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

medical ethics

Colonic irrigation is the alternative therapy of celebrities (and those who like to imitate them): they tend to use it for all sorts of ailments, predominantly for loosing weight. And it works! When they have paid for the session, they are relieved of some cash as well as of about half a kilo of body weight. By the time they wake up the next morning, the money is still gone, but the weight is back. This is a most effective method for getting rid of some £s, but NOT an effective way for shedding a few pounds.

 Numerous synonyms for colonic irrigation exist, e.g. colonic treatment, colon cleansing, rectal irrigation, colon therapy, colon hydrotherapy, colonic. The treatment is based on the ancient but obsolete theory of ‘autointoxication’, i.e. the body is  assumed to poison itself with, ‘autotoxins’ which, in turn, cause various illnesses. So, it is implausible and there is also no evidence to suggest it is effective. But this does not stop professional organisations to make claims which are good for business.

My analysis of the claims made by professional organisations of practitioners of colonic irrigation across the globe aimed at assessing the therapeutic claims made by these institutions. Six such organisations were identified, and the contents of their websites were studied. The results showed that all of the six organisations make therapeutic claims on their websites. Frequently mentioned themes are ‘detoxification’, normalisation of intestinal functions, treatment of inflammatory bowel diseases and body weight reduction. The claims are mostly confined to symptomatic improvements – but there are exceptions, e.g. prevention of bowel cancer or sorting out Irritable Bowel Syndrome ‘once and for all’ . Other therapeutic claims pertain to asthma, menstrual irregularities, circulatory disorders, skin problems, improvement in energy levels and no longer requiring pharmacotherapy. All these claims represent testable hypotheses.

The question therefore arises whether these hypotheses have been tested and, if so, what the results of such investigations suggest? The use of colonic irrigation by alternative practitioners for any indications is not supported by any sound evidence at all. There are simply no trials to show effectiveness. Even worse is the fact that, although touted as safe, colonic irrigation can lead to serious complications.

The conclusion is therefore simple: colonic irrigation is neither demonstrably effective nor safe, and the information supplied by its professional organisations is therefore a significant contributor to the sea of misinformation in the realm of alternative medicine.

The UK ‘Society of Homeopaths’ (SoH) is the largest professional organisation of UK non-doctor, so-called lay- homeopaths. On their website, the SoH made very specific claims about homeopathy; in particular, they listed conditions for which homeopathy had allegedly been proven to be effective. These claims have now thoroughly been debunked, and the evidence the SoH produced in support of their claims has been shown to be misleading, cherry-picked or misinterpreted.

I have no idea who conducted the above-named investigation and made a youtube video of it, but I think it is essentially correct and well worth watching. My own experiences with the SoH relate mainly to two encounters.

The first was a complaint I made about one of their high-ranking officers, Ralf Jeutter. He had been promotiong homeopathic vaccinations on his website (needless to stress, I think, that there is no evidence to support the notion that homeopathic vaccinations are effective). As I felt that the SoH dragged their feet pursuing my complaint, I had to send several reminders. Eventually, they considered it and concluded that Reuter had done nothing wrong. This, presumably, is the reason why, even today, he can state on his website that Homeopathy is used to help individuals in dealing better with kinds of infections such as leptospirosis, meningitis and cholera. All is fine, it seems as long as a disclaimer is added: Any information obtained here is not to be construed as medical OR legal advice. The decision to vaccinate and how you implement that decision is yours and yours alone. The evidence for the efficacy of homeopathic immunisation is ‘anecdotal’. That means it is based on individuals’ reports past and present.

My second encounter with the SoH relates to my 2010 analysis of the SoH code of ethics and their adherence to it. The code demanded that:

 

  • ‘all speculative theories will be stated as such and clearly distinguished’
  • ‘no advertising may be used which expressly or implicitly claims to cure named diseases’
  • ‘Advertising shall not be false, fraudulent, misleading, deceptive, extravagant or sensational.’

