MD, PhD, FMedSci, FRSB, FRCP, FRCPEd

progress

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Doctor Jonas is an important figure head of US ‘Integrative Medicine’. As we discussed in a recent post, he pointed out that many US hospital doctors fail to answer the following questions relating to their chronically ill patients:

  1. “What matters most for this patient?
  2. What is the person’s lifestyle like – their nutrition, movement and sleep?
  3. How does that patient manage their stress?
  4. Does that patient have a good support system at home?
  5. What supplements does that patient take? Has your patient seen any CAM practitioners to cope with their condition?
  6. Why do they want to get well?”

In my previous post, I tried to explain that this is embarrassing – embarrassing for doctor Jonas, I meant.

But Jonas also claims that most US hospital doctors he addressed during his lecture tour, were unable to answer these questions. And that might be embarrassing not for Jonas, but for those physicians. Let’s consider this possibility for a moment.

The way I see it, the doctors in question might not have answered to Jonas for the following reasons:

  • They felt that the questions were simply too daft to bother.
  • They were too polite to tell Jonas what they think of him.
  • They were truly unable to answer the questions.

Here I want to briefly deal with the last category.

I do not doubt for a minute that this category of physician exists. They have little interest in what matters to their patients, don’t ask the right questions, have no time and even less empathy and compassion. Yet nobody can deny that medical school teaches all of these qualities, skills and attitudes. And there is no doubt that good doctors practice them; it is not a choice but an ethical and moral imperative.

So, what went wrong with these doctors?

Probably lots, and I cannot begin to tell you what exactly. However, I can easily tell you that those doctors are not practicing good medicine. Similarly, I can tell you what these doctors ought to do: re-train and be reminded of what medical school has once taught them.

And what about those physicians who advocate ‘integrated medicine’ reminding everyone of the core values of healthcare?

Aren’t they fabulous?

No, they aren’t!

Why?

Because they too have evidently forgotten what they should have learnt at medical school. If not, they would not be able to pretend that ‘integrative medicine’ has a monopoly on core values of all healthcare. Their messages are akin to a new ‘school’ of ship-building insisting that it is beneficial to build ships that do not leak.

What I am trying to say in my clumsy way is this:

DOCTORS WHO PRACTICE BAD MEDICINE SHOULD RE-TRAIN – TOGETHER WITH THOSE PHYSICIANS WHO ADVOCATE ‘INTEGRATIVE MEDICINE‘, BECAUSE THEY BOTH HAVE FORGOTTEN WHAT THEY LEARNT AT MEDICAL SCHOOL.

How often have we heard this? YOU ARE WRONG! MY TREATMENT DOES WORK!!! ONLY THE OTHER DAY, I HAD A PATIENT WHO WAS CURED BY IT.

Take for instance this tweet I got yesterday:

F SThomas‏ @spenthomf

You go too far @EdzardErnst. In fact I was consulted about a child who hadn’t grown after an accident. She responded well to homoeopathy and grew. How much are you being paid for your attempts to deny people’s health choices?

The tweet refers to my last post where I exposed homeopathic child abuse. Having thought about Thomas’ tweet, I must say that I find it too to be abusive – even abusive on 4 different levels.

  1. First, the tweet is obviously a personal attack suggesting that I am bribed into doing what I do. I have stated it many times, and I do so again: I receive no payment from anyone for my work. How then do I survive? I have a pension and savings (not that this is anyone’s business).
  2. Second, it is abusive because it claims that children who suffer from a pathological growth retardation can benefit from homeopathy. There is no evidence for that at all, and making false claims of this nature is unethical and, in this case, even abusive.
  3. Third, if Thomas really did make the observation she suggests in her tweet and is convinced that her homeopathic treatment was the cause of the child’s improvement, she has an ethical duty to do something more about it than just shooting off a flippant tweet. She could, for instance, run a clinical trial to find out whether her observation was correct. I admit this might be beyond her means. So alternatively, she could write up the case in full detail and publish it for all of us to scrutinise her findings. This is the very minimum a responsible clinician ought to do when she comes across a novel and potentially important result. Anything else is my view unethical and hinders progress.

I do, of course, sympathise with lay people who fail to fully understand the concept of causality. But surely, healthcare professionals who pride themselves of taking charge of patients ought to have some comprehension of it. They should know that clinical improvements after a treatment is not necessarily the same as clinical improvement because of the treatment. Is it really too much to ask of them to know the criteria for causality? There is plenty of easy-reading on the subject; even Wikipedia has a good article on it:

In 1965, the English statistician Sir Austin Bradford Hill proposed a set of nine criteria to provide epidemiologic evidence of a causal relationship between a presumed cause and an observed effect. (For example, he demonstrated the connection between cigarette smoking and lung cancer.) The list of the criteria is as follows:

