MD, PhD, FMedSci, FSB, FRCP, FRCPEd

patient choice

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.

 

 

THE TELEGRAPH reported that “homeopathic medicines will escape an NHS prescribing ban even though the Chief Medical Officer Dame Sally Davies has dismissed the treatments as ‘rubbish’ and a waste of taxpayers money.”

But why?

This sounds insane!

Sorry, I do not know the answer either, but below I offer 10 possible options – so bear with me, please.

The NHS spends around £4 million a year on homeopathic remedies, the article claimed. Sandra Gidley, chairwoman of the Royal Pharmaceutical Society, said: “We are surprised that homeopathy, which has no scientific evidence of effectiveness, is not on the list for review. We are in agreement with NHS England that products with low or no clinical evidence of effectiveness should be reviewed with urgency.”

The NHS Clinical Commissioners, the body which was asked to review which medications should no longer be prescribed for NHS England, said it had included drugs with ‘little or no clinical value’, yet could not offer an explanation  why homeopathic medicines had escaped the cut. Julie Wood, Chief Executive, NHS Clinical Commissioners said: “Clinical commissioners have always had to make difficult choices about prioritising how they spend their budget on services, but the finance and demand challenges we face at the moment are unprecedented. Clinical Commissioning Groups have been looking at their medicines spend, and many are already implementing policies to reduce spending on those prescribeable items that have little or no clinical value for patients, and are therefore not an effective use of the NHS pound.”

Under the new rules, NHS doctors will be banned from routinely prescribing items that are cheaply available in chemists. The list includes heartburn pills, paracetamol, hayfever tablets, sun cream, muscle rubs, Omega 3 fish oils, medicine for coughs and colds and travel vaccinations. Coeliacs will also be forced to buy their own gluten-free food.

So, why are homeopathic remedies excluded from this new cost-saving exercise?

I am puzzled!

Is it because:

  1. The NHS has recently found out that homeopathy is effective after all?
  2. The officials have forgotten to put homeopathics on the list?
  3. In times of Brexit, the government cannot be bothered about reason, science and all that?
  4. The NHS does not need the money?
  5. Homeopathic globuli look so pretty?
  6. Our Health Secretary is in love with homeopathy?
  7. Experts are no longer needed for decision-making?
  8. EBM has suddenly gone out of fashion?
  9. Placebos are now all the rage?
  10. Some influential person called Charles is against it?

Sorry, no prizes for the winner of this quiz!

 

The love-affair of many nurses with complementary medicine is well-known. We have discussed it many times on this blog – see for instance here, here and here. Yet the reasons for it remain somewhat mysterious, I find. Therefore I was interested to see a new paper on the subject.

The aim of this ‘meta-synthesis‘ was to review, critically, appraise and synthesize the existing qualitative research to develop a new, more substantial interpretation of nurses’ attitudes regarding the, use of complementary therapies by patients. Fifteen articles were included in the review.

Five themes emerged from the data relating to nurses’ attitude towards complementary therapies:

  1. the strengths and weaknesses of conventional medicine;
  2. complementary therapies as a way to enhance nursing practice;
  3. patient empowerment and patient-centeredness;
  4. cultural barriers and enablers to integration;
  5. structural barriers and enablers to integration.

Nurses’ support for complementary therapies, the authors of this article claim, is not an attempt to challenge mainstream medicine but rather an endeavour to improve the quality of care available to patients. There are, however, a number of barriers to nurses’ support including institutional culture and clinical context, as well as time and knowledge limitations.

The authors concluded that some nurses promote complementary therapies as an opportunity to personalise care and practice in a humanistic way. Yet, nurses have very limited education in this field and a lack of professional frameworks to assist them. The nursing profession needs to consider how to address current deficiencies in meeting the growing use of complementary therapies by patients.

In my view, there are two most remarkable misunderstandings here:

  1. While it is undoubtedly laudable that nurses “endeavour to improve the quality of care available to patients”, it has to be said that such an endeavour does not require complementary medicine. Are they implying that with conventional medicine the quality of care cannot be improved?
  2. I fail to understand why the lack of good evidential support for most complementary therapies did not emerge as a prominent theme. Are nurses not concerned about the (lack of) evidence that underpins their actions?

‘The use of a harmless alternative therapy is not necessarily wrong. Even if the treatment itself is just a placebo, it can help many patients. Some patients feel better with it, and it would be arrogant, high-handed and less than compassionate to reject such therapies simply because they are not supported by sufficient scientific evidence’.

How often have I heard this notion in one or another form?

I hear such words almost every day.

Arguments along these lines are difficult to counter. Any attempt to do so is likely to make us look blinkered, high-handed and less than compassionate.

Yet we all – well almost all – know that the notion is wrong. Not only that, it can be dangerous.