Encouraged by these assurances, I decided to study the websites of some members of the SoH, and soon discovered numerous and very obvious violations of the above-mentioned imperatives. In an attempt to find the root of these transgressions, I scrutinised the SoH’s own website where I found a multitude violations on all levels of the SoH’s own code of ethics. Many of the violations related to claims which were not supported by evidence. In other words, the largest professional UK organisation of lay- homeopaths misled the public in several rather devious ways:

  • they pretended to adhere to a code of ethics which forbids members to mislead the public
  • SoH -members nevertheless did mislead the public in ways that public health at risk
  • and they did so not least because the SoH followed exactly the same strategy
  • thus the SoH violated its own code of ethics to the detriment of public health.

My analysis was conducted a while ago, and some might hope that the SoH has stopped systematically misleading the public. This hope, however, is harshly disappointed when you watch the brand-new video entitled TESTING HOMEOPATHY mentioned above. As the SoH is about to celebrate 35 years of wisdom, courage, knowledge and prosperity, I do wonder whether this should not be 35 years of dangerously misleading the public.

What do you think?

 

 

In my last post and several others before, I have stated that consumers are incessantly being mislead about the value of alternative medicine. This statement requires evidence, and I intend to provide it – not just in one post but in a series of posts following in fast succession.

I start with an investigation we did over a decade ago. Its primary aim was to determine which complementary therapies are believed by their respective representing UK professional organizations to be suited for which medical conditions.

For this purpose, we sent out 223 questionnaires to CAM organizations representing a single CAM therapy (yes, amazingly that many such institutions exist just in the UK!). They were asked to list the 15 conditions which they felt benefited most from their specific CAM therapy, as well as the 15 most important contra-indications, the typical costs of initial and any subsequent treatments and the average length of training required to become a fully qualified practitioner. The conditions and contra-indications quoted by responding CAM organizations were recorded and the top five of each were determined. Treatment costs and hours of training were expressed as ranges.

Only 66 questionnaires were returned. Taking undelivered questionnaires into account, the response rate was 34%. Two or more responses were received from CAM organizations representing twelve therapies: aromatherapy, Bach flower remedies, Bowen technique, chiropractic, homoeopathy, hypnotherapy, magnet therapy, massage, nutrition, reflexology, Reiki and yoga.

The top seven common conditions deemed to benefit from all twelve therapies, in order of frequency, were: stress/anxiety, headaches/migraine, back pain, respiratory problems (including asthma), insomnia, cardiovascular problems and musculoskeletal problems. It is perhaps important at this stage to point out that some of these conditions are serious, even life-threatening. Aromatherapy, Bach flower remedies, hypnotherapy, massage, nutrition, reflexology, Reiki and yoga were all recommended as suitable treatments for stress/anxiety. Aromatherapy, Bowen technique, chiropractic, hypnotherapy, massage, nutrition, reflexology, Reiki and yoga were all recommended for headache/migraine. Bowen technique, chiropractic, magnet therapy, massage, reflexology and yoga were recommended for back pain. None of the therapies cost more than £60 for an initial consultation and treatment. No correlation between length of training and treatment cost was noted.

I think, this article provides ample evidence to show that, at least in the UK, professional organisations of alternative medicine readily issue statements about the effectiveness of specific alternative therapies which are not supported by evidence. Several years later, Simon Singh noted that phenomenon in a Guardian-comment and wrote about the British Chiropractic Association “they happily promote bogus claims”. He was famously sued for libel but won the case. Simon had picked the BCA merely by chance. The frightening thought is that he could have targeted any other of the 66 organisations from our investigation: they all seem to promote bogus claims quite happily.

Several findings from our study stood out for being particularly worrying: according to the respective professional organisation, Bach Flower Remedies were deemed to be effective for cancer and AIDS, for instance. If their peers put out such irresponsible nonsense, we should not be amazed at the claims made by the practitioners. And if the practitioners tell such ‘tall tales’ to their clients, to journalists and to everyone else, how can we be amazed that we seem to be drowning in a sea of misinformation?