  1. Strength (effect size): A small association does not mean that there is not a causal effect, though the larger the association, the more likely that it is causal.
  2. Consistency (reproducibility): Consistent findings observed by different persons in different places with different samples strengthens the likelihood of an effect.
  3. Specificity: Causation is likely if there is a very specific population at a specific site and disease with no other likely explanation. The more specific an association between a factor and an effect is, the bigger the probability of a causal relationship.
  4. Temporality: The effect has to occur after the cause (and if there is an expected delay between the cause and expected effect, then the effect must occur after that delay).
  5. Biological gradient: Greater exposure should generally lead to greater incidence of the effect. However, in some cases, the mere presence of the factor can trigger the effect. In other cases, an inverse proportion is observed: greater exposure leads to lower incidence.
  6. Plausibility: A plausible mechanism between cause and effect is helpful (but Hill noted that knowledge of the mechanism is limited by current knowledge).
  7. Coherence: Coherence between epidemiological and laboratory findings increases the likelihood of an effect. However, Hill noted that “… lack of such [laboratory] evidence cannot nullify the epidemiological effect on associations”.
  8. Experiment: “Occasionally it is possible to appeal to experimental evidence”.
  9. Analogy: The effect of similar factors may be considered.

And this brings me to my 4th and last level of abuse in relation to the above tweet and most other claims of this nature: being ill-informed and stupid while insisting to make a nonsensical point is, in my view, offensive – so much so that it can reach the level of abuse.

On their website, the British Homeopathic Association (BHA) have launched their annual winter appeal. Its theme this year is ‘building a better future for homeopathy’. The appeal is aimed at the following specific goals:

  • Continuously fighting to retain NHS services in the UK by supporting local patients & groups and providing swift media responses employing experts in areas such as media, politics, law and reputation management for ultimate effectiveness. Currently undertaking a legal challenge to NHS England
  • Establishing charitable homeopathic clinics throughout the UK, with clinics currently in Norwich, York, Bath, Edinburgh and looking at developing other clinics in Liverpool, Wales, Oxford and London in 2018.
  • Making further investment to enhance our digital presence and promotion of key messages.
  • Continuoustly improving our website to make it the place for information on homeopathy from finding practitioners to finding the latest Health & Homeopathy online.
  • Investing in research and education to keep homeopathy strong in the long term, increasing the number of healthcare professionals using homeopathy in their everyday practice.
  • Taking homeopathy to the people and growing our community of supporters with public events, local events and national promotion.

I have to say, I find this almost touching in its naivety. I imagine another lobby group, say the cigarette industry, launching a winter appeal: BUILDING A BETTER FUTURE FOR CIGARETTES.

Do I hear you object?

Cigarettes are unhealthy and not a medical treatment!!!

Quite so! Homeopathy is also unhealthy and not a medical treatment, I would argue. Sure, highly dilute homeopathics do not kill you, but homeopathy easily can. We have seen this on this blog many times. Homeopathy kills when it is advocated and consequently used as an alternative therapy for a life-threatening disease; there is no question about it. And there also is no question about the fact that this happens with depressing regularity. If you doubt it, just read some of my previous posts on the subject.

In any case, an appeal by a medical association should not be for its own benefit (homeopathy); it should be for patients (patients tempted to try homeopathy), I would suggest. So, lets design the goals of an appeal for patients along the lines of the above appeal – except our appeal has to actually be in the best interest of vulnerable patients.

Here we go:

  • Continually fighting to stop homeopathy on the NHS. As homeopathy does not generate more good than harm (no ineffective therapy can ever do that), we have a moral, legal and ethical duty to use our scarce resources such that they create the maximum benefit; and this means we cannot use them for homeopathy.
  • Establishing charitable organisations that educate the public about science and evidence. Too many consumers are still falling victim to the pseudo-science of charlatans who mislead people for their own profit.
  • Making further investments to combating the plethora of unethical misinformation by self-interested quacks and organisations many of which even have charitable status.
  • Continually improving websites that truthfully inform the public, politicians, journalists and others about medicine, science and healthcare.
  • Investing in research and education to keep science and evidence-based medicine strong, for the benefit of vulnerable patients and in the interest of progress.
  • Taking the science agenda to the people and growing the community of science-literate supporters on a local, national and international level.

As I had to follow the lines of the BHA, these goals are regrettably not perfect – but I am sure they are a whole lot better than the BHA original!

This blog is almost entirely about critical thinking as it applies to the realm of alternative medicine, and I have written about it more often than I care to remember. For instance, in one post I concluded that criticism  in alternative medicine is directed almost exclusively towards those who are outside the realm. Criticism from the inside is as good as non-existent.

The consequences of this situation are easy to see for everyone, and they can be dramatic:

  • The journals of alternative medicine publish nothing that could be perceived to be negative for the practice of alternative medicine.
  • Self-critical thinking has no tradition and has remained an almost alien concept.
  • The very few people from the ‘inside’ who dare to criticise alternative practices are ousted and/or declared to be incompetent or worse.
  • No action is taken to initiate change.
  • The assumptions of alternative medicine remain unaltered for centuries.
  • Progress is all but absent.

