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

informed consent

Arianne Shahvisi is a lecturer in Ethics and Medical Humanities at the Brighton & Sussex Medical School. She has long had an interest is so-called alternative medicine (SCAM) – see here, for instance. Now she has published another most intriguing paper.

In it, she explains that scientific medicine (SM) neglects the needs of women relative to those of men. Subsequently she discusses the many limitations of SCAM and describe concerns about its use. Despite SCAM’s shortcommings, it is the domain of women who not only use it more frequently than men but also tend to be the practitioners practising SCAM. Arianne Shahvisi argues that, despite being chosen by women in reaction to the shortcomings of SM, SCAM cannot offer greater patient autonomy and is more liable to be exploitative.

Here conclusions are unusually long and I provide them here in full (after changing her abbreviation ‘AM’ to mine ‘SCAM’):

Within this paper I have made the following argument: SM is patriarchal and under-serves women; women dominate SCAM, both as users and service providers; women who choose SCAM often cite dissatisfaction with SM and the desire for greater autonomy and personalization within the clinical encounter. Based on these premises, it is likely that women use SCAM because it promises to offer greater autonomy and personalization than SM. This segues into a second argument: autonomy in healthcare requires informed consent; informed consent is not possible for SCAM therapies since mechanisms are either not known or not plausible, and there is no evidence base. These premises entail that SCAM cannot help patients to realize autonomy. Combining these two conclusions, it seems that SCAM does not offer the control and autonomy that is sought. Whilst it may be argued that SCAM offers personalization and a satisfactory therapeutic encounter, it must also be noted that forfeiting an evidence base, plausible mechanisms, and the ability to make autonomous decisions is a heavy loss to patients and one for which SM must take some responsibility.

I have attempted to motivate each of the above premises in the preceding sections. In this section I reflect on the implications of these conclusions and make recommendations to ensure that women’s health needs are more adequately met.

First, to the extent that rejection of SM may be seen as a form of resistance, the cost of that resistance is borne largely by the resistors themselves. Those who begin witha sense of dissatisfaction with SM—in many cases stemming from SM’s failure to provide them with adequate healthcare or to inspire trust in its own decency—end up with healthcare that is on many counts less adequate.

With the ascendance of a post-factual culture, arguments relying on evidence, reproducibility, and consistency are liable to have ever less traction. By corollary, the features that have typically worked against SCAM—its lack of an evidence base—are likely to pose less of a barrier to its uptake. This ought to be a grave public health concern, since the well-being of entire populations depends on medicine earning and retaining the trust of all. To see this, one need only consider how easily herd immunity is lost when trust in vaccination is undermined, putting entire populations at risk of disease outbreaks (Casidayetal.2006). Recommending against vaccination is common amongst SCAM practitioners (especially within chiropractic, homoeopathy, and naturopathy) whose philosophies so often rely on emphasizing, and in many cases overstating, iatrogenic risk (Ernst 2001).

Not much can be done now to atone for medicine’s history except to openly accept its shortcomings and under take particular effortS to re-engage marginal health populations. While it is easy to suggest that researchers should be devoting more time to women’s health issues and their treatments, the bench-to-bedside timeline is long, and more immediate efforts are also necessary. As Ernst (2010) has noted, concentrating on the therapeutic relationship within SM seems like the most constructive way forward. Although patients often look to SM for the ‘science of medicine’, clearly many are turning to SCAM for the ‘art of medicine^ (Ernst 2010, 1473)—for a compassionate clinical encounter in which patients are humanized and power differentials are flattened. While SM may have the upper hand in terms of mechanisms, an evidence base, and social capital, there are inadequacies in the patient–practitioner relationship, and in this respect there is much to learn from SCAM modalities, where the therapeutic relationship is key to their appeal. Even the most resolute SCAM user inevitably encounters SM professionals on occasion. Provided broader pressures on health workers permit them the time and space, those encounters present the possibility of demonstrating that SM can be person-centred, equitable, and sensitive to the differential needs of marginalized patient groups.

As I described in section 4, many of those who choose SCAM do so following a long period of unsatisfactory encounters with medical professionals as they pursue the treatment or resolution of long-term chronic ailments (Furnham and Vincent 2000; Cant and Sharma 2004). The majority of these patients are women. While SCAM practitioners are unlikely to offer therapies that are effective beyond placebo, they are able to offer consultations which are longer, more participatory, and more personalized. It is likely that most of the placebo effect is interpersonal and stems from the ritual of healing within encounters with practitioners, rather than from any specific therapy (Miller et al. 2009). There is some evidence that open label placebos still confer a placebo effect, which suggests that the therapeutic relationship plays a significant role (Kaptchuk et al. 2010). In light of these insights, Blease (2012) suggests that the placebo effect instead be referred to as the ‘positive care effect’. Given the importance of communication and autonomy amongst patients choosing SCAM, it is interesting to note that a surgical study shows that the extent of the positive care effect is contingent on the quality of the clinical encounter, with communication skills aimed at empowering patients being predictive of better clinical outcomes (Trummer et al. 2006).

