Monthly Archives: November 2019
As we discussed previously, the WHO has included TCM diagnoses in the International Classification of Diseases (ICD). The WHO claim this is not an endorsement, but experts point out that the move will promote TCM and mislead the public into thinking that TCM is safe and effective. Thus consumers might use it as an alternative for effective treatments of serious conditions, in which case they would endanger their lives.
Prof George Griffin, the president of FEAM, was quoted saying “We don’t give drugs and surgical treatments unless there is real evidence that they work and do no damage and basically the feeling is that most of the traditional Chinese medicine drugs are unregulated. They are not tested properly for toxicity. They probably vary greatly between batches produced, for example seaweed, which is the latest, and they may be harmful. The other side of the equation is that they may be deluding patients into thinking they are taking appropriate therapies for serious disease.”
“Multiple risks of harm from herbal ingredients have been documented,” the joint statement warns. Sometimes herbal remedies have been adulterated with chemicals. Interaction with conventional drugs can be a serious threat. And acupuncture, they will say, “is not necessarily harmless”. A review in 2017 as well as numerous papers discussed on this blog (for instance here and here) found injuries to vital organs, infections and other adverse reactions.
Although those who use SCAM are being misled to think of them as originating from small scale enterprises, globally it is big business. “The production and delivery of TCM has become a large industry with estimates of $60bn [£46.5bn] a year and an annual growth rate above 10%,” says the statement.
The statement authors “urge the European Commission and member states to do more to ensure that all medical products and procedures are subject to an appropriate level of evaluation for quality, safety and efficacy consistent with standardised testing procedures”.
Here are further important points from the statement:
- We agree with the underlying principle that the proponents of TCM and other CAM should be invited to seek the same rigorous assessment as is applied to innovative, evidence-based medicines (from state-of-the-art clinical trials) developed and regulated worldwide.
- We accept that WHO has tried to make clear that their chapter in ICD-11 on TCM does not refer to, nor endorse, any specific form of treatment (Anon 2019a). However, because of the perceived encouragement created by ICD-11 inclusion of TCM as a core principle and system of medicine, the qualification may be misconstrued or ignored.
- We agree that there have been examples where traditional medicine, Chinese or otherwise, has been subjected to thorough preclinical investigation and proven in rigorous clinical trials to contribute significant health benefit. The example of artemisinin therapy for malaria is notable (WHO, 2015). The success of artemisinin as an anti-malaria agent is due to meticulous research in pharmacognosy and medicinal chemistry, combined with clinical trials. Many of the artemisia TCM preparations tested originally had little reproducibility of activity. The compound that has been approved by medicinal product agencies is a chemically modified version of the naturally occurring molecule in order to improve its pharmacokinetic properties. It is well known that many natural products have significant pharmacological activities and provided the basis for much of modern medicine. And, there may be many more such leads to therapeutic benefit. But, none of this means that other claims can be accepted uncritically, even if the objective to ensure access for all to the benefits of medicine is worthy.
- European patients may be encouraged to self-administer unregulated products or seek unregulated diagnostic procedures outside of the remit and responsibility of public health services. This raises issues for efficacy, particularly if patients delay seeking evidence-based healthcare. There are also serious safety concerns. Multiple risks of harm from herbal ingredients have been documented (e.g. see Byard et al. 2017; Zhou et al. 2019) and in the absence of an approved framework for quality and formulation, adulteration and dose variation may bring additional health risks (Ching et al. 2018). Interaction with other medications is,
additionally, a serious threat. It is also noteworthy that, contrary to common assumptions, acupuncture is not necessarily harmless (Chan et al. 2017). It is not our present purpose to review the evidence on TCM or to make judgement on particular practices, rather to emphasise the need for consistency in applying common standards to all of medicine. Although there is a very large literature on TCM, we note that clinical studies often fail to meet expected methodological criteria and highquality evidence is often lacking (for example as concluded from a systematic review of the literature on use of Chinese herbal medicines for rheumatoid arthritis, Pan et al. 2017). Follow-up surveillance and procedures for assessing liability, where necessary, may also be weak.
