fraud
Dr Mathias Rath, the German born purveyor of multiple food supplements, and his organisation puzzle me a great deal. As previously reported, the ‘Dr Rath Foundation’ published an article about me. In it, the author got my name right, but not much more. Here is its opening passage [the numbers in square brackets refer to my comments below].
Professor Edzard Ernst: A Career Built On Discrediting Natural Health Science? [1]
Professor Edzard Ernst, a retired German [2] physician and academic, has recently [3] become a prominent advocate of plans that could potentially outlaw [4] the entire profession of naturopathic doctors [5] in Germany. Promoting the nonsensical idea that naturopathic medicine somehow poses a risk to public health, Ernst attacks its practitioners as supposedly having been educated in “nonsense” [6]. Tellingly, however, given that he himself has seemingly not published even so much as one completely original scientific trial of his own [7], Ernst’s apparent attempts to discredit natural healthcare approaches are largely reliant instead on his analysis or review of handpicked negative studies carried out by others [8].
- When I was appointed at Exeter to research alternative medicine in 1993, I had already been a full professor at Hannover, Germany and subsequently at Vienna, Austria. If anything, coming to Exeter was a big step down in terms of ‘career’, salary, number of co-workers etc. (full details in my memoir)
- I am German-born, became an Austrian citizen in 1990, and since 2000 I am a British national.
- I have been critical about the German ‘Heilpraktiker’ for more than 20 years.
- This refers to the recent ‘Muensteraner Memorandum’ which is the work of an entire team of multidisciplinary experts and advocates reforming this profession.
- ‘Heilpraktiker’ are certainly not doctors; they have no academic or medical background.
- This is correct, and I stand by my statement that educating people in vitalism and other long-obsolete concepts is pure nonsense.
- Since I am researching alternative medicine, I have conducted and published about 40 ‘scientific trials’, and before that time (1993) I have published about the same number again in various other fields.
- This refers to systematic reviews which, by definition, include all the studies available on a defines research question, regardless of their conclusion (their aim is to minimise random and selection biases) .
Rath states about himself that “Dr. Rath heads a research and development institute in nutritional and Cellular Medicine. His institute is conducting basic research and clinical studies to scientifically document the health benefits of micronutrients in fighting a multitude of diseases.”
But this is equally puzzling.
Firstly, because research does not aim ‘to scientifically document the health benefits of ‘ anything; it is for testing hypotheses; Rath surely must know that. Secondly, on Medline, I find dozens of publications by Rath. These refer mostly to mechanistic in-vitro or animal studies about the mode of action of vitamins and other natural compounds.
But ‘clinical studies‘?
None!
Hold on! My Medline searches did deliver one clinical trial – just one – (Rath himself lists more, but they seem to be meaningless observational studies without a control group). It was published as an abstract on his own website. Here is the abstract:
Healing of bone fractures is a prolonged process that can be affected by nutrition. Our objective was to critically evaluate the effect of supplementation with an essential nutrient complex, containing ascorbic acid, lysine, proline, and vitamin B6 on healing time of tibial fractures.
Design:
Random double-blind placebo-controlled study
Setting:
Dr. Jamdar Hospital, Jabalpur, India
Subjects and Intervention:
113 patients with unilateral displaced closed or grade I open tibial fractures were randomized to receive either standard care with placebo or with supplementation with an essential nutrient complex containing ascorbic acid, lysine, proline, and vitamin B6. Qualifying patients, on admission to the study, were clinically examined, radiographs of the affected limbs taken, fractures reduced under anesthesia, and above knee plaster casts applied. Radiographs were taken at each follow-up visit to confirm reduced alignment of fracture and proper callus formation.
Primary Outcome Measure:
The primary outcome measure was the number of weeks required for fracture to be healed. Healing was defined as absence of abnormal mobility at fracture site clinically, absence of pain elicited by stressing the fracture or by walking, and radiographic confirmation of callus formation.
Results:
Data analysis demonstrated reduced fracture-healing time associated with experimental supplementation. For PP analysis group, fracture healing time in 75% of the supplemented group of patients (N=21) was 17 weeks or less and 19 weeks or less in 75% of the placebo group patients (N=36). The percentage of patients with fractures healing in 10 weeks or less was 33.3% for the supplemented group and 11.1% for the placebo group. However, the difference in healing time between the two groups did not reach statistical significance.
Conclusion:
Results showed encouraging trends that fracture-healing time is reduced by supplementation with an essential nutrient complex containing ascorbic acid, lysine, proline, and vitamin B6. In addition, the nutrient supplemented participants reported improved feeling of well-being with use of the supplement.
