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

informed consent

I have reported previously about the tragic death of John Lawler. Now after the inquest into the events leading to it has concluded, I have the permission to publish the statement of Mr Lawler’s family:

We were devastated to lose John in such tragic and unforeseen circumstances two years ago. A much-loved husband, father and grandfather, he continues to be greatly missed by all of us. Having to re-live the circumstances of his death has been particularly difficult for us but we are grateful to have a clearer picture of the events that led to John’s death. We would like to take this opportunity to thank the coroner’s team, our legal representatives and our wider family and friends for their guidance, empathy and sensitivity throughout this process.

There were several events that went very wrong with John’s chiropractic treatment, before, during, and after the actual manipulation that broke his neck.

Firstly, John thought he was being treated by a medically qualified doctor, when he was not. Furthermore, he had not given informed consent to this treatment.

The chiropractor diagnosed so-called ‘vertebral subluxation complex’ which she aimed to treat by manipulating his neck. We heard this week from medical experts that John had ossified ligaments in his spine, where previously flexible ligaments had turned to bone and become rigid. This condition is not uncommon, and is present in about 10% of those over 50. It would have showed on an X-ray or other imaging technique. The chiropractor did not ask for any images before commencing treatment and was seemingly unaware of the risks of doing a manual manipulation on an elderly patient.

It has become clear that the chiropractor did the manipulation incorrectly, and broke these rigid ligaments during a so-called ‘drop table’ manipulation, causing discs in the cervical spine to rupture and the spinal cord to become crushed. Although these manipulations are done frequently by chiropractors, we have heard that the force applied to his neck by the chiropractor would have had to have been “significant”.

Immediately John reported loss of sensation and paralysis in his arms. At this stage the only safe and appropriate response was to leave him on the treatment bed and await the arrival of the paramedics, and provide an accurate history to the ambulance controller and paramedics. The chiropractor, in fact, manhandled John from the treatment bed into a chair; then tipped his head backwards and gave “mouth to mouth” breaths. She provided an inaccurate and misleading history to the paramedic and ambulance controller, causing the paramedic to treat the incident as “medical” not “traumatic” and to transport John downstairs to the ambulance without stabilising his neck. If the paramedics had been given the full and accurate story, they would have stabilised his neck in situ and transported him on a scoop stretcher – and he would have subsequently survived.

The General Chiropractic Council decided not to suspend the chiropractor from practicing in September 2017. They heard evidence from the chiropractor that she had “not touched the neck during the appointment” and from an expert chiropractor that it would be “physically impossible” for the treatment provided to cause the injury which followed. We have heard this week that this is incorrect. The family was not allowed to attend or give evidence at that hearing, and we are waiting – now 2 years further on – for the GCC to complete their investigations.

We hope that the publicity surrounding this event will highlight the dangers of chiropractic, especially in the elderly and those with already compromised spines. We would again urge the regulator to take immediate measures to ensure that the profession is properly controlled: that chiropractors are prevented from styling themselves as medical professionals; that patients are fully informed and consent to the risks involved; that imaging is done before certain procedures and on high risk clients; and that the limits of the benefits chiropractic can provide are fully explored.

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Before someone comments pointing out that this is merely a single case which does not amount to evidence, let me remind you of the review of cervical manipulation prepared for the Manitoba Health Professions Advisory Council. Here is the abstract:

Neck manipulation or adjustment is a manual treatment where a vertebral joint in the cervical spine—comprised of the 7 vertebrae C1 to C7—is moved by using high-velocity, low-amplitude (HVLA) thrusts that cannot be resisted by the patient. These HVLA thrusts are applied over an individual, restricted joint beyond its physiological limit of motion but within its anatomical limit. The goal of neck manipulation, referred to throughout this report as cervical spine manipulation (CSM), is to restore optimal motion, function, and/or reduce pain. CSM is occasionally utilized by physiotherapists, massage therapists, naturopaths, osteopaths, and physicians, and is the hallmark treatment of chiropractors; however the use of CSM is controversial. This paper aims to thoroughly synthesize evidence from the academic literature regarding the potential risks and benefits of cervical spine manipulation utilizing a rapid literature review method.

METHODS Individual peer-reviewed articles published between January 1990 and November 2016 concerning the safety and efficacy of cervical spine manipulation were identified through MEDLINE (PubMed), EMBASE, and the Cochrane Library.

