MD, PhD, FMedSci, FSB, FRCP, FRCPEd

regulation

Web-sites have become a leading source of information on health matters. This is particularly true in the realm of alternative medicine. Conventional health care professionals often know too little about this subject to advise their patients, and alternative practitioners are usually too biased to be trusted. So many consumers turn to the Internet and hope that it offers information which is reliable. But is it?

American pharmacists published a study evaluating the quality of on-line information on herbal supplements. They conducted a search of 13 common herbals – including black cohosh, echinacea, garlic, ginkgo, ginseng, green tea, kava, saw palmetto, and St John’s wort - and reviewed the top 50 Web sites for each using a Google search. Subsequently, they analysed clinical claims, warnings, and other safety information.

A total of 1179 Web sites were examined in this way. Less than 8% of retail sites provided information regarding potential adverse effects, drug interactions, and other safety information; only 10.5% recommended consultation with a healthcare professional. Less than 3% cited scientific literature to support their claims.

The authors’ conclusions were worrying: Key safety information is still lacking from many online sources of herbal information. Certain nonretail site types may be more reliable, but physicians and other healthcare professionals should be aware of the variable quality of these sites to help patients make more informed decisions.

Having conducted my fair share of similar research (e.g. here or here or here or here), I can only concur with these conclusions. When it comes to health care, the Internet is a scary place! In the realm of alternative medicine, it is dominated by people who seem not to care much about anything other than their profits.

But what can be done to change this situation? How can we protect the public from Internet-charlatans? How can one control the Internet? I wish I knew! But there are nevertheless means of directing consumers to those sites which do offer reliable information. Kite-marking high quality sites might be one way of achieving this. This task would, of course, be huge and difficult, but in the interest of public safety, governments and other official institutions should consider tackling it.

A recent article  by a South African homeopath promoted the concept of homeopaths taking over the role of primary care practitioners. His argument essentially was that, in South Africa, homeopaths are well trained and thus adequately equipped to do this job responsibly. Responsibly, really? You find that hard to believe? Here are the essentials of his arguments including all his references in full. I think they are worth reading.

Currently, the Durban University of Technology (DUT) and the University of Johannesburg (UJ) offer degree’s in homoeopathy. This involves a 5-year full-time theoretical and practical training course, followed by a Master’s level research project. After fulfilment of these criteria, a Master’s Degree in Technology (Homoeopathy) is awarded. The course comprises of a strong core of medical subjects, such as the basic sciences of Anatomy, Physiology, Medical Microbiology, Biochemistry and Epidemiology, and the clinical sciences of Pathology and Diagnostics. This is complemented with subjects in Classical, Clinical and Modern Homoeopathy and Homoeopharmaceutics4,5

By law, any person practicing homoeopathy in South Africa must be registered with the Allied Health Professions Council of South Africa (AHPCSA). This is essential, as the Council ensures both medical and homoeopathic competency of practitioners, and that the activities of registered practitioners are closely monitored by the Professional Board. The purpose of the AHPCSA is to ensure that only those with legitimate qualifications of a high enough standard are registered and allowed to practice in South Africa, thus protecting the public against any fraudulent behaviour and illegal practitioners. Therefore, in order to ensure effective homoeopathic treatment, it is essential that any person wishing to prescribe homoeopathic medicine or practice homoeopathy in South Africa must be registered as a Homoeopathic Practitioner with the Allied Health Professions Council of South Africa. This includes conventional Medical Practitioners (dual registration is allowed for Medical Practitioners with both the Health Professions Council and AHPCSA)6,  as homoeopathy requires several years of training in order to apply effectively in clinical practice… 

Registration with the Council affords medico-legal rights similar to those of a medical professional, where treatment is limited to the scope of homoeopathic practice. Thus a homoeopath is firstly a trained diagnostician, and with successful registration with the Council, obtains the title Doctor. A homoeopath is trained and legally obliged to conduct a full medical history, a comprehensive clinical examination, and request further medical investigations, such as blood tests and X-rays, in order to fully assess patients. This is coupled with the ability to consult with specialist pathologists and other medical specialists when necessary, and refer a patient to the appropriate practitioner if the condition falls outside the scope of homoeopathic practice. A homoeopath may also legally issue a certificate of dispensation (‘Doctor’s note’) with appropriate evidence and within reason, and is deemed responsible for the diagnosis and treatment of patients under their care6. A homoeopath is not trained or licensed in any form of surgery, specialist diagnostics (e.g. colonoscopy or angiograms), cannot prescribe prescription medication and is not lawfully allowed to conduct intra-venous treatment of any kind. However, a registered homoeopath is licensed to use intra-muscular homoeopathic injectables in the treatment of various local or systemic complaints when necessary.