This is odd in several ways:
- Even though the conclusions hide it quite well, the trial was in fact negative, i. e. it failed to show a significant difference between the verum and the placebo in the primary outcome measure.
- The trial was never published as a peer-reviewed full paper. The website refers to its publication as a ‘letter to the editor’ (LTTE) in the notorious JACM (a LTTE is not normally peer-reviewed).
- Why was it never properly published?
- Could it be because there was no ethics approval [none was mentioned in the LTTE]?
- Could it be because there was no informed consent [none was mentioned in the LTTE]?
- The LTTE mentions that a larger study with 200 patients is planned. This was 16 years ago, and to date there is no trace of such a trial.
Rath’s latest contribution to the world of science is a paper implying that his supplements could play a role in the fight against the present pandemic; it is entitled ‘Effective and safe global public health strategy to fight the COVID-19 pandemic: Specific micronutrient composition inhibits Coronavirus cell-entry receptor (ACE2) expression’. Here is the abstract which clearly shows that Rath has not a jot of clinical evidence:
Optimum micronutrient intake is the only scientifically proven way to improve general immune resistance against infections, a fact documented in every leading textbook of biology. This study provides scientific evidence that, in addition, specific micronutrient compositions are powerful tools in the fight against the COVID-19 pandemic.
Both, SARS-CoV-2 – the virus that causes the current pandemic – and other coronaviruses enter body cells via a specific receptor, the Angiotensin-Converting-Enzyme 2 (ACE2). The ACE2 receptor is expressed by many cell types, including lung epithelial cells as well as endothelial cells of the vascular system.
Based on our earlier research that demonstrated that specific micronutrients can block several mechanisms of viral infections, we tested the efficacy of these natural compounds in suppressing the expression of the ACE2 receptor on human endothelial cells and small airway epithelial cells.
Our results show that a micronutrient composition comprising vitamin C as well as certain amino acids, polyphenols, and trace elements is able to suppress this viral ‘entry door’ into the body under both normal and inflammatory conditions, which are associated with infections.
Thus, vitamin-rich nutrition and micronutrient supplementation should be implemented as effective, safe and affordable public health strategies to fight the COVID-19 pandemic and help prevent future outbreaks. Optimizing the micronutrient status of the entire population should form the basis for any global strategy to help prevent future pandemics across the world, including the developing nations.
The Wiki-page on Rath lists 10 (!) legal cases in which he has been involved. This looks like he easily sues people who disagree with his often bizarre views and sales techniques. Considering this suspicion, I better be careful what I say here. Therefore let me conclude by meekly repeating the title of this post which comes from my friend Ben Goldacre who, together with THE GUARDIAN won a famous and expensive legal battle against Rath:
Rath is an example of the worst excesses of the alternative therapy industry.
PS
What I like best about the many supplements sold by Rath is the footnote in the patient leaflets:
THIS PRODUCT IS NOT INTENDED TO DIAGNOSE, TREAT, CURE OR PREVENT ANY DISEASE
My new book has just been published. Allow me to try and whet your appetite by showing you the book’s introduction:
“There is no alternative medicine. There is only scientifically proven, evidence-based medicine supported by solid data or unproven medicine, for which scientific evidence is lacking.” These words of Fontanarosa and Lundberg were published 22 years ago.[1] Today, they are as relevant as ever, particularly to the type of healthcare I often call ‘so-called alternative medicine’ (SCAM)[2], and they certainly are relevant to chiropractic.
Invented more than 120 years ago by the magnetic healer DD Palmer, chiropractic has had a colourful history. It has now grown into one of the most popular of all SCAMs. Its general acceptance might give the impression that chiropractic, the art of adjusting by hand all subluxations of the three hundred articulations of the human skeletal frame[3], is solidly based on evidence. It is therefore easy to forget that a plethora of fundamental questions about chiropractic remain unanswered.
I wrote this book because I feel that the amount of misinformation on chiropractic is scandalous and demands a critical evaluation of the evidence. The book deals with many questions that consumers often ask:
- How well-established is chiropractic?
- What treatments do chiropractors use?
- What conditions do they treat?
- What claims do they make?
- Are their assumptions reasonable?
- Are chiropractic spinal manipulations effective?
- Are these manipulations safe?
- Do chiropractors behave professionally and ethically?
Am I up to this task, and can you trust my assessments? These are justified questions; let me try to answer them by giving you a brief summary of my professional background.
