MD, PhD, FMedSci, FRSB, FRCP, FRCPEd.

medical ethics

The ‘Pharmaceutical Journal’ just published a ‘pro/contra’ piece discussing whether UK community pharmacists should be selling homeopathic remedies to the public. Here are the essential parts of both arguments:

PRO

… I do not believe there is good scientific evidence to validate homeopathic remedies as medicines, but it is important to provide patients with choice in an informed environment — pharmacists and pharmacy teams are able to provide this expertise.

It is better for the public to buy these products from a reputable source where the community pharmacist — the expert on medicines — can provide professional advice, which is not available from unregulated online suppliers or other non-healthcare outlets…

So, I’m not here to argue the science: I argue that some people can benefit from homeopathy.

We ought to explore homeopathy’s placebo effect. Placebos are often dismissed as fakes, but they seem to act on the same brain pathways that are targeted by ‘real’ treatments. I wonder whether, through the placebo effect, homeopathy has a role to play in mental health treatment and pain relief. Whether for anxiety, mild-to-moderate depression, sleeplessness or stress, taking a little white tablet may benefit the patient, have fewer side effects than conventional medication, cause no harm, and is better than an excess of alcohol or illegal drugs.

Of course, homeopathy should not replace conventional medicines, and people should continue to be vaccinated, should use their inhalers and take their insulin. Homeopathy should not be funded on the NHS, but we do not live in a nanny state.

The clinical efficacy of many other products sold in the pharmacy is also questionable, but we still provide them. One example is guaifenesin for chesty coughs, which, at over-the-counter strength, provides a suboptimal dose. Many people are sceptical of the benefits of vitamin and mineral supplements. Bach flower remedies claim to tackle stress. We drink herbal tea for its ‘health’ benefits or buy fortified cereals because they are ‘better for you’, but these benefits are not clinically proven.

If the public finds comfort in a complementary therapy — whether it is acupuncture, reflexology, vitamins or homeopathy — I am happy to offer that choice, as long as the chosen therapies do no harm, and people continue to take their prescribed medicines.

If the patient wants my professional advice, I will explain that homeopathic medicines are not clinically proven but they may help certain conditions. I will probably recommend a different product, but at least I am there to do so.

You will not find a pharmacist in a health shop or on the internet, but in the community pharmacy you will find a highly qualified medicines expert, who will advise and inform, and who truly cares about the public’s health.

 

CONTRA

… given pharmacy’s heavy promotion of homeopathy, I feared that the profession was in danger of losing science as its bedrock.

… in 2009, a London-based pharmacy was supplying homeopathic ‘swine flu formula’. This was a dangerous practice but government agencies failed to regulate it effectively or to close it down.

In 2010, the then professional standards director at Boots, Paul Bennett (now chief executive, Royal Pharmaceutical Society), appeared before the Science and Technology Committee in its discussion of homeopathy’s availability on the NHS. Bennett stood by the sale of homeopathic remedies in Boots’ stores: “It is about consumer choice for us,” he said. I disagree with this argument.

Like the sale of cigarettes in US pharmacies, homeopathy threatens to fatally damage the reputation of community pharmacy. Pharmacies that sell homeopathic remedies give them unjustified credibility. Informed patient choice should be king; if pharmacists, pharmacy staff and shelf-barkers fail to clearly inform customers that homeopathic remedies are no more effective than placebo, we have acted unethically.

Yet Boots, perhaps alarmed by the number of subsequent protests against homeopathy outside its stores, got the message. Its website now reflects a more scientific approach: the homeopathic remedies it supplies state that they are “without approved therapeutic indications”. Boots also seems to have modified its range and offering of homeopathic remedies. So there is hope for community pharmacy.

Homeopathic remedies are still sold in pharmacies only because they make a profit. Sales in pharmacy are nonsense because, as most homeopathic practitioners claim, it is not possible to sell homeopathic remedies in isolation of a homeopathic consultation. The consultation determines the remedy. Off-the-shelf homeopathy is a relatively recent phenomenon.

The remedies are no more effective compared with placebo, anyway. Systematic reviews from the Cochrane Library — the gold standard of medical science — have considered homeopathy in the treatment of dementia, asthma and attention deficit hyperactivity disorder, all of which have confirmed the placebo effect. Irritatingly, supporters of homeopathy will always, in any debate, quote a bunkum study that shows some possible efficacy. Some might argue that placebo, or suggestion, is effective therapy, so why not use it? We must question the ethics of this approach.

Pharmacists act immorally when they sell the products without making clients aware that homeopathy does not work.

… I find that most pharmacists, when asked, appreciate that homeopathy has no scientific basis and provides merely a placebo effect. I sincerely hope that with this insight, pharmacy will finally clear its shelves of this expensive hocus pocus for good.

____________________________________________________________________________

I find both pieces quite weak and poorly argued. In fact, the ‘pro’ – arguments are quite laughable and could easily be used for teaching students the meaning and use of logical fallacies. In my view, all that needs to be pointed out here is this:

  1. Homeopathy is based on implausible assumptions.
  2. Despite 200 years of research and around 500 clinical trials, there is still no proof that highly diluted homeopathic remedies have effects beyond placebo.
  3. Therefore, selling them to the naïve public, while pretending they are real medicines, is dishonest, arguably fraudulent and certainly not the behaviour one would expect of a healthcare professional.
  4. Pharmacists who nevertheless sell these remedies as medicines are in breach of their very own regulations.