But what exactly is critical thinking? The ‘Foundation of Critical Thinking‘ defines it as follows: Critical thinking is the intellectually disciplined process of actively and skillfully conceptualizing, applying, analyzing, synthesizing, and/or evaluating information gathered from, or generated by, observation, experience, reflection, reasoning, or communication, as a guide to belief and action. In its exemplary form, it is based on universal intellectual values that transcend subject matter divisions: clarity, accuracy, precision, consistency, relevance, sound evidence, good reasons, depth, breadth, and fairness.

In an article in the Scientific American Heather butler recently provided further clarification. Here is a short extract from this most commendable paper:

START OF QUOTE

Though often confused with intelligence, critical thinking is not intelligence. Critical thinking is a collection of cognitive skills that allow us to think rationally in a goal-orientated fashion, and a disposition to use those skills when appropriate. Critical thinkers are amiable skeptics. They are flexible thinkers who require evidence to support their beliefs and recognize fallacious attempts to persuade them. Critical thinking means overcoming all sorts of cognitive biases (e.g., hindsight bias, confirmation bias).

Critical thinking predicts a wide range of life events. In a series of studies, conducted in the U.S. and abroad, my colleagues and I have found that critical thinkers experience fewer bad things in life. We asked people to complete an inventory of life events and take a critical thinking assessment (the Halpern Critical Thinking Assessment). The critical thinking assessment measures five components of critical thinking skills including verbal reasoning, argument analysis, hypothesis testing, probability and uncertainty, decision-making, and problem-solving. The inventory of negative life events captures different domains of life such as academic (e.g., I forgot about an exam), health (e.g., I contracted a sexually transmitted infection because I did not wear a condom), legal (e.g., I was arrested for driving under the influence), interpersonal (e.g., I cheated on my romantic partner who I had been with for over a year), financial (e.g., I have over $5,000 of credit card debt), etc. Repeatedly, we found that critical thinkers experience fewer negative life events. This is an important finding because there is plenty of evidence that critical thinking can be taught and improved.

Is it better to be a critical thinker or to be intelligent? My latest research pitted critical thinking and intelligence against each other to see which was associated with fewer negative life events. People who were strong on either intelligence or critical thinking experienced fewer negative events, but critical thinkers did better.

Intelligence and improving intelligence are hot topics that receive a lot of attention. It is time for critical thinking to receive a little more of that attention. Keith Stanovich wrote an entire book about What Intelligence Tests Miss. Reasoning and rationality more closely resemble what we mean when we say a person is smart than spatial skills and math ability. Furthermore, improving intelligence is difficult. Intelligence is largely determined by genetics. Critical thinking, though, can improve with training and the benefits have been shown to persist over time. Anyone can improve their critical thinking skills: Doing so, we can say with certainty, is a smart thing to do.

END OF QUOTE

We cannot learn to be intelligent, but we can learn how to think critically. If my blog helps some readers to achieve this aim, I would consider the effort worthwhile.

In 2017, Medline listed just over 1800 articles on ‘complementary alternative medicine’. If you find this number impressively high, consider that, for ‘surgery’ (a subject that has often been branded as less that active in conducting research), there were almost 18 000 Medline-listed papers.

So, the research activity in CAM is relatively small. Vis a vis the plethora of open questions, this inactivity is perhaps lamentable. What I find much more regrettable, however, is the near total lack of investigations into the ethical issues in CAM. In 2017, there were just 11 articles on Medline on ‘ethics and CAM’ (24393 articles on ‘ethics and surgery’).

One of the 11 papers that tackled the ethics directly and that was (in my opinion) one of the best is this article. Here is its concluding paragraph:

When we encounter patients who use or consider the use of complementary and/or alternative medicine, we should respect their autonomy while also fulfilling our obligations of beneficence and nonmaleficence. Physicians should become more knowledgeable about research on CAM therapies and approach discussions in an open, nonjudgmental manner to enhance patient trust. In situations where there is little risk of harm and the possibility of benefit, supporting a patient in their interest in complementary therapies can strengthen the patient-physician relationship. However, when a patient’s desire to utilize alternative therapies poses a health risk, physicians have the ethical obligation to skillfully counsel the patient toward those therapies that are medically appropriate.

I have had a long-lasting and keen interest in the ethics of CAM which resulted in the publication of many papers. Here is a selection:

Problems with ethical approval and how to fix them: lessons from three trials in rheumatoid arthritis.

‘Complementary & Alternative Medicine’ (CAM): Ethical And Policy Issues.

Pharmacists and homeopathic remedies.

No obligation to report adverse effects in British complementary and alternative medicine: evidence for double standards.