I grew up in Germany where SCAM is hugely popular. I studied medicine and, as a young doctor, was enthusiastic about SCAM. After several years in basic research, I returned to clinical medicine, became professor of rehabilitation medicine first in Hanover, Germany, and then in Vienna, Austria. In 1993, I was appointed as Chair in Complementary Medicine at the University of Exeter. In this capacity, I built up a multidisciplinary team of scientists conducting research into all sorts of SCAM with one focus on chiropractic. I retired in 2012 and am now an emeritus professor. I have published many peer-reviewed articles on the subject, and I have no conflicts of interest. If my long career has taught me anything, it is this: in the best interest of consumers and patients, we must insist on sound evidence; not opinion, not wishful thinking; evidence.
In critically assessing the issues related to chiropractic, I am guided by the most reliable and up-to-date scientific evidence. The conclusions I reach often suggest that chiropractic is not what it is often cracked up to be. Hundreds of books have been published that disagree. If you are in doubt who to trust, the promoter or the critic of chiropractic, I suggest you ask yourself a simple question: who is more likely to provide impartial information, the chiropractor who makes a living by his trade, or the academic who has researched the subject for the last 30 years?
This book offers an easy to understand, concise and dependable evaluation of chiropractic. It enables you to make up your own mind. I want you to take therapeutic decisions that are reasonable and based on solid evidence. My book should empower you to do just that.
[1] https://pubmed.ncbi.nlm.nih.gov/9820267
[2] https://www.amazon.co.uk/SCAM-So-Called-Alternative-Medicine-Societas/dp/1845409701/ref=pd_rhf_dp_p_img_2?_encoding=UTF8&psc=1&refRID=449PJJDXNTY60Y418S5J
[3] https://www.amazon.co.uk/Text-Book-Philosophy-Chiropractic-Chiropractors-Adjuster/dp/1635617243/ref=sr_1_1?keywords=DD+Palmer&qid=1581002156&sr=8-1
New German Medicine?
German New Medicine?
What on earth is that?
German New Medicine (GNM) is the creation of Ryke Geerd Hamer (1935-2017), a German doctor. The name is reminiscent of the ‘Neue Deutsche Heilkunde’ created by the Nazis during the Third Reich. Hamer received his medical licence in 1963 but was later struck off because of malpractice. He then continued his practice as a ‘Heilpraktiker’. According to proponents, GNM Therapy is a spoken therapy based on the findings and research of the Germanic New Medicine of Dr.Hamer. On the understanding that every disease is triggered by an isolating and shocking event, GNM Therapy assists in finding the DHS (shocking moment) in our lives that preceded the dis-ease and in turn allowing our bodies to complete its natural healing cycle back to full health. Hamer believed to have discovered the ‘5 laws of nature’:
- The Iron Rule of Cancer
- The two-phased development of disease
- Ontogenetic system of tumours and cancer equivalent diseases
- Ontogenetic system of microbes
- Natures biological meaning of a disease
Hamer also postulated that:
- All diseases are caused by psychological conflicts.
- Conventional medicine is a conspiracy of Jews to decimate the non-Jewish population.
- Microbes do not cause diseases.
- AIDS is just an allergy.
- Cancer is the result of a mental shock.
None of Hamer’s ‘discoveries’ and assumptions are plausible or based on facts, and none of his therapeutic approaches have been shown to be effective.
These days, I do not easily get surprised by what I read about so-called alternative medicine (SCAM), but this article entitled ‘Homoeopathy And New German Medicine: Two German Siblings‘ baffled me greatly. Here are a few short excerpts:
… German New Medicine (GNM) like Homoeopathy is one of the gentle healing methods. As siblings, they have some common features as well as their own unique features. So, let’s explore a unique relationship between these two siblings.
1) Holistic aspect:
Both therapeutic methods are believed in holistic concept of body. The disease condition in Homoeopathy and conflict in GNM are very similar in expression as they are reflecting on mental as well as physical level also. In Homoeopathy, Mind, Body and Soul are one of the important trios to understand the Homoeopathic philosophy. While in GNM, Psyche, Brain, Body are important aspect in learning the GNM. Let’s see these trio in their founder’s language,
• Homoeopathy:
Dr. Hahnemann in his oragnon of medicine, 6th edition mentioned about a unity of materialistic body and vital force. Last lines of aphorism 15 are as follows, “…although in thought our mind separates these two unities into distinct conceptions for the sake of easy comprehension.
• German New Medicine:
Dr. Ryke Geerd Hamer, founder of GNM said that, “The differentiation between psyche, brain and the body is purely academic. In reality, they are one.”
