On their website, the American Chiropractic Association (ACA) recently updated its members on their lobbying activities aimed at having US chiropractors recognised as primary care physicians. The president of the ACA posted the following letter to ACA members:
For much of this past year, ACA’s staff and key volunteers have been laying the groundwork to achieve just that — quietly spending time building key support on Capitol Hill for this important legislative change. As you know, our progress advanced to the point where we were able on Oct. 27 to publically launch our grassroots campaign centered on the widespread circulation of our National Medicare Equality Petition.
Since the launch of our campaign, through very public and transparent means, ACA has received the support of various organizations and individuals within the profession. These supporters fully understand the importance of eliminating any and all provider discrimination by CMS. Further they fully understand and agree with the soundness of the strategic and tactical decisions we have made and continue to make an effort to achieve the desired reformation in Medicare.
Towards building a unified consensus within the profession for our objectives and plans to accomplish them, we have engaged in prolonged discussions, mostly via the Chiropractic Summit Steering Committee and Roundtable process that includes ACA, COCSA, ACC, ICA, NBCE, FCLB and CCE. Throughout this process we have provided for them written legal opinions and analyses relative to the precise legislative language needed to achieve the full-physician status we seek. We have outlined our strategy numerous times; have shared our materials and updates with any group wishing to review them; and have repeatedly urged state chiropractic associations, chiropractic colleges, corporate partners and individual DCs to join with us and enthusiastically support this reformation campaign.
While there was high consensus on the objective of Medicare reform during the Summit Roundtable process, there was much discussion surrounding the proposed legislative language. Specifically, whether or not “detection and correction of subluxation of the spine through manual manipulation” would need to be eliminated and replaced with language simply designating DCs as physician level providers on the same level as MDs and DOs who report/bill services to Medicare based on their individual state laws.
ACA is of the opinion that nothing less than removal of the “subluxation” language in the definition of physician section will accomplish our objectives. Historically, the facts are that this language has proven to be the major barrier within HHS and CMS when we advocated for regulatory remedies expanding our reimbursement and coverage for the full range of services provided by a DC. ACA (and our profession) has expended massive resources over the past decade or longer to no avail through regulatory channels (HHS, CMS). Based on these experiences, the only reasonable recourse to eliminate 40+ years of Medicare discrimination is through a thoughtful profession-wide legislative effort.
During the Roundtable discussions, compromise language was reached placing the current “subluxation language” into the preamble of a proposed law stating that DCs must continue to have the ability to detect and correct subluxations of the spine for Medicare beneficiaries. Six of seven Summit Roundtable organizations voted in favor of this language that was offered by the Association of Chiropractic Colleges.
ACA`s intent on removing the “subluxation” reference in the Social Security Administrative statute is in no way an attempt to quash our ability to perform those services that so many of the Medicare population need and deserve. Rather, the ultimate goal of this historic effort is to gain the privilege to manage our Medicare patients within state scopes of practice and allow reimbursement for all those services that the Medicare beneficiaries are currently forced to pay out of pocket. ACA supports fully our continued ability to correct subluxations through appropriate active care and, in fact, achieve coverage for manipulation of all areas, not simply limited to the spine.
Expanding Medicare scope reimbursement will allow our profession to practice contemporary chiropractic and to potentially increase utilization of our services to the ever-increasing aging population. Expansion and reformation will also place DCs in a position to participate in alternative payment models, quality healthcare initiatives, community health centers, hospitals and other integrated settings which are vital to professional growth.
In conclusion, should you as an HOD member be questioned on our intent you should be able to answer unequivocally that ACA supports the right to manage our patients as dictated by our training and competencies based on state scopes of practice. Further, we support those who wish to provide necessary active subluxation care for the Medicare population. Please support this initiative and let’s join together to encourage your state association, colleges and universities, corporate partners, patients and individual DCs to become true partners in order to make this a success for our patients and for our grand profession.
A list of talking points will be distributed in the coming days.
Sincerely, Tony Hamm, DC President, ACA
Do I read this correctly?
The term subluxation is a hindrance to business. Therefore chiros need to do something about it. Never mind that the principle of subluxation as used in the realm of chiropractic is nonsense!
This might throw an entirely different light on those chiros who want to get rid of the term ‘subluxation’.
And what about chiros as primary care physicians?
Recently Dave Newell posted on this blog: “chiropractors in the UK … are primary care clinicians”. I objected and he insisted to be correct because “Primary Care is defined as a clinician that is the first port of call for patients seeking help.” Frank Odds then countered: “This business of “primary care provider” is becoming enervating! Edzard has now spelt out the meaning of the term as defined by Wikipedia. You are quite right that a dentist is a primary care provider: people go to a dentist when they have symptoms affecting their mouth in general — more often their teeth and gums in particular. They know that’s what dentists deal with. A general practitioner is a primary care provider: people go to a GP when they have symptoms anywhere. They know that’s what GPs deal with. A chiropractor is indeed a primary care provider: of chiropractic. ”
I think that primary care physicians are doctors who are capable of handling everything or at least most of what primary care may present to them. Chiros do not fulfil this criterion, I think.
I would be interested what you feel on this important issue.
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.
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)
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
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 firstname.lastname@example.org (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