Can one design a clinical study in such a way that it looks highly scientific but, at the same time, has zero chances of generating a finding that the investigators do not want? In other words, can one create false positive findings at will and get away with it? I think it is possible; what is more, I believe that, in alternative medicine, this sort of thing happens all the time. Let me show you how it is done; four main points usually suffice:

  1.  The first rule is that it ought to be an RCT, if not, critics will say the result was due to selection bias. Only RCTs have the reputation of being ‘top notch’.
  2.  Once we are clear about this design feature, we need to define the patient population. Here the trick is to select individuals with an illness that cannot be quantified objectively. Depression, stress, fatigue…the choice is vast. The aim must be to employ an outcome measure that is well-accepted, validated etc. but which nevertheless is entirely subjective.
  3.  Now we need to consider the treatment to be “tested” in our study. Obviously we take the one we are fond of and want to “prove”. It helps tremendously, if this intervention has an exotic name and involves some exotic activity; this raises our patients’ expectations which will affect the result. And it is important that the treatment is a pleasant experience; patients must like it. Finally it should involve not just one but several sessions in which the patient can be persuaded that our treatment is the best thing since sliced bread – even if, in fact, it is entirely bogus.
  4.  We also need to make sure that, for our particular therapy, no universally accepted placebo exists which would allow patient-blinding. That would be fairly disastrous. And we certainly do not want to be innovative and create such a placebo either; we just pretend that controlling for placebo-effects is impossible or undesirable. By far the best solution would be to give the control group no treatment at all. Like this, they are bound to be disappointed for missing out a pleasant experience which, in turn, will contribute to unfavourable outcomes in the control group. This little trick will, of course, make the results in the experimental group look even better.

That’s about it! No matter how ineffective our treatment is, there is no conceivable way our study can generate a negative result; we are in the pink!

Now we only need to run the trial and publish the positive results. It might be advisable to recruit several co-authors for the publication – that looks more serious and is not too difficult: people are only too keen to prolong their publication-list. And we might want to publish our study in one of the many CAM-journals that are not too critical, as long as the result is positive.

Once our article is in print, we can legitimately claim that our bogus treatment is evidence-based. With a bit of luck, other research groups will proceed in the same way and soon we will have not just one but several positive studies. If not, we need to do two or three more trials along the same lines. The aim is to eventually do a meta-analysis that yields a convincingly positive verdict on our phony intervention.

You might think that I am exaggerating beyond measure. Perhaps a bit, I admit, but I am not all that far from the truth, believe me. You want proof? What about this one?

Researchers from the Charite in Berlin just published an RCT to investigate the effectiveness of a mindful walking program in patients with high levels of perceived psychological distress.

To prevent allegations of exaggeration, selective reporting, spin etc. I take the liberty of reproducing the abstract of this study unaltered:

Participants aged between 18 and 65 years with moderate to high levels of perceived psychological distress were randomized to 8 sessions of mindful walking in 4 weeks (each 40 minutes walking, 10 minutes mindful walking, 10 minutes discussion) or to no study intervention (waiting group). Primary outcome parameter was the difference to baseline on Cohen’s Perceived Stress Scale (CPSS) after 4 weeks between intervention and control.

Seventy-four participants were randomized in the study; 36 (32 female, 52.3 ± 8.6 years) were allocated to the intervention and 38 (35 female, 49.5 ± 8.8 years) to the control group. Adjusted CPSS differences after 4 weeks were -8.8 [95% CI: -10.8; -6.8] (mean 24.2 [22.2; 26.2]) in the intervention group and -1.0 [-2.9; 0.9] (mean 32.0 [30.1; 33.9]) in the control group, resulting in a highly significant group difference (P < 0.001).

Conclusion. Patients participating in a mindful walking program showed reduced psychological stress symptoms and improved quality of life compared to no study intervention. Further studies should include an active treatment group and a long-term follow-up

This whole thing could just be a bit of innocent fun, but I am afraid it is neither innocent nor fun, it is, in fact, quite serious. If we accept manipulated trials as evidence, we do a disservice to science, medicine and, most importantly, to patients. If the result of a trial is knowable before the study has even started, it is unethical to run the study. If the trial is not a true test but a simple promotional exercise, research degenerates into a farcical pseudo-science. If we abuse our patients’ willingness to participate in research, we jeopardise more serious investigations for the benefit of us all. If we misuse the scarce funds available for research, we will not have the money to conduct much needed investigations. If we tarnish the reputation of clinical research, we hinder progress.