KEY FINDINGS

  • A total of 159 references were identified and cited in this review: 86 case reports/ case series, 37 reviews of the literature, 9 randomized controlled trials, 6 surveys/qualitative studies, 5 case-control studies, 2 retrospective studies, 2 prospective studies and 12 others.
  • Serious adverse events following CSM seem to be rare, whereas minor adverse events occur frequently.
  • Minor adverse events can include transient neurological symptoms, increased neck pain or stiffness, headache, tiredness and fatigue, dizziness or imbalance, extremity weakness, ringing in the ears, depression or anxiety, nausea or vomiting, blurred or impaired vision, and confusion or disorientation.
  • Serious adverse events following CSM can include the following: cerebrovascular injury such as cervical artery dissection, ischemic stroke, or transient ischemic attacks; neurological injury such as damage to nerves or spinal cord (including the dura mater); and musculoskeletal injury including injury to cervical vertebral discs (including herniation, protrusion, or prolapse), vertebrae fracture or subluxation (dislocation), spinal edema, or issues with the paravertebral muscles.
  • Rates of incidence of all serious adverse events following CSM range from 1 in 10,000 to 1 in several million cervical spine manipulations, however the literature generally agrees that serious adverse events are likely underreported.
  • The best available estimate of incidence of vertebral artery dissection of occlusion attributable to CSM is approximately 1.3 cases for every 100,000 persons <45 years of age receiving CSM within 1 week of manipulative therapy. The current best incidence estimate for vertebral dissection-caused stroke associated with CSM is 0.97 residents per 100,000.
  • While CSM is used by manual therapists for a large variety of indications including neck, upper back, and shoulder/arm pain, as well as headaches, the evidence seems to support CSM as a treatment of headache and neck pain only. However, whether CSM provides more benefit than spinal mobilization is still contentious.
  • A number of factors may make certain types of patients at higher risk for experiencing an adverse cerebrovascular event after CSM, including vertebral artery abnormalities or insufficiency, atherosclerotic or other vascular disease, hypertension, connective tissue disorders, receiving multiple manipulations in the last 4 weeks, receiving a first CSM treatment, visiting a primary care physician, and younger age. Patients whom have experience prior cervical trauma or neck pain may be at particularly higher risk of experiencing an adverse cerebrovascular event after CSM.

CONCLUSION The current debate around CSM is notably polarized. Many authors stated that the risk of CSM does not outweigh the benefit, while others maintained that CSM is safe—especially in comparison to conventional treatments—and effective for treating certain conditions, particularly neck pain and headache. Because the current state of the literature may not yet be robust enough to inform definitive prohibitory or permissive policies around the application of CSM, an interim approach that balances both perspectives may involve the implementation of a harm-reduction strategy to mitigate potential harms of CSM until the evidence is more concrete. As noted by authors in the literature, approaches might include ensuring manual therapists are providing informed consent before treatment; that patients are provided with resources to aid in early recognition of a serious adverse event; and that regulatory bodies ensure the establishment of consistent definitions of adverse events for effective reporting and surveillance, institute rigorous protocol for identifying high-risk patients, and create detailed guidelines for appropriate application and contraindications of CSM. Most authors indicated that manipulation of the upper cervical spine should be reserved for carefully selected musculoskeletal conditions and that CSM should not be utilized in circumstances where there has not yet been sufficient evidence to establish benefit.

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Just three points which, in my view, sand out most in relation to Mr Lawler’s death:

  1. Mr Lawler had no proven indication (and at least one very important contra-indication)  for neck manipulation.
  2. He did not give infromed consent.
  3. The neck manipulation was not within the limits of the physiological range of motion.

The tragic case of John Lawler who died after being treated by a chiropractor has been discussed on this blog before. Naturally, it generated much discussion which, however, left many questions unanswered. Today, I am able to answer some of them.

  • Mr Lawler died because of a tear and dislocation of the C4/C5 intervertebral disc caused by considerable external force.
  • The pathologist’s report also shows that the deceased’s ligaments holding the vertebrae of the upper spine in place were ossified.
  • This is a common abnormality in elderly patients and limits the range of movement of the neck.
  • There was no adequately informed consent by Mr Lawler.
  • Mr Lawler seemed to have been under the impression that the chiropractor, who used the ‘Dr’ title, was a medical doctor.
  • There is no reason to assume that the treatment of Mr Lawler’s neck would be effective for his pain located in his leg.
  • The chiropractor used an ‘activator’ which applies only little and well-controlled force. However, she also employed a ‘drop table’ which applies a larger and not well-controlled force.

