MD, PhD, FMedSci, FRSB, FRCP, FRCPEd

patient choice

We have repeatedly discussed the fact that alternative medicine (AM) is by no means free of risks. I find it helpful to divide them into two broad categories:

  1. direct risks of the intervention (such as stroke due to neck manipulation, or cardiac tamponade caused by acupuncture, or liver damage due to a herbal remedy) and
  2. indirect risks usually due to the advice given by AM practitioners.

The latter category is often more important than the former. It includes delay of effective treatment due to treatment with an ineffective or less effective form of AM. It is clear that this will cause patients to suffer unnecessarily.

Several investigations have recently highlighted this important problem, including this study from Singapore which assessed the predictors of AM-use in patients with early inflammatory arthritis (EIA), and its impact on delay to initiation of disease-modifying anti-rheumatic drugs (DMARD). Data were collected prospectively from EIA patients aged ≥ 21 years. Current or prior AM-use was ascertained by face-to-face interviews. Predictors of AM-use and its effect on time to DMARD initiation were determined by multivariate logistic regression and Cox proportional hazards, respectively.

One hundred and eighty patients were included: 83.9% had rheumatoid arthritis, 57% were seropositive. Median (IQR). Chinese race, being non-English speaking,  smoking and high DAS28 were independent predictors of AM-use. AM-users initiated DMARD later (median [IQR] 21.5 [13.1-30.4] vs. 15.6 [9.4-22.7] weeks in non-users, P = 0.005). AM-use and higher DAS28 were associated with a longer delay to DMARD initiation. Race, education level, being non-English speaking, smoking and sero-positivity were not associated.

The authors concluded that healthcare professionals should be aware of the unique challenges in treating patients with EIA in Asia. Healthcare beliefs regarding AM may need to be addressed to reduce treatment delay.

These findings are not dissimilar to results previously discussed, for instance:

The only solution to the problem I can think of would be to educate AM practitioners and the public such that they are aware of the issue and do everything possible to prevent such problems. But this is, of course, easier said than done, and it seems more than just optimistic to hope that such endeavours might be successful. The public is currently  bombarded with misleading information and outright lies about AM (many of my previous post have addressed this problem). And practitioners would have to operate against their own financial interest to prevent these problems from occurring.

This means that treatment delays caused by AM-use and advice from AM practitioners are inevitable…

unless you have a better idea.

If so, please let me know.

 

Guest post by Richard Rawlins MB BS MBA FRCS

Doctors who are registered medical practitioners (RMPs) must comply with the standards of practice set down by the General Medical Council. ‘Homeopathy’ is a specific system of medical care, devised by Dr Samuel Hahnemann in the nineteenth century, and comprises two distinct dimensions: (i) the establishment of a constructive therapeutic relationship between an empathic homeopath and a patient. This may provide benefit due to the non-specific effects of condolence, counselling, and care – and should be a component of the practice of all doctors in any event; (ii) the homeopathically prepared (HP) remedies that are generally prescribed. To avoid confusion, these two dimensions should not be conflated.

HP remedies may be obtained over the counter, prescribed by lay homeopaths and even given out by dentists and nurses on the grounds that “30C homeopathic arnica helps bruising”. The US Federal Trades Commission has stated that “The Commission will carefully scrutinize the net impression of OTC homeopathic advertising or other marketing employing disclosures to ensure that it adequately conveys the extremely limited nature of the health claim being asserted…accordingly, unqualified disease claims made for homeopathic drugs must be substantiated by competent and reliable scientific evidence.” (FTC Policy statement 2017).

Special focus should be brought to bear on the ethical, intellectual and professional obligations of those doctors registered as medical practitioners by the GMC and practicing homeopathy in the UK. Some homeopaths may intend taking advantage of gullible and vulnerable patients. Here I take it that those practitioners who prescribe homeopathic remedies sincerely do believe they have worthwhile effects, but I contend such practice generally fails to comply with ethical and professional standards as set down by the GMC. That is to be deprecated.

Systems to regulate medical practice in the British Isles have been devised since the middle ages. In 1518, Thomas Linacre founded the College of Physicians – based on systems he had seen in Europe. From 1704, the Society of Apothecaries licensed its members to prescribe and dispense medicines, and developed the profession of general practice. In order to protect the public from charlatans, quacks and fraudsters more effectively, the Medical Act of 1858 established formal statutory regulation of doctors by the General Medical Council. Registrants who are not deemed fit to practice may be struck off the register. They can still practice, but not as registered medical practitioners. They can still use the title ‘doctor’ (as can anyone), but not for fraudulent purposes.

Dr Samuel Hahnemann qualified in Saxony in 1781 and was a good doctor, but he became disillusioned with many of the practices and practitioners of his day. He wrote about his fellow doctors: “Precious and fragile human life, so easily destroyed, was frequently placed in jeopardy at the hands of these perverted people, especially since bleedings, emetics, purges, blistering plaster, fontanels, setons, caustics and cauterisations were used.” In 1796 he wrote to a friend, “I renounced the practice of medicine that I might no longer incur the risk of doing injury, and I engaged in chemistry exclusively and in literary occupations.”

Hahnemann went on to develop his own alternative system of health care, which he styled ‘Homoeopathy’. Published as the Organon of the Healing Arts in 1810, Hahnemann set out an idiosyncratic medical system based on identifying ‘remedies’ which in large doses, could produce symptoms comparable to those suffered by the patient. The remedies he prescribed were prepared with serial dilutions so that no active principle remained. Today’s homeopaths hold that a remedy’s ‘vital force’, ‘healing energy’ or ‘memory’ provides therapeutic benefit. That may be the case, but the consensus of informed scientific and medical opinion is that any effects of ‘homeopathy’ are as a result of contextual placebo effects. The remedies themselves cannot and do not have any effect. England’s Chief Medical Officer has described homeopathy’s principles as ‘rubbish’. The government’s Chief Scientific Adviser, Sir Mark Walport has said he would tell ministers, “My view, scientifically, is absolutely clear: homeopathy is nonsense. The most it can have is a placebo effect.” Simon Stevens, CEO of the NHS, when interviewed on Radio 4 said he agrees with Sir Mark – yet failed to explain why he had not included homeopathic remedies in the 2017 list of NHS proscribed medicines. That stance is being reviewed.