Conventional (allopathic) medicine generally targets specific biochemical processes with mostly chemically synthesised medication, in an attempt to suppress a symptom. However, in doing so, this usually negatively affects other biochemical reactions which results in an imbalance within the system. Homoeopathy, by contrast, seeks to re-establish a balance within the natural functioning of the body, restore proper function and results in the reduction or cessation of symptoms.  Homoeopathy therefore enables the body to self-regulate and self-heal, a process known as homeostasis that is intrinsic to every living organism.

Conventional medical treatment is by no means risk free. Iatrogenic (medically induced) deaths in the United States are estimated at 786 000 per year, deaths which are considered avoidable by medical doctors7,8. These figures put annual iatrogenic death in the American medical system above that of cardiovascular disease and cancer as the leading cause of death in that country9, a fact that is not widely reported! South African figures are not easily available, but it is likely that we have similar rates. Although conventional medications have a vital role, are sometimes necessary and can of-course be life-saving, all too often too many patients are put on chronic medication when there are numerous effective, natural, safe and scientifically substantiated options available….

According to the World Health Organisation (WHO), homeopathy is the second largest system of medicine in the world, and world-wide use continues to grow in developed and developing nations10. Homoeopathy is widely considered to be safe and effective, with both clinical and laboratory research providing evidence for the efficacy of homoeopathy11. As the range of potential conditions that homoeopathy can treat is almost limitless, and that treatment is not associated with adverse reactions, homoeopathy should be considered a first-line therapy for all ages. As homoeopaths in South Africa are considered primary health care practitioners, if a conventional approach is deemed necessary, and further diagnostics are required, your practitioner will not hesitate to refer you to the appropriate health care practitioner. Homeopathy is also used alongside conventional medicine and any other form of therapy, and should be seen as ‘complementary’ medicine and not ‘alternative’ medicine.

 

Conclusion

Homoeopathy is an approach that is widely considered to be safe, and when utilised correctly, can be effective for a wide range of conditions. As a primary health care practitioner, a homoeopath is able to handle all aspects of general practice and family health care, including diagnostics, case management and referral to other practitioners or medical specialists. A registered homoeopath is legally responsible to ensure the adequate treatment of their patients, and is accountable for all clinical decisions and advice. A registered homoeopath understands the role of conventional medicine, and will refer to the appropriate specialist in cases that fall outside the legal scope of practice.

 

 

References

1. http://homeopathyresource.wordpress.com/what-is-homeopathy (accessed 31 March 2010)

2.  Bloch R, Lewis B. Homoeopathy for the home. Cape Town, South Africa: Struik Publishers: 2003

3. http://www.dut.ac.za/site/awdep.asp?depnum=22609 (accessed 1 April 2010)

4. http://dutweb.dut.ac.za/handbooks/HEALTH%20Homoeopathy.pdf (accessed 1 April 2010)

5. http://www.uj.ac.za/EN/Faculties/health/departments/homeopathy/coursesandprogrammes/undergraduate/Pages/default.aspx (accessed 1 April 2010)

6. http://www.ahpcsa.co.za/pb_pbhnp_homoeopathy.htm (accessed 6 April 2010)

7. Starfield, B. Is US Health Really the Best in the World? JAMA 2000; 284(4).

8. Null G, Dean C, et al. Death by Medicine. Nutrition Institute of America 2003. 9. http://www4.dr-rath-foundation.org/features/death_by_medicine.html (accessed 7 April 2010)

10. http://ukiahcommunityblog.wordpress.com/2010/03/04/worldwide-popularity-grows-for-homeopathy-alternative-medicine/#comments (accessed 7 April 2010)

11. http://liga.iwmh.net/dokumente/upload/556c7_SCIEN_FRA_2009_final_approved.pdf (accessed 7 April 2010)

I found this article extremely revealing and scary. It gives us an important glimpse into the way some or perhaps even most homeopaths think. They clearly believe that:

1) Their training is sufficient for them to become competent primary care professionals, i.e. clinicians who are the first port of call for sick people  to be diagnosed and treated effectively.

2) Homeopathy is scientifically proven to be efficacious for an ‘almost limitless’ range of conditions. Interestingly, not a single reference is provided to support this claim. Nevertheless, homeopath believe it, and that seems to be enough.

3) Homeopaths seem convinced that they perfectly understand real medicine; yet all they really do is to denounce it as one of the biggest killer of mankind.

