conflict of interest
When I first saw this press-release, I thought it was a hoax. After all, it came from a most dubious homeopathic source. Then I read it again and was no longer sure.
What do you think?
Here it is in full:
Santa Clara, Cuba, April 3,2020 (Prensa Latina) The homeopathic medicine Prevengho-VIR began to be administered as a measure to confront the Covid-19 in this province of central Cuba.
Dr. Mirtha Rosa Hernandez, head of the Department of the Elderly in Villa Clara, reported that the supply of the preparation began in the Grandparents’ Homes and Elderly Homes of the territory, which has 184,000 people over 60 years old, 23.9 percent of the local universe. The medicine is administered by doctors and nurses of the basic working group where the Grandparents’ Homes and Nursing Homes are located in the 13 municipalities of this province.
This homeopathic medicine comes in a 10-milliliter bottle, and the daily dosage is 5 drops, thrice a day; while on the tenth day a reactivation of the initial dose is performed. It is aimed at preventing the respiratory diseases in this risk group, in addition to other medical conditions, such as dengue.
In the upcoming days it will be extended to the Maternal Homes. It is administered by the doctors and the nurses from the basic work group of the senior homes.
She said, that besides avoiding the new coronavirus the formula is also aimed at preventing respiratory diseases in this risk group, in addition to others such as dengue fever.
This medicine can also be administered to children under 10 years old, pregnant women, nursing mothers, and patients with liver disorders.
Anas berberiae 200
Baptisia tinctora 200
Eupetorium perf 200
Arsenicum Album 200
As I said, I was not sure whether this was for real. Is it possible that even officials are so stupid, brainwashed or gullible to go for homeopathy in such a serious situation?
In an attempt to find out, I did a little search and quickly found that the story has been reported by multiple media. This, for instance, is what the Miami Herald reported:
As scientists around the world speed up clinical trials to find a cure or vaccine for the coronavirus, the Cuban government will begin distributing a homeopathic remedy to the elderly and other vulnerable people to “prevent” the spread of the disease, a top health official said.
Dr. Francisco Durán, national director of Epidemiology at the Ministry of Public Health, said in a press conference on Sunday that “sublingual drops” of the compound PrevengHo-Vir “prevent different diseases such as influenza, the common cold, dengue, and emerging viral infections such as this one.”
On Monday, Durán tried to correct his statements and said that the product “does not prevent contagion” but rather “increases resistance, the body’s defenses against a certain virus.”
Several state media outlets reported that PrevengHo-Vir is already being used in various Cuban provinces to treat the elderly and other groups vulnerable to the coronavirus. There is no internet record of PrevengHo-Vir, other than press reports about the announcement of its distribution in Cuba.
So, it’s not a hoax!
In this case, let me try to predict what will happen next:
- When the pandemic is over, the Cubans will publish mortality rates achieved with their homeopathic prevention [A].
- They will compare them to data from a cohort that did not receive the homeopathic treatment [B].
- Neither of the data-sets will be transparent and nobody will be able to check its reliability.
- The comparison will yield a significant difference in favour of homeopathy.
- The Cubans will use this to market their remedy.
- The world of homeopathy will use it as a proof that homeopathy is effective (it wouldn’t be the first time).
Nothing wrong with that, some will say. Others who understand research methodology will, however, point out that these data are less than convincing.
In such case/control studies, one large group of patients [A] is compared to another group [B]. Group A has been treated homeopathically, while group B received no homeopathy. Any difference in outcome between A and B might be due to a range of circumstances that are unrelated to the homeopathic treatment, for instance:
- group A might have been less ill than group B,
- group A might have been better nourished,
- group A might have benefited from better hygiene,
- group A might have received better care,
- group B might have received treatments that made the situation not better but worse,
- the researchers might have prettified the data to make group A look better.
Such concerns are not totally unfounded; after all, Cuba seems to have a long history of making irresponsible claims for their homeopathic products.
Today is the official publication date of my new book ‘DON’T BELIEVE WHAT YOU THINK‘. It is essentially a crash course in critical thinking. To give you a flavour, here is an excerpt from its preface:
… So-called alternative medicine (SCAM) is a complex and controversial subject. Many people pretend to be experts in SCAM, but few know even the basic facts about it. Many consumers talk about SCAM, but few can be bothered to look behind the smokescreen of misleading claims. Many feel emotionally attached to SCAM, but few manage to think rationally about it. Many religiously believe in SCAM, but few show concern about the evidence. Many are desperate for help, but few seem to mind getting ripped off…
Enthusiasts of SCAM tend to hope for less side-effects, symptom relief, a cure of their condition, improvements in quality of life, and protection from illness. Such high expectations are usually based on misinformation, often even on outright lies. The disappointing truth is that not many SCAMs are truly effective in treating or preventing disease, and that none is totally harmless. In fact, the dangers of SCAM are multi-fold and potentially serious:
- harm due to adverse effects such as toxicity of an herbal remedy, stroke after chiropractic manipulation, pneumothorax after acupuncture (see chapter 3.2);
- harm caused by bogus diagnostic techniques (see chapter 4.4);
- harm of using materials from endangered species (see chapter 3.15);
- harm through incompetent advice by SCAM providers (see chapter 4.5);
- harm due to using SCAM instead of an effective therapy for serious conditions (see chapter 4.5);
- harm due to the high costs of SCAM (see chapter 3.8);
- harm due to SCAM undermining evidence-based medicine (see chapter 5.4);
- harm caused by inhibiting medical progress and research (see chapter 5.1).