2) Disease origin concept:
• Homoeopathy:
In Homoeopathy, disease originates from the dynamic disturbances and followed by functional and pathological changes.
• German New Medicine:
In GNM, morbid condition starts from conflict in the psyche level and later it reflects on body. The common feature is the disturbance is at the all levels of man.
3) Cause of disease:
• Homoeopathy:
In Homoeopathy, among the web of causations, psyche (mind) is also considers as a cause of disease.
• German New Medicine:
So, in GNM, psyche is playing important role in cause of disease. When Conflict starts, its dynamic effect perceived first at mind level.
4) Individuality:
• Homoeopathy:
In Homoeopathy, diathesis is a predisposition for disease condition. i.e. According to the diathesis every individual suffers with their own individual morbid dispositions. Rheumatic diathesis, gouty diathesis, etc. are the examples of diathesis.
• German New Medicine:
In GNM, every individual suffers from the disease condition after the receiving conflict. It is different and depending upon the type of conflict they are receiving. E.g. lung cancer- death fright conflict, cervical cancer –female sexual conflict…
Conclusion:
Some similarities and with some own characteristics, these two healing methods are developing at a good length in medical science. The main aim of these both methods is – “to serve the suffering humanity in gentle way”…
_____________________
Could it be that the author forgot the most striking similarities between GNM and homeopathy? How about these points:
- There is nothing truly gentle about either methods.
- Both are based on bizarre fantasies, far removed from reality.
- Both pretend to be a panacea.
- Both lack proof of efficacy.
- Both have the potential to kill patients (mostly through neglect).
- Both mislead consumers.
- Both are deeply anti-scientific.
- Both dissuade patients from using evidence-based healthcare.
- Both are in conflict with medical ethics.
- Both have cult-like features.
- Both are far from being recognised by proper healthcare.
- Both have been repeatedly in conflict with the law.
- Both were invented by deludes fanatics.
As parts of Australia are going back into lock-down because of the increasingly high COVID-19 infection rates, the Chiropractic Board of Australia (CBA) has issued a statement on chiropractors’ claims regarding immunity:
The Board is particularly concerned that during the ongoing COVID-19 pandemic there are claims in advertising that suggest spinal adjustments and/or manipulation can boost or improve general immunity or the immune system.
There is insufficient acceptable evidence to support such claims in advertising. Acceptable evidence mostly encompasses empirical data from formal research or systematic studies, in the form of peer-reviewed publications. Information about what constitutes acceptable evidence for advertising can be found in the Advertising resources section of the Ahpra website.
Advertising that there is a relationship between manual therapy (e.g. spinal adjustments and/or manipulation) and achieving general wellness or boosting or improving immunity contravenes the National Law and the Guidelines for advertising regulated health services.
Although many claims do not directly reference spinal adjustments and/or manipulation preventing or protecting from COVID-19, there is currently greater awareness of immunity issues and the public is seeking information on ways to prevent or protect themselves from the disease. Consequently, there is a greater risk that claims about spinal adjustments and/or manipulation boosting or improving general immunity may be interpreted to be claims about boosting or improving immunity to COVID-19.
Making claims in advertising that spinal adjustments and/or manipulation can boost or improve general immunity or the immune system is likely to result in regulatory action being taken by the Board.
__________________________________
“… IS LIKELY TO RESULT IN REGULATORY ACTION …”???
Come on, pull the other one!
Bogus claims have been made by chiropractors since ages.
Bogus claims are what chiropractors thrive on.
Without them, they would go bust.
Every now and then some regulator makes some noises reminding chiropractors that bogus claims are bogus. But have they EVER taken any action?
Have they ever even INTENDED to take action?
I doubt it.
In fact, statements of this nature seem to be the chiropractic way of sanctioning false claims. The somewhat paradoxical way this works is as follows: chiropractors make bogus claims all the time; we all got so much used to them that hardly anyone bats an eyelash. But every now and then the bogus nature of the claims become noticeable to the wider public – like now with COVID-19 – and some people or organisations take offence. This is clearly not good for the chiro-business or image. Therefore, the professional chiro organisations step in by issuing a statement – like the one above – condemning the claims and threatening action. All the chiros know, of course, what this is about and change absolutely nothing. The desired effect is guaranteed: chiros can carry on as before, but the image is saved and the business can continue.
I very much doubt that, in the coming weeks, the CBA will do much about the many Australian chiropractors who will continue to mislead the public about COVID-19 or any other issues.
Nice window dressing perhaps, but no substance at all.
If you disagree with my view, please send me the details of any decisive regulatory action which the CBA took regarding immunity claims, and I will delete this post.
