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

informed consent

Dr Akbar Khan, MD, represents a novel and exciting avenue through which, in this case, a conventionally- trained family physician has come to embrace a broad array of integrative techniques; he witnessed first hand the immense magnitude of safety and efficacy of the practice … Dr Khan describes with frustration the lack of interest displayed by conventional practitioners for safe and effective solutions simply because they come from the realm of natural medicine. “My greatest concern is helping patients.”

From left to right: Douglas Andrews, Akbar Khan, Silvana Marra and Humaira Khan

From left to right: Douglas Andrews, Akbar Khan, Silvana Marra and Humaira Khan

From left to right: Douglas Andrews, Akbar Khan, Silvana Marra and Humaira Khan[/caption]

An article in the ‘Toronto Sun’, however, tells a very different story. The doctor was found ‘incompetent’ in the treatment of cancer patients. Akbar Khan told one patient she had leukemia when she did not. He told others they were improving under his alternative remedies while their cancer was actually advancing. One of them was a little boy dying of a brain tumor.

Now the Toronto family doctor has been found guilty by the Ontario Physicians and Surgeons Discipline Tribunal of

  • incompetence,
  • failure to maintain the standard of practice,
  • and conduct that’s disgraceful, dishonorable or unprofessional

in his care of a total of 12 patients between 2012 and 2017. “Whether it was ‘snake oil,’ ‘witches’ brew’ or otherwise, whatever it was that Dr. Khan was offering his patients, it was not what he claimed,” concluded the tribunal in its decision.  “In doing so, Dr. Khan set aside his obligations as a physician to uphold the College’s CAM and consent policies, and in doing so, he failed his patients.”

Khan is the founder of the Medicor Cancer Centres, which offer “unique non-toxic approaches to cancer treatment.” He treated terminally-ill patients with the unproven treatments that he called “SAFE Chemotherapy” billed as “lifesaving” and more effective than conventional chemo.

There was insufficient science and evidence to support the conclusion that “SAFE chemotherapy” works, or that it can help people in the way that Dr. Khan claims it can, and he should not have used it,” the tribunal found. Yet, Khan never told his patients it wasn’t working. According to the college’s summary: “Therapy stopped only when his patients either could not afford it any longer, their condition had deteriorated to such a degree that they could not tolerate it, they were so ill that they were admitted to hospital, or they died.”

According to the tribunal, Khan’s patients paid (US)$4,200  for one cycle of “SAFE chemotherapy”, and they received between five to 24 cycles of it. One of the most heartbreaking cases involved Khan’s treatment of a six-year-old boy with brain cancer. In 2017, his parents rejected treating him with lifesaving chemo and radiation and transferred his care to Khan, who prescribed Dichloroacetate (DCA)  — which is a medication usually used for metabolic disorders, and not a proven cancer treatment. When a follow-up MRI showed their son’s tumor had grown and progressed to his spine, Khan told them it must be wrong and “his current therapy is actually working very well!” The boy died in 2018.

In another disturbing case, Khan used an “unapproved” test to diagnose a 59-year-old woman with acute leukemia — and informed her by email. He treated the devastated woman with honokol, a biological extract from magnolia bark, and Low Dose Naltrexone (LDN) — both of which are “not informed by evidence and science,” and “not the appropriate treatment for this patient’s presumed cancer.” Khan referred her to an oncologist who performed a bone marrow biopsy and then gave her the good news: “You do not have cancer. You’ve never had cancer. Go home and enjoy your life.” Yet, Khan insisted the oncologist was wrong. “We were frankly shocked that instead of reassuring Ms. B that her ordeal of worrying that she had leukemia could come to a close, Dr. Khan insisted to Ms. B that indeed, she did still have leukemia and urged her to keep taking LDN ‘to keep this under control,’” the tribunal wrote. “In short, Dr. Khan gave Ms. B a diagnosis that she did not have, for which he sold her a remedy that she did not need, which — as per evidence and science — turned out to be no remedy at all.”Khan’s response to the newspaper: “Since the legal process is still ongoing with the CPSO, I know my lawyer Marie Henein would not like me to comment at this time. Perhaps in the near future, I will be able to share with you another side to the story. If so, I will contact you.”

A penalty hearing has yet to be scheduled.

In case you are interested, here is a short CV of Dr. Khan:

2019 FAAO – Fellow of the American Academy of Ozone Therapy
2018 Certified medical ozone therapy doctor (general ozone therapy, basic ProlozoneTM therapy and advanced ProlozoneTM therapy), certified by the American Academy of Ozone Therapy
2018 IMD, Integrative Medical Doctor (Board of Integrative Medicine)
DHS, Doctor of Humanitarian Service (Board of Integrative Medicine)
1994 CCFP, Certificant of the College of Family Physicians of Canada (University of Toronto).
1992 MD, Doctor of Medicine (University of Toronto).

