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.
I know, I have written about this guy before – and I am likely to do so again – he is just too outstanding to pass by!
A few days ago, he was in the headlines again: the Conservative health committee member David Tredinnick insisted that herbal medicine and even astrology should be given to patients in order to plug a growing hole in the NHS-budget: “I have referred to the fact that in some cultures astrology is part of healthcare because they need to have a voice and I’ve got up and said that,” he told Channel Four News. “But I also think we can reduce the bill by using a whole range of alternative medicine including herbal medicine, acupuncture, homeopathy…We could probably save five per cent of the [NHS] budget.”
Unbelievably, a man with such views is a member of the science and technology committee! This really does instil trust in politics!!!
His track record regarding the promotion of quackery might even dwarf that of Prince Charles; earlier this year he told MPs that astrology should be used to replace some “conventional” medicines on the NHS: “I am absolutely convinced that those who look at the map of the sky for the day that they were born and receive some professional guidance will find out a lot about themselves and it will make their lives easier,” he told the Commons. “I hope that in future we stop looking just at increasing the supply of drugs and consider the way that complementary and alternative medicine can reduce the demand for drugs, reduce pressures on the health service, increase patient satisfaction, and make everyone in this country happier.”
Speaking recently while thousands of NHS workers were on strike, he defended their pay freeze, stating that NHS’s budget was “finite”. However, asked whether he planned to take his own upcoming 9% pay rise, he refused to answer: “I’m not getting drawn on MPs pay… I’m not answering that question on this programme because we’re dealing with the health service.” Pushed further, he suggested that the rise was necessary in order to make MPs “good public servants… All members of parliament will be given a pay rise which is been set by an independent authority. Most of those members of parliament will take that pay rise because that is what is deemed necessary to have good public servants,” he insisted.
But is he really a “good public servant” ???
Addressing parliament about its ‘evidence check’ on homeopathy which came out squarely against it, Tredinnick once stated: “It is my belief that the advice the Clerks provided to the Science and Technology Committee Chairman was inadequate, in that the evidence taken by the Committee in its evidence check on homeopathy was biased, as they did not call representatives of the homeopathic profession and instead chose a professor who did not represent the alternative medicine world. They chose the one person who would give an answer that suited those who were in opposition.” The professor he refers to is Edzard Ernst, I think! When I was invited to give evidence to the committee, Tredinnick was in the audience; I saw him as we were waiting to go in and even had a chat with him. So, he must remember that sitting next to me were several defenders of homeopathy, amongst them the Queen’s homeopath himself.
Perhaps Tredinnick just forgot!
He couldn’t be lying, could he?
No, a good public servant wouldn’t do that!
I just came across this hilarious yet revealing article by Italian authors defending homeopathy. It is far too remarkable to keep it for myself, and I therefore decided to quote its abstract here in full:
Throughout its over 200-year history, homeopathy has been proven effective in treating diseases for which conventional medicine has little to offer. However, given its low cost, homeopathy has always represented a serious challenge and a constant threat to the profits of drug companies. Moreover, since drug companies represent the most relevant source of funding for biomedical research worldwide, they are in a privileged position to finance detractive campaigns against homeopathy by manipulating the media as well as academic institutions and the medical establishment. The basic argument against homeopathy is that in some controlled clinical trials (CCTs), comparison with conventional treatments shows that its effects are not superior to those of placebo. Against this thesis we argue that a) CCT methodology cannot be applied to homeopathy, b) misconduct and fraud are common in CCTs, c) adverse drug reactions and side effects show that CCT methodology is deeply flawed, d) an accurate testing of homeopathic remedies requires more sophisticated techniques, e) the placebo effect is no more “plausible” than homeopathy, and its real nature is still unexplained, and f) the placebo effect is nevertheless a “cure” and, as such, worthy of further investigation and analysis. It is concluded that no arguments presently exist against homeopathy and that the recurrent campaigns against it represent the specific interests of the pharmaceutical industry which, in this way, strives to protect its profits from the “threat” of a safer, more effective, and much less expensive treatment modality.
