The U.S. Food and Drug Administration has issued warning letters to four companies for selling unapproved injectable drug products labelled as homeopathic that can pose serious risks to patient health and violate federal law, as part of the agency’s efforts to protect Americans from potentially harmful products that are labelled as homeopathic.
The FDA is particularly concerned about unapproved injectable drug products labelled as homeopathic because they are injected directly into the body, often directly into the bloodstream and bypass some of the body’s key natural defences against toxins, toxic ingredients and dangerous organisms that can cause serious and life-threatening harm. Additionally, unapproved drugs that claim to cure, treat or prevent serious conditions may cause consumers to delay or stop medical treatments that have been found safe and effective through the FDA review process.
“The FDA’s drug approval requirements are designed to protect patients by ensuring, among other things, that drugs are safe and effective for their intended uses. These unapproved injectable drugs are particularly concerning because they inherently present greater risks to patients because of how they are administered,” said Donald D. Ashley, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “These products are further concerning given that they are labelled to contain potentially toxic ingredients intended for injection directly into the body. These warning letters reflect our continued commitment to patient safety.”
No currently marketed drug products labelled as homeopathic have been approved by the FDA for any use and the agency cannot assure these drugs meet modern standards for safety, effectiveness and quality. Products labelled as homeopathic can be made from a wide range of substances, including ingredients derived from plants, healthy or diseased animal or human sources, minerals and chemicals, and they can include known poisons or toxins. These drugs are often marketed as natural, safe and effective alternatives to approved prescription and non-prescription products and are widely available in the marketplace. Additionally, the lack of premarket quality review is particularly concerning for injectable drugs, which generally pose a greater risk of harm to users because the route of administration for these products bypasses some of the body’s natural defences.
The FDA issued the warning letters to Hevert Pharmaceuticals, LLC; MediNatura, Inc.; 8046255 Canada, Inc., doing business as Viatrexx; and World Health Advanced Technologies, Ltd. The products included in the warning letters are new drugs because they are not generally recognized as safe and effective for their labelled uses, and FDA has not approved these products. Some drugs, such as “Enercel,” marketed by World Health Advanced Technologies, Ltd., are intended for serious diseases such as tuberculosis and hepatitis B and C.
Many of the drugs were labelled to contain potentially toxic ingredients such as nux vomica, belladonna (deadly nightshade), mercurius solubilis (mercury), and plumbum aceticum (lead). For example, nux vomica contains strychnine, which is a highly toxic, well-studied poison that is used to kill rodents. The agency is concerned that these potentially toxic ingredients present additional risks of serious harm when delivered directly into the body, including directly into the bloodstream.
Drugs labelled as homeopathic may also cause significant and even irreparable harm if they are poorly manufactured. Viatrexx was also cited for substandard manufacturing practices for sterile drugs.
The foreign manufacturers of the injectable drugs sold by Hervert Pharmaceuticals, LLC; MediNatura New Mexico, Inc.; and Viatrexx were also placed on import alert 66-41 to stop these drugs from entering the U.S.
The FDA has taken steps to clarify for both consumers and industry how the potential safety risks of these products are assessed. On Oct. 24, 2019, the FDA withdrew Compliance Policy Guide (CPG) 400.400 “Conditions Under Which Homeopathic Drugs May be Marketed,” because it was inconsistent with the agency’s risk-based approach to regulatory and enforcement actions. The FDA also issued a revision of its draft guidance, titled Drug Products Labeled as Homeopathic: Guidance for FDA Staff and Industry, for public comment. When finalized, this guidance will explain the categories of homeopathic drug products that we intend to prioritize under our risk-based enforcement approach. In the interim, before the draft guidance is finalized, the FDA intends to apply its general approach to prioritizing risk-based regulatory and enforcement action.
The FDA encourages health care professionals and consumers to report adverse events or quality problems experienced with the use of any of these products to the FDA’s MedWatch Adverse Event Reporting program. To report adverse drug events in animals, see How to Report Animal Drug Side Effects and Product Problems…
Hevert is of course well known to readers of this blog for their attempt to silence critics of homeopathy in Germany. The FDA’s warning letter refers to their following injectable products:
- “Calmvalera comp.,”
- “Gelsemium comp.,”
- “Hepar comp.,”
- “Lymphaden comp.”
The FDA referred to the following injectable homeopathic products from 8046255 Canada:
- “Systemic Detox,”
- “Neuro 3,”
- “Lymph 1,”
The FDA warning to World Health Advanced Technologies, Ltd referred to:
- “Enercel AM,”
- “Enercel Forte,”
- “Enercel Max,”
- “Enercel Mist-Nasal,”
- “Enercel Mist Nebulizer,”
- “Enercel PM,”
- “Enercel Plus,”
- “Enercel Plus IM.”
The FDA warning referred to the following products by MediNatura, and the claims made for them include:
- Zeel Injection Solution: “… treatment of arthrosis/osteoarthritis, and/or rheumatic joint diseases and for the relief of symptoms such as pain and joint stiffness.”
- Traumeel Injection Solution: “… treatment of injuries, inflammatory and degenerative conditions of the musculoskeletal system and for the relief of associated symptoms such as pain.”
- Engystol Injection Solution: “… support of the immune system to reduce severity and duration of symptoms in viral infections, particularly in the early stages of colds and influenza-like illnesses.”
- Neuralgo-Rheum Injection Solution: “… treatment of nerve pain, soft tissue rheumatism and symptoms of disc protrusion.”
- Lymphomyosot X Injection Solution: “… improvement of lymphatic drainage, the non-specific immune defense, and conditions such as benign hypertrophy of lymph nodes, chronic tonsillitis, tonsillar hypertrophy and lymphatic edema.”
- Spascupreel Injection Solution: “… relief of spasms of the smooth musculature of the gastrointestinal and urogenital tract as well as general muscle spasms.”
The FDA has requested the companies to respond within 15 working days. The letter also states that failure to correct any violations could result in legal action against the company, including seizure and injunction.
Asked for comment, Cliff Clive, founder and CEO for MediNatura, stated that he is disappointed with the FDA’s actions and the company is in the process of developing their response. “The FDAs statements that the MediNatura injectable products present greater risk to consumers is without factual basis,” Clive said. “The MediNatura injectable products are labelled for use only under the care of licensed practitioners [and] are manufactured in [Good Manufacturing Practice]-compliant facilities to assure their quality and sterility.”
