MD, PhD, FMedSci, FRSB, FRCP, FRCPEd

regulation

The Independent asked me yesterday to write a 500-word piece on homeopathy. I accepted with pleasure. About two hours after I had sent it, my article appeared on their website. As I had not even seen their edited version, I was surprised how much they changed without my permission.

No, I am not cross about this – I know by now how journalists function. Yet I think that some of their changes did change my meaning, and therefore I have decided to post here the original. Since I did not get paid nor sign a copyright transfer, I think I am perfectly entitled to do that.

HERE IT IS

Time to get real about homeopathy

EDZARD ERNST, EMERITUS PROFESSOR, UNIVERSITY OF EXETER

The National Health and Medical Research Council of Australia recently published what might be the most thorough evaluation of homeopathy in the 200-year long history of this therapy. They assessed a total of 57 systematic reviews summarizing 176 individual clinical trials focused on 68 different conditions. They concluded that, firstly, there is no evidence that homeopathy works better than placebo, and, secondly, that patients may harm themselves, if they nevertheless employ homeopathy instead of effective therapies. Already in 2002, on the basis of a similar but less comprehensive analysis, I concluded that “the best clinical evidence for homeopathy available to date does not warrant positive recommendations for its use in clinical practice” [http://www.ncbi.nlm.nih.gov/pubmed/12492603]. Yet homeopaths around the world seemed shocked by this news and are now on the war-path to rubbish or suppress it.

This reaction is as surprising as it is ridiculous. The conclusion that highly diluted homeopathic remedies are pure placebos had already been derived from the utter implausibility of Hahnemann’s theories that like cures like and that diluting a remedy would render it not weaker but stronger. Oliver Wendell Holmes, for instance, famously wrote in 1842 that homeopathy is “a mingled mass of perverse ingenuity, of tinsel erudition, of imbecile credulity, and of artful misinterpretation, too often mingled in practice…with heartless and shameless imposition.”

Homeopaths, however, claimed for the last 200 years that science was not yet able to explain how homeopathy works, in other words, that homeopaths are ahead of their time. The fact, however, is that scientists have always been perfectly able to affirm that there cannot be an explanation for homeopathy that does not fly in the face of science.

“The proof is in the pudding”, homeopaths countered, “if patients benefit from homeopathy, it works regardless what the science tells us!” This argument too has long been shown to be based on little more than the delusion of homeopaths. Patients benefit from the therapeutic encounter, from the placebo-effect and from other phenomena that are unrelated to the sugar pills dished out by homeopaths. To convey such benefits to their patients, clinicians do not need placebos. Administering truly effective treatments with compassion will make them benefit from both the specific and the non-specific effects of the therapy in question. This means that just using placebos like homeopathics is unethical and amounts to cheating the patient.

Given the overwhelming evidence against homeopathy it seems now time to act. There is no reason any longer for consumers, patients, politicians, journalists etc. to believe in homeopathy. Pretending there is room for a legitimate debate is merely misleading the public. There is also no reason to have homeopathy on the NHS, to pay for homeopathic hospitals or to invest into further research. After researching the subject for more than two decades, I am convinced that the only legitimate place for homeopathy is in the history books.

Germany is, as we all know, the home of homeopathy. Here it has an unbroken popularity, plenty of high level support and embarrassingly little opposition. The argument that homeopathy has repeatedly been shown to merely rely on placebo effects seems to count for nothing in Germany.

Perhaps this is going to change now. On January 30, a group of experts from all walks of life have met in Freiburg to discuss ways of informing the public responsibly and countering the plethora of misinformation that Germans are regularly exposed to on the subject of homeopathy. They founded the ‘Information Network Homeopathy’ and decided on a range of actions.

No doubt, some will ask where does their financial support come from? And no doubt, some will claim that we are on the payroll of ‘Big Pharma’. The truth is that we have no funding; everyone gives his/her own time free of charge and pays for his/her own expenses etc. And why? Because we believe in progress and feel strongly that it is time to improve healthcare by relegating homeopathy to the history books.