I have the permission to publish the submissions made to the coroner by the barrister representing the family of Mr Lawler. The barrister’s evidence shows that:

a. The treating chiropractor owed a duty of care to the Deceased, her patient;
b. That duty was breached in that:
i. After the Deceased reported loss of sensation and paralysis in his arms, the only safe and appropriate response was to:
1. Leave him in situ;
2. Await the arrival of the paramedic;
3. Provide an accurate history to the ambulance controller and attending paramedic;
ii. The treating chiropractor, in fact:
1. Manhandled the Deceased from the treatment bed into a sitting position on a chair;
2. Tipped his head backwards and gave “mouth to mouth” breaths;
3. Provided an inaccurate and misleading history to the paramedic and ambulance controller, causing the paramedic to treat the incident as “medical” not “traumatic” and to transport the Deceased downstairs to the ambulance without stabilising his neck.
c. The risk of death was a reasonably foreseeable consequence of the breach;
d. In the absence of the breach:
iii. The paramedic would have stabilised the neck, in situ, and transported the Deceased on a scoop stretcher;
iv. The deceased would have survived.
e. Having regard to the risk of death involved, the misconduct was grossly negligent so as to be condemned as the serious crime of manslaughter. The decision to intervene as she did, went beyond a very serious mistake or very serious error of judgment having regard to the fact that:
i. She held herself out as a provider of (quasi) medical treatment;
ii. She styled herself as “doctor”, (when she was not entitled to do so);
iii. She intervened without any understanding of the injury she had caused nor any training in how to intervene safely.
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To put it in blunt layman’s terms, the chiropractor broke Mr Lawler’s neck and, by then moving his head the way she did (she put him into the sitting position and bent his head backwards), may well have caused his death.
Here are five lessons we might learn from this tragic case:
  1. Chiropractors are not medical doctors and should make this perfectly clear to all of their patients.
  2. Elderly patients can have several contra-indications to spinal manipulations. They should therefore think twice before consulting a chiropractor.
  3. A limited range of spinal movement usually is the sign for a chiropractor to intervene. However, this may lead to dramatically bad consequences, if the patient’s para-vertebral ligaments are ossified which happens in about 10% of all elderly individuals.
  4. Chiropractors are by no means exempt from obtaining informed consent. (In the case of Mr Lawler, this would have had to include the information that the neck manipulation carries serious risks and has not shown to work for any type of pain in the leg and might have saved his life, as he then might have refused to accept the treatment.)
  5. Chiropractors are not trained to deal with medical emergencies and must leave that to those healthcare professionals who are fully trained.

The Telegraph published an article entitled ‘Crack or quack: what is the truth about chiropractic treatment?’ and is motivated by the story of Mr Lawler, the 80-year-old former bank manager who died after a chiropractic therapy. Here are 10 short quotes from this article which, in the context of this blog and the previous discussions on the Lawler case, are worthy further comment:

1. … [chiropractic] was established in the late 19th century by D.D. Palmer, an American magnetic healer.
“A lot of people don’t realise it’s a form of alternative medicine with some pretty strange beliefs at heart,” says Michael Marshall, project director at the ‘anti-quack’ charity the Good Thinking Society. “Palmer came to believe he was able to cure deafness through the spine, by adjusting it. The theory behind chiropractic is that all disease and ill health is caused by blockages in the flow of energy through the spine, and by adjusting the spine with these grotesque popping sounds, you can remove blockages, allowing the innate energy to flow freely.” Marshall says this doesn’t really chime with much of what we know about human biology…“There is no reason to believe there’s any possible benefit from twisting vertebra. There is no connection between the spine and conditions such as deafness and measles.”…

Michael Marshall is right, chiropractic was built on sand by Palmer who was little more than a charlatan. The problem with this fact is that today’s chiros have utterly failed to leave Palmer’s heritage behind.

2. According to the British Chiropractic Association (BCA), the industry body, “chiropractors are well placed to deliver high quality evidence-based care for back and neck pain.” …

They would say so, wouldn’t they? The BCA has a long history of problems with knowing what high quality evidence-based care is.

3. But it [chiropractic] isn’t always harmless – as with almost any medical treatment, there are possible side effects. The NHS lists these as aches and pains, stiffness, and tiredness; and then mentions the “risk of more serious problems, such as stroke”….

Considering that 50% of patients suffer adverse effects after chiropractic spinal manipulations, this seems somewhat of an understatement.

4. According to one systematic review, spinal manipulation, “particularly when performed on the upper body, is frequently associated with mild to moderate adverse effects. It can also result in serious complications such as vertebral artery dissection followed by stroke.” …

Arterial dissection followed by a stroke probably is the most frequent serious complication. But there are many other risks, as the tragic case of Mr Lawler demonstrates. He had his neck broken by the chiropractor which resulted in paraplegia and death.

5. “There have been virtually hundreds of published cases where neck manipulations have led to vascular accidents, stroke and sometimes death,” says Prof Ernst. “As there is no monitoring system, this is merely the tip of a much bigger iceberg. According to our own UK survey, under-reporting is close to 100 per cent.” …

The call for an effective monitoring system has been loud and clear since many years. It is nothing short of a scandal that chiros have managed to resist it against the best interest of their patients and society at large.