The Foundation for Vertebral Subluxation has a ‘clinical practice guideline/best practices project’ that would search, gather, compile and review the scientific literature going as far back as January 1998. Their new Chapter on the chiropractic care of children was peer-reviewed and approved by 196 chiropractors from several countries and included chiropractors specializing in pediatric and maternal care such as Diplomates and others certified in such care. The Best Practices document, developed through the Foundation’s Best Practices Initiative includes a Recommendation statement as follows:

Since vertebral subluxation may affect individuals at any age, chiropractic care may be indicated at any time after birth. As with any age group, however, care must be taken to select adjustment methods most appropriate to the patient’s stage of development and overall spinal integrity. Parental education by the chiropractor concerning the importance of evaluating children for the presence of vertebral subluxation is encouraged as are public health initiatives geared toward screening of children for vertebral subluxation beginning at birth.

I am afraid there may be some errors in the new document. Allow me therefore to post a corrected version:

Since vertebral subluxations do not exist, they cannot affect individuals regardless of age. Chiropractic adjustments are thus not indicated at any time after birth. Parental education by the chiropractor concerning the importance of evaluating children for the presence of vertebral subluxation is discouraged as are public health initiatives geared toward screening of children for vertebral subluxation beginning at birth.

Or, as an American neurologist once put it so much more succinctly:

Don’t let the buggers touch your neck!

Conversion therapy has been banned last week in Canada. These therapies – also known as sexual orientation change effort (SOCE), reparative therapy, reintegrative therapy, reorientation therapy, ex-gay therapy, and gay cure – rely on the assumption that sexual orientation can be changed, an idea long discredited by major medical associations in the US, the UK, France, and elsewhere. The new law makes “providing, promoting, or advertising conversion therapy” a criminal offense. It will also be an offense to profit from the provision of conversion therapy. In addition, the bill states a person cannot remove a “child from Canada with the intention that the child undergo conversion therapy outside Canada.” Prime Minister Justin Trudeau hailed the law’s Royal Assent: “It’s official: Our government’s legislation banning the despicable and degrading practice of conversion therapy has received Royal Assent — meaning it is now law.”

Conversion therapy is the attempt to change an individual’s sexual or gender identity by psychological, medical, or surgical interventions. Often, informed consent is insufficient or lacking. In conventional medicine, numerous treatments have been tried for this purpose, some of them dangerous and all of them ineffective. In alternative medicine, approaches that have been advocated include:

  • Homeopathy (see below),
  • Hypnotherapy,
  • Spiritual healing,
  • Prayer,
  • Eye Movement Desensitization,
  • Rebirthing,
  • and others.
Survey data imply that conversion therapy is still disturbingly popular, often leads to undesirable outcomes, and is most frequently practiced by:
  • Faith-based organizations or leaders
  • Licensed healthcare professionals
  • Unlicensed healthcare professionals

As previously reported, the German ‘Association of Catholic Doctors’ claimed that homeopathic remedies can cure homosexuality. Specifically, they advised that ‘…the working group ‘HOMEOPATHY’ of the Association notes homeopathic therapy options for homosexual tendencies…repertories contain special rubrics pointing to characteristic signs of homosexual behavior, including sexual peculiarities such as anal intercourse. And a homeopathic remedy called ‘Dr. Reckeweg R20 Glandular Drops for Women’ was claimed to treat “lesbian tendencies.” The product is “derived and potentised from fetal tissues.”

Several countries are now in the process of banning conversion therapy. France has already banned it and so has Germany. The UK government intends to introduce a legislative ban on the practice of conversion therapy. The consultation on how to best do this is open until 4 February 2022.

An article in the Daily Mail (I know, not my favorite newspaper either) reported about a UK court case against the father of an 11-year-old daughter who objected to her being given conventional life-saving treatments for her leukemia. The man was said to be worried about possible side effects and wanted to explore homeopathic and natural therapies, while his estranged wife favored the conventional approach.

Mr Justice Hayden decided that there is ‘no basis’ for the man’s homeopathic option and that specialists can lawfully carry out the conventional treatments. But the father said he believed that previous chemotherapy had already weakened his daughter’s immune system and that the conventional treatment proposed has further side effects. He, therefore, wanted to try homeopathic and natural therapies, including ozone therapy. ‘I am not waiting for her to deteriorate and get worse,’ he told the judge. ‘Chemotherapy is not the only way. There are so many other different therapies I am hoping to try – anything as long as it doesn’t really affect her.’

