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

malpractice

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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.

As reported, the Bavarian government has set aside almost half a million Euros for research to determine whether the over-use of antibiotics can be reduced by replacing them with homeopathic remedies. Homeopaths in and beyond Germany were delighted, of course, but many experts were bewildered (see also this or this, if you read German).

While the Bavarians are entering the planning stage of this research, I want to elaborate on the question what methodology might be employed for this task. As far as I can see, there are, depending on the precise research questions, various options.

IN VITRO TESTS OF HOMEOPATHICS

The most straight forward way to find out whether homeopathics are an alternative to antibiotics would be to screen them for antibiotic activity. For this, we would take all homeopathic remedies in several potencies that are commonly used, for instance D12 and C30, and add them to bacterial cultures. To cover even part of the range of homeopathic remedies, several thousand such tests would be required. The remedies that show activity in vitro would then be candidates for further clinical tests.

I doubt that this will generate meaningful findings. As homeopaths would probably point out quickly, they never claimed that their remedies have any antibiotic effects. Homeopathics work not via pharmacological mechanisms (there is none), they stimulate the vital force, the immune system, or whatever mystical force you fancy. Faced with the inevitably negative results of in vitro tests, homeopaths would merely shrug their shoulders and say: ‘we told you so’.

ANIMAL MODELS

Thus it might be more constructive to go directly into animal models. Such tests could take several shapes and forms. For instance, scientists could infect animals with a bacterium and subsequently treat one group with a high potency homeopathic remedy and the control group with a placebo. If the homeopathic animals survive, while the controls die, the homeopathic treatment was effective.

Such concepts would run into problems on at least two levels. Firstly, any ethics committee worth its name would refuse to pass such a protocol and argue that it is not ethical to infect and then treat animals with two different types of placebo. Secondly, the homeopathic fraternity would explain that homeopathy must be individualised which cannot be done properly in animals. Faced with the inevitably negative results of such animal studies, homeopaths would merely shrug their shoulders and say: ‘we told you so’.

CLINICAL TRIALS

Homeopathy may, according to some homeopaths, defy in vitro and animal tests, but it is most certainly amenable to being tested in clinical trials. The simplest version of a clinical study would entail randomising a group of patients with bacterial infections – say pneumonia – into receiving either individualised homeopathy or placebo. Possibly, one could add a third group of patients being treated with appropriate antibiotics.

The problem here would again be the ethics; no proper ethic committee would pass such a concept (see above). Another problem might be that even the homeopathic fraternity would oppose such a study. Why? Because all but the most deluded homeopaths know only too well that the result of such a trial would be devastatingly negative for homeopathy.

Therefore, homeopaths are likely to go for a different study design, for instance, one where patients suspected to have a bacterial infection are randomised to two groups of GPs. One group of ‘normal’ GPs would proceed as usual, while the other group are also trained in homeopathy and would be free to give whatever they feel is right for each individual patient. With a bit of luck, the ‘normal’ GPs would over-prescribe antibiotics (because that’s what they are apparently doing routinely), while the homeopathic GPs would often use homeopathics instead.

Such a study would indeed generate a result alleging that the use of homeopathy reduces the use of antibiotics. Of course, to be truly ‘positive’ it would need to exclude any clinical outcome such as time to recovery, because that might not be in favour of homeopathy.

The problem might again be the ethics committee. Assuming they are scientifically switched on, they will see through the futility of a trial designed to produce the desired result. They might also argue that science is not for testing one faulty approach (over-prescribing) against another (homeopathy) and insist that science is about finding the best treatment (which is neither of the two).

There are, of course, many other study designs that could be considered. Generally, they fall into two different categories: if they are rigorous tests of a hypothesis, they are sure to produce a result unfavourable to homeopathy. Such studies will therefore be opposed to by the powerful homeopathic fraternity. If, however, studies are flimsily designed to generate a positive finding, they might be liked by homeopaths, yet rejected by scientists and ethicists.

SURVEYS

A much easier solution to the question ‘does the use of homeopathy reduce the use of antibiotics’ might be to not do a trial at all, but to run a simple survey. For instance, one could retrospectively assess how many antibiotics 100 homeopathic GPs have prescribed during the last year and compare this to the figure of 100 over-prescribing, ‘normal’ GPs. This type of ‘research’ is a sure winner for the homeopaths. Therefore, I predict that they will advocate this or a similarly flawed concept.