6. Chiropractors are regulated by the General Chiropractic Council (GCC). Marshall says the Good Thinking Society has looked into claims made on chiropractors’ websites, and found that 82 per cent are not compliant with advertising law, for example by saying they can treat colic or by using the misleading term ‘doctor’…

Yes, and that is yet another scandal. It shows how serious chiropractors are about the ‘evidence-based care’ mentioned above.

7. According to GCC guidelines, “if you use the courtesy title ‘doctor’ you must make it clear within the text of any information you put into the public domain that you are not a registered medical practitioner but that you are a ‘Doctor of Chiropractic’.”…

True, and the fact that many chiropractors continue to ignore this demand presenting themselves as doctors and thus misleading the public is the third scandal, in my view.

8. A spokesperson for the BCA said “Chiropractic is a registered primary healthcare profession and a safe form of treatment. In the UK, chiropractors are regulated by law and required to adhere to strict codes of practice, in exactly the same ways as dentists and doctors. Chiropractors are trained to diagnose, treat, manage and prevent disorders of the musculoskeletal system, specialising in neck and back pain.”…

Chiropractors also like to confuse the public by claiming they are primary care physicians. If we understand this term as describing a clinician who is a ‘specialist in Family Medicine, Internal Medicine or Paediatrics who provides definitive care to the undifferentiated patient at the point of first contact, and takes continuing responsibility for providing the patient’s comprehensive care’, we realise that chiropractors fail to fulfil these criteria. The fact that they nevertheless try to mislead the public by calling themselves ‘primary healthcare professionals’ and ‘doctors’ is yet another scandal, in my opinion.

9. The spokesperson said, “medication, routine imaging and invasive surgeries are all commonly used to manage low back pain, despite limited evidence that these methods are effective treatments. Therefore, ensuring there are other options available for patients is paramount.”…

Here the spokesperson misrepresents mainstream medicine to make chiropractic look good. He should know that imaging is used also by chiros for diagnosing back problems (but not for managing them). And he must know that surgery is never used for the type of non-specific back pain that chiros tend to treat. Finally, he should know that exercise is a cheap, safe and effective therapy which is the main conventional option to treat and prevent back pain.

10. According to the European Chiropractors’ Union, “serious harm from chiropractic treatment is extremely rare.”

How do they know, if there is no system to capture cases of adverse effects?

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So, what needs to be done? How can we make progress? I think the following five steps would be a good start in the interest of public health:

  1.  Establish an effective monitoring system for adverse effects that is accessible to the public.
  2. Make sure all chiros are sufficiently well trained to know about the contra-indications of spinal manipulation, including those that apply to elderly patients and infants.
  3. Change the GCC from a body defending chiros and their interests to one regulating, controlling and, if necessary, reprimanding chiros.
  4. Make written informed consent compulsory for neck manipulations, and make sure it contains the information that neck manipulations can result in serious harm and are of doubtful efficacy.
  5. Prevent chiros from making therapeutic claims that are not based on sound evidence.

If these measures had been in place, Mr Lawler might still be alive today.

 

On 11/11/2019, the York Press reported from coroner’s inquest regarding a chiropractor who allegedly killed a patient. John Lawler suffered a broken neck while being treated by a chiropractor for an aching leg, an inquest has been told. His widow told how her husband was on the treatment table when things started to go wrong. She said he started shouting at chiropractor Dr Arleen Scholten: “You are hurting me. You are hurting me.” Then he began moaning and then said: “I can’t feel my arms.”

Mrs Lawler said Scholten tried to turn him over and then manoeuvred him into a chair next to the treatment table but he had become unresponsive. “He was like a rag doll,” she said. “His lips looked a little bit blue but I knew he was breathing. “I said ‘Has he had a stroke?’ She put his head back and said ‘no, his features are symmetrical’.

When the paramedics arrived, they treated Mr Lawler and to hospital. He had an MRI scan and a doctor told Mrs Lawler that he had suffered a broken neck. She was then informed that her husband was a paraplegic and he could undergo a 14 hour operation which would be traumatic but even before that could happen he “faded away” and died.