The GMC states, “Patients must be able to trust doctors with their lives and health. To justify that trust you must show respect for human life and make sure your practice meets the standards expected.” Those standards are set down in the GMC’s Good Medical Practice which advises, “Serious or persistent failure to follow this guidance will put your registration at risk.” The GMC standards are coherent with those of the American Medical Association’s Principles of Medical Ethics (2016).

In précis, the most relevant and important GMC standards are:

  • Make the care of your patient your first concern.
  • Give patients the information they want or need in a way they can understand.
  • Be honest and open and act with integrity.
  • Never abuse your patients’ trust in you or the public’s trust in the profession.
  • You are personally accountable for your professional practice and must always be prepared to justify your decisions and actions.
  • You must  prescribe drugs or treatment only when you are satisfied that the drugs or treatment serve the patient’s needs.                                                                                                                                             
  • You must provide effective treatments based on the best available evidence.
  • You must be satisfied that you have consent or other valid authority before you carry out any examination, investigation or provide treatment.
  • You must make good use of the resources available to you.

I contend that medical practitioners who prescribe homeopathic remedies regularly fail to meet these standards. They know perfectly well that the best available evidence indicates no support for the assertion that homeopathic remedies ‘serve the patient’s needs’, except as placebos; that the treatments have no specific effects; that the remedies are placebos; and that resources are wasted by expenditure on these ineffective remedies. Medical homeopaths invariably do not give patients this information; they fail to obtain properly informed consent; they do not justify their decisions and actions rationally; and they may be obtaining financial advantage by misrepresentation to insurance companies or the NHS. This is an abuse of the public’s trust in the medical profession.

The issue of informed consent is particularly important. GMC guidance states that, “The doctor uses specialist knowledge and experience and clinical judgement, and the patient’s views and understanding of their condition, to identify which investigations or treatments are likely to result in overall benefit for the patient. The doctor explains the options to the patient, setting out the potential benefits, risks, burdens and side effects of each option, including the option to have no treatment. The doctor may recommend a particular option which they believe to be best for the patient, but they must not put pressure on the patient to accept their advice. …Before accepting a patient’s consent, you must consider whether they have been given the information they want or need, and how well they understand the details and implications of what is proposed. This is more important than how their consent is expressed or recorded.”

The GMC states that, “in order to have effective discussions with patients about risk, you must identify the adverse outcomes that may result from the proposed options… risks can take a number of forms, but will usually be: side effects; complications; failure of an intervention to achieve the desired aim.” The risk of wasting money on ineffective remedies, whether NHS or private, and of delaying treatment known to be effective should also be discussed.

Homeopaths acknowledge that after ministration of remedies, some patients experience ‘aggravations’ – a worsening of symptoms, but they advise this is evidence that the remedy is ‘working’. Medical consensus is more likely to suggest ‘aggravations’ are evidence of an underlying psychological component to the patient’s condition. Suggestions that remedies themselves have any effect, good or bad, is misrepresentation and may be fraud. Offering patients sugar pills with a claim the pills have therapeutic effects means lying to them, and is an abuse of trust.

Homeopaths’ system of diagnosis and prescription of remedies requires them to have beliefs for which there is no plausible evidence base. The Oxford Dictionary defines ‘belief’ as “assent to a proposition, statement or fact, especially on the grounds of testimony or authority, or in the absence of proof or conclusive evidence.” It might be acceptable to practice ‘homeopathy’ as a counselling modality, providing the practitioner complies with the GMC standard that, “You must not express your personal beliefs to patients in ways that exploit their vulnerability or are likely to cause them distress.”

Homeopaths are invariably non-compliant in obtaining fully informed consent. Such a failing is an abuse of patients’ trust in the medical profession. Doctors might be determined to be unfit to practice unless they clearly justify their prescriptions, and identify the evidence that supports them. All these issues should also be explored during the doctor’s annual appraisal, without which a registered medical practitioner will not be licensed to practice. Even registration without a licence requires compliance with the standards. Appraisal can be carried out by non-homeopaths, as the issue is not the assessment of the standard of ‘homeopathic practice’, but compliance with GMC standards of good medical practice.

If a medical homeopath wishes to be GMC compliant, they must properly inform patients about contentious issues. I suggest that consent should be obtained along the lines: “I propose prescribing you a remedy comprising sugar pills impregnated with a solution which has been diluted to such an extent that a sphere of water the size of the Earth’s average radius to the Sun would probably contain no more than one molecule of the original substance. Nevertheless, my clinical experience suggests to me that this remedy will improve your condition. You need to understand that colleagues who practise conventional evidence-based scientific medicine regard my belief as implausible and the methods I use as ‘alternative.’ I believe the remedy will help you, but I have no evidence accepted by the majority of doctors that the intervention I propose will achieve the desired effects. I do not believe that taking a homeopathic remedy will delay any other treatment which might reasonably help your condition and I invite you to take this remedy with understanding of the issues I have outlined.” A copy of the consent should be placed in the patient’s records.