Disputing several of the claims made in the letter, Clive noted that rather than protecting patients, “the FDA’s actions threaten to remove valuable alternatives relied upon by medical practitioners in treating their patients. These injections have been used legally by thousands of medical doctors for more than 30 years in the U.S., and in over 50 other countries for more than 60 years, with rigorous monitoring of adverse events,” Clive said. “As a result, there is a substantial amount of epidemiological data which shows that MediNatura’s injection products have a superb safety profile.”
As far as I can see, none of the above-named products are supported by sound evidence. If you ask me, it is time that homeopaths understand what proofs of safety and efficacy amount to, that they stop confusing the public, and that they stop marketing illegal products.
By guest blogger Loretta Marron
If scientists were fearful of a clinical trial’s producing negative results, would they even pursue it? A draft Chinese regulation issued in late May aims to criminalise individual scientists and organisations whom China claims damage the reputation of Traditional Chinese Medicine (TCM).
Beijing has a reputation for reprimanding those who decry TCM. Such criticism is blocked on Chinese Internet. Silencing doctors is becoming the norm.
In January 2018, former anaesthetist, Tan Qindong, was arrested and spent more than three months in detention after criticising a widely advertised, best-selling ‘medicinal’ TCM liquor. Claiming that it was a ‘poison’, he believed that he was protecting the elderly and vulnerable patients with high blood pressure. Police claimed that a post on social media damaged the reputation of the TCM ‘liquor’ and of the company making it. Shortly after release, he suffered post-traumatic stress and was hospitalised.
On 30 December 2019, Chinese ophthalmologist, the late Dr Li Wenliang, was one of the first to recognise the outbreak of COVD-19. He posted a private warning to a group of fellow doctors about a possible outbreak of an illness resembling severe acute respiratory syndrome (SARS). He encouraged them to protect themselves from infection. Days later, after his post when viral, he was summoned to the Public Security Bureau in Wuhan and forced to “admit to lying about the existence of a worrying new virus”. Li was accused of violating the provisions of the “People’s Republic of China Public Order Management and Punishment Law” for spreading “unlawful spreading of untruthful topics on the internet” and of disturbing the social order. He was made to sign a statement that he would “halt this unlawful behaviour”.
In April 2020, Chinese physician Yu Xiangdong, a senior medico who worked on the front line battling COVID-19, posted on Weibo, a Twitter-like site, a criticism of the use of antibiotics and TCM to treat COVID-19. He was demoted from his positions as assistant dean at the Central Hospital in the central city of Huangshi and director of quality management for the city’s Edong Healthcare Group. Well known for promoting modern medicine amongst the Chinese, Yu had almost a million followers on social media. All his postings vanished.
Beijing insists that TCM has been playing a crucial role in COVID-19 prevention, treatment and rehabilitation. Claims continue to be made for “effective TCM recipes”. However, no randomised clinical trial has been published in any reputable journal.
TCM needs proper scrutiny, but criticising it could land you years in prison. If the benefits of suggested herbal remedies are to be realised, good clinical studies must be encouraged. For TCM, this might never be permitted.
Don’t think for a moment that you are safe in Australia.
Traditional Chinese Medicine Services (“TCM”)
- Within the relevant committees to be established in accordance with this Agreement, and subject to available resources, Australia and China shall cooperate on matters relating to trade in TCM services.
- Cooperation identified in paragraph 2 shall:
(a) include exchanging information, where appropriate, and discussing policies, regulations and actions related to TCM services; and
(b) encourage future collaboration between regulators, registration authorities and relevant professional bodies of the Parties to facilitate trade in TCM and complementary medicines, in a manner consistent with all relevant regulatory frameworks. Such collaboration, involving the competent authorities of both Parties – for Australia, notably the Department of Health, and for China the State Administration of Traditional Chinese Medicine – will foster concrete cooperation and exchanges relating to TCM.
The Foundation for Integrated Health (FIH) does no longer exist. But it is historically important, in my view. So, I decided to do some research in order to document its perplexing history. In the course of this activity, I found that someone had beaten me to it. This article that does the job very well; I therefore take the liberty of copying it here and adding a few points at the end:
The Foundation for Integrated Health (FIH) was a controversial charity run by Charles, Prince of Wales, founded in 1993. The Foundation promoted complementary and alternative medicine, preferring to use the term “integrated health”, and lobbied for its inclusion in the National Health Service. The charity closed in 2010 after allegations of fraud and money laundering led to the arrest of a former official.
Dr Michael Dixon was appointed the Foundation’s medical director. From 2005 to 2007, FIH received a grant from the Department of Health to help organise the self-regulation of complementary therapies. There had been concern that with a large proportion of the public turning to complementary approaches, there were few safeguards in place to ensure that non-statutorily regulated therapists were safe, trained and would act in an appropriate way. FIH worked to bring together the representative bodies of many complementary professions to talk and agree standards. The result was the formation of the Complementary and Natural Healthcare Council (CNHC) which had hoped to register 10,000 practitioners of complementary medicine by the end of 2009 but which by September 2009 had succeeded in enrolling less than a tenth of that number due to lack of interest on the part of some of their professional associations. The Department of Health is currently continuing to fund the CNHC but future funding will be dependent on substantial progress being made towards the target (which has now been reduced to 2,000). Alternative medicine campaigners argued that the move toward regulation conferred undue respectability on unproven and possibly unsafe complementary & alternative medicine (CAM) approaches.
FIH also worked with medical schools to increase the understanding of complementary approaches amongst new doctors and ran an annual awards ceremony for integrated health schemes both within the medical world and in the community.
The papers of the Foundation for Integrated Health are held at the Wellcome Library, Archives and Manuscripts, and are available for consultation by appointment. Further details about the collection can be found on the Wellcome online catalogue.
The Prince of Wales has demonstrated an interest in alternative medicine, the promotion of which has occasionally resulted in controversy. In 2004, the Foundation divided the scientific and medical community over its campaign encouraging general practitioners to offer herbal and other alternative treatments to National Health Service patients, and in May 2006, The Prince made a speech to an audience of health ministers from various countries at the World Health Assembly in Geneva, urging them to develop a plan for integrating conventional and alternative medicine.
