MD, PhD, FMedSci, FRSB, FRCP, FRCPEd

Medical ethics comprise a set of rules and principles which are essential for all aspects of medicine, including of course research. The main issues are:

  • Respect for autonomy – patients must have the right to refuse or choose their treatments.
  • Beneficence – researchers and clinicians must act in the best interest of the patient.
  • Non-maleficence – the expected benefits of interventions must outweigh their risks.
  • Justice – the distribution of health resources must be fair.
  • Respect for persons – patients must be treated with dignity.
  • Truthfulness and honesty – informed consent is an essential element in research and clinical practice.

While all of this has long been fairly standard in conventional health care, it is often neglected in alternative medicine. It is therefore timely to ask, how much of research in the realm of alternative medicine abides by the rules of medical ethics?

After more than two decades of involvement in this sector, I have serious and growing concerns. The subject is, of course complex, but the way I see it, in alternative medicine there are two main areas where medical ethics are violated with some regularity.

  1. Nonsensical research projects
  2. Lack of informed consent

NONSENSICAL RESEARCH PROJECTS

At best, nonsensical research is a waste of precious resources, at worst it violates the beneficence principle. In alternative medicine, nonsensical research seems to happen ad nauseam. Regular readers of this blog will have seen plenty of examples of such abuse – for instance, if researchers conduct a clinical trial of chiropractic spinal manipulation for improving the singing voices of choir singers, or homeopaths test whether their remedies enhance female fertility. Often, nonsensical research happens when naïve enthusiasts decide to dabble a bit in science in order to promote their trade – but without realising that research would require a minimum of education.

But there are other occasions when it seems that the investigators know only too well what they are doing. Take for instance the plethora of ‘pragmatic’ trials which are currently so much ‘en vogue’ in alternative medicine. They can be designed in such a way that their results must produce what the researchers intended to show; the ‘A+B versus B’ study design is a prominent and obvious example of this type of abuse which I have repeatedly written about on this blog.

I use the term ‘abuse’ intentionally, because that is precisely what it is, in my view. Nonsensical research abuses the willingness of patients to participate by misleading them that it is a worthwhile sacrifice. In reality it is an unethical attempt to generate findings that can mislead us all. Moreover, it gives science a bad name and can lead to patients’ unwillingness to take part in research that does need doing. The damage done by nonsensical research projects is therefore immeasurable.

INFORMED CONSENT

Informed consent is essential in research for protecting the interests of the volunteering patients. When a clinical trial is first conceived, the researchers need to work out all the details, write a protocol and submit it to their ethics committee. Their submission has to give evidence that all the participating patients have given informed consent in writing before they are enrolled into the study. That means, they have to be told the essential details about what might happen to them during the trial.

In a placebo-controlled trial of homeopathy, for instance, they might be told that they will receive either a homeopathic remedy or a placebo during the study period. They might also be informed that there is some encouraging evidence that the former works, and that the trial is designed to define to what extend this is so. Generating this knowledge, they might further be told, will help future patients and will be an important contribution to improving health care. Based on such phraseology, the ethics committee is likely to allow the study to go ahead, and patients are likely to agree to take part.

But, of course, this information is less than truthful. An honest and full information for patients would need to include the following points:

  • you will receive either a homeopathic remedy or a placebo,
  • the former contains no active molecules and the totality of the most reliable evidence does not show that it works for your condition,
  • this means that you will receive either a homeopathic or a conventional placebo,
  • neither of these can possibly help your condition,
  • the study can therefore not advance our knowledge in any way,
  • during the trial your condition will remain untreated which is likely to increase your suffering unnecessarily.

If any research team would truthfully disclose this information, no ethics committee would pass their protocol. If by some weird mistake they did, no patients would volunteer to participate in the study.

I have chosen here the example of homeopathy (because most readers will understand it quite easily), but I could have used almost any other alternative treatment. The issues are identical or very similar: informed consent is usually misinformed consent. If it were fully and truthfully informed, it would neither pass the hurdle of the essential ethics approval nor would it lend itself to recruiting sufficiently large numbers of patients.

CONCLUSION

There are, I think, very serious concerns about the ethical standards in alternative medicine research. I have been banging on about these issues since many years (for instance here and here and here and here). Predictably, this did not find much resonance in the realm of alternative medicine. Regrettably, very few ethicists have so far taken this subject seriously; they seem to feel that these problems are trivial compared to the important issues medical ethics face in conventional health care. I remain unconvinced that this is true and believe it is high time to systematically address the ethics of alternative medicine.