Those who defend the right of registered medical practitioners to prescribe HP remedies do so with arguments fatally holed by a myriad of logical fallacies. Some arguments are (with fallacies in parenthesis):

  • “Homeopathy has been used for over two hundred years” (appeal to tradition and argument from ignorance);
  • “It has become very popular and is what patients want (appeal to popularity);
  • “Homeopathy has the capacity to help patients” (red herring, because present consideration is about the value of HP remedies, not relationships);
  • “Remedies are cheap” (red herring);
  • “Homeopathy does not do any harm” (irrelevant and a red herring);
  • “Pharmaceuticals have side effects” (tu quoque and red herring);
  • “The Royal Family use it” (appeal to irrelevant authority);
  • “The remedies enhance the doctor/patient relationship (straw man);
  • “Science does not know everything” (red herring and false dichotomy);
  • “Those who oppose us don’t understand homeopathy” (argumentum ad hominem and ‘poisoning the well’);
  • “I have the evidence of patients’ anecdotes and testimonials” (pseudoscience, confirmation bias and cherry picking);
  • “Homeopathic doctors are caring people” (red herring and straw man);
  • “I’ve got much evidence of  patients taking remedies and getting better” (post hoc ergo propter hoc – ‘after this, therefore because of this’ – confusion of coincidence with causation).

The latter most perverse fallacy is the foundation of homeopathic practice, based on identifying a remedy whereby ‘like cures like’ – a principle based on post hoc fallacy for which there is no scientifically credible evidence.

Unless and until medical homeopaths understand the intellectual environment in which they practice, are prepared to properly inform their patients, and obtain consent for treatment having done so, they should not prescribe homeopathic remedies. Fortunately, there is no evidence that patients who are prescribed HP remedies by empathic GMC registered homeopaths have any different outcomes from those prescribed pure sugar pills – even if they are told they are placebos. However, trust in the medical profession can only be maintained if deceptive practices are set aside and full explanations for proposed interventions are offered. Given the scientific consensus, patients have to face up to the fact that to the highest degree of probability, HP remedies have no value. Regrettably, too many patients and even homeopaths are in denial. Medical homeopaths should continue to serve their patients with care, compassion and intellectual honesty, but if they are to comply with the standards required for GMC registration, they should not prescribe homeopathically prepared remedies.

We have repeatedly discussed on this blog the fact that many alternative practitioners are advising their patients against vaccinations, e. g.:

There is little doubt that this phenomenon contributes to low immunisation rates. This, in turn, is a contributing factor to outbreaks of measles and other infectious diseases. The website of the European Centre for Disease Prevention and Control has recently published data on measles outbreaks in Europe:

Bulgaria: There is an increase by three cases since 21 July 2017. Since the beginning of 2017 and as of 16 July, Bulgaria reported 166 cases. During the same time period in 2016 Bulgaria reported one case.

France: On 27 July 2017 media quoting the French Minister of Health reported the death of a 16-year-old unvaccinated girl. She had fallen sick in Nice and died on 27 June 2017 in Marseille.

Germany: There is an increase by four cases since the last report on 21 July 2017. Since the beginning of 2017 and as of 26 July, Germany reported 801 cases. During the same time period in 2016 Germany reported 187 cases.

Italy: There is an increase by 170 cases since 21 July 2017. Since the beginning of 2017 and as of 25 July, Italy reported 3 842 cases, including three deaths. Among the cases, 271 are healthcare workers. The median age is 27 years, 89% of the cases were not vaccinated and 6% received only one dose of vaccine.

Romania: There is an increase by 229 cases, including one additional death, since 21 July 2017. Since 1 January 2016 and as of 21 July 2017, Romania reported 8 246 cases, including 32 deaths. Cases are either laboratory-confirmed or have an epidemiological link to a laboratory-confirmed case. Infants and young children are the most affected groups. Timis, in the western part of the country closest to the border with Serbia, is the most affected district with 1 215 cases. Vaccination activities are ongoing in order to cover communities with suboptimal vaccination coverage.

Spain: There is an increase by seven cases since 14 July 2017. Since the beginning of 2017 and as of 25 July, Spain reported 145  measles cases.

United Kingdom: Public Health Wales reported two additional cases related to the outbreak in Newport and Torfaen, bringing the total to ten cases related to this outbreak. In England and Wales there is an increase by 76 cases since 21 July 2017. Since the beginning of 2017 and as of 23 July 2017, England and Wales reported 922 cases. In the same time period in 2016, they reported 946 cases.

In addition to the updates listed above ECDC produces a monthly measles and rubella monitoring report with surveillance data provided by the member states through TESSy. The last report was published on 11 July 2017 with data up to 31 May 2017.

Measles outbreaks continue to occur in EU/EEA countries. There is a risk of spread and sustained transmission in areas with susceptible populations. The national vaccination coverage remains less than 95% for the second dose of MMR in the majority of EU/EEA countries. The progress towards elimination of measles in the WHO European Region is assessed by the European Regional Verification Commission for Measles and Rubella Elimination (RVC). Member States of the WHO European Region are making steady progress towards the elimination of measles. At the fifth meeting of the RVC for Measles and Rubella in October 2016, of 53 countries in the WHO European Region, 24 (15 of which are in the EU/EEA) were declared to have reached the elimination goal for measles, and 13 countries (nine in the EU/EEA) were deemed to have interrupted endemic transmission for between 12 and 36 months, meaning they are on their way to achieving the elimination goal. However, six EU/EEA countries were judged to still have endemic transmission: Belgium, France, Germany, Italy, Poland and Romania. More information on strain sequences would allow further insight into the epidemiological investigation.

All EU/EEA countries report measles cases on a monthly basis to ECDC and these data are published every month. Since 10 March 2017, ECDC has been reporting measles outbreaks in Europe on a weekly basis and monitoring worldwide outbreaks on a monthly basis through epidemic intelligence activities. ECDC published a rapid risk assessment on 6 March.

END OF QUOTE

Personally, I believe that it is high time to stop the rhetoric and actions of the anti-vaccination movements. This includes educating alternative practitioners and their patients. If necessary, we need regulation that prohibits their dangerous and unethical activities.