In April 2008, The Times published a letter from Professor Edzard Ernst that asked the Prince’s Foundation to recall two guides promoting “alternative medicine”, saying: “the majority of alternative therapies appear to be clinically ineffective, and many are downright dangerous.” A speaker for the foundation 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.” Ernst has recently published a book with science writer Simon Singh condemning alternative medicine called Trick or Treatment: Alternative Medicine on Trial . The book is ironically dedicated to “HRH the Prince of Wales” and the last chapter is very critical of his advocacy of “complementary” and “alternative” treatments.
The Prince’s Duchy Originals have produced a variety of CAM products including a “Detox Tincture” that Ernst has denounced as “financially exploiting the vulnerable” and “outright quackery“. In May 2009, the Advertising Standards Authority criticised an email that Duchy Originals had sent out to advertise its Echina-Relief, Hyperi-Lift and Detox Tinctures products saying it was misleading.
In Ernst’s book More Good Than Harm? The Moral Maze of Complementary and Alternative Medicine he and ethicist Kevin Smith call Charles “foolish and immoral” and “conclude that it is not possible to practice alternative medicine ethically”. Ernst further claims that the private secretary of the Prince contacted the vice chancellor of Exeter University to investigate Ernst’s complaints against the “Smallwood Report” which the Prince had commissioned in 2005. While Ernst was “found not to be guilty of any wrong-doing, all local support at Exeter stopped, which eventually led to my early retirement.”
The Prince personally wrote at least seven letters to the Medicines and Healthcare products Regulatory Agency (MHRA) shortly before they relaxed the rules governing labelling of herbal products such as the ones sold by his duchy, a move that has been widely condemned by scientists and medical bodies.
On 31 October 2009 it was reported that Prince Charles had personally lobbied Health Secretary Andy Burnham regarding greater provision of alternative treatments on the NHS.
Charity Commission complaint
Fraud allegations and closure
In 2010, following accounting irregularities noted by the foundation’s auditor, it was reported that the Metropolitan Police Economic and Specialist Crime Command had begun an inquiry into alleged fraud. Within weeks, two former officials at the Prince’s Foundation were arrested for fraud believed to total £300,000. Four days later, on 30 April 2010, the foundation announced that it would close. The foundation stated that its closure was the result of the fraud allegations.
Rebranding as “The College of Medicine”
Following the disbanding of the Prince’s Foundation, many of the individuals and organisations involved launched a new organisation in late 2010 called The College of Medicine, with which the Prince of Wales was not overtly involved. Several commentators writing in The Guardian and The British Medical Journal, have expressed the opinion that the new organisation is simply a re-branding of the Prince’s Foundation, describing it as “Hamlet without the Prince”.
In support of this connection with Prince Charles, alternative medicine critic and pharmacologist David Colquhoun has argued that the College (originally called “The College of Integrated Health”) is extremely well-funded and seemed from the beginning to be very confident of the Prince’s support; explicitly describing its mission as “to take forward the vision of HRH the Prince of Wales”.
- Robert Booth (26 April 2010). “Prince Charles’s aide at homeopathy charity arrested on suspicion of fraud”. London: guardian.co.uk.
- Regulating complementary therapies – Prince’s Foundation for Integrated Health
- “Wellcome Library Western Manuscripts and Archives catalogue”. Archives.wellcomelibrary.org. Retrieved 2015-09-07.
- Barnaby J. Feder, Special To The New York Times (9 January 1985). “More Britons Trying Holistic Medicine — New York Times”. Query.nytimes.com. Retrieved 2008-10-12.
- Carr-Brown, Jonathon (14 August 2005). “Prince Charles’ alternative GP campaign stirs anger”. The Times. London. Retrieved 11 March 2009.
- Revill, Jo (2004-06-27). “Now Charles backs coffee cure for cancer”. London: The Observer. Retrieved 2007-06-19.
- Cowell, Alan (2006-05-24). “Lying in wait for Prince Charles”. The New York Times. Retrieved 2009-10-15.
- Henderson, Mark (17 April 2008). “Prince of Wales’s guide to alternative medicine ‘inaccurate‘“. London: Times Online. Retrieved 2008-08-30.
- Singh, S. & Ernst, E. (2008). Trick or Treatment: Alternative Medicine on Trial. Corgi.
- Tim Walker (31 Oct 2009). “Prince Charles lobbies Andy Burnham on complementary medicine for NHS”. London: Daily Telegraph. Retrieved 2010-04-01.
- “Duchy Originals Pork Pies”. The Quackometer Blog. 11 March 2009.
- Ernst, Edzard (2018). “Why Did We Call Prince Charles Foolish and Immoral?”. Skeptical Inquirer. Committee for Skeptical Inquiry. 42 (3): 8–9.
- Charity Commission. The Prince’s Foundation for Integrated Health, registered charity no. 1026800.
- The Prince’s Foundation for Integrated Health – 2007 accounts (PDF), Charity Commission, retrieved 2010-04-30
- “HRH “meddling in politics““. DC’s Improbable Science. March 12, 2007.
- Nigel Hawkes & Mark Henderson (September 1, 2006). “Doctors attack natural remedy claims”. The Times. London.
- Booth, Robert (19 March 2010). “Prince Charles health charity accused of vendetta against critic”. London: The Guardian.
- Delgado, Martin; Young, Andrew (4 April 2010). “Police probe into missing £300k at Prince Charles’ charity after bosses fail to file accounts”. Daily Mail. London.
- “Prince Charles charity to close amid fraud inquiry”. BBC News. 30 April 2010.
- Robert Booth (30 April 2010). “Prince of Wales’s health charity wound up in wake of fraud investigation”. The Guardian.
- Laura Donnelly (15 May 2010). “Homeopathy is witchcraft, say doctors”. London: The Telegraph.
- Ian Sample (August 2, 2010). “College of Medicine born from ashes of Prince Charles’s holistic health charity”. London: The Guardian.
- Peter Dominiczak (20 August 2010). “Three years jail for accountant at Charles charity who stole £253,000”. Evening Standard. Archived from the original on 30 June 2011. Retrieved 2 February 2011.
- Jane Cassidy (15 June 2011). “Lobby Watch: The College of Medicine”. British Medical Journal. 343: d3712. doi:10.1136/bmj.d3712. PMID 21677014.