4 Responses to How much of alt med research is unethical?

  • I share Edzard’s concern about the ethics of complementary and alternative medical practices. Generally known as ‘CAM’, many practitioner are now styling their practice as ‘Integrated (UK)/Integrative (US) Medicine’ – no doubt intending to mislead patients into thinking it is rational to have pseudo-scientific medicine integrated with modern, conventional , science-based (but ever changing) ‘medicine’.

    On ‘The BMA Blog’ of August 6th 2015, the Chairman of Council Mark Porter raised the issue of homeopathy (https://bma.org.uk/news-views-analysis/the-bma-blog/2015/august/no-offence-intended#b973d2a360). Amongst responses, I called on members of the Faculty of Homeopathy (who practice a statutorily regulated healthcare profession such as medicine or nursing) to carry out audits of their work by holding consultations, determining which Homeopathically Prepared (HP) remedy would be appropriate, but then having patients placed (blindly) in either a group receiving that HP remedy, or a group receiving a non-HP remedy – identical in every respect (save being NHP. Same packaging and appearance, identical labels to the HP remedies etc.)

    I thought about the issue of informed consent for this ‘research’, but decided, contra Ernst, that none was necessary.
    This ‘research’ is not actually seeking to investigate a defined hypothesis such as ‘HP remedies have no beneficial effects greater than non-HP remedies’. What is being carried out is an audit of outcomes. And that should be part of regular practice for a registered medical practitioner in any event.

    Such an audit is so ethical (and is a GMC requirement) that no special ethical approval need be sought. Nor need the patients be told anything other than: ‘I would like you to assess the benefit or otherwise of the remedy I am prescribing for you by filling in a questionnaire’ (A Lickert analysis in respect of pain anxiety and activities of daily living seems to be most favoured by homeopaths).

    One group of patients receive HP remedies – the other, NHP. As there is no detectable difference between the HP and NHP it is ethical to use either, and there is no need to get consent, as both HP and NHP are indistinguishable. The pillules should have been obtained from the same manufacturer prior to (half) being homeopathically prepared.
    (The House of Lords Select Committee on Science and Technology report on Allergy treatment considered the effectiveness of Homeopathy (2007). Question 538 was from Lord Broers: ‘I have a simple technical question about homeopathy and drugs. Is it possible to distinguish between homeopathic drugs after they have been diluted? Is there any means of distinguishing one from the other?’ Kate Chatfield from the Society of Homeopaths replied: ‘Only by the label.’)

    If the manufacturers of HP remedies wish to claim there is a detectable difference after ‘preparation’, it is for them to demonstrate that is so. However, for 250 years, they have not been forthcoming.

    I reiterate; the object of the study would be to carry out ‘An audit of outcomes of HP remedies and of otherwise identical NHP remedies.’ Only if such audits showed any difference would there be a need to progress to formal RCTs, with informed consent. Surely, the prior probability of such a finding is zero.

    • I was asked to consent when geneticists decided to write an article about me.
      As to research: patient is not a lab rat! Of course, in real time it is physician that choses the drug and usually does not hold discussions with patient, but in that case it is known that drug works and produces specific effects (desirable and undesirable) when given in specific doses that can or cannot be adjusted. Research is a different matter, because even in the Phase III studies there are things to learn, so patient must be able to choose betwen established treatment and the experimental.
      And homeopathy for a believing patient is the same as real drug, so they must be allowed to chose wheter to participate in this research.

    • And one more: Studies of drugs (or as EMA say “medicinal products”) often (no always) seek eradicate factors that would interfere with the drug: e.g. if the patient gots drunk now and then, results will be different, so patient must agree not use alcohol and it must not be different in case of homeopathics if it is presumed that they work.
      And then there are tests and exams: patient, before entering research study, must agree to come to certain number of visits, do exams or blood/urine tests (and in some cases this requires preparation)….. Otherwise there is no way to test whether drug has worked at all (even in case of anti-pain meds research is more complicated that flipping through the questionnaires by patient). This must be discussed in case of homeopathics if research is done to show they work. And this requires official document. A consent.

  • I have translated some patient information sheets and informed consent forms – they are really detailed, even for something minor like asking permission of pregnant partner to collect data about her pregnancy, delivery and outcome of birth.

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