This post is based on an article by Ken Harvey, Associate Professor, School of Public Health and Preventive Medicine, Monash University, Australia. I took the liberty of slightly modifying his text for the purpose of this blog. The article informs us about the regulation of nonsense which, as I have often argued, is likely to result in nonsense.

Australia’s drugs regulator seems to be endorsing unfounded claims about homeopathy and traditional Chinese medicine as part of its review of how complementary medicines are regulated. In the latest proposed changes, the Therapeutic Goods Administration (TGA) is looking at what suppliers can claim their products do, known as “permitted indications”. An example of a “low level” permitted indication might be “may relieve the pain of mild osteoarthritis”.

If approved, suppliers will be able to use the permitted indication to market their products. The resulting problem is obvious.  For instance, despite the TGA’s Complaints Resolution Panel upholding complaints of a lack of evidence that magnesium and homeopathy “relieve muscle cramps (and restless legs)”, this permitted indication is on its draft list. Other examples of dodgy claims include “supports transport of oxygen in the body”, “regulates healthy male testosterone levels”. The list contains around 140 traditional Chinese medicine indications, such as “Harmonise middle burner (Spleen and Stomach)”, “Unblock/open/relax meridians”, “Balance Yin and Yang”. None of them have any basis in fact or science. There are also around 900 additional indications for unspecified “traditions”.

Traditional medicines are not necessarily safe, as emerging data highlights how common adverse reactions and drug interactions really are. For example, Hyland’s homeopathic baby teething products were recalled by the US Food and Drug Administration and then the TGA because they contained high levels of belladonna alkaloids which caused adverse events in hundreds of babies. In China, out of the 1.33 million case reports of adverse drug event reports received by the National Adverse Drug Reaction Monitoring Center in 2014, traditional Chinese medicine represented around 17.3% (equivalent to around 230,000 cases).

Listed medicines are supposed to contain pre-approved, relatively low-risk ingredients. They should be produced with good manufacturing practice and only make “low-level” health claims for which evidence is held. However, the TGA does not check these requirements before the product is marketed. To safeguard shoppers, consumer representatives, suggested the proposed list of permitted indications should be short and only contain wordings such as, “may assist” or “may help”. For consumers to make an informed purchase, claims based on “traditional use” should always have a disclaimer along the lines of what the US Federal Trade Commission uses for homeopathic products. For example, “This product’s traditional claims are based on alternative health practices that are not accepted by most modern medical experts. There is no good scientific evidence that this product works”.

MY CONCLUSION

As I see it, the problem is that the evidence for many of the claims which are about to be allowed is either absent, seriously flawed or negative. Yet, the purpose of any regulation of this kind must be to protect consumers from purchasing ineffective and sometimes dangerous products. Regulators are keen to balance this aim against another aim: helping an industry to thrive. It is never easy to get such a balance right. But to allow nonsense, pseudoscience and overt falsehoods to creep in, must surely be wrong, unethical and illegal.

 

In my previous post, I reported that the NHS has included homeopathy and herbal medicine on the list of medications that might no longer get reimbursed. The news was reported by most newspapers in the UK. All of the papers correctly quote NHS England giving their reasons for black-listing homeopathy and herbal remedies. Some papers also quote critics of homeopathy providing short ‘sound bites’ and opinions. None of the articles bother to explain in any detail why homeopathy is so ridiculously implausible or how strong the evidence against it has become. In this post, I intend to analyse some of this press coverage by copying those excerpts from the newspaper articles which I find odd or misleading and by adding short comments by myself.

THE DAILY MAIL claimed that homeopathic remedies are treatments using heavily diluted forms of plants, herbs and minerals. This is factually incorrect; think of remedies like X-ray! The Mail also quoted Don Redding, director of policy at National Voices, stating: ‘Whilst some treatments are available to purchase over the counter, that does not mean that everyone can afford them. There will be distinct categories of people who rely on NHS funding for prescriptions of remedies that are otherwise available over the counter. Stopping such prescriptions would break with the principle of an NHS “free at the point of use” and would create a system where access to treatments is based on a person’s ability to pay.’  This argument might apply to medicines that are proven to work; it does, however, not apply to homeopathy.

THE INDEPENDENT cited Professor Helen Stokes-Lampard, chair of the Royal College of GPs, who said: “If patients are in a position that they can afford to buy over the counter medicines and products, then we would encourage them to do so rather than request a prescription – but imposing blanket policies on GPs, that don’t take into account demographic differences across the country, or that don’t allow for flexibility for a patient’s individual circumstances, risks alienating the most vulnerable in society.” Again, this argument might apply to medicines that are proven to work; it does, however, not apply to homeopathy.

THE DAILY TELEGRAPH also reported the quote from Don Redding, Director of Policy at National Voices which I cited above.

THE DAILY MIRROR quoted The Royal Pharmaceutical Society claiming that such a move raised “serious concerns” for poorer Brits. RPS England Board Chair Sandra Gidley said: “A blanket ban on prescribing of items available to buy will not improve individual quality of life or health outcomes in England. “Those on low incomes will be disproportionately affected.” THE MIRROR also reported what had to say and added that the NHS constitution states that: “Access to NHS services is based on clinical need, not an individual’s ability to pay; NHS services are free of charge, except in limited circumstances sanctioned by parliament.”

THE NEWS & STAR repeated the above quote from The Royal Pharmaceutical Society.

THE GUERNSEY PRESS repeated what RPS England board chair Sandra Gidley said: “We would encourage people with minor health problems to self-care with the support of a pharmacist and to buy medicines where appropriate and affordable to the individual. However, expecting everyone to pay for medicines for common conditions will further increase health inequalities and worsen the health of patients who cannot afford them. A blanket ban on prescribing of items available to buy will not improve individual quality of life or health outcomes in England. Those on low incomes will be disproportionately affected. They should not be denied treatment because of an inability to pay.”

