conflict of interest
A recent comment to a post of mine (by a well-known and experienced German alt med researcher) made the following bold statement aimed directly at me and at my apparent lack of understanding research methodology:
C´mon , as researcher you should know the difference between efficacy and effectiveness. This is pharmacological basic knowledge. Specific (efficacy) + nonspecific effects = effectiveness. And, in fact, everything can be effective – because of non-specific or placebo-like effects. That does not mean that efficacy is existent.
The point he wanted to make is that outcome studies – studies without a control group where the researcher simply observe the outcome of a particular treatment in a ‘real life’ situation – suffice to demonstrate the effectiveness of therapeutic interventions. This belief is very wide-spread in alternative medicine and tends to mislead all concerned. It is therefore worth re-visiting this issue here in an attempt to create some clarity.
When a patient’s condition improves after receiving a therapy, it is very tempting to feel that this improvement reflects the effectiveness of the intervention (as the researcher mentioned above obviously does). Tempting but wrong: there are many other factors involved as well, for instance:
- the placebo effect (mainly based on conditioning and expectation),
- the therapeutic relationship with the clinician (empathy, compassion etc.),
- the regression towards the mean (outliers tend to return to the mean value),
- the natural history of the patient’s condition (most conditions get better even without treatment),
- social desirability (patients tend to say they are better to please their friendly clinician),
- concomitant treatments (patients often use treatments other than the prescribed one without telling their clinician).
So, how does this fit into the statement above ‘Specific (efficacy) + nonspecific effects = effectiveness’? Even if this formula were correct, it would not mean that outcome studies of the nature described demonstrate the effectiveness of a therapy. It all depends, of course, on what we call ‘non-specific’ effects. We all agree that placebo-effects belong to this category. Probably, most experts also would include the therapeutic relationship and the regression towards the mean under this umbrella. But the last three points from my list are clearly not non-specific effects of the therapy; they are therapy-independent determinants of the clinical outcome.
The most important factor here is usually the natural history of the disease. Some people find it hard to imagine what this term actually means. Here is a little joke which, I hope, will make its meaning clear and memorable.
CONVERATION BETWEEN TWO HOSPITAL DOCTORS:
Doc A: The patient from room 12 is much better today.
Doc B: Yes, we stared his treatment just in time; a day later and he would have been cured without it!
I am sure that most of my readers now understand (and never forget) that clinical improvement cannot be equated with the effectiveness of the treatment administered (they might thus be immune to the misleading messages they are constantly exposed to). Yet, I am not at all sure that all ‘alternativists’ have got it.
The founder of Johrei Healing (JH), Mokichi Okada, believed that “all human beings have toxins in their physical bodies. Some are inherited, others are acquired by ingesting medicines, food additives, unnatural food, unclean air, most drugs, etc. all of these contain chemicals which cannot be used by the body and are treated as poisons…….. Illness is no more than the body’s way of purifying itself to regain health…… The more we resist illness by taking suppressive medications, the harder and more built up the toxins become…… If we do not allow the toxins to be eliminated from the body, we will suffer more, and have more difficult purification…..on the other hand, if we allow illness to take its course by letting the toxins become naturally eliminated from our bodies, we will be healthier.”
Johrei healers channel light or energy or warmth etc. into the patient’s or recipient’s body in order to stimulate well-being and healing. Sounds wacky? Yes!
Still, at one stage my team conducted research into all sorts of wacky healing practices (detailed reasons and study designs can be found in my recent book ‘A SCIENTIST IN WONDERLAND‘). Despite the wackiness, we even conducted a study of JH. Dr Michael Dixon, who was closely collaborating with us at the time, had persuaded me that it would be reasonable to do such a study. He brought some Japanese JH-gurus to my department to discuss the possibility, and (to my utter amazement) they were happy to pay £ 70 000 into the university’s research accounts for a small pilot study. I made sure that all the necessary ethical safe-guards were in place, and eventually we all agreed to design and conduct a study. Here is the abstract of the paper published once the results were available and written up.
