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

medical ethics

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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.

I almost forgot!

This would have been no good, after all, Charles has for decades been the most influential supporter of so-called alternative medicine (SCAM) in the UK. He is one of SCAM’s greatest proponent.

So, here is my up-dated, extended and illustrated summary of his achievements in this area.

HAPPY BIRTHDAY CHARLES!

Charles went on a journey of ‘spiritual discovery’ into the wilderness of northern Kenya. His guru and guide at the time was Laurens van der Post (later discovered to be a fraud and compulsive fantasist and to have fathered a child with a 14-year old girl entrusted to him during a sea voyage).

Van der Post wanted to awake Charles’ mind and attune it to the vitalistic  ideas of Carl Jung’s ‘collective unconscious’, and it is this belief in vitalism that provides the crucial link to alternative medicine: virtually every form of alternative therapies is based on the assumption that some sort of vital force exists. Charles was so taken by van der Post that he made him the godfather of Prince William. After Post’s death, he established an annual lecture in his honour (the lecture series was discontinued after Van der Post was discovered to be a fraud).

Some time in the 1970s, Charles met Jimmy Saville and befriended him. Apparently, Saville later advised Charles on several occasions in various health-related matters.

Throughout the 1980s, Charles lobbied for the statutory regulation of chiropractors and osteopaths in the UK. In 1993, this finally became reality. These two SCAM professions are to this day the only ones regulated by statute in the UK.

Osteopathy has strong Royal links: Prince Charles is the President of the GOsC; Princess Diana was the President of the GCRO; and Princess Anne is the patron of the British School of Osteopathy (statement dated 2011).

In 1982, Prince Charles was elected as President of the British Medical Association (BMA) and promptly challenged the medical orthodoxy by advocating alternative medicine. In a speech at his inaugural dinner as President, the Prince lectured the medics: ‘Through the centuries healing has been practised by folk healers who are guided by traditional wisdom which sees illness as a disorder of the whole person, involving not only the patient’s body, but his mind, his self-image, his dependence on the physical and social environment, as well as his relation to the cosmos.’ The BMA-officials ordered a full report on alternative medicine which promptly condemned this area as implausible nonsense.

Six years later, a second report, entitled Complementary Medicine – New Approaches to Good Practice, heralded an astonishing about-turn stating that: “the demand for non-conventional therapies had become so pressing that organised medicine in Britain could no longer ignore its contribution”. At the same time, however, the BMA set in motion a further chapter in the history of SCAM by insisting that it was “unacceptable” to allow the unrestricted practice of non-conventional therapies, irrespective of training or experience.

In 1993, Charles founded his lobby group which, after being re-named several times, ended up being called the ‘Foundation for Integrated Health’ (FIH). It was closed down in 2010 amidst allegations of money laundering and fraud. Its chief executive, George Gray, was later convicted and went to jail. The FIH had repeatedly been a little economical with the truth.

In 2000, Charles wrote an open letter to The Times stating that…It makes good sense to evaluate complementary and alternative therapies. For one thing, since an estimated £1.6 billion is spent each year on them, then we want value for our money. The very popularity of the non-conventional approaches suggests that people are either dissatisfied with their orthodox treatment, or they find genuine relief in such therapies. Whatever the case, if they are proved to work, they should be made more widely available on the NHS…But there remains the cry from the medical establishment of “where’s the proof?” — and clinical trials of the calibre that science demands cost money…The truth is that funding in the UK for research into complementary medicine is pitiful…So where can funding come from?…Figures from the department of complementary medicine at the University of Exeter show that less than 8p out of every £100 of NHS funds for medical research was spent on complementary medicine. In 1998-99 the Medical Research Council spent no money on it at all, and in 1999 only 0.05 per cent of the total research budget of UK medical charities went to this area…

In 2001, Charles worked on plans to help build a model hospital of integrated medicine. It was to train doctors to combine conventional medicine and alternative treatments, such as homeopathy, Ayurvedic medicine and acupuncture, and was to have up to 100 beds. The prince’s intervention marked the culmination of years of campaigning by him for the NHS to assign a greater role to alternative medicine. Teresa Hale, founder of the Hale Clinic in London, said: “Twenty-five years ago people said we were quacks. Now several branches, including homeopathy, acupuncture and osteopathy, have gained official recognition.” The proposed hospital, which was due to open in London in 2003/4, was to be overseen by Mosaraf Ali, who runs the Integrated Medical Centre (IMC) in London. But the hospital never materialised.