I will try to explain this with a concrete example of a patient employing a harmless alternative remedy with great success… until… well, you’ll see.

The patient is a married women with two kids. She is well known to her doctor because she has suffered from a range of symptoms for years, and the doctor – despite extensive tests – could never find anything really wrong with her. He knows about his patient’s significant psychological problems and has, on occasion, been tempted to prescribe tranquilizers or anti-depressants. Before he does so, however, he tells her to try Rescue Remedies@ (homeopathically diluted placebos from the range of Bach Flower Remedies). The patient is generally ‘alternatively inclined’, seems delighted with this suggestion and only too keen to give it a try.

After a couple of weeks, she reports that the Rescue Remedies (RR) are helping her. She says she can cope much better with stressful situations and has less severe and less frequent headaches or other symptoms. As she embarks on a long period of taking RR more or less regularly, she becomes convinced that the RR are highly effective and uses them whenever needed with apparent success. This goes on for months, and everyone is happy: the patient feels she has finally found a ‘medication that works’, and the doctor (who knows only too well that RR are placebos) is pleased that his patient is suffering less without needing real medication.

Then, a few months later, the patient notices that the RR are becoming less and less effective. Not only that, she also thinks that her headaches have changed and are becoming more intense. As she has been conditioned to believe that the RR are highly effective, she continues to take them. Her doctor too agrees and encourages her to carry on as before. But the pain gets worse and worse. When she develops other symptoms, her doctor initially tries to trivialise them, until they cannot be trivialised any longer. He eventually sends her to a specialist.

The patient has to wait a couple of weeks until an appointment can be arranged. The specialist orders a few tests which take a further two weeks. Finally, he diagnoses a malignant, possibly fast growing brain tumour. The patient has a poor prognosis but nevertheless agrees to an operation. Thereafter, she is paralysed on one side, needs 24-hour care, and dies 4 weeks post-operatively.

The surgeon is certain that, had he seen the patient several months earlier, the prognosis would have been incomparably better and her life could have been saved.

I suspect that most seasoned physicians have encountered stories which are not dissimilar. Fortunately they often do not end as tragically as this one. We tend to put them aside, and the next time the situation arises where a patient reports benefit from a bogus treatment we think: ‘Even if the treatment itself is just a placebo, it might help. Some patients feel better with it, and it would be arrogant, high-handed and less than compassionate to reject this ‘feel-good factor’.

I hope my story might persuade you that this notion is not necessarily correct.

If you are unable to make your patient feel better without resorting to quackery, my advice is to become a pathologist!!!

A new joint position statement of the Italian Society of Diabetology (SID) and of the Italian Society for the Study of Arteriosclerosis (SISA) has recently been published. In the context of this blog, it seems relevant enough for its summary to be reproduced here:

Evidence showed that LDL-cholesterol lowering is associated with a significant cardiovascular risk reduction. The initial therapeutic approach to hypercholesterolaemia includes dietary modifications but the compliance to recommendations is often inadequate. Some dietary components with potential cholesterol-lowering activity are present in small amounts in food. Therefore, in recent years the use of “nutraceuticals” (i.e., nutrients and/or bioactive compounds with potential beneficial effects on human health) has become widespread. Such substances may be added to foods and beverages, or taken as dietary supplements (liquid preparations, tablets, capsules). In the present manuscript, the cholesterol-lowering activity of some nutraceuticals (i.e. fiber, phytosterols, soy, policosanol, red yeast rice and berberine) will be discussed along with: 1) the level of evidence on the cholesterol-lowering efficacy emerging from clinical trial; 2) the possible side effects associated with their use; 3) the categories of patients who could benefit from their use.

DATA SYNTHESIS:

Based on the current literature, the cholesterol-lowering effect of fiber, phytosterols and red yeast rice is consistent and supported by a good level of evidence. Over berberine, there is sufficient evidence showing significant cholesterol-lowering effects, although the results come from studies carried out almost exclusively in Asian populations. Data on the effects of soy are conflicting and, therefore, the strength of recommendation is quite low. The evidence on policosanol is inconclusive.

CONCLUSION:

Although health benefits may arise from the use of nutraceuticals with cholesterol-lowering activity, their use might be also associated with possible risks and pitfalls, some of which are common to all nutraceuticals whereas others are related to specific nutraceuticals.

END OF QUOTE

Many advocates of alternative medicine are highly sceptical of the value of statins. Yet, it seems clear that statins exert considerably larger effects on our lipid profile than nutraceuticals. So, why not use the treatment that is best documented and most efficacious? One answer could lie in the well-known adverse effects of statins. However, can we be sure that nutraceuticals are devoid of serious side-effects? I am not sure that we can: statins have been fully investigated, and we therefore are well-informed about their risks. Nutraceuticals, by contrast, have not been monitored in such detail, and their safety profile is therefore not as well-understood.