“Johrei is a form of spiritual healing comprising “energy channelling” and light massage given either by a trained healer or, after some basic training, by anyone. This pilot trial aimed to identify any potential benefits of family-based Johrei practice in childhood eczema and for general health and to establish the feasibility of a subsequent randomised controlled trial. Volunteer families of 3-5 individuals, including at least one child with eczema were recruited to an uncontrolled pilot trial lasting 12 months. Parents were trained in Johrei healing and then practised at home with their family. Participants kept diaries and provided questionnaire data at baseline, 3,6 and 12 months. Eczema symptoms were scored at the same intervals. Scepticism about Johrei is presently an obstacle to recruitment and retention of a representative sample in a clinical trial, and to its potential use in general practice. The frequency and quality of practise at home by families may be insufficient to bring about the putative health benefits. Initial improvements in eczema symptoms and diary recorded illness, could not be separated from seasonal factors and other potential confounders. There were no improvements on other outcomes measuring general health and psychological wellbeing of family members.”
Our findings were hugely disappointing for the JH-gurus, of course, but we did insist on our right to publish them. Dr Dixon was not involved in the day to day running of our trial, nor in evaluating its results, nor in writing up the paper. He nevertheless showed a keen interest in the matter, kept in contact with the Japanese sponsors, and arranged regular meetings to discuss our progress. It was at one of those gatherings when he mentioned that he was about to fly to Japan to give a progress report to the JH organisation that had financed the study. My team felt this was odd (not least because, at this point, the study was far from finished) and we were slightly irritated by this interference.
When Dixon had returned from Japan, we asked him how the meeting had been. He said the JH sponsors had received him extremely well and had appreciated his presentation of our preliminary findings. As an ‘aside’, he mentioned something quite extraordinary: he, his wife and his three kids had all flown business class paid for by the sponsors of our trial. This, we all felt, was an overt abuse of potential research funds, unethical and totally out of line with academic behaviour. Recently, I found this fascinating clip on youtube, and I wonder whether it was filmed when Dr Dixon visited Japan on that occasion. One does get the impression that the Johrei organisation is not short of money.
A few months later, I duly reported this story to my dean, Prof Tooke, who was about to get involved with Dr Dixon in connection with a postgraduate course on integrated medicine for our medical school (more about this episode here or in my book). He agreed with me that such a thing was a most regrettable violation of academic and ethical standards. To my great surprise, he then asked me not to tell anybody about it. Today I feel very little loyalty to either of these two people and have therefore decided to publish my account – which, by the way, is fully documented as I have kept all relevant records and a detailed diary (in case anyone should feel like speaking to libel lawyers).
In my last post, I claimed that researchers of alternative medicine tend to be less than rigorous. I did not link this statement to any evidence at all. Perhaps I should have at least provided an example!? As it happens, I just came across a brand new paper which nicely demonstrates what I meant.
According to its authors, this non-interventional study was performed to generate data on safety and treatment effects of a complex homeopathic drug. They treated 1050 outpatients suffering from common cold with a commercially available homeopathic remedy for 8 days. The study was conducted in 64 German outpatient practices of medical doctors trained in CAM. Tolerability, compliance and the treatment effects were assessed by the physicians and by patient diaries. Adverse events were collected and assessed with specific attention to homeopathic aggravation and proving symptoms. Each adverse effect was additionally evaluated by an advisory board of experts.
The physicians detected 60 adverse events from 46 patients (4.4%). Adverse drug reactions occurred in 14 patients (1.3%). Six patients showed proving symptoms (0.57%) and only one homeopathic aggravation (0.1%) appeared. The rate of compliance was 84% for all groups. The global assessment of the treatment effects resulted in the verdict “good” and “very good” in 84.9% of all patients.
The authors concluded that the homeopathic complex drug was shown to be safe and effective for children and adults likewise. Adverse reactions specifically related to homeopathic principles are very rare. All observed events recovered quickly and were of mild to moderate intensity.
