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
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.
April 20-21, 2015
9:00 am to 4:00 pm
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.
If you cannot attend in person, information about how you can access a live Webcast will be located at Homeopathic Product Regulation
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.
Homeopathy has a long history in Canada. In 1842, James Lilli was probably the first Canadian homeopath to begin practicing in Toronto. Joseph J. Lancaster, who had studied in New York, began practicing sometime in the 1840s in Ontario. The ‘Homeopathic Medical Society of Canada’ was established in 1854 in Hamilton, Ontario.
Since these early days much has changed. At present, all health care professions in Ontario are governed by the ‘Regulated Health Professions Act’ which allows all health-care professions the same right to practice. This law upholds the belief that the public has the right to choose what health care it wishes, and that the government should only intervene to regulate where a profession poses a significant risk of harm to the public. Only allopathic professions are currently regulated, and, in Ontario, doctors are censured if they practice homeopathy.
All schools of homeopathy in Canada offer ‘diplomate status’ and all offer three-year, part-time courses (one or two weekends per month plus perhaps one or two evenings per week). There are no legal doctorate or university degree programs for homeopathy in Canada. A doctorate in any field other than allopathic medicine cannot legally be used while practicing homeopathy.
I have been reliably informed that the regulation of homeopathy in Ontario is about to change. A transitional council of the ‘College of Homeopaths of Ontario’ had already been appointed in September 2009. The next step in the regulatory process is now imminent. On April 1 this year, Ontario will proclaim the ‘Homeopathy Act’. The bill will further empower the ‘College of Homeopaths of Ontario’. This regulatory body will hence forth have control over who gets to call themselves a homeopath. In addition, it will also have a complaint tracking system.
This moves comes only days after the ‘Australian National Health and Medical Research Council’ has published the most thorough and independent assessment of homeopathy in the history of this form of alternative therapy. It concluded that homeopathy should not be used to treat health conditions that are chronic, serious, or could become serious. People who choose homeopathy may put their health at risk if they reject or delay treatments for which there is good evidence for safety and effectiveness.
In view of the fact that homeopathy has been disproven as a treatment that fails to have a positive risk/benefit balance, the move of the regulators in Ontario seems pure madness to me. It sends the wrong signal to consumers and gives credibility to a form of quackery.
In a nutshell: EVEN THE BEST REGULATION OF NONSENSE WILL RESULT IN NONSENSE!
The UK Professional Standards Authority for Health and Social Care (PSA) tries to promote the health, safety and wellbeing of patients, service users and the public by raising standards of regulation and voluntary registration of people working in health and care. They are an independent body, accountable to the UK Parliament.
In July 2014, the PSA audited all 75 of the cases that the General Chiropractic Council (GCC) had closed at the initial stages of its fitness to practise (FTP) process during the 12 month period from 1 June 2013 to 30 May 2014. The final verdict of the PSA’s audit seems devastating. Here is a short excerpt from the conclusions of its report:
The extent of the deficiencies we found in this audit (as set out in detail above) which related to failures across every aspect of the casework framework, as well as widespread failures to comply with the GCC’s own procedures, raises concern about the extent to which the public can have confidence in the GCC’s operation of its initial stages FTP process.
In summary, the particular areas of failures/weaknesses identified in our audit include:
- Ineffective screening on receipt of ‘complaints’ and inconsistent completion and updating of risk assessments
- Customer service issues, including failing to respond to/acknowledge correspondence promptly, failing to provide clear information about the FTP process and failing to provide updates about progress and outcomes within reasonable timeframes
- Inadequate investigation of cases through failures to gather or validate relevant evidence or to do so promptly – sometimes as a result of inconsistent and ineffective use of case plans and case reviews
- Deficiencies in the evaluation of information by decision-makers and weaknesses in the reasoning provided for decisions, including failures to address all the relevant allegations and/or reaching decisions on the basis of insufficient evidence
- Poor record keeping and various data protection breaches or potential breaches
- Ineffective systems for the sharing of relevant information between the Registration and FTP teams, leading to inappropriate action being taken in some cases
- Widespread non-compliance with internal guidance and procedures.
We have also concluded that the steps taken by the GCC, in particular the processes it introduced in its procedure manual in February had not at the time of the audit resulted in consistent improvement in the quality of its casework.
What does all of this mean?