- European patients may be encouraged to seek diagnosis according to the proffered TCM precepts through public health services, thereby causing additional pressures on limited resources. It is likely that there will be increasing demands for these services across the EU. The European Commission, the EMA and Member State health authorities must revisit their regulatory strategies to ensure that appropriate, evidence-based patient information is readily accessible.
- There should be consistent proof underlying the regulatory requirements for scrutiny to demonstrate efficacy, safety and quality for all products and practices for human medicine. There must be verifiable and objective evidence, commensurate with the nature of the claims being made. In the absence of such evidence, a product should be neither approvable nor registrable by national regulatory agencies for the designation medicinal product. The current EU Directive on Traditional Herbal Medical Products (Directive 2004/24/EC amending Directive 2001/83/EC) was established to provide a simplified regulatory approval process for traditional herbal medicines, and national procedures are overseen by the national competent authorities. However, designated categories within this legislation allow treatment based on traditional or well-established use in the absence of robust evidence. Medicinal herbal products registered by the European Medicines Agency for traditional use have the requirement of “bibliographical or expert evidence to the effect that the medicinal product in question, or a corresponding product has been in medicinal use throughout a period of at least 30 years preceding the date of the application, including at least 15 years in the Community”5. Thus, the regulation is essentially to ensure that the product is harmless and there is no real requirement for demonstration of effect. As recommended in our previous assessment of homeopathy (EASAC, 2017) it would now be timely to reassess the validity and value of continuing to allow these simpler regulatory approval categories to apply.
- Diagnostic procedures should also be evidence-based and include validated diagnostic instruments to provide objective, reliable, reproducible assessment and reduce inter-rater variability. Whatever the diagnostic approach utilised, practitioners should be appropriately trained and audited by professional bodies.
- Similarly, use of other TCM procedures such as acupuncture should be evidence-based to demonstrate efficacy and safety, and subject to professional standards.
- Evidence-based public health systems and medical insurance systems should not reimburse products and practices unless they are demonstrated to be efficacious and safe by rigorous pre-marketing testing: a robust evidence base is essential for all medicines.
- The composition of standardised TCM remedies should be labelled in a similar way to other health products. That is, there should be an accurate, clear, verifiable and simple description of the ingredients and their amounts present in the formulation. TCM diagnostic and therapeutic procedures should, likewise, be clearly explained in patient information literature.
- Advertising and marketing of TCM products and services must conform to established standards of accuracy and clarity6. Promotional claims for efficacy, safety and quality should not be made without demonstrable and reproducible evidence
This review provides published data on so-called alternative medicine (SCAM)-related liver injuries (DILI) in Asia, with detail on incidences, lists of most frequently implicated herbal remedies, along with analysis of patient population and their clinical outcomes.
Its authors conclude that SCAM use is widely prevalent in Asia and is associated with, among other adverse effects, hepatotoxicity. Both proprietary as well as non-proprietary or traditional SCAMs have been implicated in hepatotoxicity. Acute hepatocellular pattern of liver injury is the most common type of liver injury seen, and the spectrum of liver-related adverse events range from simple elevation of liver enzymes to the very serious ALF and ACLF, which may, at times, require liver transplant.
SCAM-related liver injury is one among the major causes for hepatotoxicity, including ALF and ACLF worldwide, with high incidence among Asian countries. Patient outcomes associated with SCAM-DILI are generally poor, with very high mortality rates in those with chronic liver disease. Stringent regulations, at par with that of conventional modern medicine, are required, and may help improve safety of patients seeking SCAM for their health needs. Regional surveillance including post-marketing analysis from government agencies associated with drug regulation and control in tandem with national as well as regional level hepatology societies are important for understanding the true prevalence of DILI associated with SCAM. An integrated approach used by practitioners combining conventional and traditional medicine to identify safety and efficacy of SCAMs is an unmet need in most of the Asian countries. Endorsement of scientific methodology with good quality preclinical and clinical trials and abolishment of unhealthy publication practices is an area that needs immediate attention in SCAM practice. Such holistic standard science-based approaches could help ameliorate liver disease burden in the general and patient population.
