MD, PhD, FMedSci, FRSB, FRCP, FRCPEd

Before starting to treat a patient, all health care professionals – including of course alternative practitioners – have to obtain informed consent. This is not optional but an ethical and legal imperative. Informed consent must usually include full information on:

  • the diagnosis
  • its natural history
  • the most effective treatment options available
  • the proposed therapy
  • its effectiveness
  • its risks
  • its cost
  • a rough treatment plan

Only when this information has been transmitted to and understood by the patient can informed consent be considered complete.

One could easily argue that, in alternative medicine, informed consent is a practical impossibility.

To explain why, let us consider two scenarios.

SCENARIO 1

A patient with fatigue and headaches consults a Reiki healer. The practitioner asks a few questions and proceeds to apply Reiki. The therapist has no means to obtain informed consent because:

  • he is not qualified to make diagnoses
  • he knows little about the natural condition of the patient
  • he is ignorant of the most effective treatment options
  • he is convinced that Reiki works but is unaware of the evidence

SCENARIO 2

A patient with fatigue and headaches consults a chiropractor. The chiropractor takes a history, conducts a physical examination, tells the patient that her headaches are due to spinal misalignments which he suggests to treat with spinal manipulations, and proceeds to apply his treatments. The chiropractor has no means to obtain informed consent because:

  • he has insufficient knowledge of other therapeutic options
  • he is biased as to the effectiveness of spinal manipulations
  • he believes that they are risk-free
  • he has an overt conflict of interest (he earns his money by applying his treatments)

In some respects, these might be extreme scenarios. They were chosen to explain why informed consent is rarely possible in the realm of alternative medicine. Put simply, informed consent requires knowledge that alternative practitioners almost never possess. I know this will sound chauvinistic, but it requires knowledge that normally only doctors have – I mean doctors who have been through medical school. Moreover, it requires a lack of financial interest such that the clinician is not in danger of loosing out on some income, if he advises his patient not to receive treatment from him. Finally, informed consent requires information about the treatment. Arguably, this should include explanations how it works. For many alternative therapies, this information is not available. If it is unavailable, informed consent is impossible.

If I am correct – and I am fully aware that many will think I am not – what implications would this have? If informed consent is usually not provided or even impossible, one cannot help but conclude that alternative medicine, as it is practised in most places today, is not ethical.

14 Responses to INFORMED CONSENT IN ALTERNATIVE MEDICINE: ethical imperative + practical impossibility

  • Dear Prof. Ernst,

    the dilemma of informed consent is a problem for the entire field of naturopathy, especially point three, most effective treatment options. The medical approach is diagnosis -> treatment options -> risk/benefit assessment -> selection of treatment.

    The naturopathic approach is radically different. Diagnosis -> attempt to strengthen the self healing of the body -> attempt to “repair” damaged structures -> try “natural” treatments -> do the stronger stuff.

    The latter is akin to treating by trial and error and is much akin to scenario 2 points 2,3 and possible 4

    • You, as usual, are lost in the fairyland!!!!!!!!!!!

      “The medical approach is diagnosis -> treatment options -> risk/benefit assessment -> selection of treatment.”

      “Why do physicians vary so much in the way they practice medicine?

      At first view, there should be no problem. There are diseases–neatly named and categorized by text books, journal articles, and medical specialty societies. There are various procedures physicians can use to diagnose and treat these diseases. It should be possible to determine the value of any particular procedure by applying it to patients who have a disease and observing the outcome. And the rest should be easy – if the outcome is good, the procedure should be used for patients with that disease; if the outcome is bad, it should not. Some variation in practice patterns can be expected due to differences in the incidence of various diseases, patients’ preferences, and the available resources, but these variations should be small and explainable.

      The problem of course is that nothing is this simple. Uncertainty, biases, errors, and differences of opinions, motives, and values weaken every link in the chain that connects a patient’s actual condition to the selection of a diagnostic test or treatment. This paper describes some of the factors that cause decisions about the use of medical procedures to be so difficult, and that contribute to the alarming variations we observe in actual practice. It examines the components of the decision problem a physician faces, and the psychology of medical reasoning, focusing in particular on the role of uncertainty. Finally, it suggests some actions to reduce uncertainty and encourage consistency of good medical practice.

      Uncertainty creeps into medical practice through every pore. Whether a physician is defining a disease, making a diagnosis, selecting a procedure, observing outcomes, assessing probabilities, assigning preferences, or putting it all together, he is walking on very slippery terrain. It is difficult for non physicians, and for many physicians, to appreciate how complex these tasks are, how poorly we understand them, and how easy it is for honest people to come to different conclusions.”

      http://content.healthaffairs.org/content/3/2/74.full.pdf

      This is opinion of a highly qualified, well known doctor.

      Is there a better definition of trial and error?

      • Let me explain something to you, Iqbal. Humans err and there is a certain statistical uncertainty. Homeopaths, however, err *by design*. Even the very founding of homeopathay is a huge error committed by a bad scientist. As for the rest, do you have any data on the superior safety and efficacy of homeopathy ?