So why do I think this is ‘positively barmy’?
The study had no control group. This means that there is no way anyone can attribute the observed ‘treatment effects’ to the homeopathic remedy. There are many other phenomena that may have caused or contributed to it, e. g.:
- a placebo effect
- the natural history of the condition
- regression to the mean
- other treatments which the patients took but did not declare
- the empathic encounter with the physician
- social desirability
To plan a study with the aim as stated above and to draw the conclusion as cited above is naïve and unprofessional (to say the least) on the part of the researchers (I often wonder where, in such cases, the boundary between incompetence and research misconduct might lie). To pass such a paper through the peer review process is negligent on the part of the reviewers. To publish the article is irresponsible on the part of the editor.
In a nut-shell: COLLECTIVELY, THIS IS ‘POSITIVELY BARMY’!!!
On this blog, we have discussed the Alexander Technique before; it is an educational method promoted for all sorts of conditions, including neck pain. The very first website I found when googling it stated the following: “Back and neck pain can be caused by poor posture. Alexander Technique lessons help you to understand how to improve your posture throughout your daily activities. Many people, even those with herniated disc or pinched nerve, experience relief after one lesson, often permanent relief after five or ten lessons.”
Sounds too good to be true? Is there any good evidence?
The aim of this study, a randomized controlled trial with 3 parallel groups, was to test the efficacy of the Alexander Technique, local heat and guided imagery on pain and quality of life in patients with chronic non-specific neck pain. A total of 72 patients (65 females, 40.7±7.9 years) with chronic, non-specific neck pain were recruited. They received 5 sessions of the Alexander Technique, while the control groups were treated with local heat application or guided imagery. All interventions were conducted once a week for 45 minutes each.
The primary outcome measure at week 5 was neck pain intensity quantified on a 100-mm visual analogue scale; secondary outcomes included neck disability, quality of life, satisfaction and safety. The results show no group differences for pain intensity for the Alexander Technique compared to local heat. An exploratory analysis revealed the superiority of the Alexander Technique over guided imagery. Significant group differences in favor of the Alexander Technique were also found for physical quality of life. Adverse events were mild and mainly included slightly increased pain and muscle soreness.
The authors concluded that Alexander Technique was not superior to local heat application in treating chronic non-specific neck pain. It cannot be recommended as routine intervention at this time. Further trials are warranted for conclusive judgment.
I am impressed with these conclusions: this is how results should be interpreted. The primary outcome measure failed to yield a significant effect, and therefore such a negative conclusion is the only one that can be justified. Yet such clear words are an extreme rarity in the realm of alternative medicine. Most researchers in this area would, in my experience, have highlighted the little glimpses of the possibility of a positive effect and concluded that this therapeutic approach may be well worth a try.
In my view, this article is a fine example for demonstrating the difference between true scientists (who aim at testing the effectiveness of interventions) and pseudo-scientists (who aim at promoting their pet therapy). I applaud the authors of this paper!
Many experts have argued that the growing popularity of alternative medicine (AM) mandates their implementation into formal undergraduate medical education. Most medical students seem to feel a need to learn about AM. Yet little is known about the student-specific need for AM education. The objective of this paper was address this issue, specifically the authors wanted to assess the self-reported need for AM education among Australian medical students.
Thirty second-year to final-year medical students participated in semi-structured interviews. A constructivist grounded theory methodological approach was used to generate, construct and analyse the data.
The results show that these medical students generally held favourable attitudes toward AM but had knowledge deficits and did not feel adept at counselling patients about AMs. All students were supportive of integrating AM into education, noting its importance in relation to the doctor-patient encounter, specifically with regard to interactions with medical management. Students recognised the need to be able to effectively communicate about AMs and advise patients regarding safe and effective AM use.
