When I previously wrote about Pranic Healing I boldly asked whether it is a hoax. This prompted several furious reactions of believers who thought my question was insulting. Meanwhile, I informed myself more thoroughly and am happy to confirm that Pranic Healing is not a hoax at all. In fact, it is much worse.
What, you forgot what Pranic Healing is?
How could you?
According to one website, Pranic Healing is a
no touch, non-invasive healing technique that was founded by Grand Master Choa Kok Sui. It is a synthesis of healing techniques from ancient China, Tibet and India in which Prana is used to heal a wide variety of illnesses. Pranic Healing is not only used to cure illness or physical ailments but also can be cure person of his psychological ailments. To be very simple in this computer age as the computer contains the hardware and the software. In human body hardware is our physical body and the software’s are the Human emotions which includes Anger, Grief, Anxiety, Stress , fatigue, our karmas, pride, fear, Phobias and many more.
These human viruses affect the physical body of a person. In Pranic healing Grand Master Choa kok Sui has taught to remove these negative emotions from our system in a very simple but powerful and effective way. Grand Master Choa Kok Sui did lot of research and experiment for treating different diseases and ailments and made is very simple so that anybody can learn it. Today Pranic healing is taught and practiced in more than 80 countries of the world and its books are available in more than 34 languages. Pranic Healing is not intended to replace orthodox western medicine, but rather to complement it. Countless people and their families have been treated and are enjoying a better quality of life through Pranic Healing.
‘Grand Master’ Choa was born August 15, 1952, in the Philippines. His parents were of Chinese descent and became successful business people. Choa was raised in this environment of business and absorbed its lessons only too well. Sadly, he seemed to have been immune to his own healing innovation, as he died young in 2007. But his Pranic Healing empire lives on and today it is a hugely profitable business.
Prana Crystals sell a wide range of products, for instance ‘healing wants’ which they advertise as follows:
Healing Wands made from various stones and crystals have been used round the globe for healing purposes since ages. They help in cleansing of the entire body or aura or they can also be used to heal an affected part of the body or chakra. These wands can also be used for massaging purpose. They absorb the negative energy and release stress and pressure and help in transferring the positive energy of the stone. Healing Wands are available in variety of stones and crystals in different sizes. Each one of them have specific characteristics and uses. We have a variety of Wands available to meet your requirements.
My favourite wand is the one pictured on the right here. It is the Rolls Royce of all the wands on offer and therefore it can obviously not come cheap. But at US$ 1999 (yes, one thousand nine hundred and ninety-nine American dollars) it is still a bargain, because it rids you of all the diseases and negative energy that you can dream of.
During my recent crash course in Pranic Healing, I came across dozens of websites, hundreds of testimonials, uncounted comments and a plethora of curious things. Let me share just one of them with you:
Pranic Weight Loss Body Sculpting Face Lift is a fascinating area of the applications of the teachings of Master Choa Kok Sui for health and beauty. This workshop helps you look prettier and loose weight without surgery, exhausting exercises and medicine, just by using the knowledge of subtle energy.
Using specific combination of colour pranas and techniques, your skin can look 10 to 20 years younger. In fact the lines and wrinkles of the face are storage of negative and unpleasant feelings and experiences such as anger, fear and grief. When this emotional garbage is cleared and released, the face will look younger, brighter and revitalized.
Certain colour Pranas have the power to disintegrate and remove fat, wrinkles and lines from your system to create a healthier and better-looking body. In fact the lines and wrinkles of the face are storage of negative and unpleasant feelings and experiences such as anger, fear and grief. When this emotional garbage is cleared and released, the face will look younger, brighter and revitalized.
No, Pranic Healing is most certainly not hoax, and I was wrong to imply it. My sincere apologies! It is pure and simple exploitation of vulnerable people who have not had the opportunity to learn how to think critically.
Aromatherapy is currently one of the most popular of all alternative therapies. It consists of the use of essential oils for medicinal purposes. Aromatherapy usually involves the application of diluted essential oils via a gentle massage of the body surface. Less frequently, the essential oils are applied via inhalation. The chemist Rene-Maurice Gattefosse (1881-1950) coined the term ‘aromatherapy’ after experiencing that lavender oil helped to cure a serious burn. In 1937, he published a book on the subject: Aromathérapie: Les Huiles Essentielles, Hormones Végétales. Later, the French surgeon Jean Valnet used essential oils to help heal soldiers’ wounds in World War II.