A specialist treating the girl told the judge that the treatments proposed are the best option and that they know of no homeopathic options which would help. Mr Justice Hayden approved Great Ormond Street’s plan and said doctors should start the treatments as soon as possible. ‘If she receives no treatment then her life expectancy is weeks,’ he said. ‘There is no basis for the father’s homeopathic option.’

This case highlights the indirect risks of homeopathy and similar treatments in an exemplary fashion. The therapies per se might be harmless but the therapists are clearly not. There are enough homeopaths who are deluded enough to persuade their patients that homeopathy can alter the natural history of even serious conditions such as cancer. And, as we have discussed recently, these irresponsible fools are not just from the ranks of the lay-homeopaths (homeopaths who have not been to medical school) who might not know better; they also include medically trained homeopaths and even professors at leading medical schools.

 

I have not often seen a paper reporting a small case series with such an impressively long list of authors from so many different institutions:

  • Hospital of Lienz, Lienz, Austria.
  • WissHom: Scientific Society for Homeopathy, Koethen, Germany; Umbrella Organization for Medical Holistic Medicine, Vienna, Austria; Vienna International Academy for Holistic Medicine (GAMED), Otto Wagner Hospital Vienna, Austria; Professor Emeritus, Medical University of Vienna, Department of Medicine I, Vienna, Austria. Electronic address: [email protected].
  • Resident Specialist in Hygiene, Medical Microbiology and Infectious Diseases, Außervillgraten, Austria.
  • St Mary’s University, London, UK.
  • Umbrella Organization for Medical Holistic Medicine, Vienna, Austria.
  • Shaare Zedek Medical Center, The Center for Integrative Complementary Medicine, Jerusalem, Israel.
  • Apotheke Zum Weißen Engel – Homeocur, Retz, Austria.
  • Reeshabh Homeo Consultancy, Nagpur, India.
  • Umbrella Organization for Medical Holistic Medicine, Vienna, Austria; Vienna International Academy for Holistic Medicine (GAMED), Otto Wagner Hospital Vienna, Austria; Chair of Complementary Medicine, Medical Faculty, Sigmund Freud University Vienna, Austria; KLITM: Karl Landsteiner Institute for Traditional Medicine and Medical Anthropology, Vienna, Austria.
  • WissHom: Scientific Society for Homeopathy, Koethen, Germany.

In fact, there are 12 authors reporting about 13 patients! But that might be trivial – so, let’s look at the paper itself. The aim of this study was to describe the effect of adjunctive individualized homeopathic treatment delivered to hospitalized patients with confirmed symptomatic SARS-CoV-2 infection.

Thirteen patients with COVID-19 were admitted. The mean age was 73.4 ± 15.0 (SD) years. The treating homeopathic doctor was instructed by the hospital on March 27, 2020, to adjunctively treat all inpatient COVID-19 patients homeopathically. The high potency homeopathic medicinal products were administered orally. Five globules were administered sublingually where they dissolved, three times a day. In ventilated patients in the ICU, medication was administered as a sip from a water beaker or 1 ml three times a day using a syringe. All ventilated patients exhibited dry cough resulting in respiratory failure. They were given Influenzinum, as were the patients at the general inpatient ward.

Twelve patients (92.3%) were speedily discharged without relevant sequelae after 14.4 ± 8.9 days. A single patient admitted in an advanced stage of septic disease died in the hospital. A time-dependent improvement of relevant clinical symptoms was observed in the 12 surviving patients. Six (46.2%) were critically ill and treated in the intensive care unit (ICU). The mean stay at the ICU of the 5 surviving patients was 18.8 ± 6.8 days. In six patients (46.2%) gastrointestinal disorders accompanied COVID-19.

The authors conclude that adjunctive homeopathic treatment may be helpful to treat patients with confirmed COVID-19 even in high-risk patients especially since there is no conventional treatment of COVID-19 available at present.

In the discussion section of the paper, the authors state this: “Given the extreme variability of pathology and clinical manifestations, a single universal preventive homeopathic medicinal product does not seem feasible. Yet homeopathy may have a relevant role to play precisely because of the number and diversity of its homeopathic medicinal products which can be matched with the diversity of the presentations. Patients with mild forms of disease can use homeopathic medicinal products at home using our simple algorithm. As this Case series suggests, adjunctive homeopathic treatment can play a valuable role in more serious presentations. For future pandemics, homeopathy agencies should be prepared by establishing rapid-response teams and efficacious lines of communication.”

There is nothing in this paper that would lead me to conclude that the homeopathic remedies had a positive effect on the natural history of the disease. All this article actually does do is this: it provides a near-perfect insight into the delusional megalomania of some homeopaths. These people are even more dangerous than I had feared.