In this book, I address these issues in detail and explain how consumers get manipulated into believing things that are evidently wrong. Using plenty of real-life examples, I outline how the constant flow of misinformation, coupled with motivated ignorance, motivated reasoning, and cognitive bias can produce a form of wishful thinking that is detached from reality. In the interest of my readers’ health, I aim to correct some of these false beliefs and fallacious thought processes.
My book consists of 35 concise essays each of which addresses one commonly held belief about SCAM. The essays can be read as stand-alone articles; occasionally, this necessitates a degree of repetition which, however, is minimal. The text avoids technical jargon and is therefore easy to follow. For those who want to dig deeper into the scientific evidence, links are provided to numerous papers that might prove to be helpful. A glossary is added at the end to explain some terms that might be unfamiliar.
This book is meant to stimulate critical thinking not just about SCAM, but also in a more general way. Science deniers employ similar techniques no matter whether they focus on health, climate change, evolution or other subjects. Exposing their techniques for what they are is thus important.
- They ignore the scientific consensus.
- They cherry-pick their evidence.
- They rely on poor quality studies, opinion and anecdotes.
- They invent conspiracy theories.
- They defame their opponents.
- They point out that science has been wrong before.
- They say, ‘science does not know everything’.
Critical thinking is the best, perhaps even the only protection we have from being fooled and, crucially, from fooling ourselves. If my book enables you to question nonsense, call out untruths, correct falsehoods, ridicule stupidity, and disclose fake news, it surely was worth the effort.
As so often in the realm of so-called alternative medicine (SCAM), the Australians are setting an example. The Australian Health Practitioner Regulation Agency (Ahpra) is the national organisation responsible for implementing the National Registration and Accreditation Scheme (the National Scheme) across Australia. Yesterday, the Ahpra have issued an important press-release. Here is an excerpt:
… While the vast majority of health practitioners are responding professionally to the COVID-19 emergency and focusing on providing safe care, Ahpra and National Boards are seeing some examples of false and misleading advertising on COVID-19.
During these challenging times, it is vital that health practitioners only provide information about COVID-19 that is scientifically accurate and from authoritative sources, such as a state, territory or Commonwealth health department or the World Health Organization (WHO). According to these authoritative sources, there is currently no cure or evidence-based treatment or therapy which prevents infection by COVID-19 and work is currently underway on a vaccine.
Other than sharing health information from authoritative sources, registered health practitioners should not make advertising claims on preventing or protecting patients and health consumers from contracting COVID-19 or accelerating recovery from COVID-19. To do so involves risk to public safety and may be unlawful advertising. For example, we are seeing some advertising claims that spinal adjustment/manipulation, acupuncture and some products confer or boost immunity or enhance recovery from COVID-19 when there is no acceptable evidence in support.
Advertisers must be able to provide acceptable evidence of any claims made about treatments that benefit patients/health consumers. We will consider taking action against anyone found to be making false or misleading claims about COVID-19 in advertising. If the advertiser is a registered health practitioner, breaching advertising obligations is also a professional conduct matter which may result in disciplinary action, especially where advertising is clearly false, misleading or exploitative. There are also significant penalties for false and misleading advertising claims about therapeutic products under the Therapeutic Goods Act 1989.
Patients and health consumers should treat any advertising claims about COVID-19 cautiously and check authoritative sources for health information about COVID-19, such as state, territory and Commonwealth health departments.
As always, patients and health consumers should ask their practitioner for information to support any advertising claims before making decisions about treatment. Patients and health consumers should receive accurate and truthful messages so they can make the right choices about their health.
Many of my posts during the last weeks have dealt with this problem. The sad truth is that charlatans of all types are trying to exploit the fear of consumers during the current crisis for making a fast buck. This is despicable, unethical, unprofessional and possibly criminal.I do hope that the authorities of other countries follow the Australian example.
The objective of this trial, just published in the BMJ, was to assess the efficacy of manual acupuncture as prophylactic treatment for acupuncture naive patients with episodic migraine without aura. The study was designed as a multi-centre, randomised, controlled clinical trial with blinded participants, outcome assessment, and statistician. It was conducted in 7 hospitals in China with 150 acupuncture naive patients with episodic migraine without aura.
They were given the following treatments:
- 20 sessions of manual acupuncture at true acupuncture points plus usual care,
- 20 sessions of non-penetrating sham acupuncture at heterosegmental non-acupuncture points plus usual care,
- usual care alone over 8 weeks.
The main outcome measures were change in migraine days and migraine attacks per 4 weeks during weeks 1-20 after randomisation compared with baseline (4 weeks before randomisation).