Chiropractors across the world tend to make false claims. This has been shown with such embarrassing regularity that there is no longer any question about it. Should someone have the courage to disclose and criticises this habit, chiropractors tend to attack their critic, rather than putting their house in order. One of their more devious strategies, in my view, is their insistence on claiming to effectively treat all sorts of childhood conditions.

What could be more evil than treating sick children with ineffective and harmful spinal manipulations? The answer is surprisingly simple: PREVENTING CHILDREN FROM PROFITTING FROM ONE OF THE MOST BENEFICIAL INTERVENTIONS EVER DISCOVERED!

The National Vaccine Information Center (NVIC) is an organisation which seems to support anti-vaxers of various kinds. Officially they try hard to give the image of being neutral about vaccinations and state that they are dedicated to the prevention of vaccine injuries and deaths through public education and to defending the informed consent ethic in medicine. As an independent clearinghouse for information on diseases and vaccines, NVIC does not advocate for or against the use of vaccines. We support the availability of all preventive health care options, including vaccines, and the right of consumers to make educated, voluntary health care choices.

In my view, this is thinly disguised promotion of an anti-vaccination stance. The NVIC recently made the following announcement:

The International Chiropractic Pediatric Association (ICPA), which was founded by Dr. Larry Webster and represents doctors of chiropractic caring for children, has supported NVIC’s mission to prevent vaccine injuries and deaths through public education and to protect informed consent rights for more than two decades. ICPA’s 2013 issue of Pathways to Family Wellness magazine features an article written by Barbara Loe Fisher on “The Moral Right to Religious and Conscientious Belief Exemptions to Vaccination.”

Pathways to Family Wellness is a full-color, quarterly publication that offers parents timely, relevant information about health and wellness options that will help them make conscious health choices for their families. ICPA offers NVIC donor supporters and NVIC Newsletter subscribers a complimentary digital version or print version of Pathways to Family Wellness magazine at a significant discount. Visit the Pathways subscription page and, when checking out in the shopping cart, add the exclusive code: NVIC. 

ICPA also has initiated parenting support groups that meet monthly to discuss health and parenting topics. Meetings are hosted by local doctors of chiropractic and the Pathways website features a directory of local groups. ICPA Executive Director Dr. Jeanne Ohm said “We look forward to many more years of collaborating with NVIC to forward our shared goal of enhancing and protecting the ability of parents to make fully informed health and wellness choices for their children.”

Why, we may well ask, are so many chiropractors against immunisations? The answer might be found in the history of chiropractic. Their founding fathers believed and taught that “subluxations” are the cause of all human diseases. To uphold this ridiculous creed, it was necessary to deny that infections play an important role in many illnesses. In other words, early chiropractors negated the germ theory of disease. Today, of course, they claim that all of this is ancient history – but the stance of many chiropractors against immunisations discloses fairly clearly, I think, that this is not true. Many chiropractic institutions still teach obsolete pseudo-knowledge and many chiropractors seem unable to totally free themselves from such obvious nonsense.

But back to the ICPA: they profess to be a non-profit organization whose mission is to engage and serve family chiropractors worldwide through education, training, and research, establishing evidenced informed practice, excellence in professional skills and unity in a global community which cooperatively and enthusiastically participates in advancing chiropractic for both the profession and the public.

What does “evidence informed practice” mean? This bizarre creation is alarmingly popular with quacks of all kinds and seems to aim at misleading the unsuspecting public. It clearly has little to do with EVIDENCE-BASED PRACTICE as globally adopted by responsible clinicians. If not, the ICPA would inform its members and the public at large that immunisations are amongst the most successful preventive measures in the history of medicine. It is hard to think of another medical intervention where the benefits so clearly and hugely outweigh the risks. Immunisations have saved more lives than most other medical treatments. To not make this crystal clear to concerned parents is, in my view, wholly irresponsible.

Hot flushes are a big problem; they are not life-threatening, of course, but they do make life a misery for countless menopausal women. Hormone therapy is effective, but many women have gone off the idea since we know that hormone therapy might increase their risk of getting cancer and cardiovascular disease. So, what does work and is also risk-free? Acupuncture?

Together with researchers from Quebec, we wanted to determine whether acupuncture is effective for reducing hot flushes and for improving the quality of life of menopausal women. We decided to do this in form of a Cochrane review which was just published.