The authors of this survey concluded that Australian medical students expressed interest in, and the need for, AM education in medical education regardless of their opinion of it, and were supportive of evidence-based AMs being part of their armamentarium. However, current levels of AM education in medical schools do not adequately enable this. This level of receptivity suggests the need for AM education with firm recommendations and competencies to assist AM education development required. Identifying this need may help medical educators to respond more effectively.
One might object to such wide-reaching conclusions based on a sample size of just 30. However, there are several similar surveys from other parts of the world which seem to paint a similar picture: most medical students clearly do want to learn about AM. But this issue raises several important questions:
- How can this be squeezed into the already over-full curriculum?
- Should students learn about AM or should they learn how to practice AM?
- Who should teach this subject?
In my view, students should learn the essentials about AM but not how to do this or that therapy. Most deans of medical schools seem to agree with me on that particular point.
The question as to who should teach students about AM is, however, much more contentious. Most conventional medical instructors have no interest in and/or no knowledge of the subject. Consequently, there is a tendency for medical schools to delegate AM by hiring a few alternative practitioners to cover AM. Thus we see homeopaths teaching medical students all (well, almost all) about homeopathy, acupuncturists teaching acupuncture, herbalists teaching herbal medicine etc. To many observers, this might sound right and reasonable – but I beg to differ resolutely.
Most alternative practitioners who I have met (and these were many over the last 20 years) are clearly not capable of teaching their own subject in a way that befits a medical school. They have little or no idea about the nature of scientific evidence and usually lack the slightest hint of critical analysis. Thus a homeopaths might teach homeopathy such that students get the impression that it is well grounded in evidence, for instance. Students who have been taught in this fashion are not likely to advise their future patients responsibly on the subject in question: THE TEACHING OF NONSENSE IS BOUND TO RESULT IN NONSENSICAL PRACTICE!
In my view, AM is an ideal subject to acquaint medical students with the concepts of critical thinking. In this respect, it offers an almost opportunity for medical schools to develop much-needed skills in their students. Sadly, however, this is not what is currently happening. All too often, medical school deans find themselves caught between the devil and the deep blue sea. In the end, they tend to delegate the subject of AM to people who are not competent and should not be let loose on impressionable students.
I fear that progress and care of future patients are bound to suffer.
Distant healing is one of the most bizarre yet popular forms of alternative medicine. Healers claim they can transmit ‘healing energy’ towards patients to enable them to heal themselves. There have been many trials testing the effectiveness of the method, and the general consensus amongst critical thinkers is that all variations of ‘energy healing’ rely entirely on a placebo response. A recent and widely publicised paper seems to challenge this view.
This article has, according to its authors, two aims. Firstly it reviews healing studies that involved biological systems other than ‘whole’ humans (e.g., studies of plants or cell cultures) that were less susceptible to placebo-like effects. Secondly, it presents a systematic review of clinical trials on human patients receiving distant healing.
All the included studies examined the effects upon a biological system of the explicit intention to improve the wellbeing of that target; 49 non-whole human studies and 57 whole human studies were included.
The combined weighted effect size for non-whole human studies yielded a highly significant (r = 0.258) result in favour of distant healing. However, outcomes were heterogeneous and correlated with blind ratings of study quality; 22 studies that met minimum quality thresholds gave a reduced but still significant weighted r of 0.115.
Whole human studies yielded a small but significant effect size of r = .203. Outcomes were again heterogeneous, and correlated with methodological quality ratings; 27 studies that met threshold quality levels gave an r = .224.
From these findings, the authors drew the following conclusions: Results suggest that subjects in the active condition exhibit a significant improvement in wellbeing relative to control subjects under circumstances that do not seem to be susceptible to placebo and expectancy effects. Findings with the whole human database suggests that the effect is not dependent upon the previous inclusion of suspect studies and is robust enough to accommodate some high profile failures to replicate. Both databases show problems with heterogeneity and with study quality and recommendations are made for necessary standards for future replication attempts.
In a press release, the authors warned: the data need to be treated with some caution in view of the poor quality of many studies and the negative publishing bias; however, our results do show a significant effect of healing intention on both human and non-human living systems (where expectation and placebo effects cannot be the cause), indicating that healing intention can be of value.