A total of 147 were included in the final analyses. Compared with sham acupuncture, manual acupuncture resulted in a significantly greater reduction in migraine days at weeks 13 to 20 and a significantly greater reduction in migraine attacks at weeks 17 to 20. The reduction in mean number of migraine days was 3.5 (SD 2.5) for manual versus 2.4 (3.4) for sham at weeks 13 to 16 and 3.9 (3.0) for manual versus 2.2 (3.2) for sham at weeks 17 to 20. At weeks 17 to 20, the reduction in mean number of attacks was 2.3 (1.7) for manual versus 1.6 (2.5) for sham. No severe adverse events were reported. No significant difference was seen in the proportion of patients perceiving needle penetration between manual acupuncture and sham acupuncture (79% v 75%).
The authors concluded that twenty sessions of manual acupuncture was superior to sham acupuncture and usual care for the prophylaxis of episodic migraine without aura. These results support the use of manual acupuncture in patients who are reluctant to use prophylactic drugs or when prophylactic drugs are ineffective, and it should be considered in future guidelines.
Considering the many flaws in most acupuncture studies discussed ad nauseam on this blog, this is a relatively rigorous trial. Yet, before we accept the conclusions, we ought to evaluate it critically.
The first thing that struck me was the very last sentence of its abstract. I do not think that a single trial can ever be a sufficient reason for changing existing guidelines. The current Cochrance review concludes that the available evidence suggests that adding acupuncture to symptomatic treatment of attacks reduces the frequency of headaches. Thus, one could perhaps argue that, together with the existing data, this new study might strengthen its conclusion.
In the methods section, the authors state that at the end of the study, we determined the maintenance of blinding of patients by asking them whether they thought the needles had penetrated the skin. And in the results section, they report that they found no significant difference between the manual acupuncture and sham acupuncture groups for patients’ ability to correctly guess their allocation status.
I find this puzzling, since the authors also state that they tried to elicit acupuncture de-qi sensation by the manual manipulation of needles. They fail to report data on this but this attempt is usually successful in the majority of patients. In the control group, where non-penetrating needles were used, no de-qi could be generated. This means that the two groups must have been at least partly de-blinded. Yet, we learn from the paper that patients were not able to guess to which group they were randomised. Which statement is correct?
This may sound like a trivial matter, but I fear it is not.
Like this new study, acupuncture trials frequently originate from China. We and others have shown that Chinese trials of acupuncture hardly ever produce a negative finding. If that is so, one does not need to read the paper, one already knows that it is positive before one has even seen it. Neither do the researchers need to conduct the study, one already knows the result before the trial has started.
You don’t believe the findings of my research nor those of others?
Excellent! It’s always good to be sceptical!
But in this case, do you believe Chinese researchers?
In this systematic review, all RCTs of acupuncture published in Chinese journals were identified by a team of Chinese scientists. An impressive total of 840 trials were found. Among them, 838 studies (99.8%) reported positive results from primary outcomes and two trials (0.2%) reported negative results. The authors concluded that publication bias might be major issue in RCTs on acupuncture published in Chinese journals reported, which is related to high risk of bias. We suggest that all trials should be prospectively registered in international trial registry in future.
So, at least three independent reviews have found that Chinese acupuncture trials report virtually nothing but positive findings. Is that enough evidence to distrust Chinese TCM studies?
But there are even more compelling reasons for taking evidence from China with a pinch of salt:
A survey of clinical trials in China has revealed fraudulent practice on a massive scale. China’s food and drug regulator carried out a one-year review of clinical trials. They concluded that more than 80 percent of clinical data is “fabricated“. The review evaluated data from 1,622 clinical trial programs of new pharmaceutical drugs awaiting regulator approval for mass production. According to the report, much of the data gathered in clinical trials are incomplete, failed to meet analysis requirements or were untraceable. Some companies were suspected of deliberately hiding or deleting records of adverse effects, and tampering with data that did not meet expectations. “Clinical data fabrication was an open secret even before the inspection,” the paper quoted an unnamed hospital chief as saying. Chinese research organisations seem have become “accomplices in data fabrication due to cutthroat competition and economic motivation.”
So, am I claiming the new acupuncture study just published in the BMJ is a fake?
Am I saying that it would be wise to be sceptical?
Sadly, my scepticism is not shared by the BMJ’s editorial writer who concludes that the new study helps to move acupuncture from having an unproven status in complementary medicine to an acceptable evidence based treatment.
Call me a sceptic, but that statement is, in my view, hard to justify!
Guest post by Richard Rawlins
Ever since its inception, Homeopathy has struggled to establish principled medical ethics amongst its practitioners. For sure, Samuel Hahnemann was good doctor who achieved much by denying his patients the bleeding, emetics, expectorants, laxatives and poly-pharmacy conventional at the turn of the nineteenth century. But he then lost his way in spiritism and vitalism, devised a system of care which could not, and did not, provide any benefit beyond placebo responses, and inveigled many colleagues to share his delusion. Many derided him.