Focusing on the U.K. healthcare system, I therefore recommend that general practitioners, who are the gatekeepers of the medical profession, make efforts to address the inadequacies in the clinical encounter, specifically for those with long-term health conditions or medically unexplained symptoms. As it stands, general practitioners in the United Kingdom spend ten minutes with each patient and are encouraged to focus on a single health issue. It is therefore unsurprising to note that dissatisfaction with the clinical encounter is shared by clinicians. In a recent survey, 55 per cent of general practice surgeries in the United Kingdom reported concerns about the quality of care they could provide and described their workload as unmanageable most of the time; 13 per cent reported that it was unmanageable all of the time (Iacobucci 2016). In another study, 68 percent  of general practitioners expressed the view that care could be improved by longer, higher-quality consultations, while 67 percent felt that patients with long-term conditions should be afforded longer consultations (Rimmer 2015). It has been demonstrated that longer consultation times correlate with a greater likelihood of taking a thorough medical history and conducting examinations in accordance with good practice, a lower prescribing rate, a greater likelihood of offering advice about preventative healthcare, and fewer follow-up consultations (Wilson and Childs 2002).

General practitioners are currently able to make referrals to specialists in various clinical disciplines. In addition to lengthening standard consultation times, the option of making general referrals may be a constructive way forward, i.e. arranging for the patient to have a lengthier consultation with a general practitioner rather than being siloed into a specialist referral (which is liable to be  an even less holistic encounter) or sent away. Given the importance of the therapeutic encounter, it is also worth considering increasing the number of talking therapies referrals for long-term physical health problems. As it stands, talking therapies are recommended within the U.K. National Health Service for a range of social, mental, and physical conditions. This could be broadened, so that those whose physical symptoms are not being satisfactorily resolved within the biomedical paradigm are able to benefit from a personalized therapeutic relationship which does not rely on implausible mechanisms (NHS Choices 2016).

That women may be less likely to benefit from medicine and therefore more likely to spend time and money  seeking therapies whose claims are questionable, whose benefits are negligible, and whose potential for exploitation is considerable, is a grave matter. Researchers and clinicians must take responsibility by consciously modernizing biomedicine to ensure that its goods are accessible to all and that the benefits of a positive therapeutic encounter are acknowledged and prioritized in the delivery of care.

One does not need to be a feminist to see that Arianne Shahvisi is correct in her line of arguing. Her insights are important and very well-put. Yet, they represent merely one aspect of SCAM, and there are many others. For instance, many consumers are not motivated to try SCAM by a disenchantment with SM. In fact, most of the research shows that this is not the main reason for becoming a SCAM proponent.

But, whatever the reason, it seems clear to me that those who subscribe to SCAM are getting a poor bargain. Arianne Shahvisi is therefore entirely correct in demanding that SM has to get its act together to avoid this from happening. I must have written and said it hundreds of times: whatever SCAM is, it is a poignant criticism of SM which must be used constructively for improving SM.

We have discussed the tragic case of John Lawler before. Today, the Mail carries a long article about it. Here I merely want to summarise the sequence of events and highlight the role of the GCC.

  • In 2017, Mr Lawler, aged 79 at the time, has a history of back problems, including back surgery with metal implants and suffers from pain in his leg.
  • His GP recommends to consult a physiotherapist.
  • As waiting lists are too long, Mr Lawler sees a chiropractor shortly after his 80th birthday who calls herself ‘doctor’ and who he assumes to be a medic specialising in back pain.
  • The chiropractor uses a spinal manipulation of the neck with the drop table.
  • There is no evidence that this treatment is effective for pain in the leg.
  • No informed consent is obtained from the patient.
  • This is acutely painful and brakes the calcified ligaments of Mr Lawler’s upper spine.
  • Mr Lawler is immediately paraplegic.
  • The chiropractor who had no training in resuscitation is panicked tries mouth to mouth.
  • Bending the patient’s neck backwards the chiropractor further compresses his spinal cord.
  • When ambulance arrives, the chiropractor misleads the paramedics telling them nothing about a forceful neck manipulation with the drop and suspecting a stroke.
  • Thus the paramedics do not stabilise the patient’s neck which could have saved his life.
  • Mr Lawler dies the next day in hospital.
  • The chiropractor is arrested immediately by the police but then released on bail.
  • The expert advising the police is a prominent chiropractor.
  • One bail condition is not to practise, pending a hearing by the GCC.
  • The GCC decide not to take any action.
  • The police therefore release the bail conditions and she goes back to practising.
  • The interim suspension hearing of the GCC is being held in September 2017.
  • The deceased’s son wants to attend but is not allowed to be present at the hearing even though such events are normally public.
  • The coroner’s inquest starts in 2019.
  • In November 2019, a coroner rules that Mr Lawler died of respiratory depression.
  • The coroner also calls on the GCC to bring in pre-treatment imaging to protect vulnerable patients.
  • The GCC announce that they will now continue their inquiry to determine whether or not chiropractor will be struck off the register.