The General Chiropractic Council’s (GCC) Registrant Survey 2020 was conducted in September and October 2020. Its aim was to gain valuable insights into the chiropractic profession to improve the GCC’s understanding of chiropractic professionals’ work and settings, qualifications, job satisfaction, responsibilities, clinical practice, future plans, the impact of the COVID-19 pandemic on practice, and optimism and pessimism about the future of the profession.

The survey involved a census of chiropractors registered with the GCC. It was administered online, with an invitation email was sent to every GCC registrant, followed by three reminders for those that had not responded to the survey. An open-access online survey was also available for registrants to complete if they did not respond to the mailings. This was promoted using the GCC website and social media channels. In total, 3,384 GCC registrants were eligible to take part in the survey. A fairly miserable response rate of 28.6% was achieved.

Here are 6 results that I found noteworthy:

  • Registrants who worked in clinical practice were asked if performance was monitored at any of the clinical practices they worked at. Just over half (55%) said that it was and a third (33%) said it was not. A further 6% said they did not know and 6% preferred not to say. Of those who had their performance monitored, only 37% said that audits of clinical care were conducted.
  • Registrants working in clinical practice were asked if any of their workplaces used a patient safety incident reporting system. Just under six in ten (58%) said at least one of them did, whilst 23% said none of their workplaces did. A further 12% did not know and 7% preferred not to say.
  • Of the 13% who said they had a membership of a Specialist Faculty, a third (33%) said it was in paediatric chiropractic, 25% in sports chiropractic, and 16% in animal chiropractic. A further 13% said it was in pain and the same proportion (13%) in orthopaedics.
  • Registrants who did not work in chiropractic research were asked if they intended to work in that setting in the next three years. Seven in ten (70%) said they did not intend to work in chiropractic research in the next three years, whilst 25% did not know or were undecided. Only 5% said they did intend to work in chiropractic research.
  • Registrants were also asked how easy it is to keep up to date with recommendations and advances in clinical practice. Overall, two-thirds (67%) felt it was easy and 30% felt it was not.
  • Registrants were asked in the survey whether they felt optimistic or pessimistic about the future of the profession over the next three years. Overall, half (50%) said they were optimistic and 23% were pessimistic. A further 27% said they were neither optimistic nor pessimistic.

Perhaps even more noteworthy are those survey questions and subject areas that might have provided interesting information but were not included in the survey. Here are some questions that spring into my mind:

  • Do you believe in the concept of subluxation?
  • Do you treat conditions other than spinal problems?
  • How frequently do you use spinal manipulations?
  • How often do you see adverse effects of spinal manipulation?
  • Do you obtain informed consent from all patients?
  • How often do you refer patients to medical doctors?
  • Do you advise in favour of vaccinations?
  • Do you follow the rules of evidence-based medicine?
  • Do you offer advice about prescribed medications?
  • Which supplements do you recommend?
  • Do you recommend maintenance treatment?

I wonder why they were not included.

 

On this blog we have seen just about every variation of misdemeanors by practitioners of so-called alternative medicine (SCAM). Today, I will propose a scale and rank order of these lamentable behaviours. As we regularly discuss chiropractic and homeopathy here, I decided to use these two professions as examples (but I could, of course, have chosen almost any other SCAM).