Some chiropractors seem too uninformed, stupid or greedy to stop claiming that spinal manipulation boosts the immune system. In the current situation, this is not just annoying, it is positively dangerous.
Here is a fine example of such a person; he is even so convinced of his views that he felt like giving an interview:
How can/does chiropractic care improve your immune system? What happens to our bodies physiologically when we get chiropractic adjustments?
Chiropractic care addresses the vertebral subluxation. This occurs when a vertebra becomes misaligned. This misalignment can result in irritation to the spinal nerve roots, which exit the spinal cord.
When a spinal nerve root is irritated, it stresses the nervous system — thus the potential to weaken the immune system. When we evaluate the spine for these subluxations and identify a misalignment, chiropractors can adjust the spine to alleviate the irritation to the spinal nerve root. This in turn helps to remove the stress from the nervous system.
If people have problems with their immune systems, can chiropractic care help make them better?
Chiropractic care is not a panacea for disease. Its main role is to remove the interference on the nervous system. The three main stresses on the nervous system are thoughts, traumas, and toxins. These are mainly caused by poor lifestyle choices.
Negative thoughts and self-doubt, physical trauma, and environmental toxins all affect the body in ways that stress the nervous system, thus weakening the immune response. Chiropractic care can address the entire nervous system by not only creating a physiological change, but also inducing a reduction of stress, which results in emotional regulation.
Is there any particular research that gives evidence on how chiropractic care can improve your immune system?
Three past studies suggest that manipulation consistently reduced the production of pro-inflammatory mediators associated with tissue damage and pain from articular structures. Two studies provide evidence that manipulation consistently reduced the production of pro-inflammatory mediators associated with tissue damage and pain from articular structures.
Two studies provide evidence that manipulation may induce and enhance production of the immunoregulatory cytokine IL-2 and the production of immunoglobulins as well.
There are a multitude of clinical studies demonstrating the effects of stress on the body and the correlation between stress and immune function. More double blind, randomized clinical trials need to be conducted on the direct relationship between spinal subluxation and the effect on the immune system. In private practice, we observe the impact that adjusting the spine has on overall wellness and its undeniable effect on boosting the body’s ability to adapt to stress and improve your immune system.
Is there anything else about the physiology of how chiropractic care impacts the immune system that you think is important for readers to know?
Our health is our wealth. Taking responsibility for our wellbeing and being preventative affords the body the best possible chance of protecting itself from illness and disease.
Chiropractic care is rooted in the fundamentals that our negative thoughts, traumas, and toxins can lead to disease. By properly evaluating every patient and addressing their physical and emotional challenges, we as a profession can be the leaders of preventative care and restore health naturally and effectively.
On the one hand this is embarrassing, as it exposes almost everything that is wrong with chiropractic. On the other hand, it is informative, as it demonstrates how deeply some chiropractors are entrenched in platitudes, half-truths and blatant lies. The inevitable question is: do these chiropractors really believe this nonsense, or do they merely promote it because it is good for business?
Whatever the answer may be, one thing is fairly obvious: the ones who are being harmed by such drivel are the patients who lack sufficient critical thinking abilities to look through it. They pay not just with their money, but also with their health.
SO, PLEASE LEARN TO THINK CRITICALLY, FOLKS!
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:
- “Arnica,”
- “Calmvalera comp.,”
- “Gelsemium comp.,”
- “Hepar comp.,”
- “Lymphaden comp.”
The FDA referred to the following injectable homeopathic products from 8046255 Canada:
- “Articula,”
- “Mesenchyme,”
- “Connectissue,”
- “MuSkel-Neural,”
- “Ouch,”
- “Ithurts,”
- “Adipose,”
- “Systemic Detox,”
- “Hair,”
- “Neuro 3,”
- “Infla,”
- “Collagen,”
- “Prolo,”
- “Lymph 1,”
- “GI,”
- “Neuro,”
- “Arthros,”
- “Male+,”
- “Immunexx,”
- “Relief+,”
- “Intra-Cell,”
- “Facial,”
- “ANS/CNS”.
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,”
- “Vanicel,”
- “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.
Yesterday, I received a tweet from a guy called Bart Huisman (“teacher beekeeping, nature, biology, classical homeopathy, agriculture, health science, social science”). I don’t know him and cannot remember whether I had previous contact with him. His tweet read as follows:
“Why should anyone believe what Professor Edzard Ernst says, after he put his name to a BBC programme, he now describes as “deception”.”