_____________________________________________________________________________

Strangely enough, when trying to find the relevant passage from the code of ethics for UK pharmacists, I struggled. The General Pharmaceutical Council’s ‘Standards fro Pharmacy Professionals‘ merely states this:

People receive safe and effective care when pharmacy professionals reflect on the application of their knowledge and skills and keep them up-to-date, including using evidence in their decision making. A pharmacy professional’s knowledge and skills must develop over the course of their career to reflect the changing nature of healthcare, the population they provide care to and the roles they carry out. There are a number of ways to meet this standard and below are examples of the attitudes and behaviours expected.

People receive safe and effective care when pharmacy professionals:

  • recognise and work within the limits of their knowledge and skills, and refer to others when needed
  • use their skills and knowledge, including up-to-date evidence, to deliver care and improve the quality of care they provide
  • carry out a range of continuing professional development (CPD) activities relevant to their practice
  • record their development activities to demonstrate that their knowledge and skills are up to date
  • use a variety of methods to regularly monitor and reflect on their practice, skills and knowledge

This, I admit, is not as clear as I had hoped (if my memory serves me right, this used to be much more explicit; in case anyone knows of a more suitable section in the code of ethics, please let me know); but it does preclude selling placebos, while pretending they are effective medicines.

I have been alerted to this website; it is truly remarkable! Here is but one example, the section with advice on ‘reducing the risk of vaccine damage’:

START OF QUOTE

1. Give vitamin A before the measles vaccine (MMR).Vitamin A has been shown to reduce death in measles sufferers by 50% so will support the body in its dealing with the measles vaccine. The WHO is now giving out Vitamin A pills along with the vaccine! Consider high doses (5,000 IU or more) the day before, on the day and the day after vaccination.

2. Give increased vitamin C before and after all vaccines. Vitamin C is known to help eliminate heavy metals. Consider high doses (3,000-5,000 mg per day) the day before, day of, and day after.

3. Consider detox programs after vaccination. These include homeopathy (before and after each vaccination), supplements, especially vitamin C, probiotics etc. It can take up to a year to detox the system but it is worth the investment (Autistic children are usually highly toxic – See Treating Autism).

4. Reconsider the routine use of Calpol or similar before or after vaccination. A rise in body temperature is the immune systems healthy response to any attack. Suppressing this reaction will impair its’ ability to deal with the load imposed upon it by the vaccine. Links have been made with the use of Calpol etc after the MMR and autism because the body needs to raise a high temperature to deal with measles. Complications can arise if temperature is bought down too early in cases of measles. See ‘Dealing with Fever Naturally’ under the Health section of this site.

5. Avoid antibiotic use where possible.

Delay vaccines, especially the MMR, within up to 6 months of antibiotics.

The strength of the gut is compromised and the gut is 70% of the immune system. Autistic children often have Gut and Bowel disorders. Antibiotics during pregnancy & breast feeding can also compromise the child’s immune system.

Try not to use antibiotics, as there are links with increased asthma in the vaccinated and also with the overuse of antibiotics in children. Asthma kills 1,300 people a year in the UK and rates have doubled in the last 40 years. This is far higher than the mortality rates as a result of contracting contagious diseases before the vaccines! In the years leading up to the vaccination program between 30-50 people died of measles, for example. Nearly 200 children under 14 years now die of Asthma. Asthma UK puts this this condition down to lack of childhood infections! For most children, as they recover from illness, their immune system is strengthened. The UK, US, New Zealand, Cuba and Australia lead the world with Asthma (Vaccinated populations). Asthma UK says that ‘the goal would be to find a suitable vaccine to provide the beneficial effects of early life infection’!!!

6. Use Probiotics to strengthen the gut, in capsule form rather than from a drinking yogurt product which usually contains sugar and other additives.

7. Consider giving long term Vit B6 as “One of the components of the MMR is Neomycin. This is an antibacterial drug that is used to suppress gastrointestinal bacteria before surgery to avoid infection. …This antibiotic interferes with the absorption of Vitamin B6. An error in the uptake of Vitamin B6 can cause a rare form of epilepsy and children become mentally retarded. Vitamin B6 is the major vitamin for processingamino acids, which are the building blocks of all proteins and a few hormones. There are studies around which support the theory of treating autistic children with Vitamin B6.”

END OF QUOTE

Let me briefly comment on these 7 points.

  1. I am not aware of good evidence supporting this claim.
  2. I am not aware of good evidence supporting this claim.
  3. I am not aware of good evidence supporting this claim.
  4. I am not aware of good evidence supporting this claim.
  5. I am not aware of good evidence supporting this claim.
  6. I am not aware of good evidence supporting this claim.
  7. I am not aware of good evidence supporting this claim.

Of course, I may have missed some important evidence; if that is the case, I would appreciate someone showing it to me in the comments section below, so that we can all benefit from it.