This Iranian study aimed to investigate the effect of inhalation aromatherapy with damask rose essence on pain and anxiety in burn patients. This three group clinical trial was conducted on 120 patients with burns less than 30% of total body surface area (TBSA). The patients were randomly allocated into three groups, aromatherapy damask rose essence, placebo, and control. The pain intensity was assessed using visual analogue scale prior to intervention, immediately before, and 15 min after dressing. Anxiety was measured using Spielberger Inventory at before intervention and 15 min after dressing, also the prolonged effect of intervention on pain was assessed by number of the analgesics drugs received for four hours after dressing change. The intervention included inhalation of 6 drops of 40% damask rose essential oil in the damask group, and six drops of distilled water in placebo group one hour before dressing change. The control group received no additional intervention. All groups also received standard care.
Baseline state-trait anxiety and pain intensity were similar in these three groups. A significant reduction was found in pain intensity immediately before and after dressing and state anxiety after dressing in the damask group compared to the placebo and control groups. The researchers found no significant difference between the placebo and control groups in terms of these variables at these times. No significant difference was noted among the three groups in frequency of analgesics drugs and trait anxiety after intervention.
The authors concluded that inhaled aromatherapy with Damask rose essence reduces subjective pain intensity and state anxiety in burned patients. Therefore, it is recommended considering use of damask rose essence, as an easy and affordable method along with other treatments.
These are interesting findings for sure. Aromatherapy is far less implausible than many other so-called alternative medicines (SCAMs). It furthermore has the advantages of being safe and inexpensive.
I have no reason to doubt the validity of the study. Yet, I nevertheless think it is prudent to insist on an independent replication before issuing a general recommendation.
When tested rigorously, the evidence for so-called alternatives medicine (SCAM) is usually weak or even negative. This fact has prompted many SCAM enthusiasts to become utterly disenchanted with rigorous tests such as the randomised clinical trial (RCT). They seem to think that, if the RCT fails to generate the findings we want, let’s use different methodologies instead. In other words, they are in favour of observational studies which often yield positive results.
This line of thinking is prevalent in all forms of SCAM, but probably nowhere more so that in the realm of homeopathy. Homeopaths see that rigorous RCTs tend not to confirm their belief and, to avoid cognitive dissonance, they focus on observational studies which are much more likely to confirm their belief.
In this context, it is worth mentioning a recent article where well-known homeopathy enthusiasts have addressed the issue of observational studies. Here is their abstract:
Background: Randomized placebo-controlled trials are considered to be the gold standard in clinical research and have the highest importance in the hierarchical system of evidence-based medicine. However, from the viewpoint of decision makers, due to lower external validity, practical results of efficacy research are often not in line with the huge investments made over decades.
Method: We conducted a narrative review. With a special focus on homeopathy, we give an overview on cohort, comparative cohort, case-control and cross-sectional study designs and explain guidelines and tools that help to improve the quality of observational studies, such as the STROBE Statement, RECORD, GRACE and ENCePP Guide.
Results: Within the conventional medical research field, two types of arguments have been employed in favor of observational studies. First, observational studies allow for a more generalizable and robust estimation of effects in clinical practice, and if cohorts are large enough, there is no over-estimation of effect sizes, as is often feared. We argue that observational research is needed to balance the current over-emphasis on internal validity at the expense of external validity. Thus, observational research can be considered an important research tool to describe “real-world” care settings and can assist with the design and inform the results of randomised controlled trails.
Conclusions: We present recommendations for designing, conducting and reporting observational studies in homeopathy and provide recommendations to complement the STROBE Statement for homeopathic observational studies.
In their paper, the authors state this:
It is important to realize three areas where observational research can be valuable. For one, as already mentioned, it can be valuable as a preparatory type of research for designing good randomized studies. Second, it can be valuable as a stand-alone type of research, where pragmatic or ethical reasons stand against conducting a randomized study. Additionally, it can be valuable as the only adequate method where choices are involved: for instance, in any type of lifestyle research or where patients have very strong preferences, such as in homeopathy and other CAM. This might also lead to a diversification of research efforts and a broader, more realistic, picture of the effects of therapeutic interventions.