This might be due to Mosaraf Ali falling in disrepute: Raj Bathija, 69 and from India, went for a massage at the clinic of Dr Mosaraf Ali and his brother Imran in 2005 after suffering from two strokes. However, he claims that shortly after the treatment, his legs became pale and discoloured. Four days afterwards, Mr Bathija was admitted to hospital, where he had to have both legs amputated below the knee due to a shortage of blood. According to Mr Bathija, Dr Ali and his brother were negligent in that they failed to diagnose his condition and neglected to advise him to go to hospital. His daughter Shibani said: “My father was in a wheelchair but was making progress with his walking. He hoped he might become a bit more independent. With the amputations, that’s all gone.” Dr Ali was sued (if anyone knows the outcome of this case, please let me know).

At the age of 53, Mrs Parker Bowles went on a trek to the Himalayas to ‘re-energise’ her spirits and encourage her to give up smoking. She was in a party of 12 accompanied by the Prince of Wales’s favourite health guru, Dr Mosaraf Ali. Mrs Parker Bowles subsequently became a regular visitor to Dr Ali’s London practice where she has been encouraged to take up yoga both to combat her back pain and to help her give up smoking.

In the same year, Charles published an editorial in the BMJ promoting his ideas around integrative medicine. Its title: THE BEST OF BOTH WORLDS.

In 2003, Prince Charles’ FIH launched a five-year plan which outlined how to improve access to alternative therapies.

In 2004, Charles publicly supported the Gerson diet as a treatment for cancer and Prof Baum, an eminent oncologist, was invited to respond in an open letter to the British Medical Journal: …Over the past 20 years I have treated thousands of patients with cancer and lost some dear friends and relatives to this dreaded disease…The power of my authority comes with knowledge built on 40 years of study and 25 years of active involvement in cancer research. Your power and authority rest on an accident of birth. I don’t begrudge you that authority but I do beg you to exercise your power with extreme caution when advising patients with life-threatening diseases to embrace unproven therapies.

In 2005, the ‘Smallwood-Report’ was published; it had been commissioned by Charles and paid for by Dame Shirley Porter to inform health ministers. It stated that up to 480 million pounds could be saved, if one in 10 family doctors offered homeopathy as an “alternative” to standard drugs for asthma. Savings of up to 3.5 billion pounds could be achieved by offering spinal manipulation rather than drugs to people with back pain. Because I had commented on this report, Prince Charles’ first private secretary asked my vice chancellor to investigate my alleged indiscretion; even though I was found to be not guilty of any wrong-doing, all local support at Exeter stopped which eventually led to my early retirement. ITV later used this incident in a film entitled THE MEDDLING PRINCE, I later published a full account of this sad story in my memoir.

In a 2006 speechPrince Charles told the World Health Organisation in Geneva that alternative medicine should have a more prominent place in health care and urged every country to come up with a plan to integrate conventional and alternative medicine into the mainstream. But British science struck back. Anticipating Prince Charles’s sermon in Geneva, 13 of Britain’s most eminent physicians and scientists wrote an “Open Letter” which expressed concern over “ways in which unproven or disproved treatments are being encouraged for general use in Britain’s National Health Service.” The signatories argued that “it would be highly irresponsible to embrace any medicine as though it were a matter of principle.”

In 2008, The Times published my letter asking the FIH to withdraw two guides promoting alternative medicine, stating: “the majority of alternative therapies appear to be clinically ineffective, and many are downright dangerous.” A speaker for the FIH countered the criticism by stating: “We entirely reject the accusation that our online publication Complementary Healthcare: A Guide contains any misleading or inaccurate claims about the benefits of complementary therapies. On the contrary, it treats people as adults and takes a responsible approach by encouraging people to look at reliable sources of information… so that they can make informed decisions. The foundation does not promote complementary therapies.”

In 2009, the Prince held talks with the health Secretary to persuade him to introduce safeguards amid a crackdown by the EU that could prevent anyone who is not a registered health practitioner from selling remedies. This, it seems, was yet another example of Charles’ disregard of his constitutional role.

