During my almost 30 years of research into so-called alternative medicine (SCAM), I have published many papers which must have been severe disappointments to those who advocate SCAM or earn their living through it. Many SCAM proponents thus reacted with open hostility. Others tried to find flaws in those articles which they found most upsetting with a view of discrediting my work. The 2012 article entitled ‘A Replication of the Study ‘Adverse Effects of Spinal Manipulation: A Systematic Review‘ by the Australian chiropractor, Peter Tuchin, seems to be an example of the latter phenomenon (used recently by Jens Behnke in an attempt to defame me).
Here is the abstract of the Tuchin paper:
Objective: To assess the significance of adverse events after spinal manipulation therapy (SMT) by replicating and critically reviewing a paper commonly cited when reviewing adverse events of SMT as reported by Ernst (J Roy Soc Med 100:330-338, 2007).
Method: Replication of a 2007 Ernst paper to compare the details recorded in this paper to the original source material. Specific items that were assessed included the time lapse between treatment and the adverse event, and the recording of other significant risk factors such as diabetes, hyperhomocysteinemia, use of oral contraceptive pill, any history of hypertension, atherosclerosis and migraine.
Results: The review of the 32 papers discussed by Ernst found numerous errors or inconsistencies from the original case reports and case series. These errors included alteration of the age or sex of the patient, and omission or misrepresentation of the long term response of the patient to the adverse event. Other errors included incorrectly assigning spinal manipulation therapy (SMT) as chiropractic treatment when it had been reported in the original paper as delivered by a non-chiropractic provider (e.g. Physician).The original case reports often omitted to record the time lapse between treatment and the adverse event, and other significant clinical or risk factors. The country of origin of the original paper was also overlooked, which is significant as chiropractic is not legislated in many countries. In 21 of the cases reported by Ernst to be chiropractic treatment, 11 were from countries where chiropractic is not legislated.
Conclusion: The number of errors or omissions in the 2007 Ernst paper, reduce the validity of the study and the reported conclusions. The omissions of potential risk factors and the timeline between the adverse event and SMT could be significant confounding factors. Greater care is also needed to distinguish between chiropractors and other health practitioners when reviewing the application of SMT and related adverse effects.
The author of this ‘replication study’ claims to have identified several errors in my 2007 review of adverse effects of spinal manipulation. Here is the abstract of my article:
Objective: To identify adverse effects of spinal manipulation.
Design: Systematic review of papers published since 2001.
Setting: Six electronic databases.
Main outcome measures: Reports of adverse effects published between January 2001 and June 2006. There were no restrictions according to language of publication or research design of the reports.
Results: The searches identified 32 case reports, four case series, two prospective series, three case-control studies and three surveys. In case reports or case series, more than 200 patients were suspected to have been seriously harmed. The most common serious adverse effects were due to vertebral artery dissections. The two prospective reports suggested that relatively mild adverse effects occur in 30% to 61% of all patients. The case-control studies suggested a causal relationship between spinal manipulation and the adverse effect. The survey data indicated that even serious adverse effects are rarely reported in the medical literature.
Conclusions: Spinal manipulation, particularly when performed on the upper spine, is frequently associated with mild to moderate adverse effects. It can also result in serious complications such as vertebral artery dissection followed by stroke. Currently, the incidence of such events is not known. In the interest of patient safety we should reconsider our policy towards the routine use of spinal manipulation.
In my view, there are several things that are strange here:
- Tuchin published his paper 5 years after mine.
- He did not publish it in the same journal as my original, but in an obscure chiro journal that hardly any non-chiropractor would ever read.
- Tuchin never contacted me and never alerted me to his publication.
- The journal that Tuchin chose was not Medline-listed in 2012; consequently, I never got to know about the Tuchin article in a timely fashion. (Therefore, I did never respond to it.)
- A ‘replication study’ is a study that repeats the methodology of a previous study.
- Tuchin’s paper is therefore NOT a replication study. Firstly, mine was a review and not a study. Secondly, and crucially, Tuchin never repeated my methodology but used an entirely different one.