The son of the deceased is today quoted stating that the GCC “seems to be a little self-regulatory chiropractic bubble where chiropractors regulate chiropractors.”

I sympathise with this statement. On this blog, I have repeatedly voiced my concerns about the GCC – see here, for instance – which I therefore do not need to repeat. My opinion of the GCC is also coloured by a personal experience which I will quickly recount now:

A long time ago (I estimate 10 – 15 years), the GCC invited me to give a lecture and I accepted. I do not remember the exact subject they had given me, but I clearly recall elaborating on the risks of spinal manipulation. This was not too well received. When I had finished, a discussion ensued in which I was accused of not knowing my subject and aggressed for daring to ctiticise chiropractic. I had, of couse, given the lecture assuming they wanted to hear my criticism. In the end, I left with the impression that this assumption was wrong and that they really just wanted to lecture, humiliate and punish me for having been a long-term critic of their trade.

I therefore can fully understand of David Lawler’s opinion about the GCC. To me, they certainly behaved as though their aim was not to protect the public, but to defend chiropractors from criticism.

This letter (dated 21 June 2019) to the Safer Care Victoria review team represents a statement by the Australian Medical Association of Victoria on chiropractic for children. As it is highly relevant to many of the discussions we had on this blog, I take the liberty of copying it here in full:

RE: Review of chiropractic spinal care for children under 12 years

The Australian Medical Association (AMA Victoria) appreciates the opportunity to respond to the Safer Care Victoria (SCV) consultation on chiropractic manipulation of children under 12 years.

The AMA is pleased that SCV has decided to review this practice which is manifestly unsafe and unwarranted.

Chiropractic spinal manipulation on children has received recent media attention and prompted community concerns about its safety, appropriateness and the professional duties of those undertaking it.  Most notably, in February this year medical experts and the Victorian Government condemned the controversial practice of infant spine manipulation after footage emerged of a Melbourne chiropractor treating a two-week old baby on the chiropractor’s own site.

Treatment of infants and very young children

We are aware that chiropractors are treating children for problems such as “infantile colic” by manipulative therapies.  There is no credible evidence for this, it is a dangerous practice in itself and it potentially impedes the proper assessment and management of an infant.  Additionally, it preys on often tired parents by the promise of a frequently false unequivocal diagnosis and false “quick fix”. This is plainly unconscionable and dangerous behaviour.

In preparing our response, we engaged with doctors across many specialities who have offered valuable insights into the matters being considered as part of this review.  It is our very firm view that the risk of undertaking spinal manipulation on small infants is of no benefit and is potentially extremely dangerous.  Newborn babies are extremely fragile and AMA Victoria warns that damage done to a baby or infant may not be immediately obvious to parents, and may not manifest until many years later.  This is supported by a study conducted by the American Academy of Pediatrics [1] which found serious adverse events may be associated with paediatric spinal manipulation.1

Another critical issue is that it is very unlikely that parents are providing informed consent to such procedures.  For parents to provide informed consent, they would need to be fully advised of the risks including, for example:

• the diagnosis of “infant colic” is a catch all for a range of symptoms with different aetiologies;

• the potential drastic short and long term consequences of spinal manipulation on their baby;

• there are no scientific safety and efficacy studies undertaken; and

• there is no credible scientific evidence for manipulation.

Chiropractors should also be directing parents to general practitioners for the proper holistic assessment and care of the child and family.

Additionally, infants and very young children cannot provide assent for a procedure for which there is no evidence they require and which may leave them with long term consequences.  Consideration of whether such potentially dangerous therapies, which are not underpinned by a strong evidence-base, should be supported by private health insurance rebates is also warranted.

Treatment of children under 12 years of age

Although there is limited evidence that some musculoskeletal treatments are effective in adults, there is no credible scientific evidence that manipulation, mobilisation or any applied spinal therapy in children under 12 years of age is warranted or safe.

AMA Victoria does not support clinical interventions unless there is scientific evidence that such treatments are useful in treating the illness.  AMA Victoria also supports patients being fully informed on the illness and the risks and benefits to any treatment. When the risks are to be borne by a non-assenting child, the requirement of evidence and consent is especially important.

AMA Victoria strongly advocates that chiropractic (and other health professionals) spinal care for children under 12 years of age is dangerous, unwarranted and must cease immediately.

If you would like to discuss any aspect of our response, please contact Ms Nada Martinovic, Senior Policy Advisor on (03) 9280 8773 or nadam@amavic.com.au.

Yours sincerely

Associate Professor Julian Rait OAM AMA VICTORIA PRESIDENT

1 Sunita, V., et al., Adverse Events Associated with Pediatric Spinal Manipulation: A Systemic Review, Pediatrics, 2007: 119; 275-283.

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I am truly delighted that the AMA Victoria agrees with many points I have tried to make previously (see for instance here, here and here). The statement is unsurpassed in its directness and strength. My congratulations to Prof Raith – very well done!

Let’s hope that professional bodies of other regions and counties will swiftly follow suit with equal clarity.

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?

_________________________________________________________

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.

__________________________________________

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?

________________________________________________________________

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.

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