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There are, as far as I can see, four issues of interest here:

  1. It could be that Mr Lawler had osteoporosis; we will no doubt hear about this in the course of the inquest. If so, normal force could have led to the fracture, and the chiropractor would claim that she is not to blame for the fracture and the subsequent death of her patient. The question then would be whether she was under an obligation to check whether, in a man of Mr Lawler’s age, his bone density was normal or whether she could just assume that it was. In my view, any clinician applying a potentially harmful therapy has the obligation to make sure there are no contra-indications to it. If that all is so, the chiropractor might have been both negligent and reckless.
  2. Has neck manipulation been shown to be effective for any type of pain in the leg? That’s an easy one: No!
  3. Has the chiropractor obtained informed consent from her patient before commencing the treatment? The inquest will no doubt verify this. As many chiropractors fail to do it, I would not be too surprised if, in the present case, this was also not done. Should that be so, the chiropractor would have been negligent.
  4. One might be surprised to hear that the chiropractor manipulated the neck of a patient who consulted her not because of neck pain but because of a condition seemingly unrelated to the neck. This is an issue that comes up regularly and which is therefore importan; some people might be aware that it is dangerous to see a chiropractor when suffering from neck pain because he/she is bound to manipulate the neck. By contrast, most people would probably think it is ok to consult a chiropractor when suffering from lower back pain, because manipulations in that region is far less risky. The truth, however, is that chiropractors have been taught that the spine is one organ and one entity. Thus they tend to check for subluxations (or whatever name they give to the non-existing condition they all aim to treat) in every region of the spine. If they find one in the neck – and they usually do – they would ‘adjust’ it, meaning they would apply one or more high-velocity, low-amplitude thrusts and manipulate the neck. This could well be, I think, how the chiropractor in the case that is before the court at present came to manipulate the neck of her patient. And this might be how poor Mr Lawler lost his life.

Is there a lesson to be learnt from this tragic case?

Yes, I think there is: if you want to make sure that a chiropractor does not break your neck, don’t go and consult one – whatever your health problem happens to be.

 

 

The UK-based homeopathic pharmacy AINSWORTH has attracted my attention several times already. Amongst other things, Tony Pinkus, the director of the firm, once accused me of having faked my research and I suspected him of violating the basic principles of research ethics in his study of homeopathy for autism.

Today, THE DAILY MAIL reports about AINSWORTH’s scandalous promotion of the most dangerous quackery.

Tony Pinkus, director of AINSWORTH

Tony Pinkus, director of AINSWORTH

In a big article, the Mail informs the reader that:

  • AINSWORTH sell a guide (entitled ‘The Mother & And Child Remedy Prescriber’ and decorated with the codes of arms of both the Queen and Prince Charles) informing young mothers that homeopathy ‘will strengthen a child’s immune system more ably than any vaccine’.
  • The guide also claims that infections like mumps and measles can be treated homeopathically.
  • AINSWORTH sells homeopathic remedies used as vaccines against serious infections such as polio, measles, meningitis, etc.
  • AINSWORTH’s guide claim that homeopathy ‘offers the clearest answer as to how to deal with the prevention of disease’.
  • The guide claims furthermore that homeopathy is ‘a complete alternative to vaccination’.
  • It even lists 7 homeopathic remedies for measles.
  • AINSWORTH claim that homeopathy provides ‘natural immunity’.
  • AINSWORTH sell products called ‘polio nosode’, and ‘meningeoma nosode’.

The Mail quotes several experts – including myself – who do not mince their words in condemning AINSWORTH for jeopardising public health. The paper also calls for AINSWORTH’s two royal warrants to be removed.

AINSWORTH, Buckingham Palace, and Clarence House all declined to comment.

The World Federation of Chiropractic (WFC) claim to have been at the forefront of the global development of chiropractic. Representing the interests of the profession in over 90 countries worldwide, the WFC has advocated, defended and promoted the profession across its 7 world regions. Now, the WFC have formulated 20 principles setting out who they are, what they stand for, and how chiropractic as a global health profession can, in their view, impact on nations so that populations can thrive and reach their full potential. Here are the 20 principles (in italics followed by some brief comments by me in normal print):

1. We envision a world where people of all ages, in all countries, can access the benefits of chiropractic.

That means babies and infants! What about the evidence?

2. We are driven by our mission to advance awareness, utilization and integration of chiropractic internationally.

One could almost suspect that the drive is motivated by misleading the public about the risks and benefits of spinal manipulation for financial gain.

3. We believe that science and research should inform care and policy decisions and support calls for wider access to chiropractic.

If science and research truly did inform care, it would soon be chiropractic-free.

4. We maintain that chiropractic extends beyond the care of patients to the promotion of better health and the wellbeing of our communities.

The best example to show that this statement is a politically correct platitude is the fact that so many chiropractors are (educated to become) convinced that vaccinations are undesirable or harmful.

5. We champion the rights of chiropractors to practice according to their training and expertise.

I am not sure what this means. Could it mean that they must practice according to their training and expertise, even if both fly in the face of the evidence?

6. We promote evidence-based practice: integrating individual clinical expertise, the best available evidence from clinical research, and the values and preferences of patients.