My thoughts on this article are not very complimentary, I am afraid. The problems are, it seems to me, too numerous to discuss in detail:
- The article is written such that it is exceedingly difficult to make sense of it.
- It was published in a journal which is not exactly known for its cutting edge science; this may seem a petty point but I think it is nevertheless important: if distant healing works, we are confronted with a revolution in the understanding of nature – and surely such a finding should not be buried in a journal that hardly anyone reads.
- The authors seem embarrassingly inexperienced in conducting and publishing systematic reviews.
- There is very little (self-) critical input in the write-up.
- A critical attitude is necessary, as the primary studies tend to be by evangelic believers in and amateur enthusiasts of healing.
- The article has no data table where the reader might learn the details about the primary studies included in the review.
- It also has no table to inform us in sufficient detail about the quality assessment of the included trials.
- It seems to me that some published studies of distant healing are missing.
- The authors ignored all studies that were not published in English.
- The method section lacks detail, and it would therefore be impossible to conduct an independent replication.
- Even if one ignored all the above problems, the effect sizes are small and would not be clinically important.
- The research was sponsored by the ‘Confederation of Healing Organisations’ and some of the comments look as though the sponsor had a strong influence on the phraseology of the article.
Given these reservations, my conclusion from an analysis of the primary studies of distant healing would be dramatically different from the one published by the authors: DESPITE A SIZABLE AMOUNT OF PRIMARY STUDIES ON THE SUBJECT, THE EFFECTIVENESS OF DISTANT HEALING REMAINS UNPROVEN. AS THIS THERAPY IS BAR OF ANY BIOLOGICAL PLAUSIBILITY, FURTHER RESEARCH IN THIS AREA SEEMS NOT WARRANTED.
Twenty years ago, I published a short article in the British Journal of Rheumatology. Its title was ALTERNATIVE MEDICINE, THE BABY AND THE BATH WATER. Reading it again today – especially in the light of the recent debate (with over 700 comments) on acupuncture – indicates to me that very little has since changed in the discussions about alternative medicine (AM). Does that mean we are going around in circles? Here is the (slightly abbreviated) article from 1995 for you to judge for yourself:
“Proponents of alternative medicine (AM) criticize the attempt of conducting RCTs because they view this is in analogy to ‘throwing out the baby with the bath water’. The argument usually goes as follows: the growing popularity of AM shows that individuals like it and, in some way, they benefit through using it. Therefore it is best to let them have it regardless of its objective effectiveness. Attempts to prove or disprove effectiveness may even be counterproductive. Should RCTs prove that a given intervention is not superior to a placebo, one might stop using it. This, in turn, would be to the disadvantage of the patient who, previous to rigorous research, has unquestionably been helped by the very remedy. Similar criticism merely states that AM is ‘so different, so subjective, so sensitive that it cannot be investigated in the same way as mainstream medicine’. Others see reasons to change the scientific (‘reductionist’) research paradigm into a broad ‘philosophical’ approach. Yet others reject the RCTs because they think that ‘this method assumes that every person has the same problems and there are similar causative factors’.
The example of acupuncture as a (popular) treatment for osteoarthritis, demonstrates the validity of such arguments and counter-arguments. A search of the world literature identified only two RCTs on the subject. When acupuncture was tested against no treatment, the experimental group of osteoarthritis sufferers reported a 23% decrease of pain, while the controls suffered a 12% increase. On the basis of this result, it might seem highly unethical to withhold acupuncture from pain-stricken patients—’if a patient feels better for whatever reason and there are no toxic side effects, then the patient should have the right to get help’.
But what about the placebo effect? It is notoriously difficult to find a placebo indistinguishable to acupuncture which would allow patient-blinded studies. Needling non-acupuncture points may be as close as one can get to an acceptable placebo. When patients with osteoarthritis were randomized into receiving either ‘real acupuncture or this type of sham acupuncture both sub-groups showed the same pain relief.
