I have warned you before to be sceptical about Chinese studies. This is what I posted on this blog more than 2 years ago, for instance:
Imagine an area of therapeutics where 100% of all findings of hypothesis-testing research are positive, i.e. come to the conclusion that the treatment in question is effective. Theoretically, this could mean that the therapy is a miracle cure which is useful for every single condition in every single setting. But sadly, there are no miracle cures. Therefore something must be badly and worryingly amiss with the research in an area that generates 100% positive results.
Acupuncture is such an area; we and others have shown that Chinese trials of acupuncture hardly ever produce a negative finding. In other words, one does not need to read the paper, one already knows that it is positive – even more extreme: one does not need to conduct the study, one already knows the result before the research has started. But you might not believe my research nor that of others. We might be chauvinist bastards who want to discredit Chinese science. In this case, you might perhaps believe Chinese researchers.
In this systematic review, all randomized controlled trials (RCTs) of acupuncture published in Chinese journals were identified by a team of Chinese scientists. A total of 840 RCTs were found, including 727 RCTs comparing acupuncture with conventional treatment, 51 RCTs with no treatment controls, and 62 RCTs with sham-acupuncture controls. Among theses 840 RCTs, 838 studies (99.8%) reported positive results from primary outcomes and two trials (0.2%) reported negative results. The percentages of RCTs concealment of the information on withdraws or sample size calculations were 43.7%, 5.9%, 4.9%, 9.9%, and 1.7% respectively.
The authors concluded that publication bias might be major issue in RCTs on acupuncture published in Chinese journals reported, which is related to high risk of bias. We suggest that all trials should be prospectively registered in international trial registry in future.
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Now an even more compelling reason emerged for taking evidence from China with a pinch of salt:
A recent survey of clinical trials in China has revealed fraudulent practice on a massive scale. China’s food and drug regulator carried out a one-year review of clinical trials. They concluded that more than 80 percent of clinical data is “fabricated“. The review evaluated data from 1,622 clinical trial programs of new pharmaceutical drugs awaiting regulator approval for mass production. Officials are now warning that further evidence malpractice could still emerge in the scandal.
According to the report, much of the data gathered in clinical trials are incomplete, failed to meet analysis requirements or were untraceable. Some companies were suspected of deliberately hiding or deleting records of adverse effects, and tampering with data that did not meet expectations.
“Clinical data fabrication was an open secret even before the inspection,” the paper quoted an unnamed hospital chief as saying. Contract research organizations seem have become “accomplices in data fabrication due to cutthroat competition and economic motivation.”
A doctor at a top hospital in the northern city of Xian said the problem doesn’t lie with insufficient regulations governing clinical trials data, but with the failure to implement them. “There are national standards for clinical trials in the development of Western pharmaceuticals,” he said. “Clinical trials must be carried out in three phases, and they must be assessed at the very least for safety,” he said. “But I don’t know what happened here.”
Public safety problems in China aren’t limited to the pharmaceutical industry and the figure of 80 percent is unlikely to surprise many in a country where citizens routinely engage in the bulk-buying of overseas-made goods like infant formula powder. Guangdong-based rights activist Mai Ke said there is an all-pervasive culture of fakery across all products made in the country. “It’s not just the medicines,” Mai said. “In China, everything is fake, and if there’s a profit in pharmaceuticals, then someone’s going to fake them too.” He said the problem also extends to traditional Chinese medicines, which are widely used in conjunction with Western pharmaceuticals across the healthcare system.
“It’s just harder to regulate the fakes with traditional medicines than it is with Western pharmaceuticals, which have strict manufacturing guidelines,” he said.
According to Luo, academic ethics is an underdeveloped field in China, leading to an academic culture that is accepting of manipulation of data. “I don’t think that the 80 percent figure is overstated,” Luo said.
And what should we conclude from all this?
I find it very difficult to reach a verdict that does not sound hopelessly chauvinistic but feel that we have little choice but to distrust the evidence that originates from China. At the very minimum, I think, we must scrutinise it thoroughly; whenever it looks too good to be true, we ought to discard it as unreliable and await independent replications.
Bogus claims of alternative therapists are legion, particularly in homeopathy. But bogus claims are neither ethical nor legal. Homeopathy works for no human condition, and therefore any medical claim made for homeopathy is unethical, false, misleading and illegal.