I congratulate the authors to this excellent paper. It contains a wealth of information and is well worth reading in full. The review will serve me as a valuable source of data for many years to come.
The U.S. Food and Drug Administration (FDA) issued another warning about homeopathy. Here are some of the most relevant excerpts:
… Homeopathic products … are marketed without FDA review and may not meet modern standards for safety, effectiveness, quality and labeling. FDA uses a risk-based approach to monitor these products and to evaluate reports of adverse effects.
… Homeopathic drug products are made from a wide range of substances, including ingredients derived from plants, healthy or diseased animal or human sources, minerals and chemicals, including known poisons. These products have the potential to cause significant and even permanent harm if they are poorly manufactured, since that could lead to contaminated products or products that have potentially toxic ingredients at higher levels than are labeled and/or safe, or if they are marketed as substitute treatments for serious or life-threatening diseases and conditions, or to vulnerable populations. In addition, some products may be labeled as homeopathic that do not conform to traditional homeopathic principles.
As the homeopathy industry continues to grow at a rapid pace, we want to clarify for both consumers and industry how we assess the potential safety risks of these products. That’s why in 2017, the FDA issued a draft guidance discussing our, risk-based enforcement approach to drug products labeled as homeopathic. Today, we are taking two new steps toward clarifying this approach.
First, we have revised the 2017 draft guidanceExternal Link Disclaimer to provide further information around our approach and are asking for public input on the revised draft. The draft guidance details a risk-based enforcement policy prioritizing certain categories of homeopathic products that could pose a higher risk to public health, including products with particular ingredients and routes of administration, products for vulnerable populations, and products with significant quality issues. We encourage the public to review this revised draft guidance and comment before it is finalized. We will consider feedback gathered through this new public comment period, the more than 4,500 comments interested stakeholders submitted on the original 2017 draft guidance, and information gleaned from a 2015 public hearing on the current use of homeopathic drug products. When finalized, this guidance will help provide transparency regarding the categories of homeopathic drug products that we intend to prioritize under our risk-based enforcement approach.
Second, the agency is withdrawingExternal Link Disclaimer the Compliance Policy Guide (CPG) 400.400, entitled “Conditions Under Which Homeopathic Drugs May be Marketed.” Risk is an important driver of the FDA’s regulatory and enforcement actions for all drug products, including homeopathic drug products. Since the issuance of CPG 400.400 in 1988, the FDA has encountered multiple situations in which homeopathic drug products posed a significant risk to patients, even though the products, as labeled, appeared to meet the conditions described in CPG 400.400. However, CPG 400.400 is inconsistent with our risk-based approach to regulatory and enforcement action generally and therefore does not reflect our current thinking. Therefore, it is appropriate to withdraw CPG 400.400 at this time.
… the FDA has issued warning letters to companies who produce homeopathic drug products for significant violations of current good manufacturing practice (CGMP) regulations and various other violations. So far in 2019, we’ve issued more than 10 warning letters to companies for violations concerning homeopathic products. Recently, we issued warning letters to Kadesh Inc., U.S. Continental Marketing, Inc., Fill It Pack It Inc. and Bershtel Enterprises LLC dba WePackItAll, which had jointly manufactured and packaged eye drops produced in non-sterile conditions which could result in serious eye infections. These warning letters should alert all companies that homeopathic drug products must be manufactured and labeled in accordance with the requirements of the Federal Food, Drug, and Cosmetic Act and agency regulations…
If you ask me, ‘homeopathic drug products’ is a misleading name. A drug is defined as a medicine or other substance which has a physiological effect when ingested or otherwise introduced into the body. But highly diluted homeopathics do not contain a substance that has physiological effects.
They should be called
- homeopathic pseudo-drugs,
- homeopathic placebos,
- or fake drugs.
And their labels should make it clear that:
- these products contain no active ingredients,
- and have not been shown to work beyond placebo.
That would be the type of honest and transparent information which consumers deserve and have a right to.