These findings (similar results have been published for other AMs) are compatible only with two explanations. Firstly acupuncture might be a powerful placebo. If this were true, we need to establish how safe acupuncture is (clearly it is not without potential harm); if the risk/benefit ratio is favourable and no specific, effective form of therapy exists one might still consider employing this form as a ‘placebo therapy’ for easing the pain of osteoarthritis sufferers. One would also feel motivated to research this powerful placebo and identify its characteristics or modalities with the aim of using the knowledge thus generated to help future patients.
Secondly, it could be the needling, regardless of acupuncture points and philosophy, that decreases pain. If this were true, we could henceforward use needling for pain relief—no special training in or equipment for acupuncture would be required, and costs would therefore be markedly reduced. In addition, this knowledge would lead us to further our understanding of basic mechanisms of pain reduction which, one day, might evolve into more effective analgesia. In any case the published research data, confusing as they often are, do not call for a change of paradigm; they only require more RCTs to solve the unanswered problems.
Conducting rigorous research is therefore by no means likely to ‘throw out the baby with the bath water’. The concept that such research could harm the patient is wrong and anti-scientific. To follow its implications would mean neglecting the ‘baby in the bath water’ until it suffers serious damage. To conduct proper research means attending the ‘baby’ and making sure that it is safe and well.
In the realm of homeopathy there is no shortage of irresponsible claims. I am therefore used to a lot – but this new proclamation takes the biscuit, particularly as it currently is being disseminated in various forms worldwide. It is so outrageously unethical that I decided to reproduce it here [in a slightly shortened version]:
“Homeopathy has given rise to a new hope to patients suffering from dreaded HIV, tuberculosis and the deadly blood disease Hemophilia. In a pioneering two-year long study, city-based homeopath Dr Rajesh Shah has developed a new medicine for AIDS patients, sourced from human immunodeficiency virus (HIV) itself.
The drug has been tested on humans for safety and efficacy and the results are encouraging, said Dr Shah. Larger studies with and without concomitant conventional ART (Antiretroviral therapy) can throw more light in future on the scope of this new medicine, he said. Dr Shah’s scientific paper for debate has just been published in Indian Journal of Research in Homeopathy…
The drug resulted in improvement of blood count (CD4 cells) of HIV patients, which is a very positive and hopeful sign, he said and expressed the hope that this will encourage an advanced research into the subject. Sourcing of medicines from various virus and bacteria has been a practise in the homeopathy stream long before the prevailing vaccines came into existence, said Dr Shah, who is also organising secretary of Global Homeopathy Foundation (GHF)…
Dr Shah, who has been campaigning for the integration of homeopathy and allopathic treatments, said this combination has proven to be useful for several challenging diseases. He teamed up with noted virologist Dr Abhay Chowdhury and his team at the premier Haffkine Institute and developed a drug sourced from TB germs of MDR-TB patients.”
So, where is the study? It is not on Medline, but I found it on the journal’s website. This is what the abstract tells us:
“Thirty-seven HIV-infected persons were registered for the trial, and ten participants were dropped out from the study, so the effect of HIV nosode 30C and 50C, was concluded on 27 participants under the trial.
Results: Out of 27 participants, 7 (25.93%) showed a sustained reduction in the viral load from 12 to 24 weeks. Similarly 9 participants (33.33%) showed an increase in the CD4+ count by 20% altogether in 12 th and 24 th week. Significant weight gain was observed at week 12 (P = 0.0206). 63% and 55% showed an overall increase in either appetite or weight. The viral load increased from baseline to 24 week through 12 week in which the increase was not statistically significant (P > 0.05). 52% (14 of 27) participants have shown either stability or improvement in CD4% at the end of 24 weeks, of which 37% participants have shown improvement (1.54-48.35%) in CD4+ count and 15% had stable CD4+ percentage count until week 24 week. 16 out of 27 participants had a decrease (1.8-46.43%) in CD8 count. None of the adverse events led to discontinuation of study.