THE TIMES also quoted the RPS and Don Redding misleadingly (see above and below) and concluded their article by citing Cristal Summer, chief executive of the British Homeopathic Association saying: Patients will be prescribed more expensive conventional drugs in place of homeopathy, which defeats the object of the exercise. The NHS also claims it wants to reduce the amount of prescription drugs patients take, then stops offering complementary therapies which can help achieve this. This clearly ignores the fact that ‘the object of the exercise’ for any health service must be to provide effective treatments and avoid placebo therapies like homeopathy. 

THE SUN quoted The Royal Pharmaceutical Society saying such a move raised “serious concerns” for poorer Brits. But it said banning NHS-funded homeopathy was long overdue. THE SUN continued by citing John O’Connell, Chief Executive of the TaxPayers’ Alliance: “The NHS are absolutely right to look at removing homeopathy from their approved prescription list and it’s astonishing that it hasn’t happened sooner.”

METRO pointed out that actress Gwyneth Paltrow, ex-Beatle Paul McCartney and world record sprinter Usain Bolt are all known to swear by homeopathic remedies.

Generally speaking, the newspaper coverage was not bad, in my view. The exception evidently is THE TIMES (see above). Several other articles also have a slight whiff of false balance, introducing seemingly rational counter-arguments where none exist. Even though the headlines invariably focus on homeopathy, some of the quotes used by the papers are clearly about other medicines black-listed. This seems particularly obvious with the quotes by the RPS. Many readers might thus be misled into thinking that there is opposition by reputable organisations to the ban on homeopathy. None of the articles that I read quoted a homeopath at the end saying something like  WE KNOW OF MANY PATIENTS WHOSE LIVES WERE SAVED BY HOMEOPATHY. JUST BECAUSE WE DON’T UNDERSTAND HOW IT WORKS DOES NOT MEAN IT DOES NOT WORK. A BAN WOULD PUT PUBLIC HEALTH AT RISK.

Only a few years ago, this type of conclusion to an article on homeopathy would have been inevitable! Could it be that UK journalists (with the exception of those at THE TIMES?) are slowly learning?

 

Isn’t it wonderful when your long-held views are confirmed by someone with influence?

This, of course, is a rhetorical question – I can tell you: it is wonderful!

Matthew Stanbrook, MD PhD recently published an editorial in CMAJ which I find delightful; let me present you a few quotes from it:

The multibillion-dollar market for “natural” health products has flourished under lax government regulations. These regulations have enabled manufacturers to exploit the public’s difficulty in distinguishing nonprescription drugs, with scientifically proven therapeutic benefits, from herbal or homeopathic preparations and supplements that often make similar health claims with little or no evidence and are frequently grounded in unscientific belief systems about health and disease…

In pharmacies, supermarkets and convenience stores, natural health products are displayed side by side with nonprescription drugs. Both tout their approval by Health Canada as an implicit endorsement of efficacy and safety on package labels that make similar health claims. However, although nonprescription drugs and their therapeutic claims require scientific evidence that is carefully scrutinized by Health Canada, natural health products have a separate regulatory system that typically imposes such minimal requirements that it is effectively a rubber stamp. Unlike nonprescription drugs, if a problem arises with a natural health product, Health Canada has little or no authority to compel any changes to its manufacture, labelling or sale.

…Risk is often difficult to perceive accurately without direct evidence. For example, under the proposed framework, Health Canada would continue to classify most homeopathic preparations as low-risk products and, thus, exempt from scientific review. Recently, a homeopathic product sold in the United States that claimed to relieve teething pain in infants and supposedly contained a very dilute extract from the belladonna plant was associated with several deaths of infants who manifested classic signs of anticholinergic poisoning…

…If consumers are unable to separate products with no scientific proof behind them from products supported by evidence, then we need to separate them in stores. Natural health products should be pulled from the shelves where they are mixed with nonprescription drug products and confined to their own separate section, away from any signage implying a therapeutic use.

The double standard perpetuated by both regulators and retailers that enables the deception of unsuspecting Canadians must end. Alternative medicines with claims based on alternative facts do not deserve an alternative, easy regulatory road to market — at the very least, they need to be moved to an alternative shelf.

END OF QUOTES

This, of course, is Canada. But elsewhere progress is also being made.The Australian reported about plans in Australia whereby pharmacies would be banned from selling useless and possibly dangerous homoeopathic remedies. The Australian last year ­revealed a review of pharmacy regulation, headed by Stephen King from the Productivity ­Commission, identified a potential conflict of interest in pharmacists selling vitamins, for example, that may not have a significant ­evidence base, alongside more stringently regulated and government-subsidised medicines. In its interim report, the review panel was “concerned that the sale of complementary medicines alongside other medicines may mislead consumers”. It therefore concludes that “complementary medicines should be held in a separate area within community pharmacies, where customers can easily access a pharmacist for appropriate advice.”

“To avoid potential harm, or the confusion between the efficacies of different types of medicines, pharmacists need to be easily ­accessible to give needed advice when consumers choose a complementary or pharmacy-only medicine,” the review panel said. It was scathing of homo­eopathy and the perception of legitimacy given to those so-called remedies sold in pharmacies. “The only defence put to the panel regarding homoeopathy was that it was harmless and able to be used as a placebo in certain circumstances,” the review panel noted. “The panel does not believe that this argument is sufficient to justify the continued sale of these products in pharmacies …”

AUSTRALIAN JOURNAL OF PHARMACY (AJP) noted that the interim report of the Review of Pharmacy Remuneration and Regulation states that “there are unacceptable risks where community pharmacies are allowed to sell homeopathic products”.