As medicine in all developed countries became better regulated, so the associated ethics became better focussed. “First do no harm” is common to all systems, but in the UK, the four ‘A’s of avoiding adultery with a patient, alcohol whilst in a clinical situation, advertising, and association formed the next domain. ‘Association’ meant having a professional medical relationship with anyone not also a GMC registrant. Times, and standards have changed, but quackery, charlatanism and health care fraud has always been unethical. The problem for society has been the GMC’s reluctance to take any action against its registrants who lack integrity, promote quackery, or seek to defraud. The general response has been “we only act on complaints by a patient, health authority or fellow registrant – and complaints have to be specific.”
So it is that about 400 registrants of the GMC continue practising homeopathy with impunity. Sir Simon Stevens has now all but banned homeopathy from the NHS, but a medically qualified practitioner, in the private sector can do as they please, no matter how vulnerable and gullible the patient.
Doctors are of course required to obtain fully informed consent to treatment, and that should mean advising patients that homeopathic remedies are but placebos. Many patients so treated will declare they “feel better” and are content – but in practice, no explanation is offered to patients attending homeopaths. A classic charlatonnade (a charade promulgated by a charlatan).
But perhaps the vicissitudes of Covid-19 is exposing the hypocrisy of the GMC’s position, and might yet enable some redress for patients seeking redress for unethical medically qualified homeopathic attention.
The Guardian and Sunday Times of 22nd March 2020 reported that Dr Mark Ali allegedly made £1.7M profit in one week from selling kits to test for COVID -19.
“The GMC said no doctor should try to ‘profit from the fear and uncertainly caused by the pandemic…We would be concerned to learn that doctors are exploiting patient’s vulnerability or lack of medical knowledge, in order to profit from fear and uncertainty…’ “
The rationale for that fear is surely irrelevant – any health practice which takes advantage of the patient’s vulnerability or lack of medical knowledge is unethical. Simple.
“We also expect doctors… not to offer or recommend tests that are unproven, clinically unverified or otherwise unreliable.”
This is in the context of the serious issues of SARS-CoV-2 (the name of the corona virus which causes the illness COVID-19) – but it is helpful that the GMC’s ethical principles have been clearly stated.
May we take it the GMC will be equally as stringent with their registrants (doctors) who take advantage of the patient’s vulnerability or lack of medical knowledge, and recommend tests such as homeopathic provings “that are unproven, clinically unverified or otherwise unreliable.”?
And if not, why not?
All homeopathic remedy prescriptions are ‘tests’: “Take this, see how you go, I’ll adjust if needed…”. The German word pruefung used by Hahnemann (meaning ‘testing’ or ‘examination’) has been translated into English as ‘proving’. But the word for ‘to prove’ is beweisen, and that is not the word Hahnemann used. The use of ‘proving’ in English implies merit which is not deserved. All part of the delusion.
Clearly, any doctor who recommends homeopathic remedies, but does not explain the conventional view of the remedy, lacks integrity and is unethical – by definition. If the doctor is GMC registered (which a ‘doctor’ does not have to be – e.g., dentists are not) – they should be subject to sanction by the GMC. The GMC should do its duty to protect the public, and not wait for a crisis to stir them into action.
Sadly, if practitioners are not GMC registered, caveat emptor.
Friends of Science in Medicine (FSM) President, Assoc Professor Ken Harvey MB BS (Melb), FRCPA, AM congratulates Professor Jon Wardle, nurse and naturopath, with postgraduate qualifications in public health, law and health economics, on being appointed to Southern Cross University’s (SCU) Maurice Blackmore Chair of Naturopathic Medicine in Lismore. Professor Wardle has also been appointed as Foundation Director of the National Centre for Naturopathic Medicine (NCNM) funded with $10 Million from the Blackmore Foundation set up to sponsor research into ‘complementary medicine’.
Vice Chancellor, Professor Adam Shoemaker BA (Hons), PhD (ANU), researcher in Indigenous literature and culture, said the benefits of basing the NCNM at Southern Cross were enormous, “Being in a region like the Northern Rivers of New South Wales means we have brilliant local networks in this field. We are also supported by a local community who, like the University, are really receptive to trying new things in order to create a healthier future”.
Professor Harvey comments, “Professor Wardle certainly has challenges ahead. The Northern Rivers region is the anti-vax capital of Australia and some naturopaths advise against vaccination. Degree courses in naturopathy such as the Torrens Bachelor of Health Science (Naturopathy) degree, include studies of homeopathy, iridology and flower essence therapy. None have scientific evidence of efficacy”.
FSM has long argued that health care should be based on scientifically sound research, published in peer-reviewed journals of accepted standing. FSM is equally concerned about medical practitioners offering unproven and often exploitative treatments as it is about complementary medicine practitioners. Professor Harvey said, “some naturopaths practicing in Lismore, associated with SCU, work at clinics that use unverified laboratory tests to make dubious diagnoses and recommend treatment programs that lack evidence of efficacy”.
Professor Harvey (and FSM) conclude that there is an urgent need for evidence-based science to be applied to naturopathy. They trust that Professor Wardle will emulate Professor Edzard Ernst, Foundation Professor of Complementary Medicine at Exeter University, by applying accepted scientific standards to the evaluation of naturopathic interventions.