In the same year, Charles urged the government to protect alternative medicine because “we fear that we will see a black market in herbal products”, as Dr Michael Dixon (LVO,2015; OBE 2001), then medical director of Charles’ FIH, put it.

In 2009, the health secretary wrote to the prince suggesting a meeting on the possibility of a study on integrating complementary and conventional healthcare approaches in England. The prince had written to Burnham’s predecessor, Alan Johnson, to demand greater access to complementary therapies in the NHS alongside conventional medicine. The prince told him that “despite waves of invective over the years from parts of the medical and scientific establishment” he continued to lobby “because I cannot bear people suffering unnecessarily when a complementary approach could make a real difference”. He opposed “large and threatened cuts” in the funding of homeopathic hospitals and their possible closure. He complained that referrals to the Royal London homeopathic hospital were increasing “until what seems to amount to a recent ‘anti-homeopathic campaign’”. He warned against cuts despite “the fact that these homeopathic hospitals deal with many patients with real health problems who otherwise would require treatment elsewhere, often at greater expense”.

In 2009, it was announced that the ‘College of Integrated Medicine’ (the name was only later changed to ‘College of Medicine’, see below) was to have a second base in India. An Indian spokesman commented: “The second campus of the Royal College will be in Bangalore. We have already proposed the setting up of an All India Institute of Integrated Medicine to the Union health ministry. At a meeting in London last week with Prince Charles, we finalized the project which will kick off in July 2010”.

In 2010, Charles publicly stated that he was proud to be perceived as ‘an enemy of the enlightenment’.

In 2010, ‘Republic’ filed an official complaint about FIH alleging that its trustees allowed the foundation’s staff to pursue a public “vendetta” against a prominent critic of the prince’s support for complementary medicines. It also suggested that the imminent closure of Ernst’s department may be partly down to the charity’s official complaint about him after he publicly attacked its draft guide to complementary medicines as “outrageous and deeply flawed”.

In 2010, former fellows of Charles’ disgraced FIH launched a new organisation, The College of Medicine’ supporting the use of integrated treatments in the NHS. One director of the college is Michael Dixon, a GP in Cullompton, formerly medical director of the Foundation for Integrated Health. My own analysis of the activities of the new college leaves little doubt that it is promoting quackery.

In 2010, Charles published his book HARMONY which is full of praise for even the most absurd forms of alternative therapies and even bogus diagnostic tests used by alternative practitioners.

In 2011, after the launch of Charles’ range of herbal tinctures, I had the audacity to publicly criticise Charles for selling the Duchy Herbals detox tincture which I named ‘Dodgy Originals Detox Tincture’.

In 2011, Charles forged a link between ‘The College of Medicine’ and an Indian holistic health centre (see also above). The collaboration was reported to include clinical training to European and Western doctors in ayurveda and homoeopathy and traditional forms of medicine to integrate them in their practice. The foundation stone for the extended campus of the Royal College known as the International Institution for Holistic and Integrated Medicine was laid by Dr Michael Dixon in collaboration with the Royal College of Medicine.

In 2012, Charles was nominated for ‘THE GOLDEN DUCK AWARD’ for his achievements in promoting quackery. However, Andrew Wakefield beat him to it; Charles certainly was a deserving runner-up.

In 2013, Charles called for society to embrace a broader and more complex concept of health. In his article he described a vision of health that includes the physical and social environment, education, agriculture and architecture.

In 2013, Charles’ Highgrove enterprise offered ‘baby-hampers’ for sale at £195 a piece and made a range of medicinal claims for the products it contained. As these claims were not supported by evidence, there is no way to classify them other than quackery.

By 2013, the ‘Association of Osteomyologists’ were seeking to become regulated by statute, with the help of Prince Charles as their patron. The chairman and founder of this organisation was knighted for services to alternative medicine.  Osteomyologists encourage the use of techniques including cranio-sacral therapy and claim that “we all know that Colleges, Institutions, and Medical Practitioners, are brain washed from the very outset into believing that their discipline is the only way to go.”

In November 2013, Charles invited alternative medicine proponents from across the world, including Dean Ornish, Michael Dixon, chair of College of Medicine, UK and Issac Mathai of Soukya Foundation, Bangalore, to India for a ‘brain storm’ and a subsequent conference on alternative medicine. The prince wanted the experts to collaborate and explore the possibilities of integrating different systems of medicines and to better the healthcare delivery globally, one of the organisers said.