In 2015 Pharmaceutical Society of Australia (PSA) said it did not support the sale of homeopathy in pharmacy. “Our position is that pharmacists must use their professional judgement to prevent the supply of products with evidence of no effect,” PSA president Joe Demarte said at the time. Ian Carr, of Saxby’s Pharmacy in Taree, NSW, and Friends of Science in Medicine member, told the AJP that “in terms of homeopathic products being recommended not to be sold by PBS-approved pharmacies, I one hundred per cent heartily agree with that finding. “I love saying that I believe homeopathy works. But it has never been shown to work better than placebo. There are many things that will work as well as placebo, but it’s not ethical to be selling them as a cure or treatment for something. I would have a bit more time for it if there was a plausible theory behind it, but its basis is entirely implausible – it pushes all the buttons for being a pseudoscience, so I agree it has no place in Australian pharmacy. However, I am at a bit of a loss to understand why they haven’t carried some of that logic over into the comments on complementary medicines generally.”

Mr Carr also told the AJP that “If one conceives of complementary medicines as being vitamins and minerals, that’s one thing. But the marketing of those items has become so diffuse and so wide that on most of these CM shelves we have traditional medicines, we’ve got herbal medicines, we’ve got items that are basically just marketing formulas for certain conditions. The evidence behind most of these things is very very slim, and we still have the possibility of health fraudsters just marching in and taking advantage of the lack of regulation in the industry.”

So, Canada and Australia are making progress in protecting consumers from bogus healthcare products and from pharmacists selling them.

Hurray!!!

When, I ask myself, are the UK, the US and other countries following suit?

 

According to Wikipedia, “the Bundesverband der Pharmazeutischen Industrie (BPI) with headquarters in Berlin is an Eingetragener Verein and the German industry association/trade group for the pharmaceutical industry. It represents 240 German pharmaceutical and Biotech companies in with altogether approximately 70,000 employees. BPI has an office in Brussels. The focus of the BPI is on political consulting and public relations on the EU-level.” 

The BPI has recently published a remarkable press-release about homeopathy. As it is in German, I will translate it for you (and append the original text for those who can read German).

HERE WE GO:

Homeopathy is a recognised and proven therapy for patients in Germany [1]. This is demonstrated by a new, BPI-sponsored survey [2]. About half of all questioned had experience with homeopathic remedies [3]. More than 70% of those people are satisfied or very satisfied with their effectiveness and safety [4].

“Homeopathic remedies are important for many patients in Germany”[3], says Dr. Norbert Gerbsch, deputy chair of the BPI. ” If therapists and patients use them correctly, they can support the therapeutic success [5]. Therefore, they should be recognised by conventional medicine as an integrative medicine [5] – that is what patients in Germany clearly want [6].”

Two thirds of the people surveyed think it is important or very important, that therapies like anthroposophical medicine and homeopathy are supported politically next to conventional medicine [7]. More than 70% find it personally important or very important that health insurances pay for selected anthroposophical and homeopathic services [8]. More than 80% said they would favour this. Thus, the majority is for keeping homeopathy amongst the services that can be chosen by the insurances for reimbursement [8].

Dr. Norbert Gerbsch: “The survey proves that very many individuals integrate, use and treasure homeopathy as an additional and usually safe therapy [3]. Those who aim at curtailing therapeutic freedom patronise numerous patients in Germany who can benefit from it [9]. There are numerous diseases for which homeopathy can be used as an integrative therapeutic option [10]. Thus, many conventional physicians employ homeopathic and anthroposophic remedies in parallel to guideline-orientated medicine [3, 11].”

(Homöopathie ist eine anerkannte und bewährte Therapieform für Patienten in Deutschland. Das belegt eine neue, vom BPI beauftragte Forsa-Umfrage. Rund die Hälfte der Befragten hat demnach bereits Erfahrung mit homöopathischen Arzneimitteln. Über 70 Prozent von ihnen sind zufrieden oder sehr zufrieden mit der Wirksamkeit und Verträglichkeit.

„Homöopathische Arzneimittel haben für viele Patienten in Deutschland einen hohen Stellenwert“, sagt Dr. Norbert Gerbsch, stellvertretender BPI-Hauptgeschäftsführer. „Wenn Behandler und Patienten sie richtig und verantwortungsvoll einsetzen, kann sie den Therapieerfolg unterstützen. Sie sollte insofern als wichtige Ergänzung der Schulmedizin im Sinne einer Integrativen Medizin anerkannt werden – das wünschen sich die Patienten in Deutschland eindeutig.“

Fast zwei Drittel der von Forsa Befragten finden es wichtig bis sehr wichtig, dass sich die Politik neben schulmedizinischen Behandlungsmethoden auch aktiv für Heilmethoden wie etwa Homöopathie oder Anthroposophische Medizin einsetzt. Über 70 Prozent finden es persönlich wichtig bis sehr wichtig, dass Krankenkassen ihren Versicherten auch die Kosten für ausgewählte Leistungen aus dem Bereich der homöopathischen Medizin erstatten. Mit über 80 Prozent überdurchschnittlich häufig plädieren Befragte mit Homöopathie-Erfahrung für die Kostenübernahme ausgewählter Leistungen durch die Krankenkassen. Damit stimmt die Mehrheit für den Erhalt der Homöopathie im Rahmen von sogenannten Satzungsleistungen, die von den Krankenkassen individuell festgelegt werden können.

Dr. Norbert Gerbsch: „Die Umfrage belegt, dass sehr viele Menschen Homöopathie als ergänzende und in der Regel nebenwirkungsarme Therapieoption in die Behandlung integrieren, sie nutzen und achten. Wer die Therapiefreiheit und -vielfalt beschneiden will, bevormundet zahlreiche Patienten in Deutschland, die davon profitieren können. Es gibt eine Vielzahl an Erkrankungen, bei denen homöopathische Arzneimittel als integraler Bestandteil von Therapien einsetzbar sind. So nutzen viele Schulmediziner neben dem gesamten Spektrum der leitlinienorientierten Medizin gleichzeitig die integrativen Angebote der Homöopathie und Anthroposophischen Medizin.“)

I DO APPOLOGISE FOR MY POOR TRANSLATION; I HAVE ALWAYS FOUND THAT IT IS VERY HARD TO TRANSLATE SOMETHING THAT SIMPLY DOES NOT MAKE SENSE!