Despite (or is it because?) of such nonsense, homeopathy seems to be very popular, especially in the treatment of small children, and particularly for conditions where conventional medicine has no effective treatment. Teething problems are thus an ideal target for the homeopathic industry.
A survey of British GPs found that the most frequently prescribed homeopathic remedies were for common self-limiting infantile conditions such as colic, cuts and bruises, and teething. Similarly, the Avon-study suggested that homeopathic Chamomillia is popular to alleviate the pain of teething. And prominent homeopaths recommend that “teething often responds to Chamomilla.“
One website also recommends Chamomilla as well as several other homeopathic remedies leaving little doubt about their efficacy:
Chamomilla 6c: When teething is very painful and the child becomes quite cranky, satisfied with nothing and pacified only by being carried, then Chamomilla may help. Sometimes, the child seeking some relief from the discomfort will demand one thing after another, rejecting each one when it does not give relief. Children who could benefit from this remedy are very irritable, with a cry that sounds as if they are in pain. Chamomilla 6c can be taken every thirty minutes, up to six times per day, while symptoms persist.
Mercurius sol 6c: This remedy may be of help in cases where teething is accompanied by excessive salivation and drooling. In addition, the gums are likely to be red and sore, and the child may have diarrhea with a foul smell to it. Mercurius sol 6c can be taken four to six times per day for two to three days; its use should be discontinued when the symptoms diminish.
>Belladonna 30c: For children who tend to develop a fever with a flushed, red face when they are cutting teeth, Belladonna may be a good choice. Often the eyes have a glassy look due to the dilation of the pupils. The child may be irritable and crying as if angry. Belladonna 30c can be taken every thirty minutes up to four times per day, while symptoms continue.
Aconite napellus 30c: When the symptoms come on quickly and include physical and mental restlessness, this remedy may be useful. The affected gums will be hot, swollen, and inflamed and there may also be an earache with aversion to loud noises. The condition may come on following exposure to cold, dry winds. Try Aconite napellus 30c every hour for up to six times per day.
Calcarea carbonica 6c: When children are finally cutting teeth that have been late in erupting, Calcarea carbonica could be helpful. This remedy is often helpful with “late bloomers,” babies who develop a little more slowly, crawling, walking, and cutting teeth on their own schedule, weeks or months later than some other babies or toddlers. Children likely to benefit from Calcarea carbonica often have sweaty heads and feet and may have a tendency to develop cradle cap or yeast infections. With teething, they often do not show the extreme irritability that calls for Chamomilla, or the fever that indicates Belladonna, but they may have teeth that seem permanently on the verge of breaking through the surface. Calcarea carbonica 6c can be taken three times per day, for up to ten days; its use should be discontinued when symptoms improve.
Given this level of assurance, it not really surprising that manufacturers of homeopathic remedies want to profit from all this. Anxious mothers must seem like sitting ducks to the homeopathic industry.
Camilia, a homeopathic teething remedy that contains Chamomillia in the 9c potency from Boiron, the world’s largest producer of homeopathic products, will be launched shortly in the UK. The PR-agency in charge of the UK campaign to promote camilia announced that they will focus on a “national awareness drive through earned and paid-for media along with influencer engagement.” The agency is also responsible for re-building the brand’s website and implementing a strategy to drive discovery online. Amanda Meyrick of Clarion Communications, said: “Launching a product into a new market gives us the opportunity to work in partnership from the beginning to establish Camilia in the UK, and we are looking forward to seeing the results of our planning and creativity.” Remarkably, nobody seems to mention efficacy as a factor in the promotion of camilia.
However, the product is already available in the US, and from the US website we learn that this remedy “temporarily relieves symptoms of teething, including painful gums and irritability.” So, there are clear claims of efficacy after all!