  1. Treating conditions which are not indicated: SCAM practitioners of all types are often asked by their patients to treat conditions which their particular SCAM cannot not affect. Instead of honestly saying so, they frequently apply their SCAM, wait for the natural history of the condition to do its bit, and subsequently claim that their SCAM was effective.
  2. Over-charging: asking too much money for services or goods is common (not just) in SCAM. It raises the question, what is the right price? There is, of course, no easy answer to it. Over-charging is therefore mostly a judgement call and not something absolute.
  3. Misleading a patient: there are numerous ways in which patients can be misled by their SCAM practitioners. A chiropractor who uses the Dr title, without explaining that it is not a medical title, is misleading his/her patients. A homeopath who implies that the remedy he/she is selling is a proven treatment is also misleading his/her patients.
  4. Being economical with the truth: the line between lying (see below) and being economical with the truth is often blurred. In my view, a chiropractor who does not volunteer the information that acute back pain, in most cases, resolves within a few days regardless of whether he/she mapipulates the patient’s spine or not, is economical with the truth. Similarly, a homeopath who does not explain up front that the remedy he/she prescribes does not contain a single active molecule is economical with the truth.
  5. Employing unreasonably long series of therapy: A chiropractor or homeopath, who treats a patient for months without any improvement in the patient’s condition, should suggest to call it a day. Patients should be given a treatment plan at the first consultation which includes the information when it would be reasonable to stop the SCAM.
  6. Failing to refer: A chiropractor or homeopath, who treats a patient for months without any improvement in the patient’s condition should refer the patient to another, better suited healthcare provider. Failing to do so is a serious disservice to the patient.
  7. Unethical behaviour: there are numerous ways SCAM practitioners regularly violate healthcare ethics. The most obvious one, as discussed often before on this blog, is to cut corners around informed consent. A chiropractor might, for instance, not tell his/her patient before sarting the treatment that spinal manipulation is not supported by sound evidence for efficacy or safety. A homeopathy might not explain that homeopathy is generally considered to be implausible and not evidence-based.
  8. Neglect: medical neglect occurs when patients are harmed or placed at significant risk of harm by gaps in their medical care. If a chiropractor or a homeopath, for instance, claim to be able to effectively treat asthma and fail to insist that all prescribed asthma medications must nevertheless be continued – as both often do – they are guilty of neglect, in my view. Medical neglect can be a reason for starting legal proceedings.
  9. Lying: knowingly not telling the truth can also be a serious legal issue. An example would be a chiropractor who, after beeing asked by a patient whether neck manipulation can cause harm, answers that it is an entirely safe procedure which has never injured anyone. Similarly, if a homeopaths informs his/her patient that the remedy he/she is prescribing has been extensively tested and found to be effective for the patient’s condition, he must be lying. If these practitioners believe what they tell the patient to be true, they might not technically be lying, but they would be neglecting their ethical duty to be adequately informed and they would therefore present an even greater danger to thier patients.
  10. Abuse: means to use something for the wrong purpose in a way that is harmful or morally wrong. A chiropractor who tells the mother of a healty child that they need maintenance care in order to prevent them falling ill in the future is abusing her and the child, in my view. Equally, I think that a homeopath, who homeopathically treats a disease that would otherwise be curable with conventional treatments, abuses his patient.
  11. Fraud: fraud is a legal term referring to dishonest acts that intentionally use deception to illegally deprive another person or entity of money, property, or legal rights. It relies on the use of intentional misrepresentation of fact to accomplish the taking. Arguably, most of the examples listed above are fraud by this definition.
  12. Sexual misconduct: the term refers to any behaviour which is sexual in nature and which is unwelcome and engaged in without consent. It ranges from unwanted groping to rape. There is, for instance, evidence that sexual misconduct is not a rarety in the realm of chiropractic. I have personally served once as an expert witness against a SCAM practitioner is a court case at the Exeter Crown Court.

The 12 categories listed above are not nearly as clearly defined as one would wish, and there is plenty of overlap. I am not claiming that my suggested ‘scale of misdemeanors by SCAM practitioners‘ or the proposed rank order are as yet optimal or even adequate. I am, however, hoping that readers will help me with their suggestions to improve them. Perhaps your input might then generate a scale of practical use for the future.

One of my last posts re-ignited the discussion about the elementary issue of informed consent, specifically about informed consent for chiropractors. As it was repeatedly claimed that, in Australia, informed consent is a legal requirement for all chiros, I asked on Wednesday 11 November 2020 at 07:12

FOUR QUESTIONS TO DC + CRITICAL CHIRO (CC):

1) what does the law say about informed consent for Australian chiros?
2) what info exactly do you have to provide?
3) who monitors it?
4) what published evidence do we have about compliance?

CC then posted this reply:

Here we go again you demand evidence while providing little if any for your own assumptions (poor case studies do not count. The pleural of anecdote does not equal evidence whether it’s from chiro’s or you).
We have been over this many times over many years, I cite research/provide links yet you still find it challenging to take it onboard. It is human nature to feel obligated once making a public statement to defend it no matter how much evidence is sent your way. So not surprising.

“1) what does the law say about informed consent for Australian chiros?”
It is all freely available on the national regulators website (as you know and as I have referenced in the past):
https://www.chiropracticboard.gov.au/Codes-guidelines/Code-of-conduct.aspx
https://www.chiropracticboard.gov.au/Search.aspx?q=Informed+consent
Some research by chiropractors on this topic (cited many times in the past):
Risk Management for Chiropractors and Osteopaths. Informed consent
A Common Law Requirement (2004):
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2051308/
Quick advanced PubMed with filters set to “Chiropractic” AND “Informed consent”.
https://www.ncbi.nlm.nih.gov/pmc/?term=(Chiropractic)+AND+Informed+consent
Not rocket science
Latest paper that you wrote an ill informed blog on and the comments were not going as you expected (So I expected you to double down like Donald Trump with a new blog within days. Your getting predictable).
https://chiromt.biomedcentral.com/articles/10.1186/s12998-020-00342-5
This paper questions the legal implications of vertebral subluxations with high powered legal input and is a broadside by evidence based chiropractors against vitalistic chiropractors. You respond a snide fantasy informed consent dialogue when you should be supporting the authors:
https://edzardernst.com/2020/11/informed-consent-why-chiropractors-dont-like-it/

