not been fulfilled, and especially when persons have died, and to criminal actions in respect of the financial advantage that is obtained by its practitioners from their representations.
The distressing cases referred to here which led to avoidable deaths and the multiple accusations leveled against homoeopathy require of the profession at least a formal repudiation of the practitioners concerned… In addition, they demand an unequivocal response that homoeopathy will discipline its own in a robust and open way. If the profession is to acquire any scientific credibility, which is difficult to conceive of, the deaths to which homoeopathy has contributed…also require that homoeopathy actively generate a defensible research basis that justifies its claims to efficacy of outcome for its patients. It is only then that the claims of the medical establishment that homoeopathy is a dangerous and too often a lethal form of quackery will be able to be contested rationally. In the meantime, it is timely to consider further the status that homoeopathy has within the general and health care communities and whether that status can be scientifically, ethically or legally justified”.
I believe this legal view to be highly significant. The persistent criticism from skeptics, concerned scientists and doctors has rarely been translated into decisions about health care provision. Homeopaths tended to respond to our criticism by producing anecdotes, unconvincing or cherry-picked data or by producing outright lies, for instance in relation to the “Swiss government’s report” on homeopathy.
In this context, it is worth noting that, in some countries, homeopaths who have no medical qualifications have been accused to practice medicine without a licence. The case of Dana Ullman in the US is probably the most spectecular such incident; this is how one pro-homeopathy site describes it:
Dana is perhaps the person who has done the most for homeopathy since his court case in that he pursues the evangelism of homeopathy through the NCH and his mail order company… He prescribed homeopathic medicine and was arrested for practicing medicine without a license. But he won an important settlement in 1977 in the Oakland Municipal Court in which the court allowed his practice under two stipulations:
- that he did not diagnose or treat disease and that he refers to medical doctors for the diagnosis and treatment of disease;
- that he makes contracts with his patients that clearly define his role as a non-medical homeopathic practitioner and the patient’s role in seeking his care.
But such cases are not the only occasions for lawyers to look at homeopathy. Recently there has been a class action against the Boiron, the world’s largest manufacturer of homeopathic preparations. It was alleged that Boiron made bogus claims for one of its remedies, and there was a settlement worth millions of dollars. Similar cases are likely to follow, e.g.:
- Nelsons Homeopathy (Rescue Remedy, Bach Original Flower Remedies, Pure & Clear, Arnileve, H+Care)
- CVS Homeopathic Products (Flu Relief, Cold Relief, Cold Remedy, Ear Pain Relief)
- Nature’s Innovation (Naturasil Skin Tags, Bed Bug Patrol, Naturasil Scabies)
- Boericke & Tafel Cold/Flu
- Homeolab USA (Kids Relief Cough & Cold)
In June 2003, a British High Court Judge ordered two mothers to ensure that their daughters are appropriately vaccinated. The ruling concerned two separate cases brought by fathers who wanted their daughters immunized despite opposition by the girls’ unwed mothers
The fact that, in the UK and other countries, homeopathic placebos are still being sold as “vaccines” for the prevention of serious, life-threatening infections is, in my view nothing short of a scandal. The fact that a leading figure at Ainsworth actively misleads the public about these products is an outrage. It is high time therefore that the legal profession looks seriously at the full range of issues related to homeopathy with a view of stopping the dangerous nonsense.
On the last day of the year, is time to contemplate the achievements and failures of the past 12 months and think about the future. For me, it is also the moment to once again place my tongue in my cheek, empathise with my opponents and think of what they might hope for in the coming year.
Here is a brief yet somewhat ambitious expose of what I came up with: the charlatan’s wish list for 2013.
1 Let the Daily Mail and similar publications continue to promote uncritical thinking and bogus claims for alternative medicine.
2 Make sure that politicians remain blissfully ignorant of all matters related to science.
3 Let the anecdote continue to reign over evidence, for instance, in the popular press.
4 Regulate alternative practitioners such that they benefit from the added status without any obligation to abide by the generally accepted rules of evidence-based practice.
