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

risk

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Recently, we discussed the findings of a meta-analysis which concluded that walking, which is easy to perform and highly accessible, can be recommended in the management of chronic LBP to reduce pain and disability.

At the time, I commented that

this will hardly please the legions of therapists who earn their daily bread with pretending their therapy is the best for LBP. But healthcare is clearly not about the welfare of the therapists, it is/should be about patients. And patients should surely welcome this evidence. I know, walking is not always easy for people with severe LBP, but it seems effective and it is safe, free and available to everyone.

My advice to patients is therefore to walk (slowly and cautiously) to the office of their preferred therapist, have a little rest there (say hello to the staff perhaps) and then walk straight back home.

Now, there is new evidence that seems to confirm what I wrote. An international team of researchers requested individual participant data (IPD) from high-quality randomised clinical trials of patients suffering from persistent low back pain. They conducted descriptive analyses and one-stage IPD meta-analysis. They received IPD for 27 trials with a total of 3514 participants.

For studies included in this analysis, compared with no treatment/usual care, exercise therapy on average reduced pain (mean effect/100 (95% CI) -10.7 (-14.1 to -7.4)), a result compatible with a clinically important 20% smallest worthwhile effect. Exercise therapy reduced functional limitations with a clinically important 23% improvement (mean effect/100 (95% CI) -10.2 (-13.2 to -7.3)) at short-term follow-up.

Not having heavy physical demands at work and medication use for low back pain were potential treatment effect modifiers-these were associated with superior exercise outcomes relative to non-exercise comparisons. Lower body mass index was also associated with better outcomes in exercise compared with no treatment/usual care.

But you cannot dismiss so-called alternative medicine (SCAM), just like that, I hear my chiropractic and other manipulating friends exclaim – at the very minimum, we need direct comparisons of the two approaches!!!

Alright, you convinced me; here you go:

The purpose of this systematic review was to determine the effectiveness of spinal manipulation vs prescribed exercise for patients diagnosed with chronic low back pain (CLBP). Only RCTs that compared head-to-head spinal manipulation to an exercise group were included in this review. Only three RCTs met the inclusion criteria. The outcomes used in these studies included Disability Indexes, Pain Scales and function improvement scales. One RCT found spinal manipulation to be more effective than exercise, and the results of another RCT indicated the reverse. The third RCT found both interventions offering equal effects in the long term. The author concluded that there is no conclusive evidence that clearly favours spinal manipulation or exercise as more effective in treatment of CLBP. More studies are needed to further explore which intervention is more effective.

Convinced?

No?

But I am!

Exercise is preferable to chiropractic and other manipulating SCAMs because:

  1. It is cheaper.
  2. It is safer.
  3. It is readily available to anyone.
  4. And you don’t have to listen to the bizarre and often dangerous advice many chiros offer their clients.

On 6 November the Guardian published an article in which acupuncture and its risks were briefly mentioned. It prompted a complaint by the British Acupuncture Council which, I think, is sufficiently interesting to merit a discussion. The British Acupuncture Council (BAcC) has a membership of around 3,000 professionally qualified acupuncturists. It is the UK’s largest professional/ self-regulatory body for the practice of traditional acupuncture. Here is their complaint in full:

Re: Guardian article ‘Doctors call for tighter regulation of traditional Chinese medicine’, published 6 November 2019. We wish to respond to the article referenced above, specifically with regards to the two sentences relating to the safety of acupuncture. We request you correct the misleading comments made in the article and publish this letter online.

1. ‘And acupuncture, they will say, “is not necessarily harmless.”’

Yes, of course it may not be harmless: it involves piercing the skin with a sharp object. Hence the need for proper training of acupuncturists, together with evidenced guidelines, a robust code of safe practice and regulatory teeth. These components are all in place for members of the British Acupuncture Council (BAcC). Acupuncture has not been taken into state control in the UK precisely because it has been found to be so safe; instead, the BAcC is entrusted with self-regulation and is an accredited member of the Professional Standards Authority. Statements about the safety of acupuncture commonly conclude: ‘Acupuncture seems, in skilled hands, one of the safer forms of medical intervention’ (White 2001).