This is not just my view (after studying the subject for more than two decades) but also that of the UK regulators. In case you doubt it, please read the full notice which the UK ‘Advertising Standards Authority’ has just published (dated 29/9/2016):
This week, our sister organisation, the Committee of Advertising Practice (CAP) Compliance team has written to homeopaths across the UK to remind them of the rules that govern what they can and can’t say in their marketing materials, including on their websites.
Homeopathy is based on the principle of treating like with like; in other words a substance which causes certain symptoms can also help remove those symptoms when it is diluted heavily in water before being consumed. Practitioners believe that this stimulates the body to heal itself. However, to date, despite having considered a body of evidence, neither us nor CAP has seen robust evidence that homeopathy works. Practitioners should therefore avoid making direct or implied claims that homeopathy can treat medical conditions.
We have no intention of restricting the ability of practitioners to advertise legitimate and legal services, nor do we seek to restrict the right of individuals to choose treatment. However, when advertisers make claims about these products or services, in all sectors, they must hold appropriate evidence to back up those claims. If they do not, then we have a responsibility to intervene to protect consumers by ensuring that those ads are amended or withdrawn.
If you are a practicing homeopath, please ensure that you carefully read CAP’s advice and guidance. It includes a non-exhaustive list of the types of claims you can and can’t make. You will then need to make changes, as necessary, to your marketing materials, including on your website, if you have one.
Further guidance can be found on the Society of Homeopaths’ website. We have worked closely with the Society over the course of the last year, to help them produce detailed guidance to support their members.
I think this notice speaks for itself. All I want to add at this stage is my hope that UK homeopaths comply asap to avoid getting penalised and – much more importantly – to avoid continuing to mislead consumers.
According to Wikipedia, Swiss state insurance funding of homeopathy and four other alternative therapies had been withdrawn after a review in 2005, and a 2009 referendum vote called for state backed health insurance to once more pay for these therapies. In 2012 the Swiss government reinstated them for a trial period until 2017, pending an independent investigation of the efficacy and cost-effectiveness of the therapies. The rules for the registration of homeopathic remedies without a concrete field of application are more liberal in Switzerland than they are in member countries of the EU. For homeopathic medicines based on well-known low-risk substances, Swissmedic, the regulatory authority, offers inexpensive registration by means of a simplified electronic registration procedure.
Several weeks ago, I have commented on the remarkable position of alternative medicine in Switzerland. Now this website offers further information specifically on homeopathy in Switzerland:
According to a report jointly issued by the Swiss Federal Health Office and the Swiss State Secretariat for Economic Affairs (SECO), the annual expenses for homeopathic treatments and medications in Switzerland amount to roughly CHF 50 million and CHF 31 million, respectively. These numbers seem impressive, particularly if we consider how little each homeopathic remedy costs and how ineffective it is.
But the argument that homeopathy somehow defies scientific testing does not seem to die. For instance, SantéSuisse, the umbrella organisation of health insurers, argues that standardised methods used to test conventional treatments cannot be applied to homeopathy. “It would be unfair to homeopathy if we borrowed the methodologies from conventional therapeutic options when evaluating its effectiveness. The potential risk is that these systematic and internationally accepted methods of biomedical science go against the underlying principles of homeopathy,” said SantéSuisse spokesman Christophe Kämpf. I am afraid, he is talking complete tosh – and he should, of course, know better.
The Swiss Federal Health Office admitted in its press release at the end of March that “no evidence has so far been found to prove that complementary and alternative therapies”, including homeopathy, meet the standard criteria for “effectiveness, appropriateness, and costs.” And a Swiss health office spokesman, Daniel Dauwalder, explained that the decision “reflected the will of the people” in a 2009 referendum. “The health insurance system will cover the cost of alternative therapies according to the principle of trust,” Dauwalder explained. He added that, if the standards of effectiveness, suitability and economy are called into question, SantéSuisse have the right to deny payment.
The core of the issue centres on the questions
- How to ensure that the physical conditions of patients will not be compromised by unqualified, self-proclaimed clinicians?
- How can health insurers deal with the potential challenges?
The truth is, alternative treatments will not be unconditionally covered by the basic insurance policies which every Swiss resident must have. Only the costs of treatments administered by certified medical doctors will be considered. Otherwise, the costs incurred can only be reimbursed, if the person insured has purchased supplementary health coverage.
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That, however, does not mean that only doctors can practice homeopathy in Switzerland. Lay-homeopaths do exist in the form of Heilpraktiker. While it is true that the national health insurance only covers the treatment by medical doctors, some private health insurances also cover homeopathy by Heilpraktiker.