In June 2014, BBC NEWS published the following text about a BBC4 broadcast entitled ‘THE ROYAL ACTIVIST’ aired on the same day: Prince Charles has been a well-known supporter of complementary medicine. According to a… former Labour cabinet minister, Peter Hain, it was a topic they shared an interest in. He had been constantly frustrated at his inability to persuade any health ministers anywhere that that was a good idea, and so he, as he once described it to me, found me unique from this point of view, in being somebody that actually agreed with him on this, and might want to deliver it. Mr Hain added: “When I was Secretary of State for Northern Ireland in 2005-7, he was delighted when I told him that since I was running the place I could more or less do what I wanted to do.*** I was able to introduce a trial for complementary medicine on the NHS, and it had spectacularly good results, that people’s well-being and health was vastly improved. And when he learnt about this he was really enthusiastic and tried to persuade the Welsh government to do the same thing and the government in Whitehall to do the same thing for England, but not successfully,” added Mr Hain. On this blog, I have pointed out that the research in question was fatally flawed and that Charles, once again, overstepped the boundaries of his constitutional role.

In 2015, two books were published which are relevant in this context. My memoir A SCIENTIST IN WONDERLAND recounts most of my dealings with Charles and his sycophants, including how an intervention from his first private secretary eventually led to the closure of my department. The book by Catherine Meyer CHARLES, THE HEART OF A KING is far less critical about our heir to the throne; it nevertheless severely criticises his stance on alternative medicine.

In October 2015, the Guardian obtained the infamous “black spider memos” which revealed that Charles had repeatedly lobbied politicians in favour of alternative medicine (see also above).

In 2016, speaking at a global leaders summit on antimicrobial resistance, Prince Charles warned that Britain faced a “potentially disastrous scenario” because of the “overuse and abuse” of antibiotics. The Prince explained that he had switched to organic farming on his estates because of the growing threat from antibiotic resistance and now treats his cattle with homeopathic remedies rather than conventional medication. “As some of you may be aware, this issue has been a long-standing and acute concern to me,” he told delegates from 20 countries “I have enormous sympathy for those engaged in the vital task of ensuring that, as the world population continues to increase unsustainably and travel becomes easier, antibiotics retain their availability to overcome disease… It must be incredibly frustrating to witness the fact that antibiotics have too often simply acted as a substitute for basic hygiene, or as it would seem, a way of placating a patient who has a viral infection or who actually needs little more than patience to allow a minor bacterial infection to resolve itself.”

In 2017, the ‘College of Medicine’ mentioned above was discretely re-named ‘College of Medicine and Integrated Health’

In the same year, Charles declared that he will open a centre for alternative medicine in the recently purchased Dumfries House in Scotland. Currently, the College of Medicine and Integrated Health is offering two-day Foundation Courses at this iconic location. Gabriel Chiu, a US celebrity cosmetic and reconstructive surgeon, and his wife Christine, joined the Prince of Wales as he opened the integrated health and wellbeing centre on the Dumfries House Estate in East Ayrshire in 2019. As he unveiled a plaque at the event, Prince Charles said: “I’m so glad that all of you have been able to get here today, particularly because I could not be more proud to see the opening of this new integrated health centre at Dumfries House. It’s something I’ve been wanting to do for the last 35 years. I’m also so proud of all the team at Dumfries House who built it, an all in-house team.

“To reach this point where we can now offer a range of social prescribing opportunities is enormously encouraging and I hope it will be able to make some difference to a lot of the health issues that exist in this area.”

Also in 2017, ‘Country News’ published an article about our heir to the throne stating that Prince of Wales has revealed he uses homeopathic treatments for animals on his organic farm at Highgrove to help reduce reliance on antibiotics, the article stated. He said his methods of farming tried wherever possible to ‘‘go with the grain of nature’’ to avoid dependency on antibiotics, pesticides and other forms of chemical intervention.

In 2018, The Prince of Wales accompanied the Prime Minister of India, Narendra Modi, to the Science Museum in London, and praised Asian medicine practices. The heir to the throne and the Indian Prime Minister then jointly unveiled a plaque for the UK’s first centre of excellence for Indian traditional medicine.