Homeopathy, a “helpful placebo” or an unethical intervention?

Advice offered by practitioners of complementary/ alternative medicine: an important ethical issue.

The ethics of British professional homoeopaths.

Evidence-based practice in British complementary and alternative medicine: double standards?

Ethics of complementary medicine: practical issues.

The ethics of chiropractic.

Reporting of ethical standards: differences between complementary and orthodox medicine journals?

Informed consent: a potential dilemma for complementary medicine.

Ethical problems arising in evidence based complementary and alternative medicine.

Complementary medicine: implications for informed consent in general practice.

Ethics and complementary and alternative medicine.

Research ethics questioned in Qigong study.

Informed consent in complementary and alternative medicine.

The ethics of complementary medicine.

For most of the time conducting this research, I felt that I was almost alone in realising the importance of this topic. And all this time, I was convinced that the subject needed more attention and recognition. Therefore, I teamed up with with the excellent ethicist Kevin Smith from the University of Dundee, and together we spent the best part of 2017 writing about it.

Our book is entitled ‘MORE HARM THAN GOOD? THE MORAL MAZE OF COMPLEMENTARY AND ALTERNATIVE MEDICINE’ and will be published shortly by Springer.

Product Details

It is an attempt to highlight some of the most important topics in this broad and under-researched area. While working on it, I was continually struck by the fact that most of the issues we have been struggling with on this blog are, in the final analysis, ethical by nature.

My hope is that, in 2018, we will see many more high quality papers filling the almost total void of ethical perspectives on CAM. In my view, it is unquestionably an area that needs to be addressed with some urgency.

At this time of the year it is customary to look back and highlight some remarkable things that occurred during the last 12 months. Here I will try to identify for each month the most important event. My choice is entirely subjective, and I invite everybody to disagree with it and add other happenings.

JANUARY

The U.S. Food and Drug Administration announced today that its laboratory analysis found inconsistent amounts of belladonna, a toxic substance, in certain homeopathic teething tablets, sometimes far exceeding the amount claimed on the label. The agency is warning consumers that homeopathic teething tablets containing belladonna pose an unnecessary risk to infants and children and urges consumers not to use these products.

FEBRUARY

It has just been reported that the Russian Academy of Sciences (RAS) has labelled homeopathic medicine a health hazard. The organization is now petitioning Russia’s Ministry of Health to abandon the use of homeopathic medicine in the country’s state hospitals, the RBC news outlet reported Monday.

A RAS committee warns that some patients were rejecting standard medicine for serious conditions in favour of homeopathic remedies, a move that almost inevitably puts their lives in danger. The committee also noted that, because of sloppy quality control during the manufacturing processes, some unlicensed homeopathic remedies contain toxic substances which harm patients in a direct fashion.

“The principles of homeopathy contradict known chemical, physical and biological laws and persuasive scientific trials proving its effectiveness are not available,” the committee stated in its report.

MARCH

George Lewith has died on 17 March, aged 67. He was one of the most productive researchers of alternative medicine in the UK; specifically he was interested in acupuncture. If you search this blog, you find several posts that mention him or are entirely dedicated to his work. Undeniably, my own views and research were often very much at odds with those of Lewith.

APRIL

A new review of the risks of spinal manipulative therapy (SMT) concluded that it is currently not possible to provide an overall conclusion about the safety of SMT; however, the types of SAEs reported can indeed be significant, sustaining that some risk is present. High quality research and consistent reporting of AEs and SAEs are needed.

MAY

My favourite journal has succumbed to BS. A review that is ‘state of the art’ must fulfil certain criteria; foremost it should be informative, unbiased and correct. The paper I am discussing here has, I think, neither of these qualities. It is entitled ‘Management of chronic pain using complementary and integrative medicine’, and here is its abstract:

Complementary and integrative medicine (CIM) encompasses both Western-style medicine and complementary health approaches as a new combined approach to treat a variety of clinical conditions. Chronic pain is the leading indication for use of CIM, and about 33% of adults and 12% of children in the US have used it in this context. Although advances have been made in treatments for chronic pain, it remains inadequately controlled for many people. Adverse effects and complications of analgesic drugs, such as addiction, kidney failure, and gastrointestinal bleeding, also limit their use. CIM offers a multimodality treatment approach that can tackle the multidimensional nature of pain with fewer or no serious adverse effects. This review focuses on the use of CIM in three conditions with a high incidence of chronic pain: back pain, neck pain, and rheumatoid arthritis. It summarizes research on the mechanisms of action and clinical studies on the efficacy of commonly used CIM modalities such as acupuncture, mind-body system, dietary interventions and fasting, and herbal medicine and nutrients.

JUNE

Scientology seems to have started an aggressive campaign in the UK to promote its cult.

JULY

The NHS seems to be edging towards banning homeopathy.