Boiron is not the only firm who aim to profit from the vast market of teething problems. Nelson’s Teetha, for instance, is already available in the UK. Each 300mg sachet of TEETHA contains “the active ingredient of Chamomilla 6c.” Even Boots, the UK’s ‘trusted’ high street pharmacy, sell a product called ‘TEETHING PAIN RELIEF’ which also contains Chamomilla 6c, its only ‘active’ ingredient. Even the name of their product carries a therapeutic claim for efficacy, in my view.
But hold on! A 6c dilution equals one ml of plant extract diluted in 1 000 000 000 litres of water (add 6 zeros to that figure for the Boiron product)!!! Is that really going to alleviate teething problems?
Of course not!, you will say. Dilutions of this nature will do nothing whatsoever.
But they are not just dilutions, they are potentiations! would the homeopaths counter; they have been succussed at each dilution step, and this process transfers a vital force from the Chamomilla extract to the remedy. Yes, of course, how could I forget – it’s homeopathy where LIKE CURES LIKE and people believe in the tooth fairy.
But this does not make any sense either!
Chamomillia is nothing other than chamomile, a plant known to sooth through its anti-inflammatory actions. So, in highly diluted homeopathic products, the actions of this plant should be reversed according to the ‘like cures like’ principle. That means that these teething products, according to homeopathic ‘logic’, is not for treating inflamed gums but for treating the absence of inflammation.
My mind boggles because nothing seems to make sense any more:
- according to real science (or just common sense), the dilutions are far to high to have any effect at all,
- according to homeopathic ‘logic’, these products should, if anything, produce inflammation and not alleviate it,
- according to the best clinical evidence, homeopathic remedies are not effective for teething; I am not aware of a single rigorous trial that would show its efficacy, and current reviews do not recommend homeopathy for teething problems,
- regardless of all this and despite of regulations prohibiting it, therapeutic claims are being made for these over-priced placebos.
IT’S HOMEOPATHY STUPID!
Many experts have warned us that, when we opt for dietary supplements, we might get more than we bargained for. A recent article reminded us that the increased availability and use of botanical dietary supplements and herbal remedies among consumers has been accompanied by an increased frequency of adulteration of these products with synthetic pharmaceuticals. Unscrupulous producers may add drugs and analogues of various classes, such as phosphodiesterase type 5 (PDE-5) inhibitors, weight loss, hypoglycemic, antihypertensive and anti-inflammatory agents, or anabolic steroids, to develop or intensify biological effects of dietary supplements or herbal remedies. The presence of such adulterated products in the marketplace is a worldwide problem and their consumption poses health risks to consumers.
Other authors recently warned that these products are often ineffective, adulterated, mislabeled, or have unclear dosing recommendations, and consumers have suffered injury and death as a consequence. When Congress passed the Dietary Supplement Health and Education Act, it stripped the Food and Drug Administration of its premarket authority, rendering regulatory controls too weak to adequately protect consumers. State government intervention is thus warranted. This article reviews studies reporting on Americans’ use of dietary supplements marketed for weight loss or muscle building, notes the particular dangers these products pose to the youth, and suggests that states can build on their historical enactment of regulatory controls for products with potential health consequences to protect the public and especially young people from unsafe and mislabeled dietary supplements.
A new study has shown that these problems are not just theoretical but are real and common.
Twenty-four products suspected of containing anabolic steroids and sold in fitness equipment shops in the UK were analyzed for their qualitative and semi-quantitative content using full scan gas chromatography-mass spectrometry (GC-MS), accurate mass liquid chromatography-mass spectrometry (LC-MS), high pressure liquid chromatography with diode array detection (HPLC-DAD), UV-Vis, and nuclear magnetic resonance (NMR) spectroscopy. In addition, X-ray crystallography enabled the identification of one of the compounds, where reference standard was not available.
Of the 24 products tested, 23 contained steroids including known anabolic agents; 16 of these contained steroids that were different to those indicated on the packaging and one product contained no steroid at all. Overall, 13 different steroids were identified; 12 of these are controlled in the UK under the Misuse of Drugs Act 1971. Several of the products contained steroids that may be considered to have considerable pharmacological activity, based on their chemical structures and the amounts present.