The GCC’s website informs us that this organisation regulates all chiropractors in the UK to ensure the safety of patients undergoing chiropractic treatment. The GCC is an independent statutory body established by Parliament to regulate the chiropractic profession. We protect the health and safety of the public by ensuring high standards of practice in the chiropractic profession. The title of ‘chiropractor’ is protected by law and it is a criminal offence for anyone to describe themselves as any sort of chiropractor without being registered with the GCC. We check that all chiropractors are properly qualified and are fit to practise.
The conclusions of the PSA audit seem to indicate nothing less than this: the GCC is not fit for purpose!
I have often said that the regulation of nonsense must inevitably result in nonsense – but I did not expect to get a confirmation from the GCC in this fashion.
While the previous post was about seeing a traditional herbalist (who prescribe their own herbal mixtures, tailor-made for each individual patient), this post provides essential information for those consumers who are tempted to take a commercially available herbal remedy available in pharmacies, health food shops, over the Internet etc. These remedies are usually bought by consumers and then be self-administered, or (less frequently) they might be prescribed/recommended/sold by a clinician such as a doctor, naturopath, chiropractor etc. Typically, they contain just one (or relatively few) herbal extracts and are used under similar assumptions as conventional medicines: one (hopefully well-tested) remedy is employed for treating a defined condition, diagnosed according to validated and generally accepted criteria (for instance, St John’s Wort for depression or Devil’s claw for back pain). This approach is sometimes referred to as ‘rational phytotherapy’ – it is certainly more rational than the traditional herbalism referred to in my previous post. The manufacture, promotion and sale of commercial herbal remedies (in many countries marketed as ‘dietary supplements’) has grown into a multi-billion dollar industry.
Here are a few essentials you ought to know before you decide to take such an herbal remedy:
- Many people claim that herbal medicine is effective because many of our modern drugs are based on plants. The latter part of this claim is true, of course, but this does not necessarily mean that herbal remedies are effective. The drugs derived from plants contain one single, well-defined, extensively researched molecule (by definition, this makes them conventional drugs and not herbal remedies), while herbal remedies are based on entire (parts of) plants; thus they contain many pharmacologically active molecules. This often means that it is difficult or impossible to tell what dose of which ingredient is being administered and what pharmacological actions can be expected.
- Even though national regulations differ greatly, herbal remedies generally do not have to be supported by evidence for efficacy in order to be legally available. This means that a given remedy might or might not have been tested in clinical trials to determine whether it works for the condition advertised. In fact, only very few (less than 30, I estimate) herbal remedies are supported by sound evidence for efficacy; thousands do not meet this criterion.
- The extremely wide-spread notion that herbal remedies are by definition natural and therefore safe is nothing but a promotional myth. Plants contain many chemicals which can have pharmacological activity. This means they might be therapeutic, but it also means that they might be toxic (traditionally the most powerful poisons originated from the plant kingdom). If anyone uses the ‘natural = safe fallacy’ remind him/her of hemlock, poison ivy etc.
- In addition to potential toxicity of an herbal ingredient, there are other important safety issues to be considered. Most importantly, herbal remedies can interact with prescribed medicines. For instance, St John’s Wort (one of the best-studied herbal remedies in this respect) powerfully interacts with about 50% of all prescription drugs – in fact, it lowers their level in the blood which means that a patient on anti-coagulants would lose her anti-coagulant protection and might suffer from a (potentially fatal) blood clot.
- In many countries, including the US, the regulation of herbal remedies is so lax, that there is no guarantee that an herbal remedy which is being legally sold is safe. The regulators are only allowed to intervene once there are reports of adverse effects. This means that the burden of proof of safety is effectively reversed which obviously exposes consumers to incalculable risks.
- The quality of the herbal product is equally poorly regulated in most countries. A plethora of investigations in the US, for instance, has shown that the dose of the herbal ingredient printed on the label of a commercial product can range virtually from 0 – 100%. Similarly there is little safe-guard that the ingredients listed on the label correspond to the ones in the preparation. This means that it is worth purchasing not just well-researched herbal remedies but also those marketed by high quality manufacturers via respectable outlets.
- Any regulation of herbal remedies, even the European one that is often praised as protecting consumers adequately, is null and void once consumers go on the Internet and purchase their herbal remedies from one of the many dubious sources found there in truly alarming profusion. Bogus claims, inferior quality and even outright dangerous products abound, and it is often impossible to tell the acceptable from the fraudulent product.