AUGUST

A group of German experts published a document pointing out that the ‘Heilpraktiker’ has introduced two hugely different quality standards into the German healthcare system. In the interest of the patient and of good healthcare, this double standard must be addressed. We are demanding the profession of the Heilpraktiker either is completely abolished, or is reformed such that it no longer poses a threat to public health in Germany. Our document makes concrete suggestions for such reforms.

SEPTEMBER

It has been announced that Susan and Henry Samueli have given US$ 200 million to medical research at the University of California, Irvine (UCI). Surely this is a generous and most laudable gift! How could anyone doubt it?

OCTOBER

I feel deeply honoured to have received the Ockham Award. It is a generous appreciation of our small efforts in decreasing the ignorance and stupidity that seems to be all around us today – sadly not just in the realm of alternative medicine (but that would be the subject of another blog). I thank everyone who contributed to our blog’s success and hope you keep the comments coming.

NOVEMBER

The RCVS publishes a position paper on alternative medicine for animals: “Homeopathy exists without a recognised body of evidence for its use. Furthermore, it is not based on sound scientific principles. In order to protect animal welfare, we regard such treatments as being complementary rather than alternative to treatments for which there is a recognised evidence base or which are based in sound scientific principles. It is vital to protect the welfare of animals committed to the care of the veterinary profession and the public’s confidence in the profession that any treatments not underpinned by a recognised evidence base or sound scientific principles do not delay or replace those that do.”

DECEMBER

The US Food and Drug Administration proposed a new, risk-based enforcement approach to drug products labeled as homeopathic. To protect consumers who choose to use homeopathic products, this proposed new approach would update the FDA’s existing policy to better address situations where homeopathic treatments are being marketed for serious diseases and/or conditions but where the products have not been shown to offer clinical benefits. It also covers situations where products labeled as homeopathic contain potentially harmful ingredients or do not meet current good manufacturing practices…

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This time of the year is also a good moment for thanking those who made writing this blog an exercise that is fun and hopefully constructive. Happy New Year to all of you.

On their  website, the US Food and Drug Administration (FDA) has recently published a statement on homeopathy which, I think, is important enough to get cited extensively:

… Food and Drug Administration proposed a new, risk-based enforcement approach to drug products labeled as homeopathic. To protect consumers who choose to use homeopathic products, this proposed new approach would update the FDA’s existing policy to better address situations where homeopathic treatments are being marketed for serious diseases and/or conditions but where the products have not been shown to offer clinical benefits. It also covers situations where products labeled as homeopathic contain potentially harmful ingredients or do not meet current good manufacturing practices…

The FDA’s proposed approach prioritizes enforcement and regulatory actions involving unapproved drug products labeled as homeopathic that have the greatest potential to cause risk to patients…  The FDA intends to focus its enforcement authorities on the following kinds of products:

  • products with reported safety concerns;
  • products that contain or claim to contain ingredients associated with potentially significant safety concerns;
  • products for routes of administration other than oral and topical;
  • products intended to be used for the prevention or treatment of serious and/or life-threatening diseases and conditions;
  • products for vulnerable populations; and
  • products that do not meet standards of quality, strength or purity as required under the law.

Examples of products that may be subject to the enforcement priorities in the draft guidance are infant and children’s products labeled to contain ingredients associated with potentially significant safety concerns, such as belladonna and nux vomica; and products marketed for serious conditions, such as cancer and heart disease.

While the FDA considers comments to the draft guidance, the FDA intends to examine how the agency is implementing its current compliance policy. Given the concerns about the proliferation of potentially ineffective and harmful products labeled as homeopathic, the FDA will consider taking additional enforcement and/or regulatory actions, consistent with the current enforcement policies, which also align with the risk-based categories described in the draft guidance, in the interest of protecting the public…

Until relatively recently, homeopathy was a small market for specialized products. Over the last decade, the homeopathic drug market has grown exponentially, resulting in a nearly $3 billion industry that exposes more patients to potential risks associated with the proliferation of unproven, untested products and unsubstantiated health claims. During this time, the FDA has seen a corresponding increase in safety concerns, including serious adverse events, associated with drug products labeled as homeopathic. In addition, the agency has also found an increasing number of poorly manufactured products that contain potentially dangerous amounts of active ingredients that can create additional risks.

In September 2016, the FDA warned against the use of homeopathic teething tablets and gels containing belladonna, a toxic substance that has an unpredictable response in children under two years of age, after the products were associated with serious adverse events, including seizures and deaths, in infants and children. An FDA lab analysis later confirmed that certain homeopathic teething tablets contained elevated and inconsistent levels of belladonna. A similar issue occurred in 2010 when Hyland’s Teething Tablets were found to contain varying amounts of belladonna. An FDA inspection of that product’s manufacturing facility indicated substandard control of the product’s manufacturing.