- David Colquhoun (12 July 2011). “The College of Medicine is Prince’s Foundation reincarnated”. British Medical Journal. 343: d4368. doi:10.1136/bmj.d4368. PMID 21750061.
- James May (12 July 2011). “College of Medicine: What is integrative health?”. British Medical Journal. 343: d4372. doi:10.1136/bmj.d4372. PMID 21750063.
- Edzard Ernst (12 July 2011). “College of Medicine or College of Quackery?”. British Medical Journal. 343: d4370. doi:10.1136/bmj.d4370. PMID 21750062.
- Nigel Hawkes (2010). “Prince’s foundation metamorphoses into new College of Medicine”. 341. British Medical Journal. p. 6126. doi:10.1136/bmj.c6126.
- David Colquhoun (July 25, 2010). “Buckinghamgate: the new “College of Medicine” arising from the ashes of the Prince’s Foundation for Integrated Health”. DC’s Improbable Science.
- David Colquhoun (29 October 2010). “Don’t be deceived. The new “College of Medicine” is a fraud and delusion”.
- Lewith, G. T.; Catto, G; Dixon, M; Glover, C; Halligan, A; Kennedy, I; Manning, C; Peters, D (12 July 011). College of Medicine replies to its critics”. British Medical Journal. 343: d4364. :10.1136/bmj.d4364. 21750060.
This article is, as far as I can see, factually correct. I might just add some details:
- Dixon became medical director of the FIH only a few months before it had to close.
- The FIH was also involved in Prince Charles’ complaint about me alleging I had breached confidence in relation to the Smallwood report, even though the FHI had officially nothing to do with the report.
- Mr Smallwood told me that, at that stage, Prince Charles considered the FIH to be ‘a waste of space’.
- Some time ago, the College of Medicine quietly re-named itself as the ‘College of Medicine and Integrated Health’.
- Prince Charles recently became the patron of the College of Medicine and Integrated Health.
This study by Australian pharmacists, assessed the quality and relevance of community pharmacists’ information gathering (questioning), counselling and product selection when interacting with customers requesting a s0-called alternative medicine (SCAM) product for stress and consequently determine whether Australian pharmacy practice indicates the need for guidelines similar to those provided for ‘pharmacy only’ (S2) and ‘pharmacist only’ (S3) medicines.
A covert simulated patient (SP) was used to investigate the response of pharmacists to a request for a natural product for stress. The SP documented the details of the pharmacist-simulated patient interaction immediately on leaving the pharmacy and then re-entered the pharmacy to debrief the pharmacist. The quality of the interaction was scored as a Total CARE (check, assess, respond, explain) Score, based on anticipated questions and counselling advice. The appropriateness of the product was scored as a Product Efficacy Score, based on evidence-based literature.
Data from 100 pharmacies was provided. Information gathering illustrated by the questioning components Check and Assess (C and A) of the total CARE score by pharmacists was poor. The number of questions asked ranged from zero (13 pharmacists) to 7 (four pharmacists), the average being 3.1 (SD 1.9). Provision of advice was generally better (a description of the suggested product was offered by 87 pharmacists) but was lacking in other areas (duration of use and side effects were explained by only 41 and 16 pharmacists respectively). The most common product suggested was B-group vitamins (57 pharmacists) followed by a proprietary flower essence product (19 pharmacists). A two-step cluster analysis revealed two sub-groups of pharmacists: one cluster (74 pharmacists) with a high Total CARE score provided an appropriate product. The other cluster (20 pharmacists) had a low total CARE score and provided an inappropriate product.
The authors concluded that the pharmacy visits revealed major shortcomings in questioning, counselling and product recommendation. There is a need to develop guidelines for pharmacists to make evidence-based decisions in recommending SCAMs.
This paper offers a host of interesting information. For instance, it reveals that almost all pharmacists recommended at least one product for sale, about half of them recommended more than one. Considering that the evidence for most of the products in question is weak (to say the least), this seems concerning.
The second most recommended product, the ‘Bach Rescue Remedy‘, is perhaps a good case in point. There is no evidence that it has any effect on stress or any other condition. As the product contains no active ingredient, it is also implausible to assume it might work beyond placebo. Yet, many pharmacists are happy not only to sell it to the unsuspecting public, but even to recommend it to a customer who seeks out their advice.
I find this quite intolerable.
The paper thus confirms the point I have made repeatedly on this blog and elsewhere: community pharmacists seem to behave like commercially motivated shopkeepers, yet they are healthcare professionals who have to abide by an ethical code. When confronted with this overt conflict of interest, their vast majority seem to opt for violating their professional ethics in favour of profit.
I fail to understand why, despite these facts being well-known for so long, the professional organisations of pharmacists are doing do very little to rectify this appalling situation.
Boris Johnson said we should take the coronavirus ‘on the chin’ and count on ‘herd-immunity’. This, he claimed, is what his scientific advisers recommended.
I find this very hard to believe and have many doubts and questions.
To start with, I doubt that this is what Johnson’s scientific advisers recommend – it is a solution that SOME of his scientific advisers recommend. And it is a solution that seems easy to follow. It is, however, by no means the only strategy for tacking the pandemic; it is just one of several options.
The fact that all other countries have opted for other solutions, suggests to me that it is an unusual path to go down to. The modellers who obviously like it had to make a number of assumptions; that’s what modellers always have to do and rarely tell us about. But what if not all of these assumptions are correct?
The herd-immunity strategy counts on the fact that, once a certain percentage of the population has taken the infection ‘on the chin’, it is immune and therefore the transmission of the virus within such a population will be dramatically reduced or even zero. The percentage of the population needed for that to happen depends on how contagious the virus is. For the measles virus, herd immunity requires 90% of the population to be immune. For the coronavirus, the figure is said to be 60 – 70%. Is that an assumption or a fact? If it is a current fact, would the figure change, if the virus mutates? Could it be that a mutated virus can re-infect formerly immune people?
But let’s postulate that the herd-immunity assumption is both correct and stable. Johnson’s herd-immunity strategy would thus require that about 40 million Brits get infected with the virus to generate the required herd-immunity. Assuming a mortality rate of 1 – 2%, this means that Johnson is cheerfully accepting 400 000 – 800 000 fatalities.