This refers to a story that I had almost forgotten. It’s a nice one with a ‘happy ending’, so let me recount it here briefly.
In 2005, the BBC had hired me as an advisor for their 4-part TV series on alternative medicine.
The first part of the series was on acupuncture, and Prof Kathy Sykes presented the opening scene taking place in a Chinese operation theatre. In it a Chinese women was having open heart surgery with the aid of acupuncture. Kathy’s was visibly impressed and said on camera that the patient was having the surgery “with only needles to control the pain.” However, the images clearly revealed that the patient was receiving all sorts of other treatments given through intra-venous lines. So, Prof Sykes was telling the UK public a bunch of porkies. This was bound to confuse many viewers.
One of them was Simon Singh. At the time, I did not know Simon (to be honest, I did not even know of him) and was surprised to receive a phone call from him. He politely asked me to confirm that I had been the adviser of the BBC on this production. I was happy to confirm this fact. Then he asked why I had missed such a grave error. I replied that I could not possibly have spotted it, because all I had been asked to do was to review and correct the text of the programme which the BBC had sent to me by email. Before it was broadcast, I had not seen a single passage of the film.
Correcting the text had already led to several problems (not so much regarding the acupuncture part but mostly the other sections), because the BBC was reluctant to change several of the mistakes I had identified. When I told them that, in this case, I would quit, they finally found a way to alter them. But the cooperation had been far from easy. I explained all this to Simon and eventually he asked me whether I would be willing to support the official complaint he was about to file with the BBC. I agreed. This is probably where I used the term ‘deception’ that Mr Huisman mentioned in his tweet.
So, Simon submitted his complaint and eventually won the case.
But this is not the happy ending I was referring to.
During the course of the complaint, Simon and I realised that we were thinking alike and were getting on well. A few months later, he suggested that the two of us write a book together about alternative medicine. At first, I was hesitant. Simon said, “let’s try just one chapter, and see how it works out.” So we did. It turned out to be fun and instructive for both of us. So we did the other chapters as well. The book was published in 2008 and is called TRICK OR TREATMENT. It was published in about 20 different languages and the German version became ‘science book of the year in 2011 (I think).
And that’s not the happy ending either (in fact, it caused a lot of hardship for Simon who was sued by the BCA; luckily, he won that case too).
The real happy ending is the fact that Simon and I became friends for life.
Thank you Bart Huisman for reminding me of this rather lovely story.
This was essentially the question raised in a correspondence with a sceptic friend. His suspicion was that statistical methods might produce false-positive overall findings, if the research is done by enthusiasts of the so-called alternative medicine (SCAM) in question (or other areas of inquiry which I will omit because they are outside my area of expertise). Consciously or inadvertently, such researchers might introduce a pro-SCAM bias into their work. As the research is done mostly by such enthusiasts; the totality of the evidence would turn out to be heavily skewed in favour of the SCAM under investigation. The end-result would then be a false-positive overall impression about the SCAM which is less based on reality than on the wishful thinking of the investigators.
How can one deal with this problem?
How to minimise the risk of being overwhelmed by false-positive research?
Today, we have several mechanisms and initiatives that are at least partly aimed at achieving just this. For instance, there are guidelines on how to conduct the primary research so that bias is minimised. The CONSORT statements are an example. As many studies pre-date CONSORT, we need a different approach for reviews of clinical trials. The PRISMA guideline or the COCHRANE handbook are attempts to make sure systematic reviews are transparent and rigorous. These methods can work quite well in finding the truth, but one needs to be aware, of course, that some researchers do their very best to obscure it. I have also tried to go one step further and shown that the direction of the conclusion correlates with the rigour of the study (btw: this was the paper that prompted Prof Hahn’s criticism and slander of my work and person).
So, problem sorted?
Not quite!
The trouble is that over-enthusiastic researchers may not always adhere to these guidelines, they may pretend to adhere but cut corners, or they may be dishonest and cheat. And what makes this even more tricky is the possibility that they do all this inadvertently; their enthusiasm could get the better of them, and they are doing research not to TEST WHETHER a treatment works but to PROVE THAT it works.
In the realm of SCAM we have a lot of this – trust me, I have seen it often with my own eyes, regrettably sometimes even within my own team of co-workers. The reason for this is that SCAM is loaded with emotion and quasi-religious beliefs; and these provide a much stronger conflict of interest than money could ever do, in my experience.
And how might we tackle this thorny issue?