“2) what info exactly do you have to provide?”
“4) what published evidence do we have about compliance?”
We have discussed this as well. It is a common law requirement for every profession and is checked upon re-registration by AHPRA every year and by the professional indemnity insurers every year. No informed consent, no registration and no professional indemnity insurance.
Checked AHPRA’s panel decisions and went back 5 YEARS and found ONE decision relating to informed consent:
https://www.ahpra.gov.au/Publications/Panel-decisions.aspx

“3) who monitors it?”
Another of your tired old arguments that we have discussed many times over the years.
In the UK there is the “‘Chiropractic Reporting and Learning System’ (CRLS)” but this is set up by the association representing chiropractors and not the registration board that advocates for patients. Right idea and step in the right direction, wrong organization.
Here years ago there was a trial of an adverse event reporting system in a Melbourne emergency department systematically collected relevant AE information on all professions which was sent to the relevant board for investigation.
It was supported by doctors and chiropractors while physio’s were not involved. A doctor involved told me it was killed off by ER doctors who “snivelled” about the extra paperwork.
There is no AE reporting system for physio’s, chiro’s, osteo’s, GP’s in private practice etc.
Over the years you have harped on and on about this topic as if it is a failing purely of the chiropractic profession when we have supported initiatives for its implementation.
You have also kept up with the research even commenting on an chiropractic researcher on AE’s Charlotte Leboeuf-Yde (who you highly regard) yet ignored until you could take issue with two sentences written in a blog then you wrote this hatchet blog:
https://edzardernst.com/2017/04/we-have-an-ethical-legal-and-moral-duty-to-discourage-chiropractic-neck-manipulations/
So you are asking for evidence yet willfully ignore an author who “I have always thought highly of Charlotte’s work”.

Stop the cynical cherry picked blogs and start supporting the researchers and reformers otherwise you are just someone standing on the sidelines blindly throwing grenades. You do not care who you hit or the damage you do to the chiropractors leading the reform you demand yet consistently fail to support.

____________________________________

I thought the tone of this response was oddly aggressive and found that CC had failed to understand some of my questions. Yet the link to the chiro’s code of conduct https://www.chiropracticboard.gov.au/Codes-guidelines/Code-of-conduct.aspx was useful. This is what it says about informed consent:

3.5 Informed consent
Informed consent is a person’s voluntary decision about healthcare that is made with knowledge and understanding of the benefits and risks involved. A useful guide to the information that chiropractors need to give to patients is available in the National Health and Medical Research Council (NHMRC) publication General guidelines for medical practitioners in providing information to patients.3 The NHMRC guidelines cover the information that chiropractors should provide about their proposed management or approach, including the need to provide more information where the risk of harm is greater and likely to be more serious, and advice about how to present information. Good practice involves:
a) providing information to patients in a way they can understand before asking for their consent
b) providing an explanation of the treatment/care recommended, its likely duration, expected benefits and cost, any alternative(s) to the proposed care, their relative risks/benefits, as well as the likely consequences of no care
c) obtaining informed consent or other valid authority before undertaking any examination or investigation, providing treatment/care (this may not be possible in an emergency) or involving patients in teaching or research, including providing information on material risks
 d) consent being freely given, without coercion or pressure
 e) advising patients, when referring a patient for investigation or treatment/ care, that there may be additional costs, which they may wish to clarify before proceeding
 f) obtaining (when working with a patient whose capacity to give consent is or may be impaired or limited) the consent of people with legal authority to act on behalf of the patient, and attempting to obtain the consent of the patient as far as practically possible
 g) being mindful of additional informed consent requirements when supplying or prescribing products not approved or made in Australia, and
h) documenting consent appropriately, including considering the need for written consent for procedures that may result in serious injury or death.
_______________________________________
This does indeed clarify some of my questions. Related to the fictional patient with neck pain who consults a chiropractor in my previous post, this means the chiro must inform the patient that:
  • the chiro suggests a manipulation of the neck;
  • this often involves forcing a spinal joint beyond its physiological range of motion;
  • the treatment will be short but needs repeating several times during the coming weeks;
  • the expected benefits are a reduction of pain and improvement of motion;
  • the total cost of the treatment series will be xy;
  • there are many other treatment options for neck pain;
  • most of these have a better risk/benefit profile than neck manipulation;
  • having no treatment for neck pain at all is likely to lead to full resolution of the problem over time.

Apart from any doubts that chiropractors would actually comply with these requirements, the question remains: is the listed information sufficient? Does it outline a truly a fully informed consent? I think that essential aspects of informed consent are missing.