So far, I have seen little to convince me that chiropractors care a hoot about the best available evidence and plenty to fear that they supress it, if it does not enhance their business.

7. We are committed to supporting our member national associations through advocacy and sharing best practices for the benefit of patients and society.

Much more likely for the benefit of chiropractors, I suspect.

8. We acknowledge the role of chiropractic care, including the chiropractic adjustment, to enhance function, improve mobility, relieve pain and optimize wellbeing.

Of course, you have to pretend that chiropractic adjustments (of subluxations) are useful. However, evidence would be better than pretence.

9. We support research that investigates the methods, mechanisms, and outcomes of chiropractic care for the benefit of patients, and the translation of research outcomes into clinical practice.

And if it turns out to be to the detriment of the patient? It seems to me that you seem to know the result of the research before you started it. That does not bode well for its reliability.

10. We believe that chiropractors are important members of a patient’s healthcare team and that interprofessional approaches best facilitate optimum outcomes.

Of course you do believe that. Why don’t you show us some evidence that your belief is true?

11. We believe that chiropractors should be responsible public health advocates to improve the wellbeing of the communities they serve.

Of course you do believe that. But, in fact, many chiropractors are actively undermining the most important public health measure, vaccination.

12. We celebrate individual and professional diversity and equality of opportunity and represent these values throughout our Board and committees.

What you should be celebrating is critical assessment of all chiropractic concepts. This is the only way to make progress and safeguard the interests of the patient.

13. We believe that patients have a fundamental right to ethical, professional care and the protection of enforceable regulation in upholding good conduct and practice.

The truth is that many chiropractors violate medical ethics on a daily basis, for instance, by not obtaining fully informed consent.

14. We serve the global profession by promoting collaboration between and amongst organizations and individuals who support the vision, mission, values and objectives of the WFC.

Yes, those who support your vision, mission, values and objectives are your friends; those who dare criticising them are your enemies. It seems far from you to realise that criticism generates progress, perhaps not for the WFC, but for the patient.

15. We support high standards of chiropractic education that empower graduates to serve their patients and communities as high value, trusted health professionals.

For instance, by educating students to become anti-vaxxers or by teaching them obsolete concepts such as adjustment of subluxation?

16. We believe in nurturing, supporting, mentoring and empowering students and early career chiropractors.

You are surpassing yourself in the formulation of platitudes.

17. We are committed to the delivery of congresses and events that inspire, challenge, educate, inform and grow the profession through respectful discourse and positive professional development.

You are surpassing yourself in the formulation of platitudes.

18. We believe in continuously improving our understanding of the biomechanical, neurophysiological, psychosocial and general health effects of chiropractic care.

Even if there are no health effects?!?

19. We advocate for public statements and claims of effectiveness for chiropractic care that are honest, legal, decent and truthful.

Advocating claims of effectiveness in the absence of proof of effectiveness is neither honest, legal, decent or truthful, in my view.

20. We commit to an EPIC future for chiropractic: evidence-based, people-centered, interprofessional and collaborative.

And what do you propose to do with the increasing mountain of evidence suggesting that your spinal adjustments are not evidence-based as well as harmful to the health and wallets of your patients?

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What do I take out of all this? Not a lot!

Perhaps mainly this: the WFC is correct when stating that, in the interests of the profession in over 90 countries worldwide, the WFC has advocated, defended and promoted the profession across its 7 world regions. What is missing here is a small but important addition to the sentence: in the interests of the profession and against the interest of patients, consumers or public health in over 90 countries worldwide, the WFC has advocated, defended and promoted the profession across its 7 world regions.

Another presentation from the 2nd OFFICIAL SIPS CONFERENCE ON PLACEBO STUDIES caught my eye. As it is not available on-line, I have copied here the unabbreviated abstract:

Open-label placebo vs. conventional and alternative medicine – An online study on expected effectiveness 1. Marcel Wilhelm. Philipps-University Marburg, Marburg, Germany. 2. Winfried Rief. Philipps-University Marburg, Marburg, Germany. 3. Frank Euteneuer. Medical School Berlin, Berlin, Germany.