The above advice is from the ‘ARNICA’ group (as the name suggests, they are close to or even led by homeopaths). They believe that the non-vaccinated child is potentially healthier than the vaccinated child.  

They also claim they  want to reduce the fear often felt by parents with their young children on health issues, whether that is to learn how to look after children when they have a fever, or to suggest ways to reduce the adverse reactions from vaccines.

I respectfully suggest that they are dismally failing in their aims. In fact, they seem to promote fear and issue bogus advice.

Shiatsu is an alternative therapy that is popular, but has so far attracted almost no research. Therefore, I was excited when I saw a new paper on the subject. Sadly, my excitement waned quickly when I stared reading the abstract.

This single-blind randomized controlled study was aimed to evaluate shiatsu on mood, cognition, and functional independence in patients undergoing physical activity. Alzheimer disease (AD) patients with depression were randomly assigned to the “active group” (Shiatsu + physical activity) or the “control group” (physical activity alone).

Shiatsu was performed by the same therapist once a week for ten months. Global cognitive functioning (Mini Mental State Examination – MMSE), depressive symptoms (Geriatric Depression Scale – GDS), and functional status (Activity of Daily Living – ADL, Instrumental ADL – IADL) were assessed before and after the intervention.

The researchers found a within-group improvement of MMSE, ADL, and GDS in the Shiatsu group. However, the analysis of differences before and after the interventions showed a statistically significant decrease of GDS score only in the Shiatsu group.

The authors concluded that the combination of Shiatsu and physical activity improved depression in AD patients compared to physical activity alone. The pathomechanism might involve neuroendocrine-mediated effects of Shiatsu on neural circuits implicated in mood and affect regulation.

The Journal Complementary Therapies in Medicine also published three ‘Highlights’ of this study:

  • We first evaluated the effect of Shiatsu in depressed patients with Alzheimer’s disease (AD).
  • Shiatsu significantly reduced depression in a sample of mild-to-moderate AD patients.
  • Neuroendocrine-mediated effect of Shiatsu may modulate mood and affect neural circuits.

Where to begin?

1 The study is called a ‘pilot’. As such it should not draw conclusions about the effectiveness of Shiatsu.

2 The design of the study was such that there was no accounting for the placebo effect (the often-discussed ‘A+B vs B’ design); therefore, it is impossible to attribute the observed outcome to Shiatsu. The ‘highlight’ – Shiatsu significantly reduced depression in a sample of mild-to-moderate AD patients – therefore turns out to be a low-light.

3 As this was a study with a control group, within-group changes are irrelevant and do not even deserve a mention.

4 The last point about the mode of action is pure speculation, and not borne out of the data presented.

5 Accumulating so much nonsense in one research paper is, in my view, unethical.

Research into alternative medicine does not have a good reputation – studies like this one are not inclined to improve it.

Grace Dasilva-Hill has just published an article entitled “Autism/ADHD and Vaccines – are we walking a tightrope whilst blindfolded?“. Who is Grace Dasilva-Hill, you will ask.

She is a professional registered homeopath, based in Charing – East Kent, UK. She has been in practice since 1997. During this time she has developed a busy practice, alongside teaching, running students’ clinics and tutorials. She was a team member of the Ghana Homeopathy Project soon after it started, and later became their treasurer as well. Grace has published in the Journal Homeopathy in Practice, and HPathy. She also is an ‘Energy EFT Master Practitioner Trainer’ and a ‘qualified CEASE therapist’.

And what is the Ghana Homeopathy Project ? It is an organization whose goal is the establishment of homeopathy as a recognised part of the health care system in Africa and Ghana in particular. Their objective is the relief and prevention of disease. They support the development of homeopathic education and wish to make homeopathy available to deprived communities as a valid and affordable form of treatment.

The lengthy article by Grace Dasilva-Hill re-hashes all the bogus arguments about immunisation that you could ever wish for. I will show you only what she calls her ‘conclusions’:

START OF QUOTE

…at the present time we have only just scratched the surface of the issue of autism and ADHD; my aim in this article is to challenge the reader to pause, reflect and ask: do vaccines do more good than harm, or it is actually the other way round? Just who is considered to be responsible for my health and that of my family – my doctor, my country’s government or myself? Do we need to stand up as a profession, and be more pro-active?

The big question seems to be, are we not only failing our patients but also the greater good of the world’s populations, unless we question and do not just ‘accept’ what science and medicine tells us, especially as ‘vested interests’ seem to have such a strong influence on what we are told?
The health journalist Phillip Day has done just that in his book ‘Health Wars’ – he argues how the multinationals have a vested interest in keeping all of us ill, for this is the only way that they can continue making money. His propositions are supported by Goldman Sacks Bank which recently stated that they would not invest in the alternative health industry because it tends to cure people, so there is little profit to be made from it.

I invite you to become an advocate for those who are unable or who are too young to ask questions, or to stand up for themselves, or whose parents don’t have the knowledge or tenacity to challenge.
Children and young adults suffering with autism, ADHD, ASD, deserve our loyalty, support and action.