  • The code does not explicidly require an explanation about the possible harms of spinal manipulation (i.e. 50% of all patients will suffer mild to moderate adverse effects lasting 2-3 days, and occasionally patients will have a stroke of which some have died).
  • Moreover, the code mentions EXPECTED benefits, but not benefits supported by evidence. Chiros may well EXPECT their treatment to work, but what does the evidence show? As often discussed on this blog, the evidence is negative or very week, depending how you want to interpret it. The code does not require a chiro to inform his patients about this fact.

So, the way I see it, the code does not expressedly demand the chiro to explain his patient that the treatment he is being asked to consent to is

  1. not supported by sound evidence for effectiveness,
  2. nor that the treatment is burdened with significant risks.

And what about the other questions listed above? An Australian chiropractor who will remain anonymous gave me the following answers:

Who monitors Informed Consent?
 
The short answer here is nobody monitors informed consent.  Typically informed consent is a side issue whenever a negligence claim is made.  Similarly, clinical records are a side issue as well.   Thus, when a patient alleges they were injured a complaint is lodged.  As part of the investigation consideration is given regarding the consent process.  If the analysis determines that the adverse outcome was maloccurence rather than negligence  but valid consent was not obtained, the practitioner will still face disciplinary action. 
 
As we are all too well aware, the Boards show little or no desire to be proactive.  I have yet to see any results from the pilot advertising audit project which began approximately 2 years ago.
 
What published evidence have we ab​out compliance?
 
Good question.  To my knowledge Langworthy & Flemming’s 2005 paper is the only one looking at compliance.  Their results suggest that the majority of respondents would be unable to successfully defend a negligence in consent liability charge.  In my experience providing expert opinions in Australian cases, valid consent was not obtained in a single case.  The most bizarre case had the practitioner their expert argue that consent obtained 7 years prior to the injury was still valid.  
 
Langworthy J.M., Cambron J. Consent: its practices and implications in United Kingdom and the United States chiropractic practice. J Manip Physiol Ther. 2007;(6):419–431.

_____________________________________

Yet, Australian chiropractors claim that they abide by the ethical imperative of informed consent. Are they taking the Mickey?

Perhaps not. Perhaps they are merely trying to make sure they do not lose the majority of their clientele. As I already pointed out in my previous post, fully informed consent would make most chiropractic patients turn round and run a mile.

I was alerted to an outstanding article by an unusual author, a law firm, on the subject of chiropractic. Allow me to quote a few passages from it (without changing a word or adding a comment):

When Katie May passed away suddenly from a stroke at just 34 years old, it was initially ruled an accident. After further investigation, a coroner determined the stroke that claimed the model and single mother’s life was caused by injuries sustained during neck manipulation by a chiropractor. And Ms. May is not the first to be affected by this seemingly harmless procedure…

What health issues can be caused by chiropractic manipulation?

Chiropractors typically use their hands to apply pressure to joints, aiming to help alleviate pain and improve body function. This is referred to as a chiropractic adjustment.

Adjustments are commonly performed for neck and/or back pain. Although the Mayo Clinic says the risk of a serious complication is relatively small, these complications can include:

  • A herniated disk, or worsening of an existing herniated disk
  • Compression of nerves in the lower spinal column
  • Stroke, which can result in paralysis or death

The last item on this list is particularly concerning.

Patients who receive neck manipulation are at risk for a stroke caused by vertebral artery dissection. Located in the neck, the vertebral arteries supply blood to the brain and can be torn by stretching and sudden force applied during a neck adjustment.

Studies have shown that vertebral artery dissection occurs in approximately 1 in 100,000 people and can be caused by something as simple as cracking your neck.

How could a chiropractor be responsible for a patient’s injury?

Although the risk of being seriously injured by a chiropractor is low, tragic accidents can and do happen. If you or a loved one believe you have been the victim of medical malpractice, please contact an experienced personal injury attorney.

Explaining how an injury or medical error occurred will help your attorney determine the potential liability of a chiropractor and any other involved parties. A chiropractor’s liability could fall into a legal category such as:

  • Failure to Diagnose a Medical Condition – The chiropractor breaches a duty of care to their patients by failing to diagnose an underlying medical condition. This could occur when a patient reveals or exhibits symptoms of a severe issue, such as a stroke, and is not referred for appropriate medical attention.
  • Lack of Informed Consent – A patient is treated without being properly informed of the potential risks or side effects, and experiences an injury from that treatment.
  • Negligent Manipulation – The patient’s body is adjusted by the chiropractor in such a way that it causes a new injury or worsens an existing injury. This could also include manipulation of a patient who is pregnant and goes into premature labor.
  • Chiropractic Induced Injury – A patient suffers injury, permanent irreversible damage such as paralysis or wrongful death as the direct result of a chiropractic manipulation.

To find out whether or not you may have a case, please discuss your concerns with a qualified personal injury attorney.