5 Prevent the closure of more homeopathic hospitals.
6 Ensure that the public continues to be mislead about nonsensical scams such as “integrated medicine”.
7 Increase the influence of Prince Charles in the realm of health care.
8 Give Royal status to the ‘College of Medicine’.
9 Appoint Dr Michael Dixon, chair of the ‘NHS-Alliance’ and the above-named “college”, as advisor to the government.
10 Introduce more post-modern thinking into health care; after all, there is more than one way of knowing!
11 Defame all those terrible sceptics who always doubt our claims.
12 Cherish double standards in medicine; they are essential for our survival!
13 Make sure researchers of alternative medicine use science not for testing but for proving the value of alternative therapies.
14 Continue to allow promotion of alternative medicine to masquerade as research.
15 Ensure that all our celebrity clients tell every journalist how young they look thanks to alternative medicine.
16 Let ‘Duchy’s Original detox Tincture’ become a financial success – Charles needs the added income for promoting quackery.
17 Open more woo-institutes in academia to spread the gospel of belief-based medicine.
18 Prevent anyone from finding out that many of us break even the most fundamental rules of medical ethics in our daily practice.
I am aware that the list is probably not nearly complete, and I invite everyone to add items of importance. Happy New Year!
The question whether spinal manipulation is an effective treatment for infant colic has attracted much attention in recent years. The main reason for this is, of course, that a few years ago Simon Singh had disclosed in a comment that the British Chiropractic Association (BCA) was promoting chiropractic treatment for this and several other childhood condition on their website. Simon famously wrote “they (the BCA) happily promote bogus treatments” and was subsequently sued for libel by the BCA. Eventually, the BCA lost the libel action as well as lots of money, and the entire chiropractic profession ended up with enough egg on their faces to cook omelets for all their patients.
At the time, the BCA had taken advice from several medical and legal experts; one of their medical advisers, I was told, was Prof George Lewith. Intriguingly, he and several others have just published a Cochrane review of manipulative therapies for infant colic. Here are the unabbreviated conclusions from their article:
“The studies included in this meta-analysis were generally small and methodologically prone to bias, which makes it impossible to arrive at a definitive conclusion about the effectiveness of manipulative therapies for infantile colic. The majority of the included trials appeared to indicate that the parents of infants receiving manipulative therapies reported fewer hours crying per day than parents whose infants did not, based on contemporaneous crying diaries, and this difference was statistically significant. The trials also indicate that a greater proportion of those parents reported improvements that were clinically significant. However, most studies had a high risk of performance bias due to the fact that the assessors (parents) were not blind to who had received the intervention. When combining only those trials with a low risk of such performance bias, the results did not reach statistical significance. Further research is required where those assessing the treatment outcomes do not know whether or not the infant has received a manipulative therapy. There are inadequate data to reach any definitive conclusions about the safety of these interventions”
Cochrane reviews also carry a “plain language” summary which might be easier to understand for lay people. And here are the conclusions from this section of the review:
The studies involved too few participants and were of insufficient quality to draw confident conclusions about the usefulness and safety of manipulative therapies. Although five of the six trials suggested crying is reduced by treatment with manipulative therapies, there was no evidence of manipulative therapies improving infant colic when we only included studies where the parents did not know if their child had received the treatment or not. No adverse effects were found, but they were only evaluated in one of the six studies.
If we read it carefully, this article seems to confirm that there is no reliable evidence to suggest that manipulative therapies are effective for infant colic. In the analyses, the positive effect disappears, if the parents are properly blinded; thus it is due to expectation or placebo. The studies that seem to show a positive effect are false positive, and spinal manipulation is, in fact, not effective.
The analyses disclose another intriguing aspect: most trials failed to mention adverse effects. This confirms the findings of our own investigation and amounts to a remarkable breach of publication ethics (nobody seems to be astonished by this fact; is it normal that chiropractic researchers ignore generally accepted rules of ethics?). It also reflects badly on the ability of the investigators of the primary studies to be objective. They seem to aim at demonstrating only the positive effects of their intervention; science is, however, not about confirming the researchers’ prejudices, it is about testing hypotheses.
The most remarkable thing about the new Cochrane review is, I think, the in-congruence of the actual results and the authors’ conclusion. To a critical observer, the former are clearly negative but the latter sound almost positive. I think this begs the question about the possibility of reviewer bias.