In the same year, it was revealed that UK farmers are being taught how to treat their livestock with homeopathy “by kind permission of His Royal Highness, The Prince Of Wales”

In 2019, the Faculty of Homeopathy announced that His Royal Highness The Prince of Wales had accepted to become Patron of the Faculty of Homeopathy. Dr Gary Smyth, President of the Faculty of Homeopathy comments, “As the Faculty celebrates its 175th anniversary this year, it is an enormous honour for us to receive the Patronage of His Royal Highness The Prince of Wales and I am delighted to announce this news today.” Charles’ move amazed observers who saw it as a deliberate protest against the discontinuation of reimbursement of homeopathy by the NHS.

In 2019, Prince Charles said that yoga had “proven beneficial effects on both body and mind,” and has “tremendous social benefits” that help build “discipline, self-reliance and self-care.”

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So again, Happy Birthday Your Royal Highness – and please don’t forget: it’s not too late to start doing good in the realm of healthcare by supporting good science, critical thinking and evidence-based medicine.

Sincerely yours

Edzard Ernst

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

 

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

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

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

__________________________________________

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

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

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

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

 

 

The 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.

 

The Society of Homeopaths (SoH) is the UK’s professional organisation of lay-homeopaths, therapists who treat patients without having studies medicine. This is what they say about themselves:

Everyone needs a healthcare professional they can trust – one who’s trained to rigorous standards, bound by a strict code of ethics, and subject to independent regulation. That’s what the Society of Homeopaths stands for. We’re the UK’s largest group of professional homeopaths, and the only dedicated register accredited by the Professional Standards Authority, an independent body set up by the government to protect the public.

We work to uphold standards of homeopathic care, support our members in their practices, and help their patients back to good health. We ensure that the letters RSHom are your guarantee of a well-trained, registered and insured professional homeopath.

This sounds fine, but is any of this true? Because of their dubious activities endangering public health, the SoH has attracted my attention many times before (for instance here, here and here). Today, they made national headlines.

It has been reported that Linda Wicks, chair of the Society of Homeopaths (S0H), has shared a series of bizarre petitions claiming that childhood immunisations are unsafe, and calling for The Medicines and Healthcare products Regulatory Agency (MHRH) to be disbanded. Mrs Wicks also posted a petition supporting Andrew Wakefield, the disgraced former doctor who falsely linked the MMR vaccine to autism. It claimed that the scientific establishment’s rejection of his flawed research was ‘the greatest lie ever told’.

Mrs Wicks, a Cornwall-based lay-homeopath and owner of the Linda Wicks Homeopathy Clinic in Truro, has been an adviser to the society for 16 years. She was appointed to the SoH chair in April. She has used her Facebook account to spread ‘anti-vaxx’ propaganda for years. Mrs Wicks must now consider whether such to resign.

Two other members of the board of directors of the SoH are also under pressure to quit. One of them, Francis Treuherz, used his Facebook feed to share a petition describing Mr Wakefield as a ‘hero’ who ought to be ‘honoured’ with the Nobel Peace Prize. In 2016 Treuherz endorsed a campaign urging the then education secretary Justine Greening to ‘STOP vaccination’ of schoolchildren against flu.

The flu petition was shared on Facebook by a third member of the SoH’s board, Maggie Dixon, who owns a homeopathic clinic in Bath. Mrs Dixon works as a member of the ‘team of practitioners’ at Ainsworths, the homeopathic pharmacy boasting of royal warrants from the Queen as well as Prince Charles.

It seems clear to me that the behaviour of Wicks, Treuherz and Dixon endangers public health and is deeply unethical. Considering what the SoH say about themselves (see above), it looks like a bad joke. In my view, it is incompatible with holding an office in a professional organisation of healthcare professionals.

Homeopathy does not have a good name when it comes to advising the public responsibly. Such behaviour is hardly going to improve this situation. The recent call of NHS leaders to stop the accreditation of homeopaths in the UK seems therefore well-justified.

Mrs Wicks meekly apologised yesterday, saying: ‘I regret my association with these petitions and any confusion this may have caused, and I have removed the page which allegedly showed this historic material.’ Confusion? At this stage, I must conclude that she is joking!

The SoH said it was working to improve communication standards ‘with clearer guidelines’. Improve communication standards. Yes, definitely, they are taking the Mikey!

Mr Treuherz and Mrs Dixon did not comment.

So, should they resign?

Would that save the reputation of the SoH?

Is there any reputation to save?