In the UK, we recently shared the anguish and pain felt by baby Alfie Evans’ parents and family. It is impossible for anyone who is caring to witness such horror, and not to ask any questions. Hopefully we will learn much from this very sad event. There are questions not only about causative factors (ie. the role that vaccinations may have played), but also the issue of parental rights versus the State’s perceived protectionist rights.

What has been happening in the field of healthcare is fast becoming unsustainable. On the other hand Homeopathy has so much to offer, being a sustainable form of medicine not influenced by market forces.

One could argue that one of the reasons why the denialists want to see the demise of homeopathy and other natural modalities, is that more and more people are choosing these modes of healthcare in place of conventional medicine which is reductionist in approach and only has drugs to offer.

I find myself wondering whether there is a need for something radically different to happen. As a profession, do we need to do something collectively? Do we need to stand up more, do we need to speak up more? How do we go about doing this? I know that I am asking more questions than providing answers, and this is because at the moment I don’t have the answers either. But I have a deep and sincere desire to do my best to make a difference that will be both worthwhile and sustainable.
I would like to believe that others in our community would like to do the same for the bigger benefit of sustainable and effective healthcare for all.

Footnote: I have just carried out an impromptu, unrepresentative survey of homeopathic colleagues on a homeopathic professional group. I asked them if they knew of any health care professionals (doctors, nurses, midwives) who did not vaccinate their children. Most of those who replied, surprisingly said that they do know of at least one doctor, or nurse or midwife who did not vaccinate their children, and they added that these professionals keep this quiet. I certainly know of two medical doctors who do not vaccinate their children, and again they do not talk about it. It was shared with me in confidence.

END OF QUOTE

Of course, these words are not really ‘conclusions’, they are just a continuation of a barmy rant.

And yes, such articles exist in abundance. Many homeopaths are active campaigners against vaccination.

The Society of Homeopaths (SoH), the professional UK organisation for lay homeopaths, has recently stated that it is unethical for a homeopath to advise a patient against the use of conventional vaccines…  This could not be clearer! Yet, I suspect that the homeopaths put out such statements mainly to cover their backs and subsequently they do what they feel like – and they rarely feel like supporting vaccinations.

They obviously try to give the impression that lay homeopaths are not antivaxers. I fear, however, this impression is wrong: as we have discussed repeatedly on this blog, many homeopaths do advise their patients against immunisation. And many claim that homeopathic immunisations are an effective alternative. It takes not long to find even VIP-members of the SoH putting parents off from immunising their kids. And thanks to the Ghana Homeopathy and several similar projects, this is happening not just in the UK but also in Africa and elsewhere.

Is that not irresponsible?

In my view, it is!

Is that not illegal?

Apparently not, because such homeopaths usually add a clever disclaimer; Grace Dasilva-Hill for instance states that  Any information obtained here is not to be construed as medical OR legal advice. The decision to vaccinate and how you implement that decision is yours and yours alone. 

The HRI is an innovative international charity created to address the need for high quality scientific research in homeopathy… HRI is dedicated to promoting cutting research in homeopathy, using the most rigorous methods available, and communicating the results of such work beyond the usual academic circles… HRI aims to bring academically reliable information to a wide international audience, in an easy to understand form. This audience includes the general public, scientists, healthcare providers, healthcare policy makers, government and the media.

This sounds absolutely brilliant!

I should be a member of the HRI!

For years, I have pursued similar aims!

Hold on, perhaps not?

This article makes me wonder:

START OF QUOTE

… By the end of 2014, 189 randomised controlled trials of homeopathy on 100 different medical conditions had been published in peer-reviewed journals. Of these, 104 papers were placebo-controlled and were eligible for detailed review:
41% were positive (43 trials) – finding that homeopathy was effective
5% were negative (5 trials) – finding that homeopathy was ineffective
54% were inconclusive (56 trials)

How does this compare with evidence for conventional medicine?

An analysis of 1016 systematic reviews of RCTs of conventional medicine had strikingly similar findings2:
44% were positive – the treatments were likely to be beneficial
7% were negative – the treatments were likely to be harmful
49% were inconclusive – the evidence did not support either benefit or harm.

END OF QUOTE

The implication here is that the evidence base for homeopathy is strikingly similar to that of real medicine.

Nice try! But sadly it has nothing to do with ‘reliable information’!!!

In fact, it is grossly (and I suspect deliberately) misleading.

Regular readers of this blog will have spotted the reason, because we discussed (part of) it before. Let me remind you:

_______________________________________________________________________________

A clinical trial is a research tool for testing hypotheses; strictly speaking, it tests the ‘null-hypothesis’: “the experimental treatment generates the same outcomes as the treatment of the control group”. If the trial shows no difference between the outcomes of the two groups, the null-hypothesis is confirmed. In this case, we commonly speak of a negative result. If the experimental treatment was better than the control treatment, the null-hypothesis is rejected, and we commonly speak of a positive result. In other words, clinical trials can only generate positive or negative results, because the null-hypothesis must either be confirmed or rejected – there are no grey tones between the black of a negative and the white of a positive study.