4) The fact that homeopaths cannot prescribe real medicine is not seen as a hindrance to their role as primary care practitioner; if anything, homeopaths consider this to be an advantage.

5) Homeopaths view registration with some sort of governing body as the ultimate legitimation of their trade. Once such regulatory measures are in place, the need to support any of their claims with evidence is nil and void.

This article did remind me of the wry statement that ‘HOMEOPATHY IS TO MEDICINE WHAT THE CARPET INDUSTRY IS TO AVIATION’. Homeopaths truly live on a different planet, a planet where belief is everything and responsibility is an alien concept. I certainly hope that they will not take over planet earth in a hurry. If I imagine a world where homeopaths dominate primary care in the way it is suggested in this article, I start having nightmares. It seems to me that people who harbour ideas of this type are not just deluded to the point of madness but they are a danger to public health.

What is a competent homeopath? This intriguing question was addressed in a recent article by researchers from the Department of Public Health, School of Health and Related Research, University of Sheffield, UK, and the Department of Public Health and General Practice, Norwegian University of Science and Technology, Trondheim, Norway. Non-homeopaths would probably argue that either a clinician is competent or he/she is a homeopath; being a competent homeopath seems like a contradiction in terms. So, is is interesting to see what these authors had to say on the subject.

They started by pointing out that homeopathy is unregulated in most European countries, it is therefore not clear, in their view, what it means to be a “competent homeopath”. To clarify this issue, they decided to conduct a small survey investigating homeopathy-educators’ views on what a “competent homeopath” might be and what homeopaths might require in their education. They did a qualitative study based on grounded theory methodology involving telephone interviews with 17 homeopathy-educators from different schools in 10 European countries. The main questions asked were “What do you think is necessary in order to educate and train a competent homeopath?” and “How would you define a competent homeopath?

The results indicate that the homeopathy-educators defined a “competent homeopath” as a professional who, through his/her knowledge and skills together with an awareness of his/her bounds of competence, is able to help his/her patients in the best way possible. This is achieved through the processes of study and self-development, and is supported by a set of basic resources. Becoming and being a “competent homeopath” is underpinned by a set of basic attitudes. These attitudes include course providers and teachers being student-centred, and students and homeopaths being patient-centred. Openness on the part of students is important to learn and develop themselves, on the part of homeopaths when treating patients, and for teachers when working with students. Practitioners have a responsibility towards their patients and themselves, course providers and teachers have responsibility for providing students with effective and appropriate teaching and learning opportunities, and students have responsibility for their own learning and development (in order to avoid confusion or misinterpretation, I have copied this section almost verbatim from the abstract).

The authors consider that, according to homeopathy-educators’ understanding, basic resources and processes contribute to the development of a competent homeopath, who possesses certain knowledge and skills, all underpinned by a set of basic attitudes. And they conclude that this study proposes a substantive theory to answer what homeopathy educators believe a competent homeopath is and what it takes to be educated and trained to become one. The model suggests that certain basic resources and educational and self-developmental processes contribute to developing knowledge and skills necessary to be competent homeopaths. It also pinpoints underlying attitudes needed in the education as well as the clinical practice of competent homeopaths.

I find two things particularly striking in this text which I have copied almost unchanged from the abstract of the original paper (the full text is hardly more illuminating).

Firstly, these statements tell me virtually nothing that is specific to homeopathy. In my view, they are merely a bonanza of platitudes without much real meaning. We could substitute almost any other health care profession for “homeopath”, and the text would still be applicable in a very general and politically correct sort of way. I see nothing here that is specific to homeopathy.

Secondly, according to the findings of this survey, a “competent homeopath” does not seem to have much need for evidence. With virtually every other health care profession I know, one would expect a very strong emphasis on the need for the competent clinician to abide by the rules of evidence-based medicine. Not so in homeopathy!

Why? The answer seems obvious: if a clinician practices evidence-based medicine, he/she cannot possibly practice homeopathy – the evidence shows that homeopathy is a placebo-therapy. So, here we have it: a competent homeopath has to be a contradiction in terms because either someone practices homeopathy or he/she practices evidence-based medicine. Doing both at the same time is simply not possible.

S.O. Hansson from the Royal Institute of Technology, Stockholm, Sweden recently published an interesting comment on the law regulating the labelling of homeopathic products. In it he points out that, in the European Union (EU), all pre-packaged food products must contain a list of ingredients and their quantities. The list should be “accurate, clear and easy to understand for the consumer.” Similar requirements apply to pharmaceutical drugs and products – with one notable exception: homeopathic preparations.