All this is very different from what some enthusiasts report about homeopathy in Switzerland. Probably the best example for someone obscuring the truth is (yet again) Dana Ullman who stated that “the Swiss government has determined that the very small doses commonly used in homeopathic medicine are both effective and cost-effective.” Little wonder, I might add, because Dana Ullman also keeps on referring to “a remarkable report on homeopathic medicine conducted by and for the government of Switzerland”. He does so despite having been told over and over again that the report in question is firstly utterly unreliable and secondly not by the Swiss government.
Why this odd insistence on disseminating wrong information? Is it because it is good for business, or because homeopaths are not capable of learning (otherwise they would not be homeopaths), or both?
This recent report is worth a mention, I think:
The Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG) is aware that some chiropractors are advertising and attempting to turn breech babies in utero using the “Webster Technique”.
On 7 March 2016, the Chiropractic Board of Australia released the following statement in relation to chiropractic care of pregnant women and their unborn child:
“Care of pregnant patients
Chiropractors are not trained to apply any direct treatment to an unborn child and should not deliver any treatment to the unborn child. Chiropractic care must not be represented or provided as treatment to the unborn child as an obstetric breech correction technique.
RANZCOG supports the Chiropractic Board of Australia in its clear position that chiropractic care must not be represented or provided as a treatment to the unborn child as an obstetric breech correction technique. Chiropractors should not be using the “Webster Technique” or any other inappropriate breech correction technique to facilitate breech version as there is insufficient scientific evidence to support this practice.
In addition, RANZCOG does not support chiropractors treating pregnant women to reduce their risk of caesarean delivery. There is insufficient evidence to make any claims to consumers regarding the benefits of chiropractic treatment to reduce the risk of caesarean delivery. We commend the Chiropractic Board on their statement that:
“Advertisers must ensure that any statements and claims made in relation to chiropractic care are not false, misleading or deceptive or create an unreasonable expectation of beneficial treatment.”1
Recommendations for the management of a breech baby at term are outlined in the RANZCOG statement, Management of breech presentation at term
External Cephalic Version (ECV) is a procedure where a care provider puts his or her hands on the outside of the mother’s belly and attempts to turn the baby from breech to cephalic presentation. It is recommended that women with a breech presentation at or near term should be informed about external cephalic version (ECV) and offered it if clinically appropriate. Attempting cephalic version at term reduces the chance of non-cephalic presentation at birth, vaginal cephalic birth not achieved and caesarean section. There is not enough evidence from randomised trials to assess complications of ECV at term. Large observational studies suggest that complications are rare. ECV should only be performed by suitably trained health professionals where there is facility for emergency caesarean section. Each institution should have its own documented protocol for offering and performing ECVs.
This communiqué highlights the need for patients to be adequately informed when making health care choices.
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These are clear and badly needed words. As we have discussed often on this blog, chiropractors make all sorts of bogus claims. Those directed at children and unborn babies are perhaps the most nonsensical of them all. I applaud the College for their clear statements and hope that other institutions follow this example.
Since several years, there has been an increasingly vociferous movement within the chiropractic profession to obtain limited prescription rights, that is the right to prescribe drugs for musculoskeletal problems. A recent article by Canadian and Swiss chiropractors is an attempt to sum up the arguments for and against this notion. Here I have tried to distil the essence of the pros and contras into short sentences.
1) Arguments in favour of prescription rights for chiropractors
1.1 Such privileges would be in line with current evidence-based practice. Currently, most international guidelines recommend, alongside prescription medication, a course of manual therapy and/or exercise as well as education and reassurance as part of a multi-modal approach to managing various spine-related and other MSK conditions.
1.2 Limited medication prescription privileges would be consistent with chiropractors’ general experience and practice behaviour. Many clinicians tend to recommend OTC medications to their patients in practice.
1.3 A more comprehensive treatment approach offered by chiropractors could potentially lead to a reduction in healthcare costs by providing additional specialized health care options for the treatment of MSK conditions. Namely, if patients consult one central practitioner who can effectively address and provide a range of treatment modalities for MSK pain-related matters, the number of visits to providers might be reduced, thereby resulting in better resource allocation.
1.4 Limited medication prescription rights could lead to improved cultural authority for chiropractors and better integration within the healthcare system.
1.5 With these privileges, chiropractors could have a positive influence on public health. For instance, analgesics and NSAIDs are widely used and potentially misused by the general public, and users are often unaware of the potential side effects that such medication may cause.