For enthusiasts of alternative medicine, this can create a dilemma, particularly if there are lots of published studies with negative results. In this case, the totality of the available trial evidence is negative which means the treatment in question cannot be characterised as effective. It goes without saying that such an overall conclusion rubs the proponents of that therapy the wrong way. Consequently, they might look for ways to avoid this scenario.

One fairly obvious way of achieving this aim is to simply re-categorise the results. What, if we invented a new category? What, if we called some of the negative studies by a different name? What about INCONCLUSIVE?

That would be brilliant, wouldn’t it. We might end up with a simple statistic where the majority of the evidence is, after all, positive. And this, of course, would give the impression that the ineffective treatment in question is effective!

How exactly do we do this? We continue to call positive studies POSITIVE; we then call studies where the experimental treatment generated worst results than the control treatment (usually a placebo) NEGATIVE; and finally we call those studies where the experimental treatment created outcomes which were not different from placebo INCONCLUSIVE.

In the realm of alternative medicine, this ‘non-conclusive result’ method has recently become incredibly popular . Take homeopathy, for instance. The Faculty of Homeopathy proudly claim the following about clinical trials of homeopathy: Up to the end of 2011, there have been 164 peer-reviewed papers reporting randomised controlled trials (RCTs) in homeopathy. This represents research in 89 different medical conditions. Of those 164 RCT papers, 71 (43%) were positive, 9 (6%) negative and 80 (49%) non-conclusive.

This misleading nonsense was, of course, warmly received by homeopaths. The British Homeopathic Association, like many other organisations and individuals with an axe to grind lapped up the message and promptly repeated it: The body of evidence that exists shows that much more investigation is required – 43% of all the randomised controlled trials carried out have been positive, 6% negative and 49% inconclusive.

Let’s be clear what has happened here: the true percentage figures seem to show that 43% of studies (mostly of poor quality) suggest a positive result for homeopathy, while 57% of them (on average the ones of better quality) were negative. In other words, the majority of this evidence is negative. If we conducted a proper systematic review of this body of evidence, we would, of course, have to account for the quality of each study, and in this case we would have to conclude that homeopathy is not supported by sound evidence of effectiveness.

The little trick of applying the ‘INCONCLUSIVE’ method has thus turned this overall result upside down: black has become white! No wonder that it is so popular with proponents of all sorts of bogus treatments.

__________________________________________________________________________________

But one trick is not enough for the HRI! For thoroughly misinforming the public they have a second one up their sleeve.

And that is ‘comparing apples with pears’  – RCTs with systematic reviews, in their case.

In contrast to RCTs, systematic reviews can be (and often are) INCONCLUSIVE. As they evaluate the totality of all RCTs on a given subject, it is possible that some RCTs are positive, while others are negative. When, for example, the number of high-quality, positive studies included in a systematic review is similar to the number of high-quality, negative trials, the overall result of that review would be INCONCLUSIVE. And this is one of the reasons why the findings of systematic reviews cannot be compared in this way to those of RCTs.

I suspect that the people at the HRI know all this. They are not daft! In fact, they are quite clever. But unfortunately, they seem to employ their cleverness not for informing but for misleading their ‘wide international audience’.

Personally, I find our good friend Dana Ullman truly priceless. There are several reasons for that; one is that he is often so exemplarily wrong that it helps me to explain fundamental things more clearly. With a bit of luck, this might enable me to better inform people who might be thinking a bit like Dana. In this sense, our good friend Dana has significant educational value.

Recently, he made this comment:

According to present and former editors of THE LANCET and the NEW ENGLAND JOURNAL OF MEDICINE, “evidence based medicine” can no longer be trusted. There is obviously no irony in Ernst and his ilk “banking” on “evidence” that has no firm footing except their personal belief systems: https://medium.com/@drjasonfung/the-corruption-of-evidence-based-medicine-killing-for-profit-41f2812b8704

Ernst is a fundamentalist whose God is reductionistic science, a 20th century model that has little real meaning today…but this won’t stop the new attacks on me personally…

END OF COMMENT

Where to begin?

Let’s start with some definitions.

  • Evidence is the body of facts that leads to a given conclusion. Because the outcomes of treatments such as homeopathy depend on a multitude of factors, the evidence for or against their effectiveness is best based not on experience but on clinical trials and systematic reviews of clinical trials (this is copied from my book).
  • EBM is the integration of best research evidence with clinical expertise and patient values. It thus rests on three pillars: external evidence, ideally from systematic reviews, the clinician’s experience, and the patient’s preferences (and this is from another book).

Few people would argue that EBM, as it is applied currently, is without fault. Certainly I would not suggest that; I even used to give lectures about the limitations of EBM, and many experts (who are much wiser than I) have written about the many problems with EBM. It is important to note that such criticism demonstrates the strength of modern medicine and not its weakness, as Dana seems to think: it is a sign of a healthy debate aimed at generating progress. And it is noteworthy that internal criticism of this nature is largely absent in alternative medicine.

