MD, PhD, FMedSci, FSB, FRCP, FRCPEd

regulation

Homeopathic remedies are being marketed and sold as though they are medicines, yet highly diluted preparations contain nothing and do nothing. This means consumers are constantly mislead into believing that they are drugs. This situation seems to be changing dramatically in the US, and hopefully – led by the American example – elsewhere as well.

It has been reported that the US Federal Trade Commission issued a statement which said that, in future, homeopathic remedies have to be held to the same standard as other medicinal products. In other words, American companies must now have reliable scientific evidence for health-related claims that their products can treat specific conditions and illnesses.

The ‘Enforcement Policy Statement on Marketing Claims for Over-the-Counter (OTC) Homeopathic Drugs’ makes it clear that “the case for efficacy is based solely on traditional homeopathic theories and there are no valid studies using current scientific methods showing the product’s efficacy.”

However, an [over-the-counter] homeopathic drug claim that is not substantiated by competent and reliable scientific evidence might not be deceptive if the advertisement or label where it appears effectively communicates that: 1) there is no scientific evidence that the product works; and 2) the product’s claims are based only on theories of homeopathy from the 1700s that are not accepted by most modern medical experts. In other words, if no evidence for efficacy exists, companies must advertise this fact clearly on their labelling, and also disclose that claims are today rejected by the majority of the scientific community. Failure to do this will be considered a violation of the FTC Act.

“This is a real victory for reason, science, and the health of the American people,” said Michael De Dora, public policy director for The Center for Inquiry in a statement issued in response to the new act. “The FTC has made the right decision to hold manufacturers accountable for the absolutely baseless assertions they make about homeopathic products.”

The new regulation will make sure that customers are informed explicitly about whether the product they purchase at a pharmacy has any scientific basis. This is important because homeopathic remedies aren’t just ineffective, but they can be dangerous too. The FDA is currently investigating the deaths of 10 babies who were given homeopathic teething tablets that contained deadly nightshade.

“Consumers can’t help but be confused when snake oil is placed on the same pharmacy shelves as real science-based medicine, and they throw away billions of dollars every year on homeopathy based on its false promises,” said De Dora. “The dangers of homeopathy are very real, for when people choose these deceptive, useless products over proven, effective medicine, they risk their health and the health of their families.”

These are clear words indeed; the new regulation is bound to make a dramatic change for homeopathy in the US. The winner will undoubtedly the consumer who can no longer be so openly and shamelessly misled as before. The FTC has set an example for other national regulators who will hopefully follow suit.

I have published many articles on the risks of various alternative treatments (see for instance here, here, here, here, here and here) – not because I am alarmist but because I have always felt very strongly that, for a researcher into alternative medicine, the most important issue must be to make sure users of these therapies are as safe as possible. Usually I differentiated between direct and indirect risks. The former relate to the risks of the treatment and include, for instance, liver damage caused by a herbal remedy or stroke due to neck manipulation. The latter are mainly due to the poor, often irresponsible advice given by many therapists.

A recent article adopted the same terminology when reviewing the risks of alternative medicine specifically for cancer patients. As the indirect risks are often neglected, I will here quote the relevant section of this paper in full:

…Health care physicians and oncology experts have an ethical responsibility to initiate the communication regarding the use of complementary therapies with cancer patients. However, according to data obtained from this literature review, oncology doctors and physicians will discuss complementary therapies only when a patient him/herself raises this issue within a consultation. This passive attitude was linked to a lack of sufficient scientific evidence for positive outcomes of complementary therapies found in high quality randomized controlled trials (RCTs). Oncology nurses, on the other hand, sometimes actively promote complementary modalities that they find to correspond with their vision of holistic care.

According to the included studies, complementary providers often differ from conventional health care providers in their understanding of treatment concepts, philosophies and diagnostic procedures. This leads to different models of disease causality (cells, blood, nerves vs. energy, vital force, meridians) and treatment philosophy (reductionism vs. holism). As many complementary providers are philosophically oriented towards personal and spiritual growth, patients may feel guilty if the disease continues to advance despite the patients’ best spiritual and mental efforts. According to Broom and colleagues, such philosophies may also give patients false hope of recovery.

Another indirect risk connected to the combination of conventional and complementary treatment in cancer care is the lack of regulation and standardized education in many countries. Currently, there are, for example, no standard training requirements for complementary providers working in cancer care or any other health care setting in the EU. According to Mackareth et al., complementary providers in England need specific training to learn how to practice safely.

Moreover, there is a need for common medical terminology to bridge the communication gap between health care providers working outside the conventional health care system. Common medical terminology may reduce the existing communication gap between conventional and complementary providers about mutual patients. To minimize communication gap between physicians, oncology experts and complementary providers, a medical complementary record should include a treatment plan with conventional and complementary diagnosis, explanation of terminology, possible treatment interactions, description of the complementary treatment plan and goals. If possible, the quality of any complementary supplement given should be reported.