This came a few days ago, completely out of the blue. To be honest, I did not even know what the BOOK AUTHORITY is. So, I looked them up; this is what they say about themselves:
BookAuthority is the world’s leading site for nonfiction book recommendations, helping you find the best books on various topics to develop your skills
BookAuthority uses a proprietary technology to identify and rate the best nonfiction books, using dozens of different signals, including public mentions, recommendations, ratings, sentiment, popularity and sales history. This includes maintaining the most comprehensive collection of book recommendations from domain experts such as Elon Musk, Warren Buffett, Prof. Daniel Kahneman, Sheryl Sandberg, and David Allen.
Only the very best books are featured on BookAuthority. To keep our site objective and unbiased, ratings are calculated purely based on data. We do not accept requests to feature a book, nor are we doing business with publishers or authors.
BookAuthority serves millions of book recommendations every month, was ranked #1 on ProductHunt, and has been featured on CNN, Forbes and Inc.
If you are a blogger, feel free to check out our tools for bloggers.
It does not happen often but, today, I am speechless.
The Society of Homeopaths (SoH) is the UK’s professional organisation of lay-homeopaths, therapists who treat patients without having studies medicine. This is what they say about themselves:
Everyone needs a healthcare professional they can trust – one who’s trained to rigorous standards, bound by a strict code of ethics, and subject to independent regulation. That’s what the Society of Homeopaths stands for. We’re the UK’s largest group of professional homeopaths, and the only dedicated register accredited by the Professional Standards Authority, an independent body set up by the government to protect the public.
We work to uphold standards of homeopathic care, support our members in their practices, and help their patients back to good health. We ensure that the letters RSHom are your guarantee of a well-trained, registered and insured professional homeopath.
This sounds fine, but is any of this true? Because of their dubious activities endangering public health, the SoH has attracted my attention many times before (for instance here, here and here). Today, they made national headlines.
It has been reported that Linda Wicks, chair of the Society of Homeopaths (S0H), has shared a series of bizarre petitions claiming that childhood immunisations are unsafe, and calling for The Medicines and Healthcare products Regulatory Agency (MHRH) to be disbanded. Mrs Wicks also posted a petition supporting Andrew Wakefield, the disgraced former doctor who falsely linked the MMR vaccine to autism. It claimed that the scientific establishment’s rejection of his flawed research was ‘the greatest lie ever told’.
Mrs Wicks, a Cornwall-based lay-homeopath and owner of the Linda Wicks Homeopathy Clinic in Truro, has been an adviser to the society for 16 years. She was appointed to the SoH chair in April. She has used her Facebook account to spread ‘anti-vaxx’ propaganda for years. Mrs Wicks must now consider whether such to resign.
Two other members of the board of directors of the SoH are also under pressure to quit. One of them, Francis Treuherz, used his Facebook feed to share a petition describing Mr Wakefield as a ‘hero’ who ought to be ‘honoured’ with the Nobel Peace Prize. In 2016 Treuherz endorsed a campaign urging the then education secretary Justine Greening to ‘STOP vaccination’ of schoolchildren against flu.
The flu petition was shared on Facebook by a third member of the SoH’s board, Maggie Dixon, who owns a homeopathic clinic in Bath. Mrs Dixon works as a member of the ‘team of practitioners’ at Ainsworths, the homeopathic pharmacy boasting of royal warrants from the Queen as well as Prince Charles.
It seems clear to me that the behaviour of Wicks, Treuherz and Dixon endangers public health and is deeply unethical. Considering what the SoH say about themselves (see above), it looks like a bad joke. In my view, it is incompatible with holding an office in a professional organisation of healthcare professionals.
Homeopathy does not have a good name when it comes to advising the public responsibly. Such behaviour is hardly going to improve this situation. The recent call of NHS leaders to stop the accreditation of homeopaths in the UK seems therefore well-justified.
Mrs Wicks meekly apologised yesterday, saying: ‘I regret my association with these petitions and any confusion this may have caused, and I have removed the page which allegedly showed this historic material.’ Confusion? At this stage, I must conclude that she is joking!
The SoH said it was working to improve communication standards ‘with clearer guidelines’. Improve communication standards. Yes, definitely, they are taking the Mikey!