The criticism of EBM is often focussed on the unreliability of the what I called above the ‘best research evidence’. Let me therefore repeat what I wrote about it on this blog in 2012:

… The multifactorial nature of any clinical response requires controlling for all the factors that might determine the outcome other than the treatment per se. Ideally, we would need to create a situation or an experiment where two groups of patients are exposed to the full range of factors, and the only difference is that one group does receive the treatment, while the other one does not. And this is precisely the model of a controlled clinical trial.

Such studies are designed to minimise all possible sources of bias and confounding. By definition, they have a control group which means that we can, at the end of the treatment period, compare the effects of the treatment in question with those of another intervention, a placebo or no treatment at all.

Many different variations of the controlled trial exist so that the exact design can be adapted to the requirements of the particular treatment and the specific research question at hand. The over-riding principle is, however, always the same: we want to make sure that we can reliably determine whether or not the treatment was the cause of the clinical outcome.

Causality is the key in all of this; and here lies the crucial difference between clinical experience and scientific evidence. What clinician witness in their routine practice can have a myriad of causes; what scientists observe in a well-designed efficacy trial is, in all likelihood, caused by the treatment. The latter is evidence, while the former is not.

Don’t get me wrong; clinical trials are not perfect. They can have many flaws and have rightly been criticised for a myriad of inherent limitations. But it is important to realise that, despite all their short-comings, they are far superior than any other method for determining the efficacy of medical interventions.

There are lots of reasons why a trial can generate an incorrect, i.e. a false positive or a false negative result. We therefore should avoid relying on the findings of a single study. Independent replications are usually required before we can be reasonably sure.

Unfortunately, the findings of these replications do not always confirm the results of the previous study. Whenever we are faced with conflicting results, it is tempting to cherry-pick those studies which seem to confirm our prior belief – tempting but very wrong. In order to arrive at the most reliable conclusion about the efficacy of any treatment, we need to consider the totality of the reliable evidence. This goal is best achieved by conducting a systematic review.

In a systematic review, we assess the quality and quantity of the available evidence, try to synthesise the findings and arrive at an overall verdict about the efficacy of the treatment in question. Technically speaking, this process minimises selection and random biases. Systematic reviews and meta-analyses [these are systematic reviews that pool the data of individual studies] therefore constitute, according to a consensus of most experts, the best available evidence for or against the efficacy of any treatment.

END OF QUOTE

Other criticism is aimed at the way EBM is currently used (and abused). This criticism is often justified and necessary, and it is again the expression of our efforts to generate progress. EBM is practised by humans; and humans are far from perfect. They can be corrupt, misguided, dishonest, sloppy, negligent, stupid, etc., etc. Sadly, that means that the practice of EBM can have all of these qualities as well. All we can do is to keep on criticising malpractice, educate people, and hope that this might prevent the worst abuses in future.

Dana and many of his fellow SCAMers have a different strategy; they claim that EBM “can no longer be trusted” (interestingly they never tell us what system might be better; eminence-based medicine? experience-based medicine? random-based medicine? Dana-based medicine?).

The claim that EBM can no longer be trusted is clearly not true, counter-productive and unethical; and I suspect they know it.

Why then do they make it?

Because they feel that it entitles them to argue that homeopathy (or any other form of SCAM) cannot be held to EBM-standards. If EBM is unreliable, surely, nobody can ask the ‘Danas of this world’ to provide anything like sound data!!! And that, of course, would be just dandy for business, wouldn’t it?

So, let’s not be deterred  or misled by these deliberately destructive people. Their motives are transparent and their arguments are nonsensical. EBM is not flawless, but with our continued efforts it will improve. Or, to repeat something that I have said many times before: EBM is the worst form of healthcare, except for all other known options.

Nipah virus (NiV) infection is a zoonosis that causes severe disease in both animals and humans. The natural host of the virus are fruit bats of the Pteropodidae Family, Pteropus genus. Human-to-human transmission has also been documented, including in a hospital setting in India. Clinical presentations range from asymptomatic infection to acute respiratory syndrome and fatal encephalitis. There is no vaccine for either humans or animals. The primary treatment for human cases is intensive supportive care. In Kerala, India, several people have died of the deadly NiV.  The infection has a mortality rate of around 70%.

It was predictable that such events would bring homeopaths to the fore. This article explains:

The Indian Homeopathic Medical Association’s Kerala unit has claimed to have the medicines to treat Nipah virus. B Unnikrishnan, an association official, said homeopathy has the appropriate medicines for all types of fever and hence they should be allowed to treat the infected patients. The association has requested the state Health Minister KK Shailaja to allow their professionals to examine the records of all those patients who have been tested positive for Nipah… So far, 16 people have died and two are recovering. Some 2,000 people who came in contact with the infected patients are also being monitored.

Knowing that an international delegation of homeopaths travelled to Liberia to treat Ebola (with the official support of their respective professional organisations), this news cannot surprise anyone.

Homeopaths dilute their remedies and delude themselves.

Sadly, the victims of their dilutions/delusions are: 

  • their patients,
  • public health,
  • progress,
  • and rationality.

Our good friend Dana Ullman commented on my last post that doctors are being unethical by NOT prescribing homeopathic medicines because they are breaking one of the most important medical guidelines: “First, do no harm.” Here I do not want to discuss in-depth the nonsense about homeopathy in his sentence, rather I want to focus on the notion that doctors are obliged to foremost do no harm.