But arguably, these points are trivial. They should not distract from the fact that I might have made mistakes. So, let’s look at the substance of Tuchin’s claim, namely that I made errors or omissions in my review.
As to ‘omissions’, one could argue that a review such as mine will always have to omit some details in order to generate a concise summary. The only way to not omit any details is to re-publish all the primary papers in one large volume. Yet, this can hardly be the purpose of a systematic review.
As to the ‘errors’, it seems that the ages and sex of three patients were wrong (I have not checked this against the primary publications but, for the moment, I believe Tuchin). This is, of course, lamentable and – even though I have no idea whether the errors happened at the data extraction phase, during the typing, the revising, or the publishing of the paper – it is entirely my responsibility. I also seem to have mistaken a non-chiropractor for a chiropractor. This too is regrettable but, as the review was about spinal manipulation and not about chiropractic, the error is perhaps not so grave.
Be that as it may, these errors are unquestionably not good, and I can only apologise for them. If Tuchin had dealt with them in the usual way – by publishing in a timely fashion a ‘letter to the editor’ of the JRSM – I could have easily corrected them for everyone to see.
But I think there is a more important point to be made here:
Tuchin concludes his paper stating that it is unwise to make conclusions regarding causality from any case study or multiple case studies. The number of errors or omissions in the 2007 Ernst paper significantly limit any reported conclusions. I believe that both sentences are unjustified. The safety of any intervention in routine use has to be examined on the basis of published case studies. This is particularly true for chiropractic where no post-marketing surveillance similar to that for drugs exists.
The conclusions based on such evidence can, of course, never be firm, but they provide valuable signals that can prompt more rigorous investigations in the interest of patient safety. In view of such considerations, my own conclusions in my 2007 paper were, I think, correct and are NOT invalidated by my relatively trivial mistakes: spinal manipulation, particularly when performed on the upper spine, has repeatedly been associated with serious adverse events. Currently the incidence of such events is unknown. Adherence to informed consent, which currently seems less than rigorous, should therefore be mandatory to all therapists using this treatment. Considering that spinal manipulation is used mostly for self-limiting conditions and that its effectiveness is not well established, we should adopt a cautious attitude towards using it in routine health care.
And my conclusions in the abstract have now, I believe, become established wisdom. They are thus even less in jeopardy through my calamitous lapsus or Tuchin’s ‘replication study’: Spinal manipulation, particularly when performed on the upper spine, is frequently associated with mild to moderate adverse effects. It can also result in serious complications such as vertebral artery dissection followed by stroke. Currently, the incidence of such events is not known. In the interest of patient safety we should reconsider our policy towards the routine use of spinal manipulation.
Deep venous thrombosis (DVT) is usually a blood clot in a deep vein of a leg. It is a potentially life-threatening condition, because the clot can detach itself and end up in the lungs thus causing a pulmonary embolism which can be fatal. A DVT therefore is a medical emergency which is typically managed by immobilising the patient and putting him/her on anticoagulants.
Yet, homeopaths seem to have discovered another approach. Indian homeopaths just published a case report of a DVT in an old patient totally cured exclusively by the non-invasive method of treatment with micro doses of potentized homeopathic drugs selected on the basis of the totality of symptoms and individualization of the case. The authors concluded that, since this report is based on a single case of recovery, results of more such cases are warranted to strengthen the outcome of the present study.
The patient was advised by his doctor to have surgery which he refused. Instead, he consulted a homeopath who treated him homoeopathically. No conventional treatments were given. The patient recovered, yet his recovery is almost certainly unrelated to the homeopathics he received. Spontaneous recovery after DVT is not uncommon, and it is almost certain that it is this what the case report describes.
It is simply not plausible, nor is there evidence that homeopathy can alter the natural history of a DVT. This means that what the Indian homeopaths have described in their paper is nothing less than a case of gross negligence. Had the patient died of a pulmonary embolism due to an untreated DVT, it could have put them behind bars.
