MD, PhD, FMedSci, FSB, FRCP, FRCPEd

medical ethics

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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’!!!

Yoga is a popular form of alternative medicine. Evidence for its effectiveness is scarce and generally far from convincing. But at least it is safe! At least this is what yoga enthusiasts would claim. Unfortunately, this is not entirely true; adverse events have also been reported with some regularity. Their frequency is, however, not known.

A new study was aimed at filling this gap. It was conducted to elucidate the frequencies and characteristics of adverse events of yoga performed in classes and the risk factors of such events.

The subjects were 2508 people taking yoga classes and 271 yoga therapists conducting the classes. A survey for yoga class attendees was performed on adverse events that occurred during a yoga class on the survey day. A survey for yoga therapists was performed on adverse events that the therapists had observed in their students to date. Adverse events were defined as “undesirable symptoms or responses that occurred during a yoga class”.

Among 2508 yoga class attendees, 1343 (53.5%) had chronic diseases and 1063 (42.3%) were receiving medication at hospitals. There were 687 class attendees (27.8%) who reported some type of undesirable symptoms after taking a yoga class. Musculoskeletal symptoms such as myalgia were the most common symptoms, involving 297 cases, followed by neurological symptoms and respiratory symptoms. Most adverse events (63.8%) were mild and did not interfere with class participation. The risk factors for adverse events were examined, and the odds ratios for adverse events were significantly higher in attendees with chronic disease, poor physical condition on the survey day, or a feeling that the class was physically and mentally stressful. In particular, the occurrence of severe adverse events that interfered with subsequent yoga practice was high among elderly participants (70 years or older) and those with chronic musculoskeletal diseases.

The authors concluded that the results of this large-scale survey demonstrated that approximately 30% of yoga class attendees had experienced some type of adverse event. Although the majority had mild symptoms, the survey results indicated that attendees with chronic diseases were more likely to experience adverse events associated with their disease. Therefore, special attention is necessary when yoga is introduced to patients with stress-related, chronic diseases.

I find these findings interesting and thought-provoking. The main question that they raise is, I think, the flowing: ARE THERE ANY CONDITIONS FOR WHICH YOGA DEMONSTRABLY GENERATES MORE GOOD THAN HARM?

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 FDA just made the following significant announcement:

The Food and Drug Administration (FDA) is announcing a public hearing to obtain information and comments from stakeholders about the current use of human drug and biological products labeled as homeopathic, as well as the Agency’s regulatory framework for such products. These products include prescription drugs and biological products labeled as homeopathic and over-the-counter (OTC) drugs labeled as homeopathic. FDA is seeking participants for the public hearing and written comments from all interested parties, including, but not limited to, consumers, patients, caregivers, health care professionals, patient groups, and industry. FDA is seeking input on a number of specific questions, but is interested in any other pertinent information participants would like to share.

Date

April 20-21, 2015

Time

9:00 am to 4:00 pm

Location

FDA White Oak Campus
10903 New Hampshire Avenue
Bldg. 31, Room 1503A (Great Room)
Silver Spring, Maryland 20993

Attendance, Registration, and Oral Presentations

Registration is free and available on a first-come, first-served basis. If you wish to attend or make an oral presentation, please reference section III of the forthcoming Federal Register Notice (Attendance and/or Participation in the Public Hearing) for information on how to register and the deadline for registration.

Webcast Information

If you cannot attend in person, information about how you can access a live Webcast will be located at Homeopathic Product Regulation

Agenda

The agenda will be posted soon

And this is what Reuters reported about the planned event:

The hearing, scheduled for April 20-21, will discuss prescription drugs, biological products, and over-the-counter drugs labeled homeopathic, a market that has expanded to become a multimillion dollar industry in the United States. The agency is set to evaluate its regulatory framework for homeopathic products after a quarter century. (http://1.usa.gov/1Hxwup3) An Australian government study released this month concluded that homeopathy does not work. (http://bit.ly/1BheAmR) The FDA issued a warning earlier this month asking consumers not to rely on asthma products labeled homeopathic that are sold over the counter. (http://1.usa.gov/1EEuKrC) Homeopathic medicines include pellets placed under the tongue, tablets, liquids, ointments, sprays and creams. The basic principles of homeopathy, formulated by German physician Samuel Hahnemann in the late 18th century, are based on a theory that a disease can be treated using small doses of natural substances that in a healthy person would produce symptoms of the disease. The agenda for the hearing will be posted soon, the FDA said on Tuesday.