What should I do if I think I have been injured by chiropractic manipulation?

A personal injury attorney can help recover compensation for victims of medical malpractice, including those who have experienced a chiropractic injury. Surviving loved ones can also pursue their case after a family member’s wrongful death.

An attorney will help you collect documents, photos and other items pertaining to your case – but staying organized early in the process will be helpful. Try to preserve important documents, such as:

  • Photographs before and after treatment
  • Medical records and medical bills
  • Receipts, appointment confirmations and other paperwork from your chiropractor

There is a time limit to file a medical malpractice lawsuit, referred to as a statute of limitations…

The issue of informed consent has made regular appearances on this blog. It is important and has many intriguing aspects, particularly for so-called alternative medicine (SCAM). On the one hand, it is a ‘conditio sine qua non’ for any form of healthcare, while, on the other hand, it is a near impossibility in SCAM practice.

In this new article published in a chiro-journal, the authors review the origins of informed consent and trace the duty of disclosure and materiality through landmark medical consent cases in four common law (case law) jurisdictions. The duty of disclosure has evolved from a patriarchal exercise to one in which patient autonomy in clinical decision making is paramount. Passing time has seen the duty of disclosure evolve to include non-medical aspects that may influence the delivery of care. The authors argue that a patient cannot provide valid informed consent for the removal of vertebral subluxation. Further, vertebral subluxation care cannot meet code of conduct standards because it lacks an evidence base and is practitioner-centered.

The uptake of the expanded duty of disclosure has been slow and incomplete by practitioners and regulators. The expanded duty of disclosure has implications, both educative and punitive for regulators, chiropractic educators and professional associations. The authors discuss how practitioners and regulators can be informed by other sources such as consumer law. For regulators, reviewing and updating informed consent requirements is required. For practitioners it may necessitate disclosure of health status, conflict of interest when recommending “inhouse” products, recency of training after attending continuing professional development, practice patterns, personal interests and disciplinary findings.

The authors conclude that, ultimately such matters are informed by the deliberations of the courts. It is our opinion that the duty of a mature profession to critically self-evaluate and respond in the best interests of the patient before these matters arrive in court.

In their paper, the authors also provide a standard list of items required for ‘informed’ consent:

(1) emphasizing the patient’s role in shared decision-making

(2) disclosure of information

a. explaining the patient’s medical status including diagnosis and prognosis

b. describing the proposed diagnostic and therapeutic intervention, including the likelihood and effect of associated risks and benefits of the proposed action, including material risks

c. discussing alternatives to the proposed intervention, including doing nothing

(3) prompting and answering patient questions related to the proposed course of action (NB. this involves probing for understanding, not simply asking ‘do you have any questions’), and

(4) eliciting the patient’s preference (usually by signature). (NB. A signed form is not consent. The conversation between the clinician and the patient or carer is the true process of obtaining informed consent. The signature on the consent form is proof that the conversation took place and that the patient understood and agreed.)

The authors of this article – I do commend it to all chiropractors – take a mostly judicial view of informed consent (for an ethical perspective on the subject, I recommend our book). They do not discuss, whether chiropractors do, in fact, adhere to the ethical imperative of informed consent. As I have stated before, there is not much research on this issue. But the little that does exist fails to show that chiropractors care much about it.

But why?

If it’s an ethical imerative, why do chiropractors not abide by it?

The answer to this question is not difficult to find. Just imagine a conversation between a chiropractor (C) and a patient with neck pain (P):

  • P: What’s your diagnisis?
  • C: You are suffering from acute neck pain.
  • P: Thanks, that much was clear to me. What do you suggest I do?
  • C: I will perform a manipulation of your neck, if you agree.
  • P: Why would this help?
  • C: It can realign the vertebrae that are out of place, simply put.
  • P: And my pain will disappear?
  • C: Sometimes it does, yes.
  • P: But will it disappear quicker than without manipulation.
  • C: Some of the evidence says so.
  • P: Ok, but what does the most reliable evidence say?
  • C: It is not entirely clear cut.
  • P: Hmm, that does not sound too good.
  • P: So, tell me, are there any risks?
  • C: About 50% of patients suffer from minor to moderate pain for 2-3 days afterwards.
  • P: That’s a lot!
  • P: Anything else?
  • C: In some cases, neck manipulation was followed by a stroke.
  • P: Gee that’s bad; how often has this happened?
  • C: We know of about 500 such cases.
  • P: Heavens!
  • C: Now, do you want the treatment or not?
  • P: How much will you charge?
  • C: Only 60 Euros per session.
  • P: You mean I have to come back for more, each time risking a stroke?
  • C: Well… You don’t have to.
  • P: Thanks for the info; I am off. Cherio!

I rest my case. 

 

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