Conclusion: The study results revealed improvement in immunological parameters, treatment satisfaction, reported by an increase in weight, relief in symptoms, and an improvement in health status, which opens up possibilities for future studies.”
In other words, the study had not even a control group. This means that the observed ‘effects’ are most likely just the normal fluctuations one would expect without any clinical significance whatsoever.
The homeopathic Ebola cure was bad enough, I thought, but, considering the global importance of AIDS, the homeopathic HIV treatment is clearly worse.
My memoir ‘A SCIENTIST IN WONDERLAND’ has already brought many surprises (and about 20 most flattering reviews). A few days ago, the German version was published entitled ‘NAZIS, NADELN UND INTRIGEN’ (people who have not read it might find this title puzzling). The German publisher reported that the first print-run was sold out in the first 4 days.
In order to tempt you to read my memoir, I publish here the final section of the book which affirms that the link between my rather diverse experiences boils down to ethics.
…the most important link between my research into alternative medicine and that related to the Third Reich was that of medical ethics.
It should be axiomatic that ethics is indispensable to the practice of medicine, and is not something that can just be switched off at will. No branch of health care, including alter-native medicine, can be considered exempt from it. But the subject of ethics is seldom even considered in alternative medicine; many alternative practitioners have never been taught medical ethics, and where training in this area does exist, it tends to be at best superficial. There are thousands of books on alternative medicine but hardly more than a handful cover the subject of medical ethics in any depth. It is perhaps not surprising, therefore, that the principles of medical ethics are routinely ignored and frequently violated by promoters of alternative medicine.
Medical ethics seem to me to be violated, for example: when homeopaths prescribe or recommend homeopathic vaccinations for which there is not a shred of evidence; when chiropractors or other alternative practitioners happily promote bogus treatments for children with asthma or other serious conditions; when practitioners fail to obtain informed consent before commencing their treatments; when Prince Charles sells his “detox tincture” which is unable to eliminate poisons from your body, merely cash from your purse; when quacks inveigle desperate cancer patients by pretending they have found a cure; when pharmacists sell Bach Flower Remedies or other glorified placebos; when applied kinesiologists, iridologists, etc. claim that their baseless diagnostic tests are able to identify serious diseases; when pseudoscientists claim that certain alternative therapies are evidence-based because they managed to generate a false positive result purely by cherry-picking or massaging their data; when politicians who lack even the most basic understanding of science publicly support quackery, proclaiming that it is evidence-based.
And so on, and so on.
Some might criticize me here for claiming the moral high ground. But if I do so, it is for a good reason. Medical consultations are intrinsically unequal, with the clinician occupying a position of considerable power over often highly vulnerable patients. This places an important ethical onus on the caregiver to assist patients in making informed choices—an imperative and a trust that is breached each and every time that unproven nostrums born of ideology and wishful thinking are offered to people with assertions that they are an effective, valid approach to the treatment of disease.
When science is abused, hijacked or distorted in order to serve political or ideological belief systems, ethical standards will inevitably slip. The resulting pseudoscience is a deceit perpetrated on the weak and the vulnerable. We owe it to ourselves, and to those who come after us, to stand up for the truth, no matter how much trouble this might bring.
Today, I look back at the often stormy past from the peaceful vantage point of my retirement with a mixture of satisfaction and incredulity. The doctor and scientist may still be full of questions, but the musician in me breathes a sigh of relief that the performance, with all its impossible demands and fiendishly difficult passages, is finally over.