Mr Treuherz and Mrs Dixon did not comment.
So, should they resign?
Would that save the reputation of the SoH?
Is there any reputation to save?
WHAT DO YOU THINK?
I have recently gone to the trouble of evaluating 150 different modalities from the realm of so-called alternative medicine (SCAM) in a book. This is what it tells you about Reiki:
Reiki is a form of paranormal or energy healing popularised by Japanese Mikao Usui (1865-1926). Rei means universal spirit (sometimes thought of as a supreme being) and ki is the assumed universal life energy.
- Reiki is based on the assumptions of Traditional Chinese Medicine and the existence of ‘chi’, the life-force that determines our health.
- Reiki practitioners believe that, with their hands-on healing method, they can transfer ‘healing energy’ to a patient which, in turn, stimulates the self-healing properties of the body. They assume that the therapeutic effects of this technique are obtained from a ‘universal life energy’ that provides strength, harmony, and balance to the body and mind.
- There is no scientific basis for such notions, and reiki is therefore not plausible.
- Reiki is used for a number of conditions, including the relief of stress, tension and pain.
- There have been several clinical trials testing the effectiveness of reiki. Unfortunately, their methodological quality is usually poor.
- A systematic review summarising this evidence concluded that the evidence is insufﬁcient to suggest that reiki is an effective treatment for any condition. Therefore, the value of reiki remains unproven. And a Cochrane review found that there is insufficient evidence to say whether or not Reiki is useful for people over 16 years of age with anxiety or depression or both.
- Reiki appears to be generally safe, and serious adverse effects have not been reported. Some practitioners advise caution about using reiki in people with psychiatric illnesses because of the risk of bringing out underlying psychopathology.
So, Reiki is both implausible and unproven. Now a new, large trial has emerged that might change this verdict. The main purpose of this study (published in JCAM) was to measure the effect of a single session of Reiki on physical and psychological health in a large nonclinical sample.
The study design was a single arm effectiveness trial with measures at pre-and postintervention. The study took place at private Reiki practices across the United States. Reiki practitioners were recruited from an online mailing list to participate in the study with their Reiki clients. A total of 99 Reiki practitioners met the inclusion criteria and participated in the study. Reiki practitioners were instructed to give a flyer to each of their Reiki clients that contained information about the study and invited the client to complete a survey before and after their Reiki session.
Trained and certified Reiki Masters conducted the Reiki sessions in person, with each session lasting between 45 and 90 min. The 20-item Positive and Negative Affect Schedule was used to assess affect, and brief, single-item self-report measures were used to assess a wide range of physical and psychological variables immediately before (pre) and after (post) the Reiki session.
A total of N = 1411 Reiki sessions were conducted and included in the analysis. Statistically significant improvements were observed for all outcome measures, including positive affect, negative affect, pain, drowsiness, tiredness, nausea, appetite, shortness of breath, anxiety, depression, and overall well-being (all p-values <0.001).
The authors concluded that the results from this large-scale multisite effectiveness trial suggest that a single session of Reiki improves multiple variables related to physical and psychological health.
This ‘large scale’ effectiveness trial’ could make you laugh and cry at the same time.
- Laugh, because it is almost comically daft.
- Cry, because the conclusion is bound to mislead a lot of gullible people.
Without a control group, the study cannot even attempt to determine anything like the effectiveness of Reiki. What the results truly show is that consumers who consult (and pay) a Reiki master expect to have a positive effect. The expectation translates into a sizable placebo response. The investigators seem to be clueless scientists, or they wilfully mislead the public (the senior author is from the ‘The Center for Reiki Research‘ which, according to its mission statement, is dedicated to gaining acceptance for the practice of Reiki by the medical community).
The only conclusion that can honestly be drawn from the data is that consumers who pay for a serivce often like this service (otherwise they would not use it!). It’s a bit like the thing with the hamburger joint that I often cite: if you ask people eating in a McDonalds whether they enjoy hamburgers, most will answer in the affirmative.
But there might be a valuable lesson in this paper after all: never trust the JACM further than you can throw it.