We searched 16 electronic databases in order to identify all relevant studies and included all RCTs comparing any type of acupuncture to no treatment/control or other treatments. Sixteen studies, with a total of 1155 women, were eligible for inclusion. Three review authors independently assessed trial eligibility and quality, and extracted data. We pooled data where appropriate.

Eight studies compared acupuncture versus sham acupuncture. No significant difference was found between the groups for hot flush frequency, but flushes were significantly less severe in the acupuncture group, with a small effect size. There was substantial heterogeneity for both these outcomes. In a post hoc sensitivity analysis excluding studies of women with breast cancer, heterogeneity was reduced to 0% for hot flush frequency and 34% for hot flush severity and there was no significant difference between the groups for either outcome. Three studies compared acupuncture with hormone therapy, and acupuncture turned out to be associated with significantly more frequent hot flushes. There was no significant difference between the groups for hot flush severity. One study compared electro-acupuncture with relaxation, and there was no significant difference between the groups for either hot flush frequency or hot flush severity. Four studies compared acupuncture with waiting list or no intervention. Traditional acupuncture was significantly more effective in reducing hot flush frequency, and was also significantly more effective in reducing hot flush severity. The effect size was moderate in both cases.

For quality of life measures, acupuncture was significantly less effective than HT, but traditional acupuncture was significantly more effective than no intervention. There was no significant difference between acupuncture and other comparators for quality of life. Data on adverse effects were lacking.

Our conclusion: We found insufficient evidence to determine whether acupuncture is effective for controlling menopausal vasomotor symptoms. When we compared acupuncture with sham acupuncture, there was no evidence of a significant difference in their effect on menopausal vasomotor symptoms. When we compared acupuncture with no treatment there appeared to be a benefit from acupuncture, but acupuncture appeared to be less effective than HT. These findings should be treated with great caution as the evidence was low or very low quality and the studies comparing acupuncture versus no treatment or HT were not controlled with sham acupuncture or placebo HT. Data on adverse effects were lacking.

I still have to meet an acupuncturist who is not convinced that acupuncture is not an effective treatment for hot flushes. You only need to go on the Internet to see the claims that are being made along those lines. Yet this review shows quite clearly that it is not better than placebo. It also demonstrates that studies which do suggest an effect do so because they fail to adequately control for a placebo response. This means that the benefit patients and therapists observe in routine clinical practice is not due to the acupuncture per se, but to the placebo-effect.

And what could be wrong with that? Quite a bit, is my answer; here are just 4 things that immediately spring into my mind:

1) Arguably, it is dishonest and unethical to use a placebo on ill patients in routine clinical practice and charge for it pretending it is a specific and effective treatment.

2) Placebo-effects are unreliable, small and usually of short duration.

3) In order to generate a placebo-effect, I don’t need a placebo-therapy; an effective one administered with compassion does that too (and generates specific effects on top of that).

4) Not all placebos are risk-free. Acupuncture, for instance, has been associated with serious complications.

The last point is interesting also in the context of our finding that the RCTs analysed failed to mention adverse-effects. This is a phenomenon we observe regularly in studies of alternative medicine: trialists tend to violate the most fundamental rules of research ethics by simply ignoring the need to report adverse-effects. In plain English, this is called ‘scientific misconduct’. Consequently, we find very little published evidence on this issue, and enthusiasts claim their treatment is risk-free, simply because no risks are being reported. Yet one wonders to what extend systematic under-reporting is the cause of that impression!

So, what about the legion of acupuncturists who earn a good part of their living by recommending to their patients acupuncture for hot flushes?

They may, of course, not know about the evidence which shows that it is not more than a placebo. Would this be ok then? No, emphatically no! All clinicians have a duty to be up to date regarding the scientific evidence in relation to the treatments they use. A therapist who does not abide by this fundamental rule of medical ethics is, in my view, a fraud. On the other hand, some acupuncturists might be well aware of the evidence and employ acupuncture nevertheless; after all, it brings good money! Well, I would say that such a therapist is a fraud too.