In my view, this is an important occasion for experts believing in evidence to make their position regarding homeopathy heard. I therefore encourage all my readers who have an evidence-based opinion on homeopathy to submit it to the hearing.

My memoir ‘A SCIENTIST IN WONDERLAND’ continues to get rather splendid reviews. On 23 March, it will be published also in a German edition. Probably a good time to post another short excerpt from it.

The following episode gives just one of many examples of attempts by my Exeter peers to sabotage my scientific, moral and ethical standards. The players in this scene are:

By the year 2000, I began to experience unnecessary unpleasantness at Exeter on a more and more regular basis. This passage from my book describes the key moment when it became clear to me that something profoundly wrong was going on:

The watershed came in 2003, when I saw an announcement published in the newsletter of the Prince of Wales’ Foundation for Integrated Health:

“The Peninsula Medical School aims to become the UK’s first medical school to include integrated medicine at postgraduate level. The school also plans to extend the current range and depth of programmes offered by including healthcare ethics and legislation. Professor John Tooke, dean of the Peninsula Medical School, said: “The inclusion of integrated medicine is a patient driven development. Increasingly the public is turning to the medical profession for information about complementary medicines. This programme will play an important role in developing critical understanding of a wide range of therapies”.

When I stumbled on this announcement, I was truly puzzled. Tooke is obviously planning a new course for me, I thought, but why has he not told me about it? When I enquired, Tooke informed me that the medical school was indeed preparing to offer a postgraduate “Pathway in Integrated Health”; this exciting new innovation had been initiated by Dr Michael Dixon, a general practitioner who, after working in collabora-tion with my unit for several years, had become one of the UK’s most outspoken proponents of spiritual healing and other similarly dubious forms of alternative medicine. For this reason, Dixon was apparently very well regarded by Prince Charles.

A few days after I had received this amazing news, Dixon arrived at my office and explained, with visible embarrassment, that Prince Charles had expressed his desire to him personally to establish such a course at Exeter. His Royal Highness had already facilitated its funding which, in fact, came from “Nelsons”, one of the UK’s largest manufacturers of homeopathic remedies. The day-to-day running of the course was to be put into the hands of the ex-director of the Centre for Complementary Health Studies (CCHS), the very unit that, almost a decade earlier, I had struggled—and eventually even paid—to be separated from because of its overtly anti-scientific agenda. The whole thing had been in the planning for many months. I was, it seemed, the last to know—but now that I had learnt about it, Dixon and Tooke leaned on me with all their might to persuade me to contribute to this course by giving a few lectures.

I could no more comply with this request than fly. Apart from anything else, anyone who had read my papers would have known that I was opposed in principle to the concept of “Integrated Health”. As I saw it, “integrating” quackery with genuine, science-based medicine was nothing less than a profound betrayal of the ethical basis of medical practice. By putting its imprimatur on this course, and by offering it under the auspices of a mainstream medical school, my institution would be encouraging the dangerously erroneous idea of equivalence—i.e. the notion that alternative and mainstream medicine were merely two parallel but equally valid and effective methods of treating illness.

To add insult to injury, the course was to be run by someone who I had good reason to reject and sponsored by a major manufacturer of homeopathic remedies. In all conscience, the latter circumstance seemed to me to be the last straw. Study after study carried out by my unit had found homeopathy to be not only conceptually absurd but also therapeutically worthless. To all intents and purposes, the discussion about the value of homeopathy was closed. Even a former director of the Royal London Homeopathic Hospital had concluded in his book that “homeopathy has not been proved to work… the great majority… of the improvement that patients experience is due to non-specific causes”. If we did not take a stand on this issue, we might as well give up and go home. Consequently, I politely but firmly declined the offer of participating in this course.
By now numerous other incidents of a similar nature had poisoned the atmosphere at my own medical school and university so much that both my work and my health were suffering. How had it come to this? Why was even the most obvious and demonstrable truth being turned upside down so that it could be used against me? Why were my peers seemingly bent on constraining me and making life increasingly difficult for me?