2. ‘…A review in 2017 found many injuries, infections and adverse reactions.’
That first part of your acupuncture safety comment was a direct quote from the FEAM/EASAC statement, which was the focus of the article, but it then departs from the script to manufacture the colourful soundbite above. You refer to the same acupuncture safety overview paper (Chan et al 2017) that FEAM/EASAC drew on, but then substantially misrepresent its content and messages. It is neither a quote from the FEAM/EASAC statement, nor from the overview paper. In fact, the latter sums up the findings of the 17 included reviews thus:  ‘However, all the reviews have suggested that adverse events are rare and often minor.’ Your statement about many injuries, infections and adverse reactions gives a very different message to the paper’s authors.
The Guardian article appears to have been written with little understanding of the science involved in investigating medical adverse events. In particular, it is impossible to establish the significance of the numbers of adverse events reported without knowing how many treatments they came from. Chan et al (2017) noted that incidence rates could not be calculated ‘because many adverse events came from case reports and many of the reviews did not include full details about the number of participants in their included studies’. The 17 reviews between them covered literature from 1950 to 2014 and countries across the globe, so potentially millions and millions of treatments. No wonder they turned up plenty of incidents!
One of the ‘gold standard’ acupuncture safety reviews (Xu et al 2013), which was included in Chan’s overview, provides the following information on this issue:

‘Incidence rates for major AEs [adverse events] of acupuncture are best estimated from large prospective surveys of practitioners. Four recent surveys of acupuncture safety among regulated, qualified practitioners, two conducted in Germany (Melchart 2004; Witt 2009), and two in the United Kingdom (MacPherson 2001; White 2001), confirm that serious adverse events after acupuncture are uncommon. Indeed, of these surveys, covering more than 3 million acupuncture treatments all together, there were no deaths or permanent disabilities, and all those with AEs fully recovered (Witt 2011). Thus, it can be concluded that acupuncture has a very low rate of AEs, when conducted among licensed, qualified practitioners in the West.’

The overview authors also raised this concern: ‘A major limitation of the presented information was that no causality could be determined’. In other words there is often no evidence to link acupuncture to the reported event: it is implicated just because it was around at the time. Adverse events only become adverse reactions (your words) if there is a substantiated link.
Your article (and indeed the FEAM/EASAC statement) completely omits perhaps the most important consideration: how does acupuncture compare to other available treatment options? It is most often used by people for chronic pain. The evidence base for this is good (Vickers 2018) and supports acupuncture’s effectiveness compared to conventional treatments (Trinh 2019). The potential harms of opioids and non-steroidal anti-inflammatory drugs are well known and acupuncture is associated with fewer adverse events than medications in controlled trials across a wide range of conditions (Cao 2018; Xu 2018; Lu 2016).  It was estimated that one in 1,200 people taking NSAIDS for at least two months will die of gastrointestinal complications (Tramer 2000). Six percent of hospitalisations in developed countries are due to adverse drug reactions (Angamo 2016).

On safety grounds there is no comparison: no serious adverse events were reported in a survey covering 34,407 acupuncture treatments given by BAcC members (Macpherson 2001). Of the mild transient reactions reported, the most frequent were ‘feeling relaxed’, and ‘feeling energised’. This is not to downplay the potential harms, for they can be serious, but as with any medical intervention there should be a proper assessment of how likely this is, which the Guardian article signally failed to do.
Yours sincerely

Mark Bovey Research Manager British Acupuncture Council

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I had no involvement in the Guardian article; I nevertheless feel that several things need to be pointed out about this bizarre complaint:

  1. The quote attributed to White A is, in fact, by White, Hayhoe, Hart and Ernst (yes, petty point), and our investigation showed (not petty point) that there were 43 significant minor adverse events reported, a rate of 14 per 10,000, of which 13 (30%) interfered with daily activities. One patient suffered a seizure (probably reflex anoxic) during acupuncture, but no adverse event was classified as serious. Avoidable events included forgotten patients, needles left in patients, cellulitis and moxa burns. This, I think, entirely justifies the words -is not necessarily harmless – published by the Guardian.
  2. The complaint states that there is often no evidence to link acupuncture to the reported event: it is implicated just because it was around at the time. Adverse events only become adverse reactions (your words) if there is a substantiated link. What this seems to imply is this: the BAcC claim that causality of adverse effects remains speculative, while having failed to establish a surveillance system that could establish their causality more firmly. Perhaps the BAcC should file a complaint about themselves?
  3. The BAcC claim that the author of the Guardian article lacks understanding of the science of adverse effect reporting. However, I get the impression that the lack of understanding is embarrassingly evident on the side of the BAcC.
  4. The BAcC then highlight the most important consideration: how does acupuncture compare to other available treatment options? This is more than a little odd. Firstly, such comparisons hardly were the aim of the Guardian article. Secondly, such comparisons only make sense with options that have a comparable risk/benefit profile. As the benefits of acupuncture for most conditions are still debatable, and since its risks are finite, its risk/benefit balance might not be clearly positive. Therefore, such comparisons are of doubtful value and could easily turn out to generate unfavourable evidence against acupuncture.
  5. Comparisons to opioids or NSAIDS are evidently nonsensical for the reason just mentioned.
  6. The Guardian article’s comments on acupuncture risks were of a general nature and were unelated to any specific issues about BAcC members. There are many non-medically trained acupuncturists – both in the UK and abroad – who might represent a substantially higher risk. Therefore the Guardian should not be criticised but praised for publishing words of caution.

The BAcC state that this is not to downplay the potential harms, yet I fear that this is precisely what they are trying to do. Until there is a post-marketing surveillance system, it would be honest and ethical to admit that the risks of acupuncture are essentially not known.

In my view, the complaint has no reasonable basis, tells us more about the BAcC than the Guardian, and should not be acted upon by the Guardian.

 

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.
___________________________________________________________________________
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.

 

 

This review provides published data on so-called alternative medicine (SCAM)-related liver injuries (DILI) in Asia, with detail on incidences, lists of most frequently implicated herbal remedies, along with analysis of patient population and their clinical outcomes.

Its authors conclude that SCAM use is widely prevalent in Asia and is associated with, among other adverse effects, hepatotoxicity. Both proprietary as well as non-proprietary or traditional SCAMs have been implicated in hepatotoxicity. Acute hepatocellular pattern of liver injury is the most common type of liver injury seen, and the spectrum of liver-related adverse events range from simple elevation of liver enzymes to the very serious ALF and ACLF, which may, at times, require liver transplant.

SCAM-related liver injury is one among the major causes for hepatotoxicity, including ALF and ACLF worldwide, with high incidence among Asian countries. Patient outcomes associated with SCAM-DILI are generally poor, with very high mortality rates in those with chronic liver disease. Stringent regulations, at par with that of conventional modern medicine, are required, and may help improve safety of patients seeking SCAM for their health needs. Regional surveillance including post-marketing analysis from government agencies associated with drug regulation and control in tandem with national as well as regional level hepatology societies are important for understanding the true prevalence of DILI associated with SCAM. An integrated approach used by practitioners combining conventional and traditional medicine to identify safety and efficacy of SCAMs is an unmet need in most of the Asian countries. Endorsement of scientific methodology with good quality preclinical and clinical trials and abolishment of unhealthy publication practices is an area that needs immediate attention in SCAM practice. Such holistic standard science-based approaches could help ameliorate liver disease burden in the general and patient population.

I congratulate the authors to this excellent paper. It contains a wealth of information and is well worth reading in full. The review will serve me as a valuable source of data for many years to come.