One of the first fruits of the network’s endeavours is the Freiburger Erklärung zur Homöopathie’, the ‘Freiburg Declaration on Homeopathy’. I have the permission to reproduce the document here in full (the translation is mine):

HOMEOPATHY IS NEITHER NATUROPATHY NOR MEDICINE

Despite the support of politicians and the silence of those who should know better, homeopathy has remained a method which is in clear opposition to the proven basics of science. The members and supporter of the ‘Information Network Homeopathy’ view homeopathy as a stubbornly surviving belief system, which cannot be accepted as part of naturopathy nor medicine. The information network is an association of physicians, pharmacists, veterinarians, biologists, scientists and other critics of homeopathy who are united in their aim to disclose this fact more openly and make the public more aware of it.

NO SPECIAL STATUS FOR HOMEOPATHY

During the more than 200 years of its existence, homeopathy has not managed to demonstrate its specific effectiveness. Homeopathy only survives because it has been granted special status in the German healthcare system which is, in the opinion of the experts of the network, unjustified. Drugs have to prove their effectiveness according to objective criteria, but homeopathics are exempt from this obligation. We oppose such double standards in medicine.

Homeopathy has also not managed to demonstrate a plausible mode of action. Instead its proponents pretend that there are uncertainties which need to be clarified. We oppose such notions vehemently. Homeopathy is not an unconventional method that requires further scientific study. Its basis consists of long disproven theories such as the ‘law of similars’, ‘vital force’ or ‘potentisation by dilution’.

SELF-DECEPTION OF PATIENT AND THERAPIST

We do not dispute the therapeutic effects of a homeopathic treatment. But they are unrelated to the specific homeopathic remedy. The perceived effectiveness of homeopathics is due to suggestion and auto-suggestion of the patient and the therapist. The mechanisms of such (self-) deceit are multi-fold but well-known and researched. Symptomatic improvements caused by context-effects must not be causally associated with the homeopathic remedy. We assume that many physicians and alternative practitioners using homeopathy are unaware of the existence and multitude of such mechanisms and are acting in good faith. This, however, does not alter the fact that their conclusions are wrong and thus potentially harmful.

MEDICINE AND SCIENCE

We do not claim that the scientific method which we uphold can currently research and explain everything. However, it enables us to explain that homeopathy cannot explain itself. The scientific method shows the best way we have for differentiating effective from ineffective treatments. A popular belief in therapeutic claims nourished by politicians and journalists can never be a guide for medical activities.

AIM OF THIS DECLARATION

Our criticism is not aimed at needy patients or practising homeopathic clinicians; it is aimed at the school of homeopathy and the healthcare institutions which could have long recognised the nonsensical nature of homeopathy, but have chosen not to interfere. We ask the players within our science-based healthcare system to finally reject homeopathy and other pseudoscientific methods and to return to what should be self-evident: scientifically validated, fair and generally reproducible rules promoting top-quality medicine for he benefit of the patient.

Authors:

Dr.-Ing. Norbert Aust, Initiator Informationsnetzwerk Homöopathie

Dr. med. Natalie Grams, Leiterin Informationsnetzwerk Homöopathie

Amardeo Sarma, GWUP Vorsitzender und Fellow von CSI (Committee for Skeptical Inquiry)

Signatories:

Edzard Ernst, Emeritus Professor, Universität Exeter, UK

Prof. Dr. Rudolf Happle, Verfasser der Marburger Erklärung zur Homöopathie

Prof. Dr. Wolfgang Hell, Vorsitzender des Wissenschaftsrates der GWUP

Prof. Norbert Schmacke, Institut für Public Health und Pflegeforschung, Universität Bremen

Dr. rer. nat. Christian Weymayr, freier Medizinjournalist

A friend alerted me to this website: Hungarian Academy of Sciences statement proposing the same scientific standards for homeopathic drug registration as for normal drugs

Members of the Section of Medical Sciences of the Hungarian Academy of Sciences (HAS) voted unanimously on 9 November 2015 for supporting the earlier proposal of the Royal Swedish Academy of Sciences. The Swedish statement requested that the homeopathic remedies should go through the same efficacy trials as normal drugs should.