2) Arguments against prescription rights for chiropractors
2.1 Chiropractors and their governing bodies would start reaching out to politicians and third-party payers to promote the benefits of making such changes to the existing healthcare system.
2.2 Additional research may be needed to better understand the consequences of such changes and provide leverage for discussions with healthcare stakeholders.
2.3 Existing healthcare legislation needs to be amended in order to regulate medication prescription by chiropractors.
2.4 There is a need to focus on the curriculum of chiropractors. Inadequate knowledge and competence can result in harm to patients; therefore, appropriate and robust continuing education and training would be an absolute requirement.
2.5 Another important issue to consider relates to the divisiveness around this topic within the profession. In fact, some have argued that the right to prescribe medication in chiropractic practice is the profession’s most divisive issue. Some have argued that further incorporation of prescription rights into the chiropractic scope of practice will negatively impact the distinct professional brand and identity of chiropractic.
2.6 Such privileges would increase chiropractors’ professional responsibilities. For example, if given limited prescriptive authority, chiropractors would be required to recognize and monitor medication side effects in their patients.
2.7 Prior to medication prescription rights being incorporated into the chiropractic scope of practice worldwide, further discussions need to take place around the breadth of such privileges for the chiropractic profession.
In my view, some of these arguments are clearly spurious, particularly those in favour of prescription rights. Moreover, the list of arguments against this notion seems a little incomplete. Here are a few additional ones that came to my mind:
- Patients might be put at risk by chiropractors who are less than competent in prescribing medicines.
- More unnecessary NAISDs would be prescribed.
- The vast majority of the drugs in question is already available OTC.
- Healthcare costs would increase (just as plausible as the opposite argument made above, I think).
- Prescribing rights would give more legitimacy to a profession that arguably does not deserve it.
- Chiropractors would then continue their lobby work and soon demand the prescription rights to be extended to other classes of drugs.
I am sure there are plenty of further arguments both pro and contra – and I would be keen to hear them; so please post yours in the comments section below.
Guest post by Frank Van der Kooy
Something happened in 2008. Something, or a number of things, triggered an exponential rise in the number of rhinos being killed in South Africa. Poaching numbers remained quite low and was stable for a decade with only 13 being killed in 2007. But then suddenly it jumped to 83 in 2008 and it reached a total of 1 175 in 2015. To explain this will be difficult and it will be due to a number of factors or events coinciding in 2008. One possible contributing factor, which I will discuss here, is the growing acceptance of TCM in western countries! For example: Phynova recently advertised a new product as being the first traditional Chinese medicine (TCM) being registered in the UK. By directing customers to a separate site for more information regarding their product they ‘accidently’ linked to a site which ‘advertised’ rhino horn (this link has since been removed). Another example is a University in Australia who published a thesis in 2008, in which they described the current use of Rhino horn as a highly effective medicine, just like you would describe any other real medicine. Surely this will have an impact!
But first a bit of background, so please bear with me. There are two ‘opposing’ aspects regarding TCM that most members of the public do not seem to understand well. Not their fault, because the TCM lobby groups are spending a huge amount of effort to keep the lines between these two aspects as blurred as possible. The first aspect is the underlying pseudoscientific TCM principles; the yin and yang and the vitalistic “energy” flow through “meridians” and much more. Science has relegated this to the pseudosciences, just like bloodletting, which was seen as a cure-all hundreds of years ago. Unfortunately, the pseudoscientific TCM principles are still with us and based on these principles almost every single TCM modality works! From acupuncture to herbs to animal matter (including rhino horn) – everything is efficacious, safe and cost effective. Evidence for this is that close to a 100% of clinical trials done on TCM in China give positive results. Strange isn’t it! People in China should thus no die of any disease – they have ‘effective’ medicine for everything! This is the world of TCM in a nutshell.
The second aspect of TCM is the application of the modern scientific method to test which of the thousands of TCM modalities are really active, which ones are useless and which ones are dangerous. Decades of investigation have come up empty-handed with one or two exceptions. One notable exception is Artemisia annua which contain a single compound that is highly effective for the treatment of malaria, and once identified and intensely studied, it was taken up into conventional medicine – not the herb, but the compound. If you investigate all the plants in the world you are bound to find some compounds that can be used as medicine – it has nothing to do with TCM principles and it can most definitely not be used as evidence that the TCM principles are correct or that it based on science.
These two aspects are therefore quite different.