For such products, the ingredients need not be disclosed on the label, which should instead specify “the scientific name of the stock or stocks followed by the degree of dilution.” The degree of homeopathic dilutions is, in turn, given in an understandable jargon, such as “C60″, which actually describes a dilution of 1:10120.

The point Hansson is trying to make is that very few health care professionals and even fewer consumers would understand such abbreviations and jargon. This means that, manufacturers of homeopathic products are legally permitted to hide the fact from their customers that their remedies typically contain no active ingredient at all. Considering that homeopathic products are typically bought ‘over the counter’ (OTC), i.e. without interference from a health care professional, just like food products, the exemption seems most surprising.

The most OTC homeopathic remedies are in the “C30” potency; this signifies a dilution of 1: 1 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000. The likelihood that any potency higher than “C12” might contain a single molecule of active ingredient is very close to zero. In order to comprehend the degree of dilution in homeopathy more fully, a visual approach might be best: for it to have a reasonable chance to contain just one single molecule of active ingredient, a homeopathic pill in a “C30” potency would need to have a diameter roughly equal to the distance between the earth and the sun. Homeopathy is truly impossible to swallow.

If homeopathic manufacturers were obliged to provide a description that is “accurate, clear and easy to understand for the consumer”, it would need to state that any dilution beyond “C12” contains no active molecule. It seems clear that such accurate, clear and understandable information would discourage most consumers to spend their hard-earned money for such nonsense. It seems thus to be obvious that the EU exemption of homeopathic remedies from honest labelling protects the interests of the homeopathic industry.

But surely, this is deeply wrong. Regulations in health care are not supposed to protect commercial interests, they should protect the consumer. In my view, it is time to change such profoundly misguided EU-regulation – in the interest of honesty, single standards, transparency and foremost in the interest of the patient and the consumer.

There are at least two dramatically different kinds of herbal medicine, and the proper distinction of the two is crucially important. The first type is supported by some reasonably sound evidence and essentially uses well-tested herbal remedies against specific conditions; this approach has been called by some experts RATIONAL PHYTOTHERAPY. An example is the use of St John’s Wort for depression.

The second type of herbal medicine. It entails consulting a herbal practitioner who takes a history, makes a diagnosis (usually according to obsolete concepts) and prescribes a mixture of several herbal remedies tailor-made to the characteristics of his patient. Thus 10 patients with the identical diagnosis (say depression) might receive 10 different mixtures of herbs. This is true for individualized herbalism of all traditions, e.g. Chinese, Indian or European, and virtually every herbalist you might consult will employ this individualized, traditional approach.

Many consumers know that, in principle, there is some reasonably good evidence for herbal medicine. They fail to appreciate, however, that this does only apply to (sections of) rational phytotherapy. So, they consult herbal practitioners in the belief that they are about to receive an evidence-based therapy. Nothing could be further from the truth! The individualised approach is not evidence-based; even if the individual extracts employed were all supported by sound data (which they frequently are not) the mixutres applied are clearly not.

And this is where the danger of traditional herbalism lies; over the years, herbalists have fooled us all with this fundamental misunderstanding. In the UK, they might even achieve statutory regulation on the back of this self-serving misconception. When this happens, we would have a situation where a completely unproven practice has obtained the same status as doctors, nurses and physiotherapists. If this is not grossly misleading for the consumer, I do not know what is!!!

Some claim that individualized herbalism cannot be tested in clinical trials. This notion can very easily be shown to be wrong: several such studies testing individualized herbalism have been published. To the dismay of traditional herbalists, their results fail to confirm that such treatments are effective for any condition.

Now a further trial has become available that importantly contributes to this knowledge-base. Its authors (all enthusiasts of individualized herbalism) randomized 102 patients suffering from hip or knee-osteoarthritis into two groups. The experimental group received tailor-made mixtures of 7 to 10 Chinese herbs which were traditionally assumed to be helpful. The control group took a mixture of plants known to be ineffective but tasting similar. After 20 weeks of treatment, there were no differences between the groups in any of the outcome measures: pain, stiffness and function. These results thus confirm that this approach is not effective. Not only that, it also carries more risks.

As individualized herbalism employs a multitude of ingredients, the dangers of adverse-effects and herb-drug interactionscontamination, adulteration etc. are bigger that those with the use of single herbal extracts. It seems to follow therefore that the risks of individualized herbalism do not outweigh its benefit.