The Hungarian statement refers to various recent scientific statements for example to the study of the Australian Government’s National Health and Medical Research Council that analysed 175 publications and concluded that there was no reasonable scientific proof for the efficacy of homeopathy for any health conditions. The HAS also refers to the European Academies Science Advisory Council that is allegedly considering an investigation among the academies of the UN countries about this topic. The statement points out that another Hungarian scientific body (Health Science Committee – Egészségügyi Tudományos Tanács) had made a similar statement already in 1991 and opposed using and registering those drugs for that efficacy had not been proved and that had not gone through adequate research procedures.

József Mandl – biochemist, member of HAS, president of Health Science Committee said: “The Australian and Swedish statements had raised the interest of the Hungarian scientific community and now members of the Medical Sciences Section of the Hungarian Academy of Sciences voted unanimously to join the Swedish initiation… Science has well defined, rigorous methods and systems. Homeopathy can’t be fitted to these. Homeopathic remedies don’t meet the criteria of evidence based medicine. There might be various hypotheses, theories, but everything should be proved. This is what science means and this is what we would like to highlight now.”

Well said, indeed!

It is high time that the authorities concede that there can be only one standard in medicine regulation. The ‘free ride’ homeopathy has had for 200 years must now come to an end.

This notion also seems to be increasingly supported by the legal profession. An Australian lawyer just published this abstract:

The 2010 report of the United Kingdom Science and Technology Committee of the House of Commons and the 2015 report of the Australian National Health and Medical Research Council have overtaken in significance the uncritical Swiss report of 2012 and have gone a long way to changing the environment of tolerance toward proselytising claims of efficacy in respect of homeopathy. The inquiry being undertaken in the United States by the Food and Drug Administration during 2015 may accelerate this trend. An outcome of the reports and inquiries has been a series of decisions from advertising regulators and by courts rejecting medically unjustifiable claims in respect of the efficacy of homeopathy. Class actions have also been initiated in North America against manufacturers of homeopathic products. The changing legal and regulatory environment is generating an increasingly scientifically marginalised existence for homeopathy. That new environment is starting to provide effective inhibition of assertions on behalf of homeopathy and other health modalities whose claims to therapeutic efficacy cannot be justified by reference to the principles of evidence-based health care. This has the potential to reduce the financial support that is provided by insurers and governments toward homeopathy and to result in serious liability exposure for practitioners, manufacturers and those who purvey homeopathic products, potentially including pharmacists. In addition, it may give a fillip to a form of regulation of homeopaths if law reform to regulate unregistered health practitioners gathers momentum, as is taking place in Australia.

As though this is not enough, today it was reported that the UK NHS is considering to blacklist homeopathic remedies:

The Good Thinking Society has been campaigning for homeopathy to be added to the NHS blacklist – known formally as Schedule 1 – of drugs that cannot be prescribed by GPs. Drugs can be blacklisted if there are cheaper alternatives or if the medicine is not effective. After the Good Thinking Society threatened to take their case to the courts, Department of Health legal advisers replied in emails that ministers had “decided to conduct a consultation”. Officials have now confirmed this will take place in 2016.

It seems to me that the position of homeopathy as a form of health care is less and less tenable. Its place is in the history books. To satisfy the need for consumer/patient choice, the remedies should be moved to the confectionary shelves of the supermarkets.

All across the world we see initiatives to regulate alternative medicine. The most recent news in this sphere comes from Switzerland. The ‘Swissinfo’ website reported that the training of alternative medicine practitioners is to be regulated by creating a ‘COMPLEMENTARY MEDICINE DIPLOMA’.

The decision was welcomed by the Organisation of Swiss Alternative Medicine Professionals (OdA KT), which will conduct the exams for the diploma in question. The five therapies selected by the government for the complementary medicine diploma are yoga, ayurveda, shiatsu, craniosacral therapy and eutony. The first exams are expected to be held in 2016.

“Recognition by the state provides an important political basis for these therapies,” Christoph Q Meier, secretary general of OdA KT told swissinfo.ch. “The diploma will also improve the quality of therapy offered in Switzerland, as until now anybody could call themselves a therapist.” Meier estimates that there are between 12-15,000 practitioners of complementary therapies in Switzerland. Applicants for the national diploma will first have to pass a series of pre-exams. However, those with recognised qualifications and at least five years of experience could be exempt from the pre-exams. The exam is open to foreign nationals but will only be offered in German, French and Italian. In April this year, ayurveda was also included for a separate national diploma in naturopathy medicine along with Chinese and European traditional medicine, as well as homeopathy. Switzerland has around 3,000 naturopaths.