My comments to this are as follows:
- Observational research can be valuable as a preparatory type of research for designing good randomized studies. This purpose is better fulfilled by pilot studies (which are often abused in SCAM).
- Observational research can be valuable as a stand-alone type of research, where pragmatic or ethical reasons stand against conducting a randomized study. Such situations rarely arise in the realm of SCAM.
- Observational research can be valuable as the only adequate method where choices are involved: for instance, in any type of lifestyle research or where patients have very strong preferences, such as in homeopathy and other CAM. I fail to see that this is true.
- Observational research leads to a diversification of research efforts and a broader, more realistic, picture of the effects of therapeutic interventions. The main aim of research into the effectiveness of SCAM should be, in my view, to determine whether the treatment per se works or not. Observational studies are likely to obscure the truth on this issue.
Don’t get me wrong, I am not saying that observational studies are useless; quite to the contrary, they can provide very important information. But what I am trying to express is this:
- We should not allow double standards in medical research. The standards and issues of observational research as they exist in conventional medicine must also apply to SCAM.
- Observational studies cannot easily determine cause and effect between the therapy and the outcome.
- Observational studies cannot be a substitute for RCTs.
- Depending on their exact design, observational studies measure the outcome caused by a whole range of factors, including the therapy per se, the placebo-effect, the natural history of the disease, the regression towards the mean.
- Observational studies are particularly useful in effectiveness research, AFTER the efficacy of a therapy has been established by RCTs.
- If RCT fail to show that a therapy is effective and observational studies seem to indicate that they work, the therapy in question is probably a placebo.
- SCAM-enthusiasts’ preference for observational studies is transparently due to motivated reasoning.
I started my full-time research into so-called alternative medicine (SCAM) at Exeter in 1993. It became soon clear to me that the most urgent subject to investigate was the safety of SCAM. Safety is more important than efficacy for treatments that are already out there. My decision to prioritise safety quickly led to the bewilderment of the SCAM community. They pointed out that SCAM was safe and that the true risks in healthcare were with conventional medicine. Belief was strong, but data were scarce.
My counter arguments therefore were:
- Safety is too important a subject to leave it to belief, and we need evidence.
- SCAM is hugely popular and it was my ethical duty to provide data on safety.
The SCAM community were unconvinced by my logic. But that did not stop me.
In the course of dozens of investigations, we then found that adverse effects of SCAM do exist and some can be quite dramatic. Again, I was told that this might be so, but the real dangers surely lie elsewhere, namely in conventional medicine.
Meanwhile, I began to find that, while the direct risks of SCAM were real, the indirect risks were much more important. During virtually every talk I gave and in most papers I published, I started including this message:
EVEN A HARMLESS SCAM WILL BECOME LIFE-THREATENING, IF IT IS USED AS AN ALTERNATIVE TO CONVENTIONAL CARE FOR A SERIOUS CONDITION.
Even though the statement seems quite clear, it does not really capture the complexity of the issues involved. Let’s take (yet again) the example of homeopathy (because it is one of the most clear-cut cases).
The remedy is normally harmless; after all it contains nothing. Therefore, there are no or very few adverse effects. If a patient is naïve enough to use homeopathy in an attempt to cure a life-threatening condition, it is hardly the fault of homeopathy – at least this is what some defenders of the homeopathic realm claim. So why blame homeopathy?
Indeed, this could be unfair, because then we would have to say that water is dangerous because you can easily kill yourself with it.
But the water companies do not recommend abusing water for suicidal purposes!
And homeopaths do unquestionably recommend homeopathy for serious conditions!
So, it is not the remedy and not homeopathy itself that makes it dangerous. What makes it risky is the combination of two things:
- the inertness of the remedy
- the unsubstantiated claims that are being made for it.
The two together create a potentially deadly mixture. Without false claims, nobody could classify homeopathy as life-threatening. Due to the plethora of false claims, nobody can reasonably deny that it is.
What follows is simple, I think: one would only need to stop the claims. Subsequently, homeopathy – and many other forms of SCAM – could be classified as harmless (yes, I know, this is purely theoretical because in practice this will never happen). They would still be ineffective, of course, but safety was and is the priority.
In 2012, we evaluated the efficacy/effectiveness of lavender for the reduction of stress/anxiety.