We have recently discussed on this blog whether reviews by one single author are necessarily biased. The new Cochrane review has 6 authors, and it seems to me that its conclusions are considerably more biased than my single-author review of chiropractic spinal manipulation for infant colic; in 2009, I concluded simply that “the claim [of effectiveness] is not based on convincing data from rigorous clinical trials”.
Which of the two conclusions describe the facts more helpfully and more accurately?
I think, I rest my case.
Would it not be nice to have a world where everything is positive? No negative findings ever! A dream! No, it’s not a dream; it is reality, albeit a reality that exists mostly in the narrow realm of alternative medicine research. Quite a while ago, we have demonstrated that journals of alternative medicine never publish negative results. Meanwhile, my colleagues investigating acupuncture, homeopathy, chiropractic etc. seem to have perfected their strategy of avoiding the embarrassment of a negative finding.
Since several years, researchers in this field have adopted a study-design which is virtually sure to generate nothing but positive results. It is being employed widely by enthusiasts of placebo-therapies, and it is easy to understand why: it allows them to conduct seemingly rigorous trials which can impress decision-makers and invariably suggests even the most useless treatment to work wonders.
One of the latest examples of this type of approach is a trial where acupuncture was tested as a treatment of cancer-related fatigue. Most cancer patients suffer from this symptom which can seriously reduce their quality of life. Unfortunately there is little conventional oncologists can do about it, and therefore alternative practitioners have a field-day claiming that their interventions are effective. It goes without saying that desperate cancer victims fall for this.
In this new study, cancer patients who were suffering from fatigue were randomised to receive usual care or usual care plus regular acupuncture. The researchers then monitored the patients’ experience of fatigue and found that the acupuncture group did better than the control group. The effect was statistically significant, and an editorial in the journal where it was published called this evidence “compelling”.
Due to a cleverly over-stated press-release, news spread fast, and the study was celebrated worldwide as a major breakthrough in cancer-care. Finally, most commentators felt, research has identified an effective therapy for this debilitating symptom which affects so many of the most desperate patients. Few people seemed to realise that this trial tells us next to nothing about what effects acupuncture really has on cancer-related fatigue.
In order to understand my concern, we need to look at the trial-design a little closer. Imagine you have an amount of money A and your friend owns the same sum plus another amount B. Who has more money? Simple, it is, of course your friend: A+B will always be more than A [unless B is a negative amount]. For the same reason, such “pragmatic” trials will always generate positive results [unless the treatment in question does actual harm]. Treatment as usual plus acupuncture is more than treatment as usual, and the former is therefore moer than likely to produce a better result. This will be true, even if acupuncture is no more than a placebo – after all, a placebo is more than nothing, and the placebo effect will impact on the outcome, particularly if we are dealing with a highly subjective symptom such as fatigue.
I can be fairly confident that this is more than a theory because, some time ago, we analysed all acupuncture studies with such an “A+B versus B” design. Our hypothesis was that none of these trials would generate a negative result. I probably do not need to tell you that our hypothesis was confirmed by the findings of our analysis. Theory and fact are in perfect harmony.
You might say that the above-mentioned acupuncture trial does still provide important information. Its authors certainly think so and firmly conclude that “acupuncture is an effective intervention for managing the symptom of cancer-related fatigue and improving patients’ quality of life”. Authors of similarly designed trials will most likely arrive at similar conclusions. But, if they are true, they must be important!
Are they true? Such studies appear to be rigorous – e.g. they are randomised – and thus can fool a lot of people, but they do not allow conclusions about cause and effect; in other words, they fail to show that the therapy in question has led to the observed result.
Acupuncture might be utterly ineffective as a treatment of cancer-related fatigue, and the observed outcome might be due to the extra care, to a placebo-response or to other non-specific effects. And this is much more than a theoretical concern: rolling out acupuncture across all oncology centres at high cost to us all might be entirely the wrong solution. Providing good care and warm sympathy could be much more effective as well as less expensive. Adopting acupuncture on a grand scale would also stop us looking for a treatment that is truly effective beyond a placebo – and that surely would not be in the best interest of the patient.
I have seen far too many of those bogus studies to have much patience left. They do not represent an honest test of anything, simply because we know their result even before the trial has started. They are not science but thinly disguised promotion. They are not just a waste of money, they are dangerous – because they produce misleading results – and they are thus also unethical.