Whenever issues like this come up, I ask myself: IS REGULATION OF ALTERNATIVE MEDICINE A GOOD OR A BAD THING?

On the one hand, one might be pleased to hear that therapists receive some training and that not everyone who feels like it can do this job. On the other hand, it has to be said that regulation of nonsense will inevitably result in nonsense. What is more, regulation will also be misused by the practitioners to claim that their treatment is now well-established and supported by the government. This phenomenon can already be seen in the comments above and it misleads the public who understandably believe that, once a form of health care is regulated officially, it must be evidence-based.

So, what is the solution? I wish I knew the answer.

Any suggestion is welcomed.

I just came across an announcement which could be important. Here are what I consider the important passages:

The Federal Trade Commission will host a public workshop on Monday, September 21, 2015 in Washington, DC, to examine advertising for over-the-counter (OTC) homeopathic products…

Because of rapid growth in the marketing and consumer use of homeopathic products, the FTC is hosting a workshop to evaluate the advertising for such products. The workshop will bring together a variety of stakeholders, including medical professionals, industry representatives, consumer advocates, and government regulators.

The FTC invites the public to submit research, recommendations for topics of discussion, and requests to participate as panelists. The workshop will cover topics including:

  • A look at changes in the homeopathic market, its advertising, and what consumers know;
  • The science behind homeopathy and its effectiveness;
  • The effects of recent class actions against homeopathic product companies;
  • The application of Section 5 of the FTC Act to advertising claims for homeopathic products; and
  • Public policy concerns about the current regulation of homeopathic products.

Public comments can be submitted electronically. Paper submissions should be sent to: Federal Trade Commission, Office of the Secretary, 600 Pennsylvania Avenue, NW, Suite CC-5610 (Annex B), Washington, DC 20580, or delivered to: Federal Trade Commission, Office of the Secretary, Constitution Center, 400 7th Street, SW, 5th Floor, Suite 5610 (Annex B), Washington, DC 20024. Paper submissions should reference the Homeopathic Medicine & Advertising Workshop both in the text and on the envelope. The deadline for submitting public comments is Friday, November 20, 2015.

The FTC also has set up an email box for anyone interested in being a panelist at the event or suggesting additional topics for discussion. It is homeopathy@ftc.gov (link sends e-mail), and will be open until August 1, 2015.

The workshop is free and open to the public. It will be held at the Constitution Center, 400 7th St., SW, Washington, DC 20024. The Commission will publish a detailed agenda at a later date…

The Federal Trade Commission works for consumers to prevent fraudulent, deceptive, and unfair business practices and to provide information to help spot, stop, and avoid them. To file a complaint in English or Spanish, visit the FTC’s online Complaint Assistant or call 1-877-FTC-HELP (1-877-382-4357). The FTC enters complaints into Consumer Sentinel, a secure, online database available to more than 2,000 civil and criminal law enforcement agencies in the U.S. and abroad…

In my view, this is a long overdue initiative. Consumers are constantly and outrageously misled by the advertising of homeopathic products. This has the potential to impact negatively on public health.

It would not surprise me, if homeopathy advocates were to try to swamp this event with their promotion of homeopathy. Therefore, I thought it was important to post the announcement on my blog, in the hope that as many scientifically minded people as possible might file their evidence and objections.

A recent post of mine prompted this categorical statement by one of the leading alt med researchers in Germany: naturopathy does not include homeopathy.” This caused several counter-comments claiming that homeopathy is an established part of naturopathy. Now a regular reader has alerted me to the current position paper on homeopathy by the ‘AMERICAN ASSOCIATION OF NATUROPATHIC PHYSICIANS’ (AANP). It clarifies the issue fairly well, and I therefore take the liberty of citing it here in full:

“Overview of Naturopathic Medicine and Homeopathy

Homeopathy has been an integral part of naturopathic medicine since its inception and is a recognized specialty for which the naturopathic profession has created a distinct specialty organization, the Homeopathic Academy of Naturopathic Physicians. Homeopathy has been recognized, through rigorous testing and experimentation, as having significant scientific evidence supporting its efficacy and safety. Single medicines are given on the basis of an individual’s manifestation of a disease state in comparison to combination remedies which are given on the basis of a particular diagnostic category.