But, as I said, this scenario is based on wild assumptions. It applies only if the virus does not mutate. And it only applies, if we do not run out of intensive care (IC) beds. However, running out seems possible, perhaps even likely, considering that we have only about half of the French and just one third of the German IC capacity. Sod’s law has it that both might happen. In this case, we might easily have far in excess of 800 000 fatalities. How should we take that ‘on the chin’, Mr Johnson?
Sadly, this is not all; I have further doubts about our PM’s ideas.
The present strategy regarding diagnosis of coronavirus cases is to self-isolate once suspicious symptoms start. Even if someone is seriously ill (with high fever etc.), they are told to stay at home and sit it out. This means we will never know whether these patients had or had not suffered from a coronavirus infection. How then can we ever be sure that the 60% target of infection has been reached? And if we are uncertain about it, how can we be sure that herd-immunity will work in the way the modellers predicted?
Moreover, we now know that people who caught the virus are infective BEFORE they develop symptoms. If that is so, the strategy of self-isolation will be far less effective than predicted. And, given this fact, are we not much more likely to have a sharp peak of cases early on which would make us run out of IC capacity? When that happens, even the pessimistic death rates might turn out to be too optimistic.
It seems to me that Johnson’s herd-immunity strategy is risky to the point of being reckless. It also seems to me that there are very good reasons why other countries have not adopted it.
But what is the solution?
In my view, the solution cannot be to uncritically adopt the theories and assumptions of modellers. This is not a computer game; we are talking about human lives, many human lives!
I wish I new what the best solution is – but I don’t. I merely fear that ‘taking it on the chin’ is not a solution at all. In any case, a wise move for Johnson and his team might be to consider that foreigners might be at least as clever as they are. Subsequently they could carefully study the actions of those countries which managed to bring down their death-rates despite being attacked by the coronavirus.
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They recently conducted independent lab tests on the purity of 33 samples of essential ois from well-known names in the essential oil industry to see what was really inside each bottle. Their report raises lots of concerns, in my view. The team that wrote the report kindly sent me a summary and asked me to publish it here which I now do without any alteration, abbreviation or further comment:
Everybody’s talking about essential oils. More importantly, everybody’s using them. The global demand for these fragrant chemical compounds reached an extraordinary 226.9 kilotons in 2018 and further growth is projected by the marketing people who measure such things. The proliferation of essential oil users is tied to growth in the food and beverage, personal care and aromatherapy industries.
It’s not surprising that the scientific study of essential oils has also increased with demand for the products. The best essential oil brands invest in quality testing but don’t necessarily follow scientific protocol or make detailed testing results available to consumers. So the literature is still limited— and the jury is still out on whether these compounds are effective in treating medical conditions.
Essential oils are extracted from plants. In their pure form, they are highly concentrated—and sometimes toxic. To make them practical to use, essential oils are typically mixed with diluting carrier oils. Methods of extraction include cold-pressing, steam and water distillation, and the use of chemical solvents. Evaluating individual products made with essential oils is challenging because there are thousands of brands on the market. Neither the extraction methods used or the potency of the products—let alone, testing methods—are standardized. Manufacturers’ ambitious marketing claims, which often rely on ambiguous language, further obscure consumers’ ability to judge for themselves which oils are best suited to their purposes. The list of problems some products purport to solve can run the gamut from an itchy scalp to menopause symptoms.
What’s more, few essential oil manufacturers educate consumers on proper dosage or contraindications, which can lead to accidental misuse and illness. Children are particularly sensitive to many oils and yet most manufacturers fail to warn against applying oils to children’s skin. Pregnant women are usually advised not to use essential oils during their first trimesters, though some studies have suggested they can help alleviate pain during childbirth. Some essential oils should never be used during pregnancy. Essential oils can interact or interfere with prescription medicines and nutritional supplements. But unlike prescription drugs, they don’t come with warning labels about these potential interactions.
Genuinely scientific, peer-reviewed studies of essential oils have primarily focused on using aromatherapy as an adjunct to conventional medical treatment. Science has confirmed that when inhaled, essential oil molecules travel quickly to the brain—specifically the limbic region, which controls pulse, respiration, sexual arousal, and other autonomic functions. Emotional responses like fear and motivation originate in the limbic system. The most promising applications of aromatherapy appear to be in diminishing stress and offering pain relief. But actual clinical trials into such topics as reducing nausea in by chemotherapy patients, relieving anxiety during childbirth, alleviating headaches, and improving sleep have been inconclusive.
Other studies have focused on the subject of inflammation, which is known to contribute to a wide range of medical problems. Essential oils derived from the thyme, clove, rose, eucalyptus, fennel, and bergamot have been demonstrated through one study to activate chemicals in the body which suppress inflammation and suppress chemicals that activate it.
Researchers are also exploring the potential of essential oils as antibacterial agents. Parts of the juniper, cumin, coriander and lavender plants may be effective in battling E coli, while cinnamon may prove useful in treating strep throat and pneumonia.
As ancient and traditional as their use may be in certain cultures, the scientific reality is it’s too early to tell how effective essential oils are in treating the wide range of conditions they are theorized (and now, commonly advertised) to treat.
But that’s not to say you shouldn’t use them, according to recommendations from your doctor. When considering the efficacy of essential oils, bear in mind that the act of self-care can be therapeutic in and of itself. We all know that treating ourselves to a hot bath—or an ice cream cone for that matter—can give us a temporary sense of well-being. For the time being, short-term selfsoothing may be all we can count on from essential oils. But there’s something to be said for even temporary relief. An entire industry of over-the-counter medicines has been founded upon it.
Guest post by Richard Rasker
Almost two years ago, in March 2018, a group of 124 doctors and other medical professionals published an article in the French newspaper ‘Le Figaro’, warning the general public for the false promises, unproven claims and dangers of alternative medicine.
Homeopathy in particular is denounced as an unscientific belief in magic, utterly lacking in plausibility as well as in evidence of efficacy for any condition. Subjecting people to these kinds of unproven treatments is unethical, and may result in serious harm by delaying proper medical treatment. Also, homeopaths and other alternative practitioners often express anti-vaccine sentiments, endangering children by dissuading their parents from vaccination.