  • I think that only an uninformed consent is possible. I am thinking of Robert O. Young, who in one and the same interview with Giles Yeo (in the documentary ‘Clean Eating: The Dirty Truth’) claims that thousands/millions have been ‘helped’ (whatever that means) by his system while also saying that his system has to be studied and when confronted with the mention of people who died on his ranch, also claimed that he did not ‘force them’ to come to him.

    Essentially, what the alternologist/quack wants is to be absolved from any and all responsibility while retaining the right to blatantly lie to her/his victims.

    Still, I think there may be room for an uninformed consent, a form that patients must read and sign before starting any adventure with any alternologist/quack, and that states that in spite of what the ‘therapist’ says, he/she has no evidence of his claims and that her/his system may be dangerous to the point of being deadly. That document should also state that the alternologist/quack has no medical knowledge and is completely unqualified (which is almost always the case) to diagnose and treat any disease/condition.

  • You mention “legal imperative” and my question is, what law do these people (continue to) break? I am no legal expert, but if there is a clear set of laws (country dependant of course) that they break then surely legal action should be a viable option? Science is not going to convince any of these folks, as it is. But I guess, very few people have the money or the time to go down that path.

  • I don’t see how AltMed practitioners could be described as “health care professionals”. No doubt, some believe themselves to be caring, but I’m reminded of a question used in job interviews – when the interviewer’s lost the plot – is “how do you remain professional?”
    When a person is what they profess to be, I’d accept them to be a professional, be they mechanic, pilot, cleaner, doctor, diarist or dentist. When they profess to be heath care professionals but put income first…

    • Places like India where Ayurvedic medicine plays an important role as alternative medicine has some procedures. But Homeopathy, Siddha etc., has nothing!

  • Veterinary medicine was founded by a guild that proposed the profession be founded by the use of “rational and scientific” thought to treat illness in animals. When it comes to alt med, call it whatever you want…healing, therapy , curing, but don’t call it veterinary medicine.

  • Moreover, it requires a lack of financial interest such that the clinician is not in danger of loosing out on some income, if he advises his patient not to receive treatment from him

    While I think this is a great idea, in countries with fee-for-service model of payment for medical care I’m not sure how to do this.

  • Of course there are situations where you will have to forgo the informed consent bit.

    To take an example, the cold, blue and clammy victim of drowning may not be in the mood for a prolonged lecture on the pro’s (there are no con’s of course) of the smart measures you are going to apply for resuscitation…
    after calling for an ambulance of course: http://www.homeopathycenter.org/drowning
    Should you be all out of antimonium tartaricum in your first-aid kit, which may of course happen if you e.g. live at the seaside and see a lot of drowning victims. Or if you have seen many sufferers of flatulence and diarrea or burning of the urethra (http://www.homeoint.org/books/boericmm/a/ant-t.htm)
    In such case you might want to pull out your acupuncture kit and smartly expose the victim’s REN-1 spot, located between the vagina (scrotum in men) and the anal orifice (in both men and women), which you should smartly puncture to a depth of at least an inch, or even more if the victim is in dire straits http://www.acupuncture-points.org/conception-vessel-1.html

    If you unfortunately find yourself attending to a victim of drowning without both your remedy kit and your acupuncture etui and you find no cactus nearby from which to borrow a convenient thorn to make the life-saving puncture, fear not dear alternative emergency technician, because there are always other alternatives in the world of alternatives.
    Reiki-CPR is of course a life-saving measure requiring no tools or paraphernalia, only your hands and your licensed connection with the force (as low as $1600 http://www.naturalhealers.com/alternative-medicine/reiki-training/)
    In the future, Reiki CPR will hopefully be part of first grade curriculum https://youtu.be/ZKixTihi5m4

    (This episode of irony was inspired by Clay Jones’s excellent article in SBM: https://sciencebasedmedicine.org/quackery-for-kids/)

  • We have discussed Informed Consent before and here in Australia it has been a common law requirement for ALL health care providers since 2000. That is 18 years and my informed consent form is on its 6th revision. I have been obtaining written informed consent on every new patient and on follow up clinical reviews and on any new presenting complaint since 1995. Additionally, it is checked every year by the National Registration Board and my Professional Indemnity insurance provider.
    The patient reads the form, I explain it to the patient and answer any questions, I discuss all possible risks during the initial examination and also prior to treatment. That is on average 4-5 times on every patient prior to their initial treatment. I also go over it during progress examinations, clinical reviews. It is all in the records and averages 7 informed consents per patient. In the last 23 years I have had one patient refuse treatment and 4 patients request that I do not adjust their neck but use soft tissue techniques instead. It has become so standard with patients seeing any health provider that often the patient will not even read it and just sign. I will then read it to the patient with a full explanation.
    Here is the relevant legislation:
    https://www.alrc.gov.au/publications/10-review-state-and-territory-legislation/informed-consent-medical-treatment
    https://www.healthdirect.gov.au/informed-consent
    And relevant papers:
    https://www.ncbi.nlm.nih.gov/pubmed/7717938
    Risk Management for Chiropractors and Osteopaths. Informed consent. A Common Law Requirement
    https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2051308

    @Björn Geir
    Advanced First Aid is also a requirement here for all health care providers prior to registration, that includes GP’s (Not sure about specialists). This is also checked prior to registration every year and must be updated every 2 years.