The FDA has issued warnings related to a number of other homeopathic drug products over the past several years. These include certain homeopathic zinc-containing intranasal products that may cause a loss of sense of smell, homeopathic asthma products that have not been shown to be effective in treating asthma and various homeopathic drug products labeled to contain potentially toxic ingredients, like nux vomica, which contains strychnine (a highly toxic, well-studied poison often used to kill rodents).

“Homeopathic products have not been approved by the FDA for any use and may not meet modern standards for safety, effectiveness and quality,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “The draft guidance is an important step forward in the agency’s work to protect patients from unproven and potentially dangerous products.”…

The FDA is not alone in reexamining its approach to homeopathy. In November 2016, the Federal Trade Commission (FTC) announced a new enforcement policy explaining that they will hold efficacy and safety claims for over-the-counter homeopathic drugs to the same standard as other products making similar health claims. Notably, the FTC said that companies must have competent and reliable scientific evidence for health-related claims, including claims that a product can treat specific conditions…

END OF QUOTE

US homeopaths were quick to respond, as reported here:

The National Center for Homeopathy’s board of directors stated:

The National Center for Homeopathy supports the FDA’s efforts to ensure safety and good manufacturing practices in the industry. We are committed to working with industry partners to protect consumer access to homeopathic medicines, and we are hopeful that this action will not impede access. Homeopathic medicines are safe, gentle and effective when products are manufactured in accordance with HPUS (Homoeopathic Pharmacopoeia of the United States) guidelines under CGMPs (Current Good Manufacturing Practices). We welcome the opportunity to educate consumers and healthcare professionals about the unique aspects of homeopathic medicine.

Of course, the unique aspect of homeopathic medicines undoubtedly is that they usually contain no active molecules and therefore do not work. But somehow, I doubt that the NCH was thinking of telling consumers the truth.

The NCH statement is tame in comparison with the NCH’s response to the FDA’s actions during the homeopathic teething investigation last year. Prior to the recall, the FDA issued a warning to consumers, which the NCH dubbed as “arbitrary and capricious.” The NCH went on to say that the FDA’s warning led to “exaggerated fear mongering” in the media and a “public scare” that threatened access to homeopathic products. “[G]roups interested in seeing homeopathy destroyed continue to hammer away at the system—making exaggerated claims that create misunderstandings about and limit consumer access,” the NCH wrote [emphasis theirs].

And this response is tame compared to what a prominent US homeopaths claimed at the time:

“It’s time to hold these people accountable. There are laws in every country against officials taking bribes and malfeasance in office. Write to your legislators and demand that they investigate and bring these criminals to justice. Send them the links to hundreds of homeopathy studies, including disease prevention with homeopathy, at the end of this article.   Tell them that the regulatory agencies are protecting Pharma profits, not the public.

Meanwhile, let us insist that pharmaceutical drugs be labeled honestly, like this:

“This drug was tested by the same company that profits from it, and which company has been fined millions of dollars in the past for lying about test results. This drug does not cure any medical condition, but only suppresses symptoms which may ultimately make the patient sicker. This drug has already  killed or injured X  number of people.”

The outrage is understandable for two reasons, I think:

  1. even homeopaths cannot deny that the days of unchecked claims are counted;
  2. against rage of this sort homeopathic remedies are obviously not working.

This overview by researchers from that Arthritis Research UK Primary Care Centre, Research Institute for Primary Care & Health Sciences, Keele University, UK, was aimed at summarising the current best evidence on treatment options for 5 common musculoskeletal pain presentations: back, neck, shoulder, knee and multi-site pain. Reviews and studies of treatments were considered of the following therapeutic options: self-management advice and education, exercise therapy, manual therapy, pharmacological interventions (oral and topical analgesics, local injections), aids and devices, other treatments (ultrasound, TENS, laser, acupuncture, ice / hot packs) and psychosocial interventions (such as cognitive-behavioural therapy and pain-coping skills).

Here are the findings for those treatments most relevant in alternative medicine (it is interesting that most alternative medicines were not even considered because of lack of evidence and that the team of researchers can hardly be accused of an anti-alternative medicine bias, since its senior author has a track record of publishing results favourable to alternative medicine):

EXERCISE

Current evidence shows significant positive effects in favour of exercise on pain, function, quality of life and work related outcomes in the short and long-term for all the musculoskeletal pain presentations (compared to no exercise or other control) but the evidence regarding optimal content or delivery of exercise in each case is inconclusive.

ACUPUNCTURE

The evidence from a good quality individual patient data meta-analysis suggests that acupuncture may be effective for short-term relief of back pain and knee pain with medium summary effect sizes respectively compared with usual care or no acupuncture. However, effects on function were reported to be minimal and not maintained at longer-term follow-up. Similarly for neck and shoulder pain, acupuncture was only found to be effective for short-term (immediately post-treatment and at short-term follow-up) symptom relief compared to placebo.