The authors concluded that such adulteration could unwittingly expose users to a significant risk to their health, which is of particular concern for naïve users.
The Internet offers thousands of supplements for sale; specifically for bodybuilders there are hundreds of supplements all claiming things that are untrue or untested. The lax regulations that exist in this area seem to be often ignored completely. I think it is important to inform customers that most supplements are a waste of money and some even a waste of health.
The UK ‘Society of Homeopaths’ just proudly made this announcement: “From today, patients will be able to choose a homeopath belonging to a register vetted and approved by the Professional Standards Authority for Health and Social Care (PSA). The Society of Homeopaths’ voluntary register has been accredited under a new scheme set up by the Department of Health and administered by an independent body, accountable to Parliament.”
No, it is not April fools day, but it is clearly time to rejoice and to start believing in homeopathy. Not an easy task, you might say; perhaps this new and equally amazing article outlining 10 reasons to love homeopathy will make it a little more feasible (as it is pure comedy gold, I have only shortened it very slightly)?
1. For Love: Love your family, love thy neighbor, love your homeopath. Even if you don’t need a homeopath, your aunt, your grandmother, or grandchild might…
2. For money. Homeopathic medicines are generally less expensive than patent medicines, which have prices driven by profit, not by cost nor benefit…
3. For your bodies, minds, spirits, and communities. Homeopathy works… How is it possible that everyone can find instances where a homeopathic doctor was able to solve a problem…?
4. Because you are royalty. Kings and queens have used homeopathy – with positive effects. The Queen of England, Queen Elizabeth II has a personal physician – a homeopath. She has used homeopathic medicines for her pets as well. If it’s good enough for royalty, it’s good enough for you.
5. Because someday you might need a chiropractor, a Traditional Chinese Medicine Practitioner, Acupuncturist, an Osteopathic Doctor, an Ayurvedic practitioner, or even a midwife. …Attacking homeopathy, suggesting it be banned, is a first step in the wrong direction. Many medical disciplines are attacked independently, with a goal to remove them all from your market, your freedom to choose. If we ban homeopaths, ask yourself – who’s next?
6. For Your Freedoms: Freedom to choose Homeopathy. Freedom to choose your medicines and treatments. There are many who might prefer that you have fewer freedoms, especially those with something to sell. There are many nonsense restrictions on your freedom to choose, and freedoms avoid, specific medical treatments. It’s your body, your mind, your spirit, and your life. You have the right to choose…
7. For your symptoms. The medical model classifies all symptoms as indications of illness. It does not recognize that symptoms can be indications of healthiness, and seldom recognizes that symptoms can be indications of healing or fighting illness. Homeopathy looks at symptoms from a completely different viewpoint…
8. For your health. Today, it’s illegal to market a product that claims to ‘improves your health’, without reference to illness. All ‘health claims’ must reference ‘a disease or health related condition’. It is illegal to sell a ‘health product’ without a reference to scientific studies of ‘illness’. Medicine, is blind to health. Homeopathy challenges many medical dogmas, opening a door open to a more comprehensive, broader, more clear view of healthiness – not just illness.
9. For your Doctor. Whether your doctor is a homeopath or not, she might need access to homeopathic ideas and medicines. Homeopathy is practiced by many doctors, dentists, naturopaths, chiropractors, acupuncturists, physician assistants, nurses, even veterinarians, and more. If homeopathy is banned, these medical professionals will be limited, or forced to hide their beliefs and activities.
10. For science. Some argue that homeopathy cannot pass the tests of science. These are people who do not understand science. Science does not find truths, it asks questions and seeks answers. The answers it finds, if they are useful, raise higher, more important questions. When science is stifled, when science becomes illegal, we all lose.
This is all so very sweet that I almost hesitate to bring you back to reality. But I have to, this is no blog for dreamers!
Here is a reminder what level-headed, independent and thorough experts have to say about homeopathy; I am sorry, if their statement comes a bit like a cold shower to the irrationalists: “the evidence from research in humans does not show that homeopathy is effective for treating the range of health conditions considered.”