Our systematic review included 15 RCTs. Two trials scored 4 points on the 5-point Jadad scale, the remaining 13 scored two or less. Results from seven trials appeared to favour lavender over controls for at least one relevant outcome. We concluded that methodological issues limit the extent to which any conclusions can be drawn regarding the efficacy/effectiveness of lavender. The best evidence suggests that oral lavender supplements may have some therapeutic effects. However, further independent replications are needed before firm conclusions can be drawn.
Since 2012, more evidence has emerged. The latest study on the subject aimed to investigate the effects of lavender oil on sleep and quality of life of menopausal women through steam inhalation. It was quasi-experimental with pre-test/post-test placebo control groups. It was conducted with 57 women, 27 of whom were subject to aromatherapy and 30 to a placebo. Data were collected using the Questionnaire Form, the Pittsburgh Sleep Quality Index (PSQI) and the Menopause-Specific Quality of Life Questionnaire (MENQOL).
For the intervention group, the PSQI median scores after the administration of aromatherapy were found to be significantly lower than those before the administration (p < 0.001) and those of the placebo group (p < 0.001). Similarly, for the intervention group, the total median MENQOL scores after the administration of the aromatherapy were found to be significantly lower than the scores prior to the administration (p < 0.001) as well as the scores of the placebo group (p < 0.001).
The authors of the new study concluded that that aromatherapy involving lavender-scented steam inhalation increased sleep quality and quality of life in women with sleep deprivation problems during menopause.
Hurray, this seems to be a decent trial with a positive result for SCAM!
And why not? It is not at all implausible that lavender has hypnotic effects. There are now quite a few reasonably sound trials that suggest it works. Moreover, it is safe and not very expensive (or even free, if you can grow it yourself).
I for one am more than happy to report a positive finding for a SCAM and merely regret that I cannot do so more often.
Pisa syndrome (PS) is a condition in which there is sustained involuntary flexion of the body and head to one side and slight rotation of the trunk so the person appears to lean like the Leaning Tower of Pisa. The PS can occur as a complication of Parkinson’s disease (PD). It can also be an adverse effect of some medications. It is characterized by a trunk lateral flexion higher than 10 degrees which is reversible when lying. The underlying pathophysiological mechanisms responsible for the development of PS are poorly understood. One pathophysiological hypothesis is that PS in PD is caused by an altered verticality perception, due to a somatosensory impairment.
The management of PS remains a challenge. Physiotherapy with early rehabilitation emphasising stretching exercises for the external oblique and paraspinal muscles is usually recommended. Therapy is also needed to improve static, dynamic posture and the control of pain symptoms. Osteopathic Manipulative Treatment (OMT) is also sometimes advocated for PS, but does it work?
The aim of the study was to assess OMT efficacy on postural control in PD-PS patients by stabilometry. In this single-blinded trial the investigators studied 24 PD-PS patients, 12 of whom were randomly assigned to receive a multidisciplinary physical therapy protocol (MIRT) and sham OMT, while the other 12 received OMT plus MIRT for one month. The primary endpoint was the eye closed sway area assessment after the intervention. Evaluation of trunk lateral flexion (TLF) was also performed.
At one month, the sway area of the OMT group significantly decreased compared to placebo (mean delta OMT – 326.00±491.24 mm2, p = 0.01). The experimental group TLF showed a mean inclination reduction of 3.33 degrees after treatment (p = 0.044, mean d = 0.54). Moreover, a significant positive association between delta ECSA and delta TLF was observed (p = 0.04, r = 0.46).
The authors concluded that among PD-PS patients, MIRT plus OMT showed preliminary evidence of postural control and TLF improvement, compared to the control group.
The authors entitled their paper ‘Efficacy of Osteopathic Manipulative Treatment on Postural Control in Parkinsonian Patients With Pisa Syndrome: A Pilot Randomized Placebo-Controlled Trial’. As a pilot study, it should not test efficacy but explore the feasibility of a definitive trial. The fact the authors report outcome data, indicates to me that this is, in fact, not a pilot study, but a hopelessly underpowered clinical trial. This means that the findings could be due merely to chance alone. And this, in turn, means that the researchers owe it to their patients to conduct a properly powered RCT.