MANUAL THERAPY

Current evidence regarding manual therapy is beset by heterogeneity. Due to paucity of high quality evidence, it is uncertain whether the efficacy of manual therapy might be different for different patient subgroups or influenced by the type and experience of professional delivering the therapy. On the whole, the available evidence suggests that manual therapy may offer some beneficial effects on pain and function, but it may not be superior to other non-pharmacological treatments (e.g. exercise) for patients with acute or chronic musculoskeletal pain.

Overall. the authors concluded that the best available evidence shows that patients with musculoskeletal pain problems in primary care can be managed effectively with non-pharmacological treatments such as self-management advice, exercise therapy, and psychosocial interventions. Pharmacological interventions such as corticosteroid injections (for knee and shoulder pain) were shown to be effective treatment options for the short-term relief of musculoskeletal pain and may be used in addition to non-pharmacological treatments. NSAIDs and opioids also offer short-term benefit for musculoskeletal pain, but the potential for adverse effects must be considered. Furthermore, the optimal treatment intensity, methods of application, amount of clinical contact, and type of provider or setting, are unclear for most treatment options.

These findings confirm what we have pointed out many times before on this blog. There is very little that alternative therapies have to offer for musculoskeletal pain. Whenever it is possible, I would recommend exercise therapy initiated by a physiotherapist; it is inexpensive, safe, and at least as effective as acupuncture or chiropractic or osteopathy.

Practitioners of alternative medicine will, of course, not like this solution.

Acupuncturists may not be that bothered by such evidence: their focus is not necessarily on musculoskeletal but on a range of other conditions (with usually little evidence, I hasten to add).

But for chiropractors and osteopaths, this is much more serious, in my view. Of course, some of them also claim to be able to treat a plethora of non-musculoskeletal conditions (but there the evidence is even worse than for musculoskeletal pain, and therefore this type of practice is clearly unethical). And those who see themselves as musculoskeletal specialists have to either accept the evidence that shows little benefit and considerable risk of spinal manipulation, or go in a state of denial.

In the former case, the logical conclusion is to look for another job.

In the latter case, the only conclusion is that their practice is not ethical.

This is a fascinating new review of upper neck manipulation. It raises many concerns that we, on this blog, have been struggling with for years. I take the liberty of quoting a few passages which I feel are important and encourage everyone to study the report in full:

The Minister of Health, Seniors and Active Living gave direction to the Health Professions Advisory Council (“the Council”) to undertake a review related to high neck manipulation.

Specifically, the Minister directed the Council to undertake:

1) A review of the status of the reserved act in other Canadian jurisdictions,

2) A literature review related to the benefits to patients and risks to patient safety associated with the procedure, and

3) A jurisprudence review or a review into the legal issues that have arisen in Canada with respect to the performance of the procedure that touch upon the risk of harm to a patient.

In addition, the Minister requested the Council to seek written input on the issue from:

  • Manitoba Chiropractic Stroke Survivors
  • Manitoba Chiropractic Association
  • College of Physiotherapists of Manitoba
  • Manitoba Naturopathic Association
  • College of Physicians and Surgeons of Manitoba
  • other relevant interested parties as determined by the Council

… The review indicated that further research is required to:

  • strengthen evidence for the efficacy of cervical spinal manipulations (CSM) as a treatment for neck pain and headache, “as well as for other indications where evidence currently does not exist (i.e., upper back and should/arm pain, high blood pressure, etc.)”
  • establish safety and efficacy of CSM in infants and children
  • assess the risk versus benefit in consideration of using HVLA cervical spine manipulation, which also involve cost-benefit analyses that compare CSM to other standard treatments.

… the performance of “high neck manipulation” or cervical spine manipulation does present a risk of harm to patients. This risk of harm must be understood by both the patient and the practitioner.

Both the jurisprudence review and the research literature review point to the need for the following actions to mitigate the risk of harm associated with the performance of cervical spine manipulation:

  • Action One: Ensure that the patient provides written informed consent prior to initiating treatment which includes a discussion about the risk associated with cervical spine manipulation.
  • Action Two: Provide patients with information to assist in the early recognition of a serious adverse event.

There has been a flurry of legal actions against manufacturers of homeopathic products (mostly) in the US. Many of these cases seem to settle out of court which means that we hardly hear about them. Of those that go to court, most are being won by the plaintiffs, but unfortunately some are also lost.

The recent case of Allen v. Hyland’s, Inc. is such an incidence. The US lawyer Robert G Knaier has analysed this case in detail and recently published a paper about it. The article is fascinating and well worth reading in full.

Here I take the liberty to show you a (shorted) section of Knaier’s paper where he asks what went wrong:

… How did a jury decide that Hyland’s did not misrepresent the efficacy of its products? Surely, the court’s instruction that Hyland’s would be liable only if the plaintiffs proved homeopathy “cannot work” contributed to the result. So long as defense experts were able to propose ways that homeopathy might work, the jury was left with the difficult decision—for laypersons, in any event—of rejecting that testimony.