The March 24 opening of the NCNM in Lismore will feature a panel discussion on the future of health care with guest speakers: Professor Kerryn Phelps AM, former President of the Australasian Integrative Medicine Association, Marcus Blackmore AM, naturopath and Executive Director of Blackmores Ltd, which markets vitamin and herbal products, and Professor Jon Wardle. FSM hopes that the panel will discuss some of the issues raised above.
Sounds exciting, but is Wardle up to the job?
Judging from his publication record, he is certainly a naturopath through and through. He has published lots of papers; as far as I can see most of them are surveys of some sort or another. Many leave me somewhat bewildered. Two examples must suffice:
Objectives: To explore the recommendations of naturopathic medicine for the management of endometriosis, dysmenorrhea, and menorrhagia, drawing on traditional and contemporary sources.
Design: Content analysis.
Setting: Australia, Canada, and the United States of America (USA).
Subjects: Contemporary sources were identified from reviewing naturopathic higher education institutions’ recommended texts, while traditional sources were identified from libraries which hold collections of naturopathic sources. Sources were included if they were published from 1800 to 2016, were in English, published in Australia, Canada, or the USA, and reported on the topic. Included sources were as follows: 37 traditional texts; 47 contemporary texts; and 83 articles from naturopathic periodicals.
Results: Across included sources, the most reported disciplines were herbal medicine, clinical nutrition, mineral medicines, homeopathy, hydrotherapy, and chemical-based medicines. Herbal medicines were extensively reported from all sources for the management of endometriosis, dysmenorrhea, and menorrhagia. Clinical nutrition was only recommended from contemporary sources for all three conditions. Mineral medicines were mentioned in both traditional and contemporary sources, but were only recommended for dysmenorrhea and menorrhagia. There were limited recommendations for homeopathy and hydrotherapy treatments in all conditions across all sources. Chemical-based medicines were only mentioned for dysmenorrhea and menorrhagia, and recommendations ceased after 1922. Recommendations for endometriosis were not present in any of the traditional sources, across all reported disciplines.
Conclusions: The findings of this article provide insights into the documented historical and contemporary treatments within naturopathic medicine for endometriosis, dysmenorrhea, and menorrhagia. While philosophical principles remain the core of naturopathic practice, the therapeutic armamentarium appears to have changed over time, and a number of the original naturopathic treatments appear to have been retained as key elements of treatment for these conditions. Such insights into naturopathic treatments will be of particular interest to clinicians providing care to women, educators designing and delivering naturopathic training, and researchers conducting clinical and health service naturopathic research.
Complementary and alternative medicine (CAM) is an increasingly prevalent part of contemporary health care. Whilst there have been some attempts to understand the dynamics of CAM integration in the health care system from the perspective of conventional care providers and patients, little research has examined the view of CAM practitioners. This study aims to identify the experiences of integration within a conventional healthcare system as perceived by naturopaths. Qualitative semi-structured interviews were conducted using a purposeful sample of 20 practising naturopaths in South East Queensland, Australia to discuss their experiences and perceptions of integrating with conventional medical providers. Analysis of the interviews revealed five broad challenges for the integration of CAM according to naturopaths: competing paradigms between CAM and conventional medicine; co-option of CAM by conventional medical practitioners; the preservation of separate CAM and conventional medical worlds by patients and providers due to lack of formalised relations; negative feedback and biases created through selective or limited experience or information with CAM; and indifferent, reactive and one-sided interaction between CAM and conventional medical providers. Naturopaths support the integration of health services and attempt to provide safe and appropriate care to their patients through collaborative approaches to practice. The challenges identified by naturopaths associated with integration of CAM with conventional providers may impact the quality of care of patients who choose to integrate CAM and conventional approaches to health. Given the significant role of naturopaths in contemporary health-care systems, these challenges require further research and policy attention.
So, is Jon Wardle up to the job?
The answer obviously depends on what the job is.
If it is about publishing 100 more surveys that show nothing of much value and are essentially SCAM-promotion, then he ought to be fine. If it is about rigorously testing which SCAMs generate more good than harm, then ‘Houston, we have a problem’!
During my almost 30 years of research into so-called alternative medicine (SCAM), I have published many papers which must have been severe disappointments to those who advocate SCAM or earn their living through it. Many SCAM proponents thus reacted with open hostility. Others tried to find flaws in those articles which they found most upsetting with a view of discrediting my work. The 2012 article entitled ‘A Replication of the Study ‘Adverse Effects of Spinal Manipulation: A Systematic Review‘ by the Australian chiropractor, Peter Tuchin, seems to be an example of the latter phenomenon (used recently by Jens Behnke in an attempt to defame me).
Here is the abstract of the Tuchin paper:
Objective: To assess the significance of adverse events after spinal manipulation therapy (SMT) by replicating and critically reviewing a paper commonly cited when reviewing adverse events of SMT as reported by Ernst (J Roy Soc Med 100:330-338, 2007).