Most politicians are scientifically illiterate to such a degree that they might actually agree to finance such a survey and then confuse correlation with causation by triumphantly stating that the use of homeopathy reduces over-prescribing of antibiotics. Few, I fear, will realise that there is only one method for reducing the over-prescribing of antibiotics: remind doctors what they all learnt in medical school, namely to prescribe antibiotics only in cases where they are indicated. And for that we evidently need no homeopathy or other SCAM.

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

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

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

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

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

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

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

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

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

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

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

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

KEY FINDINGS

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

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

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

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

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

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

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

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

It has been reported that pharmacies in New Zealand continue to ignore a code of ethics that requires them to inform customers, if a product has no evidence of efficacy. The code of ethics states: “Pharmacists must advise patients when scientific support for treatment is lacking.”

Eight Auckland pharmacies were visited to enquire about a homeopathic product for sale. Pharmacy staff were asked what they knew about a homeopathic product on their shelves and if it worked. All failed to share information about the lack of scientific evidence showing the product works. Instead, they claimed that homeopathic solution of arnica sold as a treatment for injuries, bruising and post-surgery trauma “works really, really well”, was “awesome” and could also cure headaches. One salesperson checked with the pharmacist whether the product was suitable for swelling post-surgery and was told it was fine as long as no other medication was being taken at the same time.

There is no credible evidence the highly diluted homeopathic remedies sold by pharmacists work better than a placebo. Homeopathy’s effectiveness has been rejected by many scientists and by large government reviews conducted in the UK, Australia and Europe.

Even if a staff member personally believes a homeopathic product works, guidelines referenced by the code of ethics say this should not sway the information given to the customer: “Patients must be made aware of the likely effectiveness of a given therapy according to recognised peer-reviewed medical publications, in spite of your personal beliefs.”

Shortly after the code was changed in March 2018, Newsroom performed the same secret shopper experiment at four pharmacies and found the new rule was not followed. Eighteen months on, nothing has improved.

The chair of the consumer advocate group the ‘Society for Science Based Healthcare’, Mark Hanna, said there was no excuse for pharmacies to sell this kind of thing without warning. “Pharmacists should know better. Full stop. They should not be misleading their patients, they should not be letting their staff mislead their patients. If they don’t know, that’s incompetence. I would expect to be given reasonable, evidence-based advice, possibly some different options with the reason why I might choose one over the other. I wouldn’t expect to be misled and sold something that wouldn’t work.

Asked why the code was not being followed a spokesperson of the NZ pharmacists said a reminder of the code of ethics had been sent to pharmacies in June. It was recommended all staff be made aware of the code: “We encourage you to share this protocol with your entire team – even though it is a protocol for pharmacists, the reasoning also extends to other staff members in the pharmacy and it is important that all staff ensure that the patient has been provided with sufficient information to make an informed choice.”

By Jove, we have discussed this issue often enough. If you are interested, here are a few of my more recent posts on this subject:

But pharmacists seem utterly reluctant to change – in NZ or elsewhere. Why? Could it have something to do with money?

If doctors violate their code of ethics, they face being reprimanded by their professional body. It is high time that the same happens with pharmacists, I feel.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

 

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…

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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.

 

The medical literature is currently swamped with reviews of acupuncture (and other forms of TCM) trials originating from China. Here is the latest example (but, trust me, there are hundreds more of the same ilk).

The aim of this review was to evaluate the effectiveness of scalp, tongue, and Jin’s 3-needle acupuncture for the improvement of post-apoplectic aphasia. PubMed, Cochrane, Embase databases were searched using index words to identify qualifying randomized controlled trials (RCTs). Meta-analyses of odds ratios (OR) or standardized mean differences (SMD) were performed to evaluate the outcomes between investigational (scalp / tongue / Jin’s 3-needle acupuncture) and control (traditional acupuncture; TA and/or rehabilitation training; RT) groups.

Thirty-two RCTs (1310 participants in investigational group and 1270 in control group) were included. Compared to TA, (OR 3.05 [95% CI: 1.77, 5.28]; p<0.00001), tongue acupuncture (OR 3.49 [1.99, 6.11]; p<0.00001), and Jin’s 3-needle therapy (OR 2.47 [1.10, 5.53]; p = 0.03) had significantly better total effective rate. Compared to RT, scalp acupuncture (OR 4.24 [95% CI: 1.68, 10.74]; p = 0.002) and scalp acupuncture with tongue acupuncture (OR 7.36 [3.33, 16.23]; p<0.00001) had significantly better total effective rate. In comparison with TA/RT, scalp acupuncture, tongue acupuncture, scalp acupuncture with tongue acupuncture, and Jin’s three-needling significantly improved ABC, oral expression, comprehension, writing and reading scores.