But should the jury ever have been put in the position of having to make that choice? Should the defense experts ever have been allowed to testify? Had the court in Allen granted the plaintiffs’ motions to exclude those experts, the case likely would have ended with a settlement. Without the ability to put on evidence supporting its products, Hyland’s may very well have recognized that it had no realistic chance of prevailing at trial. But the court denied those motions.

In this respect, the court erred. There can be little doubt that expert testimony in support of the efficacy of homeopathy fails tests of admissibility. Consider the Federal Rules of Evidence and the factors that courts should evaluate under Daubert and its progeny. Is testimony that homeopathy is effective “the product of reliable principles and methods”?

In other words, does it have a “reliable foundation”? Is “the reasoning or methodology underlying [it] . . . scientifically valid”?  As explained above, homeopathy’s core principles—provings, like cures like, and the law of minimum dose—are based on little more than Samuel Hahnemann’s late eighteenth-century speculations. They were not developed through, nor have they been validated by, controlled scientific studies… the principles and efficacy of homeopathy have been “tested” and “subjected to peer review and publication” — but they have consistently failed those tests and the scrutiny of that review process… Indeed, the FDA has stated that it simply is “not aware of scientific evidence to support homeopathy as effective.”

Thus, homeopathy’s “rate of error” is known, and far from gaining “general acceptance” in the scientific and medical community, it has gained near-universal condemnation. The defense of homeopathy, in some respects, presents a classic example of “unjustifiably extrapolat[ing] from an accepted premise to an unfounded conclusion.”  Advocates extrapolate from the efficacy of vaccines that similia similibus currentur has a sound scientific basis, and from the concept of hormesis that providing ultralow doses is well-founded methodology. But as one contemporary skeptic has explained, unlike homeopathic remedies, vaccines actually “contain measurable numbers of antigen molecules,” and “act by well-understood scientific mechanisms”; and hormesis, even in the limited circumstances in which it appears to operate, “describes a response to a low dose, not to no dose.”  As Martin Gardner noted many decades ago, the defense of homeopathy thus begins with plausible-sounding principles, and then “exaggerate[s] them to the point of absurdity.”  In other words, it impermissibly extrapolates to “unfounded conclusion[s].”

Finally, the defense of homeopathy glaringly fails to “account for obvious alternative explanations.” Do people who take homeopathic remedies sometimes feel better? Of course they do. But studies of homeopathy have overwhelmingly concluded that the reason for this is not that homeopathy is actually efficacious, but rather because it is “the ideal placebo.” It is cheap. It has no side effects (unless, as discussed below, it is adulterated). And practitioners spend substantial time with their “patients,” thus encouraging psychosomatic effects.

In the end, advocates of homeopathy may have little to stand on other than that many people—including some “experts” who would gladly be paid to testify—inexplicably seem to believe that it works. But this will not do. That homeopathy has many believers does not validate it as a scientifically sound “field of expertise,” or color it, against nearly 200 years of evidence to the contrary, as one “known to reach reliable results for the type of opinion the expert would give.”  As our Supreme Court perhaps most saliently observed, “general acceptance” of a principle cannot “help show that an expert’s testimony is reliable where the discipline itself lacks reliability.” As the Court explained, general acceptance of “principles of astrology or necromancy,” for example, would not transform those subjects into appropriately reliable subjects of expert testimony.  The Court could easily have added homeopathy to that list.

Thus, in allowing the jury to receive testimony about the principles of homeopathy—not as a matter of historic curiosity, but as a matter of scientific validity—the Allen court arguably abdicated its gatekeeping responsibility to screen out unreliable expert testimony. By permitting “experts” to testify in favor of a field the bases of which defy basic principles of biology, chemistry, and physics — indeed, in some respects “basic logical principles” — the “integrity and fairness of the trial process” was compromised.

END OF QUOTE

I fully agree with Knaier. Allowing the ‘flat earth society’ to present to a court their views about the shape of our planet, while instructing the jury that they must accept them as ‘evidence’ (unless the plaintiff can prove it to be untrue) cannot be the right way forward. In fact, it is a method of preventing progress. Following this logic, I cannot imagine the proponents of any absurdity – however ridiculous – to not be victorious in court.

Knaier’s ultimate conclusion is, I think correct: “Trial courts have robust power and clear responsibility to preclude litigants from introducing irrelevant and unreliable evidence in support of purportedly scientific claims… To the extent that courts continue abdicating their evidentiary gatekeeping role in this way, they may contribute to a waste of time and resources, financial harm to consumers, and risks to public health. But to the extent that litigants and courts strengthen their spines in this regard, take seriously the dangers of unfounded expert testimony, and make genuine efforts to seek and grant its exclusion, they might contribute to the health and well-being of both the courts and those who turn to them for help.”

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