My recommendations are thus fairly straight forward: if we consider herbal medicine, it is vital to differentiate between the two types. Rational phytotherapy might be fine – of course, depending on the remedy and the condition we are aiming to treat. Individualised or traditional herbalism is not fine; it is not demonstrably effective and has considerable risks. This means consulting a herbalist is not a reasonable approach to treating any human ailment. It also means that regulating herbalists (as we are about to do in the UK) is a seriously bad idea: the regulation of non-sense will result in non-sense!

 

Since homeopathy was invented by Samuel Hahnemann about 200 years ago, a steadily growing group of critics have raised their voices more and more loudly. Usually they come from doctors or scientists and only rarely from the legal profession.

Yet, there are exceptions: an Australian barrister and professor of law has published an analysis of “a series of criminal, civil, disciplinary and coronial decisions from difference countries in relation to homeopathic medicine where outcomes have been tragic”. He concludes that “there is an urgent need for reflection and response within the health sector generally, consumer protection authorities, and legal policy-makers about the steps that should be taken to provide community protection from dangerous homeopathic practice”.

He also questions whether homeopathy can ever be registered alongside other health care professionals:

“Until such time as homoeopathy can scientifically justify its fundamental tenets,… it cannot be said that its claims for therapeutic efficacy can be justifiable. This leaves the profession not just exposed to criticisms,… but potentially open to consumer protection actions directed toward whether its representations are false, misleading and deceptive, to civil litigation when its promises have not been fulfilled, and especially when persons have died, and to criminal actions in respect of the financial advantage that is obtained by its practitioners from their representations.

The distressing cases referred to here which led to avoidable deaths and the multiple accusations leveled against homoeopathy require of the profession at least a formal repudiation of the practitioners concerned… In addition, they demand an unequivocal response that homoeopathy will discipline its own in a robust and open way. If the profession is to acquire any scientific credibility, which is difficult to conceive of, the deaths to which homoeopathy has contributed…also require that homoeopathy actively generate a defensible research basis that justifies its claims to efficacy of outcome for its patients. It is only then that the claims of the medical establishment that homoeopathy is a dangerous and too often a lethal form of quackery will be able to be contested rationally. In the meantime, it is timely to consider further the status that homoeopathy has within the general and health care communities and whether that status can be scientifically, ethically or legally justified”.

I believe this legal view to be highly significant. The persistent criticism from skeptics, concerned scientists and doctors has rarely been translated into decisions about health care provision. Homeopaths tended to respond to our criticism by producing anecdotes, unconvincing or cherry-picked data or by producing outright lies, for instance in relation to the “Swiss government’s report” on homeopathy.

In this context, it is worth noting that, in some countries, homeopaths who have no medical qualifications have been accused to practice medicine without a licence. The case of Dana Ullman in the US is probably the most spectecular such incident; this is how one pro-homeopathy site describes it:

Dana is perhaps the person who has done the most for homeopathy since his court case in that he pursues the evangelism of homeopathy through the NCH and his mail order company… He prescribed homeopathic medicine and was arrested for practicing medicine without a license. But he won an important settlement in 1977 in the Oakland Municipal Court in which the court allowed his practice under two stipulations:

  1. that he did not diagnose or treat disease and that he refers to medical doctors for the diagnosis and treatment of disease;
  2. that he makes contracts with his patients that clearly define his role as a non-medical homeopathic practitioner and the patient’s role in seeking his care.

But such cases are not the only occasions for lawyers to look at homeopathy. Recently there has been a class action against the Boiron, the world’s largest manufacturer of homeopathic preparations. It was alleged that Boiron made bogus claims for one of its remedies, and there was a settlement worth millions of dollars. Similar cases  are likely to follow, e.g.:

  • Nelsons Homeopathy (Rescue Remedy, Bach Original Flower Remedies, Pure & Clear, Arnileve, H+Care)
  • CVS Homeopathic Products (Flu Relief, Cold Relief, Cold Remedy, Ear Pain Relief)
  • Nature’s Innovation (Naturasil Skin Tags, Bed Bug Patrol, Naturasil Scabies)
  • Boericke & Tafel Cold/Flu
  • Homeolab USA (Kids Relief Cough & Cold)

In June 2003, a British High Court Judge ordered two mothers to ensure that their daughters are appropriately vaccinated. The ruling concerned two separate cases brought by fathers who wanted their daughters immunized despite opposition by the girls’ unwed mothers

The fact that, in the UK and other countries, homeopathic placebos are still being sold as “vaccines” for the prevention of serious, life-threatening infections is, in my view nothing short of a scandal. The fact that a leading figure at Ainsworth actively misleads the public about these products is an outrage. It is high time therefore that the legal profession looks seriously at the full range of issues related to homeopathy with a view of stopping the dangerous nonsense.

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