In the TCM world just about everything works, but it is not backed up by science. It is huge market ($170 billion) and it creates employment for many – something that make politicians smile. In the modern scientific world, almost nothing in TCM works, but it is based on science. It is however not profitable at all – you have to investigate thousands of plants in order to find one useful compound.
Many TCM practitioners and researchers are avidly trying to combine the positives of these two worlds. They focus mainly on the money and employment aspect of the TCM world and try and combine this with the modern scientific approach. They tend to focus on the one example where modern science discovered a useful compound (artemisinin) in the medicinal plant Artemisia annua, which was also coincidently used as an herb in TCM – as evidence that TCM works! Here are some examples:
“To stigmatise all traditional medicine would be unfair. After all, a Chinese medicine practitioner last year won a Nobel prize.” No, a Chinese scientist using the modern scientific method identified artemisinin after testing hundreds or even thousands of different plants.
“This year, Chinese medicine practitioners will be registered in Australia. ….. Chinese herbal medicine is administered routinely in hospitals for many chronic diseases. …… This has led to recognising herbs such as Artemisia as a proven anti-malarial ……” No, the compound artemisinin is a proven anti-malarial!
“There has been enormous progress in the last 20 years or so. I am sure you are familiar with the use of one of the Chinese herbs in managing resistant malaria.” No, very little progress and no, the compound artemisinin!
So this is a game that is being played with the simple intention to blur the lines between these two aspects regarding TCM – but the real reason might simply be “A new research-led Chinese medicine clinic in Sydney, better patient outcomes and the potential for Australia to tap into the $170 billion global traditional Chinese medicine market”
Prof Alan Bensoussan the director of the National Institute of Complementary Medicine (NICM) and registered in Australia as a TCM and acupuncture practitioner is a champion in blurring this line. Alan has been instrumental in lobbying the Australian regulatory agency that a long tradition of use is all you need to be able to register new products. He was also influential in establishing the Chinese medicine practitioner registry in Australia, in 2012, and thereby legitimising TCM in Australia. He has been actively chipping away at the resistance that the Australian public have against these pseudoscientific healthcare systems such as TCM – one can argue that he has done so quite successfully because they are expanding their operations into the Westmead precinct of Sydney with a new TCM clinic/hospital.
Enough background; so what does all of this have to do with Rhino horn? (and for that matter other endangered species). We have to remember that in the TCM world just about everything works and that includes rhino horn! Searching Western Sydney University’s theses portal for Xijiao (Chinese for Rhino horn) I found a thesis published in 2008 from the NICM and co-supervised by Alan; “Development of an evidence-based Chinese herbal medicine for the management of vascular dementia”
On page 45-46: “Recently, with fast developing science and technologies being applied in the pharmaceutical manufacturing area, more and more herbs or herbal mixtures have been extracted or made into medicinal injections. These have not only largely facilitated improved application to patients, but also increased the therapeutic effectiveness and accordingly reduced the therapeutic courses …… lists the most common Chinese herbal medicine injections used for the treatment of VaD. “
“Xing Nao Jing Injection (for clearing heat toxin and opening brain, removing phlegm) contains ….. Rhinoceros unicornis (Xijiao), …… Moschus berezovskii (Shexiang), …..”
“…. Xing Nao Jing injection has been widely applied in China for stroke and vascular dementia. …. After 1-month treatment intervention, they found the scores in the treatment group increased remarkably, as compared with the control group …… “
They list two endangered species; the Rhino and the Chinese forest musk deer (Moschus berezovskii). But what is truly worrying is that they don’t even mention the endangered status or at least recommend that the non-endangered substitutes, which do exist in the TCM world, should be used instead – or maybe use fingernails as a substitute? It is not discussed at all. Clearly they are stating that using these endangered animals are way more effective than western medicine (the control group) for the treatment of vascular dementia! This is deplorable to say the least. Statements like this fuels the decimation of this species. But this shows that they truly believe and support the underlying pseudoscientific principles of TCM – they have to, their ability to tap into the TCM market depends on it!
As a scientist you are entitled to discuss historic healthcare treatments such as bloodletting. But make sure to also state that this practice has been shown to be ineffective, and quite dangerous, and that modern science has since come up with many other effective treatments. If it is stated that bloodletting is currently being used and it is effective – then you will simply be promoting bloodletting! The same goes for Rhino horn and this is exactly what they have done here. But then again they live in a world where all TCM modalities are active!