WHAT DO YOU THINK?

I have recently gone to the trouble of evaluating 150 different modalities from the realm of so-called alternative medicine (SCAM) in a book. This is what it tells you about Reiki:

Reiki is a form of paranormal or energy healing popularised by Japanese Mikao Usui (1865-1926). Rei means universal spirit (sometimes thought of as a supreme being) and ki is the assumed universal life energy.

    1. Reiki is based on the assumptions of Traditional Chinese Medicine and the existence of ‘chi’, the life-force that determines our health.
    2. Reiki practitioners believe that, with their hands-on healing method, they can transfer ‘healing energy’ to a patient which, in turn, stimulates the self-healing properties of the body. They assume that the therapeutic effects of this technique are obtained from a ‘universal life energy’ that provides strength, harmony, and balance to the body and mind.
    3. There is no scientific basis for such notions, and reiki is therefore not plausible.
    4. Reiki is used for a number of conditions, including the relief of stress, tension and pain.
    5. There have been several clinical trials testing the effectiveness of reiki. Unfortunately, their methodological quality is usually poor.
    6. A systematic review summarising this evidence concluded that the evidence is insufficient to suggest that reiki is an effective treatment for any condition. Therefore, the value of reiki remains unproven.[1] And a Cochrane review found that there is insufficient evidence to say whether or not Reiki is useful for people over 16 years of age with anxiety or depression or both.[2]
    7. Reiki appears to be generally safe, and serious adverse effects have not been reported. Some practitioners advise caution about using reiki in people with psychiatric illnesses because of the risk of bringing out underlying psychopathology.

PLAUSIBILITY

Negative

EFFICACY

Negative

SAFETY

Positive

COST

Positive

RISK/BENEFIT BALANCE

Negative

[1] https://www.ncbi.nlm.nih.gov/pubmed/?term=lee+pittler+ernst%2C+reikiv

[2] https://www.ncbi.nlm.nih.gov/pubmed/25835541

So, Reiki is both implausible and unproven. Now a new, large trial has emerged that might change this verdict. The main purpose of this study (published in JCAM) was to measure the effect of a single session of Reiki on physical and psychological health in a large nonclinical sample.

The study design was a single arm effectiveness trial with measures at pre-and postintervention. The study took place at private Reiki practices across the United States. Reiki practitioners were recruited from an online mailing list to participate in the study with their Reiki clients. A total of 99 Reiki practitioners met the inclusion criteria and participated in the study. Reiki practitioners were instructed to give a flyer to each of their Reiki clients that contained information about the study and invited the client to complete a survey before and after their Reiki session.

Trained and certified Reiki Masters conducted the Reiki sessions in person, with each session lasting between 45 and 90 min. The 20-item Positive and Negative Affect Schedule was used to assess affect, and brief, single-item self-report measures were used to assess a wide range of physical and psychological variables immediately before (pre) and after (post) the Reiki session.

A total of N = 1411 Reiki sessions were conducted and included in the analysis. Statistically significant improvements were observed for all outcome measures, including positive affect, negative affect, pain, drowsiness, tiredness, nausea, appetite, shortness of breath, anxiety, depression, and overall well-being (all p-values <0.001).

The authors concluded that the results from this large-scale multisite effectiveness trial suggest that a single session of Reiki improves multiple variables related to physical and psychological health.

Really?

This ‘large scale’ effectiveness trial’ could make you laugh and cry at the same time.

  • Laugh, because it is almost comically daft.
  • Cry, because the conclusion is bound to mislead a lot of gullible people.

Without a control group, the study cannot even attempt to determine anything like the effectiveness of Reiki. What the results truly show is that consumers who consult (and pay) a Reiki master expect to have a positive effect. The expectation translates into a sizable placebo response. The investigators seem to be clueless scientists, or they wilfully mislead the public (the senior author is from the ‘The Center for Reiki Research‘ which, according to its mission statement, is dedicated to gaining acceptance for the practice of Reiki by the medical community).

The only conclusion that can honestly be drawn from the data is that consumers who pay for a serivce often like this service (otherwise they would not use it!). It’s a bit like the thing with the hamburger joint that I often cite: if you ask people eating in a McDonalds whether they enjoy hamburgers, most will answer in the affirmative.

But there might be a valuable lesson in this paper after all: never trust the JACM further than you can throw it.

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.

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