Other advocates of alternative medicine argue that cholesterol (I use the term simplistically without differentiating between the ‘good and bad’ cholesterol) has been hyped by the pharmaceutical industry and is, in truth, not nearly as important a risk factor as we have been led to believe. This line of thought would consequently deny the need to lower elevated cholesterol levels and therefore negate the need for cholesterol-lowering treatments. This stance may be popular, particularly in the realm of alternative medicine, but, to the best of my knowledge, it is erroneous.

Obviously, the first line treatment for people with pathological lipid profiles is the adoption of different life-styles, particularly in terms of nutrition. This may well incorporate some of the nutraceuticals mentioned above. If that strategy is unsuccessful in normalizing our blood lipids – and it often is – we should consider the more effective conventional medications; and that unquestionably includes statins.

I do not expect that everyone reading these lines will agree with me, yet, after studying the evidence, this is my honest conclusion – and NO, I am not paid or otherwise rewarded by the pharmaceutical industry or anyone else!

 

You probably remember: the US Federal Trade Commission’s (FTC) has issued a statement announcing that unsupported claims for homeopathic remedies will be no longer allowed. Specifically, they said that, in future, homeopathic remedies have to be held to the same standard as other medicinal products. In other words, American companies must now have reliable scientific evidence for health-related claims that their products can treat specific conditions and illnesses.

Now the AMERICAN INSTITUTE OF HOMEOPATHY (AIH) has published a rebuttal. It is hilarious and embarrassing in equal measure. Here it is in full (I have only omitted their references – they can be seen in the linked original –  and added footnotes in bold square brackets with my very short comments):

START OF QUOTE

November 30, 2016

The American Institute of Homeopathy applauds the Federal Trade Commission’s (FTC) goal of protecting the American public from false advertising claims, but in a recent circumstance we believe the FTC has overstepped its jurisdictional bounds and promulgated false information in what appears to be a bid to restrict health care choices [1] available to the American public.

In Response to the recent Enforcement Policy Statement1 and a Consumer Information Blog,2 both issued by the FTC on November 15, 2016, the American Institute of Homeopathy registers our strong concern regarding the content of the following inaccurate statements:

  1. “Homeopathy… is based on the view that disease symptoms can be treated by minute doses of substances that produce similar symptoms…”

Homeopathy is not based on a “view” or an opinion. It is based on reliable, reproducible, clinically acquired, empiric evidence [2] gathered through two centuries of corroborated data, assisted by thousands of practitioners worldwide [3], demonstrating the actions of different medicinal substances in living systems, aka: the science of homeopathy. In fact, the homeopathic scientific community were pioneers of the modern scientific method including the widespread adoption of blinded and placebo controlled studies in 1885 [4], decades before conventional medicine.3

Homeopathy is not based on a theory or on conjecture, but on principles that have been confirmed by long-studied clinical data, meticulously gathered and analyzed over many years [5].

  1. “Many homeopathic products are diluted to such an extent that they no longer contain detectable levels of the initial substance.”

While the dilution and succussion process of formulating homeopathic medicines does reduce the concentration (and the toxicity) of the original substances, detectable amounts of these materials remain quantifiable in the form of nanoparticles [6] dispersed throughout.4 Multiple independent laboratories, worldwide have confirmed that these nanoparticles persist,5 and that they are biologically active.6 Many other homeopathic products (particularly those sold OTC and described as “low potency”) have dilute amounts of the original substance [7] that remain chemically detectable by straightforward titration.

  1. “…homeopathic product claims are not based on modern scientific methods…”

This statement is false and misleading. The active ingredients within most OTC homeopathic products have hundreds or thousands of case reports from physicians who have used these medicines [8]. These reports of direct clinical experiences establish a collective, real-world dataset that demonstrates which conditions have been observed to respond to treatment. Such historical data is similar to the types of information used to demonstrate effectiveness for many conventional OTC medicines on the market today [9].

The Homeopathic Pharmacopeia Convention of the United States (HPCUS) maintains a formulary describing the appropriate manufacturing standards for homeopathic medicines [10]. Every homeopathic manufacturer member of the American Association of Homeopathic Pharmacists in good ethical standing complies with both manufacturing and labeling standards set by the HPCUS. Consumers should be cautious when using any products that are not distinguished by conformance with “HPUS” on the label.

  1. “…the case for efficacy is based solely on traditional homeopathic theories…”

This statement is false. Neither homeopathy nor homeopathic efficacy is based on any theories. Efficacy for various homeopathic medicines has been established by scientifically reproducible clinical empiric research evidence [11] and cured patient cases followed over many years [12]. Homeopathy is an evidence-based medical subspecialty rooted in patient care.