Indian homeopaths recently published a clinical trial aimed at evaluating homeopathic treatment in the management of diabetic polyneuropathy. The condition affects many diabetic patients; its symptoms include tingling, numbness, burning sensation in the feet and pain, particularly at night. The best treatment consists of adequate metabolic control of the underlying diabetes. The pain can be severe often does not respond adequately to conventional pain-killers. It is therefore obvious that any new, effective treatment would be more than welcome.

The new trial  is a prospective observational study which was carried out from October 2005 to September 2009 by the Indian Central Council for Research in Homeopathy at its five Institutes. Patients suffering diabetic polyneuropathy (DPN) were screened and enrolled in the study, if they fulfilled the inclusion and exclusion criteria. The Diabetic Distal Symmetric Polyneuropathy Symptom Score (DDSPSS), developed by the Council, served as the primary outcome measure.

A total of 15 homeopathic medicines were identified after repertorizing the nosological symptoms and signs of the disease. The appropriate constitutional medicine was selected and prescribed in the 30, 200 and 1 M potencies on an individualized basis. Patients were followed up for 12 months.

Of 336 diabetics enrolled in the study, 247 patients who attended at least three follow-up appointments and baseline nerve conduction studies were included in the analysis. A statistically significant improvement in DDSPSS total score was found at 12 months. Most objective measures did not show significant improvements. Lycopodium clavatum (n = 132), Phosphorus (n = 27) and Sulphur (n = 26) were the most frequently prescribed homeopathic remedies.

From these results, the authors concluded that: “homeopathic medicines may be effective in managing the symptoms of DPN patients.”

Does this study tell us anything worth knowing? The short answer to this question, I am afraid, is NO.

Its weaknesses are all too obvious:

1) There was no control group.

2) Patients who did not come back to the follow-up appointments – presumably because they were not satisfied – were excluded from the analyses. The average benefit reported is thus likely to be a cherry-picked false positive result.

3) The primary outcome measure was not validated.

4) The observed positive effect on subjective symptoms could be due to several factors which are entirely unrelated to the homeopathic treatments’ e.g. better metabolic control, regression towards the mean, or social desirability.

Anyone who had seen the protocol of this study would have predicted the result; I see no way that such a study does not generate an apparently positive outcome. In other words, conducting the investigation was superfluous, which means that the patients’ participation was in vain; and this, in turn, means that the trial was arguably unethical.

This might sound a bit harsh, but I am entirely serious: deeply flawed research should not happen. It is a waste of scarce resources and patients’ tolerance; crucially, it has a powerful potential to mislead us and to set back our efforts to improve health care. All of this is unethical.

The problem of research which is so poor that it crosses the line into being unethical is, of course, not confined to homeopathy. In my view, it is an important issue in much of alternative medicine and quite possibly in conventional medicine as well. Over the years, several mechanisms have been put in place to prevent or at least minimize the problem, for instance, ethic committees and peer-review. The present study shows, I think, that these mechanisms are fragile and that, sometimes, they fail altogether.

In their article, the authors of the new homeopathic study suggest that more investigations of homeopathy for diabetic polyneuropathy should be done. However, I suggest almost precisely the opposite: unethical research of this nature should be prevented, and the existing mechanisms to achieve this aim must be strengthened.

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.

As I am drafting this post, I am in a plane flying back from Finland. The in-flight meal reminded me of the fact that no food is so delicious that it cannot be spoilt by the addition of too many capers. In turn, this made me think about the paper I happened to be reading at the time, and I arrived at the following theory: no trial design is so rigorous that it cannot to be turned into something utterly nonsensical by the addition of a few amateur researchers.

The paper I was reading when this idea occurred to me was a randomised, triple-blind, placebo-controlled cross-over trial of homeopathy. Sounds rigorous and top quality? Yes, but wait!

Essentially, the authors recruited 86 volunteers who all claimed to be suffering from “mental fatigue” and treated them with Kali-Phos 6X or placebo for one week (X-potencies signify dilution steps of 1: 10, and 6X therefore means that the salt had been diluted 1: 1000000 ). Subsequently, the volunteers were crossed-over to receive the other treatment for one week.