I have rarely seen such an unscientific, irrational, nonsensical and promotional comment from an organisation and an individual that should know better. Mr. Gerbsch studied biotechnology and graduated in 1997 in bioprocess engineering. He headed a scientific team following his promotion to director of a trans-departmental research topic with 13 professorships at the Technical University of Berlin. He later took on responsibilities as commissioner, officer and director of various companies. Since 2006, Mr. Gerbsch works as department manager of biotechnology / research & development at BPI and is responsible for the biotechnology department and innovation & research committee.

Here are just a few short points of criticism referring to the numbers I have added in my translation:

  1. Homeopathy is recognised and proven to be a pure placebo-therapy.
  2. A survey of this nature can at best gauge the current opinion.
  3. Fallacy: appeal to popularity.
  4. Perceived effectiveness/safety is not the same as true effectiveness/safety.
  5. There is no good evidence for this statement.
  6. What patients want might be interesting, but it cannot determine what they need; medicine is not a supermarket!
  7. I suspect this is the result of a leading question.
  8. This is where the BPI discloses the aim of the survey and their comment about it: they want the German health insurances to continue paying for homeopathic and anthroposophical placebos because some of their member companies earn their money selling them. In other words, the BPI actively hinder progress.
  9. No, those who advocate not paying for placebos want to encourage progress in healthcare for the benefit of patients and society.
  10. “Can be used” is an interesting phraseology! It is true, one can use homeopathy – but one cannot use it effectively because it has no effect beyond placebo.
  11. Yes, many physicians are sadly more focussed on their own cash-flow than on the best interest of their patients. Not all that different from the BPI, it seems.

It is beyond me how an organisation like the BPI can produce such shamefully misleading, dangerous and unethical drivel. Not one word about the fact that all international bodies have condemned homeopathy as being a useless and dangerous placebo-therapy! Who ever thought that the BPI was an independent organisation (homeopathy manufacturers belong to its membership) has been proven wrong by the above press-release.

The BPI clearly needs reminding of their duty to inform the public responsibly. I recommend that the leading heads of this organisation urgently attend one course on critical thinking followed by another on medical ethics.

Currently, over 50 000 000 websites promote alternative medicine, and consumers are bombarded with information not just via the Internet, but also via newspapers, magazines and other sources. This has the potential of needlessly separating them from their cash or even seriously harming their health. As there is little that protects us from greedy entrepreneurs and over-enthusiastic therapists, we should think about protecting ourselves. Here I will provide five simple tips that may fortify you against fake news in the realm of alternative medicine.

Imagine you read somewhere that the condition you are affected by is curable (or at least improvable) by THERAPY XY. It is only natural that you are exited by this news. Before you now rush to the next health shop or alternative medicine centre, it is worth asking yourself the following questions:

  • Is the claim plausible? As a rule of thumb, it is fair to say that, if it sounds too good to be true, it probably is too good to be true. Not so long ago, UK newspapers reported that a herbal mixture called ‘CARCTOL’ had been discovered to be an efficacious and safe cancer cure (before that, it was Essiac, shark cartilage, Laetrile and many more). I only needed a minimal amount of research to find that the claim had no basis in fact. Come to think of it, it is not plausible that any alternative therapy will ever emerge as a miracle cure for any condition, particularly a serious disease like cancer. It is also not plausible that a herbal mixture would ever prove to be a cure for a wide range of different cancers. The very idea of such ‘cures’ is a contradiction in terms. If an alternative therapy ever did turn out to be efficacious, it would become mainstream even before the clinical tests to prove its efficacy are fully concluded. The notion of an alternative cure presumes that conventional scientists and clinicians reject a treatment simply because it originated from the realm of alternative medicine. There is no precedent that this has ever occurred, and I am sure it will never happen in future.
  • What is the evidence for the claim? In the case of CARCTOL, the claim was based on a UK doctor apparently observing that, in several patients, tumours had been melting like butter in the sun after they took this herbal mixture. One particularly irresponsible headline read: “I’ve seen herbal remedy make tumours disappear, says respected cancer doctor.” This, however, is no evidence but mere anecdotes, and we confuse the two at our peril. Remember: the plural of anecdote is anecdotes, not evidence. With anecdotes, we can never be sure about cause and effect. Therapeutic claims must be based on good evidence, e.g. controlled clinical trials.
  • Who is behind the claim? In the UK, the CARCTOL claim emerged around 2004 and originated mainly from Dr Rosy Daniel. In the above newspaper article, she was called ‘a respected cancer doctor’. Personally, I do NOT ‘respect’  someone who makes claims of this nature without having good evidence. And a ‘cancer doctor’ is usually understood to be an oncologist; to the best of my knowledge, Dr Daniel is NOT an oncologist. In fact, she now calls herself a ‘Lifestyle and Integrative Medicine Consultant’. Faced with an important new health claim, one should always check who is behind it. Check out whether this person is reputable and free of conflicts of interest. An affiliation to a reputable university is usually more convincing than being a director of your own private heath centre.
  • Where was the claim published? The CARCTOL story had been published in newspapers – and nowhere else! Even today, there is only one Medline-listed publication on the subject. It is my own review of the evidence which, in 2004, concluded that “The claim that Carctol is of any benefit to cancer patients is not supported by scientific evidence.”   *** If important new therapeutic claims like ‘therapy xy cures cancer’ are reported in the popular media, you should always check where they were first published (or simply dismiss it without researching it). It is unthinkable that such an important claim is not made first in a proper, peer-reviewed article in a good medical journal. Go on ‘Medline’, conduct a quick search and find out whether the new findings have been published. If the claim does not come from peer-reviewed journals, forget about it. If it has been published in any journal that has alternative, complementary, integrative or similar terms in its name, take it with a good pinch of salt.
  • Is there money involved? In the case of CARCTOL, the costs were high. I was called once by a woman who had read my article telling me that she was pursued by the doctor who had treated her husband. Tragically, the man had nevertheless died of his cancer, and the widow was now pursued for £8 000 which she understandably was reluctant to pay. Many new treatments are expensive. So, high costs are not necessarily suspicious. Still, I advise you to be extra cautious in situations where there is the potential for someone to make a fast buck. Financial exploitation is sadly rife in the realm of alternative medicine.