  1. “…there are no valid studies using current scientific methods showing the product’s efficacy.”

While this statement may have limited accuracy with respect to some OTC products, it is false and misleading with respect to most homeopathic medicines listed in the Homeopathic Pharmacopeia of the United States. Hundreds of state-of-the-art double-blinded, randomized, placebo-controlled studies, many in peer-reviewed journals, demonstrate the superior efficacy of homeopathic medicines in a wide range of conditions, including asthma,7 depression and anxiety,8 chronic illness,9 allergic rhinitis,10 hypertension,11 headaches/migraines,12 sepsis,13 mild traumatic brain injury,14 otitis media,15 cancer,16 and many other conditions [13]. The American Institute of Homeopathy maintains and continually updates an extensive database, available free to the public, with over 6,000 research articles [14].17

Multiple meta-analyses published in peer reviewed medical journals that conclude that homeopathic medicine effects are superior to placebo [15] and that additional study of this therapeutic system is warranted.18,19,20,21,22,23  To that end, we encourage the National Institutes of Health to reverse their current position of blocking funding for homeopathic trials.24

  1. “…marketing claims that such homeopathic products have a therapeutic effect lack a reasonable basis and are likely misleading…”

The conclusion of whether a product has a “reasonable basis” is entirely irrelevant if that product has demonstrable clinical effectiveness. The important question, when it comes to homeopathy, is whether it is effective in clinical settings, not whether it has a “reasonable basis” for how it works. The mechanism by which homeopathy works differs from conventional medicines [16], but this fact does not make these products “misleading”.

Several recent class-action lawsuits brought against homeopathic manufacturers confirm that marketing practices were neither deceptive nor misleading [17].25

The FTC’s inability to formulate a reasonable basis for why homeopathic medicines work should not enter into any governmental enforcement policy statement. The FTC is not a medical organization, lacks expertise in interpreting scientific research [18], and is not qualified to make any comment on the validity of any field of medicine. To be less misleading, the FTC should exclude opinions from its policy statements.

  1. “Homeopathy: Not backed by modern science”

Homeopathy, as a system of medicine, does not fall under the purview of the FTC. Therefore, the FTC has been reckless in expressing an opinion of this magnitude. In this situation, the FTC’s comments can only be construed as being prejudicially biased and intentionally discriminatory against homeopathy. Such statements cause unwarranted harm to public trust and damage to a respected traditional system of medicine in the United States [19].

The American Institute of Homeopathy strongly objects to the FTC’s characterization of the entire field of homeopathic medicine as being without scientific evidence of efficacy. These comments are unqualified and wholly lacking in merit. The release of this Enforcement Policy Statement serves only to align the FTC with several recently released scientifically fraudulent [20] reports by a variety of pseudoscientists [21] and lowers the credibility of this valued consumer protection agency.

This type of misinformation should be embarrassing to a government organization striving to be nonpartisan and objective. The FTC owes an apology to the American Institute of Homeopathy as well as the many consumer groups that look toward this agency for fair and accurate information.

END OF QUOTE

My comments:

1 In healthcare, choice must be restricted to treatments which demonstrably generate more good than harm.

2 The AIH seems to be unaware of the difference between the nature of evidence, anecdote and experience.

3 Fallacy – appeal to popularity.

4 The first randomized, placebo-controlled study of homeopathy was, in fact, published in 1835 – its results were negative.

5 Fallacy – appeal to tradition.

6 The nano-particle explanation of homeopathy is but a theory (at best).

7 Fallacy – appeal to tradition.

8 Fallacy – appeal to authority.

9 Really? Which ones? Examples would help, but I doubt they exist.

10 The proper manufacturing of nonsense must still result in nonsense.

11 See footnote number 2

12 Fallacy – appeal to tradition.

13 For all of these conditions, the totality of the reliable evidence fails to demonstrate efficacy.

14 In this context, only clinical trials are relevant, and their number is nowhere near 6,000.

15 Most of the independent systematic reviews fail to be positive.

16 The mechanism is well-known and is called ‘placebo-effect’.

17 Many class actions also went against the manufacturers of homeopathic preparations.

18 I assume they ‘bought in’ the necessary expertise.

19 Surely, the damage is only to the cash-flow of firms selling bogus products.

20 Really? Name the report you libel here or be quiet!

21 Name the individuals you attack in this way or be quiet!

I must say, I had fun reading this. In fact, I cannot remember having seen a document by an organisation of healthcare professionals which was so embarrassingly nonsensical that it becomes comedy gold. If one of my PhD students, for instance, had submitted such drivel, I would have had no choice but to fail him or her.

Having said that, I need to stress to the AIH:

FULL MARKS FOR AMUSEMENT!!!

 

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