The UK Professional Standards Authority for Health and Social Care (PSA) tries to promote the health, safety and wellbeing of patients, service users and the public by raising standards of regulation and voluntary registration of people working in health and care. They are an independent body, accountable to the UK Parliament.

In July 2014, the PSA audited all 75 of the cases that the General Chiropractic Council (GCC) had closed at the initial stages of its fitness to practise (FTP) process during the 12 month period from 1 June 2013 to 30 May 2014. The final verdict of the PSA’s audit seems devastating. Here is a short excerpt from the conclusions of its report:

The extent of the deficiencies we found in this audit (as set out in detail above) which related to failures across every aspect of the casework framework, as well as widespread failures to comply with the GCC’s own procedures, raises concern about the extent to which the public can have confidence in the GCC’s operation of its initial stages FTP process.

In summary, the particular areas of failures/weaknesses identified in our audit include:

  • Ineffective screening on receipt of ‘complaints’ and inconsistent completion and updating of risk assessments
  • Customer service issues, including failing to respond to/acknowledge correspondence promptly, failing to provide clear information about the FTP process and failing to provide updates about progress and outcomes within reasonable timeframes
  • Inadequate investigation of cases through failures to gather or validate relevant evidence or to do so promptly – sometimes as a result of inconsistent and ineffective use of case plans and case reviews
  • Deficiencies in the evaluation of information by decision-makers and weaknesses in the reasoning provided for decisions, including failures to address all the relevant allegations and/or reaching decisions on the basis of insufficient evidence
  • Poor record keeping and various data protection breaches or potential breaches
  • Ineffective systems for the sharing of relevant information between the Registration and FTP teams, leading to inappropriate action being taken in some cases
  • Widespread non-compliance with internal guidance and procedures.

We have also concluded that the steps taken by the GCC, in particular the processes it introduced in its procedure manual in February had not at the time of the audit resulted in consistent improvement in the quality of its casework.

What does all of this mean?

The GCC’s website informs us that this organisation regulates all chiropractors in the UK to ensure the safety of patients undergoing chiropractic treatment. The GCC is an independent statutory body established by Parliament to regulate the chiropractic profession. We protect the health and safety of the public by ensuring high standards of practice in the chiropractic profession. The title of ‘chiropractor’ is protected by law and it is a criminal offence for anyone to describe themselves as any sort of chiropractor without being registered with the GCC.  We check that all chiropractors are properly qualified and are fit to practise.

The conclusions of the PSA audit seem to indicate nothing less than this: the GCC is not fit for purpose!

I have often said that the regulation of nonsense must inevitably result in nonsense – but I did not expect to get a confirmation from the GCC in this fashion.

Homeopathy has many critics who claim that there is no good evidence for this type of therapy. Homeopaths invariably find this most unfair and point to a plethora of studies that show an effect. They are, of course, correct! There are plenty of trials that suggest that homeopathic remedies do work. The question, however, is HOW RELIABLE ARE THESE STUDIES?

Here is a brand new one which might stand for dozens of others.

In this study, homeopaths treated 50 multimorbid patients with homeopathic remedies identifies by a method called ‘polarity analysis’ (PA) and prospectively followed them over one year (PA enables homeopaths to calculate a relative healing probability, based on Boenninghausen’s grading of polar symptoms).

The 43 patients (86%) who completed the observation period experienced an average improvement of 91% in their initial symptoms. Six patients dropped out, and one did not achieve an improvement of 80%, and was therefore also counted as a treatment failure. The cost of homeopathic treatment was 41% of projected equivalent conventional treatment.

Good news then for enthusiasts of homeopathy? 91% improvement!

Yet, I am afraid that critics might not be bowled over. They might smell a whiff of selection bias, lament the lack of a control group or regret the absence of objective outcome measures. But I was prepared to go as far as stating that such results might be quite interesting… until I read the authors’ conclusions that is:

Polarity Analysis is an effective method for treating multimorbidity. The multitude of symptoms does not prevent the method from achieving good results. Homeopathy may be capable of taking over a considerable proportion of the treatment of multimorbid patients, at lower costs than conventional medicine.

Virtually nothing in these conclusions is based on the data provided. They are pure extrapolation and wild assumptions. Two questions seem to emerge from this:

  1. How on earth can we take this and so many other articles on homeopathy seriously?
  2. When does this sort of article cross the line between wishful thinking and scientific misconduct?
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