The Telegraph today reports that, despite relentless lobbying from the Prince of Wales, UK herbalists will not, after all, be regulated by statute. Here are the most important statements from this article:
Prof David Walker, deputy chief medical officer, said he had taken the decision because there was insufficient evidence that the alternative therapy works, making it impossible to set standards of good practice. Three years ago ministers had pledged to bring in an official register of practitioners of herbal and Chinese medicines, which would see therapists regulated alongside other health workers, such as physiotherapists and speech therapists…But ministers blocked the proposals, instead setting up a new committee, led by the NHS deputy chief medical officer – which has now ruled against statutory regulation. The decision came despite lobbying from Prince Charles, a keen advocate of complementary medicines, and a supporter of regulation, who held a meeting with Jeremy Hunt in 2013 in which his concerns were raised…Prof Walker said that although most herbal practitioners were in favour of regulation, those opposed to it feared it would “confer an inappropriate level of legitimacy on herbal practice which was poorly supported by scientific evidence.” He said the decision to rule against regulation was “undoubtedly the most contentious area” addressed by the working party, which also looked at the safety of herbal medicine products. Instead, the report calls for a review of all ingredients sold in such medicines, to check their safety, with a “voluntary register” for practitioners who use them. It says there is too little evidence to show that herbal medicines improve health outcomes, making it “difficult to establish the boundaries of good practice” in regulating practitioners. It also says there is very little understanding of the risks posed to patients from current practices in herbal medicine…Prof Walker’s recommendation has triggered an immediate rift among the 26 members of his working party. Twelve members of the working party have written to Dr Dan Poulter, health minister, alleging that the decision will put the safety of the public at risk, because anyone will be able to promote themselves as an expert in herbal medicine, without any training. Research suggests around three million Britons a year consult herbal practitioners, operating in shops, online and in private clinics, with up to one in 12 of all adults using a herbal medicine at some stage. Michael McIntyre, chairman of the European Herbal and Traditional Medicine Practitioners Association, said the decision not to regulate practitioners could put the public at risk from rogue operators, with no training. The herbal practitioner, who was a member of the DoH working party, said: “We are deeply disappointed by this. We feared this issue was going to be kicked into the long grass, by quietly putting something out just before the election – and that is exactly what has happened.” He said the public needed the reassurance of statutory regulation, to know that any herbal doctor who is practising had received some training. The association disputed claims there was insufficient evidence to show that herbal medicines worked, saying that several trials had shown its impact for a number of conditions, but that the sector had less money than the pharmaceutical industry had to undertake mass research. The report says that although ministers promised “some form of regulation of herbal practitioners” this only committed the working party to consider the options, and that the introduction of regulation would require the sector to be “more science and evidence-based”.
Perhaps I should first state that I was not involved in any way in this process. Furthermore, I must say that I do think it is the right decision. To understand it better, I need to refer to several previous posts: yes, some herbal medicines are demonstrably effective. But the regulation in question is NOT about herbal medicines; it is about herbal practitioners, and the two are not necessarily related. UK herbal practitioners practice within a range of traditions including traditional European herbalism, TCM, or other schools of thought. They differ vastly but have one characteristic in common: they individualise their prescriptions according to the specific characteristics of the patient. Thus they would rarely prescribe the evidence-based herbal medicines but mix up prescriptions composed of several herbal ingredients. The problems with this approach are numerous:
- there is no good evidence that this approach of individualised herbalism is effective;
- the safety of the herbs used by traditional herbalists is often unknown;
- traditional herbalists tend to use obsolete diagnostic techniques, false-positive and false-negative diagnoses are thus inevitable;
- some of the herbal mixtures have been shown to be contaminated with toxic ingredients;
- some mixtures are adulterated with powerful prescription drugs;
- the herbal ingredients could interact with each other in an unpredictable manner;
- the herbal mixtures might interact with prescribed drugs.
The long and short of it is that nobody knows whether the treatments of traditional herbalists generate more good than harm. Regulating these professions by statute would merely give them a level of credibility that they do not deserve. As with the regulation of chiropractors or osteopaths in the UK, the regulation of herbalists would simply misled the public about the value of traditional herbalism, and it most likely would have prompted the herbalists to happily rest on their assumed merits claiming that their effectiveness and safety has been officially acknowledged and is therefore no longer in doubt.
In a nutshell: THE ‘PROPER’ REGULATION OF NONSENSE GENERATES PROPER NONSENSE