While it is, of course, most laudable that homeopaths have taken to publishing even their most serious errors, it would be more reassuring, if they developed some sort of insight into their mistakes. Instead, they seem naively confident and stupidly ignorant of the danger they pose to the public: homeopathy can play significant therapeutic roles in very serious diseases like DVT, provided the drugs are needs to be carefully selected on the basis of i) individualization of cases, ii) the totality of symptoms and personalized data, and iii) taking into consideration the pathogenicity level and proper diagnosis of the disease. Further, homeopathy may also be safely used in patients with conventional drug allergy (antibiotics) or other physical conditions preventing intake of conventional medicines.
My conclusion and recommendation: stay away from homeopaths, folks!
A team of chiropractic researchers conducted a review of the safety of spinal manipulative therapy (SMT) in children under 10 years. They aimed to:
1) describe adverse events;
2) report the incidence of adverse events;
3) determine whether SMT increases the risk of adverse events compared to other interventions.
They searched MEDLINE, CINAHL, and Index to Chiropractic Literature from January 1, 1990 to August 1, 2019. Eligible studies were case reports/series, cohort studies and randomized controlled trials. Studies of high and acceptable methodological quality were included.
Most adverse events are mild (e.g., increased crying, soreness). One case report describes a severe adverse event (rib fracture in a 21-day-old) and another an indirect harm in a 4-month-old. The incidence of mild adverse events ranges from 0.3% (95% CI: 0.06, 1.82) to 22.22% (95% CI: 6.32, 54.74). Whether SMT increases the risk of adverse events in children is unknown.
The authors concluded that the risk of moderate and severe adverse events is unknown in children treated with SMT. It is unclear whether SMT increases the risk of adverse events in children < 10 years.
Thanks to their ingenious methodology, the authors managed to miss 11 of the 13 studies included in the review by Vohra et al which reported 9 serious adverse events and 20 cases of delayed diagnosis associated with SMT. Another review reported 15 serious adverse events and 775 mild to moderate adverse events following manual therapy. As far as I can see, the authors of the new review make just one reasonable point:
We recommend the implementation of a population-based active surveillance program to measure the incidence of severe and serious adverse events following SMT treatment in this population.
In the absence of such a surveillance system, any incidence figures are not just guess-work but also a depiction of the tip of a much bigger iceberg. So, why do the authors of this review not make this point clearly and powerfully? Why does the review read mostly like an attempt to white-wash a thorny subject? Why do they not provide a breakdown of the adverse events according to profession? The answer to these questions can be found at the very end of the paper:
This study was supported by the College of Chiropractors of British Columbia to Ontario Tech University. The College of Chiropractors of British Columbia was not involved in the design, conduct or interpretation of the research that informed the research. This research was undertaken, in part, thanks to funding from the Canada Research Chairs program to Pierre Côté who holds the Canada Research Chair in Disability Prevention and Rehabilitation at Ontario Tech University, and from the Canadian Chiropractic Research Foundation to Carol Cancelliere who holds a Research Chair in Knowledge Translation in the Faculty of Health Sciences at Ontario Tech University.
This study was supported by the College of Chiropractors of British Columbia to Ontario Tech University. The College of Chiropractors of British Columbia was not involved in the design, conduct or interpretation of the research that informed the research. This research was undertaken, in part, thanks to funding from the Canada Research Chairs program to Pierre Côté who holds the Canada Research Chair in Disability Prevention and Rehabilitation at Ontario Tech University, and funding from the Canadian Chiropractic Research Foundation to Carol Cancelliere who holds a Research Chair in Knowledge Translation in the Faculty of Health Sciences at Ontario Tech University.
I have often felt that chiropractic is similar to a cult. An investigation by cult members into the dealings of a cult is not the most productive of concepts, I guess.
In 2017, John Lawler died after receiving a chiropractic neck manipulation. The therapist was not just incompetent at providing first aid to her patient, her clumsy attempts to save his life might even have contributed to his death. Now the General Chiropractic Council (GCC) issued a special bulletin to all registrants setting out in detail the action they must take in relation to first aid:
… it is a requirement of our educational programmes that students are trained to deal with medical emergencies and thereafter it is important that chiropractors keep their knowledge and skills up to date.
We expect all chiropractors to consider their own first aid knowledge and skills and determine whether or not to undertake further specific first aid training. We said that registrants should start by considering whether their first aid skills and knowledge are sufficient, appropriate and current.