How to solve this problem of growing acceptance of TCM in western countries? A simple step could be that people like Alan publicly denounce the underlying pseudoscientific TCM principles and make the ‘difficult’ switch to real science! Admittedly, he will have to part with lots of money from the CM industry and his Chinese partners, and maybe not built his new TCM hospital! But for some reason I strongly doubt that this will happen. The NICM have successfully applied a very thin, but beautiful, veneer of political correctness and modernity over the surface of complementary medicine. Anyone who cares to look underneath this veneer will find a rotten ancient pseudoscientific TCM world – in this case the promotion and the use of endangered animals.
After reading chapter two of this thesis one cannot believe that this is from an Australian University and paid for by the Australian taxpayer! The main question though: Can I directly link this thesis with the increase in rhino poaching? This will be very difficult if not impossible to do. But that is not the problem. Promoting the pseudoscientific principles of TCM in Australia expands the export market for TCM, and hence will lead to an increased need for raw materials, including the banned Rhino horn. That Rhino horn has been a banned substance since the 1980’s clearly does not seem to have any impact looking at the poaching statistics. In an unrelated paper published in 2010 the ingredients in the Xingnaojing injection is listed as “…. consisting of Chinese herbs such as Moschus, Borneol, Radix Curcumae, Fructus Gardeniae, ….” No full list is given in the paper – dare I say because it contains Rhino horn as well? The drug Ice is also banned, but if you are going to promote it at a ‘trusted’ university, then you shouldn’t be surprised that Ice production increases and more of it flows into Australia – even if it is illegal. The same goes for Rhino horn!
A survey published in 2011 showed that one-third of Danish hospitals offered alternative therapies. In total, 38 hospitals offered acupuncture and one Eye Movement Desensitization and Reprocessing Light Therapy. The most commonly reported reason for offering CAM was “scientific evidence”.
Many readers of this blog might be amazed with both the high level of alternative medicine presence in Danish hospitals and the notion that this was due to ‘scientific evidence’. A recent article provides even more surprises about the Danish alternative medicine scene.
It revealed that 8 out of 10 Danes are interested in using some form of alternative medicine…Some 67 percent of Danes say the national healthcare system should be more open to alternative healing practices, such as homeopathy, acupuncture or chiropractic, and 60 percent would like to see these treatments covered by the public health insurance system. More than half of the 6,000 respondents believe alternative therapies can be just as effective as traditional medicine.
Charlotte Yde, the chairwoman at Sundhedsrådet, which is the umbrella organisation for alternative practitioners in Denmark, contends many Danes feel frustrated because they cannot freely discuss alternative treatment with their doctors. Alternative treatment researcher Helle Johannessen agrees that Danish doctors should openly discuss alternative medicine options with patients. “In other European countries doctors use alternative treatment to a much greater extent than doctors in Denmark,” Johannessen told DR. “[International experience] shows that some forms of alternative therapy can improve quality of life and reduce anxiety and nausea in cancer patients.”
This, it seems to me, is little more than a bonanza of fallacious thinking and misleading information.
- The notion that popularity of a therapy has anything to do with its usefulness is a classical fallacy.
- The notion that belief determines efficacy (More than half of the 6,000 respondents believe alternative therapies can be just as effective as traditional medicine.) or vice versa is complete nonsense.
- The notion that many Danes … cannot freely discuss alternative treatment with their doctors is misleading: patients can discuss what they feel like with whom they feel like.
- The notion that in other European countries doctors use alternative treatment to a much greater extent than doctors in Denmark is also misleading: there are many European countries where LESS alternative therapies are being paid for via the public purse.
- Finally, the notion that that some forms of alternative therapy can improve quality of life and reduce anxiety and nausea in cancer patients – even if it were correct – does not mean that ALL alternative therapies are efficacious, safe, or cost-effective.
Who cares about Denmark?
Why should this be important?
Well, the Danes might care, and it is important because it provides an excellent example of how promoters of bogus treatments tend to argue – not just in Denmark, but everywhere. Unfortunately, politicians all too often fall for such fallacious notions. For them, a popular issue is a potential vote-winner. Within medical systems that are notoriously strapped for money, the looser will inevitably be optimal healthcare.
Medical ethics are central to any type of healthcare – and this includes, of course, alternative medicine. The American Medical Association (AMA) have just published their newly revised code of ethics, AMA Principles of Medical Ethics.
It has long been my impression that, in alternative medicine, ethics receive no or far too little attention. Some alternative practitioners thrive to be able to call themselves ‘physicians’. Therefore, it seems interesting to ask whether they would also be able to comply with the ethical duties of a physician as outlined by the AMA.