Michael Dixon LVO, OBE, MA, FRCGP has been a regular feature of this blog (and elsewhere). He used to be a friend and colleague until … well, that’s a long story. Recently, I came across his (rather impressive) Wikipedia page. To my surprise, it mentions that Dixon
“has been criticised by professor of complementary medicine and alternative medicine campaigner Edzard Ernst for advocating the use of complementary medicine. Ernst said that the stance of the NHS Alliance on complementary medicine was “misleading to the degree of being irresponsible.” Ernst had previously been sympathetic to building a bridge between complementary and mainstream medicine, co-writing an article with Michael Dixon in 1997 on the benefits of such an approach. Ernst and Dixon write “missed diagnoses by complementary therapists giving patients long term treatments are often cited but in the experience of one of the authors (MD) are extremely rare. It can also cut both ways. A patient was recently referred back to her general practitioner by an osteopath, who was questioning, as it turned out quite correctly, whether her pain was caused by metastates. Good communication between general practitioner and complementary therapist can reduce conflicts and contradictions, which otherwise have the potential to put orthodox medicine and complementary therapy in an either/or situation.”
31) February 2009, 24. “Academics and NHS Alliance clash over complementary medicine”. Pulse Today.
32) ^ Update – the journal of continuing education for General Practitioners, 7th May 1997
I have little recollection of the paper that I seem to have published with my then friend Michael, and it is not listed in Medline, nor can I find it in my (usually well-kept) files; the journal ‘Update’ does not exist anymore and was obviously not a journal good enough for keeping a copy. But I do not doubt that Wiki is correct.
In fact, it is true that, in 1997, I was still hopeful that bridges could be built between conventional medicine and so-called alternative medicine (SCAM). But I had always insisted that they must be bridges built on solid ground and with robust materials.
Put simply, my strategy was to test SCAM as rigorously as I could and to review the totality of the evidence for and against it. Subsequently, one could consider introducing those SCAMs into routine care that had passed the tests of science.
Dixon’s strategy differed significantly from mine. He had no real interest in science and wanted to use SCAM regardless of the evidence. Since the publication of our paper in 1997, he has pursued this aim tirelessly. On this blog, we find several examples of his activity.
And what happened to the bridges?
I’m glad you ask!
As it turns out, very few SCAMs have so far passed the test of science and hardly any SCAM has been demonstrated to generate more good than harm. The material to build bridges is therefore quite scarce, hardly enough for solid constructions. Dixon does still not seem to be worried about this indisputable fact. He thinks that INTEGRATED MEDICINE is sound enough for providing a way to the future. I disagree and still think it is ‘misleading to the degree of being irresponsible’.
Who is right?
Dixon or Ernst?
Opinions about this differ hugely.
Time will tell, I suppose.
The objective of this survey was to assess the prevalence and types of so-called alternative medicine (SCAM) usage as well as the participants’ spirituality/religiousness in an outpatient department for endocrinology and metabolic diseases. All individuals visiting the outpatient department at a German university hospital from April to June 2009 were offered a standardized questionnaire on the use of dietary supplements and other SCAMs as well as their religiousness/spirituality. Demographic and clinical data of 428 respondents were taken from the electronic health record.
Of the respondents, 16.4% (n = 66) classified themselves to be religious/spiritual and 67.9% (n = 273) as not religious/spiritual. The results show that:
- 41.4% of the respondents used supplements and 27.4% additional therapies;
- the use of supplements and other SCAMs was more frequent in people with higher religiousness/spirituality (p = 0.005 and p = 0.01,resp.);
- there were no associations between religiousness/spirituality and the number of consultations, costs for drugs, appraisal of the physicians treatment methods, the perceived effectiveness of prescribed drugs, fear of late complications or of side effects.
The authors concluded that a higher religiousness/spirituality is associated with a more frequent use of supplements or additional therapies in individuals with endocrinopathies or metabolic diseases. As SCAM has been shown to be associated with worse outcome, addressing religiousness/spirituality which stresses the responsibility of the person for his life might offer an additional resource and should be further studied.