Every chiropractor is likely to encounter potential traumatic and medical emergencies at some point in their professional life. Like all registered health care professionals chiropractors have a duty to their patients during emergencies. Chiropractors therefore must recognise, assess and manage the potential for emergency medical and traumatic conditions that may be encountered in chiropractic settings.
Many providers of first aid training are available offering a range of courses delivered in a range of different ways, for example, the Royal College of Chiropractors has partnered with a training provider to provide first aid training courses for chiropractors across the UK: http://bit.ly/rccfirstaid
In September 2020, as part of registrants’ continuing professional development submission to the GCC, we expect to see information from each chiropractor on their first aid knowledge and skills, and the steps taken so they are assured of their competence to administer first aid should the need arise.
One could read this statement as an admission that:
- UK chiropractors are currently not adequately trained in first aid,
- chiropractic manipulations can cause medical emergencies,
- and possibly that Mr Lawler lost his life because his chiropractor was incompetent in first aid.
At the same time, I find that the statement comes many months too late and is neither clear nor compelling. Why not making it plain:
- exactly which first aid qualification every UK chiropractor must have
- by what time,
- and state what penalty they will face, if they fail to comply?
And, if the GCC are aware that spinal manipulation can cause serious emergencies, why have they not established a proper reporting scheme for such events so that we all know of the frequency of such risks? Could it be that the son of the deceased John Lawler was correct when he said the GCC “seems to be a little self-regulatory chiropractic bubble where chiropractors regulate chiropractors?” And could it be that I was justified in suspecting that the GCC is not fit for purpose?
What do you think?
Ever since the government in Bavaria has been misguided enough to agree to a research programme testing whether homeopathy has a role in curtailing the over-use of anti-biotics, the subject of homeopathics as a replacement of antibiotics has been revived.
In this paper, homeopaths describe four female cases with recurrent urinary tract infections. The patients were treated successfully with the homeopathic strategy after several conventional approaches revealed no improvement. The follow-up period was a minimum of 3 years and the frequency of episodes with urinary tract infection as well as of antibiotic treatment was documented. Additionally, the patients were asked to assess the treatment outcome retrospectively in a validated questionnaire.
The treatment resulted in a reduction of urinary tract infections and the need for antibiotics from monthly to less than 3 times a year. Three of the four women had no cystitis and related intake of antibiotics for more than 1.5 years. A relapse of symptoms could be treated efficiently with a repetition of the homeopathic remedy. All subjective outcome assessments resulted positive.
The authors concluded that this case series suggests a possible benefit of individualized homeopathic treatment for female patients with recurrent urinary tract infections. Larger observational studies and controlled investigations are warranted.
Such articles make me quite angry! They have the potential to mislead many patients and, in extreme cases, might even cost lives.
The ‘possible benefit’ of any treatment cannot be demonstrated with such flimsy case series. It has to be shown in properly controlled clinical trials. The findings of case series are confounded by dozens of variables and tell us next to nothing about cause and effect.
Case series make sense when they explore possible new therapeutic avenues. Homeopathy does certainly not fall into this category. The notion that homeopathics might be an alternative to antibiotics has been tested many times before in different settings, in animals, in humans, it vivo and in vitro. This has never generated convincingly positive findings. To re-address it by reporting uncontrolled cases is not just a nonsense; in my view, it is an unethical attempt to mislead us.
- 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.
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.
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.
- 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.
Just three points which, in my view, sand out most in relation to Mr Lawler’s death:
- Mr Lawler had no proven indication (and at least one very important contra-indication) for neck manipulation.
- He did not give infromed consent.
- 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:
- Chiropractors are not medical doctors and should make this perfectly clear to all of their patients.
- Elderly patients can have several contra-indications to spinal manipulations. They should therefore think twice before consulting a chiropractor.
- 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.
- 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.)
- Chiropractors are not trained to deal with medical emergencies and must leave that to those healthcare professionals who are fully trained.
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:
- 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.
- Has neck manipulation been shown to be effective for any type of pain in the leg? That’s an easy one: No!
- 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.
- 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.