For these and several other reasons, these 124 medical professionals made an appeal for alternative and esoteric treatments to be excluded from the field of science-based medicine, and to stop reimbursement of homeopathic and other alternative treatments under France’s national health care insurance system.
In a somewhat belated response, French homeopaths are now filing no less than 63 disciplinary complaints with the French Medical Council against the signatories of the appeal in Le Figaro, apparently for “uncollegial behaviour” and “defiling medical ethics”. The homeopaths are represented by homeopathic doctor Daniel Scimeca, president of the French Federation of Homeopathic Societies, who also has close relations with Boiron laboratories, the biggest manufacturer of homeopathic products in the world.
At the time of this writing, 11 complaints have been adjudicated, resulting in 7 warnings, and 4 releases or dismissals. It is unclear how serious such a ‘warning’ should be taken, but it is clear that homeopaths are trying to punish real doctors for supporting and expressing an overwhelming scientific consensus, i.e. that there is no evidence whatsoever that homeopathy is actually good for anything.
And even though these French homeopaths do not resort to the sort of vile, underhanded media smear campaign perpetrated by the late Claus Fritzsche against Dr. Ernst, there are certain parallels – the most important of which is that proponents of unproven ‘medicine’ attempt to silence science-based criticism by unscientific means, instead of open discourse about the merits (or more precisely: the lack thereof) of their chosen profession.
I personally find it rather worrying that almost two-thirds of the complaints resulted in a slap on the wrist for the medical professional involved. Especially in a field that is so strongly dependent on both science and trust, well-founded criticism should be encouraged and made public, not punished and silenced.
I have to admit, I only read the DAILY MAIL, if I have to (and certainly not today). This is probably why I missed this article announcing the 1st traditional Chinese medicine to be licensed in the UK.
The plant Sigesbeckia, which has an unpleasant smell, is renowned for its ability to treat aches and pains – including those caused by arthritis. It is the active ingredient in Phynova Joint and Muscle Relief Tablets, which have just been licensed by drug safety watchdog the Medicines and Healthcare Products Regulatory Agency.
The directive also made it more difficult for medicines to get a licence as it demanded they had to have been in use for 30 years, of which at least 15 years had to be in the EU. Some Western herbal medicines have managed to gain licences in a process costing thousands of pounds to verify their ingredients. But the Phynova tablets are the first traditional Chinese medicine to be approved.
Robert Miller, chief executive of Oxford-based Phynova, said he was ‘extremely proud’, adding: ‘This has come from years of working with our Chinese colleagues. ‘Britain can now benefit from having access to high quality, regulated Chinese medicines.’ He also said that the company is planning to apply for a licence for a second traditional Chinese medicine, a cold and flu remedy.
Dr Chris Etheridge, a medical herbalist and adviser to Potter’s Herbals, celebrated the ‘good news’, adding that Sigesbeckia, which is not commonly used in the West, ‘offers an alternative to those who prefer not to take non-steroidal anti-inflammatory drugs for muscle and joint pain’.
But Michael McIntyre, chairman of the European Herbal and Traditional Medicine Practitioners Association, warned that the new product demonstrates the difficulties the EU rules created for supplying herbal products safely to the public. He said it is ‘almost impossible to satisfy the licensing conditions’. He added that some people have therefore turned to the internet to buy unlicensed products, but this means they have ‘no idea whether they are safe or effective’.
Exciting enough to do a quick search for the evidence. Are there any clinical trials to show or suggest that this herbal remedy does anything other than filling the bank account of the manufacturer? Sadly, the answer seems to be NO! At least, I could not find a single such study (if anyone knows more, I’d be pleased to stand corrected).
Frustrated I looked at the website of the manufacturer. Here I found this:
Exclusively containing Sigesbeckia extract, Phynova Joint and Muscle Relief Tablets is a traditional herbal medicinal product used for the relief of backache, rheumatic, joint and muscle pain as well as minor sports injuries. Sigesbeckia has been used for thousands of years around the world to relieve painful joints and muscles.
– Relief from joint & muscle pain
– Gentle on the stomach
– No known side effects
– No known drug indications or contraindications
– Can be taken with or without food
What can Sigesbeckia be used to treat?
Traditionally used for arthritic pain, rheumatic pain, back pain and sciatica. Today, Sigesbeckia can be used for;
Back pain can occur through a sprain or strain, spasms, nerve compression, herniated discs and other problems in your lower, middle and upper back.
Poor posture, lifting and stretching, sudden movements placing strain on your lower back and sports injuries, are amongst the main culprits for causing back pain.
Minor sports injuries
Minor sports injuries can be caused by an accident such as a fall or blow, not warming up properly before exercise, pushing yourself too hard and not using the appropriate equipment or perhaps poor technique.
Rheumatic and muscular pain
Common causes of rheumatic and muscle pain can be due to; tension and stress, lack of minerals, certain medication, dehydration, sprains and strains, sleep deficiency, too much physical activity and sometimes other underlying health conditions and diseases.
General aches and pains in muscles and joints
Overexertion due to a new exercise routine or from a sprain or strain can cause general aches and pains in muscles and joints. But so too can modern day busy life. The impact on our bodies can trigger aches and pains in your muscles and joints and lower your resistance to illness and disease.
The Benefit of Sigesbeckia extract
One of the benefits of Sigesbeckia extract, as used in approved licensed products, is that it has no known side effects or interactions with other medications according to the Summary of Product Characteristics (SmPC). Always check that the product you purchase is an approved Traditional Herbal Medicine Product in the UK.
In summary: Look after your joints and muscles with Sigesbeckia
Our bodies are all different, and our approach and tolerances will vary. Used for over a thousand years and known for its anti-inflammatory and mobility benefits alongside being used for joint and muscle pain; Sigesbeckia is a herbal medicine that works best when used over time.
Looking for a traditional remedy for joint and muscle relief? Why not try Sigesbeckia?
But again no sign of a clinical trial to back up this plethora of therapeutic claims. How can this be? The answer lies in the directive mentioned in the Mail article. To obtain a licence that enables the manufacturer to make therapeutic claims, a herbal remedy merely needs to demonstrate that it has been in use for 30 years, of which at least 15 years had to be in the EU.
I think I understand the intention of the directive. But I would nevertheless have thought that, 4 years after obtaining a license, the manufacturer could have conducted a study to test whether the product works. In my view this should be a moral and ethical, if not legal obligation. The ‘test of time’ is woefully insufficient and unreliable and no basis for generating progress or securing the best interests of patients.