The following 9 points are taken without change from the new AMA code; in brackets I have put my own, very brief comments pertaining to alternative practitioners. There is much more to be said about each of these points, of course, and I encourage my readers to do so in the comments section.
- A physician shall be dedicated to providing competent medical care, with compassion and respect for human dignity and rights. [Most alternative practitioners use unproven treatments; I doubt whether this can be called ‘competent medical care’.]
- A physician shall uphold the standards of professionalism, be honest in all professional interactions, and strive to report physicians deficient in character or competence, or engaging in fraud or deception, to appropriate entities. [Treating patients with unproven therapies in the absence of fully informed consent is arguably unprofessional, dishonest and deceptive. Crucially, alternative practitioners never object to even the worst excesses of quackery that occur in their realm.]
- A physician shall respect the law and also recognize a responsibility to seek changes in those requirements which are contrary to the best interests of the patient. [Treatment with unproven therapies can hardly be in the best interest of the patient.]
- A physician shall respect the rights of patients, colleagues, and other health professionals, and shall safeguard patient confidences and privacy within the constraints of the law. [The right of patients includes full informed consent which is, according to my impression, rare in alternative medicine.]
- A physician shall continue to study, apply, and advance scientific knowledge, maintain a commitment to medical education, make relevant information available to patients, colleagues, and the public, obtain consultation, and use the talents of other health professionals when indicated. [Alternative medicine is frequently out of line with or even opposed to medical knowledge.]
- A physician shall, in the provision of appropriate patient care, except in emergencies, be free to choose whom to serve, with whom to associate, and the environment in which to provide medical care.
- A physician shall recognize a responsibility to participate in activities contributing to the improvement of the community and the betterment of public health. [Some activities of some alternative practitioners are directly opposed to public health, for instance when they advise against immunising children.]
- A physician shall, while caring for a patient, regard responsibility to the patient as paramount. [Arguably this is not possible when using unproven therapies.]
- A physician shall support access to medical care for all people. [Some alternative practitioners advise their patients against accessing conventional healthcare.]
As I stated above, medical ethics are neglected in alternative medicine. The 9 points of the AMA together with my comments go some way towards explaining why this is so. If ethical principles were applied to alternative medicine, much of it would have to stop instantly.
Yesterday, a press-release reached me announcing that a Chinese herbal medicine, ‘Phynova Joint and Muscle Relief Tablets’, containing the active ingredient Sigesbeckia, is now on sale in the UK for the first time in Boots The Chemist:
Sigesbeckia is the first traditional Chinese treatment granted a traditional herbal registration (THR) under the traditional herbal medicines product directive in the UK, by drug safety watchdog the Medicines and Healthcare Products Regulatory Agency (MHRA). Oxford based Phynova which manufactures the product was granted the UK licence last year.
Containing 500mg of the active ingredient, Phynova Joint and Muscle Relief Tablets are specially formulated for the relief of backache, arthritis, minor sports injuries, rheumatic or muscular pains and general aches and pains in muscles or joints. Two tablets are taken each day, one in the morning and one in the evening. They have no known side effects and are non-addictive. ..
The product, which retails at £19.99 for one month’s supply of 60 tablets, is available in 950 UK Boots outlets and online via Click and Collect from all stores. It will be sold both Over the Counter (OTC) by pharmacist staff and off the shelf as part of Boots’ pain relief fixture…
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What on earth is a ‘joint and muscle relief’? Personally I do not want to be relieved of my joints and muscles!!!
Yes, I know, they probably mean ‘joint and muscle pain relief’ but were not allowed to say so because this is a medical indication.
And what about the claim of ‘no side-effects’; is it possible that a pharmacological treatment has positive effects without any risks at all? This is not what they told me during my pharmacology course, if I remember correctly. And anyway, even placebos have side-effects!
I admit, I was puzzled.
The covering letter of the press-release provided more amazement: it informed me that “Phynova joint and muscle relief contains the active ingredient Sigesbeckia which has been through clinical trials and has been used for pain relief in China for hundreds of years…” It was the remark about clinical trials (PLURAL!!!) that caught my interest most.
So, I looked up ‘Sigesbeckia’ on Medline and found as good as nothing. This is mainly because the plant is spelled correctly ‘Siegesbeckia’ in honour of the famous botanist Siegesbeck.
Looking up ‘Siegesbeckia’, I found many pre-clinical studies but no clinical trials.