Homeopathic products are being subjected to intensified federal regulations and restrictions. Products are being promoted and marketed as “homeopathic” for a variety of uses ranging from weight-loss aids to immunizations. Many of these preparations are not homeopathic and many have not been satisfactorily proven to be efficacious. Homeopathy is practiced in a variety of traditional and non-traditional forms.

Position of the American Association of Naturopathic Physicians:

  • Homeopathy is taught in the naturopathic colleges and its practice should be included in the naturopathic licensing laws. Naturopathic physicians recognize other licensed practitioners of the healing arts who are properly trained in homeopathy.
  • The naturopathic profession initiates more clinical trials and provings to further evaluate the effectiveness of homeopathy.
  • Naturopathic physicians shall be authorized to prescribe and dispense all products included in the Homeopathic Pharmacopoeia of the United States (HPUS).
  • Homeopathic products shall be subject to strict labeling requirements. Preparations which are not prepared in accord with the manufacturing principles in the HPUS should not use the term “homeopathic.” If parents choose homeopathic preparations for their children or their wards for the prophylaxis of infectious disease as an alternative to conventional immunizations, the physician should clearly state that they are unproven and that they are not legal substitutes for the state-mandated requirements.
  • Homeopathic prescriptions should be made with careful evaluation of their effect on the entire organism.
  • Electro-diagnostic testing is an investigational tool. Electro-diagnostic testing should be used according to accepted protocol and it is recommended that it not be relied on as the sole determinant in homeopathic prescribing.”

So, was Prof Michalsen wrong when he stated that “naturopathy does not include homeopathy. It is established in Germany as the application of nutritional therapy, exercise, herbal medicine, balneotherapy and stress reduction, defined by the German Board of Physicians. In conclusion, my general and last suggestion to these kinds of comments and blogs: Please first learn the facts and then comment.”? Not wrong, perhaps – but just a little Teutonic and provincial? The Germans like their own definitions which do not apply to the rest of the world. Nothing wrong with that, I think. But, in this case, they should make it clear that they are talking about something else than the international standard, and perhaps they should also publish their national drivel in their provincial journals in German language. This would avoid all sorts of misunderstandings, I am sure.

But this may just be a trivial aside. The more interesting issue here is the above AANP-statement itself. The AANP has the following vision: “Naturopathic physicians will guide and empower people to discover and experience improved health, optimal wellness, and effective management of disease through the principles and practices of naturopathic medicine.”

These are very nice words; but they are just that: WORDS. The AANP clearly does not believe in their own vision. If they did, they could never speak of ‘EFFECTIVE MANAGEMENT OF DISEASE’ while condoning the use of therapies that have been shown to be ineffective.

And this is where, in my view, the importance of their ‘position paper’ really lies: it demonstrates once again that, in the realm of alternative medicine, organisations and individuals make statements that sound fine and are politically correct, while at the same time disregarding these pompous aims/visions/objectives by promoting outright quackery. This sort of thing is so wide-spread that most of us just take it for granted and very few have the nerve to object. The result of this collective behaviour is obvious: on the one hand, charlatans can claim to be entirely in line with public health, EBM etc.; on the other hand, they are free to exploit the public with their bogus treatments.

Could this be the true common denominator of naturopathy in Germany and the rest of the world?

Ayurvedic medicine has become highly popular in Western countries; it originates, of course, from India, and is considered to be one of the world’s oldest health care systems. Its adherents claim to create harmony between the body, mind, and spirit, maintaining that this balance prevents illness, treats acute conditions, and contributes to a long and healthy life. In India Ayurveda is mainstream and more than 90% of the population are said to use it. Outside India, Ayurveda is usually classified as an alternative therapy.

Ayurvedic treatments can consist of a range of modalities, including herbal remedies taken by mouth. These preparations have often been reported to be contaminated with toxic metals. Despite several case reports of poisoning from such contamination, the epidemiological evidence is still limited. A new paper on this important topic is therefore welcome. It reports on a cluster of lead and mercury toxicity cases which occurred 2011 among a community of users of Ayurvedic remedies in the US.