The authors concluded that compared to traditional acupuncture and/or rehabilitation training, scalp acupuncture, tongue acupuncture, and Jin’ 3-needle acupuncture can better improve post-apoplectic aphasia as depicted by the total effective rate, the ABC score, and comprehension, oral expression, repetition, denomination, reading and writing scores. However, quality of the included studies was inadequate and therefore further high-quality studies with lager samples and longer follow-up times and with patient outcomes are necessary to verify the results presented herein. In future studies, researchers should also explore the efficacy and differences between scalp acupuncture, tongue acupuncture and Jin’s 3-needling in the treatment of post-apoplectic aphasia.

I’ll be frank: I find it hard to believe that sticking needles in a patient’s tongue restores her ability to speak. What is more, I do not believe a word of this review and its conclusion. And now I better explain why.

  • All the primary studies originate from China, and we have often discussed how untrustworthy such studies are.
  • All the primary studies were published in Chinese and cannot therefore be checked by most readers of the review.
  • The review authors fail to provide the detail about a formal assessment of the rigour of the included studies; they merely state that their methodological quality was low.
  • Only 6 of the 32 studies can be retrieved at all via the links provided in the articles.
  • As far as I can find out, some studies do not even exist at all.
  • Many of the studies compare acupuncture to unproven therapies such as bloodletting.
  • Many do not control for placebo effects.
  • Not one of the 32 studies reports findings that are remotely convincing.

I conclude that such reviews are little more than pseudo-scientific propaganda. They seem aim at promoting acupuncture in the West and thus serve the interest of the People’s Republic of China. They pollute our medical literature and undermine the trust in science.

I seriously ask myself, are the editors and reviewers all fast asleep?

The journal ‘BMC Complement Altern Med‘  has, in its 18 years of existence, published almost 4 000 Medline-listed papers. They currently charge £1690 for handling one paper. This would amount to about £6.5 million! But BMC are not alone; as I have pointed out repeatedly, EBCAM is arguably even worse.

And this is, in my view, the real scandal. We are being led up the garden path by people who make a very tidy profit doing so. BMC (and EBCAM) must put an end to this nonsense. Alternatively, PubMed should de-list these publications.

This has been going on for far too long; urgent action is required!

 

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

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

Tony Pinkus, director of AINSWORTH

Tony Pinkus, director of AINSWORTH

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

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

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

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

I must have published well over two dozen articles in the peer-reviewed literature (and many more on this blog) warning of the indirect risks of homeopathy. The most obvious example of such risks is the advice many homeopaths give about vaccinations. Here is, for instance, a quote from an abstract I published in 1996:

… the question whether the homeopath is risk-free in all cases needs discussing. As a case in point, the attitude of some homeopaths towards immunization is quoted as an example of particular concern… the notion of totally risk-free homeopathy is untenable.

Almost a quarter of a century later, it seems that my cautions might finally be heeded. Several of today’s daily papers –THE GUARDIAN, THE DAILY MAIL, THE TIMES and THE DAILY TELEGRAPH – report that the message seems to have reached the higher echelons of the NHS in England. Here are a few short excerpts of what the TELEGRAPH tells its readers.

NHS leaders have gone to war on homeopathy by attempting to have the practice blacklisted amid fears it is fuelling anti-vax propaganda. The chief executive and medical director of NHS England have written to the Professional Standards Authority (PSA), the statutory body that oversees healthcare regulation, urging it to strip accreditation from the Society of Homeopaths (SoH). They argue that endorsing the society affords it a “veneer of credibility” that lures vulnerable patients towards “bogus treatments”.
In particular, the health chiefs accuse homeopaths of propagating “mis-information” about vaccines. It follows the release of a major report last week which showed the uptake of pre-school vaccines is declining…
Mr Stevens said last night: “Anything that gives homeopathy a veneer of credibility risks chancers being able to con more people into parting with their hard-earned cash in return for bogus treatments which at best do nothing, and at worst can be potentially dangerous. Whether touted as a miracle cure or as protection from serious diseases – like so-called homeopathic vaccines – homeopathy is no replacement for rigorously tried and tested medical treatments delivered or prescribed by properly-qualified professionals, and by stopping people seeking expert help, misinformation and ineffective remedies pose a significant risk to people’s health.” His letter points out that both the NHS and the National Institute for Health and Care Excellence (Nice), take the position that homeopathic remedies are not scientifically valid.

________________________________________________________

What can I say?

I am, of course, tempted to say: I told you so!

But, on second thought, I prefer: BETTER LATE THAN NEVER.

And then I am bound to add: next, have a look at some other SCAM providers. Perhaps start with:

In the name of public health, I thank you.

 

 

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