After thinking long and hard about it, I came up in 2012 with my TRUSTWORTHYNESS INDEX:
If we calculated the percentage of a researcher’s papers arriving at positive conclusions and divided this by the percentage of his papers drawing negative conclusions, we might have a useful measure. A realistic example might be the case of a clinical researcher who has published a total of 100 original articles. If 50% had positive and 50% negative conclusions about the efficacy of the therapy tested, his TI would be 1.
Depending on what area of clinical medicine this person is working in, 1 might be a figure that is just about acceptable in terms of the trustworthiness of the author. If the TI goes beyond 1, we might get concerned; if it reaches 4 or more, we should get worried.
An example would be a researcher who has published 100 papers of which 80 are positive and 20 arrive at negative conclusions. His TI would consequently amount to 4. Most of us equipped with a healthy scepticism would consider this figure highly suspect.
Of course, this is all a bit simplistic, and, like all other citation metrics, my TI provides us not with any level of proof; it merely is a vague indicator that something might be amiss. And, as stressed already, the cut-off point for any scientist’s TI very much depends on the area of clinical research we are dealing with. The lower the plausibility and the higher the uncertainty associated with the efficacy of the experimental treatments, the lower the point where the TI might suggest something to be fishy.
Based on this concept, I later created the ALTERNATIVE MEDICINE HALL OF FAME. This is a list of researchers who manage to go through life researching their particular SCAM without ever publishing a negative conclusion about it. In terms of TI, these people have astronomically high values. The current list is not yet long, but it is growing:
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)
The logical consequence of a high TI would be that researchers of that nature are banned from obtaining research funds and publishing papers, because their contribution is merely to confuse us and make science less reliable.
I am sure there are other ways of addressing the problem of being mislead by false-positive research. If you can think of one, I’d be pleased to hear about it.
In the wake of both the NEJM and the LANCET withdrawing two potentially influential papers due unanswered questions about the source and reliability of the data, one has to ask how good or bad the process of peer review is.
Peer review is the evaluation of work by one or more people with similar competences as the producers of the work (peers). It functions as a form of self-regulation by qualified members of a profession within the relevant field. It normally involves multiple steps:
- Authors send their manuscript to a journal of their choice for publication.
- The journal editor has a look at it and decides whether to reject it straight away (for instance, because the subject area is not of interest) or whether to send it out to referees for examination (often to experts suggested by the authors of the submission).
- The referees (usually 2 or 3) have the opportunity to reject or accept the invitation to review the submission.
- If they accept, they review the paper and send their report to the editor (usually following a deadline).
- The editor tries to come to a decision about publication; often the referees are not in agreement, and a further referee has to be recruited.
- Even if the submission is potentially publishable, the referees will have raised several points that need addressing. In such cases, the editor sends the submission back to the original authors asking them to revise the article.
- The authors do their revision (often following a deadline) and re-submit their paper.
- Now the editor can decide to either publish it or send it back to the referees asking them whether they feel their criticisms have been adequately addressed.
- Depending on the referees’ verdicts, the editor makes the final decision and informs all the involved parties accordingly.
- If the paper was accepted, it then goes into production.
- When this process is finished, the authors receive the proofs for final a check.
- Eventually, the paper is published and the readers of the journal may scrutinise it.
- Often this prompts comment which may get published.
- In this case, the authors of the original paper may get invited to write a reply.
- Finally the comments and the reply are published in the journal side by side.
The whole process takes time, sometimes lots of time. I have had papers that took almost two years from submissions to publications. This delay seems tedious and, if the paper is important, unacceptable (if it is not important, it should arguably not be published at all). Equally unacceptable is the fact that referees are expected to do their reviewing for free. The consequence is that many referees do their reviewing less than well.
When I was still at Exeter, I had plenty of opportunity to see the problems of peer review from the reviewers perspective. At a time, I accepted about 5 reviews per week, and in total I surely have reviewed over 1000 papers. I often recommended inviting a statistician to do a specialist review of the stats. Only rarely were such suggestions accepted by the journal editors. Very often I recommended rejecting a submission because it was rubbish, and occasionally, I told the editor that there was a strong suspicion of the paper being fraudulent. The editors very often (I estimate in about 50% of cases) ignored my suggestions and comments and published the papers nonetheless. If the editor did follow my advice to reject a paper, I regularly saw it published elsewhere later (usually in a less well-respected journal). Several times, an author of a submission contacted me directly after seeing my criticism of his paper. Occasionally this resulted in unpleasantness, once or twice even in threats. Eventually I realised that improving the publications in the realm of SCAM was a Sisyphean task, became quite disenchanted with all this and accepted less and less reviews. Today, I do only very few.