Following the identification of the index case, adherents of Ayurveda were offered heavy metals screening. The results showed that 46 of 115 participants (40%) had elevated blood lead levels (BLLs) of 10 μg/dl or above, with 9.6% of BLLs at or above 50 μg/dl.

The authors issued the following warning: this is the largest cluster of lead and mercury toxicity following use of Ayurvedic supplements described in the literature in the US. Contamination of herbal products is a public health issue of global significance. There are few regulations addressing contamination of “natural” products or supplements.

Rasa shastra, the practice of adding metals, minerals or gems to herbal preparations, is a well-documented part of Ayurveda. Adverse reactions to herbs are described in traditional Ayurvedic texts, but practitioners tend to be reluctant to admit that their remedies could be toxic and that reliable information on their risks is not readily available.

Already in 1990, a study on Ayurvedic medicines in India found that 41% of the products tested contained arsenic, and that 64% contained lead and mercury. A 2004 study found toxic levels of heavy metals in 20% of Ayurvedic preparations sold in the Boston area. A 2008 study of more than 230 products found that approximately 20% of remedies (and 40% of rasa shastra medicines) purchased over the Internet from U.S. and Indian suppliers contained lead, mercury or arsenic.

My 2002 systematic review summarised all the available evidence and concluded that heavy metals, particularly lead, have been a regular constituent of traditional Indian remedies. This has repeatedly caused serious harm to patients taking such remedies. The incidence of heavy metal contamination is not known, but one study shows that 64% of samples collected in India contained significant amounts of lead (64% mercury, 41% arsenic and 9% cadmium). These findings should alert us to the possibility of heavy metal content in traditional Indian remedies and motivate us to consider means of protecting consumers from such risks.

Despite these concerns, Ayurveda-fans continue to believe that the toxicity of these remedies is reduced through the purification processes of Ayurvedic remedy preparation. Bizarrely, they may involve prayers as well as physical pharmacy techniques.

The Indian government ruled that Ayurvedic products must be labelled with their metallic content. However, one Indian expert, has been quoted claiming that “the absence of post-market surveillance and the paucity of test laboratory facilities [in India] make the quality control of Ayurvedic medicines exceedingly difficult at this time”. In the US, most Ayurvedic products are marketed without having been approved by the FDA. Since 2007, the FDA has placed an import alert on some Ayurvedic products in order to prevent them from entering the US.

Protecting consumers from heavy metal poisoning by Ayurvedic remedies is certainly not easy – but, in the interest of public health, it is a task that we must tackle with some ungency.

The task of UK Clinical Commissioning Groups (CCGs) is to ensure NHS funds are spent as effectively and responsibly as possible. This is particularly important in the current financial climate, as NHS budgets are under enormous pressure. For that reason, The Good Thinking Society (GTS, a pro-science charity) invited Liverpool CCG to reconsider whether the money (~ £ 30,000 pa) they spend on homeopathy represents good service to the public. Recently the CCG agreed to make a fresh decision on this contentious issue.

The GTS would prefer to see limited NHS resources spent on evidence-based medicine rather than on continued funding of homeopathy which, as readers of this blog will know, has repeatedly failed to demonstrate that it is doing more good than harm. It is encouraging to see Liverpool CCG take a first step in the right direction by agreeing to properly consider the best evidence and expertise on this issue.

Supporters of homeopathy frequently cite the concept of patient choice and claim that, if patients want homeopathy, they should have it free on the NHS. The principle is obviously important, but it is crucial that this choice is an informed one. The best evidence has conclusively shown that homeopathy is not an effective treatment, and to continue to offer ineffective treatments under the guise of patient choice raises troubling questions about the important concept of informed choice, and indeed of informed consent as well as medical ethics.

The GTS were represented by Salima Budhani and Jamie Potter of Bindmans LLP. Salima said: “This case underlines the necessity of transparent and accountable decision making by the controllers of health budgets, particularly in the light of the current financial climate in the NHS. CCGs have legal obligations to properly consider relevant evidence, as well as the views of experts and residents, in deciding how precious NHS resources are to be spent. It is essential that commissioning decisions are rational and evidence-based. Liverpool CCG’s decision to reconsider its position on the funding of homeopathy in these circumstances is to be welcomed.