Method: Replication of a 2007 Ernst paper to compare the details recorded in this paper to the original source material. Specific items that were assessed included the time lapse between treatment and the adverse event, and the recording of other significant risk factors such as diabetes, hyperhomocysteinemia, use of oral contraceptive pill, any history of hypertension, atherosclerosis and migraine.
Results: The review of the 32 papers discussed by Ernst found numerous errors or inconsistencies from the original case reports and case series. These errors included alteration of the age or sex of the patient, and omission or misrepresentation of the long term response of the patient to the adverse event. Other errors included incorrectly assigning spinal manipulation therapy (SMT) as chiropractic treatment when it had been reported in the original paper as delivered by a non-chiropractic provider (e.g. Physician).The original case reports often omitted to record the time lapse between treatment and the adverse event, and other significant clinical or risk factors. The country of origin of the original paper was also overlooked, which is significant as chiropractic is not legislated in many countries. In 21 of the cases reported by Ernst to be chiropractic treatment, 11 were from countries where chiropractic is not legislated.
Conclusion: The number of errors or omissions in the 2007 Ernst paper, reduce the validity of the study and the reported conclusions. The omissions of potential risk factors and the timeline between the adverse event and SMT could be significant confounding factors. Greater care is also needed to distinguish between chiropractors and other health practitioners when reviewing the application of SMT and related adverse effects.
The author of this ‘replication study’ claims to have identified several errors in my 2007 review of adverse effects of spinal manipulation. Here is the abstract of my article:
Objective: To identify adverse effects of spinal manipulation.
Design: Systematic review of papers published since 2001.
Setting: Six electronic databases.
Main outcome measures: Reports of adverse effects published between January 2001 and June 2006. There were no restrictions according to language of publication or research design of the reports.
Results: The searches identified 32 case reports, four case series, two prospective series, three case-control studies and three surveys. In case reports or case series, more than 200 patients were suspected to have been seriously harmed. The most common serious adverse effects were due to vertebral artery dissections. The two prospective reports suggested that relatively mild adverse effects occur in 30% to 61% of all patients. The case-control studies suggested a causal relationship between spinal manipulation and the adverse effect. The survey data indicated that even serious adverse effects are rarely reported in the medical literature.
Conclusions: Spinal manipulation, particularly when performed on the upper spine, is frequently associated with mild to moderate adverse effects. It can also result in serious complications such as vertebral artery dissection followed by stroke. Currently, the incidence of such events is not known. In the interest of patient safety we should reconsider our policy towards the routine use of spinal manipulation.
In my view, there are several things that are strange here:
- Tuchin published his paper 5 years after mine.
- He did not publish it in the same journal as my original, but in an obscure chiro journal that hardly any non-chiropractor would ever read.
- Tuchin never contacted me and never alerted me to his publication.
- The journal that Tuchin chose was not Medline-listed in 2012; consequently, I never got to know about the Tuchin article in a timely fashion. (Therefore, I did never respond to it.)
- A ‘replication study’ is a study that repeats the methodology of a previous study.
- Tuchin’s paper is therefore NOT a replication study. Firstly, mine was a review and not a study. Secondly, and crucially, Tuchin never repeated my methodology but used an entirely different one.
But arguably, these points are trivial. They should not distract from the fact that I might have made mistakes. So, let’s look at the substance of Tuchin’s claim, namely that I made errors or omissions in my review.
As to ‘omissions’, one could argue that a review such as mine will always have to omit some details in order to generate a concise summary. The only way to not omit any details is to re-publish all the primary papers in one large volume. Yet, this can hardly be the purpose of a systematic review.
As to the ‘errors’, it seems that the ages and sex of three patients were wrong (I have not checked this against the primary publications but, for the moment, I believe Tuchin). This is, of course, lamentable and – even though I have no idea whether the errors happened at the data extraction phase, during the typing, the revising, or the publishing of the paper – it is entirely my responsibility. I also seem to have mistaken a non-chiropractor for a chiropractor. This too is regrettable but, as the review was about spinal manipulation and not about chiropractic, the error is perhaps not so grave.
Be that as it may, these errors are unquestionably not good, and I can only apologise for them. If Tuchin had dealt with them in the usual way – by publishing in a timely fashion a ‘letter to the editor’ of the JRSM – I could have easily corrected them for everyone to see.
But I think there is a more important point to be made here:
Tuchin concludes his paper stating that it is unwise to make conclusions regarding causality from any case study or multiple case studies. The number of errors or omissions in the 2007 Ernst paper significantly limit any reported conclusions. I believe that both sentences are unjustified. The safety of any intervention in routine use has to be examined on the basis of published case studies. This is particularly true for chiropractic where no post-marketing surveillance similar to that for drugs exists.
The conclusions based on such evidence can, of course, never be firm, but they provide valuable signals that can prompt more rigorous investigations in the interest of patient safety. In view of such considerations, my own conclusions in my 2007 paper were, I think, correct and are NOT invalidated by my relatively trivial mistakes: spinal manipulation, particularly when performed on the upper spine, has repeatedly been associated with serious adverse events. Currently the incidence of such events is unknown. Adherence to informed consent, which currently seems less than rigorous, should therefore be mandatory to all therapists using this treatment. Considering that spinal manipulation is used mostly for self-limiting conditions and that its effectiveness is not well established, we should adopt a cautious attitude towards using it in routine health care.