The U.S. Food and Drug Administration (FDA) issued another warning about homeopathy. Here are some of the most relevant excerpts:

… Homeopathic products … are marketed without FDA review and may not meet modern standards for safety, effectiveness, quality and labeling. FDA uses a risk-based approach to monitor these products and to evaluate reports of adverse effects.

… Homeopathic drug products are made from a wide range of substances, including ingredients derived from plants, healthy or diseased animal or human sources, minerals and chemicals, including known poisons. These products have the potential to cause significant and even permanent harm if they are poorly manufactured, since that could lead to contaminated products or products that have potentially toxic ingredients at higher levels than are labeled and/or safe, or if they are marketed as substitute treatments for serious or life-threatening diseases and conditions, or to vulnerable populations. In addition, some products may be labeled as homeopathic that do not conform to traditional homeopathic principles.

As the homeopathy industry continues to grow at a rapid pace, we want to clarify for both consumers and industry how we assess the potential safety risks of these products. That’s why in 2017, the FDA issued a draft guidance discussing our, risk-based enforcement approach to drug products labeled as homeopathic. Today, we are taking two new steps toward clarifying this approach.

First, we have revised the 2017 draft guidanceExternal Link Disclaimer to provide further information around our approach and are asking for public input on the revised draft. The draft guidance details a risk-based enforcement policy prioritizing certain categories of homeopathic products that could pose a higher risk to public health, including products with particular ingredients and routes of administration, products for vulnerable populations, and products with significant quality issues. We encourage the public to review this revised draft guidance and comment before it is finalized. We will consider feedback gathered through this new public comment period, the more than 4,500 comments interested stakeholders submitted on the original 2017 draft guidance, and information gleaned from a 2015 public hearing on the current use of homeopathic drug products. When finalized, this guidance will help provide transparency regarding the categories of homeopathic drug products that we intend to prioritize under our risk-based enforcement approach.

Second, the agency is withdrawingExternal Link Disclaimer the Compliance Policy Guide (CPG) 400.400, entitled “Conditions Under Which Homeopathic Drugs May be Marketed.” Risk is an important driver of the FDA’s regulatory and enforcement actions for all drug products, including homeopathic drug products. Since the issuance of CPG 400.400 in 1988, the FDA has encountered multiple situations in which homeopathic drug products posed a significant risk to patients, even though the products, as labeled, appeared to meet the conditions described in CPG 400.400. However, CPG 400.400 is inconsistent with our risk-based approach to regulatory and enforcement action generally and therefore does not reflect our current thinking. Therefore, it is appropriate to withdraw CPG 400.400 at this time.

… the FDA has issued warning letters to companies who produce homeopathic drug products for significant violations of current good manufacturing practice (CGMP) regulations and various other violations. So far in 2019, we’ve issued more than 10 warning letters to companies for violations concerning homeopathic products. Recently, we issued warning letters to Kadesh Inc., U.S. Continental Marketing, Inc., Fill It Pack It Inc. and Bershtel Enterprises LLC dba WePackItAll, which had jointly manufactured and packaged eye drops produced in non-sterile conditions which could result in serious eye infections. These warning letters should alert all companies that homeopathic drug products must be manufactured and labeled in accordance with the requirements of the Federal Food, Drug, and Cosmetic Act and agency regulations…

_________________________________________________

If you ask me, ‘homeopathic drug products’ is a misleading name. A drug is defined as a medicine or other substance which has a physiological effect when ingested or otherwise introduced into the body. But highly diluted homeopathics do not contain a substance that has physiological effects.

They should be called

  • homeopathics,
  • homeopathic pseudo-drugs,
  • homeopathic placebos,
  • or fake drugs.

And their labels should make it clear that:

  • these products contain no active ingredients,
  • and have not been shown to work beyond placebo.

That would be the type of honest and transparent information which consumers deserve and have a right to.

 

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