The sentence ‘first do no harm’ is supposed to originate from the Hippocratic oath which allegedly all doctors have to take when finishing medical school. This is twice wrong:

  1. we don’t take this oath – I have read it, and it is something utterly non-applicable to today;
  2. the famous sentence does not appear in the oath.

But never mind the history and all that! Doctors are nevertheless obliged to ‘first do no harm’ because it is an important principle of medical ethics.

This is also not true, I’m afraid.

If it were true, doctors would have to stop practicing much of medicine instantly. Clinicians do harm all the time. Their injections hurt, their diagnostic procedures can be unpleasant and painful, their medications cause adverse effects, their surgical interventions are full of risks, etc., etc. None of this would be remotely acceptable, if it did not also some good.

And that is why the ethical imperative of doing no harm has sensibly been changed to the imperative of doing more good than harm. Of course, doctors must be allowed to do even quite serious harm, as long as their actions can be expected to generate even more good. In more common medical terms, we speak of the risk/benefit balance of an intervention:

  • if the known risks of a treatment are greater than the expected benefits, we cannot ethically prescribe it;
  • if the benefits outweigh the risks, we can consider it as a reasonable option.

That is all very well, but it can only apply to treatments where both the risks and the benefits are well-understood. What about the many treatments where there is uncertainty regarding either or both of these factors? This question is impossible to answer in the abstract. We need to look at the best evidence we have for each specific case and, together with the patient, try to make an informed judgement.

Now, let’s please our good friend Dana and do such an evaluation for homeopathy, as one of many examples of an alternative therapy:

Therefore, one might argue that the balance of risk versus benefit might not look all that bad. Dana and his colleagues would thus feel that it ethically legitimate to routinely use homeopathy. But this line of thought would ignore an important issue: harm can be done not just by the remedy itself. The harm caused by applying an ineffective treatment for conditions that are otherwise effectively treatable (usually referred to as neglect) can be considerable, even fatal. So, for homeopathy the true situation presents itself as follows:

This results in a negative risk/benefit balance which means, as outlined above, we cannot ethically use homeopathy.

… and, of course, Dana’s statement (doctors are being unethical by NOT prescribing homeopathic medicines because they are breaking one of the most important medical guidelines: “First, do no harm.” ) turns out to be wrong on several levels.

My previous post was about the question whether lay-homeopaths can practise homeopathy without breaking their code of ethics. The answer was NO, because they lack most of the skills needed to obtain informed consent.

What about doctor homeopaths?

Can they practice homeopathy ethically?

Doctors are, of course, also obliged to follow their ethical code, and that means they too must obtain informed consent from their patients before starting a therapy. This is, for instance, what the UK General Medical Council tells their members:

You must give patients the information they want or need about:

  1. the diagnosis and prognosis
  2. any uncertainties about the diagnosis or prognosis, including options for further investigations
  3. options for treating or managing the condition, including the option not to treat
  4. the purpose of any proposed investigation or treatment and what it will involve
  5. the potential benefits, risks and burdens, and the likelihood of success, for each option; this should include information, if available, about whether the benefits or risks are affected by which organisation or doctor is chosen to provide care
  6. whether a proposed investigation or treatment is part of a research programme or is an innovative treatment designed specifically for their benefit4 
  7. the people who will be mainly responsible for and involved in their care, what their roles are, and to what extent students may be involved
  8. their right to refuse to take part in teaching or research
  9. their right to seek a second opinion
  10. any bills they will have to pay
  11. any conflicts of interest that you, or your organisation, may have
  12. any treatments that you believe have greater potential benefit for the patient than those you or your organisation can offer.

You should explore these matters with patients, listen to their concerns, ask for and respect their views, and encourage them to ask questions.

You should check whether patients have understood the information they have been given, and whether or not they would like more information before making a decision. You must make it clear that they can change their mind about a decision.

Following the 8 points from my previous post (I am trying to apply the same criteria to both types of homeopaths), a medical homeopath might tell her patient (whose stomach pain turns out to be caused, let’s assume, by a stomach ulcer) roughly this:

  1. The tests show that you are suffering from stomach ulcer.
  2. The natural history of this condition is usually benign, but it needs effective treatment; if not, the problem would become serious.
  3. Conventional medicine has several effective therapeutic options.
  4. I nevertheless propose to treat you with a homeopathic remedy.
  5. There is no good evidence that it will work beyond a placebo effect.
  6. The remedy is harmless, but not giving you an effective treatment might cause considerable harm.
  7. The cost of the consultation is £80, and the remedy will cost you around £15.
  8. I suggest you come again in a week or two; perhaps we need quite a few consultations altogether.

Again, as with the lay-homeopath from my previous post, any sensible patient would walk away without accepting the treatment. This means that our doctor homeopath can only practice homeopathy, if she does not inform her patient about points 5 and 6. In other words, doctors who practice homeopathy cannot obtain adequately informed consent. We have recently seen a real case of this happening and ending in the death of the patient.

Of course, the homeopath might send her patient to a specialist; or she might decide to administer a conventional therapy herself. Either way, she would not be practising homeopathy.