“Our client has also called upon the Secretary of State for Health to issue guidance on the funding of homeopathy on the NHS. Public statements by the Secretary of State indicate that he does not support ongoing funding, yet he has so far declined to ask NICE to do any work on this issue. The provision of such guidance would be of significant benefit to CCGs in justifying decisions to terminate funding.”

Commenting on their decision, a Liverpool CCG spokesperson said: “Liverpool CCG currently resources a small homeopathy contract to the value of £30,000 per year that benefits a small number of patients in the city who choose to access NHS homeopathy care and treatment services. The CCG has agreed with the Good Thinking Society to carry out further engagement with patients and the general public to inform our future commissioning intentions for this service.”

Over the last two decades, prescriptions fulfilled in community pharmacies for homeopathy on the NHS in England have fallen  by over 94% and homeopathic hospitals have seen their funding reallocated. This reduction indicates that the majority of doctors and commissioning bodies have acted responsibly by terminating funding for homeopathic treatments.

The GTS are currently fundraising in order to fund further legal challenges – donate now to support our campaign at justgiving.com/Good-Thinking-Society-Appeal/.

The Telegraph today reports that, despite relentless lobbying from the Prince of Wales, UK  herbalists will not, after all, be regulated by statute. Here are the most important statements from this article:

Prof David Walker, deputy chief medical officer, said he had taken the decision because there was insufficient evidence that the alternative therapy works, making it impossible to set standards of good practice. Three years ago ministers had pledged to bring in an official register of practitioners of herbal and Chinese medicines, which would see therapists regulated alongside other health workers, such as physiotherapists and speech therapists…But ministers blocked the proposals, instead setting up a new committee, led by the NHS deputy chief medical officer – which has now ruled against statutory regulation. The decision came despite lobbying from Prince Charles, a keen advocate of complementary medicines, and a supporter of regulation, who held a meeting with Jeremy Hunt in 2013 in which his concerns were raised…Prof Walker said that although most herbal practitioners were in favour of regulation, those opposed to it feared it would “confer an inappropriate level of legitimacy on herbal practice which was poorly supported by scientific evidence.” He said the decision to rule against regulation was “undoubtedly the most contentious area” addressed by the working party, which also looked at the safety of herbal medicine products. Instead, the report calls for a review of all ingredients sold in such medicines, to check their safety, with a “voluntary register” for practitioners who use them. It says there is too little evidence to show that herbal medicines improve health outcomes, making it “difficult to establish the boundaries of good practice” in regulating practitioners. It also says there is very little understanding of the risks posed to patients from current practices in herbal medicine…Prof Walker’s recommendation has triggered an immediate rift among the 26 members of his working party. Twelve members of the working party have written to Dr Dan Poulter, health minister, alleging that the decision will put the safety of the public at risk, because anyone will be able to promote themselves as an expert in herbal medicine, without any training. Research suggests around three million Britons a year consult herbal practitioners, operating in shops, online and in private clinics, with up to one in 12 of all adults using a herbal medicine at some stage. Michael McIntyre, chairman of the European Herbal and Traditional Medicine Practitioners Association, said the decision not to regulate practitioners could put the public at risk from rogue operators, with no training. The herbal practitioner, who was a member of the DoH working party, said: “We are deeply disappointed by this. We feared this issue was going to be kicked into the long grass, by quietly putting something out just before the election – and that is exactly what has happened.” He said the public needed the reassurance of statutory regulation, to know that any herbal doctor who is practising had received some training. The association disputed claims there was insufficient evidence to show that herbal medicines worked, saying that several trials had shown its impact for a number of conditions, but that the sector had less money than the pharmaceutical industry had to undertake mass research. The report says that although ministers promised “some form of regulation of herbal practitioners” this only committed the working party to consider the options, and that the introduction of regulation would require the sector to be “more science and evidence-based”.