    @EE
    “he has insufficient knowledge of other therapeutic options” – Incorrect. Treatment options are also a mandatory requirement of informed consent. I also read the literature on all the alternatives to stay current with medical procedures. I wonder how many doctors bother to read the chiro, physio, osteo, sports med, pain and spine literature? At least I know that my referring doctors read this literature as I send them monthly clinical updates. They are all busy and time poor and appreciate the regular clinical updates.
    The alternative treatments are also taught in the universities here to chiropractic students by medical doctors.
    “he is biased as to the effectiveness of spinal manipulations” – Correct. We are all biased towards what we do and I also discuss this with my patients, including my bias.
    “he believes that they are risk-free” – Incorrect. Risk is a mandatory requirement and I cite the literature in my informed consent form. I also discuss this with my referring doctors.
    “he has an overt conflict of interest (he earns his money by applying his treatments)” – Correct. As does every health care provider and guess what? I discuss this with all my patients as well. Candour is very important when communicating with patients.
    Informed Consent should be standard and a non-issue. Resistance from some chiropractors in the US to its introduction has Australian chiropractors baffled. It is about empowering and educating the patient which is essential. The days of “doctor knows best and just do as you are told” are long gone which is a relief.

    • Cool patient data. Let’s gather from all your peers too.

      A third party can anonymise it, code for it, and assess it statistically. I hope we trust the status quo in MATH!

      Science and Nature are standing by for such results.

      Until the risk and effecacy is revealed to be top notch (best in breed) across the board it would be premature to trust an alternative to the MEDICAL status quo.

      The wheel of medical ethics moves slowly and surely.

      Let’s learn from history. Look what science did with IT!

  • The issue of informed consent is considered in ‘Real Secrets of Alternative Medicine’ (Amazon):

    Rational responses to CAMs:
    2. The doctor, nurse and other health professional.
    You are between a rock and a hard place: You will want to please individual patients, many of whom have irrational beliefs which have to go un-challenged. You will want to apply good scientific critical thinking and ensure alternative systems of healthcare are clearly identified as such.
    If you are going to maximise the utility of placebo interventions and harness their effects overtly, you must acknowledge that the science behind such intervention is presently of poor quality, and obtain informed consent on that basis. Not to do so would be deceptive and risk damaging the trust between patient and healthcare professional. If patients know a placebo intervention is being used, any beneficial effect is probably weakened, but not entirely – and honesty demands candidness. That is one difference between an ethical practitioner and a quack.

    Physician and lawyer Jay Katz explored these issues in ‘The Silent World of Doctor and Patient’. Even in the 1980s he found doctors too wedded to the maxim that ‘doctors know best’ – remaining silent about matters patients should have considered:
    For conversation to be meaningful, both parties must be entitled to make decisions and to have their choices treated with respect. Trust, based on blind faith must be distinguished from trust that is earned after having first acknowledged to oneself and then shared with the other what one knows and does not know about the decision to be made. Although such mutual trust is difficult to embrace and to sustain, it is important to strive for it. The proponents of informed consent and patient self-determination have insufficiently appreciated that trusting oneself and others to become aware of the certainties and uncertainties that surround the practice of medicine and integrate them with one’s hopes, fears and realistic expectations, are inordinately difficult tasks. They are among the tasks, however, that fidelity to disclosure and consent requires physicians and patients to undertake. The opponents of informed consent, on the other hand, have insufficiently appreciated that disclosure and consent do not abolish trust. Disclosure and consent only banish unilateral blind trust; they make mutual trust possible for the first time.

    For millennia, patients were expected to do as their magi, priests and physicians told them – now the days of medical paternalism have passed. Today, patients expect to understand what is proposed for them and to be involved in decision making. ‘The doctrine of informed consent’ was first formalised by Justice Bray in the California Court of Appeals in 1957. Taking the term from a brief submitted by the American College of Surgeons, he opined: ‘A physician violates his duty to his patient and subjects himself to liability if he withholds any facts which are necessary to form the basis of an intelligent consent by the patient to the proposed treatment….In discussing the elements of risk a certain amount of discretion must be employed consistent with the full disclosure of facts necessary to an informed consent.’

    The GMC requires that doctors must respect patients’ beliefs and avoid confrontation. This may present difficulties in dealing with individual patients but should not preclude patients being fully informed, nor doctors’ engagement in the political process, healthcare commissioning – and the writing of books! Other conventional healthcare professions should exhibit comparable ethical considerations.

  • Eternal thanks to Prof. Ernst for all your informative blogs. And thank you Björn Geir for your comments and the links above to the unbelievable alternative ways of treating drowning. You may like to see the links shared in this Facebook group: https://www.facebook.com/groups/homeopati.bluffmedicin/

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