The dilemma is real, yet it is rarely considered. Here is a short passage from our book where we discuss the ethics of alternative medicine in full detail:

Genuine informed consent is unattainable for most CAM modalities. This presents a serious and intractable ethical problem for CAM practitioners. Attempts to square this circle by watering down or redefining the criteria for informed consent are ethically indefensible. The concept of informed consent and its centrality in medical ethics therefore renders most CAM practice unacceptable. Conventional healthcare subscribes to the ethical principle ‘no consent, no treatment’; we are not aware of the existence of any good reasons to excuse CAM from this dictum.

As I said, the ethical practice of homeopathy is a practical impossibility.

Or do you think I got this wrong?

I am not a regular reader of the ‘HALTERNER ZEITUNG’, I have to admit; but this article from the paper came to me because of my interest in homeopathy. It tells a tragic story of a German women who paid dearly for consulting a homeopath.

Here is an excerpt – as it is in German, I will sum up the essence of the story below in English.

_______________________________________________________________________________________________

…Die traurige Geschichte beginnt im Jahr 2012. Die später verstorbene Frau aus Haltern lässt sich von ihrer Ärztin wegen Heiserkeit behandeln und bekommt homöopathische Mittel. Rund zehn Monate später wechselt die Seniorin den Arzt und muss umgehend ins Krankenhaus: Luftröhrenschnitt, Kehlkopf-Entfernung, Krebs. Die Frau verstirbt nach vierjähriger Leidenszeit.

Für Schwester und Tochter war das nicht nur ein Schock, sie machen der Ärztin nun auch schwere Vorwürfe. Aus ihrer Sicht hätte praktisch sofort eine Überweisung zu einem HNO-Arzt und damit eine schulmedizinische Behandlung erfolgen müssen.

Genau das habe die Patientin aber nicht gewollt, sagte die Ärztin. „Sie hat sich immer dagegen gewehrt.“ Angeblich soll das auch dokumentiert sein. Doch auch das ist umstritten. Die Hinterbliebenen werfen der Ärztin nämlich vor, die Unterlagen gefälscht zu haben.

150.000 Euro haben sie als Schmerzensgeld eingeklagt. Dafür sah die Medizinkammer zum jetzigen Zeitpunkt jedoch keine Grundlage. „Die Haftung ist vollkommen offen“, sagte Richter Norbert Schalla.

Man wolle die Leiden der Frau zwar nicht in Abrede stellen. Die Frage sei jedoch, inwieweit die Behandlung eines krankheitsbedingten Leidens tatsächlich verzögert worden sei. „Wir müssten erstens eine Pflichtverletzung und zweitens die Kausalität feststellen“, so Schalla. Beides sei aber außerordentlich schwierig, weil es außer der Ärztin keine Zeugen gebe.

Trotzdem hatten die Richter am Essener Landgericht am Ende eine „Goodwill-Zahlung“ vorgeschlagen, um einen möglicherweise jahrelangen Rechtsstreit zu verhindern. „Manchmal ist es besser, zu einem Abschluss zu kommen, damit man seinen inneren Frieden wiederfinden kann.“

Genau so hat es die Ärztin am Ende wohl auch gesehen. Ob die 10.000 Euro aber wirklich gezahlt werden, hängt allerdings noch von ihrer Haftpflicht-Versicherung ab. Die kann in den nächsten zwei Wochen noch ihr Veto einlegen.

Auch die Hinterbliebenen können die Einigung noch immer widerrufen. Sie müssen von dem Geld nämlich 94 Prozent der Prozesskosten tragen.

_______________________________________________________________________________________________

Here is my summary:

  • An elderly woman with a sore throat consults her doctor who happens to be a homeopath.
  • The doctor prescribes homeopathic remedies.
  • The homeopathic treatment continues for months, evidently without success.
  • 10 months later, the patient changes her doctor, and her new physician sends her straight away into hospital.
  • There she is diagnosed with throat cancer.
  • After 4 years of suffering, the woman dies.
  • The patients relatives sue the homeopath for the relatively modest sum of 150 000 Euros.
  • The homeopath claims that the old woman had refused to be referred to a specialist and that the case notes provide proof for that claim.
  • The relatives suspect that the case notes have been altered retrospectively.
  • The judge suggest a ‘good will’ payment of 10 000 Euro.
  • The homeopath accepts, but it remains unclear whether the insurance agrees to pay this sum.
  • The relatives have to pay 94% of the costs for the court proceedings.

_______________________________________________________________________________________________

Anyone who claims that homeopathy is harmless should remember this story. Similar (but hopefully less dramatic) things happen almost every time a homeopath treats a patient, we argue in our book. The practice of homeopathy is by and large medical neglect. Because homeopathy is employed mostly for minor, self-limiting conditions, the neglect usually remains invisible. However, as soon as homeopath venture to treat serious diseases, the neglect (the deliberate treatment of a disease with an ineffective therapy) becomes obvious.

Recent Comments

Note that comments can be edited for up to five minutes after they are first submitted.


Click here for a comprehensive list of recent comments.

Categories