Perhaps I should first state that I was not involved in any way in this process. Furthermore, I must say that I do think it is the right decision. To understand it better, I need to refer to several previous posts: yes, some herbal medicines are demonstrably effective. But the regulation in question is NOT about herbal medicines; it is about herbal practitioners, and the two are not necessarily related. UK herbal practitioners practice within a range of  traditions including traditional European herbalism, TCM, or other schools of thought. They differ vastly but have one characteristic in common: they individualise their prescriptions according to the specific characteristics of the patient. Thus they would rarely prescribe the evidence-based herbal medicines but mix up prescriptions composed of several herbal ingredients. The problems with this approach are numerous:

  • there is no good evidence that this approach of individualised herbalism is effective;
  • the safety of the herbs used by traditional herbalists is often unknown;
  • traditional herbalists tend to use obsolete diagnostic techniques, false-positive and false-negative diagnoses are thus inevitable;
  • some of the herbal mixtures have been shown to be contaminated with toxic ingredients;
  • some mixtures are adulterated with powerful prescription drugs;
  • the herbal ingredients could interact with each other in an unpredictable manner;
  • the herbal mixtures might interact with prescribed drugs.

The long and short of it is that nobody knows whether the treatments of traditional herbalists generate more good than harm. Regulating these professions by statute would merely give them a level of credibility that they do not deserve. As with the regulation of chiropractors or osteopaths in the UK, the regulation of herbalists would simply misled the public about the value of traditional herbalism, and it most likely would have prompted the herbalists to happily rest on their assumed merits claiming that their effectiveness and safety has been officially acknowledged and is therefore no longer in doubt.

In a nutshell: THE ‘PROPER’ REGULATION OF NONSENSE GENERATES PROPER NONSENSE

The FDA just made the following significant announcement:

The Food and Drug Administration (FDA) is announcing a public hearing to obtain information and comments from stakeholders about the current use of human drug and biological products labeled as homeopathic, as well as the Agency’s regulatory framework for such products. These products include prescription drugs and biological products labeled as homeopathic and over-the-counter (OTC) drugs labeled as homeopathic. FDA is seeking participants for the public hearing and written comments from all interested parties, including, but not limited to, consumers, patients, caregivers, health care professionals, patient groups, and industry. FDA is seeking input on a number of specific questions, but is interested in any other pertinent information participants would like to share.

Date

April 20-21, 2015

Time

9:00 am to 4:00 pm

Location

FDA White Oak Campus
10903 New Hampshire Avenue
Bldg. 31, Room 1503A (Great Room)
Silver Spring, Maryland 20993

Attendance, Registration, and Oral Presentations

Registration is free and available on a first-come, first-served basis. If you wish to attend or make an oral presentation, please reference section III of the forthcoming Federal Register Notice (Attendance and/or Participation in the Public Hearing) for information on how to register and the deadline for registration.

Webcast Information

If you cannot attend in person, information about how you can access a live Webcast will be located at Homeopathic Product Regulation

Agenda

The agenda will be posted soon

And this is what Reuters reported about the planned event:

The hearing, scheduled for April 20-21, will discuss prescription drugs, biological products, and over-the-counter drugs labeled homeopathic, a market that has expanded to become a multimillion dollar industry in the United States. The agency is set to evaluate its regulatory framework for homeopathic products after a quarter century. (http://1.usa.gov/1Hxwup3) An Australian government study released this month concluded that homeopathy does not work. (http://bit.ly/1BheAmR) The FDA issued a warning earlier this month asking consumers not to rely on asthma products labeled homeopathic that are sold over the counter. (http://1.usa.gov/1EEuKrC) Homeopathic medicines include pellets placed under the tongue, tablets, liquids, ointments, sprays and creams. The basic principles of homeopathy, formulated by German physician Samuel Hahnemann in the late 18th century, are based on a theory that a disease can be treated using small doses of natural substances that in a healthy person would produce symptoms of the disease. The agenda for the hearing will be posted soon, the FDA said on Tuesday.

In my view, this is an important occasion for experts believing in evidence to make their position regarding homeopathy heard. I therefore encourage all my readers who have an evidence-based opinion on homeopathy to submit it to the hearing.

Gravityscan Badge

Recent Comments

Note that comments can be edited for up to five minutes after they are first submitted.


Click here for a comprehensive list of recent comments.

Categories