Considering the total lack of efficacy and safety data, do you agree that the above comment by Michael McIntyre are ironic to the extreme? And do you agree that manufacturers who manage to obtain such a license should be obliged to deliver a proof of efficacy within a reasonable period of time?
Many patients with chronic pain (CP) are prescribed opioids, a situation which has led to the much-discussed opioid crisis. Integrative medicine (IM), which combines pharmacological and so-called alternative medicine (SCAM), has been proposed as a solution. Yet, the role of SCAM therapies in reducing opioid use remains unclear.
This systematic review explored the effectiveness of the IM approach or any of the SCAM therapies to reduce or cease opioid use in CP patients. Electronic searches yielded 5,200 citations. Twenty-three studies were selected. Eight studies were randomized controlled trials, seven were retrospective studies, four studies were prospective observational, three were cross-sectional, and one was quasi-experimental. The majority of the studies showed that opioid use was reduced significantly after using IM/SCAM. Cannabinoids were among the most commonly investigated approaches in reducing opioid use, followed by multidisciplinary approaches, cognitive-behavioral therapy, and acupuncture. The majority of the studies had limitations related to sample size, duration, and study design.
The authors concluded that there is a small but defined body of literature demonstrating positive preliminary evidence that the IM approach including SCAM therapies can help in reducing opioid use. As the opioid crisis continues to grow, it is vital that clinicians and patients be adequately informed regarding the evidence and opportunities for IM/SCAM therapies for CP.
I am unimpressed by this review.
And here is why:
- Because of their design, most of the included studies do not allow any conclusions about cause and effect.
- The 8 RCTs that would allow such conclusions are mostly of poor quality.
- Some of the 8 RCTs are not even what the review authors claim to be. Here is just one example:
Background: Current levels and dangers of opioid use in the U.S. warrant the investigation of harm-reducing treatment alternatives.
Purpose: A preliminary, historical, cohort study was used to examine the association between enrollment in the New Mexico Medical Cannabis Program (MCP) and opioid prescription use.
Methods: Thirty-seven habitual opioid using, chronic pain patients (mean age = 54 years; 54% male; 86% chronic back pain) enrolled in the MCP between 4/1/2010 and 10/3/2015 were compared to 29 non-enrolled patients (mean age = 60 years; 69% male; 100% chronic back pain). We used Prescription Monitoring Program opioid records over a 21 month period (first three months prior to enrollment for the MCP patients) to measure cessation (defined as the absence of opioid prescriptions activity during the last three months of observation) and reduction (calculated in average daily intravenous [IV] morphine dosages). MCP patient-reported benefits and side effects of using cannabis one year after enrollment were also collected.
Results: By the end of the 21 month observation period, MCP enrollment was associated with 17.27 higher age- and gender-adjusted odds of ceasing opioid prescriptions (CI 1.89 to 157.36, p = 0.012), 5.12 higher odds of reducing daily prescription opioid dosages (CI 1.56 to 16.88, p = 0.007), and a 47 percentage point reduction in daily opioid dosages relative to a mean change of positive 10.4 percentage points in the comparison group (CI -90.68 to -3.59, p = 0.034). The monthly trend in opioid prescriptions over time was negative among MCP patients (-0.64mg IV morphine, CI -1.10 to -0.18, p = 0.008), but not statistically different from zero in the comparison group (0.18mg IV morphine, CI -0.02 to 0.39, p = 0.081). Survey responses indicated improvements in pain reduction, quality of life, social life, activity levels, and concentration, and few side effects from using cannabis one year after enrollment in the MCP (ps<0.001).
Conclusions: The clinically and statistically significant evidence of an association between MCP enrollment and opioid prescription cessation and reductions and improved quality of life warrants further investigations on cannabis as a potential alternative to prescription opioids for treating chronic pain.
This study is evidently NOT an RCT!
Most of the 8 RCTs investigate whether SCAM is useful for weaning opioid-dependent patients off their drug. To equate this with the question whether IM/SCAM can reduce or cease opioid use in CP patients is, I think, wrong. The way to reduce opioid use in CP patients is to prescribe less opioids. And for prescribing less opioids, we need no SCAM but we need to remember what we learned in medical school: opioids are not for routine treatment of CP!
So, why do the authors of this review try to mislead us?
Could it have something to do with some of their affiliations and the bias that goes with it?
- Canadian College of Naturopathic Medicine, North York, Ontario, Canada.
- Australian Research Centre in Complementary and Integrative Medicine, University of Technology Sydney, Ultimo, Australia.
- Pacific College of Oriental Medicine, San Diego, California, USA.
What do you think?
I have reported previously about the tragic death of John Lawler. Now after the inquest into the events leading to it has concluded, I have the permission to publish the statement of Mr Lawler’s family:
We were devastated to lose John in such tragic and unforeseen circumstances two years ago. A much-loved husband, father and grandfather, he continues to be greatly missed by all of us. Having to re-live the circumstances of his death has been particularly difficult for us but we are grateful to have a clearer picture of the events that led to John’s death. We would like to take this opportunity to thank the coroner’s team, our legal representatives and our wider family and friends for their guidance, empathy and sensitivity throughout this process.
There were several events that went very wrong with John’s chiropractic treatment, before, during, and after the actual manipulation that broke his neck.
Firstly, John thought he was being treated by a medically qualified doctor, when he was not. Furthermore, he had not given informed consent to this treatment.
The chiropractor diagnosed so-called ‘vertebral subluxation complex’ which she aimed to treat by manipulating his neck. We heard this week from medical experts that John had ossified ligaments in his spine, where previously flexible ligaments had turned to bone and become rigid. This condition is not uncommon, and is present in about 10% of those over 50. It would have showed on an X-ray or other imaging technique. The chiropractor did not ask for any images before commencing treatment and was seemingly unaware of the risks of doing a manual manipulation on an elderly patient.
It has become clear that the chiropractor did the manipulation incorrectly, and broke these rigid ligaments during a so-called ‘drop table’ manipulation, causing discs in the cervical spine to rupture and the spinal cord to become crushed. Although these manipulations are done frequently by chiropractors, we have heard that the force applied to his neck by the chiropractor would have had to have been “significant”.