END OF QUOTE

As I said, I find it important to discuss the indirect risks of alternative medicine, and I am therefore pleased that the authors of this article addressed them. At the same time, I find their text remarkably tame.

Why are they not more open and forceful about what, after all, amounts to a serious public health issue? The answer might be simpler than expected: most of them are affiliated with the ‘National Research Center in Complementary and Alternative Medicine (NAFKAM), UiT The Arctic University of Norway, Tromsø, Norway’. Could it be that open warnings about outright quackery is not what suits this unit?

So, what might be an open and frank approach to discussing the indirect risks of alternative medicine? In my view, it should make several points abundantly clear and transparent:

  • Alternative practitioners (APs) are usually not trained to advise patients responsibly, particularly in cases serious disease.
  • The training of APs is often inadequate and sometimes resembles more to brain-washing than to proper education.
  • Consequently, APs often woefully over-estimate what their therapy can achieve.
  • The patients of APs are often desperate and ready to believe even the tallest tales.
  • APs have a huge conflict of interest – in order to make a living they need to treat as many patients as possible and are therefore not motivated to refer them to more suitable care.
  • APs are frequently in denial when it comes to the risks of their treatments.
  • APs are not educated such that they understand the full complexities of serious illness.
  • As a result, APs far too often misguide their patients to make tragically wrong choices thus putting their health at serious risk.
  • In most countries, the regulators turn a blind eye to this huge problem.

These are by no means trivial  points, and they have nothing to do with a ‘turf war’ between conventional and alternative medicine. They relate to our ethical duty to keep our patients as safe as we can. It has been estimated that, in oncology alone, 1 – 5% of deaths are due to patients opting to have alternative instead of conventional treatments. This amounts to an unbearably high absolute number of patients dying prematurely due to the indirect risks of alternative medicine.

It is high time, I think, that we tackle this issue systematically and seriously.

This press-release just came to my attention:

Today, with the stroke of his pen, Governor Tom Wolf adds Pennsylvania to the list of states that acknowledge the value of alternative healthcare from a qualified professional. Pennsylvania becomes the 21st U.S. jurisdiction to regulate naturopathic medicine. The new law HB516 regulates naturopathic doctors; ensuring patients can trust that their wellness professional holds a graduate degree from an accredited naturopathic medical school.

Heidi Weinhold, N.D. and Legislative Chair of the Pennsylvania Association of Naturopathic Physicians (PANP), says, “This is a historic day for naturopathic medicine. The governor’s approval will throw open the doors for more Pennsylvania students to choose this academic course of study. Then, they can return home from a four-year graduate program to set up a practice as a naturopathic doctor.”

The PANP members worked for the last 16 years with the state legislature to advance the much-needed recognition of this growing medical field. Their goal was to increase the credibility and minimize the confusion between professionals with an advance degree and the self-study practitioner. “Naturopathic professionals also seek to better coordinate and collaborate with medical professionals across the spectrum. We believe in integrative care, and this law gives us the stature we need to work N,” explains Dr. Weinhold.

Under the new law, the terms Naturopathic Doctor and ND will be reserved exclusively for those who have attended four-year, post-graduate level programs at institutions recognized by the United States Department of Education. “This protects the scope-of-work and title for graduates from an accredited N.D. program,” offers Dr. JoAnn Yanez, executive director of the Association of Accredited Naturopathic Colleges.

Naturopathic Doctors are currently practicing at Cancer Treatment Centers of America in Philadelphia, as well as the University of Pittsburgh Medical Centers, where they work side by side with medical doctors in an integrative setting. More patients could be served in this manner once naturopathic doctors are registered in this state. Both Penn State Hershey Medical Center and West Penn Allegheny General Hospital have indicated that they would hire Naturopathic Doctors if they were registered in the state.

“The PANP will be working over the next year on implementation of the legislation in order that NDs can begin to register with the Board of Medicine. A number of Representatives and Senators have encouraged us to come back to the legislature next session in order to expand the scope of this bill. We are very encouraged about the future of naturopathic medicine in Pennsylvania,” says Dr. Marie Winters, manager of the Naturopathic Medicine Department of the Cancer Treatment Centers of America and president of PANP.

The law will go into effect January 1, 2018.

Pennsylvania joins these other jurisdictions which regulate naturopathic medicine: Alaska, Arizona, California, Colorado, Connecticut, District of Columbia, Kansas, Maine, Maryland, Minnesota, Montana, New Hampshire, North Dakota, Oregon, Rhode Island, Utah, Vermont, Washington, Puerto Rico and U.S. Virgin Islands, and these provinces in Canada: Alberta, British Columbia, Manitoba, Ontario, Saskatchewan.