Background: Treatment expectations are a key mechanism in placebo effects. Optimizing these expectations is a main goal in placebo designs but is often based on deception. To address ethical concerns, open-label placebo treatments seem to be effective without deception, although the role of expectations for their effect is rather unclear. Methods: Participants (N=253) who occasionally suffer from headaches were recruited online and randomized to receive one of three hypothetical descriptions of a doctor-patient-situation in which a certain headache treatment is prescribed: 1) conventional medicine, 2) open-label placebo, 3) alternative medicine (homeopathy). Subsequently, participants rated how strongly they expect that the given treatment can be effective. Results: One-way ANOVA revealed differences in expected effectiveness between groups. The highest expected effectiveness occurred in the conventional medicine group, the lowest in the open-label placebo group as well as in the homeopathy group. Potential moderators are discussed, e.g., socioeconomic variables, health literacy, locus of control. Conclusions: Participants expect lower effectiveness of treatment if they are truthfully informed about the inertness of a prescribed treatment (open-label placebo). While the descriptions were otherwise identical, the homeopathy group also scored lower levels of expectancy compared to conventional medicine. Homeopathy can be interpreted as a placebo prescription with deception as it does not contain pharmacologically active substances. The expected effectiveness in the homeopathy group did not differ from open-label placebo. These results suggest that prescribing a placebo while truthfully informing about placebo effects seems to be as feasible as to prescribe homeopathy regarding the expected effectiveness.

I am not sure what these results indicate. However, the fact that the authors describe homeopathy as a ‘placebo prescription with deception’ is definitely interesting.

I wonder whether homeopaths agree.

An article in the ‘Chronicle of Chiropractic’ defends the currently much debated chiropractic care for children. It is authored by ‘ChiroFuture‘, a Risk Purchasing Group founded by chiropractors. Here is the unabridged article (the references were added by me and refer to my comments below):

The chiropractic care of children has been the subject of increased media attention and scrutiny following decisions by chiropractic regulatory boards in Europe, Australia and Canada. These decisions were not based on science, research or data but rather a purposeful misrepresentation of the concept of evidence informed practice (1) and its application coupled with compelled speech.

As with the chiropractic care of adults, an evidence informed perspective (2) respects the needs and wants of parents for the care of their child, the published research evidence and the clinical expertise of chiropractors in the care of children.

ChiroFutures Malpractice Program does not base its malpractice insurance rates on the age of the patients a chiropractor sees.  In fact, we are not aware of any actuarial data showing an increase in adverse events from the tens of millions of pediatric chiropractic visits per year (3). The vast majority of claims or incidents alleging chiropractic negligence involve adult patients (4).

What chiropractors do is minimally invasive and typically nothing else but their hands are used to gently ease any obstruction to the functioning of the patient’s nervous system (5). Since the nervous system controls and coordinates all functions of the body it is important to be sure it is functioning as best it can with no obstructions and no matter the disease afflicting the patient.

State and provincial laws, federal governments, international, national and state chiropractic organizations and chiropractic educational institutions all support the role and responsibility of chiropractors in the management of children’s health (6). The rationale for chiropractic care of children is supported by published protocols that are safe, efficacious, and valid (7). The scientific literature is sufficiently supportive of the usefulness of these protocols in regard to the chiropractic care of children (8).

Those contending that there is no evidence supporting the safety and efficacy of the chiropractic care of children demonstrate a complete disregard for the evidence and scientific facts related to the chiropractic care of children (9).

ChiroFutures encourages and supports a shared decision making process between doctors (10) and patients regarding health needs. As a part of that process, patients have a right to be informed about the state of their health as well as the risks, benefits and alternatives related to care. Any restriction on that dialogue or compelled statements inconsistent with the doctrine of informed consent present a threat to public health (11).

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Here are my comments:

  1. Why ‘evidence informed’ and not evidence-based’? The term ‘evidence informed’ is popular with SCAM practitioners. Barratt and Hodson noted, “The evidence-informed practitioner carefully considers what research evidence tells them in the context of a particular child, family or service, and then weighs this up alongside knowledge drawn from professional experience and the views of service users to inform decisions about the way forward.”  This seems to imply that the two terms are synonymous. However, in reality they are not.
  2. Does that mean that ‘evidence-informed’ is defined as the practice wanted by patients, regardless of the evidence?
  3. There is no post-marketing surveillance in chiropractic. Therefore we do not have reliable data on adverse events.
  4. That might be true but it is unclear what it tells us. It might simply mean that chiropractors treat more adults than children.
  5. There is no good evidence to show that the function of the nervous system can be enhanced by manual therapy.
  6. Provincial laws and federal governments might tolerate but I don’t think they ‘support’ the role and responsibility of chiropractors. That chiropractic organisations support it surprises nobody.
  7. This sentence does not make sense to me. The facts, however, are clear: there is no sound rational for chiropractic manipulations and they are neither efficacious nor totally safe for children.
  8. The scientific evidence does not show that chiropractic care is effective for any paediatric condition.
  9. I think the complete disregard is shown not by critics but by the authors of these lines.
  10. Calling chiropractors ‘doctors’ gives the impression they have  been to medical school and is therefore misleading the public.
  11. The threat to public health are those chiropractors who advise parents not to immunise their children.