I had even more opportunity to see the peer review process from the author’s perspective. All authors must have suffered from unfair or incompetent reviews and most will have experienced the frustrations of the endless delays. Once (before my time in alternative medicine) a reviewer rejected my paper and soon after published results that were uncannily similar to mine. In alternative medicine, researchers tend to be rather emotional about their subject. Imagine, for instance, the review you might get from Dana Ullmann of a trial of homeopathy that fails to show what he believes in.
Finally, since 40 years, I have also had the displeasure of experiencing peer review as an editor. This often seemed like trying to sail between the devil and the deep blue sea. Editors want to fill their journals with the best science they can find. But all too often, they receive the worst science they can imagine. They are constantly torn by tensions pulling them in opposite directions. And they have to cope not just with poor quality submissions but also with reviewers who miss deadlines and do their work badly.
So, peer review is fraught with problems! The trouble is that there are few solutions that would keep a better check on the reliability of science. Peer review, it often seemed to me, is the worst idea, except for all others. If peer review is to survive (and I think it probably will), there are a few things that could, from my point of view, be done to improve it:
- Make it much more attractive for the referees. Payment would be the obvious thing – and by Jove, the big journals like the LANCET and NEJM could afford it. But recognising refereeing academically would be even more important. At present, academic careers depend largely of publications; if they also depended on reviewing, experts would queue up to do it.
- The reports of the referees should get independently evaluated according to sensible criteria. These data could be conflated an published as a criterion of academic standing. Referees who fail to to a good job would spoil their chances to get re-invited for this task.
- Speed up the entire process. Waiting months on months is hugely counter-productive for all concerned.
- Today many journals ask authors for the details of experts who are potential reviewers of their submission and then send the paper in question to them for review. I find this ridiculous! No author I know of has ever resisted the temptation to name people who are friends or owe a favour. Journals should afford the extra work to find who the best independent experts on any particular subject are.
None of this is simple or fool-proof or even sure to work well, of course. But surely it is worth trying to get peer-review right. The quality of future science depends on it.
Cochrane reviews have the reputation to be the most reliable evidence available anywhere. They are supposed to be independent, rigorous, transparent and up-to-date. Usually, this reputation is justified, in my view. But do the 54 Cochrane reviews of acupuncture quoted in my previous post live up to it?
If one had to put the entire body of evidence in a nutshell, it would probably look something like this:
TOTAL NUMBER OF SYSTEMATIC REVIEWS = 54
POSITIVE CONCLUSIONS BASED ON MORE THAN ONE HIGH QUALITY STUDY = 2
FAILURE TO REACH CONVINCINGLY POSITIVE CONCLUSIONS = 52
The two positive reviews are on:
1) prevention of migraine
2) prevention of tension-type headache
Both of the positive reviews are by Linde et al.
Allow me to raise just a few further critical points:
- If I counted correctly, 19 of the 54 reviews are authored entirely by Chinese authors. Why could this be a problem? One reason could be that many Chinese authors seem to be biased in favour of acupuncture. Another reason could be that data fabrication is rife in China.
- Many if not most of the primary studies are published in Chinese. This means that it is impossible for most non-Chinese co-authors of the review as well as for the referees of the paper to check the accuracy of the data extraction.
- I counted a total of 15 reviews which were by authors who one could categorise as outspoken enthusiasts of acupuncture. In these cases, one might be concerned about the trustworthiness of the review’s conclusion.
- Many (some would say most) of the reviews cover subject areas which are frankly bizarre. Who would, for instance, consider acupuncture a plausible treatment for Glaucoma, Mumps or chronic hepatitis B?
- Despite almost all of the reviews demonstrating that there is no good reason to recommend acupuncture for the condition in question, hardly any of them draw a transparent, helpful and clear conclusion. One example might suffice: the review of acupuncture for hordeolum concluded that “Low‐certainty evidence suggests that acupuncture with or without conventional treatments may provide short‐term benefits for treating acute hordeolum…” Its Chinese authors reached this conclusion on the basis of 6 primary studies (all from China) which were all of lousy quality. In such a case, the only justified conclusion would be, in my view, something like this: THERE IS NO RELIABLE EVIDENCE …
Despite these serious limitations and avoidable confusions, the totality of the evidence from these 54 Cochrane reviews does send an important message: there is hardly a single condition for which acupuncture is clearly, convincingly and indisputably effective. What I find most regrettable, however, is that the Cochrane Collaboration allowed the often biased review authors to obscure this crucial message so thoroughly. One needs a healthy portion of critical thinking to get through to the truth here – and how many fans of acupuncture possess such a thing?