A similar checklist originates from a team of experts. Researchers from Uganda, Kenya, Rwanda, Norway, and England, worked to identify the most important ideas a person would need to grasp thinking critically about health claims. They came up with excellent points:

  1. Just because a treatment is popular or old does not mean it’s beneficial or safe.
  2. New, brand-name, or more expensive treatments may not be better than older ones.
  3. Treatments usually come with both harms and benefits.
  4. Beware of conflicts of interest — they can lead to misleading claims about treatments.
  5. Personal experiences, expert opinions, and anecdotes aren’t a reliable basis for assessing the effects of most treatments.
  6. Instead, health claims should be based on high-quality, randomized controlled trials.

Alternative medicine can easily turn into a jungle or even a nightmare. Before you fall for any dubious claim that THERAPY XY is good for you, please go through the simple sets of questions above. This might protect you from getting ripped off or – more importantly – from getting harmed.

 

*** After this article had been published, I received letters from layers threatening me with legal action unless I withdrew the paper. I decided to ignore them, and no legal action followed.

In 2006, the World Health Organization and UNICEF created the ‘Global Immunization Vision and Strategy’, a 10-year strategy with 4 main goals:

  1. to immunize more people against more diseases,
  2. to introduce a range of newly available vaccines and technologies,
  3. to integrate other critical health interventions with immunization,
  4. to manage vaccination programmes within the context of global interdependence.

More than a decade later, we have to realise that this vision has been frustrated, not least by fans of alternative medicine (FAMs). They are almost by definition more negative about the value and achievements of conventional medicine and science. This shows in all sorts of ways; the clearest this phenomenon is documented must be the FAMs’ attitude towards immunisations. Few rational thinkers would doubt that vaccinations are amongst the most important achievement in the history of medicine.

Vaccination is a miracle of modern medicine. In the past 50 years, it’s saved more lives worldwide than any other medical product or procedure.”

Yet FAMs are not impressed by such statements and often refuse to have their kids vaccinated according to the recommended schedule. This trend has significantly contributed to vaccination rates that, in some parts of the world, are now dropping so low that our ‘herd immunity’ is jeopardised.

One such place is Germany, and the German government is now making a controversial move against parents who choose to refrain from vaccinating their children. Germany is presently passing a law that will force kindergartens to inform the authorities, if parents don’t provide evidence that they have gotten advice from their doctor on vaccinations for their children.

The aim of this paper was to systematically review surveys of 12-month prevalence of homeopathy use by the general population worldwide. Studies were identified via database searches to October 2015. Study quality was assessed using a six-item tool. All estimates were in the context of a survey which also reported prevalence of any complementary and alternative medicine use. A total of 36 surveys were included. Of these, 67% met four of six quality criteria.

Twelve-month prevalence of treatment by a homeopath was reported in 24 surveys of adults (median 1.5%, range 0.2–8.2%). Estimates for children were similar to those for adults. Rates in the USA, UK, Australia and Canada all ranged from 0.2% to 2.9% and remained stable over the years surveyed (1986–2012). Twelve-month prevalence of all use of homeopathy (purchase of over-the-counter homeopathic medicines and treatment by a homeopath) was reported in 10 surveys of adults (median 3.9%, range 0.7–9.8%) while a further 11 surveys which did not define the type of homeopathy use reported similar data. Rates in the USA and Australia ranged from 1.7% to 4.4% and remained stable over the years surveyed. The highest use was reported by a survey in Switzerland where homeopathy is covered by mandatory health insurance.

The authors concluded that each year a small but significant percentage of these general populations use homeopathy. This includes visits to homeopaths as well as purchase of over-the-counter homeopathic medicines.

These data thus indicate that the percentage of the adult general population using homeopathy over the previous 12 months was in the range of 0.7–9.8%, with a median estimate of 3.9%, and the percentage accessing treatment by a homeopath over the previous 12 months was in the range of 0.2–8.2%, with a median estimate of 1.5%. The data also suggest that, over the last few decades, use of homeopathy has remained fairly stable. These facts are in sharp contrast to the claims by homeopaths that:

  • Homeopathy is hugely popular.
  • Homeopathy is being used by more and more people across the globe.
  • Homeopathy is the medicine of the future.

The well-documented and undeniable unpopularity of homeopathy begs the question, I think, why so many people seem to get so excited about homeopathy. The level of usage is nothing to write home about! Therefore, why don’t we just put it down to an aberration like believing the earth is flat? Why don’t we just concede that some minor, harmless stupidity will always exist in some people’s minds?

Here are some reasons why:

  • It is not about the amount of people using homeopathy, but about the principle that any of the increasingly scarce public funds for healthcare are wasted on something as irrational and useless as homeopathy.
  • Homeopathy makes a mockery of EBM.
  • Homeopathy and homeopaths are by no means harmless.
  • Homeopaths tell too many lies to be allowed to get away with them.
  • Homeopathy and its followers systematically undermine rational thought.

 

 

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