END OF QUOTE

Here are a few comments and issues that I find remarkable about this announcement:

  • Naturopaths are called ‘naturopathic doctors’, yet in the same sentence it is pointed out that they are ‘wellness professionals’. I am not sure what the latter, woolly term is supposed to mean – perhaps that naturopathy cannot effectively treat diseases?
  • The document speaks of ‘accredited naturopathic medical schools’. Has anyone checked the utter nonsense that is being taught there? The answer is yes, Britt Marie Hermes has, and her verdict is truly depressing and devastating.
  • Naturopaths instantly interpret the new regulation as a ‘governor’s approval’ and ‘recognition’. It shows why alternative practitioners want to be regulated: they foremost crave the APPROVAL and the RECOGNITION they clearly do not deserve.
  • Naturopaths believe in ‘integrative care’ – of course they do, because this is nothing but a ploy for smuggling quackery into evidence-based medicine (EBM).
  • Naturopaths want to be ‘peer-to-peer with other disciplines’ – but they are unable to show that their interventions generate more good than harm. This effectively is an attempt to place quackery on the same level as EBM.
  • Naturopaths already treat cancer patients in the state! Really? Do they use Laetrile, or homeopathy?
  • Naturopaths are portrayed as being a benefit to public health. Has anyone considered that the opposite might be the case? See for instance here and here.

It would be wrong to call the Czech Republic the promised land for homeopathy. For instance, the only research paper by Czech authors related to the subject that I could locate was published in the Journal ‘Homeopathy‘ and, on even superficial reading, it has little to do with homeopathy. Here is the abstract:

We discovered a previously unknown phenomenon in liquid water, which develops over time when water is left to stand undisturbed, and which made precise gravimetric measurement impossible. We term this property autothixotropy (weak gel-like behaviour developing spontaneously over time) and propose a possible explanation. The results of quantitative measurements, performed by two different methods, are presented. We also report the newly discovered phenomenon of autothixotropy-hysteresis and describe the dependence of autothixotropy on the degree of molecular translative freedom. A very important conclusion is that the presence of very low concentration of salt ions, these phenomena do not occur in deionized water. Salt ions may be the determinative condition for the occurrence of the phenomena.

In fact, historically, homeopathy had had a hard time in this country. Until World War II only very few doctors practiced homeopathy on Czech territory. Dr. Quin, founder of British homeopathy, practiced a short time in the small town of Tisnov. A Catholic homeopathic hospital existed at Kromeriz since 1860. During the communist era of 1948-89, homeopathy was prohibited, and, until 1991, no books about homeopathy were available in the Czech language. More recently, about 20 titles were published by the Alternativa Publishing house. The Czech Homeopathic Medical Chamber is an organisation that only permits MDs and currently has about 1000 members. The Czech Medical Homeopathic Society has only about 300 members.

After the fall of the ‘iron curtain’, homeopathy evidently became more popular. It has recently been reported that the number of homeopathic remedies sold in the Czech Republic rose by over 50% during the past 15 years. Last year, Czechs bought homeopathic preparations for over 170 million crowns, which is 10% more than a year ago.  “The patients most frequently use homeopathics against the problems associated with common viral diseases,” said Ales Krebs, deputy chairman of the Czech Pharmacy Chamber.  The homeopathic flu remedy Oscillococcinum seems to be one of the most popular homeopathic preparation in the Czech Republic. Yet Czech chemists say that it is ‘absolute nonsense’.

Most physicians seem to be equally cynical about homeopathy and its practitioners: “Homeopathics are perfect drugs. The manufacturing is dirt cheap and they sell for 60 crowns. They cannot be forged because the fakes have the same effect as the original product,” Czech doctors joke about the growing interest in homeopathy. Stepan Svacina, chairman of the Czech Medical Society, says: “The doctor can use a placebo in a psychological therapy. It does not matter whether this may be a homeopathic preparation or jumping on one leg.” Another doctor is quoted as stating that “Advocates of homeopathy often argue with doctors’ conspiracy with pharmaceutical makers, but they themselves certainly do not offer their methods for free as a sort of philanthropy.”

The cost for a first consultation with a Czech homeopath ranges between 100 to 3,000 crowns. The patient pays another 800-1,000 crowns for each next examination. ($1 = 24.846 crowns)

In 2014, the Czech Republic Ministry of Health issued a press-release stating that…although the Ministry for Health of the Czech Republic does not perceive the evidence base for homeopathy to be strong enough yet, this does not prevent doctors from utilising this if it is desired and appropriate…

Because the use of homeopathy cannot ever be considered to be ‘appropriate’, this declaration could arguably be interpreted by those who insist on evidence as a new prohibition of homeopathy in the Czech Republic.

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.

END OF QUOTE

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.

If you are a homeopath but have not received a letter from us, please download a copy here, together with supporting FAQs about Advertising Regulation.

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.

END OF QUOTE

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.

END OF QUOTE

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!

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