Immediately John reported loss of sensation and paralysis in his arms. At this stage the only safe and appropriate response was to leave him on the treatment bed and await the arrival of the paramedics, and provide an accurate history to the ambulance controller and paramedics. The chiropractor, in fact, manhandled John from the treatment bed into a chair; then tipped his head backwards and gave “mouth to mouth” breaths. She provided an inaccurate and misleading history to the paramedic and ambulance controller, causing the paramedic to treat the incident as “medical” not “traumatic” and to transport John downstairs to the ambulance without stabilising his neck. If the paramedics had been given the full and accurate story, they would have stabilised his neck in situ and transported him on a scoop stretcher – and he would have subsequently survived.
The General Chiropractic Council decided not to suspend the chiropractor from practicing in September 2017. They heard evidence from the chiropractor that she had “not touched the neck during the appointment” and from an expert chiropractor that it would be “physically impossible” for the treatment provided to cause the injury which followed. We have heard this week that this is incorrect. The family was not allowed to attend or give evidence at that hearing, and we are waiting – now 2 years further on – for the GCC to complete their investigations.
We hope that the publicity surrounding this event will highlight the dangers of chiropractic, especially in the elderly and those with already compromised spines. We would again urge the regulator to take immediate measures to ensure that the profession is properly controlled: that chiropractors are prevented from styling themselves as medical professionals; that patients are fully informed and consent to the risks involved; that imaging is done before certain procedures and on high risk clients; and that the limits of the benefits chiropractic can provide are fully explored.
Before someone comments pointing out that this is merely a single case which does not amount to evidence, let me remind you of the review of cervical manipulation prepared for the Manitoba Health Professions Advisory Council. Here is the abstract:
Neck manipulation or adjustment is a manual treatment where a vertebral joint in the cervical spine—comprised of the 7 vertebrae C1 to C7—is moved by using high-velocity, low-amplitude (HVLA) thrusts that cannot be resisted by the patient. These HVLA thrusts are applied over an individual, restricted joint beyond its physiological limit of motion but within its anatomical limit. The goal of neck manipulation, referred to throughout this report as cervical spine manipulation (CSM), is to restore optimal motion, function, and/or reduce pain. CSM is occasionally utilized by physiotherapists, massage therapists, naturopaths, osteopaths, and physicians, and is the hallmark treatment of chiropractors; however the use of CSM is controversial. This paper aims to thoroughly synthesize evidence from the academic literature regarding the potential risks and benefits of cervical spine manipulation utilizing a rapid literature review method.
METHODS Individual peer-reviewed articles published between January 1990 and November 2016 concerning the safety and efficacy of cervical spine manipulation were identified through MEDLINE (PubMed), EMBASE, and the Cochrane Library.
- A total of 159 references were identified and cited in this review: 86 case reports/ case series, 37 reviews of the literature, 9 randomized controlled trials, 6 surveys/qualitative studies, 5 case-control studies, 2 retrospective studies, 2 prospective studies and 12 others.
- Serious adverse events following CSM seem to be rare, whereas minor adverse events occur frequently.
- Minor adverse events can include transient neurological symptoms, increased neck pain or stiffness, headache, tiredness and fatigue, dizziness or imbalance, extremity weakness, ringing in the ears, depression or anxiety, nausea or vomiting, blurred or impaired vision, and confusion or disorientation.
- Serious adverse events following CSM can include the following: cerebrovascular injury such as cervical artery dissection, ischemic stroke, or transient ischemic attacks; neurological injury such as damage to nerves or spinal cord (including the dura mater); and musculoskeletal injury including injury to cervical vertebral discs (including herniation, protrusion, or prolapse), vertebrae fracture or subluxation (dislocation), spinal edema, or issues with the paravertebral muscles.
- Rates of incidence of all serious adverse events following CSM range from 1 in 10,000 to 1 in several million cervical spine manipulations, however the literature generally agrees that serious adverse events are likely underreported.
- The best available estimate of incidence of vertebral artery dissection of occlusion attributable to CSM is approximately 1.3 cases for every 100,000 persons <45 years of age receiving CSM within 1 week of manipulative therapy. The current best incidence estimate for vertebral dissection-caused stroke associated with CSM is 0.97 residents per 100,000.
- While CSM is used by manual therapists for a large variety of indications including neck, upper back, and shoulder/arm pain, as well as headaches, the evidence seems to support CSM as a treatment of headache and neck pain only. However, whether CSM provides more benefit than spinal mobilization is still contentious.
- A number of factors may make certain types of patients at higher risk for experiencing an adverse cerebrovascular event after CSM, including vertebral artery abnormalities or insufficiency, atherosclerotic or other vascular disease, hypertension, connective tissue disorders, receiving multiple manipulations in the last 4 weeks, receiving a first CSM treatment, visiting a primary care physician, and younger age. Patients whom have experience prior cervical trauma or neck pain may be at particularly higher risk of experiencing an adverse cerebrovascular event after CSM.
CONCLUSION The current debate around CSM is notably polarized. Many authors stated that the risk of CSM does not outweigh the benefit, while others maintained that CSM is safe—especially in comparison to conventional treatments—and effective for treating certain conditions, particularly neck pain and headache. Because the current state of the literature may not yet be robust enough to inform definitive prohibitory or permissive policies around the application of CSM, an interim approach that balances both perspectives may involve the implementation of a harm-reduction strategy to mitigate potential harms of CSM until the evidence is more concrete. As noted by authors in the literature, approaches might include ensuring manual therapists are providing informed consent before treatment; that patients are provided with resources to aid in early recognition of a serious adverse event; and that regulatory bodies ensure the establishment of consistent definitions of adverse events for effective reporting and surveillance, institute rigorous protocol for identifying high-risk patients, and create detailed guidelines for appropriate application and contraindications of CSM. Most authors indicated that manipulation of the upper cervical spine should be reserved for carefully selected musculoskeletal conditions and that CSM should not be utilized in circumstances where there has not yet been sufficient evidence to establish benefit.
Just three points which, in my view, sand out most in relation to Mr Lawler’s death:
- Mr Lawler had no proven indication (and at least one very important contra-indication) for neck manipulation.
- He did not give infromed consent.
- The neck manipulation was not within the limits of the physiological range of motion.