This survey has a dismal sample size and even worse response rate and must therefore be taken with more than a pinch of salt. Yet vaguely similar associations have been shown before. For instance, analysing data from the 1995-1996 National Survey of Midlife Development in the United States (n=3032), researchers examined the correlations between four aspects of spirituality/religiousness-i.e., spiritual only, religious only, both spiritual and religious, and neither spiritual nor religious-and six measures of SCAM. Compared with spiritual only persons, the odds of using energy therapies were 86% lower for spiritual and religious persons, 65% lower for religious only persons, and 52% lower for neither spiritual nor religious persons. Compared to spiritual only persons, spiritual and religious individuals were 43% more likely to use body-mind therapies in general; however, when this category did not contain prayer, meditation, or spiritual healing, they were 44% less likely. Religious only individuals were disinclined toward SCAM use.
There might be considerable cultural and national differences, of course, but if it is true that religiousness/spirituality is associated with a more frequent use of SCAM, we ought to ask what the nature of the link between the two might be. There are, as far as I can see, three possibilities:
- religiousness/spirituality causes SCAM use;
- SCAM use causes religiousness/spirituality;
- the two are related via one or several other factors.
I see no reason why 1 or 2 should be true. More likely there is a common denominator. The obvious one might be that both religiousness/spirituality and SCAM use are somewhat irrational, more a matter of belief than evidence, and revealing a lack of scepticism or critical thinking. In this case, religiousness/spirituality and SCAM use would simply be two different expressions of the same frame of mind.
What do you think?
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:
- “Calmvalera comp.,”
- “Gelsemium comp.,”
- “Hepar comp.,”
- “Lymphaden comp.”
The FDA referred to the following injectable homeopathic products from 8046255 Canada:
- “Systemic Detox,”
- “Neuro 3,”
- “Lymph 1,”
The FDA warning to World Health Advanced Technologies, Ltd referred to:
- “Enercel AM,”
- “Enercel Forte,”
- “Enercel Max,”
- “Enercel Mist-Nasal,”
- “Enercel Mist Nebulizer,”
- “Enercel PM,”
- “Enercel Plus,”
- “Enercel Plus IM.”
The FDA warning referred to the following products by MediNatura, and the claims made for them include:
- Zeel Injection Solution: “… treatment of arthrosis/osteoarthritis, and/or rheumatic joint diseases and for the relief of symptoms such as pain and joint stiffness.”
- Traumeel Injection Solution: “… treatment of injuries, inflammatory and degenerative conditions of the musculoskeletal system and for the relief of associated symptoms such as pain.”
- Engystol Injection Solution: “… support of the immune system to reduce severity and duration of symptoms in viral infections, particularly in the early stages of colds and influenza-like illnesses.”
- Neuralgo-Rheum Injection Solution: “… treatment of nerve pain, soft tissue rheumatism and symptoms of disc protrusion.”
- Lymphomyosot X Injection Solution: “… improvement of lymphatic drainage, the non-specific immune defense, and conditions such as benign hypertrophy of lymph nodes, chronic tonsillitis, tonsillar hypertrophy and lymphatic edema.”
- Spascupreel Injection Solution: “… relief of spasms of the smooth musculature of the gastrointestinal and urogenital tract as well as general muscle spasms.”
The FDA has requested the companies to respond within 15 working days. The letter also states that failure to correct any violations could result in legal action against the company, including seizure and injunction.
Asked for comment, Cliff Clive, founder and CEO for MediNatura, stated that he is disappointed with the FDA’s actions and the company is in the process of developing their response. “The FDAs statements that the MediNatura injectable products present greater risk to consumers is without factual basis,” Clive said. “The MediNatura injectable products are labelled for use only under the care of licensed practitioners [and] are manufactured in [Good Manufacturing Practice]-compliant facilities to assure their quality and sterility.”
Disputing several of the claims made in the letter, Clive noted that rather than protecting patients, “the FDA’s actions threaten to remove valuable alternatives relied upon by medical practitioners in treating their patients. These injections have been used legally by thousands of medical doctors for more than 30 years in the U.S., and in over 50 other countries for more than 60 years, with rigorous monitoring of adverse events,” Clive said. “As a result, there is a substantial amount of epidemiological data which shows that MediNatura’s injection products have a superb safety profile.”
As far as I can see, none of the above-named products are supported by sound evidence. If you ask me, it is time that homeopaths understand what proofs of safety and efficacy amount to, that they stop confusing the public, and that they stop marketing illegal products.