The results failed to show that the homeopathic medication had any effect (not even homeopaths can be surprised about this!). The authors concluded that Kali-Phos was not effective but cautioned that, because of the possibility of a type-2-error, they might have missed an effect which, in truth, does exist.

In my view, this article provides an almost classic example of how time, money and other resources can be wasted in a pretence of conducting reasonable research. As we all know, clinical trials usually are for testing hypotheses. But what is the hypothesis tested here?

According to the authors, the aim was to “assess the effectiveness of Kali-Phos 6X for attention problems associated with mental fatigue”. In other words, their hyposesis was that this remedy is effective for treating the symptom of mental fatigue. This notion, I would claim, is not a scientific hypothesis, it is a foolish conjecture!

Arguably any hypothesis about the effectiveness of a highly diluted homeopathic remedy is mere wishful thinking. But, if there were at least some promissing data, some might conclude that a trial was justified. By way of justification for the RCT in question, the authors inform us that one previous trial had suggested an effect; however, this study did not employ just Kali-Phos but a combined homeopathic preparation which contained Kalium-Phos as one of several components. Thus the authors’ “hypothesis” does not even amount to a hunch, not even to a slight incling! To me, it is less than a shot in the dark fired by blind optimists – nobody should be surprised that the bullet failed to hit anything.

It could even be that the investigators themselves dimly realised that something is amiss with the basis of their study; this might be the reason why they called it an “exploratory trial”. But an exploratory study is one whithout a hypothesis, and the trial in question does have a hyposis of sorts – only that it is rubbish. And what exactly did the authos meant to explore anyway?

That self-reported mental fatigue in healthy volunteers is a condition that can be mediatised such that it merits treatment?

That the test they used for quantifying its severity is adequate?

That a homeopathic remedy with virtually no active ingredient generates outcomes which are different from placebo?

That Hahnemann’s teaching of homeopathy was nonsense and can thus be discarded (he would have sharply condemned the approach of treating all volunteers with the same remedy, as it contradicts many of his concepts)?

That funding bodies can be fooled to pay for even the most ridiculous trial?

That ethics-committees might pass applications which are pure nonsense and which are thus unethical?

A scientific hypothesis should be more than a vague hunch; at its simplest, it aims to explain an observation or phenomenon, and it ought to have certain features which many alt med researchers seem to have never heard of. If they test nonsense, the result can only be nonsense.

The issue of conducting research that does not make much sense is far from trivial, particularly as so much (I would say most) of alt med research is of such or even worst calibre (if you do not believe me, please go on Medline and see for yourself how many of the recent articles in the category “complementary alternative medicine” truly contribute to knowledge worth knowing). It would be easy therefore to cite more hypothesis-free trials of homeopathy.

One recent example from Germany will have to suffice: in this trial, the only justification for conducting a full-blown RCT was that the manufacturer of the remedy allegedly knew of a few unpublished case-reports which suggested the treatment to work – and, of course, the results of the RCT eventually showed that it didn’t. Anyone with a background in science might have predicied that outcome – which is why such trials are so deplorably wastefull.

Research-funds are increasingly scarce, and they must not be spent on nonsensical projects! The money and time should be invested more fruitfully elsewhere. Participants of clinical trials give their cooperation willingly; but if they learn that their efforts have been wasted unnecessarily, they might think twice next time they are asked. Thus nonsensical research may have knock-on effects with far-reaching consequences.

Being a researcher is at least as serious a profession as most other occupations; perhaps we should stop allowing total amateurs wasting money while playing at being professioal. If someone driving a car does something seriously wrong, we take away his licence; why is there not a similar mechanism for inadequate researchers, funders, ethics-committees which prevents them doing further damage?

At the very minimum, we should critically evaluate the hypothesis that the applicants for research-funds propose to test. Had someone done this properly in relatiom to the two above-named studies, we would have saved about £150,000 per trial (my estimate). But as it stands, the authors will probably claim that they have produced fascinating findings which urgently need further investigation – and we (normally you and I) will have to spend three times the above-named amount (again, my estimate) to finance a “definitive” trial. Nonsense, I am afraid, tends to beget more nonsense.

 

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:

  1. that he did not diagnose or treat disease and that he refers to medical doctors for the diagnosis and treatment of disease;
  2. 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.

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