Perhaps ChiroFuture need to brush up on their knowledge of the evidence. Chiropractic has no place in the healthcare of children. Parents should be warned!

As most of us know, the use of so-called alternative medicine (SCAM) can be problematic; its use in children is often most problematic:

In this context, the statement from the ‘Spanish Association Of Paediatrics Medicines Committee’ is of particular value and importance:

Currently, there are some therapies that are being practiced without adjusting to the available scientific evidence. The terminology is confusing, encompassing terms such as “alternative medicine”, “natural medicine”, “complementary medicine”, “pseudoscience” or “pseudo-therapies”. The Medicines Committee of the Spanish Association of Paediatrics considers that no health professional should recommend treatments not supported by scientific evidence. Also, diagnostic and therapeutic actions should be always based on protocols and clinical practice guidelines. Health authorities and judicial system should regulate and regularize the use of alternative medicines in children, warning parents and prescribers of possible sanctions in those cases in which the clinical evolution is not satisfactory, as well responsibilities are required for the practice of traditional medicine, for health professionals who act without complying with the “lex artis ad hoc”, and for the parents who do not fulfill their duties of custody and protection. In addition, it considers that, as already has happened, Professional Associations should also sanction, or at least reprobate or correct, those health professionals who, under a scientific recognition obtained by a university degree, promote the use of therapies far from the scientific method and current evidence, especially in those cases in which it is recommended to replace conventional treatment with pseudo-therapy, and in any case if said substitution leads to a clinical worsening that could have been avoided.

Of course, not all SCAM professions focus on children. The following, however, treat children regularly:

  • acupuncturists
  • anthroposophical doctors
  • chiropractors
  • craniosacral therapists
  • energy healers
  • herbalists
  • homeopaths
  • naturopaths
  • osteopaths

I believe that all SCAM providers who treat children should consider the above statement very carefully. They must ask themselves whether there is good evidence that their treatments generate more good than harm for their patients. If the answer is not positive, they should stop. If they don’t, they should realise that they behave unethically and quite possibly even illegally.

The three-year old Noah was diagnosed with acute lymphoblastic leukaemia, a blood cancer with a very good prognosis when treated (~85% of all children affected can be completely cured and expect to live a normal life). The child was admitted to hospital and, initially, chemotherapy was started. But the treatment was not finished, because the parents took their child home prematurely. The mother, a 22-year-old ‘holistic birth attendant’, had been against conventional treatments from the start. She nevertheless agreed to the first two rounds of chemotherapy — “because they can get a medical court order to force you to do it anyways for a child with his diagnosis”.

Noah’s parent treated their sons with a number of home remedies:

  • Rosemary,
  • colloidal silver,
  • Reishi mushroom tea,
  • Apricot seeds,
  • and other forms of SCAM.

After the child had gone missing, the police issued an alert:

“On April 22, 2019 the parents failed to bring in the child to a medically necessary hospital procedure. The parents have further refused to follow up with the life saving medical care the child needs.”

In a matter of hours, the parents and their child were found. Noah was then taken from his parents and was “now being medically treated,” the sheriff’s office stated. The parents, meanwhile, were being investigated on suspicion of child neglect.

They insist that they were merely trying to give their son alternative medical care, accusing the police and medical officials of stripping them of the right to choose their own treatment plan for their son. Their supporters call the state’s decision to take custody of Noah a “medical kidnapping”. Medical kidnapping is defined as the State taking away children from their parents so that the children can receive medical or surgical care which the parents would otherwise not allow to be administered.

“We’re not trying to refuse any kind of treatment,” the parents told reporters. “They think we’re refusing treatment all around, putting him in danger, trying to kill him. But not at all. We’re trying to save him.” An organization fighting on behalf of the parents, the Florida Freedom Alliance, which also supports “vaccine freedom,” argues that the couple should be entitled to “medical freedom” and freedom from “medical kidnappings.”

Who is right and who is wrong?

Are medical kidnappings legal?

I am, of course, not sure about the legalities. But I am fairly certain about the evidence in the above case:

  1. Noah’s condition is treatable, and in all likelihood he would be cured, if treated according to current oncological standards. This view was also confirmed by the oncologist who is in charge of treating him in hospital.
  2. None of the treatments mentioned by the parents are effective. In fact, alternative cancer cures are a myth; they do not exist and they will never exist. Once a treatment shows promise, it would be scientifically investigated. And, if the results are positive, it would become mainstream quicker than I can climb a tree.

Ethically Noah’s case could not be clearer: the child’s life must be saved, whether with the support of his parents or not. However strongly parents might feel about their under-age kids’ care, they do not own their children and must not be allowed to cause them significant harm.

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