And my conclusions in the abstract have now, I believe, become established wisdom. They are thus even less in jeopardy through my calamitous lapsus or Tuchin’s ‘replication study’: Spinal manipulation, particularly when performed on the upper spine, is frequently associated with mild to moderate adverse effects. It can also result in serious complications such as vertebral artery dissection followed by stroke. Currently, the incidence of such events is not known. In the interest of patient safety we should reconsider our policy towards the routine use of spinal manipulation.
He finds himself in the company of giants:
John Weeks (editor of JCAM)
Deepak Chopra (US entrepreneur)
Cheryl Hawk (US chiropractor)
David Peters (osteopathy, homeopathy, UK)
Nicola Robinson (TCM, UK)
Peter Fisher (homeopathy, UK)
Simon Mills (herbal medicine, UK)
Gustav Dobos (various, Germany)
Claudia Witt (homeopathy, Germany and Switzerland)
George Lewith (acupuncture, UK)
John Licciardone (osteopathy, US)
Why does Behnke deserve this honour?
No, there are better reasons.
On Twitter, Behnke describes himself as a research consultant for homeopathy at the Karl and Veronica Carstens-Foundation: Evidence based medicine, CAM, clinical and basic research, health. The Carstens Stiftung say he is ‘programme director integrative medicine’. On facebook, he is merely ‘ ‘Referent of ‘Redaktion Natur und Medizin’. And on ‘Research Gate’ he lists 12 areas of skills and expertise:
Evidence Based Medicine
Medical & Health Profession Education
Randomized Control Trials
Philosophy Of Science
Complementary & Alternative Medicine
If this is not impressive, I don’t know what is! Particularly, if one knows that he is not a medical doctor at all!!!
So, let’s look at the list to decide whether he deserves the honour of becoming a member of my ‘HALL OF FAME’. Specifically, let’s check how many Medline-listed articles he has to his name in each of the above areas:
Evidence Based Medicine = 0
Medical & Health Profession Education = 0
Meta-Analysis = 0
Observational Studies = 0
Science Communication = 0
Social Media = 0
Randomized Control Trials = 0
Clinical Research = 0
Philosophy Of Science = 0
Complementary & Alternative Medicine = 0e
Integrative Medicine = 0
Homeopathy = 0
(No, you don’t need to praise me for my detailed, time-consuming research. It was not difficult and very quick: Jens Behnke, the ‘research consultant, has precisely zero Medline-listed publications).
So has Behnke ever conducted:
- a meta-analysis? No
- an observational study? I don’t think so
- a randomised trial? No
- any other clinical research? No
In the past, I tended to admit to my HALL OF FAME mainly those SCAM researchers who had published plenty of papers but had no study to their name that drew a negative conclusion. Behnke is not in that league. He is nevertheless worthy for his highly elaborate concept. Remember, he is a ‘research consultant in homeopathy’, and homeopathy obeys different rules than any other form of quackery. One of its axioms holds that LESS IS MORE. And considering this principle, Behnke surely must be THE expert! No publication, in homeopathic logic, evidently means that he is better than anyone else.
So, a warm welcome to our new member Jens Behnke: MAY YOUR UNPRODUCTIVITY AS A EXPERT IN 12 DIFFERENT FIELDS OF INQUIRY LAST FOR MANY MORE YEARS!
And congratulations also to the Carstens Stiftung who have so far spent 36 000 000 Euro on SCAM-research and pay Behnke’s salary as ‘research consultant’: I am sure you guys deserve him!
In case Dr Behnke reads this: it is an internationally accepted standard of honesty and transparency that someone who has a doctor title and works in or comments on medical matters makes it clear that he/she is not medically trained or experienced, that in fact he/she is not a medical doctor. If not, one might think that this person is deliberately trying to mislead the public.
Yesterday’s blog disclosed the fact that the German ‘Natur und Medizin’, an organisation of the ‘Carstens Stiftung’, had published slanderous lies about me. Consequently, I published an ‘open letter’ urging them to correct their mistake so that they would spare us the agony and cost of using legal action.