Next I searched for a comment from the MHRA and discovered that their account makes it very clear that a licence has been granted to this product “exclusively upon long standing use… and not upon data from clinical trials.”
So, who is right?
Are there clinical trials of this product or not? And, if there are any, where are they?
Perhaps someone from Phynova can enlighten us?
Nobody can doubt that, during the last 200 years, conventional medicine has made monumental progress. Homeopathy, however, has remained more or less like Hahnemann invented it. But now it seems as though homeopathy can celebrate an unprecedented step ahead. As so often in medicine, it originates from a commercial enterprise.
Genexa is a US firm that produces natural health products. On their website, they state that “At Genexa, we believe medicine should be free from unhealthy fillers and toxins”. They recently published a press-release introducing a line of homeopathic medicines certified organic by the U.S. Department of Agriculture and Non-GMO Project verified. They are keen to point out that these products “do not contain any genetically modified ingredients.” In fact, several of their remedies do not contain any active ingredients to speak of: they are homeopathic!
“We are extremely proud of our organic and non-GMO certifications – the seals are prominently featured on all our products and website for easy label reading and patient education,” stated David Johnson, CEO of Genexa, in their press-release. “Our quality standards are among the highest in the over-the-counter medicine industry.”
Genexa’s 11 homeopathic formulations are being advertised for the treatment of common health issues such as flu, cold, allergies, stress, pain, leg cramps, sleeplessness and jet lag. An entire line of products is, according to the press-release, specially formulated for children and includes treatments for cold, allergy and calming.
Genexa’s CMO proudly announced that “It’s important to us that our retail customers feel confident in the products and know they can trust they are purchasing medicines free from unhealthy fillers and toxins and simply focus on healing.” Presumably that trust must include the trust into the efficacy of the homeopathic remedies! Yes, I am pleased to report that, apparently it does; elsewhere they confirm this by stating that “Genexa holds itself to the highest standards in both quality and ethics.” The highest standards of ethics surely include that the remedies in question are demonstrably efficacious.
But how can we be sure? Are any of these homeopathic remedies supported by reasonably strong evidence? Oddly enough, despite all these affirmations, I did get my doubts when I tried to dig a bit deeper.
Take the homeopathic remedy called SLEEPOLOGY, for instance. The website informs us that “This homeopathic formulation consists of nine leading remedies designed to treat sleeplessness, inability to fall asleep, frequent waking, restless sleep and sleeplessness from stress, exhaustion, nervousness, excitability, restlessness, worries, irritability, and pain.” So, it’s a complex homeopathic remedy with 9 different ingredients. But is there any evidence of efficacy for this mixture? I am not aware of any clinical trials that have tested its efficacy. But I must be wrong, because on the website we are being told that “Clinical trials have demonstrated efficacy for treating sleeplessness for piper methysticum, and valeriana officinalis.” That may be so, but the trials were done with herbal extracts, not with homeopathic potencies! Could the statement therefore be more than a little misleading?
On the internet, I found all sorts of fascinating bits about the new homeopathic lines (my compliments to the PR firm that organised the launch!); for instance the revelation that: “The company’s proprietary medicines were created by and are regularly reviewed and enhanced by its chief medical officer, Dr. Todd Rowe*, a nationally respected physician with an expertise in homeopathic medicine formulation. Working with the Genexa team, Dr. Rowe and his team of chemists and pharmacists spent hundreds of hours meticulously formulating and testing the products. The result is a line of effective, potent medicines that are certified organic by the USDA and non-GMO verified by the Non-GMO Project. “Our formulations are based on tried and true principles for miasmatic and energetic balance, so that the remedies potentiate each other and promote the most positive patient outcomes,” said Dr. Rowe. “These powerful medicines work with your body to help it heal itself.”” However, I was unable to find out which potencies are being used for the Genexa homeopathic products. This information might not be that relevant: according to the homeopathic ‘like cures like’ principle, the effects of a substance are reversed through potentiation. This is why coffee, for instance, is potentised by homeopath to generate a sleeping remedy. Does it not follow then that, potentising two or more herbal ingredients that have hypnotic effects (as in SLEEPOLOGY), must generate a remedy for preventing sleep? A similarly puzzling lack of ‘homeopathic logic’ seems to apply to several other products in Genexa’s line of homeopathic remedies.
I have to admit, I am confused.
Could it be that the ‘breakthrough’ turns out to be a breakdown of ‘homeopathic logic’?
Let’s hope someone from Genexa reads these lines and can enlighten us.[*he is the President of the American Medical College of Homeopathy]