So, what should we make of the UK government’s decision to register homeopaths? Personally, I now look forward to the day when parliament starts discussing the new London airport for flying carpets – but, as always, I look forward to your answers.
In the US, the scope of practice of health care professionals is a matter for each state to decide. Only the one of doctors is regulated nationwide. Other health care professions’ scope of practice can vary considerably within the US. This means that a chiropractor in one state of the US might be allowed to do more (or less) than in the next state. But what exactly are US chiropractors legally allowed to do?
A recent paper was aimed at answering this very question. Its authors assessed the current status of chiropractic practice laws in the US.
A cross-sectional survey of licensure officials from the Federation of Chiropractic Licensing Boards e-mail list was conducted in 2011 requesting information about chiropractic practice laws and 97 diagnostic, evaluation, and management procedures. To evaluate content validity, the survey was distributed in draft form at the fall 2010 Federation of Chiropractic Licensing Boards regional meeting to regulatory board members and feedback was requested. Comments were reviewed and incorporated into the final survey.
Partial or complete responses were received from 96% (n = 51) of the jurisdictions. The states with the highest number of services that could be performed were Missouri (n = 92), New Mexico (n = 91), Kansas (n = 89), Utah (n = 89), Oklahoma (n = 88), Illinois (n = 87), and Alabama (n = 86). The states with the highest number of services that cannot be performed are New Hampshire (n = 49), Hawaii (n = 47), Michigan (n = 42), New Jersey (n = 39), Mississippi (n = 39), and Texas (n = 30).
The authors conclude that the scope of chiropractic practice in the United States has a high degree of variability. Scope of practice is dynamic, and gray areas are subject to interpretation by ever-changing board members. Although statutes may not address specific procedures, upon challenge, there may be a possibility of sanctions depending on interpretation.
For me, the most surprising aspect of this article was to realise how many ‘non-chiropractic’ activities chiropractors are legally permitted in some US states. Here are some of the items that amazed me most:
- birth certificates
- death certificates
- premarital certificates
- recto-vaginal exam
- i.v. injections
- prostatic exam
- genital exam
- ear irrigation
- colonic irrigation
- oral and i.v. chelation therapy
- hyperbaric chamber
I have to admit that I did not even know what a PREMARITAL CERTIFICATE’ is; so I looked it up. The first one I found on the internet was entitled “PURITY COVENANT” and committed the couple “to abstain from fornication and remain sincere to the Lord Jesus Christ and to each other”
I have to further admit that many other of the items on this list leave me equally speechless. For example, how can chiropractors with their training focussed on the musculoskeletal system responsibly complete a death certificate? Why are they allowed in some states to examine the genitalia of their patients?
I suspect the perceived need of chiropractors to do all these things must be closely related to their long-standing ambition to become primary care physicians. Just to be clear: a primary care physician is a physician who provides both the first contact for a person with an undiagnosed health concern as well as continuing care of varied medical conditions, not limited by cause, organ system, or diagnosis. I have always been more than just a bit perplexed how chiropractors, who state that they are musculoskeletal specialists, might even consider being competent primary care providers.
But regardless of common sense, they do! The US ‘Council of Chiropractic Education’ accreditation process, for instance, requires schools to educate and train students to become a “competent doctor of chiropractic who will provide quality patient care and serve as a primary care physician” and the chiro-literature is awash with statements such as this one: “The primary care chiropractic physician is a viable and important part of the primary health care delivery system, with many chiropractic physicians currently prepared to participate effectively and competently in primary care.” Moreover, the phenomenon is by no means limited to the US: “chiropractors in the UK view their role as one of a primary contact healthcare practitioner and that this view is held irrespective of the country in which they were educated or the length of time in practice.”
As far as I am concerned, chiropractors might view their role as whatever they want. The fact is that, even if they add many more items to the list of their ‘services’, they are very far from being competent primary care physicians. Being able to provide the first contact as well as continuous care of medical conditions, not limited by cause, organ system, or diagnosis is not a matter of wishful thinking.