I never doubted for a minute that they would do this (I do not assume they are stupid, just a tiny bit dishonest) – and, as it turned out, I was correct. Here is a reminder of what they had originally published:
… er ist dafür bekannt, dass er kein gutes Haar an komplementären Therapieverfahren lässt. Notfalls greift er auch zu absichtlichen Falschdarstellungen, erfindet Daten oder behauptet einfach, klinische Studien, die nicht die Negativ-Ergebnisse erbringen, die er erwartet, seien schlicht und ergreifend Betrug.…
My rough translation:
… he [Edzard Ernst] is known for not finding anything positive in SCAM. If all else fails, he uses deliberate misrepresentation , invents data , or simply claims that clinical trials which did not generate the negative findings he expected are simply falsifications …
The corrected new text passage is a little longer and now reads as follows (my rough translation):
… he [Edzard Ernst] is known for not finding anything positive in SCAM. Analyses of his publications by independent scientists draw the conclusion that he represents case-reports demonstrably wrongly  and that he arbitrarily alters or omits data . He claims occasionally that high-quality studies of SCAM which do not generate the negative findings he expected appeared to be scientifically sound, but are nevertheless not believable …
… er ist dafür bekannt, dass er kein gutes Haar an komplementären Therapieverfahren lässt. Analysen seiner Publikationen durch unabhängige Wissenschaftler gelangen zu der Schlussfolgerung, dass er Fallberichte nachweislich falsch darstelle und Daten willkürlich verändere oder auslasse. Er selbst behauptet mitunter über methodisch hochwertige Studien zur Komplementärmedizin, die nicht die Negativ-Ergebnisse erbringen, die er erwartet, sie sähen zwar nach wissenschaftlichen Maßstäben überzeugend aus, seien aber dennoch ‚unglaubwürdig‘.…
I would like to take this occasion to sincerely thank the ‘Natur und Medizin’ and the ‘Carstens Stiftung’ for this – much obliged guys, you made my day!
- They have shown wisdom in not wasting money on expensive lawyers (even though my brother, who is a lawyer, might have enjoyed the windfall).
- They have shown courage to hide behind papers like the one by Robert Hahn which have been discussed on this blog and elsewhere and found to be deluded.
- They have shown strength by not meekly apologising to me about their attempt to slander me and my work.
- They show leadership and innovative spirit by employing Jens Behnke, the author of the above lines, who does not seem to let the truth get in the way of a good story.
Last not least, my personal thanks to dear Jens (after your generosity, I am thinking about dedicating an entire blog post to you; your employer needs to know what a genius they have in you – watch this space) for yet again having demonstrated that the phenomenon known as ERNST’ S LAW is 100% correct.
Wiki states that George Vithoulkas has been described as “the maestro of classical homeopathy” and is “widely considered to be the greatest living homeopathic theorist”. Others call him a “contemporary master of homeopathy” or credit him with the revival of the credibility of homeopathy.
A few days ago, THE MAESTRO has given an interview about the coronavirus which, I believe, is too hilarious to miss:
Q. What is your opinion of coronavirus, what homeopathy can do ?
A. Unless we have selected the real symptoms of the different stages of this influenza from the clinicians who are dealing at this moment with the infected cases, we cannot do anything substantial.
We should know the symptomatology of the beginning stages -before the pneumonia- and propose remedies for this stage in order to reduce the victims of going to the second stage. Also we should know the symptomatology of the later stage of pneumonia or diarrhea to propose different remedies for this advanced stage.
But the symptomatology has to be taken by an experienced homeopath in order to be reliable.
I think the best would be to establish contact with the clinicians in order to give us a fist hand information.
To give at random remedies as a prophylaxis and to make people think that they are protected it is irresponsible.
Q. What do you think about those homeopaths who advertise that are treating cancer cases using homeopathic remedies while at the same time the patients are treated with allopathic drugs?
Advertising that cancer cases can be cured by homeopathy in spite of the fact patients are treated with conventional drugs is an unethical act that should be avoided at all costs by any honest homeopath.
The reasons are simple.
A. The homeopathic remedy will act if it is prescribed according to the symptoms of the case. But in such a situation where the patient is under chemotherapy, the symptoms are suppressed by the allopathic drugs. Therefore the prescriptions at best are not prescribed according to the law of similars but are given in an arbitrary way, therefore instead of the similimum, several remedies are prescribed at random. Actually in this way, the case becomes more and more confused and the organism is more and more disorganised.
B. The homeopathic remedy acts on the energy level -on the vital force- inciting the organism to increase its response (initial aggravation) so the two treatments are antagonistic, the one suppresses the defense mechanism, the other strengthens it.
C. Out of such a confusion within the organism, no one can say what actually has happened in such a patient.
Of course each doctor is free to apply any treatment that according to his understanding will benefit the patient, but to claim publicly that homeopathy can cure cancer under such conditions is totally immoral.
Obviously patients will flock around such physicians in the beginning and can make them rich but in the end the disappointments will be for both parties, the doctors and the patients but mostly on the part of doctors.
Q. Perhaps because of the guilt for all the lies and false hopes?
Homeopathy is an amazing therapeutic system, that can make doctors and patients extremely happy but has limits and the doctors should not transgress these boundaries for material gain.
It is a great pity that homeopathy will be reduced to a routine massive therapy with meagre results by those who are advertising polypharmacy with such mongrel practices like the ones with prearranged therapeutic protocols or mixopathy.
If such practices prevail, finally the real classical homeopathy, that can have such amazing results, if it is learned and practiced correctly, will die out amidst an aggressive and competitive society.
So, essentially the great Vithoulkas seems to be saying that treating even the most serious diseases with homeopathy is fine, as long as homeopaths use no treatments other than homeopathy and as long as they do exactly what Vithoulkas proclaims or – even better – Vithoulkas does it himself.
I know, this is very similar to what Hahnemann, the creator of this cult, stated about 200 years ago … but it is nevertheless totally bonkers.